title: Follow-up of Study C87040: Multicentre, Double-blind Study to Describe the Efficacy and Safety of Re-treatment With CDP870 (Certolizumab Pegol) Subcutaneous at 2 Different Dose Regimens (400 mg Initial Dose at Week 0 With 200 mg Every 2 Weeks Thereafter and 400 mg Every 2 Weeks) or Placebo for 12 Weeks, in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy, Having Responded to Treatment in Study C87040 and Having Subsequently Relapsed

summary: The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 [NCT00245765] and Week 12 of re-treatment in this study.

ReferenceCitation: Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.

family: Reich

full_name: K. Reich

given: K.

family: Ortonne

full_name: J.-P. Ortonne

family: Gottlieb

full_name: A.B. Gottlieb

family: Terpstra

full_name: I.J. Terpstra

family: Coteur

full_name: G. Coteur

given: G.

family: Tasset

full_name: C. Tasset

given: C.

family: Mease

full_name: P. Mease

given: P.

journal_name: British Journal of Dermatology

title: Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab′ certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension

lead_sponsor: UCB Pharma


type: EudraCT Number

title: A Randomised, Double-blind, Placebo-controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-label Glimepiride Treatment Arm.

summary: The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Boehringer Ingelheim

location_country:
Sweden
France
Slovakia
Germany
United Kingdom
Ukraine

location_facility: 1218.6.38001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49005 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44012 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49014 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42105 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44018 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42101 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44004 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49012 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49010 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49009 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44016 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44015 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44017 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44006 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42104 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49008 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44005 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44009 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46004 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44008 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44019 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49013 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38005 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42103 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49017 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49011 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49015 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44013 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44007 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49016 Boehringer Ingelheim Investigational Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer

summary:
This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).

A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

study_completion_date_type: Actual

lead_sponsor: Eli Lilly and Company

location_country: Germany France Spain

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


title: A Double-Blind, Stratified, Randomised, Parallel, Placebo-Controlled, Multi-Centre Study to Assess the Efficacy and Safety of Duloxetine (20 mg Bid for 2 Weeks Escalating to 40 mg Bid) for up to 12 Weeks, Compared to Placebo, in Community-Dwelling Elderly Women > or = 65 Years of Age With Symptoms of Stress Urinary Incontinence or Stress-Predominant Mixed Urinary Incontinence.

summary: The purpose of this study is to determine how effective duloxetine is in treating women who are 65 years of age or older with symptoms of stress urinary incontinence, or with a combination of stress urinary incontinence and urge urinary incontinence symptoms.

location_country:
South Africa
Sweden
Switzerland
Netherlands
France
Spain
Germany

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


title: Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in older patients.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer.

enrollment_type: Anticipated

lead_sponsor: UNICANCER

location_country:
United Kingdom
France
Switzerland

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

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

location_facility: Centre for Cancer Research and Cell Biology at Belfast City Hospital

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

intervention_type: Procedure


title: Switching to Duloxetine From Other Antidepressants: A Regional Multicentre Trial Comparing Two Switching Techniques

summary: A multicentre, randomised, open label study of out-patients with major depression who have failed to respond adequately to antidepressant treatment for their current episode of depression. The study compares outcomes associated with two methods of switching from current antidepressant to duloxetine

ReferenceType: derived

ReferenceCitation: Perahia DG, Quail D, Desaiah D, Corruble E, Fava M. Switching to duloxetine from selective serotonin reuptake inhibitor antidepressants: a multicenter trial comparing 2 switching techniques. J Clin Psychiatry. 2008 Jan;69(1):95-105.

location_country:
Ireland
France
United Kingdom
Spain

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician


title: A 12-Week Randomized, Evaluator-Masked, Parallel-Group, Multinational, Multi-Center Study Comparing The Efficacy And Safety Of The Fixed Combination Of Latanoprost And Timolol (Xalacom) With The Fixed Combination Of Dorzolamide And Timolol (Cosopt) In Patients With Open-Angle Glaucoma Or Ocular Hypertension.

summary: To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.

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

location_country: Italy Sweden France Greece Germany


title: Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.

status: Terminated

location_country: Italy France Switzerland

location_facility: Istituto Nazionale Di Riposo e Cura per Anziani

status_simplified: Unknown


title: Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT

acronym: RESTO

summary:
The statistical risk of intrastent stenosis has fallen considerably with the emergence of latest generation coated stents (drug-eluting stents: DES). The number and clinical lifespan of stents implanted over the last twenty-five years, however, explain the fact that restenosis remains a not unusual clinical problem which is expressed as a recurrence of angina or of an acute coronary syndrome (ACS).

The mechanisms involved in this restenosis are multifactorial in nature and differ depending on the type of stent and the time since the restenosis occurred. In symptomatic stent restenosis (angina or acute coronary syndrome), a further angioplasty is usually required, occasionally on an emergency basis. Coronary angiography is often not capable of explaining the mechanical causes of this complication.

Optical coherence tomography (OCT), a high-resolution endocoronary imaging technique can assist in the understanding of the mechanism of restenosis and guide treatment. OCT during angiography provides a detailed analysis of the stents and potential complications: the presence of neoatherosclerosis with or without plaque rupture, intimal hyperplasia, stent under-deployment, stent fracture and distal or proximal progression of the atherosclerosis.

The investigators propose a prospective, multicentre study of all cases of intrastent restenosis, examined by angiography, causing clinical features involving stable angina and acute coronary syndrome. The coronary artery involved will be routinely studied by OCT for a mechanical cause of the intrastent restenosis. The routine use of intrastent OCT may assist in the understanding of causes of restenosis and in the decision on appropriate treatment. There are several possible treatments for restenosis, including balloon angioplasty, coated balloon angioplasty, stenting or aorto-coronary bypass graft surgery.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Clermont-Ferrand

location_country: Belgium France Switzerland

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: Centre Hospitalier les Hôpitaux de Chartres

location_facility: Hôpital Privé Institut Mutualiste Montsouris

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction

acronym: ROTAS

summary:
According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient (MAG) >40 mmHg, and a maximal aortic velocity >4 m/sec.

Aortic valve replacement (AVR) is recommended (class I indication) in patients with "classical" severe AS who have any symptoms related to aortic valve disease.

In 2007, Hachicha et al. described a particular pattern of severe AS, characterized by an AVA ≤0.6 cm2/m2, low mean pressure aortic gradient (MAG <40 mmHg), despite the presence of a preserved left ventricular ejection fraction (LVEF ≥50%). This pattern of AS is encountered in nearly 15-25 % of patients who have severe AS. Typically, these patients are elderly subjects, with several comorbidities, a small left ventricular (LV) cavity with pronounced LV concentric remodeling and a restrictive physiology, leading to a decrease in LV stroke volume despite a preserved LVEF. The diagnosis and management of patients with low gradient severe AS and preserved LVEF are often challenging because:

the presence of a "true" severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach;
the best therapeutic management (AVR versus conservative strategy) of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established.

In very recently updated European guidelines on the management of VHD, symptomatic patients with low gradient and low flow severe AS and preserved LVEF have only a class IIa-level C indication for AVR. No specific indications are given for the management of symptomatic patients with low gradient and normal flow severe AS. This lack of indications is clearly attributed to a gap in knowledge which requires further investigations to be filled up.

ipd_sharing: No

lead_sponsor: Rennes University Hospital

location_country: Belgium France

location_facility:
CHU Angers
CH Bretagne Atlantique - Site de Vannes
Clinique du Millénaire
CHU Toulouse - Hôpital Rangueil
CH Saint-Brieuc
CHU Brest - Hôpital La Cavale Blanche
CHU Dijon - Hôpital François Mitterrand
CH Bretagne Sud
APHM - Hôpital La Timone
CHU Nantes
CHU Lille
CHU Amiens - Picardie
CHU Nancy
CHU Liège
CHU Rennes
APHP - CHU Henri Mondor
Centre Cardiologique du Nord
CHU Tours - Hôpital Trousseau

intervention_type: Other


title: Non-interventional Study to Assess the Safety Profile of Idelalisib in Patients With Refractory Follicular Lymphoma (FL)

acronym: ZEUS

summary: The primary objective of this study is to assess the overall safety profile of idelalisib monotherapy in patients with refractory follicular lymphoma (FL).

study_type: Observational

time_perspective: Other

lead_sponsor: Gilead Sciences

location_country:
Italy
Sweden
Spain
France
Greece
Ireland
Belgium
Portugal
Germany
United Kingdom

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Istituti di Ricovero e Cura A Carattere Scientifico - Istituti Fisioterapici Ospitalieri

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Ospedali Riuniti di Ancona, Clinica Ematologica

location_facility: Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University General Hospital of Alexandroupolis

location_facility: Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico

location_facility: Universita degli Studi di Roma La Sapienza

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Universitari Arnau De Vilanova (Huav)

location_facility: South Tees Hospitals Nhs Foundation Trust

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi

location_facility: Fundació Hospital de la Santa Creu i Sant Pau

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Chalon sur Saône William Morey

location_facility: Centre Hospitalier Bourg-en-Bresse Fleyriat

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

location_facility: Instituto Português de Oncologia Francisco Gentil, Centro Regional de Lisboa SA

