acronym: ORTHOUNION

title: A Multi-centre, Open-label, Randomized, Comparative Clinical Trial of Two Doses of Bone Marrow Autologous MSC+ Biomaterial vs Iliac Crest Autologous Graft, for Bone Healing in Non-union After Long Bone Fractures

lead_sponsor: Universidad Autonoma de Madrid

ReferenceCitation: Gómez-Barrena E, Padilla-Eguiluz NG, Avendaño-Solá C, Payares-Herrera C, Velasco-Iglesias A, Torres F, Rosset P, Gebhard F, Baldini N, Rubio-Suarez JC, García-Rey E, Cordero-Ampuero J, Vaquero-Martin J, Chana F, Marco F, García-Coiradas J, Caba-Dessoux P, de la Cuadra P, Hernigou P, Flouzat-Lachaniette CH, Gouin F, Mainard D, Laffosse JM, Kalbitz M, Marzi I, Südkamp N, Stöckle U, Ciapetti G, Donati DM, Zagra L, Pazzaglia U, Zarattini G, Capanna R, Catani F. A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol. Stem Cells Int. 2018 Feb 22;2018:6025918. doi: 10.1155/2018/6025918. eCollection 2018.

location_facility: Istituto Ortopedico Galeazzi, Chirugia dell´Anca l

location_facility: Hospital U. Gregorio Marañon, Servicio de Cirugía Ortopédica y Traumatología

location_facility: Arienda Spedali Civili di Brescia II Ortopedia e Traumatologia

location_facility: Hospital U. La Princesa, Servicio de CirugíaOrtopédica y Traumatología

location_facility: Department of Orthopaedic Surgery, CHU Tours

location_facility: Department of Orthopaedic Trauma, University of Ulm

location_facility: Hospital U. Puerta de Hierro-Majadahonda, Servicio de Cirugía Ortopédica y Traumatología

location_facility: Department of Orthopaedic Surgery Toulouse University Hospital

location_facility: Department of Orthopaedic Surgery, CHU Nantes

location_facility: Istituto Ortopedico Rizzoli, SSD Fisiopatologia Ortopedica e Medicina Rigenerativa

location_facility: Hospital Clínica San Carlos, Servicio de Cirugía Ortopédica y Traumatología

location_facility: Hospital U. 12 de Octubre, Servicio de Cirugía Ortopédica y Traumatología

location_facility: Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

location_facility: Universitätsklinikum Freiburg, Klinik für Orthopädie und Unfallchirurgie

location_facility: Department of Orthopaedic Surgery, Hospital Henri Mondor

location_facility: Universitätsklinikum Frankfurt, Department of Trauma, Hand and Reconstructive Surgery

summary: ORTHOUNION is a multi-centre, open, comparative, randomized, clinical trial with three parallel arms that aims to compare the efficacy of three treatments to enhance bone healing in patients with long bone non-union.


type: EudraCT Number

title: A Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNα-Kinoid (IFN-K) in Adult Subjects With Dermatomyositis

summary: This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα antibodies (immune response) in adult subjects with dermatomyositis

study_start_date_type: Actual

status: Withdrawn

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Neovacs

location_country: Germany France Switzerland Italy

location_facility: Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Unknown


title: Open-label,Non-randomised,Multicentre,Phase I Study to Assess the Pharmacokinetics, Safety & Tolerability of Osimertinib Following a Single Oral 80mg Dose to Patients w/ Adv Solid Tumours & Normal Renal Function or Severe Renal Impairment.

summary: The purpose of this study is to assess the effect of severe renal impairment on the levels of AZD9291 in the blood in patients with advanced solid tumours compared to patients with normal renal function

status: Completed

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Vishwanathan K, Sanchez-Simon I, Keam B, Penel N, de Miguel-Luken M, Weilert D, Mills A, Marotti M, Johnson M, Ravaud A. A multicenter, phase I, pharmacokinetic study of osimertinib in cancer patients with normal renal function or severe renal impairment. Pharmacol Res Perspect. 2020 Aug;8(4):e00613. doi: 10.1002/prp2.613.

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Korea, Republic of
France
Spain

intervention_type: Drug

status_simplified: Completed


title: A Phase II, Open-label, Randomized-controlled Trial Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody Atezolizumab for the Treatment in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

acronym: ImmunoCobiVem

summary:
Most patients with locally advanced or metastatic tumors succumb to their disease. Thus, there is a substantial need for novel therapeutic strategies to improve the outcome for patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an antiPD-L1 antibody have emerged as treatment option.

In this study the best timing for sequential use of both treatment options (BRAF/MEK inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600 mutant melanoma will be assessed.

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Essen

location_country: Germany France Serbia Greece

location_facility: Gesellschaft für Klinische Forschung Ludwigshafen mbH

location_facility: University Hospital Mannheim, Clinic for Dermatology

location_facility: University Hospital Essen, Department of Dermatology, Skin Cancer Center

location_facility: National Centre for Tumour Diseases (NCT)

lead_sponsor_type: academique

status_simplified: Ongoing


title: An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial

acronym: RIALTO

summary: To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.

status: Recruiting

lead_sponsor: Bayer

location_country:
Poland
Italy
Thailand
Korea, Republic of
France


title: Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients

lead_sponsor: Hoffmann-La Roche

source: euctr

ReferenceCitation: Burmester GR, Buttgereit F, Bernasconi C, Álvaro-Gracia JM, Castro N, Dougados M, Gabay C, van Laar JM, Nebesky JM, Pethoe-Schramm A, Salvarani C, Donath MY, John MR; SEMIRA collaborators. Continuing versus tapering glucocorticoids after achievement of low disease activity or remission in rheumatoid arthritis (SEMIRA): a double-blind, multicentre, randomised controlled trial. Lancet. 2020 Jul 25;396(10246):267-276. doi: 10.1016/S0140-6736(20)30636-X.

