acronym: ISALP

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

summary: The primary objective of this study is to characterize cerebral metabolism modifications using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging within this framework, and search for optimal diagnostic thresholds.

location_facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Strasbourg - Hôpital de Hautepierre

location_facility: APHP - Groupe Hospitalier Pitié-Salpetrière

title: Evaluating the Performance of Isotopic Brain Imaging of Glucose Metabolism Via PET (18F-FDG) and Perfusion SPECT (99mTc-ECD) for the Diagnosis of Prodromal Stage Alzheimer's Disease


title: Computed Tomography Scan Versus Color Duplex Ultrasound for Surveillance of Endovascular Repair of Abdominal Aortic Aneurysm. A Prospective Multicenter Study

acronym: ESSEA

summary:
Cumulative radiation dose, cost, contrast induced nephrotoxicity and increased demand for computed tomography aortography (CTA) suggest that duplex ultrasonoraphy (DU) may be an alternative to CTA-based surveillance. The investigators compared CTA with DU during endovascular aneurysm repair (EVAR) follow-up.

Patients undergoing EVAR have radiological follow-up data entered in a prospectively multicenter database. The gold standard test for endoleak detection was CTA. DU interpretation was performed independently of CTA and vice versa.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Jean-Baptiste E, Feugier P, Cruzel C, Sarlon-Bartoli G, Reix T, Steinmetz E, Chaufour X, Chavent B, Salomon du Mont L, Ejargue M, Maurel B, Spear R, Midy D, Thaveau F, Desgranges P, Rosset E, Hassen-Khodja R; Association Universitaire de Recherche en Chirurgie Vasculaire. Computed Tomography-Aortography Versus Color-Duplex Ultrasound for Surveillance of Endovascular Abdominal Aortic Aneurysm Repair: A Prospective Multicenter Diagnostic-Accuracy Study (the ESSEA Trial). Circ Cardiovasc Imaging. 2020 Jun;13(6):e009886. doi: 10.1161/CIRCIMAGING.119.009886. Epub 2020 Jun 8.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de St Etienne - Service de Chirurgie Vasculaire

location_facility: CHU de Grenoble - Service de Chirurgie Vasculaire

location_facility: CHU de Nice - Service de chirurgie vasculaire

location_facility: CHU de Bordeaux - Service de Chirurgie Vasculaire

location_facility: CHU de Strasbourg - Service de Chirurgie Vasculaire

location_facility: CHU de Caen - Service de Chirurgie Vasculaire

location_facility: APHM - Hôpital Nord - Service de Chirurgie Vasculaire

location_facility: CHU de Montpellier - Service de Chirurgie Vasculaire

location_facility: CHRU Lille Service de Chirurgie Vasculaire

location_facility: CHU d'Amiens - Service de Chirurgie Vasculaire

location_facility: CHU Clermont-ferrand - Service de Chirurgie Vasculaire

location_facility: CHU de Besançon - Service de Chirurgie Vasculaire

location_facility: CHU de Toulouse - Service de Chirurgie Vasculaire

location_facility: CHU de Rouen - Service de Chirurgie Vasculaire

location_facility: CHU de Nantes - Service de Chirurgie Vasculaire

location_facility: AP-HP Créteil - Service de chirurgie vasculaire

location_facility: CHU d'Angers - Service de Chirurgie Vasculaire

location_facility: AP-HP - Pitié Salpétrière - Service de Chirurgie Vasculaire

location_facility: CHU de Dijon - Service de Chirurgie Vasculaire

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


intervention_type: Drug

acronym: TOLAK

lead_sponsor: Pierre Fabre Medicament

summary:
Transient local skin reactions with topical Actinic Keratosis treatments such as 5-FluoroUracil (5-FU) often lead to non-adhesion from patients and thus to treatment failure. In regards to 5-FU treatment, these local reactions are related to the pharmacological action of the molecule. The current therapeutic challenge is to reduce the local reactions induced by 5-FU without interfering with its efficacy, in particular by the use of an emollient cream.

The aim of the present study is to investigate how the use of an emollient, namely Dexeryl, could improve the local skin reactions occurring during 4 weeks of a 4% 5-FU treatment.

sponsor_collaborators:
Pierre Fabre Medicament
Clinact

location_facility: Catholic University Fondazione Policlinico Universitario A. Gemelli

location_facility: Kath. Klinikum Bochum St. Josef-Hospital

location_facility: NAPLES VANVITELLI UNIVERSITI (Federico II Hospital)

location_facility: Sapienza University of Rome - Polo Pontino

title: Frequency and Intensity of Local Reactions in Patients Treated With 4% 5-FU vs 4% 5-FU Associated With an Emollient Cream: a Randomised, Controlled Clinical Trial

primary_purpose: Supportive Care

type: EudraCT Number

source: euctr

design_allocation: Randomized

location_country: Germany Italy Spain France

ipd_sharing: No

lead_sponsor_type: industriel


title: TEMOkids Study: A Population Pharmacokinetic, Acceptability and Safety Study for KIMOZO, a Paediatric Oral Suspension of Temozolomide

summary: Non-randomized, international, multi-centre, open-label, single arm study to determine the pharmacokinetic (PK) parameters of a single dose of an oral suspension of temozolomide (KIMOZO) in the pediatric population aged 1 year and over.