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliera Universitaria Maggiore Della Carita di Novara

location_facility: Azienda Ospedaliera Universitaria Senese-L'ospedale Santa Maria alle Scotte

location_facility: AHEPA University General Hospital of Thessaloniki

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: Centre Hospitalier Universitaire d'Amiens (CHU d'Amiens) - Hopital Nord

location_facility: Hospital Clinico Universitario Lozano Blesa


title: Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab

acronym: CURE

summary: This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with early CD. This study will not change the patient/physician relationship.

status: Active, not recruiting

ipd_sharing: Undecided

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility: CHU de Colmar- Hopital Trousseau Medecine A

location_facility: CHU de Caen- Hopital de la Cote de Nacre


title: Nonfunctioning Small (≤2 cm) Neuroendocrine Pancreatic Incidentaloma: Clinical and Morphological Findings, and Therapeutic Options (IPANEMA)

summary: Neuroendocrine tumors (NETs) and carcinomas account for 10-15 % of all pancreatic incidentalomas. The management of pancreatic NETs depends on tumor stage and on presence or not of hormonal syndrome. The therapeutic approach for hormonally functional tumor, or large tumor (> 2 cm) with local, vascular or lymph nodes invasion, highly suggestive of malignancy, or in presence of metastasis, is well admitted: surgery is indicated or should be discussed. However, the attitude is less consensual for small (≤ 2 cm) non-functioning (NF) and non-metastatic lesions. In English, American or French recommendations, systematic surgical resection with lymphadenectomy is currently recommended in all medically fit patients. The follow-up (FU) is possible for tumors <2 cm (T1) located in the pancreatic head and for which enucleation is not feasible. Several recently published retrospective studies discuss the "non- surgical" management of the small NF incidentally detected pancreatic NETs (IPNETs) and highlight the necessity of developing guidelines for management of these patients. A strict correlation between tumor size and malignancy of these tumors was demonstrated in the single-center retrospective Italian study of Bettini and col., which included all patients with NF PNETs who underwent curative (R0) resection during 18 years. In the group of 51 patients with small size of T (2 cm or less), incidentally discovered, the majority of lesion was benign, and the authors concluded that follow-up can be proposed in patients with incidentally discovered NF PNETs ≤ 2 cm. However in despite of small size and asymptomatic character of the tumor, the rate of malignancy of NF IPNETs ≤ 2 cm was estimated to be 24 % (in 18% and 6% of cases, uncertain behaviour and carcinoma were present). Given the inherent morbidities associated with pancreatic surgery, a risk-benefit calculation may favour surveillance rather than surgery in highly selected patients. Thus, a better understanding of NF IPNETs and identification of their prognostic factors can be of help to select a subgroup of patients who could benefit from a long-term surveillance rather than a systematic surgical resection. Clearly, large prospective trials are needed to validate this approach.

time_perspective: Prospective

lead_sponsor: Société Française d'Endoscopie Digestive

location_facility:
Hopital Sud
Hopital Bocage central
Hopital Beaujon
Hopital Saint Joseph
Clinique Universitaire Saint Luc
Hopital Nord
CHRU Jean Minjoz
Centre Hospitalier Lyon Sud
Hopital Privé Jean Mermoz
Clinique du Trocadero
Hopital Robert Debré
Hopital Privé Européen
Hopital Européen George Pompidou
Hopital Edouard Herriot
Hopital du Haut Leveque
Hotel Dieu
Institut Paoli Calmette
CHU Angers
Hopital Cochin
Hopital de la Timone
CHU Rangueil
Hopital de l'archet 2


lead_sponsor: University Hospital, Lille

acronym: DoubleITK

location_facility: Diseases of Blood Service HURIEZ hospital CHRU de LILLE

source: euctr

title: Efficacy and Safety of Nilotinib in Patients With a Chronic Disease of the Graft Against the Host (Graft Versus Host, GVH) Did Not Respond to Imatinib Mesylate.

summary: Open label non-randomized multicenter phase 2 trial with direct individual benefice


title: Validation of the SEPSIS-3 Criterion for Sepsis and Septic Shock in the Emergency Department

acronym: SCREEN

summary:
Investigators aim to evaluate the SEPSIS 3 criterion for "sepsis" and "septic shock" in a prospective manner.

Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population of emergency patients with infection

ReferenceCitation: Freund Y, Lemachatti N, Krastinova E, Van Laer M, Claessens YE, Avondo A, Occelli C, Feral-Pierssens AL, Truchot J, Ortega M, Carneiro B, Pernet J, Claret PG, Dami F, Bloom B, Riou B, Beaune S; French Society of Emergency Medicine Collaborators Group. Prognostic Accuracy of Sepsis-3 Criteria for In-Hospital Mortality Among Patients With Suspected Infection Presenting to the Emergency Department. JAMA. 2017 Jan 17;317(3):301-308. doi: 10.1001/jama.2016.20329.

name: Sorbonne Universités, UPMC Paris Univ-06, Paris, France2Emergency Department, Hôpital Pitie-Salpêtrière, Assistance Publique–Hôpitaux de Paris (APHP), Paris, France

family: Freund

full_name: Yonathan Freund

given: Yonathan

sequence: first

family: Lemachatti

full_name: Najla Lemachatti

given: Najla

sequence: additional

name: Plateforme de recherche clinique de l'est parisien (URCEST-CRCEST), Hôpital St Antoine, APHP, Paris, France

family: Krastinova

full_name: Evguenia Krastinova

given: Evguenia

name: Emergency Department, Cliniques Universitaires St Luc, Bruxelles, Belgium

family: Van Laer

full_name: Marie Van Laer

given: Marie

name: Emergency Department, Princess Grace Hospital, Monte-Carlo, Monaco

family: Claessens

full_name: Yann-Erick Claessens

given: Yann-Erick

name: Emergency Department, Centre hospitalo-universitaire, Dijon, France

family: Avondo

full_name: Aurélie Avondo

given: Aurélie

name: Emergency Department, Hôpital Pasteur, Nice, France

family: Occelli

full_name: Céline Occelli

given: Céline

name: Emergency Department, Hôpital Européen Georges Pompidou, Paris, France

family: Feral-Pierssens

full_name: Anne-Laure Feral-Pierssens

given: Anne-Laure

name: Emergency Department, Hôpital Lariboisière, APHP, Paris, France

family: Truchot

full_name: Jennifer Truchot

given: Jennifer

name: Emergency Department, Hospital Clinic, Barcelona, Spain

family: Ortega

full_name: Mar Ortega

given: Mar

name: Emergency Department, Centre hospitalo-universitaire, Angers, France

family: Carneiro

full_name: Bruno Carneiro

given: Bruno

name: Emergency Department, Hôpital Tenon, APHP, Paris, France

family: Pernet

full_name: Julie Pernet

given: Julie

name: Emergency Department, Centre hospitalo-universitaire, Nîmes, France

family: Claret

full_name: Pierre-Géraud Claret

given: Pierre-Géraud

name: Emergency Department, CHUV, Lausanne, Switzerland

family: Dami

full_name: Fabrice Dami

given: Fabrice

name: Emergency Department, Barts Health NHS trust, London, United Kingdom

family: Bloom

full_name: Ben Bloom

given: Ben

family: Riou

full_name: Bruno Riou

name: Emergency Department, Hôpital Ambroise-Paré, Boulogne, France, and Paris Diderot University, INSERM UMRS 1144, Paris, France

family: Beaune

full_name: Sébastien Beaune

given: Sébastien

name: for the French Society of Emergency Medicine Collaborators Group

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Université de Lausanne - SERVAL

version: publishedVersion

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

repository_normalized: HAL

version: submittedVersion

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

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

location_facility:
Clinic hospital Barcelona
Ambroise Paré
Nancy
St Luc
Pitie-salpetriere
Princess Grace
Toulouse
CHIPO
CHUV
St Louis
Longjumeau
Cochin
Saint-Antoine
Strasbourg
Lyon
Vienne
Tenon
Grenoble
Lariboisière
Avicenne
CHU Angers
Dijon
Bichat
Tours
HEGP
Nice
Saint Camille


title: A EUROPEAN, MULTICENTRE, PHASE II/III RANDOMISED DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING LANREOTIDE AS MAINTENANCE THERAPY IN PATIENTS WITH NON-RESECTABLE DUODENO-PANCREATIC NEUROENDOCRINE TUMOURS AFTER FIRST-LINE TREATMENT

acronym: REMINET

summary: This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.