location_country:
Serbia
Italy
Russian Federation
Tunisia
France
Germany

location_facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

location_facility: Military Medical Academy; Clinic of Rheumatology

location_facility: Special hospital for rheumatic diseases Novi Sad

location_facility: SchlossPark-Klinik Berlin; Int. Med. II, Rheum. Osteo

location_facility: Rheumazentrum Ratingen - Studienambulanz

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Rheumatologie/Immunologie

location_facility: Rheumatologisches MVZ Dresden GmbH, Dres. Holger Schwenke, Reiner Schwenke, Annekatrin Georgi

location_facility: Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

location_facility: Asklepios Kllinikum Bad Abbach; Klinik für Rheumatologie und Klinische Immunologie

location_facility: Dres. Florian Schuch, Ruediger de la Camp, Martin Hammerschmidt u.w.

location_facility: Klinikum der Universitat Munchen; Bereich Pettenkoferstr; Rheumaeinheit der medizinischen Klinik IV

location_facility: FSBI Scientific Research Institute of Clinical and Experimental Lymphology of SB of RAMS

location_facility: SMO.MD GmbH, Zentrum für klinische Studien

location_facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Med.Klinik III

location_facility: Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: Hopital Farhat Hached; Service Rhumatologie

location_facility: Republican clinical hospital named after G.G. Kuvatov

location_facility: Rheumatologische Facharztpraxis Maren Sieburg

location_facility: Irccs Policlinico San Matteo; Reumatologia Adulti

location_facility: Ospedale Careggi Villa Monnatessa ; Sezione Di Reumatologia

location_facility: Rheumatologische Schwerpunktpraxis am Feuersee

location_facility: Arcispedale Santa Maria Nuova; Reumatologia

location_facility: Rheumatologische Gemeinschaftspraxis Grafschaft, Dr. med. Dorothea Pick, Dr. med. Christopher Amberg

summary: This Phase IIIb/IV, two-arm, randomized, double-blind, placebo-controlled, parallel-group, international, multicenter trial compares the change in disease activity (as assessed by Disease Activity Score in 28 joints [DAS28] erythrocyte sedimentation rate [ESR]) from randomization to Week 24 post-randomization, in participants with stable low disease activity [LDA] (DAS28 ESR score less than or equal to [<=] 3.2) who receive tocilizumab, and have been randomized to either continue or taper prednisone in a double-blinded fashion.


title: A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp

acronym: SAKOS

summary: The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.

ipd_sharing: Undecided

lead_sponsor: Vexim SA

location_country: Spain Italy Switzerland France Germany

location_facility: Klinik und Poliklinik fur Orthopädie Universitatsklinikum

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital Clinico Universitario de Valladolid,

location_facility: Krankenhaus NEUWERK Sankt Augustinus kliniken

location_facility: Hôpital Jean Minjoz Service Neurochirurgie

location_facility: CHU Hôtel Dieu Service Neuro traumatologie

intervention_type: Procedure


title: Phase II Biomarker Study Evaluating The Upfront Combination Of BRAF Inhibitor Dabrafenib With MEK Inhibitor Trametinib Versus The Combination After Eight Weeks Of Monotherapy With Dabrafenib Or Trametinib In Patients With Metastatic And Unresectable Stage III Or IV Melanoma Harbouring An Activating BRAF Mutation

summary: This is a three-arm, open-label, randomised Phase II study to evaluate whether the different sequencing of dabrafenib and trametinib monotherapies and the upfront combination has an impact on translational or clinical activity in subjects with BRAF mutant metastatic unresectable stage IIIc or IV melanoma. Both dabrafenib and trametinib have demonstrated clinical activity as monotherapies and in combination in BRAF-mutant melanoma. However, duration of responses seem to be limited due to acquired drug resistance. The goal of this protocol is to study the sequential effects of BRAF and MEK inhibition on skin, blood and tumour biomarkers and to study the correlation between biomarkers and response to treatment and intrapatient toxicity. Approximately 54 eligible subjects will be randomised in the ratio of 1:1:1 to one of the three treatment arms.

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: GlaxoSmithKline

location_country: France Spain


title: Lung Water By Ultra-Sound Guided Treatment To Prevent Death and Cardiovascular Complications in High Risk End Stage Renal Disease Patients With Cardiomyopathy (Lust Study)

acronym: LUST

summary:
Volume overload is a leading risk factor for death and cardiovascular events in end stage renal disease patients maintained on chronic dialysis, particularly in those with myocardial ischemia and heart failure which represent a substantial fraction of this population. Early identification of volume overload may prevent cardiovascular sequel in these patients but clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk and to monitor them over time. On the other hand, however reliable, standard techniques for measuring extracellular or circulating (blood) volume do not convey information on fundamental heart function parameters that determine the individual haemodynamic tolerance to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling pressure and LV function.

Extra-vascular lung water is critically dependent on these parameters and represents a proxy of both, circulating volume and LV filling pressure and function, and may therefore be a better criterion to identify patients at a higher risk of volume-dependent adverse clinical outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung water by using standard ultrasound (US) machines has been validated in dialysis patients. Whether systematic measurement of lung water by this technique may translate into better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested.