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Treatment

lead_sponsor: Orphelia Pharma

sponsor_collaborators:
Orphelia Pharma
ClinSearch

location_country:
Germany
United Kingdom
Netherlands
Spain
France

location_facility: Great Ormond Street Hospital for Children

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Hopp Children's Cancer Center Heidelberg

location_facility: Princess Maxima Center for Pediatric Oncology

status_simplified: Ongoing


type: Other Identifier

title: A Phase 1, FIH, Dose Escalation Study of JNJ-74856665 (Dihydroorotate Dehydrogenase [DHODH] Inhibitor) Alone or in Combination in Participants With AML or MDS

acronym: DHODH

summary: The purpose of this study is to determine the safety, tolerability, maximum tolerated doses (MTDs) and recommended Phase 2 doses (RP2Ds) of JNJ-74856665 as monotherapy and/or in combinations.

design_allocation: Non-Randomized

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Korea, Republic of
Spain
United Kingdom
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: Institut Universitaire du Cancer Toulouse Oncopole


title: Interventions to Curb Hepatitis C Reinfections Among Men Who Have Sex With Men

acronym: ICECREAM

summary: Men who have sex with men (MSM) who cured from hepatitis C virus (HCV) infection are at substantial risk of HCV reinfection. In this study, the investigators aim to evaluate the effectiveness of an online behavioural intervention, a home-based testing intervention and a combination of both on risk behaviour, and ultimately preventing HCV reinfection and onward spread of HCV.

status: Recruiting

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Newsum AM, Stolte IG, van der Meer JT, Schinkel J, van der Valk M, Vanhommerig JW, Buve A, Danta M, Hogewoning A, Prins M; MOSAIC collaborators. Development and validation of the HCV-MOSAIC risk score to assist testing for acute hepatitis C virus (HCV) infection in HIV-infected men who have sex with men (MSM). Euro Surveill. 2017 May 25;22(21):30540. doi: 10.2807/1560-7917.ES.2017.22.21.30540.

ReferenceCitation: Lambers FA, Prins M, Thomas X, Molenkamp R, Kwa D, Brinkman K, van der Meer JT, Schinkel J; MOSAIC (MSM Observational Study of Acute Infection with hepatitis C) study group. Alarming incidence of hepatitis C virus re-infection after treatment of sexually acquired acute hepatitis C virus infection in HIV-infected MSM. AIDS. 2011 Nov 13;25(17):F21-7. doi: 10.1097/QAD.0b013e32834bac44.

ReferenceCitation: Lambers F, van der Veldt W, Prins M, Davidovich U; MOSAIC study. Changing the odds: motives for and barriers to reducing HCV-related sexual risk behaviour among HIV-infected MSM previously infected with HCV. BMC Infect Dis. 2018 Dec 18;18(1):678. doi: 10.1186/s12879-018-3571-1.

lead_sponsor: Public Health Service of Amsterdam

collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

collaborators: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

collaborators: The National Institute for STI and Aids Control in the Netherlands (Soa Aids Nederland)

collaborators: Julius Centre for Health Sciences and Primary Care, UMC Utrecht

location_country: Netherlands France

location_facility: Service de maladies infectieuses et tropicales, Hôpital Saint-Antoine

location_facility: Service de maladies infectieuses et tropicales, Hôpital La Pitié-Salpêtrière

location_facility: Service de maladies infectieuses et tropicales, Hôpital Tenon

location_facility: Public Health Service of Amsterdam (GGD Amsterdam)

intervention_type: Diagnostic Test


title: AXONE-Acute II: Acute Assessment of a Micro Multipolar Lead for Enhanced Cardiac Resynchronisation Therapy

summary: Pilot study to evaluate the performance of a lead below 2 French with specific distal shape to deliver efficient LV pacing

status: Unknown status

primary_purpose: Other

lead_sponsor: University Hospital, Rouen

sponsor_collaborators:
University Hospital, Rouen
MicroPort CRM

location_country: Spain France

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hospital Universitari Germans Trias i Pujol

intervention_type: Device

status_simplified: Unknown


title: Evaluation of Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer

summary:
Neoadjuvant chemotherapy (NAC) is frequently proposed to patients with large tumours that can be operated in order to increase the chances of breast conservation. After NAC, patients are operated with systematic axillary lymph node dissection (ALND), although more than half of these patients do not have lymph node involvement. These results lead us to consider the indication of the sentinel lymph node (SLN) technique after NAC in order to avoid unnecessary ALND in patients whose SLN is free of involvement.

We need to validate the SLN technique after NAC in patients who have proven lymph node involvement prior to NAC.