ReferenceType: background

ReferenceCitation: Lepage C, Dahan L, Bouarioua N, Toumpanakis C, Legoux JL, Le Malicot K, Guimbaud R, Smith D, Tougeron D, Lievre A, Cadiot G, Di Fiore F, Bouhier-Leporrier K, Hentic O, Faroux R, Pavel M, Borbath I, Valle JW, Rinke A, Scoazec JY, Ducreux M, Walter T. Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours. Dig Liver Dis. 2017 May;49(5):568-571. doi: 10.1016/j.dld.2017.02.004. Epub 2017 Mar 11.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country:
Germany
United Kingdom
Belgium
France

location_facility: Hôpital Haut Lévêque Bat Magellan, Service d'hépato-gastroentérologie

location_facility: Royal Free Hospital Neuroendocrine Tumour Unit

location_facility: Manchester Academic Health Sciences Centre (MAHSC)


title: Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants

acronym: GIHP-NACO

summary:
The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel questions among clinicians confronted with the emergency management of patients treated with these new drugs. It is likely that these new oral anticoagulants (NOACs) will eventually win a significant market share in the indications secondary prevention of venous thromboembolism and prevention of cardioembolic events in patients with nonvalvular atrial fibrillation, due to their net clinical benefit and their practicality of use compared with vitamin K antagonists (VKAs).

However, despite the fact that NOACs reduce the incidence of intracranial bleeding by about half compared with VKAs, the risk remains significant; furthermore, in clinical trials, these drugs had little or no effect on reducing the incidence of major extracranial bleeding. In everyday practice, where the indication could be expanded to unselected populations and due to a potential for misuse, it is likely that the incidence of bleeding complications will be higher than that reported in clinical trials. Indeed, the numerous alerts emanating from regulatory agencies in various countries (US, Australia, etc.) bear witness to this, and should serve as a reminder that these anticoagulants have a real potential for bleeding complications and, in the absence of an antidote, there is no validated management strategy.

Furthermore, as these drugs can be prescribed for months or years, patients may eventually be exposed to situations at high hemorrhagic risk, such as emergency surgery or invasive procedures, trauma, etc. Analysis of data from the trial : dabigatran versus warfarin in patients with atrial fibrillation (RE-LY) showed that during the two years of follow-up, approximately 25% of the patients underwent an invasive procedure, ranging from pacemaker insertion to major surgery. Thus, a large proportion of patients treated with NOACs are concerned by this issue.

In anticipation of a gradually increasing influx of patients in a critical situation (active bleeding or need to rapidly secure hemostasis before an invasive procedure), it is urgent to define the conduct to adopt based on the experience gained from the earliest cases. This is the objective of the French-speaking GIHP-NACO observatory set up by the GIHP (French Working Group on Perioperative Hemostasis).

For the moment, then, the management recommendations derive from expert opinions based on pharmacokinetic data and on the partial correction of NOAC-induced hypocoagulability by various nonspecific procoagulants (non-activated or activated prothrombin complex concentrates, recombinant factor VIIa). These procoagulants are currently used in an empirical manner to control bleeding, with as many successes as failures reported in the literature, and their benefit-risk ratio in these patients is therefore uncertain.

ReferenceCitation: Pernod G, Albaladejo P, Godier A, Samama CM, Susen S, Gruel Y, Blais N, Fontana P, Cohen A, Llau JV, Rosencher N, Schved JF, de Maistre E, Samama MM, Mismetti P, Sié P; Working Group on Perioperative Haemostasis. Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013. Arch Cardiovasc Dis. 2013 Jun-Jul;106(6-7):382-93. doi: 10.1016/j.acvd.2013.04.009. Epub 2013 Jun 25.

ReferenceCitation: Marlu R, Hodaj E, Paris A, Albaladejo P, Cracowski JL, Pernod G. Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban: a randomised crossover ex vivo study in healthy volunteers. Thromb Haemost. 2012 Aug;108(2):217-24. doi: 10.1160/TH12-03-0179. Epub 2012 May 25. Erratum in: Thromb Haemost. 2013 Jan;109(1):169.

ReferenceCitation: Sié P, Samama CM, Godier A, Rosencher N, Steib A, Llau JV, Van der Linden P, Pernod G, Lecompte T, Gouin-Thibault I, Albaladejo P; Working Group on Perioperative Haemostasis; French Study Group on Thrombosis and Haemostasis. Surgery and invasive procedures in patients on long-term treatment with direct oral anticoagulants: thrombin or factor-Xa inhibitors. Recommendations of the Working Group on Perioperative Haemostasis and the French Study Group on Thrombosis and Haemostasis. Arch Cardiovasc Dis. 2011 Dec;104(12):669-76. doi: 10.1016/j.acvd.2011.09.001. Epub 2011 Oct 29.

ReferenceCitation: Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang S, Themeles E, Heidbuchel H, Avezum A, Reilly P, Connolly SJ, Yusuf S, Ezekowitz M; RE-LY Investigators. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation. 2012 Jul 17;126(3):343-8. doi: 10.1161/CIRCULATIONAHA.111.090464. Epub 2012 Jun 14. Erratum in: Circulation. 2012 Sep 4;126(10):e160. Heidbuchle, Hein [corrected to Heidbuchel, Hein].

name: From the Population Health Research Institute, McMaster University, Hamilton, Canada (J.S.H., J.E., S.Y., E.T., S.J.C., S.Y.); St. Joseph's Healthcare Hamilton, McMaster University, Hamilton, Canada (J.D.); Uppsala Clinical Research Centre, Uppsala, Sweden (L.W., J.O.); University Hospitals Leuven, University of Leuven, Leuven, Belgium (H.H.); Instituto Dante Pazzenese de Cardiologia, Hospital Do Coracao, Sao Paolo, Brazil (A.A.); Boehringer-Ingelheim Pharmaceuticals, Ridgefield, CT (P.R.); and...

family: Healey

full_name: Jeff S. Healey

given: Jeff S.

family: Eikelboom

full_name: John Eikelboom

given: John

family: Douketis

full_name: James Douketis

given: James

family: Wallentin

full_name: Lars Wallentin

given: Lars

family: Oldgren

full_name: Jonas Oldgren

given: Jonas

family: Yang

full_name: Sean Yang

given: Sean

family: Themeles

full_name: Ellison Themeles

given: Ellison

family: Heidbuchel

full_name: Hein Heidbuchel

given: Hein

family: Avezum

full_name: Alvaro Avezum

given: Alvaro

family: Reilly

full_name: Paul Reilly

given: Paul

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Ezekowitz

full_name: Michael Ezekowitz

given: Michael

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Periprocedural Bleeding and Thromboembolic Events With Dabigatran Compared With Warfarin

ReferenceCitation: Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P; European Heart Rhythm Association. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace. 2013 May;15(5):625-51. doi: 10.1093/europace/eut083.

lead_sponsor: University Hospital, Grenoble

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

acronym: Per-DRISLA

summary:
The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast.

Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CH St Antoine
Hôpital Purpan
CH Rouen
CH Amiens
CHRU de Brest
Hopîtal Beaujon
CH Saint-Denis - Hôpital de la Fontaine
CH Cholet
CH Rennes
CH Dijon
CH Vannes
CH Caen
CH Lille
CH Gonesse
CHU Besançon
CHD Vendée
CH Orléans
CH Reims
CH Yves Le Foll
Hopital Laennec
CHU Nice
Hopital Jolimont


title: TRANSFORM - Observational Cohort Study of Aranesp Use in EU Haemodialysis Patients Switched From Mircera

acronym: TRANSFORM

summary: To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).

ReferenceCitation: Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Adv Ther. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. Epub 2014 Nov 1.

family: Donck

full_name: Jan Donck

given: Jan

family: Gonzalez-Tabares

full_name: Lourdes Gonzalez-Tabares

given: Lourdes

family: Chanliau

full_name: Jacques Chanliau

given: Jacques

family: Martin

full_name: Heike Martin

given: Heike

family: Stamatelou

full_name: Kyriaki Stamatelou

given: Kyriaki

family: Manamley

full_name: Nick Manamley

given: Nick

family: Farouk

full_name: Mourad Farouk

given: Mourad

family: Addison

full_name: Janet Addison

given: Janet

journal_name: Advances in Therapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Preservation of Anemia Control and Weekly ESA Dosage After Conversion from PEG-Epoetin Beta to Darbepoetin Alfa in Adult Hemodialysis Patients: The TRANSFORM Study

lead_sponsor: Amgen

location_country: Switzerland Netherlands France Greece Belgium Spain Germany


title: Multinational European Trial for Children With the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome

summary:
The OMS/DES study is a multinational European Trial for Children with the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome.

This trial brought on the way by specialists of the EPNS (European Paediatric Neurology Society), the GPOH (Gesellschaft für Pädiatrische Hematologic und Oncologie) and the SIOPEN (SIOP (International Society Oncology Pediatric) Europe Neuroblastoma).

This protocol will investigate an escalating treatment schedule starting with a corticosteroid standard treatment with dexamethasone pulses (first step), which is followed, if response has been inadequate after 3 months of treatment, by the addition of CP (second step) and, if still no sufficient improvement, by the replacement of CP by Rituximab (third step). Treatment intensification is decided on the basis of standardized scoring of OMS/DES severity.

lead_sponsor: Institut Curie

location_country:
Italy
Austria
Sweden
Switzerland
France
Spain
United Kingdom

location_facility: The Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

location_facility: St. Anna Kinderkrebsforschung e.V. CHILDREN'S CANCER RESEARCH INSTITUTE


title: Validation of a Predictive Risk Equation for Type 2 Diabetes in Children With Diabetes to Achieve a Predictive Diagnostic Biochip for the Early Detection of Individuals at Risk in Families.

acronym: DESCENDANCE

summary:
Considering its epidemic-like development worldwide, associated with modifications in lifestyle, as well as its enormous social and economic weight, the prevention of type II diabetes is certain to be a central concern of health systems within the developed countries in the decades to come. However, while simple obesity concerns the entire population, type 2 diabetes affects only one sub-population at high genetic risk. To be effective and realistic in economic terms, efforts at prevention must be thus targeted towards these subjects at high risk. The key issue involves identifying such subjects early enough so that a strategy of effective prevention can be organized in good time.

