title: Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)

acronym: TRIOCAPI

summary: Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.

ReferenceCitation: Rozé JC, Cambonie G, Le Thuaut A, Debillon T, Ligi I, Gascoin G, Patkai J, Beuchee A, Favrais G, Flamant C, Durrmeyer X, Clyman R. Effect of Early Targeted Treatment of Ductus Arteriosus with Ibuprofen on Survival Without Cerebral Palsy at 2 Years in Infants with Extreme Prematurity: A Randomized Clinical Trial. J Pediatr. 2021 Jun;233:33-42.e2. doi: 10.1016/j.jpeds.2020.12.008. Epub 2020 Dec 9.

family: Rozé

full_name: Jean-Christophe Rozé

given: Jean-Christophe

family: Cambonie

full_name: Gilles Cambonie

given: Gilles

family: Le Thuaut

full_name: Aurelie Le Thuaut

given: Aurelie

family: Debillon

full_name: Thierry Debillon

given: Thierry

family: Ligi

full_name: Isabelle Ligi

given: Isabelle

family: Gascoin

full_name: Geraldine Gascoin

given: Geraldine

family: Patkai

full_name: Juliana Patkai

given: Juliana

family: Beuchee

full_name: Alain Beuchee

given: Alain

family: Favrais

full_name: Geraldine Favrais

family: Flamant

full_name: Cyril Flamant

given: Cyril

family: Durrmeyer

full_name: Xavier Durrmeyer

given: Xavier

family: Clyman

full_name: Ronald Clyman

given: Ronald

journal_name: The Journal of Pediatrics

ReferenceCitation: Mitra S, Scrivens A, von Kursell AM, Disher T. Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants. Cochrane Database Syst Rev. 2020 Dec 10;12:CD013278. doi: 10.1002/14651858.CD013278.pub2.

name: Departments of Pediatrics, Community Health & Epidemiology; Dalhousie University & IWK Health Centre; Halifax Canada

family: Mitra

full_name: Souvik Mitra

given: Souvik

name: Neonatal Care Unit; Oxford University Hospitals NHS Foundation Trust; Oxford UK

family: Scrivens

full_name: Alexandra Scrivens

given: Alexandra

name: Community Health and Epidemiology; Dalhousie University; Halifax Canada

family: von Kursell

full_name: Adelaide M von Kursell

given: Adelaide M

name: Evidence Synthesis and Data Analytics; EVERSANA Inc; Sydney Canada

family: Disher

full_name: Tim Disher

given: Tim

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Nantes University Hospital

location_facility: University Hospital (AP-HP Groupe hospitalier)


title: Efficacy of Sacral Nerve Modulation in Severe Refractory Constipation

acronym: CONSTIMOD

summary: Subjects with refractory chronic constipation are offered two conventional therapeutic strategies: either medical treatment, either surgery (in the case of medication failure). Nevertheless, a procedure less invasive than surgery could be an alternative strategy: the sacral nerve modulation. This procedure consists in stimulating the nerves which control the contractions of the colon and so the defecation phenomenon. Several open trials have suggested that sacral nerve modulation may be effective in reducing constipation and related symptoms. The aim of this randomized clinical trial is to assess the efficacy of the sacral nerve stimulation in patients with constipation.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Zerbib F, Siproudhis L, Lehur PA, Germain C, Mion F, Leroi AM, Coffin B, Le Sidaner A, Vitton V, Bouyssou-Cellier C, Chene G; CONSTIMOD study investigators. Randomized clinical trial of sacral nerve stimulation for refractory constipation. Br J Surg. 2017 Feb;104(3):205-213. doi: 10.1002/bjs.10326. Epub 2016 Oct 25.

name: Department of Gastroenterology, Bordeaux University Hospital, and Université de Bordeaux and Institut National de la Santé et de la Recherche Médicale (INSERM) CIC 1401, Bordeaux, France

family: Zerbib

full_name: F Zerbib

given: F

sequence: first

name: Department of Gastroenterology, Rennes University Hospital, and Université de Rennes, Rennes, France

family: Siproudhis

full_name: L Siproudhis

given: L

sequence: additional

name: Institut des Maladies de l'Appareil Digestif, Nantes University Hospital, Nantes, France

family: Lehur

full_name: P-A Lehur

given: P-A

name: Clinical Epidemiology Unit, and Bordeaux University Hospital and INSERM CIC 1401-EC, Bordeaux, France

family: Germain

full_name: C Germain

given: C

name: Department of Digestive Physiology, Lyon University Hospital, and Université Claude Bernard, Lyon, France

family: Mion

full_name: F Mion

name: Department of Digestive and Urinary Physiology, Rouen University Hospital, and Université de Rouen, Rouen, France

family: Leroi

full_name: A-M Leroi

given: A-M

name: Department of Gastroenterology, Louis Mourier University Hospital, Assistance Publique – Hôpitaux de Paris, Colombes, and Université Denis Diderot Paris 7, Paris, France

family: Coffin

full_name: B Coffin

given: B

name: Department of Gastroenterology, Limoges University Hospital, Limoges, France

family: Le Sidaner

full_name: A Le Sidaner

given: A

name: Department of Gastroenterology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, and Plateforme d'Interface Clinique, CRN2M, Unité Mixte de Recherche 7286, and Aix Marseille Université, Marseille, France

family: Vitton

full_name: V Vitton

given: V

family: Bouyssou-Cellier

full_name: C Bouyssou-Cellier

family: Chene

full_name: G Chene

given: G

family: Simon

full_name: M Simon

given: M

family: Denost

full_name: Q Denost

given: Q

family: Lepicard

full_name: P Lepicard

given: P

family: Meurette

full_name: G Meurette

family: Wyart

full_name: V Wyart

family: Kubis

full_name: C Kubis

family: Roman

full_name: S Roman

given: S

family: Damon

full_name: H Damon

given: H

family: Barth

full_name: X Barth

given: X

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

location_facility: Service d'exploration fonctionnelle digestive -Hospices Civils de Lyon

location_facility: Service de Chirurgie générale - CHU de Grenoble

location_facility: Service d'hépato-gastroentérologie - CHU estaing

location_facility: Service d'hépato-gastroentérologie et oncologie digestive

location_facility: Service de gastroentérologie - hopital nord -AP-HM

location_facility: Service de physiologie digestive, urinaire, respiratoire et sportive - CHU de rouen

location_facility: : Clinique de chirurgie digestive et endocrinienne. Institut des Maladies de l'Appareil Digestif (IMAD

location_facility: Service d'hépato-gastroentérologie et explorations fonctionnelles digestives - CHU de Tours


type: Other Identifier

title: A Phase III Randomized, Multicenter, Two Arms Double-blind Trial Versus Placebo, Evaluating the Interest of a Dietary Supplementation With Docosahexaenoic Acid (DHA) During Chemotherapy for Metastatic Breast Cancer

acronym: DHALYA

summary: The aim of this study is to increase, by DHA-induced chemosensitization, the activity of anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a nutritional approach with marin-derived PolyUnsaturated Fatty Acids (PUFA).

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Tours

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

location_facility: Centre Hospitalier Départemental Les Oudairies

intervention_type: Dietary Supplement

lead_sponsor_type: academique

status_simplified: Unknown


intervention_type: Drug

status: Active, not recruiting

lead_sponsor: UNICANCER

acronym: PREDICTOR

location_facility: Institut de cancérologie de l'Ouest - Site Paul Papin

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

study_completion_date_type: Anticipated

source: euctr

title: Multi-centric Randomized Phase II Study of Pre-operative Afatinib (BIBW2992) Aiming at Identifying Predictive and Pharmacodynamic Biomarkers of Biological Activity and Efficacy in Untreated Non-metastatic Head and Neck Squamous Cell Carcinoma Patients

summary: The purpose of this study is to identify predictive and pharmacodynamic biomarkers of activity and efficacy of pre-operative Afatinib (BIBW2992) in untreated non-metastatic head and neck squamous cell carcinoma patients

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter Phase IB Dose Escalation Study to Evaluate the Safety, Feasibility and Efficacy of the Torisel-Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (T-R-CHOP), Torisel-Rituximab-Fludarabine-Cyclophosphamide (T-R-FC) and Torisel-Rituximab-Aracytine High Dose-Dexamethasone (T-R-DHA) for the Treatment of Patients in Relapsed/Refractory Mantle Cell Lymphoma

acronym: T³

summary:
This is a multicenter, open label, three arms, Phase IB study.

A dose escalation phase of Temsirolimus (Torisel™) administered in intravenous (IV) at day 2, day 8 and day 15 in combination with three chemotherapies regimens for patients in relapsed/refractory Mantle Cell Lymphoma (MCL):

Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks for 6 cycles,
Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks for 6 cycles,
Rituximab-Aracytine high dose-Dexamethasone (R-DHA) administered every 4 weeks for 6 cycles.

study_start_date_type: Actual

design_allocation: Non-Randomized

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Groupe hospitalier Sud Hôpital Haut-Lévêque

status_simplified: Completed


title: Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study

summary: The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.

ReferenceCitation: Canis MJ, Triopon G, Daraï E, Madelenat P, LeVêque J, Panel P, Fernandez H, Audebert A, Descamps P, Castaing N, Roman H, Fauconnier A, Benifla JL. Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH™. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:42-7. doi: 10.1016/j.ejogrb.2014.03.020. Epub 2014 Apr 8.

family: Canis

full_name: Michel J. Canis

given: Michel J.

family: Triopon

full_name: Grégory Triopon

given: Grégory

family: Daraï

full_name: Emile Daraï

given: Emile

family: Madelenat

full_name: Patrick Madelenat

given: Patrick

family: LeVêque

full_name: Jean LeVêque

given: Jean

family: Panel

full_name: Pierre Panel

given: Pierre

family: Fernandez

full_name: Hervé Fernandez

given: Hervé

family: Audebert

full_name: Alain Audebert

given: Alain

family: Descamps

full_name: Philippe Descamps

given: Philippe

family: Castaing

full_name: Nicolas Castaing

given: Nicolas

full_name: Horace Roman

given: Horace

family: Fauconnier

full_name: Arnaud Fauconnier

given: Arnaud

family: Benifla

full_name: Jean Louis Benifla

given: Jean Louis

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Obstetrics & Gynecology and Reproductive Biology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Medtronic - MITG

location_facility: Béclère Hospital (Public Assistance of Paris Hospital)

location_facility: Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital)

location_facility: TENON Hospital (Public Assistance of Paris Hospital)

location_facility: TROUSSEAU Hospital (Public Assistance of Paris Hospital)

intervention_type: Other


title: Multicentre Randomized Open-label Trial to Compare Efficacy and Tolerance of Corticosteroids and IVIg in Patients With Chronic Inflammatory Demyelinating Polyneuropathy on a One Year Follow up

acronym: PRNC

summary: Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a challenge because disease may generate important disability in patients including young adults. Randomized trials showed that corticosteroids, plasma exchanges and intravenous immunoglobulin (IVIg) can reduce impairment on a short term period but the treatment of a chronic disease doesn't agree with it. Corticosteroids and IVIg are the first line CIDP treatments. No study permits to demonstrate the superiority of one treatment to the other. Long term adverse effects of corticosteroids and IVIg cost are the respective limitation of their use. The investigators scheduled to recruit 40 CIDP patients in 23 French centres to receive either 0,8mg/kg/day of prednisone progressively tapered over 6 months or a monthly 2g/kg cure of IVIg during 6 months. Patients will be followed during 6 months after the treatment.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Nancy
Chu Marseille
Chu Dijon
Chu Strasbourg
CHU Clermont-Ferrand
Hôpital Neurologique de Lyon
Chu Nantes
Chu Saint-Etienne
CHU Grenoble
CHU Nice
Centre hospitalier de Valence


title: Evaluation of Electrostimulation Program During Dialysis Sessions in Chronic Renal Failure Patients

acronym: EMS-Dialyse

summary:
Sport improves quality of life and health, decreasing cardiovascular risks and increasing effort tolerance. Chronic renal failure (CRF) induces many clinical and biological complications leading to less effort tolerance (strength and endurance). Renal failure patients got also many cardiovascular risks : sedentarily lifestyle, hypertension (HTA), diabetes, neuropathies, bone disorders, depression and sedentarity due to dialysis sessions. Moreover, dialysis sessions three times a week induce the spiral of deconditioning. In order to counteract this, sport should be encourage in this specific hemodialysis population.