GANEA2 is a new trial based on patient treated for a large breast tumor with proven axillary involved nodes. Patients enrolled in this trial will have first an axillary sonography with fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to determine two groups of patients : group 1 (pN+) : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes (cN0). Patients of group 1, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group 2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: INSTITUT DE CANCEROLOGIE DE MONTPELLIER Val d'aurelle


title: Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer

acronym: CARACO

summary: It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.

status: Suspended

location_facility:
Hôpital Européen Georges Pompidou
Hôpital des Diaconesses
Hospital
Institut Paoli Calmette
Clinique Sainte Thérèse
Clinique Mutualiste
Centre René Huguenin
Institut Claudius Regaud
Hôpital Lariboisière
Hopital
Centre G F Leclerc
Institut Cancerologie de l'Ouest
Centre Val d'Aurelle
Centre Paul Papin
Hôpital Bretonneau
Centre Jean Perrin
Centre Paul Strauss


acronym: ORTHOUNION

lead_sponsor: Universidad Autonoma de Madrid

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.

ReferenceCitation: Gomez-Barrena E, Padilla-Eguiluz NG, Avendano-Sola C, Payares-Herrera C, Velasco-Iglesias A, Torres F, Rosset P, Gebhard F, Baldini N, Rubio-Suarez JC, Garcia-Rey E, Cordero-Ampuero J, Vaquero-Martin J, Chana F, Marco F, Garcia-Coiradas J, Caba-Dessoux P, de la Cuadra P, Hernigou P, Flouzat-Lachaniette CH, Gouin F, Mainard D, Laffosse JM, Kalbitz M, Marzi I, Sudkamp N, Stockle 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 Clínica San Carlos, Servicio de Cirugía Ortopédica y Traumatología

location_facility: Universitätsklinikum Freiburg, Klinik für Orthopädie und Unfallchirurgie

location_facility: Department of Orthopaedic Surgery, CHU Tours

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

location_facility: Department of Orthopaedic Surgery, CHU Nantes

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 Toulouse University Hospital

location_facility: Department of Orthopaedic Trauma, University of Ulm

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

location_facility: Department of Orthopaedic Surgery, Hospital Henri Mondor

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

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

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

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

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

type: Registry Identifier


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

status: Withdrawn

lead_sponsor: Neovacs

location_country: Germany Italy Switzerland France

location_facility: Charité - Universitätsmedizin Berlin Rudolf- Virchow- Haus

intervention_type: Other


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

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.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central;www.repositoriosalud.es

unpaywall_oa_status: gold

publisher_dissemination: Wiley

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

sponsor_collaborators:
AstraZeneca
Quintiles, Inc.

location_country:
Korea, Republic of
Spain
France


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.

lead_sponsor: University Hospital, Essen

location_country: Germany Serbia Greece France

location_facility: National Centre for Tumour Diseases (NCT)

location_facility: University Hospital Mannheim, Clinic for Dermatology

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

location_facility: Gesellschaft für Klinische Forschung Ludwigshafen mbH


title: European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment

acronym: EQOLOC

summary: Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more than 40% of patients are resistant to the standard pharmacological and psychotherapy approaches and about 10% show severe disability and require institutionalization. These resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate neural networks. Although promising, these results need nevertheless to be replicated and confirmed within a larger cohort of patients and considering a different main objective, instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond symptom reduction, health-related quality of life (QoL) represents a more important objective of a treatment, as it includes both the individual's functional status and the individual's subjective perception of the impact of the illness on the patient's life. STN DBS induces significant clinical improvement, which may not be proportional to the QoL gain. Consequently, QoL appears to be a better outcome to target in the coming studies than clinical improvement alone. THe investigators thus propose a prospective study assessing the QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT) at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus BMT alone.

ReferenceCitation: Subramaniam M, Soh P, Vaingankar JA, Picco L, Chong SA. Quality of life in obsessive-compulsive disorder: impact of the disorder and of treatment. CNS Drugs. 2013 May;27(5):367-83. doi: 10.1007/s40263-013-0056-z.

ReferenceCitation: Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum In: N Engl J Med. 2009 Sep 3;361(10):1027.

ReferenceCitation: Kohl S, Schonherr DM, Luigjes J, Denys D, Mueller UJ, Lenartz D, Visser-Vandewalle V, Kuhn J. Deep brain stimulation for treatment-refractory obsessive compulsive disorder: a systematic review. BMC Psychiatry. 2014 Aug 2;14:214. doi: 10.1186/s12888-014-0214-y.

ReferenceCitation: Eitan R, Shamir RR, Linetsky E, Rosenbluh O, Moshel S, Ben-Hur T, Bergman H, Israel Z. Asymmetric right/left encoding of emotions in the human subthalamic nucleus. Front Syst Neurosci. 2013 Oct 29;7:69. doi: 10.3389/fnsys.2013.00069. eCollection 2013.

ReferenceCitation: Mataix-Cols D, Fernandez de la Cruz L, Nordsletten AE, Lenhard F, Isomura K, Simpson HB. Towards an international expert consensus for defining treatment response, remission, recovery and relapse in obsessive-compulsive disorder. World Psychiatry. 2016 Feb;15(1):80-1. doi: 10.1002/wps.20299. No abstract available.