The aim of this randomized clinical trial is that of testing a treatment policy guided by extra-vascular lung water measurements by ultrasound to prevent all-cause death, decompensated heart failure and non-fatal myocardial infarction in high risk dialysis patients with myocardial ischemia (a history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG) or overt heart failure (NYHA class III-IV).

ReferenceType: background

ReferenceCitation: Kramer A, Stel V, Zoccali C, Heaf J, Ansell D, Grönhagen-Riska C, Leivestad T, Simpson K, Pálsson R, Postorino M, Jager K; ERA-EDTA Registry. An update on renal replacement therapy in Europe: ERA-EDTA Registry data from 1997 to 2006. Nephrol Dial Transplant. 2009 Dec;24(12):3557-66. doi: 10.1093/ndt/gfp519. Epub 2009 Oct 9.

ReferenceCitation: Charra B, Calemard E, Ruffet M, Chazot C, Terrat JC, Vanel T, Laurent G. Survival as an index of adequacy of dialysis. Kidney Int. 1992 May;41(5):1286-91.

ReferenceCitation: Sinha AD, Agarwal R. Can chronic volume overload be recognized and prevented in hemodialysis patients? The pitfalls of the clinical examination in assessing volume status. Semin Dial. 2009 Sep-Oct;22(5):480-2. doi: 10.1111/j.1525-139X.2009.00641.x. Epub 2009 Sep 9.

ReferenceCitation: Staub NC. Pulmonary edema. Physiol Rev. 1974 Jul;54(3):678-811. Review.

ReferenceCitation: Crandall ED, Staub NC, Goldberg HS, Effros RM. Recent developments in pulmonary edema. Ann Intern Med. 1983 Dec;99(6):808-22. Review.

ReferenceCitation: Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70.

ReferenceCitation: Picano E, Gargani L, Gheorghiade M. Why, when, and how to assess pulmonary congestion in heart failure: pathophysiological, clinical, and methodological implications. Heart Fail Rev. 2010 Jan;15(1):63-72. doi: 10.1007/s10741-009-9148-8. Review.

ReferenceCitation: Picano E, Frassi F, Agricola E, Gligorova S, Gargani L, Mottola G. Ultrasound lung comets: a clinically useful sign of extravascular lung water. J Am Soc Echocardiogr. 2006 Mar;19(3):356-63. Review.

ReferenceCitation: Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5.

ReferenceCitation: Mallamaci F, Benedetto FA, Tripepi R, Rastelli S, Castellino P, Tripepi G, Picano E, Zoccali C. Detection of pulmonary congestion by chest ultrasound in dialysis patients. JACC Cardiovasc Imaging. 2010 Jun;3(6):586-94. doi: 10.1016/j.jcmg.2010.02.005.

ReferenceCitation: Cice G, Ferrara L, Di Benedetto A, Russo PE, Marinelli G, Pavese F, Iacono A. Dilated cardiomyopathy in dialysis patients--beneficial effects of carvedilol: a double-blind, placebo-controlled trial. J Am Coll Cardiol. 2001 Feb;37(2):407-11.

lead_sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

location_country: Poland Slovenia Italy Greece Spain France Israel Romania Germany

location_facility: CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension Unit

location_facility: IASIO Hospital - General Clinic of Kallithea

location_facility: Medical University of Silesia in Katowice

location_facility: Hôpital Ambroise Paré (Assistance-Publique Hôpitaux de Paris)

intervention_type: Other


title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study to Assess Efficacy and Safety of Selexipag in Adult Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

summary: The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).

ReferenceCitation: Denton CP, Hachulla É, Riemekasten G, Schwarting A, Frenoux JM, Frey A, Le Brun FO, Herrick AL; Raynaud Study Investigators. Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis: A Randomized, Placebo-Controlled, Phase II Study. Arthritis Rheumatol. 2017 Dec;69(12):2370-2379. doi: 10.1002/art.40242.

lead_sponsor: Actelion

location_country:
Germany
France
United Kingdom


title: A Randomized Phase II Study of Fulvestrant in Combination With the Dual mTOR Inhibitor AZD2014 or Everolimus or Fulvestrant Alone in Estrogen Receptor-positive Advanced or Metastatic Breast Cancer

acronym: MANTA

summary:
This is an open-label, multicentre, 4-arm randomised phase II trial of fulvestrant + AZD2014 versus fulvestrant + everolimus versus fulvestrant alone in patients with ER-positive, HER2-negative advanced or metastatic breast cancer, whose disease relapsed during treatment with (or within 12 months after discontinuation of) an AI in the adjuvant setting or progressed during treatment with an AI in the metastatic setting. Patients will be randomised (2:3:3:2) to one of the four treatment arms:

Fulvestrant
Fulvestrant + AZD2014 (continuous daily schedule)
Fulvestrant + AZD2014 (intermittent schedule - 2 days on, 5 days off)
Fulvestrant + everolimus

Randomization will be stratified by the following criteria:

Measurable disease (vs. non-measurable).
Sensitivity to prior endocrine therapy (sensitive versus resistant)

status: Unknown status

ReferenceType: result

ReferenceCitation: Schmid P, Zaiss M, Harper-Wynne C, Ferreira M, Dubey S, Chan S, Makris A, Nemsadze G, Brunt AM, Kuemmel S, Ruiz I, Perelló A, Kendall A, Brown J, Kristeleit H, Conibear J, Saura C, Grenier J, Máhr K, Schenker M, Sohn J, Lee KS, Shepherd CJ, Oelmann E, Sarker SJ, Prendergast A, Marosics P, Moosa A, Lawrence C, Coetzee C, Mousa K, Cortés J. Fulvestrant Plus Vistusertib vs Fulvestrant Plus Everolimus vs Fulvestrant Alone for Women With Hormone Receptor-Positive Metastatic Breast Cancer: The MANTA Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Nov 1;5(11):1556-1564. doi: 10.1001/jamaoncol.2019.2526. Erratum in: JAMA Oncol. 2021 Feb 1;7(2):312.