Until now, efforts have been concentrated on individuals at risk for diabetes readily identifiable within the general population, typically subjects in the second half of adulthood, presenting abdominal obesity and mild abnormalities of blood sugar. Preventive lifestyle and dietary measures are proposed but are constrictive and difficult to maintain over time, and the results, although they may be significant, remain disappointing, with mere postponement of an outcome which at this stage appears inevitable. The reason is ascribable to excessively tardy intervention, when the pathogenic process has already been ongoing for some ten years and the endocrine function of the pancreas is probably already irreparably impaired.

The alternative thus is earlier intervention, in childhood, adolescence or early adulthood. The problem is to identify individuals at high risk of becoming diabetic at a time when they are presenting no simple clinical or laboratory abnormalities allowing easy diagnosis. The familial character of type 2 diabetes is now well established, and future diabetic subjects are themselves above all the children of diabetic subjects. However, the prevalence of the disease among the descendants of type 2 diabetic subjects is around 20-30% and predictive tools are needed to combat diabetes in these high-risk families.

We propose to create a risk equation using an algorithm to reliably predict children most likely to develop diabetes later in life.

The algorithm will include 3 classes of data:

The genotype stemming from the genetic characterization of individuals and those their parents;
Environmental data concerning childhood, especially eating habits and physical activity;
Data of the mother who was eventually diabetic during pregnancy.

From a methodological standpoint, it would be rather difficult to take blood samples from children and wait some 50 years to determine whether or not they develop diabetes. To circumvent this difficulty, we will recruit subjects in families with a history of type II diabetes:

Parents alive, including at least one type 2 diabetic subject
Adult children (aged over 35 years), some of whom are already presenting type II diabetes, and healthy brothers and sisters, who form the control population. Test will be done to determine whether healthy subjects are really safe from the risk of diabetes (HbA1c measurement and glucose load test).

The Descendence study will include 500 families at risk involving about 3000 subjects (1000 subjects with diabetes and 2000 healthy subjects). It is expected to answer the following question: for a child born in such families at risk, what is the probability of developing diabetes later in life, so that early preventive action may be taken

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
CHU de Caen
CHRU Lille
CHU Toulouse
CHU Marseille Hôpitaux Sud
CHU de Nantes
CHU de Nancy
CHU Bichat
CHU de Bondy
Centre Hospitalier Strasbourg
CHU Avicenne
University Hospital Grenoble
CHU de REIMS
CHU Sart Tilman Liège
CHU Jean Minjoz
CHU de BREST
CHU de Bicetre
CH Sud Francilien


title: Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects From Primary Care

acronym: ACCESS

summary: This is a prospective, observational, non-drug interventional, non-randomized study to compare the rate of moderate-severe COPD exacerbations in patients of all Chronic Obstructive Pulmonary Disease (COPD) severities with and without cardiovascular diseases. A total study population of 3330 subjects will be recruited by general practitioners (GPs) and assessed over a 27 month time frame.

lead_sponsor: GlaxoSmithKline

location_country: Netherlands Poland France Belgium Spain Germany


title: A Phase III Randomized Study Evaluating Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) in the Treatment of Relapse Ovarian Cancer

acronym: CHIPOR

summary: CHIPOR hypothesis is that the adjunction of platinum HIPEC in first relapsed epithelial ovarian cancer is able to improve the median Overall Survival (OS) by 12 months. In that hypothesis, with alpha risk of 5%, a power beta of 80%, during a 3 years period of inclusion and a 3 years follow-up, the number of patients to include is 404. Taking into account a 10% failure, an overall number of 444 patients is required.

ReferenceType: result

ReferenceCitation: Brigand C, Monneuse O, Mohamed F, Sayag-Beaujard AC, Isaac S, Gilly FN, Glehen O. Peritoneal mesothelioma treated by cytoreductive surgery and intraperitoneal hyperthermic chemotherapy: results of a prospective study. Ann Surg Oncol. 2006 Mar;13(3):405-12. Epub 2006 Jan 30.

ReferenceCitation: Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43.

location_country: Belgium France Spain

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Centre Hospitalier Universitaire Saint Etienne- Hopital Nord


lead_sponsor: University Hospital, Limoges

acronym: NEPHRUTIX

location_facility: Queen Fabiola Universitary Children's Hospital

title: A Prospective, Randomized, Double Blind, Placebo-controlled Phase II/III Study Evaluating the Efficacy of Rituximab in the Prevention of Relapse of Calcineurin Inhibitors Dependent Idiopathic Nephrotic Syndrome of Childhood

summary:
Background

Idiopathic nephrotic syndrome is a rare disease beginning during childhood and treated with immunosuppressants (i.e. steroids, mycophenolate mofetil, cyclophosphamide, cyclosporine).

Renal function of patients suffering from severe, steroid-dependent nephrotic syndrome with failure or toxic side effects of other immunosuppressant treatments is a major matter of concern.

Cyclosporine endangers renal parenchyma (fibrosis) in these patients who must take this treatment for years. At the same time, low doses of cyclosporine allow proteinuria to reappear, which provokes degradation of renal function by focal segmental glomerulosclerosis. Some recent data lead to the conclusion that Rituximab may be effective in such a disease, with a cyclosporin sparing effect.

Purpose

The aim of the study is to evaluate the efficacy of Rituximab versus placebo in the treatment of pediatric patients suffering from severe cyclosporine-dependent nephrotic syndrome.

Abstract Patients will be included in the study in a period of remission of proteinuria. Two infusions of Rituximab - at the dose of 375 mg/m²- or placebo will be administered at one week of interval. Other immunosuppressant treatments will be gradually tapered off with the same tapering pattern in both groups. In case of relapse of nephrotic syndrome, the blinding code will be broken. Rituximab will then be infused to patients having received placebo.


title: Value of Contrast-enhanced Ultrasonography and Magnetic Resonance Enterography to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease Complicated by Symptomatic Small Bowel Stricture

acronym: CREOLE

summary:
The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has not been clearly demonstrated. The results reported by some teams suggest no beneficial effect or even an increased risk of bowel obstruction in the case of stricture, while other publications indicate a favourable action of anti-TNF in this setting. The efficacy of anti-TNF in patients with intestinal stricture related to Crohn's disease could depend on the lesions responsible for the stricture, as anti-TNF agents are probably effective in inflammatory forms and useless or even potentially harmful in fibrotic forms. In practice, the decision is currently empirical and a trial of anti-TNF therapy is often proposed.

In view of the high incidence of intestinal strictures in CD and the need for a treatment as effective as anti-TNF in this setting, it is important to more clearly define the indications of these treatments guided by the information provided by modern imaging.

The aim of this prospective study is to determine whether certain signs detected by MR enterography and contrast-enhanced ultrasonography can help to predict failure of anti-TNF therapy in patients with CD presenting a symptomatic stricture of the small bowel and scheduled to receive this treatment.

ReferenceCitation: Bernstein CN, Greenberg H, Boult I, Chubey S, Leblanc C, Ryner L. A prospective comparison study of MRI versus small bowel follow-through in recurrent Crohn's disease. Am J Gastroenterol. 2005 Nov;100(11):2493-502.

ReferenceCitation: Biancone L, Calabrese E, Petruzziello C, Onali S, Caruso A, Palmieri G, Sica GS, Pallone F. Wireless capsule endoscopy and small intestine contrast ultrasonography in recurrence of Crohn's disease. Inflamm Bowel Dis. 2007 Oct;13(10):1256-65.

ReferenceCitation: Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. Review.

ReferenceCitation: Chiorean MV, Sandrasegaran K, Saxena R, Maglinte DD, Nakeeb A, Johnson CS. Correlation of CT enteroclysis with surgical pathology in Crohn's disease. Am J Gastroenterol. 2007 Nov;102(11):2541-50. Epub 2007 Sep 26.

ReferenceCitation: Esteban JM, Aleixandre A, Hurtado MJ, Maldonado L, Mora FJ, Nogués E. Contrast-enhanced power Doppler ultrasound in the diagnosis and follow-up of inflammatory abdominal masses in Crohn's disease. Eur J Gastroenterol Hepatol. 2003 Mar;15(3):253-9.

ReferenceCitation: Giorgio A, Ferraioli G, Tarantino L, de Stefano G, Scala V, Scarano F, Coppola C, Del Viscovo L. Contrast-enhanced sonographic appearance of hepatocellular carcinoma in patients with cirrhosis: comparison with contrast-enhanced helical CT appearance. AJR Am J Roentgenol. 2004 Nov;183(5):1319-26.