The aim of this study is to evaluate electrostimulation program during dialysis sessions for 3 months. Evaluation will be done using the Test of 6-minute walk (6MWT).

Secondary aims will be evaluated:

Muscular strength and quadriceps diameter
Equilibrium
Quality of life.
Strength developed during maximal exercise test in a subgroup (patient undergoing dialysis in Rennes center, about 40% of the total population)
Nutritional intakes (quantitative and qualitative evaluation)

lead_sponsor: Rennes University Hospital

location_facility:
Cholet Hospital
AUB Santé Fougères
Rennes University Hospital
AUB Santé Rennes
AUB Santé Brest
AUB Santé Lorient
AUB Santé Morlaix
AUB Santé Quimper
Nantes University Hospital
ECHO Nantes
AUB Santé Montgermont

intervention_type: Device


title: Study of the Effectiveness and the Tolerance of Intraprostatic A-botulinic Toxin Injection, in the Treatment of Symptomatic Benign Prostate Hypertrophy.

acronym: PROTOX

summary:
BPH is very common in elderly men, it is a stromal as well as epithelial invasion of the prostatic gland. Due to an imbalance between growth and apoptosis cellular mechanisms that are not fully elucidated. It is the same for symptomatology and urodynamic obstruction without clear identification of the part which is due to static phenomena (volume increase) and dynamic reports (α 1-receptor action). That explains the multiplicity of treatments and the difficulty of therapeutic indications between monitoring, medical treatment, and surgical operation. Experimental studies of BONT-A intra prostatic injection on animal and human models, have shown efficacy in BPH cell apoptosis, decrease in cell growth and decline in the number of adrenergic α1 receptors.

Many studies in humans show therapeutic efficacy leading to a possible use of BONT-A as mini invasive treatment of symptomatic BPH, as an alternative to medical or surgical treatment.

PROTOX study proposes to evaluate tolerance and effectiveness of the intra-prostatique BONT-A injection in the treatment of symptomatic BPH.

ReferenceType: background

ReferenceCitation: Costa P, Ben Naoum K, Boukaram M, Wagner L, Louis JF. [Benign prostatic hyperplasia (BPH): prevalence in general practice and practical approach of French general practitioners. Results of a study based on 17,953 patients]. Prog Urol. 2004 Feb;14(1):33-9. French.

ReferenceCitation: Rhodes PR, Krogh RH, Bruskewitz RC. Impact of drug therapy on benign prostatic hyperplasia-specific quality of life. Urology. 1999 Jun;53(6):1090-8. Review.

ReferenceCitation: Isaacs JT, Coffey DS. Etiology and disease process of benign prostatic hyperplasia. Prostate Suppl. 1989;2:33-50. Review.

ReferenceCitation: Chute CG, Stephenson WP, Guess HA, Lieber M. Benign prostatic hyperplasia: a population-based study. Eur Urol. 1991;20 Suppl 1:11-7.

ReferenceCitation: McConnell JD. The pathophysiology of benign prostatic hyperplasia. J Androl. 1991 Nov-Dec;12(6):356-63. Review.

ReferenceCitation: Barrack ER, Bujnovszky P, Walsh PC. Subcellular distribution of androgen receptors in human normal, benign hyperplastic, and malignant prostatic tissues: characterization of nuclear salt-resistant receptors. Cancer Res. 1983 Mar;43(3):1107-16.

ReferenceCitation: Marcelli M, Shao TC, Li X, Yin H, Marani M, Denner L, Teng B, Cunningham GR. Induction of apoptosis in BPH stromal cells by adenoviral-mediated overexpression of caspase-7. J Urol. 2000 Aug;164(2):518-25.

ReferenceCitation: Colombel M, Vacherot F, Diez SG, Fontaine E, Buttyan R, Chopin D. Zonal variation of apoptosis and proliferation in the normal prostate and in benign prostatic hyperplasia. Br J Urol. 1998 Sep;82(3):380-5.

ReferenceCitation: Radlmaier A, Eickenberg HU, Fletcher MS, Fourcade RO, Reis Santos JM, van Aubel OG, Bono AV. Estrogen reduction by aromatase inhibition for benign prostatic hyperplasia: results of a double-blind, placebo-controlled, randomized clinical trial using two doses of the aromatase-inhibitor atamestane. Atamestane Study Group. Prostate. 1996 Oct;29(4):199-208.

ReferenceCitation: Frick J. [Pathophysiology of benign prostatic hyperplasia]. Wien Med Wochenschr. 1996;146(8):158-60. Review. German.

ReferenceCitation: Hieble JP, Boyce AJ, Caine M. Comparison of the alpha-adrenoceptor characteristics in human and canine prostate. Fed Proc. 1986 Oct;45(11):2609-14.

ReferenceCitation: Hieble JP, Ruffolo RR Jr. The use of alpha-adrenoceptor antagonists in the pharmacological management of benign prostatic hypertrophy: an overview. Pharmacol Res. 1996 Mar;33(3):145-60. Review.

ReferenceCitation: Madersbacher S, Alivizatos G, Nordling J, Sanz CR, Emberton M, de la Rosette JJ. EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol. 2004 Nov;46(5):547-54.

ReferenceCitation: Wilt TJ, Ishani A, Rutks I, MacDonald R. Phytotherapy for benign prostatic hyperplasia. Public Health Nutr. 2000 Dec;3(4A):459-72.

ReferenceCitation: Wilt TJ, Ishani A, Stark G, MacDonald R, Lau J, Mulrow C. Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA. 1998 Nov 11;280(18):1604-9. Erratum in: JAMA 1999 Feb 10;281(6):515.

ReferenceCitation: Zhu YS, Imperato-McGinley JL. 5alpha-reductase isozymes and androgen actions in the prostate. Ann N Y Acad Sci. 2009 Feb;1155:43-56. doi: 10.1111/j.1749-6632.2009.04115.x. Review.

ReferenceCitation: Crawford ED, Wilson SS, McConnell JD, Slawin KM, Lieber MC, Smith JA, Meehan AG, Bautista OM, Noble WR, Kusek JW, Nyberg LM, Roehrborn CG; MTOPS RESEARCH Group. Baseline factors as predictors of clinical progression of benign prostatic hyperplasia in men treated with placebo. J Urol. 2006 Apr;175(4):1422-6; discussion 1426-7.

ReferenceCitation: Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology. 1996 Sep;48(3):398-405.

ReferenceCitation: Desgrandchamps F. [Combination therapy in benign prostatic hyperplasia (BPH)]. Ann Urol (Paris). 2004 Dec;38 Suppl 2:S24-8. Review. French.

ReferenceCitation: Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6.

ReferenceCitation: Robert G, Descazeaud A, Karsenty G, Saussine C, Azzouzi AR, de la Taille A, Desgrandchamps F, Faix A, Fourmarier M, Georget A, Benard A, Barry Delongchamps N. Prostatic injection of botulinum toxin is not inferior to optimized medical therapy in the management of lower urinary tract symptoms due to benign prostatic hyperplasia: results of a randomized clinical trial. World J Urol. 2018 Jun;36(6):921-929. doi: 10.1007/s00345-018-2193-y. Epub 2018 Jan 30.

family: Robert

full_name: Grégoire Robert

given: Grégoire

family: Descazeaud

full_name: Aurélien Descazeaud

given: Aurélien

family: Karsenty

full_name: Gilles Karsenty

given: Gilles

family: Saussine

full_name: Christian Saussine

given: Christian

family: Azzouzi

full_name: Abdel-Rahmène Azzouzi

given: Abdel-Rahmène

family: de la Taille

full_name: Alexandre de la Taille

given: Alexandre

family: Desgrandchamps

full_name: François Desgrandchamps

given: François

family: Faix

full_name: Antoine Faix

given: Antoine

family: Fourmarier

full_name: Marc Fourmarier

given: Marc

family: Georget

full_name: Aurore Georget

given: Aurore

family: Benard

full_name: Antoine Benard

family: Barry Delongchamps

full_name: Nicolas Barry Delongchamps

journal_name: World Journal of Urology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'Urologie - APHP Hôpital Saint Louis - 1, avenue Claude-vellefaux

location_facility: Service d'Urologie - CH du Pays d'Aix - Avenue de Tamaris

location_facility: Service d'Urologie - APHP Hopital Cochin - 27, Rue du faubourg Saint Jacques

location_facility: Service d'urologie - Hôpital de la Conception - 147 boulevard Baille

location_facility: Service d'Urologie, CHU d'Angers 4, rue Larrey

location_facility: Service d'urologie, Groupe Hospitalier Pellegrin, place Amélie Raba Léon

location_facility: Service d'urologie - CHU de Limoges - 2, avenue Martin Luther King

location_facility: Service d'Urologie - Hospices Civls de Lyon - 165 chemin du grand Revoyet

location_facility: Service d'urologie - CHRU Strasbourg - BP 426

location_facility: Service d'urologie - APHP Henri Mondor - 51, avenue du Maréchal de Lattre de Tassigny


title: Phase II Study: Assessing the Feasibility and Morbidity of Skin Sparing Mastectomy and Immediate Breast Reconstruction With Latissimus Dorsi Flap After Neoadjuvant Chemotherapy and Radiotherapy in Invasive Breast Carcinoma.

acronym: M-RIC

summary: The aim of the study is to evaluate the feasibility and morbidity of skin sparing mastectomy and immediate breast reconstruction with latissimus dorsi flap after neoadjuvant chemotherapy and radiotherapy in invasive breast carcinoma.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Clinique Clementville

location_facility: Groupe Hospitalier Mutualiste Clinique les Eaux Claires

intervention_type: Procedure


title: LUng Cancer Screening With Low-dose Computed Tomography in a Population Exposed to Occupational Lung Carcinogens

acronym: LUCSO

summary:
The good clinical practice guidelines for the surveillance of workers after occupational exposure to lung carcinogens were approved by the Haute Autorité de la Santé (French National Authority for Health) and the Institut National du Cancer (French National Cancer Institute) in December 2015 and one recommendation of these guidelines concerns the setting-up of a trial of low-dose chest computed tomography (CT) lung cancer screening in subjects occupationally exposed to lung carcinogens at high-risk of lung cancer (Expert consensus).