ReferenceCitation: Piallat B, Polosan M, Fraix V, Goetz L, David O, Fenoy A, Torres N, Quesada JL, Seigneuret E, Pollak P, Krack P, Bougerol T, Benabid AL, Chabardes S. Subthalamic neuronal firing in obsessive-compulsive disorder and Parkinson disease. Ann Neurol. 2011 May;69(5):793-802. doi: 10.1002/ana.22222. Epub 2010 Dec 28.

ReferenceCitation: Ooms P, Mantione M, Figee M, Schuurman PR, van den Munckhof P, Denys D. Deep brain stimulation for obsessive-compulsive disorders: long-term analysis of quality of life. J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):153-8. doi: 10.1136/jnnp-2012-302550. Epub 2013 May 28.

lead_sponsor: University Hospital, Grenoble

location_country: Germany Sweden Switzerland France

location_facility: University Hospital of Grenoble Michallon


title: One-year Mortality According to the Method of Total Intravenous Anesthesia. A Prospective, Randomized and Multicenter Study

acronym: ELA

summary:
A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than 45) and death within 1 yr after surgery has previously been reported. In order to confirm or refute these findings, the investigators have designed a study which compares two methods of administration for total intravenous anesthesia (propofol and remifentanil):

manual administration: the anesthesiologists are instructed to maintain the BIS value between 40 and 60.
closed loop administration: an algorithm is used to maintain the BIS value between 40 and 60.

Based on previous studies, the amount of time that BIS is maintained above 40 is greater when anesthetics agents are administered using closed loop compared with manual administration.

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.

ReferenceCitation: Cantraine FR, Coussaert EJ. The first object oriented monitor for intravenous anesthesia. J Clin Monit Comput. 2000 Jan;16(1):3-10. doi: 10.1023/a:1009904805940.

ReferenceType: result

ReferenceCitation: Lindholm ML, Traff S, Granath F, Greenwald SD, Ekbom A, Lennmarken C, Sandin RH. Mortality within 2 years after surgery in relation to low intraoperative bispectral index values and preexisting malignant disease. Anesth Analg. 2009 Feb;108(2):508-12. doi: 10.1213/ane.0b013e31818f603c.

ReferenceCitation: Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.

ReferenceCitation: Mahr N, Bouhake Y, Chopard G, Liu N, Boichut N, Chazot T, Claveau M, Vettoretti L, Tio G, Pili-Floury S, Samain E, Besch G. Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial. Anesth Analg. 2021 Oct 1;133(4):837-847. doi: 10.1213/ANE.0000000000005278.

evidence: open (via free article)

lead_sponsor: Hopital Foch

location_facility: Hôpitaux Universitaires Paris-Seine St Denis CHU Avicenne


title: A Phase 4, Observational Study to Explore How Different Treatment Regimens Affect Continuation With Treatment in the First 6 Months Following Initiation of XAGRID Into Adult Patients' Essential Thrombocythemia Therapy

acronym: FOX

summary: This is an observational study to explore how different treatment regimens affect continuation with treatment in the first 6 months following initiation of XAGRID into adult patients' essential thrombocythemia therapy.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Rey J, Viallard JF, Keddad K, Smith J, Wilde P, Kiladjian JJ; FOX study investigators. Characterization of different regimens for initiating anagrelide in patients with essential thrombocythemia who are intolerant or refractory to their current cytoreductive therapy: results from the multicenter FOX study of 177 patients in France. Eur J Haematol. 2014 Feb;92(2):127-36. doi: 10.1111/ejh.12210. Epub 2013 Nov 25.

oa_host_type: repository

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: green

lead_sponsor: Shire

location_facility:
CH De Bicetre
Hia Sainte Anne
Hopital Saint Jean
Institut de Cancerologie de la Loire
Ch De Brive La Gaillarde
Hopital Font Pre
Chi De Cornouaille
Hopital Dupuytren
Hopital Saint Antoine
Hopital Edouard Herriot
CH Departemental Des Oudairies
CHU Nord - Chemin Des Bourrely
Institut J Paoli Calmettes
CH De Blois
Centre De Radiotherapie
Ch D Arras
Clinique Du Parc
CME
Hopital Robert Boulin
Hotel Dieu
Ch De Fleyriat
CH DU Pays D Aix
Hopital Tenon
Hopital Henri Mondor
Hopital Hotel Dieu Et Hme
Hopital Augustin Morvan
Cabinet D'Hematologie
Nouvelles Cliniques Nantaises
Hopital Hautepierre
CHRA
CHI Poissy Saint German en Laye
GH Pitie Salpetriere
Hopital De L Archet
Ch De Vendome
Polyclinique Bordeaux Nord Aquitaine
Hopital N D Bon Secours
Hopital Emile Muller
Hopitaux de Brabois
Hopital Robert Ballanger
Clinique Pont de Chaume
Hopital Saint Philibert
Hopital Pontchaillou
Hopital de La Maison Blanche
Hopital De Haut Leveque
CHRU Lille - Hopital Huriez


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).