ReferenceCitation: Guidi L, De Franco A, De Vitis I, Armuzzi A, Semeraro S, Roberto I, Papa A, Bock E, Gasbarrini G, Fedeli G. Contrast-enhanced ultrasonography with SonoVue after infliximab therapy in Crohn's disease. Eur Rev Med Pharmacol Sci. 2006 Jan-Feb;10(1):23-6.

ReferenceCitation: Holtmann M, Wanitschke R, Helisch A, Bartenstein P, Galle PR, Neurath M. [Anti-TNF antibodies in the treatment of inflammatory intestinal stenoses in Crohn's disease]. Z Gastroenterol. 2003 Jan;41(1):11-7. German.

ReferenceCitation: Louis E, Boverie J, Dewit O, Baert F, De Vos M, D'Haens G; Belgian IBD Research Group. Treatment of small bowel subocclusive Crohn's disease with infliximab: an open pilot study. Acta Gastroenterol Belg. 2007 Jan-Mar;70(1):15-9.

ReferenceCitation: Masselli G, Brizi GM, Parrella A, Minordi LM, Vecchioli A, Marano P. Crohn disease: magnetic resonance enteroclysis. Abdom Imaging. 2004 May-Jun;29(3):326-34.

ReferenceCitation: Masselli G, Casciani E, Polettini E, Gualdi G. Comparison of MR enteroclysis with MR enterography and conventional enteroclysis in patients with Crohn's disease. Eur Radiol. 2008 Mar;18(3):438-47. Epub 2007 Sep 25.

ReferenceCitation: Negaard A, Mulahasanovic A, Reisaeter LA, Aasekjaer K, Sandvik L, Klow NE. Crohn's disease evaluated with magnetic resonance enteroclysis: diagnostic performance of experienced and inexperienced readers before and after training. Acta Radiol. 2008 Nov;49(9):967-74. doi: 10.1080/02841850802409539.

ReferenceCitation: Negaard A, Sandvik L, Mulahasanovic A, Berstad AE, Klöw NE. Magnetic resonance enteroclysis in the diagnosis of small-intestinal Crohn's disease: diagnostic accuracy and inter- and intra-observer agreement. Acta Radiol. 2006 Dec;47(10):1008-16.

ReferenceCitation: Parente F, Greco S, Molteni M, Anderloni A, Maconi G, Bianchi Porro G. Modern imaging of Crohn's disease using bowel ultrasound. Inflamm Bowel Dis. 2004 Jul;10(4):452-61. Review.

ReferenceCitation: De Pascale A, Garofalo G, Perna M, Priola S, Fava C. Contrast-enhanced ultrasonography in Crohn's disease. Radiol Med. 2006 Jun;111(4):539-50. Epub 2006 May 25. English, Italian.

ReferenceCitation: Pelletier AL, Kalisazan B, Wienckiewicz J, Bouarioua N, Soulé JC. Infliximab treatment for symptomatic Crohn's disease strictures. Aliment Pharmacol Ther. 2009 Feb 1;29(3):279-85. doi: 10.1111/j.1365-2036.2008.03887.x. Epub 2008 Nov 8.

ReferenceCitation: Di Sabatino A, Fulle I, Ciccocioppo R, Ricevuti L, Tinozzi FP, Tinozzi S, Campani R, Corazza GR. Doppler enhancement after intravenous levovist injection in Crohn's disease. Inflamm Bowel Dis. 2002 Jul;8(4):251-7.

ReferenceCitation: Rieder F, Brenmoehl J, Leeb S, Schölmerich J, Rogler G. Wound healing and fibrosis in intestinal disease. Gut. 2007 Jan;56(1):130-9. Review.

ReferenceCitation: Di Sabatino A, Pender SL, Jackson CL, Prothero JD, Gordon JN, Picariello L, Rovedatti L, Docena G, Monteleone G, Rampton DS, Tonelli F, Corazza GR, MacDonald TT. Functional modulation of Crohn's disease myofibroblasts by anti-tumor necrosis factor antibodies. Gastroenterology. 2007 Jul;133(1):137-49. Epub 2007 May 5.

ReferenceCitation: Sallomi DF. The use of contrast-enhanced power Doppler ultrasound in the diagnosis and follow-up of inflammatory abdominal masses associated with Crohn's disease. Eur J Gastroenterol Hepatol. 2003 Mar;15(3):249-51. Review.

ReferenceCitation: Schlottmann K, Kratzer W, Schölmerich J. Doppler ultrasound and intravenous contrast agents in gastrointestinal tract disorders: current role and future implications. Eur J Gastroenterol Hepatol. 2005 Mar;17(3):263-75. Review.

ReferenceCitation: Schreyer AG, Geissler A, Albrich H, Schölmerich J, Feuerbach S, Rogler G, Völk M, Herfarth H. Abdominal MRI after enteroclysis or with oral contrast in patients with suspected or proven Crohn's disease. Clin Gastroenterol Hepatol. 2004 Jun;2(6):491-7.

ReferenceCitation: Serra C, Menozzi G, Labate AM, Giangregorio F, Gionchetti P, Beltrami M, Robotti D, Fornari F, Cammarota T. Ultrasound assessment of vascularization of the thickened terminal ileum wall in Crohn's disease patients using a low-mechanical index real-time scanning technique with a second generation ultrasound contrast agent. Eur J Radiol. 2007 Apr;62(1):114-21. Epub 2007 Jan 18.

ReferenceCitation: Solt J, Hertelendi A, Szilágyi K. [Balloon catheter dilatation of lower gastrointestinal tract stenoses: long-term results]. Orv Hetil. 2002 Aug 4;143(31):1835-40. Hungarian.

ReferenceCitation: Sorrentino D. Role of biologics and other therapies in stricturing Crohn's disease: what have we learnt so far? Digestion. 2008;77(1):38-47. doi: 10.1159/000117306. Epub 2008 Feb 19. Review.

ReferenceCitation: Warnaar N, Hofker HS, Maathuis MH, Niesing J, Bruggink AH, Dijkstra G, Ploeg RJ, Schuurs TA. Matrix metalloproteinases as profibrotic factors in terminal ileum in Crohn's disease. Inflamm Bowel Dis. 2006 Sep;12(9):863-9.

ReferenceCitation: Bouhnik Y, Carbonnel F, Laharie D, Stefanescu C, Hébuterne X, Abitbol V, Nachury M, Brixi H, Bourreille A, Picon L, Bourrier A, Allez M, Peyrin-Biroulet L, Moreau J, Savoye G, Fumery M, Nancey S, Roblin X, Altwegg R, Bouguen G, Bommelaer G, Danese S, Louis E, Zappa M, Mary JY; GETAID CREOLE Study Group. Efficacy of adalimumab in patients with Crohn's disease and symptomatic small bowel stricture: a multicentre, prospective, observational cohort (CREOLE) study. Gut. 2018 Jan;67(1):53-60. doi: 10.1136/gutjnl-2016-312581. Epub 2017 Jan 24.

family: Bouhnik

full_name: Yoram Bouhnik

given: Yoram

family: Carbonnel

full_name: Franck Carbonnel

given: Franck

family: Laharie

full_name: David Laharie

given: David

family: Stefanescu

full_name: Carmen Stefanescu

given: Carmen

family: Hébuterne

full_name: Xavier Hébuterne

given: Xavier

family: Abitbol

full_name: Vered Abitbol

given: Vered

family: Nachury

full_name: Maria Nachury

given: Maria

family: Brixi

full_name: Hedia Brixi

given: Hedia

family: Bourreille

full_name: Arnaud Bourreille

given: Arnaud

family: Picon

full_name: Laurence Picon

given: Laurence

family: Bourrier

full_name: Anne Bourrier

given: Anne

family: Allez

full_name: Matthieu Allez

given: Matthieu

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Moreau

full_name: Jacques Moreau

family: Savoye

full_name: Guillaume Savoye

given: Guillaume

family: Fumery

full_name: Mathurin Fumery

given: Mathurin

family: Nancey

full_name: Stephane Nancey

given: Stephane

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

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

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

repository_institution: University of Liège - Open Repository and Bibliography

location_facility:
Hopital Bichat
Chu Besancon
Hopital Saint Louis
Chu Reims
Hopital Cochin
Hopital Avicennes
Hopital Lariboisiere
Chu Amiens
Chu Nantes
Hopital Beaujon
Ulb - Clinique Saint Luc
CHU NICE
Hopital St Antoine
Chu Rouen
Chu Montpellier
Chu Tours
Chru Lille
Hopital Bicetre


type: Registry Identifier

title: A RANDOMIZED CONTROLLED STUDY IN NEWLY DIAGNOSED SEVERE APLASTIC ANEMIA PATIENTS RECEIVING ANTITHYMOCYTE GLOBULIN (ATG), CYCLOSPORIN A, WITH OR WITHOUT G-CSF

acronym: SAA-G-CSF

summary: The purpose of this study is to examine the effect of G-CSF on disease free survival and overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.