In LUCSO study, the investigators propose to conduct, under strictly defined conditions, a feasibility study of lung cancer screening in a population defined as being at high risk of lung cancer according to these good clinical practice guidelines. This population consists of smokers, aged from 55 to 74 years, currently or previously exposed to International Agency for Research on Cancer lung group 1 lung carcinogens.

The primary objective of this study is to evaluate the complex organization of lung cancer screening in the target population. This evaluation will focus on the following indicators:

Screening activity indicator: screening coverage rate over two years
Test quality indicator: validity of self-administered questionnaires to target the high-risk population
Examination quality indicator: lung cancer detection rate, lung cancer detection rates by stage, validity of low-dose chest CT scan
Follow-up indicator: smoking cessation rate, mortality rate This trial will be conducted in 8 French departments, by six reference centers specialized in occupational health (SRC).

In view of the exploratory nature of this trial, it is proposed to initially test the feasibility and acceptability of lung cancer screening sequentially over the first two years (Phase 1: 2021-2023, 24 months) in only two SRC (Val-de-Marne and Gironde).

The trial will be conducted in several steps:

Identification of subjects currently or previously occupationally exposed to lung carcinogens by a screening invitation letter sent by Departmental Cancer Screening Centers to subjects aged from 55 to 74 years.
Evaluation of occupational exposure to lung carcinogens
Evaluation of the lung cancer risk level and verification of eligibility
Screening procedure: Chest CT scans will be performed by centers specialized in chest imaging
Lung cancer follow-up when an abnormality suggestive of lung cancer is demonstrated.

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Delva F, Laurent F, Paris C, Belacel M, Brochard P, Bylicki O, Chouaïd C, Clin B, Dewitte JD, Le Denmat V, Gehanno JF, Lacourt A, Margery J, Verdun-Esquer C, Mathoulin-Pélissier S, Pairon JC. LUCSO-1-French pilot study of LUng Cancer Screening with low-dose computed tomography in a smokers population exposed to Occupational lung carcinogens: study protocol. BMJ Open. 2019 Mar 23;9(3):e025026. doi: 10.1136/bmjopen-2018-025026.

family: Delva

full_name: Fleur Delva

given: Fleur

family: Laurent

full_name: François Laurent

family: Paris

full_name: Christophe Paris

given: Christophe

family: Belacel

full_name: Milia Belacel

given: Milia

family: Brochard

full_name: Patrick Brochard

given: Patrick

family: Bylicki

full_name: Olivier Bylicki

given: Olivier

family: Chouaïd

full_name: Christos Chouaïd

given: Christos

family: Clin

full_name: Benedicte Clin

given: Benedicte

family: Dewitte

full_name: Jean-Dominique Dewitte

given: Jean-Dominique

family: Le Denmat

full_name: Véronique Le Denmat

given: Véronique

family: Gehanno

full_name: Jean-François Gehanno

given: Jean-François

family: Lacourt

full_name: Aude Lacourt

given: Aude

family: Margery

full_name: Jacques Margery

given: Jacques

family: Verdun-Esquer

full_name: Catherine Verdun-Esquer

given: Catherine

family: Mathoulin-Pélissier

full_name: Simone Mathoulin-Pélissier

given: Simone

family: Pairon

full_name: Jean-Claude Pairon

given: Jean-Claude

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

title: LUCSO-1—French pilot study of LUng Cancer Screening with low-dose computed tomography in a smokers population exposed to Occupational lung carcinogens: study protocol

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire de Rouen


title: Impact of Blocked Cysteinyl Leukotriene Pathway on Endothelial Function in Patients With Obstructive Sleep Apnea Syndrome: Multicenter Randomized Placebo Controlled Crossover Trial

acronym: MONTSAS

summary: This study compares the effect of Montelukast vs Placebo on Flow Mediated Dilatation of the Brachial Artery (FMD) in patients with obstructive sleep apnea syndrome.

ReferenceCitation: Ingelsson E, Yin L, Bäck M. Nationwide cohort study of the leukotriene receptor antagonist montelukast and incident or recurrent cardiovascular disease. J Allergy Clin Immunol. 2012 Mar;129(3):702-707.e2. doi: 10.1016/j.jaci.2011.11.052. Epub 2012 Jan 12.

ReferenceCitation: Goldbart AD, Greenberg-Dotan S, Tal A. Montelukast for children with obstructive sleep apnea: a double-blind, placebo-controlled study. Pediatrics. 2012 Sep;130(3):e575-80. doi: 10.1542/peds.2012-0310. Epub 2012 Aug 6.

ReferenceCitation: Cereza G, Garcia Doladé N, Laporte JR. Nightmares induced by montelukast in children and adults. Eur Respir J. 2012 Dec;40(6):1574-5. doi: 10.1183/09031936.00092812.

ReferenceCitation: Marchand M-S, Jonville-Béra A-P, Autret-Leca E. [Psychiatric disorders associated with montelukast: data from the National Pharmacovigilance Database]. Arch pédiatrie organe Off la Sociéte Fr pédiatrie [Internet]. 2013 [cited 2016 Jun 14];20:269-73. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23375423

ipd_sharing: Undecided

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital
Annecy Genevois Hospital
Métropole Savoie Hospital
University Hospital Grenoble


title: Predictive Factors for Chronic Rejection in Lung Transplant Recipients: COLT Study

acronym: COLT

summary: Obliterative Bronchiolitis (OB) is the major cause of long-term lung allograft loss for patients with end stage pulmonary diseases like cystic fibrosis. Numerous cells and proteins are implicated in this process, which have never been studied prospectively in a multicentric longitudinal cohort. The aim of this study is to detect predictive risk factors of OB through a national multicentric cohort of 500 newly transplanted recipients (COLT). COLT will consist in a large database, associated with a recipient bio-collection, and specific projects using these resources. COLT will aggregate all the 11 French centres of pulmonary transplantation. Patient will be followed-up during 5 years. Blood samples will be obtained. Induced sputum, bronchoalveolar lavage fuid, exhaled breath condensate and trans bronchial biopsies will be also taken. T cells, known to be involved in chronic rejection will be studied, and genomic, microarray and proteomic approaches will be used to detect further predictive factors. A study on Circulating Endothelial Cells and Circulating Endothelial Progenitors is also realised from blood samples. COLT will prove molecular markers to be predictive of early OB, before the development of severe airway obstruction and will allow the identification of patients at high risk of OB. COLT will identify potential targets for future treatments of OB. This collaborative project makes research and clinical teams working together, and creates the conditions of a long term network, extendable to other laboratories with new projects and additional European transplant centres.

ReferenceCitation: Durand M, Lacoste P, Danger R, Jacquemont L, Brosseau C, Durand E, Tilly G, Loy J, Foureau A, Royer PJ, Tissot A, Roux A, Reynaud-Gaubert M, Kessler R, Mussot S, Dromer C, Brugière O, Mornex JF, Guillemain R, Claustre J, Degauque N, Magnan A, Brouard S; COLT and SysCLAD Consortia. High circulating CD4(+)CD25(hi)FOXP3(+) T-cell sub-population early after lung transplantation is associated with development of bronchiolitis obliterans syndrome. J Heart Lung Transplant. 2018 Jun;37(6):770-781. doi: 10.1016/j.healun.2018.01.1306. Epub 2018 Mar 20.

family: Durand

full_name: Maxim Durand

given: Maxim

family: Lacoste

full_name: Philippe Lacoste

given: Philippe

family: Danger

full_name: Richard Danger

given: Richard

family: Jacquemont

full_name: Lola Jacquemont

given: Lola

family: Brosseau

full_name: Carole Brosseau

given: Carole

full_name: Eugénie Durand

given: Eugénie

family: Tilly

full_name: Gaelle Tilly

given: Gaelle

family: Loy

full_name: Jennifer Loy

given: Jennifer

family: Foureau

full_name: Aurore Foureau

family: Royer

full_name: Pierre-Joseph Royer

given: Pierre-Joseph

family: Tissot

full_name: Adrien Tissot

given: Adrien

family: Roux

full_name: Antoine Roux

given: Antoine

family: Reynaud-Gaubert

full_name: Martine Reynaud-Gaubert

given: Martine

family: Kessler

full_name: Romain Kessler

given: Romain

family: Mussot

full_name: Sacha Mussot

given: Sacha

family: Dromer

full_name: Claire Dromer

given: Claire

family: Brugière

full_name: Olivier Brugière

family: Mornex

full_name: Jean François Mornex

given: Jean François

family: Guillemain

full_name: Romain Guillemain

family: Claustre

full_name: Johanna Claustre

given: Johanna

family: Degauque

full_name: Nicolas Degauque

given: Nicolas

family: Magnan

full_name: Antoine Magnan

family: Brouard

full_name: Sophie Brouard

given: Sophie

journal_name: The Journal of Heart and Lung Transplantation

title: High circulating CD4 + CD25 hi FOXP3 + T-cell sub-population early after lung transplantation is associated with development of bronchiolitis obliterans syndrome

ReferenceCitation: Benmerad M, Slama R, Botturi K, Claustre J, Roux A, Sage E, Reynaud-Gaubert M, Gomez C, Kessler R, Brugière O, Mornex JF, Mussot S, Dahan M, Boussaud V, Danner-Boucher I, Dromer C, Knoop C, Auffray A, Lepeule J, Malherbe L, Meleux F, Nicod L, Magnan A, Pison C, Siroux V; SysCLAD consortium. Chronic effects of air pollution on lung function after lung transplantation in the Systems prediction of Chronic Lung Allograft Dysfunction (SysCLAD) study. Eur Respir J. 2017 Jan 18;49(1). pii: 1600206. doi: 10.1183/13993003.00206-2016. Print 2017 Jan.

ReferenceCitation: Pison C, Magnan A, Botturi K, Sève M, Brouard S, Marsland BJ, Ernst F, Paprotka T, Deplanche K, Fritz A, Siroux V, Boissel JP, Corris PA, Auffray C, Nicod LP; SysCLAD consortium. Prediction of chronic lung allograft dysfunction: a systems medicine challenge. Eur Respir J. 2014 Mar;43(3):689-93. doi: 10.1183/09031936.00161313.