ReferenceCitation: Kramer A, Stel V, Zoccali C, Heaf J, Ansell D, Gronhagen-Riska C, Leivestad T, Simpson K, Palsson 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. doi: 10.1038/ki.1992.191.

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. No abstract available.

ReferenceCitation: Staub NC. Pulmonary edema. Physiol Rev. 1974 Jul;54(3):678-811. doi: 10.1152/physrev.1974.54.3.678. No abstract available.

ReferenceCitation: Crandall ED, Staub NC, Goldberg HS, Effros RM. Recent developments in pulmonary edema. Ann Intern Med. 1983 Dec;99(6):808-22. doi: 10.7326/0003-4819-99-6-808.

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. doi: 10.1016/j.amjcard.2004.02.012.

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.

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. doi: 10.1016/j.echo.2005.05.019.

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. doi: 10.1378/chest.127.5.1690.

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. doi: 10.1016/s0735-1097(00)01158-x.

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

collaborators: IASIO Hospital - General Clinic of Kallithea

location_country: Germany Italy France Poland Slovenia Romania Spain Greece Israel

location_facility: Medical University of Silesia in Katowice

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

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


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 E, 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.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

version: submittedVersion

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

unpaywall_oa_status: hybrid

lead_sponsor: Actelion

location_country:
Germany
United Kingdom
France


title: Phase IV Multicentric Study, 140 Patients Suffering of Meibomian Glands Dysfunction.

acronym: ESPOIR Ext

summary:
Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands dysfunction .

Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.

This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.

Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.

lead_sponsor: Laboratoires Thea

location_facility: Hopital d'instruction des armées LAVERAN


acronym: MANTA

lead_sponsor: Queen Mary University of London

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)

ReferenceCitation: Schmid P, Zaiss M, Harper-Wynne C, Ferreira M, Dubey S, Chan S, Makris A, Nemsadze G, Brunt AM, Kuemmel S, Ruiz I, Perello A, Kendall A, Brown J, Kristeleit H, Conibear J, Saura C, Grenier J, Mahr 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, Cortes 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.

repository_institution: Keele University - Keele Research Repository

version: acceptedVersion

publisher_dissemination: American Medical Association

sponsor_collaborators:
Queen Mary University of London
AstraZeneca

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Consorcio Hospitalario Provincial de Castellon

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

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

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

location_facility: Praxis für interdisziplinäre Onkologie & Hämatologie

location_facility: Klinik für Gynäkologie & Geburtshilfe/Brustzentrum

location_facility: Cafeteria Hospital San Pedro de Alcantara

location_facility: Schwerpunktpraxis Hämatologie / Onkologie MVZ Lahr

location_facility: Frauenärztliche Gemeinschaftspraxis - Onkologie

location_facility: Korea University Medical Center Guro Hospital

location_facility: Schwarzwald Baar Klinikum, Villingen-Schwenningen

location_facility: University of Pecs, Institute of Oncology

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

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


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 Greece France

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


lead_sponsor: Grünenthal GmbH

summary: The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.

location_facility:
Site 26
Site 36
Site 35
Site 12
Site 27
Site 23
Site 31
Site 19
Site 39
Site 22
Site 15
Site 17
Site 18
Site 20
Site 24
Site 33
Site 28
Site 30
Site 21
Site 14
Site 38
Site 34

status: Terminated

title: Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.


acronym: AVATAXHER

lead_sponsor: Hoffmann-La Roche

summary: This randomized study will assess the effect of adding bevacizumab to trastuzumab plus docetaxel in neoadjuvant therapy in participants with early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. After 2 cycles of trastuzumab and docetaxel once every 3 weeks, participants with a response (change in standard uptake value [SUV]) of less than (<) 70 percent (%) on Positron Emission Tomography (PET) will be randomized in a 2:1 ratio to receive Cycles 3 to 6 of trastuzumab (6 milligrams per kilogram [mg/kg]) and docetaxel (100 milligrams per square meter [mg/m^2]) with or without bevacizumab (15 mg/kg). Participants with a response of greater than or equal to (>/=) 70% will receive trastuzumab plus docetaxel in Cycles 3 to 6. All participants will receive trastuzumab alone in Cycle 7, and will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the treatment perfusion of Cycle 6. After surgery, all participants will receive a further 11 cycles of trastuzumab plus radiotherapy (starting from 4-8 weeks after surgery during 4-6 weeks, according to site's standard practice) with or without hormonal therapy (mandatory if positive hormone receptors). Participants will be followed for up to 5 years from start of neoadjuvant treatment.