ReferenceCitation: Tichelli A, de Latour RP, Passweg J, Knol-Bout C, Socié G, Marsh J, Schrezenmeier H, Höchsmann B, Bacigalupo A, Samarasinghe S, Rovó A, Kulasekararaj A, Röth A, Eikema DJ, Bosman P, Bader P, Risitano A, Dufour C; SAA Working Party of the EBMT. Long-term outcome of a randomized controlled study in patients with newly diagnosed severe aplastic anemia treated with antithymocyte globulin and cyclosporine, with or without granulocyte colony-stimulating factor: a Severe Aplastic Anemia Working Party Trial from the European Group of Blood and Marrow Transplantation. Haematologica. 2020 May;105(5):1223-1231. doi: 10.3324/haematol.2019.222562. Epub 2019 Oct 3.

family: Tichelli

full_name: André Tichelli

given: André

family: de Latour

full_name: Régis Peffault de Latour

given: Régis Peffault

family: Passweg

full_name: Jakob Passweg

given: Jakob

family: Knol-Bout

full_name: Cora Knol-Bout

given: Cora

family: Socié

full_name: Gérard Socié

given: Gérard

family: Marsh

full_name: Judith Marsh

given: Judith

family: Schrezenmeier

full_name: Hubert Schrezenmeier

given: Hubert

family: Höchsmann

full_name: Britta Höchsmann

given: Britta

family: Bacigalupo

full_name: Andrea Bacigalupo

given: Andrea

family: Samarasinghe

full_name: Sujith Samarasinghe

given: Sujith

family: Rovó

full_name: Alicia Rovó

given: Alicia

family: Kulasekararaj

full_name: Austin Kulasekararaj

given: Austin

family: Röth

full_name: Alexander Röth

given: Alexander

family: Eikema

full_name: Dirk-Jan Eikema

given: Dirk-Jan

family: Bosman

full_name: Paul Bosman

given: Paul

family: Bader

full_name: Peter Bader

given: Peter

family: Risitano

full_name: Antonio Risitano

given: Antonio

family: Dufour

full_name: Carlo Dufour

given: Carlo

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Tichelli A, Schrezenmeier H, Socié G, Marsh J, Bacigalupo A, Dührsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Höchsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2011 Apr 28;117(17):4434-41. doi: 10.1182/blood-2010-08-304071. Epub 2011 Jan 13.

name: Hematology, University Hospital Basel, Basel, Switzerland;

name: Institute for Clinical Transfusion Medicine and Immunogenetics, University Hospital Ulm, Ulm, Germany;

name: Hospital Saint Louis, Hematology-Transplantation and University Paris VII, Paris France;

name: Department of Haematological Medicine, King's College Hospital/King's College London, London, United Kingdom;

name: Department of Hematology II, Ospedalo San Martino, Genova, Italy;

name: Department of Hematology, University Hospital Essen, Essen, Germany;

name: Hannover Medical School, Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Hannover, Germany;

name: Department of Medicine, University of Cologne, Cologne, Germany;

name: Medizinische Klinik III, Charité–Universitätsmedizin, Berlin, Germany;

name: Med. Klinik 5, Klinikum Nürnberg, Nürnberg, Germany;

name: EBMT Clinical Trials Office Leiden, Medical Statistics and Bio-informatics, Leiden University Medical Centre, Leiden, The Netherlands;

name: EBMT Clinical Trials Office London, Guy's Hospital, London, United Kingdom; and

name: Hematology, University Hospital Geneva, Geneva, Switzerland

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
Italy
Sweden
Switzerland
Netherlands
United Kingdom
France
Greece
Germany
Czech Republic

location_facility: St George's Hospital/ St George's University of London


title: Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?

summary: The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.

primary_purpose: Supportive Care

ReferenceCitation: Riveline JP, Schaepelynck P, Chaillous L, Renard E, Sola-Gazagnes A, Penfornis A, Tubiana-Rufi N, Sulmont V, Catargi B, Lukas C, Radermecker RP, Thivolet C, Moreau F, Benhamou PY, Guerci B, Leguerrier AM, Millot L, Sachon C, Charpentier G, Hanaire H; EVADIAC Sensor Study Group. Assessment of patient-led or physician-driven continuous glucose monitoring in patients with poorly controlled type 1 diabetes using basal-bolus insulin regimens: a 1-year multicenter study. Diabetes Care. 2012 May;35(5):965-71. doi: 10.2337/dc11-2021. Epub 2012 Mar 28.

family: Riveline

full_name: J.-P. Riveline

family: Schaepelynck

full_name: P. Schaepelynck

given: P.

family: Chaillous

full_name: L. Chaillous

given: L.

family: Renard

full_name: E. Renard

given: E.

family: Sola-Gazagnes

full_name: A. Sola-Gazagnes

given: A.

family: Penfornis

full_name: A. Penfornis

family: Tubiana-Rufi

full_name: N. Tubiana-Rufi

given: N.

family: Sulmont

full_name: V. Sulmont

given: V.

family: Catargi

full_name: B. Catargi

given: B.

family: Lukas

full_name: C. Lukas

given: C.

family: Radermecker

full_name: R. P. Radermecker

given: R. P.

family: Thivolet

full_name: C. Thivolet

family: Moreau

full_name: F. Moreau

given: F.

family: Benhamou

full_name: P.-Y. Benhamou

family: Guerci

full_name: B. Guerci

family: Leguerrier

full_name: A.-M. Leguerrier

family: Millot

full_name: L. Millot

family: Sachon

full_name: C. Sachon

family: Charpentier

full_name: G. Charpentier

given: G.

family: Hanaire

full_name: H. Hanaire

given: H.

journal_name: Diabetes Care

oa_colors: green other

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_institution: University of Liège - Open Repository and Bibliography

title: Assessment of Patient-Led or Physician-Driven Continuous Glucose Monitoring in Patients With Poorly Controlled Type 1 Diabetes Using Basal-Bolus Insulin Regimens: A 1-year multicenter study

location_facility:
CHU Strasbourg
CHU La Pitié Salpetrière
CHU Toulouse
CH SUD Francilien
CHU Marseille Hôpitaux Sud
CHU Robert Debré
Hopital Haut Leveque
Hopital Hotel Dieu
CHU de Reims-Hôpital Robert debré
CHU de Reims-Hôpital Américain
Hopital Bellevue
Hopital Edouard Herriot
University Hospital Grenoble
CHU Sart Tilman Liège
CHU Jean Minjoz
Chu Montpellier
CHU Nantes
CHU Hôpital Jeanne d'Arc
CHU Rennes


title: Randomized Phase III Trial Comparing Early Treatment With Fludarabine/Cyclophosphamide + Rituximab Versus Deferred Treatment in Untreated Binet Stage A Patients With CLL and High Risk of Progression

summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is more effective than observation alone in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and cyclophosphamide to see how well they work compared to observation alone in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.

ReferenceCitation: Sachanas S, Pangalis GA, Fink AM, Bahlo J, Fischer K, Levidou G, Kyrtsonis MC, Bartzi V, Vassilakopoulos TP, Kalpadakis C, Koulieris E, Moschogiannis M, Yiakoumis X, Tsirkinidis P, Angelopoulou MK, Eichhorst B, Hallek M. Small Lymphocytic Lymphoma: Analysis of Two Cohorts Including Patients in Clinical Trials of the German Chronic Lymphocytic Leukemia Study Group (GCLLSG) or in "Real-Life" Outside of Clinical Trials. Anticancer Res. 2019 May;39(5):2591-2598. doi: 10.21873/anticanres.13382.

ReferenceCitation: Herling CD, Cymbalista F, Groß-Ophoff-Müller C, Bahlo J, Robrecht S, Langerbeins P, Fink AM, Al-Sawaf O, Busch R, Porcher R, Cazin B, Dreyfus B, Ibach S, Leprêtre S, Fischer K, Kaiser F, Eichhorst B, Wentner CM, Hoechstetter MA, Döhner H, Leblond V, Kneba M, Letestu R, Böttcher S, Stilgenbauer S, Hallek M, Levy V. Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial. Leukemia. 2020 Aug;34(8):2038-2050. doi: 10.1038/s41375-020-0747-7. Epub 2020 Feb 18.

family: Herling

full_name: Carmen D. Herling

given: Carmen D.

family: Cymbalista

full_name: Florence Cymbalista

given: Florence

family: Groß-Ophoff-Müller

full_name: Carolin Groß-Ophoff-Müller

given: Carolin

family: Bahlo

full_name: Jasmin Bahlo

given: Jasmin

family: Robrecht

full_name: Sandra Robrecht

given: Sandra

family: Langerbeins

full_name: Petra Langerbeins

given: Petra

family: Fink

full_name: Anna-Maria Fink

given: Anna-Maria

family: Al-Sawaf

full_name: Othman Al-Sawaf

given: Othman

family: Busch

full_name: Raymonde Busch

given: Raymonde

family: Porcher

full_name: Raphael Porcher

given: Raphael

family: Cazin

full_name: Bruno Cazin

given: Bruno

family: Dreyfus

full_name: Brigitte Dreyfus

given: Brigitte

family: Ibach

full_name: Stefan Ibach

given: Stefan

family: Leprêtre

full_name: Stéphane Leprêtre

given: Stéphane

family: Fischer

full_name: Kirsten Fischer

given: Kirsten

family: Kaiser

full_name: Florian Kaiser

given: Florian

family: Eichhorst

full_name: Barbara Eichhorst

given: Barbara

family: Wentner

full_name: Clemens-Martin Wentner

given: Clemens-Martin

family: Hoechstetter

full_name: Manuela A. Hoechstetter

given: Manuela A.