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

repository_institution: The Pennsylvania State University - CiteSeer X

location_facility:
CHU de Marseille
Hôpital Bichat
CHU de Bordeaux
CHU de Grenoble
CHRU de Strasbourg
HEGP
CHU Nantes
Centre Chirurgical Marie Lannelongue
CHU de Lyon
Hôpital Foch
CHU de Toulouse


title: Phase II Multicenter Study Evaluating the Efficacy of Carboplatin-Etoposide Combination in Hormone-resistant Prostate Cancers With Neuroendocrine Differentiation.

summary: The aim of our study is to assess the efficacy and toxicity of a chemotherapy regimen combining carboplatin and etoposide in patients with metastatic hormone-resistant prostate cancer and neuro-endocrine differentiation. Eligible patients are treated with the combination of carboplatin AUC4 on day 1 and etoposide 100 mg/m2 on day 1, day 2 and day 3 repeated every 3 weeks for a maximum of 6 cycles. Efficacy endpoints include Prostate Specific Antigen (PSA) and neuro-endocrine marker response (defined as a 50% or greater decrease from baseline serum values), objective response rate (according to RECIST criteria), and toxicity.

ReferenceCitation: Aumüller G, Leonhardt M, Janssen M, Konrad L, Bjartell A, Abrahamsson PA. Neurogenic origin of human prostate endocrine cells. Urology. 1999 May;53(5):1041-8.

ReferenceCitation: Bonkhoff H, Stein U, Remberger K. Endocrine-paracrine cell types in the prostate and prostatic adenocarcinoma are postmitotic cells. Hum Pathol. 1995 Feb;26(2):167-70.

ReferenceCitation: Krijnen JL, Janssen PJ, Ruizeveld de Winter JA, van Krimpen H, Schröder FH, van der Kwast TH. Do neuroendocrine cells in human prostate cancer express androgen receptor? Histochemistry. 1993 Nov;100(5):393-8.

ReferenceCitation: Hansson J, Abrahamsson PA. Neuroendocrine pathogenesis in adenocarcinoma of the prostate. Ann Oncol. 2001;12 Suppl 2:S145-52. Review.

ReferenceCitation: Abrahamsson PA. Neuroendocrine differentiation in prostatic carcinoma. Prostate. 1999 May;39(2):135-48. Review.

ReferenceCitation: Oesterling JE, Hauzeur CG, Farrow GM. Small cell anaplastic carcinoma of the prostate: a clinical, pathological and immunohistological study of 27 patients. J Urol. 1992 Mar;147(3 Pt 2):804-7.

ReferenceCitation: Kreis W. Current chemotherapy and future directions in research for the treatment of advanced hormone-refractory prostate cancer. Cancer Invest. 1995;13(3):296-312. Review.

ReferenceCitation: Tannock IF, Osoba D, Stockler MR, Ernst DS, Neville AJ, Moore MJ, Armitage GR, Wilson JJ, Venner PM, Coppin CM, Murphy KC. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol. 1996 Jun;14(6):1756-64.

ReferenceCitation: Moore MJ, Osoba D, Murphy K, Tannock IF, Armitage A, Findlay B, Coppin C, Neville A, Venner P, Wilson J. Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer. J Clin Oncol. 1994 Apr;12(4):689-94.

ReferenceCitation: Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, Wiltshaw E. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989 Nov;7(11):1748-56.

ReferenceCitation: Chatelut E, Canal P, Brunner V, Chevreau C, Pujol A, Boneu A, Roché H, Houin G, Bugat R. Prediction of carboplatin clearance from standard morphological and biological patient characteristics. J Natl Cancer Inst. 1995 Apr 19;87(8):573-80.

ReferenceCitation: Maksymiuk AW, Jett JR, Earle JD, Su JQ, Diegert FA, Mailliard JA, Kardinal CG, Krook JE, Veeder MH, Wiesenfeld M, et al. Sequencing and schedule effects of cisplatin plus etoposide in small-cell lung cancer: results of a North Central Cancer Treatment Group randomized clinical trial. J Clin Oncol. 1994 Jan;12(1):70-6.

ReferenceCitation: Loehrer PJ Sr, Ansari R, Gonin R, Monaco F, Fisher W, Sandler A, Einhorn LH. Cisplatin plus etoposide with and without ifosfamide in extensive small-cell lung cancer: a Hoosier Oncology Group study. J Clin Oncol. 1995 Oct;13(10):2594-9.

ReferenceCitation: Miller AA, Herndon JE 2nd, Hollis DR, Ellerton J, Langleben A, Richards F 2nd, Green MR. Schedule dependency of 21-day oral versus 3-day intravenous etoposide in combination with intravenous cisplatin in extensive-stage small-cell lung cancer: a randomized phase III study of the Cancer and Leukemia Group B. J Clin Oncol. 1995 Aug;13(8):1871-9.

ReferenceCitation: Larive S, Bombaron P, Riou R, Fournel P, Perol M, Lena H, Dussopt C, Philip-Joet F, Touraine F, Lecaer H, Souquet PJ; Groupe Lyon-Saint Etienne d'Oncologie Thoracique. Carboplatin-etoposide combination in small cell lung cancer patients older than 70 years: a phase II trial. Lung Cancer. 2002 Jan;35(1):1-7. Review.

ReferenceCitation: Okamoto H, Watanabe K, Nishiwaki Y, Mori K, Kurita Y, Hayashi I, Masutani M, Nakata K, Tsuchiya S, Isobe H, Saijo N. Phase II study of area under the plasma-concentration-versus-time curve-based carboplatin plus standard-dose intravenous etoposide in elderly patients with small-cell lung cancer. J Clin Oncol. 1999 Nov;17(11):3540-5.

ReferenceCitation: Quoix E, Breton JL, Daniel C, Jacoulet P, Debieuvre D, Paillot N, Kessler R, Moreau L, Coëtmeur D, Lemarié E, Milleron B. Etoposide phosphate with carboplatin in the treatment of elderly patients with small-cell lung cancer: a phase II study. Ann Oncol. 2001 Jul;12(7):957-62.

ReferenceCitation: Papandreou CN, Daliani DD, Thall PF, Tu SM, Wang X, Reyes A, Troncoso P, Logothetis CJ. Results of a phase II study with doxorubicin, etoposide, and cisplatin in patients with fully characterized small-cell carcinoma of the prostate. J Clin Oncol. 2002 Jul 15;20(14):3072-80.

ReferenceCitation: Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10.

ReferenceCitation: Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-81, 1958

ReferenceType: result

ReferenceCitation: Fléchon A, Pouessel D, Ferlay C, Perol D, Beuzeboc P, Gravis G, Joly F, Oudard S, Deplanque G, Zanetta S, Fargeot P, Priou F, Droz JP, Culine S. Phase II study of carboplatin and etoposide in patients with anaplastic progressive metastatic castration-resistant prostate cancer (mCRPC) with or without neuroendocrine differentiation: results of the French Genito-Urinary Tumor Group (GETUG) P01 trial. Ann Oncol. 2011 Nov;22(11):2476-2481. doi: 10.1093/annonc/mdr004. Epub 2011 Mar 24.

family: Fléchon

full_name: A. Fléchon

given: A.

family: Pouessel

full_name: D. Pouessel

given: D.

family: Ferlay

full_name: C. Ferlay

given: C.

family: Perol

full_name: D. Perol

family: Beuzeboc

full_name: P. Beuzeboc

given: P.

family: Gravis

full_name: G. Gravis

given: G.

family: Joly

full_name: F. Joly

given: F.

family: Oudard

full_name: S. Oudard

given: S.

family: Deplanque

full_name: G. Deplanque

family: Zanetta

full_name: S. Zanetta

family: Fargeot

full_name: P. Fargeot

family: Priou

full_name: F. Priou

family: Droz

full_name: J.P. Droz

family: Culine

full_name: S. Culine

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier Départemental Les Oudairies


title: Prevalence and Impact of Depression and Anxiety in Cystic Fibrosis

summary:
The Impact of cystic fibrosis (CF) on psychological and emotional functioning has been the focus of several studies over the past 20 years. The results from a current meta-analysis indicated that depressed patients were three times more likely to be noncompliant with treatment recommendations than nondepressed patients with chronic illness.

To date, most studies of the prevalence of psychiatric symptoms have been limited by small sample size; reliance on samples of convenience that are potentially biased in term of rates of symptomatology, and measures that contain legitimate symptoms that are part of the respondent's chronic disease. Estimating the prevalence of depression and anxiety has become important as new evidence indicates that these symptoms may have a significant impact on health outcomes, including adherence to medical treatments, utilization of health care services, and rates of morbidity and mortality. More depressive the symptoms are associated with poorer lung function, and that in the absence of depression, poor lung function is minimally associated with lower patient ratings of quality of life.

The purpose of the current study is to estimate the regional, and if possible the national prevalence of depressive and anxious symptoms in children and adults with CF and parents caregivers. Patients with CF ages 14 to 17, and parents of children ages 14 to 17, will complete and depression/anxiety screening measure at a routine clinic visit. These will then be linked with demographic and medical variables reported to the CF registry and analyzed cross sectionally. Adults with CF ages 18 and older will also complete the depression / anxiety screening measure at a routine clinic visit. Efforts will be made to recruit a representative sample of patients from each clinic.

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of Pneumology - CRCM- Necker - Enfants malades Hospital (AP-HP) -

location_facility: CRCM / Service de Médecine Infantile - Hôpital d'Enfants - CHRU Nancy

location_facility: CRCM Enfants - Service de Pneumologie - Hôpital Jean Minjoz

location_facility: CRCM - Service de Pédiatrie A - American Memorial Hospital

location_facility: CRCM - Service de Pédiatrie - Pôle FEH - CHU Caen)

location_facility: CRCM - Service de Pneumologie Pédiatrique - CHU Amiens - Site Sud

location_facility: CRCM / Service de Pédiatrie _ Hôpital de Clocheville - CHRU de Tours


title: "Comparision of Diagnostic Value of Oesophagal Videocapsul (VCO) and Oeso-gastro-duodenal Fiber Endoscopy (OGDFE) for the Screening of Oesophagal Varix (OV) for Cirrhotic Patients

acronym: VCO-VO

summary: The purpose of this study is to determine the equivalence or not of diagnosis ability of oesophagal videocapsul versus oeso-gastro-duodenal fiber endoscopy in the screening of oesophagal varix.

primary_purpose: Diagnostic

ReferenceCitation: Calès P, Sacher-Huvelin S, Valla D, Bureau C, Olivier A, Oberti F, Boursier J, Galmiche JP; multicenter group VO-VCO. Large oesophageal varice screening by a sequential algorithm using a cirrhosis blood test and optionally capsule endoscopy. Liver Int. 2018 Jan;38(1):84-93. doi: 10.1111/liv.13497. Epub 2017 Jul 7.