ReferenceCitation: Coudert B, Pierga JY, Mouret-Reynier MA, Kerrou K, Ferrero JM, Petit T, Kerbrat P, Dupre PF, Bachelot T, Gabelle P, Giard S, Coeffic D, Bougnoux P, Prevost JB, Paintaud G, Thibault G, Hernandez J, Coudert M, Arnould L, Berriolo-Riedinger A. Use of [(18)F]-FDG PET to predict response to neoadjuvant trastuzumab and docetaxel in patients with HER2-positive breast cancer, and addition of bevacizumab to neoadjuvant trastuzumab and docetaxel in [(18)F]-FDG PET-predicted non-responders (AVATAXHER): an open-label, randomised phase 2 trial. Lancet Oncol. 2014 Dec;15(13):1493-1502. doi: 10.1016/S1470-2045(14)70475-9. Epub 2014 Oct 30.

oa_host_type: closed

publisher_dissemination: Elsevier

location_facility: Pole Sante Republique;Oncologie Hematologie

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Ch De Montlucon; Sce Med Interne Hemato Onco

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Institut de Cancerologie de La Loire; Radiotherapie

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Centre Henry S Kaplan - CHU Bretonneau ; service oncologie

title: An Open-Label, Randomized, Multicenter, Phase II, Non Comparative, Exploratory Study on Neoadjuvant Treatment With Trastuzumab Plus Docetaxel Plus Bevacizumab According to Positon Emission Tomography (PET) Value Modification in Patients With Early Stage HER2 Positive Breast Cancer


title: Observational Cohort Study on the Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA

summary: Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant safety of Pradaxa in real-life conditions

lead_sponsor: Boehringer Ingelheim

location_facility: Boehringer Ingelheim Investigational Site 11

location_facility: Boehringer Ingelheim Investigational Site 17

location_facility: Boehringer Ingelheim Investigational Site 46

location_facility: Boehringer Ingelheim Investigational Site 42

location_facility: Boehringer Ingelheim Investigational Site 25

location_facility: Boehringer Ingelheim Investigational Site 14

location_facility: Boehringer Ingelheim Investigational Site 34

location_facility: Boehringer Ingelheim Investigational Site 9

location_facility: Boehringer Ingelheim Investigational Site 7

location_facility: Boehringer Ingelheim Investigational Site 8

location_facility: Boehringer Ingelheim Investigational Site 49

location_facility: Boehringer Ingelheim Investigational Site 44

location_facility: Boehringer Ingelheim Investigational Site 20

location_facility: Boehringer Ingelheim Investigational Site 52

location_facility: Boehringer Ingelheim Investigational Site 15

location_facility: Boehringer Ingelheim Investigational Site 29

location_facility: Boehringer Ingelheim Investigational Site 32

location_facility: Boehringer Ingelheim Investigational Site 51

location_facility: Boehringer Ingelheim Investigational Site 33

location_facility: Boehringer Ingelheim Investigational Site 23

location_facility: Boehringer Ingelheim Investigational Site 39

location_facility: Boehringer Ingelheim Investigational Site 43

location_facility: Boehringer Ingelheim Investigational Site 18

location_facility: Boehringer Ingelheim Investigational Site 35

location_facility: Boehringer Ingelheim Investigational Site 19

location_facility: Boehringer Ingelheim Investigational Site 26

location_facility: Boehringer Ingelheim Investigational Site 13

location_facility: Boehringer Ingelheim Investigational Site 47

location_facility: Boehringer Ingelheim Investigational Site 6

location_facility: Boehringer Ingelheim Investigational Site 41

location_facility: Boehringer Ingelheim Investigational Site 16

location_facility: Boehringer Ingelheim Investigational Site 21

location_facility: Boehringer Ingelheim Investigational Site 28

location_facility: Boehringer Ingelheim Investigational Site 50

location_facility: Boehringer Ingelheim Investigational Site 53

location_facility: Boehringer Ingelheim Investigational Site 45

location_facility: Boehringer Ingelheim Investigational Site 22

location_facility: Boehringer Ingelheim Investigational Site 36

location_facility: Boehringer Ingelheim Investigational Site 31

location_facility: Boehringer Ingelheim Investigational Site 37

location_facility: Boehringer Ingelheim Investigational Site 10

location_facility: Boehringer Ingelheim Investigational Site 38

location_facility: Boehringer Ingelheim Investigational Site 24

location_facility: Boehringer Ingelheim Investigational Site 27

location_facility: Boehringer Ingelheim Investigational Site 30

location_facility: Boehringer Ingelheim Investigational Site 12

location_facility: Boehringer Ingelheim Investigational Site 48

location_facility: Boehringer Ingelheim Investigational Site 40


title: Breast Cancer Adjuvant Hormonotherapy : Tamoxifen and the Anti-aromatases Pharmacokinetics, Correlation With the Pharmacogenetic Characteristics PHACS Protocol : Pharmacology of Adjuvant Hormonotherapy in Breast Cancer

acronym: PHACS

summary:
This is a biomedical study of interventional type, multicenter, inter-regional.

Patients with hormono-depending breast cancer, for which an indication of adjuvant hormonotherapy treatment (according to the current treatments) was retained, will be enrolled in this study. The main objective is to estimate the correlations between pharmacokinetic and pharmacogenetic parameters of adjuvant hormonal breast cancer treatment, during the first 3 years.