lead_sponsor: Queen Mary University of London

location_country:
Portugal
Spain
United Kingdom
Georgia
Hungary
Korea, Republic of
France
Romania
Germany

location_facility: Cafeteria Hospital San Pedro de Alcantara

location_facility: Schwarzwald Baar Klinikum, Villingen-Schwenningen

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Antoine Lacassagne Centre De Lutte Contre Le Cancer De Nice

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Frauenärztliche Gemeinschaftspraxis - Onkologie

location_facility: Schwerpunktpraxis Hämatologie / Onkologie MVZ Lahr

location_facility: Oncology Institute "Prof. Dr. Ion Chiricuta"

location_facility: University of Pecs, Institute of Oncology

location_facility: Korea University Medical Center Guro Hospital

location_facility: Praxis für interdisziplinäre Onkologie & Hämatologie

location_facility: Klinik für Gynäkologie & Geburtshilfe/Brustzentrum

location_facility: Cluj County Clinical Emergency Hospital, Clinical Department of Medical Oncology


title: Cryoballoon Ablation for Early Persistent Atrial Fibrillation

summary: The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early persistent atrial fibrillation (<1 year from first diagnosis of persistent AF).

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Germany France Greece

location_facility:
St. Vinzenz-Hospital
Cardioangiologisches Centrum Bethanien
Uniklinik Ulm
Asklepios Klinik St. Georg
Krankenhaus Porz am Rhein
CHU de Grenoble
Klinikum Nürnberg Süd
CHU de la Timone
Herz- und Diabeteszentrum NRW
Charite - Universitaetsmedizin
CHU - Hôpitaux de Rouen
Hôpital Henri Mondor
Clinique Pasteur
Henry Dunant Hospital Center


type: Other Identifier

title: A Prospective Randomized Multicenter Non-inferiority Clinical Study to Determine the Safety and Performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter (Hemoteq) Compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter (B.Braun) for the Treatment of Coronary In-Stent Restenosis (AGENT-ISR)

acronym: AGENT-ISR

summary:
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis).

The performance will be determined at six months post-procedure by quantitative coronary angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA results will be assessed by an independent, blinded angiographic core lab.

Study statistical hypothesis: The loss of in-stent luminal diameter at six months after treatment of the restenosed stent with the Agent™ study device is not larger than the respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is non-inferior to the control device with respect to LLL.

ReferenceCitation: Hamm CW, Dörr O, Woehrle J, Krackhardt F, Ince H, Zeus T, Berland J, Piot C, Roubille F, Schult I, Allocco DJ, Nef H. A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis. EuroIntervention. 2020 Jul 17;16(4):e328-e334. doi: 10.4244/EIJ-D-19-00051.

lead_sponsor: Hemoteq AG

location_country: Germany France

location_facility: CHU Montpellier, Hôpital Arnaud de Villeneuve

location_facility: Centre Hospitalier Saint Joseph Saint Luc de Lyon

intervention_type: Device


title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics of Thalidomide Following Multiple Oral Dosing in Subjects With Multiple Myeloma

summary: Objective of this study is to characterize the steady-state pharmacokinetics (PK) of thalidomide when given orally as monotherapy to subjects with multiple myeloma.

primary_purpose: Other

ReferenceCitation: Lund J, Gruber A, Lauri B, Duru AD, Blimark C, Swedin A, Hansson M, Forsberg K, Ahlberg L, Carlsson C, Waage A, Gimsing P, Vangsted AJ, Frølund U, Holmberg E, Gahrton G, Alici E, Hardling M, Mellqvist UH, Nahi H. Lenalidomide versus lenalidomide + dexamethasone prolonged treatment after second-line lenalidomide + dexamethasone induction in multiple myeloma. Cancer Med. 2018 Jun;7(6):2256-2268. doi: 10.1002/cam4.1422. Epub 2018 Apr 19.

lead_sponsor: Celgene

location_country:
France
United Kingdom

location_facility:
CHRU Hopital Bretonneau
Royal Marsden Hospital
CHRU-Hopital Claude Huriez
CHU Grenoble
Christie Hospital NHS Foundation Trust
Hopital Augustin Morvan
CHRU Hopital Brabois


title: A Prospective, Multicenter, Controlled Study of Implant-based Breast Reconstruction, Measuring the Safety, Efficacy and Outcomes, of Immediate Single Stage Breast Reconstruction With Strattice™ Reconstructive Tissue Matrix Versus Immediate Two Stage Breast Reconstruction Without Strattice™ TM (ESSBR-Efficacy of Single Stage Breast Reconstruction)

acronym: ESSBR

summary: The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy breast reconstruction where the initially placed expander was exchanged for a breast implant only, without any type of reinforcement.

lead_sponsor: LifeCell

location_facility: Klinik der Universität München, Campus Innenstadt

location_facility: St Luke's hospital / Bradford Royal Infirmary (BRI)

location_facility: Institut du Cancer de Montpellier Val d'Aurelle

location_facility: Wythenshawe Hospital UHSM NHS Foundation Trust


title: A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions

acronym: EuroCTO

summary:
CTOs are common among patients with angina, and are detected in around 20% of patients undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI practice on average. One of the reasons for the under-presentation of CTOs in PCI target lesions is the lack of evidence-based medical data on treatment indications, and the continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines.

Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial comparing PCI with optimal medical therapy in stable coronary disease did not show a difference in mortality or myocardial infarction between the two treatment options. However, CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic burden has never been tested in a randomized controlled trial.

While there is compelling evidence from registry studies of a clinical and prognostic benefit following successful PCI of CTO compared with PCI failure, there has been no randomized controlled trial of contemporary PCI using drug-eluting stents versus optimal medical therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related to the extent of residual ischaemia and that PCI is more effective in reducing residual ischaemia than optimal medical therapy alone. This confirms earlier retrospective data suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or severe (>20%) ischaemia.

Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to OMT alone in improving health status at 12-month follow-up, and will be noninferior with respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with evidence of ischemia and viability in the territory subtended by the CTO

ReferenceCitation: Werner GS, Martin-Yuste V, Hildick-Smith D, Boudou N, Sianos G, Gelev V, Rumoroso JR, Erglis A, Christiansen EH, Escaned J, di Mario C, Hovasse T, Teruel L, Bufe A, Lauer B, Bogaerts K, Goicolea J, Spratt JC, Gershlick AH, Galassi AR, Louvard Y; EUROCTO trial investigators. A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions. Eur Heart J. 2018 Jul 7;39(26):2484-2493. doi: 10.1093/eurheartj/ehy220.

ReferenceCitation: Azzalini L, Vo M, Dens J, Agostoni P. Myths to Debunk to Improve Management, Referral, and Outcomes in Patients With Chronic Total Occlusion of an Epicardial Coronary Artery. Am J Cardiol. 2015 Dec 1;116(11):1774-80. doi: 10.1016/j.amjcard.2015.08.050. Epub 2015 Sep 11. Review.

lead_sponsor: Euro CTO Club

location_country:
Spain
Latvia
Italy
United Kingdom
France
Germany

location_facility: Unidad de Cardiología Intervencionista Hospital de Sant Pau

location_facility: Latvian Center of Cardiology Pauls Stradins Clinical University Hospital

location_facility: National Heart and Lung Institute Imperial College

location_facility: Institut Hospitalier Jacques Cartier - ICPS

location_facility: Cardiovascular Institute - Hospital Clinico San Carlos

location_facility: Department of Cardiovascular Sciences University of Leicester

location_facility: Royal Sussex County Hospital - Brighton and Sussex University Hospitals

location_facility: Cardiac Catheterization Laboratory and Cardiovascular Interventional Unit Cannizzaro Hospita


title: An 8-week Phase I/II, Multicenter, Randomized, Double-masked, Vehicle Controlled Parallel Group Study to Evaluate the Safety and Efficacy of Two Doses of Recombinant Human Nerve Growth Factor in Patients With Stage 2 and 3 of NK

acronym: REPARO

summary: This study is aimed at assessing the safety and the efficacy of two dose regimens of recombinant human nerve growth factor (rhNGF) eye drops solution compared to vehicle for inducing a complete healing of stage 2 (persistent epithelial defect) and 3 (corneal ulcer) neurotrophic keratitis

ReferenceCitation: Yanai R, Nishida T, Chikama T, Morishige N, Yamada N, Sonoda KH. Potential New Modes of Treatment of Neurotrophic Keratopathy. Cornea. 2015 Nov;34 Suppl 11:S121-7. doi: 10.1097/ICO.0000000000000587. Review.

lead_sponsor: Dompé Farmaceutici S.p.A

location_country:
Poland
Spain
Italy
United Kingdom
France
Germany

location_facility: Manchester Royal Eye Hospital - Manchester Royal Eye Hospital

location_facility: Azienda ospedaliera di Padova - Clinica Oculistica Policlinico 7° Piano

location_facility: Moorfields Eye Hospital - Moorfields Eye Hospital

location_facility: Universität zu Köln - Zentrum für Augenheilkunde am Universitätsklinikum Köln

location_facility: "CHU Toulouse-Purpan - Service Ophtalmologie

location_facility: "Fondation Ophtalmologique Adolphe de Rothschild - "Unité de Recherche Clinique

location_facility: District Railway Hospital Katowice - Department of Ophthalmology

location_facility: "SPKSO Szpital Okulistyczny ul. - SPKSO Szpital Okulistyczny

location_facility: Hospital Clínico San Carlos - Oftalmología. Unidad de Superficie Ocular

location_facility: Vissum Corporación Oftalmológica de Alicante

location_facility: Centre Hospitalier National d'Ophtalmologie - Service d'ophtalmologie

location_facility: University of Southampton Southampton General Hospital - MP104, Eye Unit

location_facility: Klinikum der Universität München - Augenklinik der Ludwig-Maximilians-Universtiät München

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Royal Victoria Infirmary - Dept. of Ophthalmology

location_facility: Università G. D' Annunzio - Clinica Oftalmologica - Centro regionale di Eccellenza in Oftalmologia

location_facility: University of Birmingham - Academic Unit of Ophthalmology, School of Immunity and Infection, College of Medical and Dental Sciences, University of Birmingham

location_facility: Dipartimento di Scienze Neurologiche Oftalmologia e Genetica - Universtità di Genova

location_facility: Instituto Oftalmológico Fernández-Vega - Oftalmología

location_facility: Hospital Clinic de Barcelona - Oftalmología

location_facility: Johannes-Gutenberg-Universität Augenklinik und Poliklinik - Department of Ophthalmology

location_facility: Azienda Ospedaliera San Paolo - U.O. Oculistica

location_facility: Azienda Ospedaliero Universitaria di Messina - Dipartimento Specialità Chirurgiche Ambulatorio Studio delle Malattie dela Superficie Oculare Unità Operativa Complessa di Oftalmologia


title: A Phase 2A, Open-label Dose Finding Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With BETA(b)-THALASSEMIA.