name: Department of Liver-Gastroenterology; University Hospital; HIFIH Laboratory; UNIV Angers; Bretagne Loire University; Angers France

family: Calès

full_name: Paul Calès

given: Paul

name: Department of Gastroenterology; IMAD; CHU and UNIV Nantes; Bretagne Loire University; Nantes France

family: Sacher-Huvelin

full_name: Sylvie Sacher-Huvelin

given: Sylvie

name: Liver Unit; DHU UNITY; Beaujon Hospital; HUPNVS; APHP; INSERM UMR U1149; University Paris Diderot; Clichy France

family: Valla

full_name: Dominique Valla

given: Dominique

name: Department of Hepato-gastroenterology; CHU; Toulouse France

family: Bureau

full_name: Christophe Bureau

given: Christophe

family: Olivier

full_name: Anne Olivier

given: Anne

family: Oberti

full_name: Frédéric Oberti

given: Frédéric

family: Boursier

full_name: Jérôme Boursier

given: Jérôme

family: Galmiche

full_name: Jean Paul Galmiche

given: Jean Paul

journal_name: Liver International

ReferenceCitation: Sacher-Huvelin S, Calès P, Bureau C, Valla D, Vinel JP, Duburque C, Attar A, Archambeaud I, Benamouzig R, Gaudric M, Luet D, Couzigou P, Planche L, Galmiche JP, Coron E. Screening of esophageal varices by esophageal capsule endoscopy: results of a French multicenter prospective study. Endoscopy. 2015 Jun;47(6):486-92. doi: 10.1055/s-0034-1391393. Epub 2015 Mar 2.

name: Department of Hepatology, CHU Angers, Angers. France

name: Department of Hepato- gastroenterology, CHU Toulouse, Toulouse, France

name: Liver Unit, DHU UNITY, Hôpital Beaujon, HUPNVS, APHP; Université Paris Diderot et Inserm UMR U1149, Clichy, France

family: Vinel

full_name: Jean Vinel

given: Jean

name: Department of Gastroenterology, CHU St. Philibert, Lomme, France

family: Duburque

full_name: Clotilde Duburque

given: Clotilde

family: Attar

full_name: Alain Attar

given: Alain

name: Department of Gastroenterology, IMAD, CHU and University of Nantes, Nantes, France

family: Archambeaud

full_name: Isabelle Archambeaud

given: Isabelle

name: Department of Gastroenterology, CHU Bobigny, Paris, France

family: Benamouzig

full_name: Robert Benamouzig

given: Robert

name: Department of Gastroenterology, CHU Cochin, Paris, France

family: Gaudric

full_name: Marianne Gaudric

given: Marianne

family: Luet

full_name: Dominique Luet

name: Department of Gastroenterology, CHU Bordeaux, Bordeaux, France

family: Couzigou

full_name: Patrice Couzigou

given: Patrice

name: Department of Biostatistics, CHU Nantes, Nantes, France

family: Planche

location_facility:
CHU Angers
CH Cochin
CHU Strasbourg
CH Saint Philibert
CHU Toulouse - Purpan
CH Avicenne
CH Lyon - Herriot
Hôpital la conception
CHU Bordeaux
CH Beaujon
CHU Nantes


ReferenceCitation: Knuf M, Romain O, Kindler K, Walther U, Tran PM, Pankow-Culot H, Fischbach T, Kieninger-Baum D, Bianco V, Baine Y, Miller J. Immunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2-10-year-old children: results of an open, randomised, controlled study. Eur J Pediatr. 2013 May;172(5):601-12. doi: 10.1007/s00431-012-1924-0. Epub 2013 Jan 11.

intervention_type: Biological

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

primary_purpose: Prevention

location_country: Germany France

acronym: MenACWY-TT-081 PRI

ipd_sharing: Yes

type: EudraCT Number

title: Non-inferiority of GSK Biologicals' Meningococcal Vaccine (GSK134612) Compared to Licensed MenC-CRM197 Conjugate Vaccine in Healthy Children

summary: The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.


title: ClinicalTrial in Rectal Cancer Surgery Without Mechanical Bowel Preparation

acronym: PREPACOL

summary: The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation

ReferenceCitation: Bretagnol F, Panis Y, Rullier E, Rouanet P, Berdah S, Dousset B, Portier G, Benoist S, Chipponi J, Vicaut E; French Research Group of Rectal Cancer Surgery (GRECCAR). Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial. Ann Surg. 2010 Nov;252(5):863-8. doi: 10.1097/SLA.0b013e3181fd8ea9.

family: Bretagnol

full_name: Frederic Bretagnol

given: Frederic

family: Panis

full_name: Yves Panis

given: Yves

family: Rullier

full_name: Eric Rullier

given: Eric

family: Rouanet

full_name: Philippe Rouanet

given: Philippe

family: Berdah

full_name: Stephane Berdah

given: Stephane

family: Dousset

full_name: Bertrand Dousset

given: Bertrand

family: Portier

full_name: Guillaume Portier

given: Guillaume

family: Benoist

full_name: Stephane Benoist

family: Chipponi

full_name: Jacques Chipponi

given: Jacques

family: Vicaut

full_name: Eric Vicaut

journal_name: Annals of Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Rectal Cancer Surgery With or Without Bowel Preparation

location_facility:
Hopital Cochin
CHRU Trousseau
Institut Paoli Calmette
Hopital Ambroise Paré
CHU Purpan
Hopital Saint André
CRLC Val d'Aurelle
CHU
Hopital Nord
Hôpital Beaujon


title: Injection of Concentrated Autologous Bone-marrow (IMOCA) and Bone Union of Open Tibial Shaft Fracture: Randomized Study to Assess Efficiency of IMOCA in Addition to Standard of Care.

acronym: IMOCA

summary:
The treatment of open tibial shaft fracture is often complicated by delayed union or non-union. The objective of this study is to evaluate the efficacy of autologous concentrated bone-marrow to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention.

In a prospective, randomized, controlled, single-blind study, 186 patients with an open tibial will be randomized to receive either the standard of care (fixation by nail or external fixator and routine soft-tissue management), or the standard of care with percutaneous injection, one month after fracture, of autologous concentrated bone-marrow. Randomization will be stratified by severity of the open wound. The primary outcome measure will be the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months post-fracture.

location_facility:
UH Besançon Jean Minjoz
UH Grenoble South Hospital
UH Brest Cavale Blanche
UH Nantes Hôtel Dieu
UHTOURS
UH Pitié Salpétrière AH HP
UH Nancy Central Hospital
UH Angers
UH Clermont Ferrand Gabriel Montpied
UH Tours CHRU Trousseau
UH Grenoble Michallon Hospital


title: Phase II Two-step Radioimmunotherapy Clinical Study in Medullary Thyroid Carcinoma

acronym: RIT in MTC

summary: Phase II clinical trial assessing efficacy and toxicity of pretargeted radioimmunotherapy using anti-CEAxanti-DTPA bispecific antibody and di-DTPA-131I peptide in patients with reccurrence of medullary thyroid carcinoma (abnormal calcitonin level and biomarkers doubling time lower than 5 years)

location_facility:
Centre François Baclesse
Centre Claudius Régaud
Hôpital de la timone
Centre René Huguenin
Centre Paul Strauss
CHU de Grenoble
Centre René Gauducheau
hôpital du Cluzeau
CHU


title: Phase IIA Multicenter 1 Week Treatment, Randomised, Double-Blind, Placebo Controlled Study of Depelestat in Patients Suffering From Acute Respiratory Distress Syndrome

summary: The study is aimed to assess safety of Depelestat treatment, as well as efficacy on prevention and treatment of alveolar inflammation in early pulmonary fibrosis in patients suffering from persistent Acute Respiratory Distress Syndrome.

ReferenceCitation: Honoré S, Attalah HL, Azoulay E, Soussy CJ, Saudubray F, Harf A, Brochard L, Delclaux C. Beneficial effect of an inhibitor of leukocyte elastase (EPI-hNE-4) in presence of repeated lung injuries. Shock. 2004 Aug;22(2):131-6.

lead_sponsor: Debiopharm International SA

location_country: Italy Tunisia France Spain

location_facility:
Samir Jaber
Jean-Christophe Richard
Fekri Abroug
Jean-Michel Arnal
Alain Mercat
Jordi Mancebo D.
Jean-Jacques Rouby
Jean-Yves Fagon
Claude Guerin
Massimo Antonelli
Jean-François Timsit
Laurent Brochard
Yves Castaing
Jean-Daniel Chiche


title: Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]

summary: We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS with a deletion (del) 5q[31]

ReferenceCitation: Adès L, Boehrer S, Prebet T, Beyne-Rauzy O, Legros L, Ravoet C, Dreyfus F, Stamatoullas A, Chaury MP, Delaunay J, Laurent G, Vey N, Burcheri S, Mbida RM, Hoarau N, Gardin C, Fenaux P. Efficacy and safety of lenalidomide in intermediate-2 or high-risk myelodysplastic syndromes with 5q deletion: results of a phase 2 study. Blood. 2009 Apr 23;113(17):3947-52. doi: 10.1182/blood-2008-08-175778. Epub 2008 Nov 5.

name: Hôpital Avicenne, Université Paris, Paris, France;

name: Inserm U848, Institut Gustave Roussy, Villejuif, France;

family: Adès

full_name: Lionel Adès

given: Lionel

family: Boehrer

full_name: Simone Boehrer

given: Simone

name: Institut Paoli Calmettes, Marseille, France;

family: Prebet

full_name: Thomas Prebet

given: Thomas

name: Centre Hospitalo-Universitaire de Toulouse, Toulouse, France;

family: Beyne-Rauzy

full_name: Odile Beyne-Rauzy

given: Odile

name: Centre Hospitalo-Universitaire Nice, Nice, France;

family: Legros

full_name: Laurence Legros

given: Laurence

name: Hôpital de Jolimont, la Louviere, Belgium;

family: Ravoet

full_name: Christophe Ravoet

given: Christophe

name: Hôpital Cochin, Université Paris, Paris, France;

family: Dreyfus

full_name: François Dreyfus

given: François

name: Centre Hospitalo-Universitaire de Rouen, Rouen, France;

family: Stamatoullas

full_name: Aspasia Stamatoullas

given: Aspasia

name: Centre Hospitalo-Universitaire de Limoges, Limoges, France;

family: Pierre Chaury

full_name: Marie Pierre Chaury

given: Marie

name: Centre Hospitalo-Universitaire de Nantes, Nantes, France; and

family: Delaunay

full_name: Jacques Delaunay

family: Laurent

full_name: Guy Laurent

given: Guy

family: Vey

full_name: Norbert Vey

given: Norbert

family: Burcheri

full_name: Sara Burcheri

given: Sara

family: Mbida

full_name: Rose-Marie Mbida

given: Rose-Marie

family: Hoarau

full_name: Natacha Hoarau

given: Natacha

family: Gardin

full_name: Claude Gardin

given: Claude

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
CHU Angers
Hopital Archet
Hoiptal St Louis
Hopital Hotel Dieu
Hopital Paoli Calmette
Hopital Cochin
Centre Henry Becquerel
CHU Brabois
Hopital Jean-Bernard
Chu Purpan
CHRU Hurriez


title: A Phase IIb Multicentric Controlled Study Evaluating the Therapeutic Vaccine TG4010(MVA-MUC1-IL2) as an Adjunct to Standard Chemotherapy in Advanced Non Small Cell Lung Cancer

summary: The primary Objective is to assess the efficacy of TG4010 combined to chemotherapy in comparison with chemotherapy alone in patients with advanced non small cell lung cancer.