ReferenceCitation: Puszkiel A, Arellano C, Vachoux C, Evrard A, Le Morvan V, Boyer JC, Robert J, Delmas C, Dalenc F, Debled M, Venat-Bouvet L, Jacot W, Dohollou N, Bernard-Marty C, Laharie-Mineur H, Filleron T, Roche H, Chatelut E, Thomas F, White-Koning M. Model-Based Quantification of Impact of Genetic Polymorphisms and Co-Medications on Pharmacokinetics of Tamoxifen and Six Metabolites in Breast Cancer. Clin Pharmacol Ther. 2021 May;109(5):1244-1255. doi: 10.1002/cpt.2077. Epub 2020 Nov 10.

lead_sponsor: Institut Claudius Regaud

location_facility: Centre Hospitalier Intercommunal de Castres-Mazamet

location_facility: Clinique Pasteur - Département d'Oncologie Médicale

location_facility: Clinique Pasteur - Département de Radiothérapie


title: A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)

summary: This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a moderate or good response will be randomized to receive re-treatment with either 1 or 2 additional infusions of 1000 mg IV MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

ReferenceCitation: de Jong TD, Sellam J, Agca R, Vosslamber S, Witte BI, Tsang-A-Sjoe M, Mantel E, Bijlsma JW, Voskuyl AE, Nurmohamed MT, Verweij CL, Mariette X. A multi-parameter response prediction model for rituximab in rheumatoid arthritis. Joint Bone Spine. 2018 Mar;85(2):219-226. doi: 10.1016/j.jbspin.2017.02.015. Epub 2017 Mar 28.

ReferenceCitation: Sellam J, Riviere E, Courties A, Rouzaire PO, Tolusso B, Vital EM, Emery P, Ferraccioli G, Soubrier M, Ly B, Hendel Chavez H, Taoufik Y, Dougados M, Mariette X. Serum IL-33, a new marker predicting response to rituximab in rheumatoid arthritis. Arthritis Res Ther. 2016 Dec 13;18(1):294. doi: 10.1186/s13075-016-1190-z. Erratum In: Arthritis Res Ther. 2017 Jan 23;19(1):11.

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

repositories:
HAL
PubMed Central
eprints.whiterose.ac.uk

publisher_dissemination: Springer-Nature

ReferenceCitation: Sellam J, Rouanet S, Hendel-Chavez H, Miceli-Richard C, Combe B, Sibilia J, Le Loet X, Tebib J, Jourdan R, Dougados M, Taoufik Y, Mariette X. CCL19, a B cell chemokine, is related to the decrease of blood memory B cells and predicts the clinical response to rituximab in patients with rheumatoid arthritis. Arthritis Rheum. 2013 Sep;65(9):2253-61. doi: 10.1002/art.38023.

ReferenceCitation: Mariette X, Rouanet S, Sibilia J, Combe B, Le Loet X, Tebib J, Jourdan R, Dougados M. Evaluation of low-dose rituximab for the retreatment of patients with active rheumatoid arthritis: a non-inferiority randomised controlled trial. Ann Rheum Dis. 2014 Aug;73(8):1508-14. doi: 10.1136/annrheumdis-2013-203480. Epub 2013 May 30.

publisher_dissemination: British Medical Journal

ReferenceCitation: Sellam J, Rouanet S, Hendel-Chavez H, Abbed K, Sibilia J, Tebib J, Le Loet X, Combe B, Dougados M, Mariette X, Taoufik Y. Blood memory B cells are disturbed and predict the response to rituximab in patients with rheumatoid arthritis. Arthritis Rheum. 2011 Dec;63(12):3692-701. doi: 10.1002/art.30599.

ReferenceCitation: Sellam J, Hendel-Chavez H, Rouanet S, Abbed K, Combe B, Le Loet X, Tebib J, Sibilia J, Taoufik Y, Dougados M, Mariette X. B cell activation biomarkers as predictive factors for the response to rituximab in rheumatoid arthritis: a six-month, national, multicenter, open-label study. Arthritis Rheum. 2011 Apr;63(4):933-8. doi: 10.1002/art.30233.


title: Effectiveness of a "Case Management Algorithm" After a Suicide Attempt in Terms of Repetition of the Suicidal Behaviors and Medico-economic Impact

acronym: ALGOS

summary:
The suicidal behaviors are phenomena eminently multifactorial. It is thus always difficult to define univocal strategies of prevention of suicide repetition, during the emergency stay, i.e. almost in general population. One find 23 clinical trials in this topic in the past 25 years, and 18 are negative. The majority of the positive trials have the concern of being dissociated from an assumption of responsibility of care strictly speaking, to adopt a position "méta", nearer to the concept of "case management": how to remain in contact with the suicide attempter, without forcing it in this every day life, replacing a possible proposing, but assumption of responsibility resources reliable and quickly accessible in the event of at risk situation? Each one of these studies tests devices which seem more appropriate to such or such characteristic of this population, by retaining only simple criteria like the sex, the number of former suicide attempts, the proposal or not for an assumption of responsibility of care, the observance or not with the plan of care. Thus, it would seem interesting to combine these approaches in an algorithm entitled "ALGOS".