summary: Dose finding study to determine the safety and tolerability of Sotatercept (ACE-011) in adults with Beta (β)-Thalassemia

ReferenceCitation: Cappellini MD, Porter J, Origa R, Forni GL, Voskaridou E, Galactéros F, Taher AT, Arlet JB, Ribeil JA, Garbowski M, Graziadei G, Brouzes C, Semeraro M, Laadem A, Miteva D, Zou J, Sung V, Zinger T, Attie KM, Hermine O. Sotatercept, a novel transforming growth factor β ligand trap, improves anemia in β-thalassemia: a phase II, open-label, dose-finding study. Haematologica. 2019 Mar;104(3):477-484. doi: 10.3324/haematol.2018.198887. Epub 2018 Oct 18.

ReferenceCitation: Cappellini M, et al. A Phase 2a, Open-Label, Dose-Finding Study to Determine the Safety and Tolerability of Sotatercept (ACE-011) in Adults With Beta ( )-Thalassemia: Interim Results. Presented at the 55th Annual Meeting of the American Society of Hematology (ASH), December 7-10, 2013, New Orleans, LA. Abstract No. 3448

ReferenceCitation: "Porter J, et al. Interim Results From a Phase 2A, Open-Label, Dose-Finding Study To Determine The Safety, Efficacy, And Tolerability of Sotatercept (ACE-001) In Adults with Beta-Thalassemia. Presented at the 19thCongress of the European Hematology Association, June 12-15, 2015, Milan, Italy. Abstract No. S622 "

location_country:
France
Italy
United Kingdom
Greece

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Universita degli Studi di Cagliari - ASL8


title: Treatment of Diarrhea-predominant Irritable Bowel Syndrome With LACTEOL® 340 mg: A Pilot Study Evaluating Safety and Efficacy

summary: Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

lead_sponsor: Forest Laboratories


title: A Multicenter, Randomized, Comparative Study of Different Deferasirox Administration Regimens on Gastrointestinal (GI) Tolerability in Low or Intermediate (Int-1) Risk MDS Myelodysplastic Syndrome Patients With Transfusional Iron Overload.

summary: The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.

lead_sponsor: Novartis Pharmaceuticals

location_country:
France
South Africa
Spain
Italy


intervention_type: Radiation

acronym: A Study in Patients with Non-Small Cell Lung Cancer

title: Phase 2 Study of Pemetrexed and Cisplatin as Induction, Followed by Pemetrexed and Cisplatin With Concurrent Thoracic Radiotherapy, in Patients With Unresectable, Locally Advanced, Stage III, Nonsquamous Non-Small Cell Lung Cancer

lead_sponsor: Eli Lilly and Company

location_country: Germany France Spain Italy

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.

summary: This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in combination with radiotherapy in participants with locally advanced, non-small cell lung cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by progression free survival 1 year after start of treatment with study drug.


title: A Phase II, Multicentre, Open, Randomised, Dose Ranging Study to Investigate the Efficacy of Combination Therapy Containing Dacarbazine (DTIC) Plus Low Dose Interferon Alpha (aIFN) Plus Thymosin a1 Versus Both DTIC Plus Thymosin a1 and DTIC Plus aIFN in Patients With Advanced -Stage Metastatic Malignant Melanoma

summary:
The purpose of the study is to test safety and efficacy of different doses of thymosin alpha 1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon alpha in treating patients affected by stage IV melanoma.

Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free Survival.

Ninety-five patients are allocated to each arm to test the hypothesis that P0 <= 0.05 vs the alternative hypothesis that P1 >= 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).

lead_sponsor: sigma-tau i.f.r. S.p.A.

location_country: Poland Portugal Spain Italy Switzerland Hungary France Germany

location_facility: Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia de Lisboa S.A., Servicio de Medicina Oncologica 1, Pavilhao C

location_facility: Azienda Ospedaliera S. Elia, UO di Oncologia

location_facility: Klinik fur Dermatologie und Allergologie der RWTH Aachen

location_facility: Hosp. Clinic i Provincial Servicio de Oncologia

location_facility: CHU de Grenoble Hopital Albert Michallon Service de Dermatologie

location_facility: Universitatsklinik fur Dermatologie und Venerologie Otto-von-Guericke-Universitat Magdeburg

location_facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica

location_facility: CHU de Limoges Hopital Dupuytren Service de Dermatologie

location_facility: Centre Eugene Marquis Departement d'Oncologie Medicale

location_facility: Hospital General Universitario de Valencia Unidad de Oncologia Medica

location_facility: Petz Aladar Megyei Korhaz, Borgyogyaszat

location_facility: Hosp. Virgen del Rocio Servicio de Oncologia, Planta Baja - Centro de Diagnostico

location_facility: Hosp. Universitario de Jaen Servicio de Oncologia

location_facility: Hosp. Virgen de la Victoria de Malaga Servicio de Oncologia 1a planta Campus Universitario de Teatinos

location_facility: Istituto Europeo di Oncologia, Divisione di Chirurgia Generale

location_facility: Azienda Ospedaliera Garibaldi, UO Oncologia Medica

location_facility: Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte

location_facility: Dermatologische Klinik der Universitat Tubingen

location_facility: Casa di Cura San Pio X, UO Oncologia Medica

location_facility: Ospedale Sandro Pertini, Oncologia Medica

location_facility: Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia

location_facility: IFO Polo Oncologico Ist. Regina Elena, Divisione di Oncologia Medica A