family: Döhner

full_name: Hartmut Döhner

given: Hartmut

family: Leblond

full_name: Veronique Leblond

given: Veronique

family: Kneba

full_name: Michael Kneba

given: Michael

family: Letestu

full_name: Remi Letestu

given: Remi

repository_institution: Technical University Munich - mediaTUM – the media and publications repository of the Technical University Munich

location_facility: Burkhard and Reimann Gemeinschaftspraxis

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

location_facility: St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

location_facility: Internistische Gemeinschaftspraxis - Forchheim

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

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

location_facility: Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin

location_facility: Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Internistische Gemeinschaftspraxis - Berlin

location_facility: Internistische Gemeinschaftspraxis - Offenbach

location_facility: Internistische Gemeinschaftspraxis - Halle

location_facility: Internistische Gemeinschaftspraxis - Oldenburg

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Praxis Fuer Haematologie Internistische Onkologie

location_facility: Staedtisches Klinikum Magdeburg - Altstadt

location_facility: Praxis fuer Innere Medizin Haematologie und Internistische Onkologie

location_facility: Centre Hospital Universitaire Hop Huriez

location_facility: Internistische Onkologische Praxis - Kronach

location_facility: Internistische Gemeinschaftspraxis - Kassel

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Schwerpunktpraxis fuer Haematologie und Onkologie

location_facility: Haematologische Praxis - Moenchengladbach

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Internistische Gemeinschaftspraxis - Friedberg

location_facility: Onkologische Gemeinschaftspraxis - Trier

location_facility: Universitaetsklinik fuer Innere Medizin I

location_facility: Krankenhaus Siloah - Medizinische Klinik II

location_facility: Hamatologie/Onkologie Praxisgemeinschaft - Muenchen

location_facility: Klinikum Schwaebisch Gmuend Stauferklinik

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet


title: A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.

ReferenceCitation: Fizazi K, Pagliaro L, Laplanche A, Fléchon A, Mardiak J, Geoffrois L, Kerbrat P, Chevreau C, Delva R, Rolland F, Theodore C, Roubaud G, Gravis G, Eymard JC, Malhaire JP, Linassier C, Habibian M, Martin AL, Journeau F, Reckova M, Logothetis C, Culine S. Personalised chemotherapy based on tumour marker decline in poor prognosis germ-cell tumours (GETUG 13): a phase 3, multicentre, randomised trial. Lancet Oncol. 2014 Dec;15(13):1442-1450. doi: 10.1016/S1470-2045(14)70490-5. Epub 2014 Nov 13.

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Pagliaro

full_name: Lance Pagliaro

given: Lance

family: Laplanche

full_name: Agnes Laplanche

given: Agnes

family: Fléchon

full_name: Aude Fléchon

given: Aude

family: Mardiak

full_name: Josef Mardiak

given: Josef

family: Geoffrois

full_name: Lionnel Geoffrois

given: Lionnel

family: Kerbrat

full_name: Pierre Kerbrat

given: Pierre

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Delva

full_name: Remy Delva

given: Remy

family: Rolland

full_name: Frederic Rolland

given: Frederic

family: Theodore

full_name: Christine Theodore

family: Roubaud

full_name: Guilhem Roubaud

given: Guilhem

family: Gravis

full_name: Gwenaëlle Gravis

given: Gwenaëlle

family: Eymard

full_name: Jean-Christophe Eymard

given: Jean-Christophe

family: Malhaire

full_name: Jean-Pierre Malhaire

given: Jean-Pierre

family: Linassier

full_name: Claude Linassier

given: Claude

family: Habibian

full_name: Muriel Habibian

given: Muriel

family: Martin

full_name: Anne-Laure Martin

given: Anne-Laure

family: Journeau

full_name: Florence Journeau

given: Florence

family: Reckova

full_name: Maria Reckova

given: Maria

family: Logothetis

full_name: Christopher Logothetis

given: Christopher

family: Culine

full_name: Stephane Culine

given: Stephane

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

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

location_facility: M. D. Anderson Cancer Center at University of Texas

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


title: Study of Second Look Surgery With or Without Chemotherapy Intraperitoneally, in the Event of Risk of Intraperitoneal Recurrence

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

PURPOSE: Randomized phase II trial to compare the effectiveness of second-look surgery with or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who have colorectal cancer that is recurrent to the peritoneum.

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Universitaire de Dijon


title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)

acronym: AMBLED

summary: This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)

lead_sponsor: Prexton Therapeutics

location_country:
Italy
Austria
France
Spain
Germany
United Kingdom

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: IRCCS Fondazione Ospedale San Camillo (SC)

location_facility: Hospital Universitari General de Catalunya

location_facility: Practice for Neurology, Psychiatry & Psychotherapy Dr. med. I. Schoell & colleagues

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara

location_facility: Università degli Studi di Roma "La Sapienza"

location_facility: University Hospital Erlangen - Abteilung fur Molekulare Neurologie

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: CHU Grenoble - Pôle Psychiatrie et Neurologie

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum

location_facility: Clinical Ageing Research Unit, Campus for Ageing and Vitality

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Fondazione Universita G. D'Annunzio Centro Studi sull'invecchiamento Centro di Ricerca Clinica


title: Phase I-II Study of Association of Deferasirox, Vitamin D and Azacytidine as Treatment of High Risk MDS (IPSS Int-2 and High)

acronym: GFM-EXVD-AZA

summary:
Determinate safety and response rate of the association Deferasirox -Vitamine D - Azacitidine in treatment of high risk MDS

Deferasirox Exjade:

The dose of Deferasirox will be assigned according to the ferritin level. Dose escalation is scheduled during the phase I, with 5 additional patients per group.

The maximal tolerated dose of Deferasirox will be required for the phase II of the study.

The first dose will be assigned according to the ferritin level of the patient at time of inclusion:

5 mg/kg/d if the ferritin is >300ng/ml and < 1000ng/ml in Group 1 10 mg/kg/d if the ferritin is ≥1000ng/ml) in Group 2

Group 1 : Ferritin 300 to 1000ng /ml:

cohort 1 : 5 mg/kg/d
cohort 2 : 10mg/kg/d
cohort 3 : 15 mg/kg/d

Group 2 : Ferritin > 1000ng /ml:

cohort 1 : 10 mg/kg/d
cohort 2 : 15mg/kg/d

cohort 3 : 20 mg/kg/d

5 patients will be treated by cohort. In absence of toxicity (extra-hematological toxicity grade 3 or 4 or hematological grade 4), 5 additional patients will be included in the next cohort.

Deferasirox will be administrated once daily during all the study period. Uvedose will be administrated once weekly during all the study period (100.000 UI P.O).

Azacitidine will be administrated sc at 75 mg/m²/d, during 7 days, J1 to J7 of each cycles(One cycle is 28 days)

During phase I and II, Deferasirox will always be associated with Vitamin D and Azacitidine

Patients will be received 6 cycles of treatment (except if progression, unacceptable toxicity or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done to evaluate the efficacy of the treatment.

No dose modification of deferasirox will be done after 3 cycles of treatment except in case of progression). After 6 cycles, patients with CR, PR, marrow CR or HI will be treated with the same dose of Deferasirox until progression .

status: Unknown status

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
Hôpital Necker
CHU Limoges
Centre Catherine de Sienne
CHU Poitiers
Centre Hospitalier de Boulogne sur Mer
Hôpital saint Louis
Hôpital cochin
Centre Hospitalier de La Cote Basque
IUCT Oncopole Toulouse
Hôpital Saint Vincent de Paul
GENT
CHU Brabois
Hôpital Avicenne
CHU Nantes
CHU Le Mans


title: Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function

acronym: TUTOR

summary: The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.

lead_sponsor: LivaNova

location_country: Italy France Belgium Portugal Germany

location_facility: Praxis Westend Studien GbR, Medianzentrum Haus 9

location_facility: HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie

location_facility: Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen

location_facility: Centre Hospitalier Universitaire de La Timone

location_facility: Hospital de Santa Cruz - Carnaxide (Adragão)

location_facility: Centre Hospitalier Universitaire D'Amiens

location_facility: CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON

location_facility: Ccn: Centre Cardiologique Du Nord St Denis


title: TRIAGE: TRIage of Sepsis At emerGency dEpartment

acronym: TRIAGE

summary:
Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately treated cases can lead to severe sepsis or septic shock; being characterized by high mortality and morbidity.

Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment very difficult in particular on Emergency Department (ED) patients due to their infectious illness background and the frequent comorbidities. Also, the severity of the condition may not be apparent at initial contact with ED personnel: patients may arrive at ED with mild clinical manifestation and rapidly progress to critical illness, or rather at the opposite others have benign evolution despite a similar symptoms. In these conditions, the main challenge of ED clinicians is differentiating mild infections from life-threatening ones in the heavy workload of ED environment Objective of TRIAGE project is to identify and validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department.