ReferenceCitation: Quoix E, Ramlau R, Westeel V, Papai Z, Madroszyk A, Riviere A, Koralewski P, Breton JL, Stoelben E, Braun D, Debieuvre D, Lena H, Buyse M, Chenard MP, Acres B, Lacoste G, Bastien B, Tavernaro A, Bizouarne N, Bonnefoy JY, Limacher JM. Therapeutic vaccination with TG4010 and first-line chemotherapy in advanced non-small-cell lung cancer: a controlled phase 2B trial. Lancet Oncol. 2011 Nov;12(12):1125-33. doi: 10.1016/S1470-2045(11)70259-5. Epub 2011 Oct 21.

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Papai

full_name: Zsolt Papai

given: Zsolt

family: Madroszyk

full_name: Anne Madroszyk

given: Anne

family: Riviere

full_name: Alain Riviere

given: Alain

family: Koralewski

full_name: Piotr Koralewski

given: Piotr

family: Breton

full_name: Jean-Luc Breton

given: Jean-Luc

family: Stoelben

full_name: Erich Stoelben

given: Erich

family: Braun

full_name: Denis Braun

given: Denis

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Lena

full_name: Hervé Lena

given: Hervé

family: Buyse

full_name: Marc Buyse

given: Marc

family: Chenard

full_name: Marie-Pierre Chenard

given: Marie-Pierre

family: Acres

full_name: Bruce Acres

given: Bruce

family: Lacoste

full_name: Gisèle Lacoste

given: Gisèle

family: Bastien

full_name: Bérangère Bastien

given: Bérangère

family: Tavernaro

full_name: Annette Tavernaro

given: Annette

family: Bizouarne

full_name: Nadine Bizouarne

given: Nadine

family: Bonnefoy

full_name: Jean-Yves Bonnefoy

given: Jean-Yves

family: Limacher

full_name: Jean-Marc Limacher

given: Jean-Marc

journal_name: The Lancet Oncology

location_facility: Klinikum Offenburg, Medizinische Klinik II

location_facility: Centre Hospitalier de la Haute Saône, Service de Pneumologie - Allergologie

location_facility: Asklepios Fachkliniken, Zentrum für Pneumonologie

location_facility: Centre Hospitalier Général, Service de Pneumologie

location_facility: Hôpital Pasteur - Service de médecine F- Pavillon 43

location_facility: Institut Paoli-Calmettes, Service d'oncologie médicale

location_facility: Hôpital Lyautey - Service de Pneumologie


title: Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Moureau-Zabotto L, Phélip JM, Afchain P, Mineur L, André T, Vendrely V, Lledo G, Dupuis O, Huguet F, Touboul E, Balosso J, Louvet C. Concomitant administration of weekly oxaliplatin, fluorouracil continuous infusion, and radiotherapy after 2 months of gemcitabine and oxaliplatin induction in patients with locally advanced pancreatic cancer: a Groupe Coordinateur Multidisciplinaire en Oncologie phase II study. J Clin Oncol. 2008 Mar 1;26(7):1080-5. doi: 10.1200/JCO.2007.12.8223.

name: From the Hôpital Tenon and Hôpital Saint Antoine, Groupe Hospitalo-Universitaire Est, Université Paris VI, Paris; Centre Hospitalier Universitaire de Grenoble, Université Joseph Fourier, Grenoble; Institut Sainte Catherine, Avignon; Centre Hospitalier Universitaire Saint André, Université Victor Segalen, Bordeaux; Clinique Saint-Jean, Lyon; and Centre de Radiothérapie, Le Mans, France

family: Moureau-Zabotto

full_name: Laurence Moureau-Zabotto

given: Laurence

family: Phélip

full_name: Jean-Marc Phélip

family: Afchain

full_name: Pauline Afchain

given: Pauline

family: Mineur

full_name: Laurent Mineur

given: Laurent

family: André

full_name: Thierry André

given: Thierry

family: Vendrely

full_name: Veronique Vendrely

given: Veronique

family: Lledo

full_name: Gerard Lledo

given: Gerard

family: Dupuis

full_name: Olivier Dupuis

given: Olivier

family: Huguet

full_name: Florence Huguet

given: Florence

family: Touboul

full_name: Emmanuel Touboul

given: Emmanuel

family: Balosso

full_name: Jacques Balosso

given: Jacques

family: Louvet

full_name: Christophe Louvet

given: Christophe

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Concomitant Administration of Weekly Oxaliplatin, Fluorouracil Continuous Infusion, and Radiotherapy After 2 Months of Gemcitabine and Oxaliplatin Induction in Patients With Locally Advanced Pancreatic Cancer: A Groupe Coordinateur Multidisciplinaire en Oncologie Phase II Study

ReferenceCitation: Moureau-Zabotto L, Phélip J, Afchain P, et al.: Concomitant administration of weekly oxaliplatin, 5FU continuous infusion and radiotherapy in locally advanced pancreatic cancer (LAPC): a Gercor phase II study. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1077, S173-4, 2006.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

intervention_type: Radiation


title: Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure, Treated With Bilevel Positive Airway Pressure (AirCurve 10 VAutoTM) as Second-line Therapy: PoP IN VAuto

acronym: PoP IN VAuto

summary: Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM

ipd_sharing: No

lead_sponsor: ResMed

location_facility:
CH de Belfort
Hopital Saint Antoine
HCL - Croix-Rousse Hospital
Centre médical du sommeil
Clinique Aguilera
APHM
Cabinet de Pneumologie
Polyclinique Saint-Laurent


title: Phase 2 Study for Treatment of Penis Epidermoid Carcinoma Loco-regionally Advanced or Metastatic by Association Gemcitabine-Cisplatin

summary: The purpose of this study is to determine whether association Gemcitabine-Cisplatin is effective in the treatment of penis epidermoid carcinoma loco-regionally advanced or metastatic.

lead_sponsor: Institut Claudius Regaud

location_facility:
Centre Eugène Marquis
Centre Léon Bérard
Centre François Baclesse
Centre Paul Papin
Institut Claudius Regaud
Centre Médico-Chirurgical Foch
Institut Paoli Calmette
Institut Curie
Institut Val d'aurelle
CHU Grenoble
Institut Bergonie


title: APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation

summary: Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF. It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term. However definitive proof is still lacking. We conducted a randomized study in 11 french centers and included 137 kidney transplant recipients (PRA<50%) receiving a classical immunosuppressant regimen with basiliximab, Csa, MMF and steroids. The "fixed dose" group received 2 g of MMF a day. The "concentration controlled" group received MMF dose adapted to the area under the concentration curve (AUC) of MPA, with a target of 40 h.mg/L. After transplantation AUCs were calculated with a Bayesian estimator using a 3-point limited sampling strategy on day 7, 14, and months 1, 3, 6 , 12 in both groups (values note communicated to the physicians in the "fixed dose" group.

lead_sponsor: University Hospital, Limoges


title: AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment

acronym: ANTICIPATE

summary:
During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota (gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number and severity of CDI are considered as worldwide public health threats.

Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and treated with predefined antibiotic classes known to increase the risk of CDI. The incidence of CDI in this population is unknown, yet, incidence is an important determinant for the required sample size.

Therefore, the main objective of the current study is to assess CDI incidence in patients ≥50 years of age treated with predefined antibiotic classes.

In addition, to optimise the target population of the DAV132 RCT, the effect of the predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore, biomarkers predictive of CDI occurrence might help identify patients at high risk for the disease, which could further optimise the RCT. No validated biomarkers have been described in the literature yet. Assessment of potential biomarkers is another aim of the present study.

ReferenceCitation: van Werkhoven CH, Ducher A, Berkell M, Mysara M, Lammens C, Torre-Cisneros J, Rodríguez-Baño J, Herghea D, Cornely OA, Biehl LM, Bernard L, Dominguez-Luzon MA, Maraki S, Barraud O, Nica M, Jazmati N, Sablier-Gallis F, de Gunzburg J, Mentré F, Malhotra-Kumar S, Bonten MJM, Vehreschild MJGT; ANTICIPATE Study Group. Incidence and predictive biomarkers of Clostridioides difficile infection in hospitalized patients receiving broad-spectrum antibiotics. Nat Commun. 2021 Apr 14;12(1):2240. doi: 10.1038/s41467-021-22269-y.

family: van Werkhoven

full_name: Cornelis H. van Werkhoven

given: Cornelis H.

family: Ducher

full_name: Annie Ducher

given: Annie

family: Berkell

full_name: Matilda Berkell

given: Matilda

family: Mysara

full_name: Mohamed Mysara

given: Mohamed

family: Lammens

full_name: Christine Lammens

given: Christine

family: Torre-Cisneros

full_name: Julian Torre-Cisneros

given: Julian

family: Rodríguez-Baño

full_name: Jesús Rodríguez-Baño

given: Jesús

family: Herghea

full_name: Delia Herghea

given: Delia

family: Cornely

full_name: Oliver A. Cornely

given: Oliver A.

family: Biehl

full_name: Lena M. Biehl

given: Lena M.

family: Bernard

full_name: Louis Bernard

given: Louis

family: Dominguez-Luzon

full_name: M. Angeles Dominguez-Luzon

given: M. Angeles

family: Maraki

full_name: Sofia Maraki

given: Sofia

family: Barraud

full_name: Olivier Barraud

family: Nica

full_name: Maria Nica

given: Maria

family: Jazmati

full_name: Nathalie Jazmati

given: Nathalie

family: Sablier-Gallis

full_name: Frederique Sablier-Gallis

given: Frederique

family: de Gunzburg

full_name: Jean de Gunzburg

given: Jean

family: Mentré

full_name: France Mentré

given: France

family: Malhotra-Kumar

full_name: Surbhi Malhotra-Kumar

given: Surbhi

family: Bonten

full_name: Marc J. M. Bonten

given: Marc J. M.

family: Vehreschild

full_name: Maria J. G. T. Vehreschild

given: Maria J. G. T.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

ReferenceCitation: Berkell M, Mysara M, Xavier BB, van Werkhoven CH, Monsieurs P, Lammens C, Ducher A, Vehreschild MJGT, Goossens H, de Gunzburg J, Bonten MJM, Malhotra-Kumar S; ANTICIPATE study group. Microbiota-based markers predictive of development of Clostridioides difficile infection. Nat Commun. 2021 Apr 14;12(1):2241. doi: 10.1038/s41467-021-22302-0.

ipd_sharing_description: 16S rRNA and shotgun metagenomic sequence data generated and analyzed in this study have been deposited in the NCBI Sequence Read Archive with the accession code PRJNA685914. Human reads were identified and removed prior to shotgun metagenomics data upload. Access to clinical data is restricted as the informed consent provided does not allow for use of clinical data outside the research institution. Data are available from the corresponding author upon reasonable requests.

location_country: Netherlands France Greece Romania Spain Germany

location_facility: Oncology Institute Ion Chiricuta Cluj Napoca

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Cluj Napoca Infectious disease Clinical Hospital

location_facility: Clinical Hospital Of Infectious Diseases Of Iasi

location_facility: Infectious and Tropical Diseases Hospital "Dr. Victor Babes"

location_facility: The National Institute of Infectious Diseases Matei Bals


title: First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cisplatin, paclitaxel, and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer.

location_country: Monaco France

location_facility: Centre Hospitalier Regional Metz Thionville


title: Quality of Life Impact After Enhanced Follow-up of Ostomy Patients by a Home Healthcare Nursing Service Employing Stomal Therapy Nurse Consultants Compared to Conventional Care

acronym: StomaCare

summary:
In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists.