location_facility: Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: U.O. Complessa, Immunoterapia Oncologica, Policlinico "Le Scotte"

location_facility: Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat

location_facility: Università "La Sapienza" Dipartimento di Malattie Cutanee-Veneree e Chirurgia Plastica Ricostruttiva

location_facility: Instytut Onkologii im. Marii Sklodowskiej-Curie, Oddzial w Krakowie, Klinika Chemioterapii

location_facility: Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Chemioterapii Oncologicznej

location_facility: Hopital Saint-Eloi Service de Dermatologie

location_facility: Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1

location_facility: Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia

location_facility: Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej

location_facility: Policlinico "Le Scotte" Dipartimento di Medicina Clinica, Scienze Immunologiche Applicate, Divisione di Dermatologia

location_facility: Hosp. Univ. de Canarias Servicio de Oncologia Medica

location_facility: Ospedale Pierantoni, Divisione Oncologia Medica

location_facility: Orszagos Onkologiai Intezet Borgyogyaszat

location_facility: Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau

location_facility: Università di Roma "Tor Vergata" Oncologia Complementare, Dipartimento di Chirurgia

location_facility: Università di Firenze Dipartimento di Scienze Dermatologiche

location_facility: Universitatsklinikum Schlewig-Holstein Klinik fur Dermatologie, Veneralogie und Allergologie Universitats-Hautklinik Kiel

location_facility: Ospedale PF Calvi Dipartimento di Oncologia

location_facility: Klinika Onkologii Centralnego Szpitala WAM

location_facility: Ospedale San Vincenzo U.O. Oncologia Medica

location_facility: Università "G. D'Annunzio" Facoltà di Medicina e Chirurgia, Clinica Dermatologica

location_facility: Instituto Catalan Oncologico, Servicio de Oncologia

location_facility: Ospedale Umberto I°, Divisione di Oncologia Medica

location_facility: UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe

location_facility: Hosp. Clinico San Carlos Servicio de Oncologia, Pabellon B, Ala Sur-Sotano

location_facility: Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie

location_facility: Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia do Porto S.A., Servicio de Medicina Oncologica, Piso 3


title: rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

summary: This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

ReferenceCitation: Kavakli K, Makris M, Zulfikar B, Erhardtsen E, Abrams ZS, Kenet G; NovoSeven trial (F7HAEM-1510) investigators. Home treatment of haemarthroses using a single dose regimen of recombinant activated factor VII in patients with haemophilia and inhibitors. A multi-centre, randomised, double-blind, cross-over trial. Thromb Haemost. 2006 Apr;95(4):600-5.

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
Spain
United Kingdom
Hungary
France
Israel
Turkey


title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection

summary: The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.

lead_sponsor: Tibotec BVBA

location_country:
Sweden
France
United Kingdom


title: Outcomes of Stapled Trans-Anal Rectal Resection (STARR) vs. Biofeedback in the Treatment of Outlet Obstruction Associated With Rectal Intussusception and Rectocele: A Multi-center Randomized Controlled Trial

acronym: ODS II

summary: This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS).

lead_sponsor: Ethicon Endo-Surgery (Europe) GmbH

location_country:
France
United Kingdom
Italy

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Ospedale "Franchini" di Montecchio Emilia

intervention_type: Behavioral


title: A Phase II, Multicentre, Double-blind, Randomised, Dose Range Finding Placebo Controlled Study of Rifaximin-EIR Tablet: Clinical Effectiveness and Tolerability in the Treatment of Moderate, Active Crohn's Disease

summary: This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is most effective in treating active moderate Crohn's disease. Rifaximin tablets are already marketed in some European countries and the USA to treat traveller's diarrhoea. A new gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules which pass into the intestines and deliver Rifaximin directly to the site of the disease. Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of side effects.

ReferenceCitation: Prantera C, Lochs H, Campieri M, Scribano ML, Sturniolo GC, Castiglione F, Cottone M. Antibiotic treatment of Crohn's disease: results of a multicentre, double blind, randomized, placebo-controlled trial with rifaximin. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1117-25.

ReferenceCitation: Prantera C, Lochs H, Grimaldi M, Danese S, Scribano ML, Gionchetti P; Retic Study Group (Rifaximin-Eir Treatment in Crohn's Disease). Rifaximin-extended intestinal release induces remission in patients with moderately active Crohn's disease. Gastroenterology. 2012 Mar;142(3):473-481.e4. doi: 10.1053/j.gastro.2011.11.032. Epub 2011 Dec 6.

lead_sponsor: Alfasigma S.p.A.

location_country:
Poland
Italy
Russian Federation
Hungary
France
Israel
Germany

location_facility: Azienda Ospedaliera "San Camillo-Forlanini"

location_facility: Jávorszky Ödön Kórház, Gasztroenterológiai Osztály

location_facility: A.O. Luigio Sacco U.O gastraneterologia, via G.B. grassi 74

location_facility: Szpital Specjalistyczny Św. Wojciecha- Adalberta

location_facility: Debreceni Egyetem Orvos és Egészégtudományi Centrum II. Belgyógyászati Klinika

location_facility: Novosibirsk State Medical University City Hospital #7

location_facility: Abteilung Gastroenterologie, Charité Campus Benjamin Franklin

location_facility: State Scientific Centre of Coloproctology

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: Szegedi Tudományegyetem, Általános Orvostudományi Kar, I. sz. Belgyógyászati Klinika