Targeted population is adult patients freshly admitted at ED, whom blood samples will serve to validate candidate markers.

ipd_sharing: Yes

lead_sponsor: BioMérieux

location_facility: Cliniques universitaires Saint-Luc - UCL

location_facility: Centre Hospitalier Départemental - Hôpital La Roche-sur-Yon

location_facility: Centre hospitalier universitaire Grenoble Alpes

location_facility: Assistance publique - Hôpitaux de Paris Hopital de Cochin

location_facility: Centre Hospitalier Regional Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire Edouard Herriot

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Centre d'Investigation Clinique (CIC)-CHU Limoges


title: European Phase III Study Comparing a Radiation Dose Escalation Using 2 Different Approaches : External Beam Radiation Therapy Versus Endocavitary Radiation Therapy With Contact X-ray Brachytherapy 50 kiloVolts (kV) for Patients With Rectal Adenocarcinoma

acronym: OPERA

summary:
The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery.

The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%).

Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma.

Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.

lead_sponsor: Centre Antoine Lacassagne

location_country:
Denmark
Sweden
United Kingdom
France

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse

location_facility: Centre d'oncologie et de radiothérapie Mâcon

location_facility: Hôpital de la Croix Rouge Française - Centre de Radiothérapie St Louis

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud


title: Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

acronym: ANSWER

summary:
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.

The expected benefits will be a result of the reduction of the percentage of ventricular pacing.

It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.

The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)

location_country:
Italy
United States
France
Spain
Germany
United Kingdom

location_facility: Hospital Clinico universitario de Santiago

location_facility: Complejo Hospitalario Arquitecto Marcide


title: Retro-prospective Clinical Study to Evaluate the Efficacy of the Stand-alone Cervical Interbody Cage C-CURVE (Peek and Titanium) Manufactured by MEDICREA®

acronym: C-CURVE

summary:
This study includes one type of product named C-CURVE which is a Stand-alone Cervical Interbody Cage. This product is available in two materials: PEEK and Titanium.

The C-Curve Cervical Interbody Devices is one single implant used for insertion between two adjacent vertebrae (cervical spine). C-Curve has been designed to restore and/or maintain adequate interbody height, and thus help stabilize one or more cervical levels while fusion occurs. This system has also as objectives to increase of the quality of life, decrease patient's pain and decrease a potential dysphagia (clinical performances). This system must only be used in the cervical spine.

This post-market clinical follow-up (PMCF) study aims to confirm the acceptable benefits/risk profile of the device for the patients and to fill essential requirements to maintain the CE mark through a clinical evaluation.

ReferenceCitation: Alimi M, Njoku I, Hofstetter CP, Tsiouris AJ, Kesavabhotla K, Boockvar J, Navarro-Ramirez R, Härtl R. Anterior Cervical Discectomy and Fusion (ACDF): Comparison Between Zero Profile Implants and Anterior Cervical Plate and Spacer. Cureus. 2016 Apr 17;8(4):e573. doi: 10.7759/cureus.573.

ReferenceCitation: Azab W, Abdel-Razek M, Ali A, Abdelrahman A, Salaheldin W, Nasim K, Attia H, Soliman D. Outcome evaluation of a zero-profile implant for anterior cervical diskectomy with fusion. Turk Neurosurg. 2012;22(5):611-7. doi: 10.5137/1019-5149.JTN.5646-11.2.

ReferenceCitation: Barbagallo GM, Romano D, Certo F, Milone P, Albanese V. Zero-P: a new zero-profile cage-plate device for single and multilevel ACDF. A single institution series with four years maximum follow-up and review of the literature on zero-profile devices. Eur Spine J. 2013 Nov;22 Suppl 6:S868-78. doi: 10.1007/s00586-013-3005-0. Epub 2013 Sep 24. Review.

ReferenceCitation: Bucci MN, Oh D, Cowan RS, Davis RJ, Jackson RJ, Tyndall DS, Nehls D. The ROI-C zero-profile anchored spacer for anterior cervical discectomy and fusion: biomechanical profile and clinical outcomes. Med Devices (Auckl). 2017 Apr 18;10:61-69. doi: 10.2147/MDER.S127133. eCollection 2017.

ReferenceCitation: Chen Y, Liu Y, Chen H, Cao P, Yuan W. Comparison of Curvature Between the Zero-P Spacer and Traditional Cage and Plate After 3-Level Anterior Cervical Discectomy and Fusion: Mid-term Results. Clin Spine Surg. 2017 Oct;30(8):E1111-E1116. doi: 10.1097/BSD.0000000000000440.

ReferenceCitation: De Leo-Vargas RA, Muñoz-Romero I, Mondragón-Soto MG, Martínez-Anda JJ. Locking Stand-Alone Cage Constructs for the Treatment of Cervical Spine Degenerative Disease. Asian Spine J. 2019 Apr 10;13(4):630-637. doi: 10.31616/asj.2018.0234. Print 2019 Aug.

ReferenceCitation: Lee YS, Kim YB, Park SW. Does a zero-profile anchored cage offer additional stabilization as anterior cervical plate? Spine (Phila Pa 1976). 2015 May 15;40(10):E563-70. doi: 10.1097/BRS.0000000000000864.

ReferenceCitation: Li Z, Zhao Y, Tang J, Ren D, Guo J, Wang H, Li L, Hou S. A comparison of a new zero-profile, stand-alone Fidji cervical cage and anterior cervical plate for single and multilevel ACDF: a minimum 2-year follow-up study. Eur Spine J. 2017 Apr;26(4):1129-1139. doi: 10.1007/s00586-016-4739-2. Epub 2016 Aug 23.

ReferenceCitation: Lu Y, Bao W, Wang Z, Zhou F, Zou J, Jiang W, Yang H, Zhang Z, Zhu X. Comparison of the clinical effects of zero-profile anchored spacer (ROI-C) and conventional cage-plate construct for the treatment of noncontiguous bilevel of cervical degenerative disc disease (CDDD): A minimum 2-year follow-up. Medicine (Baltimore). 2018 Feb;97(5):e9808. doi: 10.1097/MD.0000000000009808.

ReferenceCitation: Nambiar M, Phan K, Cunningham JE, Yang Y, Turner PL, Mobbs R. Locking stand-alone cages versus anterior plate constructs in single-level fusion for degenerative cervical disease: a systematic review and meta-analysis. Eur Spine J. 2017 Sep;26(9):2258-2266. doi: 10.1007/s00586-017-5015-9. Epub 2017 Mar 10. Review.

ReferenceCitation: Scholz M, Schelfaut S, Pingel A, Schleicher P, Kandziora F. A cervical "zero-profile" cage with integrated angle-stable fixation: 24-months results. Acta Orthop Belg. 2014 Dec;80(4):558-66.

lead_sponsor: Medicrea International

location_facility: Centre de consultations spécialisées de la Sauvegarde

location_facility: Centre Médico-Chirurgical de Réadaptation des Massues


title: A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD® Soluble for Localised Prostate Cancer Compared to Active Surveillance. Post Study 5-year Follow-up

summary: This is an open observational extended follow-up study of patients originally randomized into TOOKAD® Soluble VTP therapy or active surveillance (control group). Additional 60-month follow-up study

lead_sponsor: Steba Biotech S.A.

location_country:
Italy
Sweden
Netherlands
Finland
France
Spain
Germany
United Kingdom

location_facility: Martini-Klinik am UKE Hamburg-Eppendorf Prostate Cancer Center

location_facility: Vinzenz Krankenhaus - Department of Urology

location_facility: Department of Urology-Tampere University Hospital-

location_facility: Complejo Hospitalario Regional Virgen Del Rocio-Department Urology

location_facility: Osp. S. Giov. Battista Molinette-Dipartimento di Discipline Medico-Chirurgiche Urologia

location_facility: Centre Hospitalier Universitaire Lyon Sud

location_facility: University College London Hospital (UCLH)

location_facility: Department of Urology-Hospital Clinic, University of Barcelona

location_facility: ATURO-Gemeinschaftspraxis für Urologie und Andrologie

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität


title: Optimization With SonR Method in the ClinicAl pRactice

acronym: OSCAR

summary: Evaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in Heart failure (HF) patients prevalently in sinus rhythm

location_country: Italy Austria Spain France Portugal Germany

location_facility: Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria


title: Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations

acronym: MAV-RAPA

summary:
The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to decrease the volume and symptoms due to superficial arteriovenous malformations (AVM).

Sirolimus has properties that reduce the activity of the immune system (immunosuppressant), to fight against the proliferation of cancer cells (anti- tumor) and also reduce the proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant patients to prevent organ transplant rejection. Many animal and laboratory studies were carried out and demonstrate in particular the activity of sirolimus on vessels. It is this anti- vascular effect that could help treat arteriovenous malformations.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
APHM
CHRU Lille
CHU Strasbourg
APHP
UCL
CHU Bordeaux
CHU Montpellier
CHU Dijon
CHU Nice
CHU Tours
CHU Nancy
HCL Lyon
CHU Amiens