The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites.

The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.

ReferenceCitation: Becker A, Schulten-Oberbörsch G, Beck U, Vestweber KH. Stoma care nurses: good value for money? World J Surg. 1999 Jul;23(7):638-42; discussion 642-3.

ReferenceCitation: Persson E, Berndtsson I, Carlsson E, Hallén AM, Lindholm E. Stoma-related complications and stoma size - a 2-year follow up. Colorectal Dis. 2010 Oct;12(10):971-6. doi: 10.1111/j.1463-1318.2009.01941.x.

family: Persson

full_name: E. Persson

given: E.

family: Berndtsson

full_name: I. Berndtsson

given: I.

family: Carlsson

full_name: E. Carlsson

family: Hallén

full_name: A.-M. Hallén

family: Lindholm

full_name: E. Lindholm

journal_name: Colorectal Disease

ReferenceCitation: Neil N, Inglese G, Manson A, Townshend A. A Cost-Utility Model of Care for Peristomal Skin Complications. J Wound Ostomy Continence Nurs. 2016 Jan-Feb;43(1):62-8. doi: 10.1097/WON.0000000000000194.

family: Neil

full_name: Nancy Neil

given: Nancy

family: Inglese

full_name: Gary Inglese

given: Gary

family: Manson

full_name: Andrea Manson

given: Andrea

family: Townshend

full_name: Arden Townshend

given: Arden

journal_name: Journal of Wound, Ostomy & Continence Nursing

oa_host_type: repository

license: implied-oa

license_normalized: implied-oa

evidence: oa repository (via pmcid lookup)

license_normalized: no license

ReferenceCitation: Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48-55.

ReferenceCitation: Danielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014.

family: Danielsen

full_name: Anne Kjaergaard Danielsen

given: Anne Kjaergaard

family: Rosenberg

full_name: Jacob Rosenberg

given: Jacob

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

license: cc-by

license_normalized: cc-by

repository_institution: University of Illinois at Chicago - INDIGO

title: Health Related Quality of Life May Increase when Patients with a Stoma Attend Patient Education – A Case-Control Study

location_facility:
ESPIC Foch - Urology Unit
Hopital Lyon-Sud
CHU Toulouse
Hopital HEGP
Hopital Saint-Antoine
Hopital SAint Louis
ESPIC FOCH - Digestige Unit
Hopital Saint-Louis
Hopital de la Pitié-Salpétrière
Hopital Bicètre


title: Post Market Clinical Follow-up of EUROSTEM Femoral Stem

summary:
EUROSSTEM is intended for use in primary and revision total hip replacement surgery.

Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

As part of post market vigilance, EUROS will collect data on EUROSTEM performances and safety

status: Recruiting

lead_sponsor: EUROS

location_facility: Hôpital privé Drôme Ardèche - Clinique Pasteur


title: The Efficacy of Traumatic Memory Modification Using a Memory Reconsolidation Procedure Under Propranolol Among Adolescents With Post-traumatic Stress Disorder

acronym: PROPRADO

summary: The aim of this study is to demonstrate the effectiveness of propranolol in blocking reconsolidation by reducing PTSD symptoms in the short and long term in adolescents with PTSD for more than 3 months.

location_facility:
CHU Angers
CH Le Havre
CHU Limoges
CHU Poitiers
CHU Rouen
CH Bohars
CH Guillaume Régnier
CHU Besançon
CHU Nantes
AP-HP Louis Mourier


title: Post-natal Post-traumatic Stress: Impact of an Early Dyadic Intervention Though Interaction Guidance Therapy on Maternal Sensitivity and Reduction of Maternal Stress

acronym: EVAGIT

summary:
The aim of this study is to assess if an early therapeutic management focused on the mother-baby interaction using Interaction Guidance Therapy (IGT) with video feedback, brings an improvement of the maternal sensitivity in the interaction but also a decrease of the post-traumatic maternal symptoms.

Post Natal Post traumatic stress is known as a disorder that impaired maternal mental health but also development of motherhood and the construction of the bond to the baby through interactive disturbances.

The investigators will screen, among women who had a traumatic perception of an event related to the pregnancy or the childbirth, those who still present posttraumatic stress symptoms at 4 weeks post-partum. Four weeks from the traumatic event is the minimum delay to qualify a PTSD.

After randomization IGT versus Treatment As Usual (TAU), the investigators planned an early therapeutic intervention, 3 sessions at 8, 10 and 12 weeks of post-partum.

The investigators will assess the effect of the IGT on Maternal sensitivity and on the intensity of post-traumatic stress symptoms at 3 month post-partum and 1year.

location_facility: Hôpital Necker - Enfants malades - pedospychiatrie

location_facility: Centre hospitalier Intercommunal André Grégoire

location_facility: Centre hospitalier - unité de périnalité

intervention_type: Behavioral


title: Deep Brain Stimulation for Parkinson's Disease: Probabilistic STN Targeting Under General Anaesthesia Without Micro-electrode Recordings (MER) vs Current Targeting Procedure

summary:
Deep brain stimulation (DBS) of the sub-thalamic nucleus (STN) has evolved over the past decades as a mainstream therapy for advanced Parkinson's disease (PD). The classical procedure consists in STN indirect targeting based on stereotactic atlases or statistical coordinates in AC-PC (Anterior Commissure - Posterior Commissure) referential along with target control and correction by micro-electrode recordings (MER) and awake clinical testing. To avoid potential complications and patient discomfort related to current procedure, asleep surgery without this control process has become more and more performed, essentially thanks to the progress of neuroimaging allowing to STN visualization. However, it has been reported a relative inaccuracy between the "radiological" STN delimitated on several types of MRI sequences (T2, T2*, SWI) and the per-operative electrophysiological findings. As a result, there are currently many types of STN-DBS procedures, and the lack of standardization between techniques complicates the interpretation of postoperative results on anatomical, electrophysiological and clinical points of view. Furthermore, to date, it has not been proven that asleep surgery without MER and clinical controls is as effective as the standard procedure in a prospective controlled randomized clinical trial.

Investigators hypothesize that the clinical-based 18 landmarks STN target will be precise enough to allow to perform surgery under general anesthesia without MER correction, and accurate enough to achieve non inferior clinical results compared to what is usually done in each centre.

The main objective is to compare at one year, the % of motor improvement after PARKEO 2-targeting asleep DBS without intraoperative MER versus the targeting procedure using intraoperative MER by the UPRDRS 3 (Unified Parkinson's disease rating scale 3).

location_facility:
CHU Marseille
CHU de Strasbourg
CHU de Bordeaux
CHU de Nice
CHU Reims
CHU Amiens
CHU Grenoble
CHU de Rouen
CHRU de Nancy
CHU de Toulouse


title: Predicting the Cumulative Live Birth Rate Further Ovarian Stimulation by Highly Purified Human Menotropin HP-hMG. A Multicentre, Retrospective Study

acronym: MEDAM

summary: French, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI). The main objective is to determine the cumulative live birth rate with highly purified menotropin (HP-hMG) which is defined as the occurrence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.

time_perspective: Retrospective

lead_sponsor: Ferring Pharmaceuticals


title: Non-inferiority Study Comparing Two Psychoeducation Programmes (Mobile Application Versus Face-to-face Psychoeducation Group) in a Population of Patients With Bipolar Disorder

acronym: AppEduc-BD

summary: This is a controlled, randomized, prospective, open-label, non-inferiority trial lasting 12 months. The effectiveness of using a psychoeducational smartphone application (SIMPLe) will be compared to the effectiveness of face-to-face group psychoeducation.

primary_purpose: Other

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
APHP - Hôpital Fernand-Widal
CHU - Hôpital Lapeyronie
APHP - Centre Hospitalier Henri Mondor
CH Charles Perrens
CHU - Hôpital Universitaire Carémeau
CHI HC site rives du Doubs Pontarlier
CHU - Hôpital de Psychiatrie
CHU
CHU - Gabriel Montpied
CH Saint-Anne


title: Multicenter Clinical Study of the Efficacy and Tolerability of INSTYLAN (Sodium Hyaluronate 80mg/50ml) in Patients With Early or Late Symptoms of Moderate to Severe Hemorrhagic Cystitis Caused by Pelvic Radiation Therapy and/or Chemotherapy

summary: The purpose of this study is to assess the efficacy and tolerability of INSTYLAN (Sodium Hyaluronate 80mg/50ml) in Patients with early or late symptoms of moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy. The study is conducted in the field of routine clinical practice and will recruit 30 subjects treated with intravesical instillations with INSTYLAN weekly for 6 weeks.

lead_sponsor: LIDDE Therapeutics

location_facility: Ajaccio Hospital Center (Notre Dame de la Miséricorde)

location_facility: Saint Louis University Hospital Center (Paris)

location_facility: Regional University Hospital Center (Strasbourg)

location_facility: Mutualist Clinic Porte de l'Orient (Lorient)


title: Evaluation of Survival Prognostic Factors for Patients With Exocrine Pancreatic Cancer Resectable or Potentially Resectable : a Multicentre Prospective Cohort

acronym: Pancreas-CGE

summary: This study aims to collect clinical, biological and quality of life data from patients with a borderline or resectable pancreatic cancer. It will collect information from the date of diagnosis along the therapeutic care of the patients, and a 3-years follow-up after the end of the treatment. The database will be updated at each patient's visit. Biological samples will include: tumor, and plasma. Epidemiological data will also be collected, whereas Quality of life will be assessed by the EORTC standard. The objectives of this database are to identify new biomarkers (genomic, immunologic, and epidemiologic) and promote high quality standard research protocol.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire Robert Debré


title: Implementation of a Screening Tool for Subjects With Benign Prostatic Enlargement/Obstruction to Identify Men >=50 Years Presenting in General Practice With Other Co-morbidities Who Should be Assessed for BPH

summary: This non-randomized, interventional study will be conducted in a general practice setting to assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO) screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed to have BPH on full urologist assessment of diagnostic test results. The tool may help a General Practitioners (GP) to identify subjects who may have BPH for further tests and improve the speed of referrals to specialists when this is appropriate. The utility of the screening tool will be compared to the validated tool in wide clinical use, the International Prostate Symptom Score (IPSS). This study does not have any formal hypothesis in terms of the primary and secondary endpoint proportions. A BPE/BPO screening tool identifies lower urinary tract symptoms (LUTS) probably due to BPH in men not yet presenting with LUTS. The results of this screening tool will be used for further investigation. All subjects testing positive on the BPE/BPO screening tool (score >=3) tool or on the IPSS (score >=8) will be enrolled and offered a PSA test and urinalysis to establish a diagnosis of probable BPH (Part I-Visit 1). The GP may perform a digital rectal examination (DRE) which will be repeated by the urologist to confirm the diagnosis and to rule out an abnormality suggesting prostate cancer. The GP will make a diagnosis of probable BPH based upon screening results and lab tests which suggest that they are related to BPH and not other causes of such symptoms. The GP will phone the subject to report yes or no for probable BPH Part II (Visit 2). If the subject has probable BPH, the GP will schedule the subject for Visit 3 with an urologist. If the subject does not have probable BPH, then it will be considered that the subject has completed the study. Subjects that proceed to Part II (Visit 3) will be scheduled for a urology assessment performed by an urologist. This assessment includes a DRE and a brief physical exam and review of the PSA test, for a confirmatory diagnosis of BPH and estimation of risk of progression of BPH. Approximately 1,500 subjects presenting to a GP for reasons unrelated to this study will be screened for probable BPH to yield 500 subjects being referred to an urologist. The duration of the study will be 1 week (+/- 4 days) and up to 6 weeks to allow for GP and urologist visit scheduling.