location_facility: Azienda Ospedaliera Universitaria Policlinico di Torvergata

location_facility: Nizhny Novgorod Regional Clinical Hospital

location_facility: Allami Egeszsegugyi Kozpont, MAV-Rendeszeti Szervek-Honvedseg Egyesitett Korhaza

location_facility: St. Petersburg Mechnikov State Medical Academy

location_facility: Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

location_facility: Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin

location_facility: Rostov State Medical University City Hospital # 20

location_facility: Azienda Ospedaliera S. Giovanni Battista Molinette

location_facility: 10 Wojskowy Szpital Kliniczny z Polikliniką

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego Ślaskiej Akademii Medycznej

location_facility: Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky

location_facility: Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny

location_facility: Russian Center of Functional Surgical Gastroenterology

location_facility: Azienda Ospedaliera-Universitaria di Bologna - Policlinico S. Orsola-Malpighi

location_facility: Békés Megyei Kèpviselőtestület, Pándy Kálmán Kórház, III. Belgyógyászat

location_facility: Tolna Megyei Önkormányzat Balassa János Kórhaz, II. Belgyógyászat


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.

lead_sponsor: UCB Pharma


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.

lead_sponsor: Boehringer Ingelheim

location_country:
United Kingdom
Ukraine
Sweden
France
Germany
Slovakia

location_facility: 1218.6.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49013 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49008 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49011 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49015 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44007 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44019 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44016 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44013 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42101 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49014 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44005 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44004 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49016 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42104 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46004 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49017 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44012 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44008 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49012 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44017 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44006 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38005 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49010 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44018 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42105 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42103 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49009 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44009 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44015 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49005 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46001 Boehringer Ingelheim Investigational Site


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.

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:
Spain
Netherlands
Switzerland
Sweden
France
South Africa
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.

lead_sponsor: UNICANCER

location_country:
France
Switzerland
United Kingdom

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

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


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

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:
United Kingdom
France
Spain
Ireland

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 Greece Sweden France 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.

location_country: France Switzerland Italy

location_facility: Istituto Nazionale Di Riposo e Cura per Anziani


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.

lead_sponsor: University Hospital, Clermont-Ferrand

location_country: France Switzerland Belgium

location_facility: Centre Hospitalier les Hôpitaux de Chartres

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: Hôpital Privé Institut Mutualiste Montsouris


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.

lead_sponsor: Rennes University Hospital

location_country: France Belgium

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


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

location_facility: University General Hospital of Alexandroupolis

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

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Fundació Hospital de la Santa Creu i Sant Pau

location_facility: Universita degli Studi di Roma La Sapienza

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

location_facility: Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

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

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Bourg-en-Bresse Fleyriat

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centre Hospitalier Chalon sur Saône William Morey

location_facility: Hospital General Universitario de Alicante

location_facility: Azienda Ospedaliera Universitaria Maggiore Della Carita di Novara

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

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

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Ospedali Riuniti di Ancona, Clinica Ematologica

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Hospital Universitari Arnau De Vilanova (Huav)

location_facility: AHEPA University General Hospital of Thessaloniki

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede

location_facility: Hospital Universitario Central de Asturias

location_facility: South Tees Hospitals Nhs Foundation Trust

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Universitario Virgen de la Arrixaca

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


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.

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


acronym: DoubleITK

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.

lead_sponsor: University Hospital, Lille

location_facility: Diseases of Blood Service HURIEZ hospital CHRU de LILLE

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.

lead_sponsor: Societe Française de Medecine d'urgence

location_country: France Switzerland Spain Belgium

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


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.

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.

ReferenceCitation: Lepage C, Phelip JM, Lievre A, Le-Malicot K, Dahan L, Tougeron D, Toumpanakis C, Di-Fiore F, Lombard-Bohas C, Borbath I, Coriat R, Lecomte T, Guimbaud R, Petorin C, Legoux JL, Michel P, Scoazec JY, Smith D, Walter T. Lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours: An international double-blind, placebo-controlled randomised phase II trial - Prodige 31 REMINET: An FFCD study. Eur J Cancer. 2022 Nov;175:31-40. doi: 10.1016/j.ejca.2022.07.033. Epub 2022 Sep 7.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country:
Germany
France
United Kingdom
Belgium

location_facility: Manchester Academic Health Sciences Centre (MAHSC)

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

location_facility: Royal Free Hospital Neuroendocrine Tumour Unit


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].

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.

ReferenceCitation: Godon A, Gabin M, Levy JH, Huet O, Chapalain X, David JS, Tacquard C, Sattler L, Minville V, Mémier V, Blanié A, Godet T, Leone M, De Maistre E, Gruel Y, Roullet S, Vermorel C, Samama CM, Bosson JL, Albaladejo P; GIHP-NACO Study Group. Management of urgent invasive procedures in patients treated with direct oral anticoagulants: An observational registry analysis. Thromb Res. 2022 Aug;216:106-112. doi: 10.1016/j.thromres.2022.06.005. Epub 2022 Jun 22.

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


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.

lead_sponsor: Amgen

location_country: Spain Greece Netherlands Switzerland France Belgium 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:
Spain
Italy
Austria
United Kingdom
Switzerland
France
Sweden

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

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


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: Poland Spain Netherlands France Belgium 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.

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: France Spain Belgium

location_facility: Centre Hospitalier Universitaire Saint Etienne- Hopital Nord

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Hospital Universitari Germans Trias I Pujol


acronym: NEPHRUTIX

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

lead_sponsor: University Hospital, Limoges

location_facility: Queen Fabiola Universitary Children's Hospital

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.

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


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.

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

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