primary_purpose: Screening

ReferenceCitation: Tubaro A, Niero M, Adalig B, Lulic Z, Plastino J, Kimbrough C, Manyak MJ. Evaluation of a 3-item screening tool to identify men with benign prostatic enlargement/obstruction in a primary care cohort. Minerva Urol Nefrol. 2020 Sep 29. doi: 10.23736/S0393-2249.20.03834-5. [Epub ahead of print]

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

location_country:
Italy
France
Russian Federation
Spain
Germany


title: Intelligent Evaluation of Diabetic Retinopathy

acronym: EviRed

summary: Brief Summary: The main objective of EviRed project is to develop and validate a system assisting the ophthalmologist by improving prediction of evolution, and decision making during diabetic retinopathy (DR) follow-up. It will replace the current classification of diabetic retinopathy (DR) which provides an insufficient prediction precision. It will use modern available fundus imaging devices and artificial intelligence (AI) to properly integrate the amount of data they provide with other medical data of the patient. A cohort of 5000 diabetic patients will be recruited and followed for an average of 2 years in order to collect data to train and validate the new prediction system.

location_facility:
Chu Lyon Croix Rousse
Centre Broca / Mutuelle Generale
Chu Avicenne
Chu Brest
Chu Pitie Salpetriere
Chu Dijon
Chic Creteil
Hôpital des 15-20
Chu Lariboisiere
Chu Bordeaux


title: Phase II Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life

summary:
Anal canal carcinoma (ACC) represents 1.2% of digestive cancers. Its incidence is increasing. As epidermoid ACC (95% of ACC) are particularly sensitive to radio and chemotherapy, concomitant radio-chemotherapy is the standard treatment of locally advanced ACC, with proven efficacy on locoregional control, anal sphincter preservation, progression-free survival and complete response rate higher than 80%.

Nevertheless, conventional radiotherapy frequently induces significant non-haematological toxicities requiring treatment interruptions. Thus, treatment usually includes a chemotherapy (5-Fluorouracil and Mitomycine-C) and 25 fractions of 1.8 Gy followed by a planned 1-week (or more) interruption and a boost, for a total 54-60 Gy radiation dose over 9 weeks.

Considering the numerous anatomic pelvic structures, ACC has become a localisation of interest for Intensity-Modulated Radiation Therapy (IMRT) associated with less toxicity.

However, IMRT induces grade≥3 cutaneous toxicities requiring irradiation breaks. Dose escalade did not show its interest: 60 Grays remains the standard.

Assuming the deleterious effect of increased overall treatment time on local control and survival in head-and-neck and cervical cancers and the epidermoid histology of ACC, the benefit of no irradiation break on ACC tumour control is of interest.

IMRT offers the possibility to deliver different doses to different target volumes simultaneously by altered fractionation schedule like SIB-IMRT (simultaneously integrated boost-IMRT). Several SIB-IMRT schedules have been retrospectively evaluated. Similar results were observed with moderate doses and schedules delivering higher doses with short interruptions. Nevertheless, standard SIB-IMRT schedule in ACC still not exist.

lead_sponsor: Centre Francois Baclesse

location_facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin


title: MS Screen Test: Using a Smartphone Application to Predict the Prognosis in Patients With Newly Diagnosed Multiple Sclerosis

acronym: MSST

summary:
Multiple sclerosis (MS) is a chronic demyelinating disease of the central nervous system for which the investigators now have many treatment alternatives. These treatments have a preventive goal and the data in the literature suggest the interest in rapidly achieving optimal control of the disease in order to decrease the risk of long-term disability progression.

One of the current unmet needs is to have markers that can be used at the individual level to predict the long-term prognosis in order to propose optimal and personalized therapeutic management.

Classically used clinical markers do not meet this need. It is recognized that there is a so-called silent course of MS (not measurable by clinical parameters), which may, after several months or years, be expressed as a physical or cognitive disability.

MRI is the reference examination for monitoring the sub-clinical activity of the disease but it does not allow the neurodegenerative side of the disease to be assessed. Other blood or imaging markers are being studied but are not yet usable in daily practice.

The project aims to evaluate the interest in using digital biomarkers, based on a rapid assessment of patients using a locally developed mobile application (MS Screen Test - MSST) to predict the evolutionary prognosis of the disease.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Paris University Hospital - la pitié salpétriere


title: Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort

acronym: COCO-LATE

summary:
Several publications document the occurrence of symptoms that persist or occur late.

The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.

Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.

lead_sponsor: Tourcoing Hospital

location_country:
French Guiana
France

location_facility:
CHRU Lille
CHU de Saint-Etienne
CHRU Nancy
CH André Rosemon de Cayenne
Centre Hospitalier Bretagne Atlantique
CHU Caen
AP-HP Hôpital Hôtel-Dieu
Ch Auxerre
CH Tourcoing
CH Melun Marc Jacquet
CHRU Tours


title: Analysis of the Evolution of Proteomic Profiles of Intestinal Microbiota in Patients With Locally Advanced or Metastatic Urothelial Carcinomas According to Their Response to Immunotherapy (Responders vs. Non-responders) : A Prospective Pilot Study

acronym: AMI

summary:
Immunotherapy has become an essential therapeutic weapon against many cancers. Control point inhibitors (CPI, PD-1/PD-L1) have shown efficacy in the therapeutic management of tumors in the bladder in progression after administering platinum derivatives. But only 20% of patients get any clinical benefit from these heavy treatments in the long term.

Treating metastatic patients without distinction means taking a considerable risk of toxicity and generates major costs. It is therefore urgent and important to exceed the current criteria for using immunotherapy. Recent studies have shown the interest of studying intestinal microbiota as a marker of the efficacy of immunotherapy.

The investigators hypothesized that the proteomic signature of the intestinal microbiota in patients with locally advanced or metastatic urothelial carcinomas who responded to immunotherapies was special, and has very different characteristics from that of patients with the same pathology who do not respond to immunotherapy.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Institut Sainte Cancerologie Lucien Neuwirth


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: Prospective Study for Delay in Surgical Treatment of Traumatic Cervical Central Cord Injury in Canal Stenosis

summary:
The studied pathology concerns post traumatic cervical spinal cord contusion on narrow spinal canal.

The pathophysiology remains controversial. This pathology does not enjoy consensus support. Many questions remain regarding the surgical care and its delay.

The purpose of the study was to demonstrate non-inferiority of early surgical treatment compared to the same surgery performed with a delay among patients identified as having a cervical spinal cord contusion on posttraumatic narrowed cervical canal.

In the current state of knowledge and practices, the treatment of post traumatic spinal cord contusions on narrow spinal canal spinal decompression is performed remote diagnosis. The generally accepted delay is 15 days.

The surgical technique is a conventional cervical spinal decompression surgery. The type of decompression (anterior or posterior) is dependent on the compression and therefore the clinical radiological analysis. The choice of the technique and the surgical approach are therefore left to the discretion of the surgeon.

After completion of the clinical and radiological diagnosis of post-traumatic spinal cord contusion on narrow spinal canal, the patient was hospitalized in intensive care or in the Neurosurgery Service of the University Hospital concerned.

After anesthetic consultation determining the feasibility or not of surgery and in the absence of other vital injury or involving life-threatening, early surgery within 48 hours of diagnosis is then considered (according to the assigned group).

The surgical technique is a conventional cervical spinal decompression surgery. Way posterior surgery, laminectomy for spinal stenosis significant if greater than or equal to 3 floors will be preferred. In other cases, the type of surgery will be at the discretion of the surgeon and the opinion of the Staff Neurosurgery.

The surgical procedure is identical in the two groups. Alone, the delay of the surgery varies : less than 48 hours for the first group and 15 days for the second.

During the different monitoring visits (D0 (surgery), D7, M3, Y1 and Y2), the following criteria will be assessed : the quality and quickness of the motor and sensory recovery, the early post-operative evolution and the long and medium term evolution but also disability and functional sequelaes.

lead_sponsor: Nantes University Hospital

location_facility:
Chu Poitiers
Hospital LA TIMONE
CHU de Marseille
CHU d'Angers
CHU de Nantes
CHU de Rennes
CHU de Brest
CHU de Besançon


lead_sponsor: ARCAGY/ GINECO GROUP

acronym: COLIBRI

location_facility: Groupe Hospitalier Diaconesses - Croix Saint-Simon

location_facility: Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, CARIO-HPCA

title: A Multicenter, Pilot Study Evaluating Immune Impact and Safety of Nivolumab in Combination With Ipilimumab (Immune Combination) Before Initial RT-CT Treatment for Cervix Cancer.: the French GINECO - COLIBRI Study

summary: This is a multicenter, single arm pilot study evaluating the biological impact of "Nivolumab + Ipilimumab" in patients with cervical squamous cell carcinoma requiring RT-CT as initial therapy


title: Open Label Phase II Randomized Non-comparative Study of SC Tocilizumab Associated With IV Pulse Steroid Versus IV Pulse Steroid Alone for the Treatment of Acute Anterior Ischemic Optic Neuropathy Associated With Giant Cell Arteritis

acronym: TOCIAION

summary: AION is the main cause of blindness in patients with GCA. High dose steroid is the reference treatment of this condition, but medical unmet need remains. Subcutaneous tocilizumab, a targeted biotherapy, recently received marketing authorization for the treatment of GCA, but only demonstrated at yet that it can allow steroid dose sparing. The aim of this study is to assess the benefit of tocilizumab and IV steroids combination or IV steroids alone, in the treatment of AION due to GCA.

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

location_facility: CHU de Caen - Hôpital de la Côte de Nacre

location_facility: Groupe Hospitalier Diaconesses-Croix Saint Simon,