Main aim: To test the effectiveness of this algorithm of case management, named "ALGOS", in reducing the number of death by suicide, in terms of reduction of suicide re-attempts and the number of loss of contact patients in the ALGOS group during 6 months period, compared to a control group of suicide attempters treated as usual (i.e. primarily transmitted to the attending physician).

Secondary objectives: To evaluate, according to the method validated by Beecham in 1992, direct medico-economic impact in the year which follows the introduction of algorithm ALGOS. Reduction of the other suicidal behaviors in 6 months (reduction in the full number of suicidal repetitions in each group, evolution of the score of suicidal ideation, etc…). To evaluate the effect of the algorithm, at the 13th month. To study the possible differences within the time in terms of suicidal repetitions in the 2 groups. To propose different profiles of answers according to psychopathology, the number of suicide attempts, suicidal character, the sex,…

Methodology: Comparative simple blind prospective multicentric controlled study

ReferenceCitation: Vaiva G, Vaiva G, Ducrocq F, Meyer P, Mathieu D, Philippe A, Libersa C, Goudemand M. Effect of telephone contact on further suicide attempts in patients discharged from an emergency department: randomised controlled study. BMJ. 2006 May 27;332(7552):1241-5. doi: 10.1136/bmj.332.7552.1241.

ReferenceCitation: Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge project: randomised controlled trial of an intervention using postcards to reduce repetition of hospital treated deliberate self poisoning. BMJ. 2005 Oct 8;331(7520):805. doi: 10.1136/bmj.38579.455266.E0. Epub 2005 Sep 23.

ReferenceCitation: Evans J, Evans M, Morgan HG, Hayward A, Gunnell D. Crisis card following self-harm: 12-month follow-up of a randomised controlled trial. Br J Psychiatry. 2005 Aug;187:186-7. doi: 10.1192/bjp.187.2.186.

ReferenceCitation: Vaiva G, Walter M, Al Arab AS, Courtet P, Bellivier F, Demarty AL, Duhem S, Ducrocq F, Goldstein P, Libersa C. ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters. BMC Psychiatry. 2011 Jan 2;11:1. doi: 10.1186/1471-244X-11-1.

ReferenceCitation: Demesmaeker A, Chazard E, Vaiva G, Amad A. Risk Factors for Reattempt and Suicide Within 6 Months After an Attempt in the French ALGOS Cohort: A Survival Tree Analysis. J Clin Psychiatry. 2021 Feb 18;82(1):20m13589. doi: 10.4088/JCP.20m13589.

publisher_dissemination: Physicians Postgraduate Press, Inc

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

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

repository_institution: University of Bristol - Bristol Research

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repository_institution: University of Nottingham - Repository@Nottingham

ReferenceCitation: Vaiva G, Berrouiguet S, Walter M, Courtet P, Ducrocq F, Jardon V, Larsen ME, Cailhol L, Godesense C, Couturier C, Mathur A, Lagree V, Pichene C, Travers D, Lemogne C, Henry JM, Jover F, Chastang F, Prudhomme O, Lestavel P, Gignac CT, Duhem S, Demarty AL, Mesmeur C, Bellivier F, Labreuche J, Duhamel A, Goldstein P. Combining Postcards, Crisis Cards, and Telephone Contact Into a Decision-Making Algorithm to Reduce Suicide Reattempt: A Randomized Clinical Trial of a Personalized Brief Contact Intervention. J Clin Psychiatry. 2018 Sep 25;79(6):17m11631. doi: 10.4088/JCP.17m11631.

lead_sponsor: University Hospital, Lille

location_facility: Georges Pompidou European Hospital, Paris

intervention_type: Behavioral


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

location_country: Germany France


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:
Italy
South Africa
Spain
France


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

lead_sponsor: Eli Lilly and Company

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.

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: 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


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: Germany Italy Poland Portugal Hungary Switzerland Spain France

location_facility: CHU de Grenoble Hopital Albert Michallon Service de Dermatologie

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

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

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

location_facility: Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau

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

location_facility: Hospital General Universitario de Valencia Unidad de Oncologia Medica

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

location_facility: Hopital Saint-Eloi Service de Dermatologie

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

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

location_facility: Petz Aladar Megyei Korhaz, Borgyogyaszat

location_facility: Ospedale Umberto I°, Divisione di Oncologia Medica

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

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

location_facility: Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie

location_facility: Università di Firenze Dipartimento di Scienze Dermatologiche

location_facility: Ospedale Sandro Pertini, Oncologia Medica

location_facility: Azienda Ospedaliera S. Elia, UO di Oncologia

location_facility: Ospedale San Vincenzo U.O. Oncologia Medica

location_facility: Ospedale PF Calvi Dipartimento di Oncologia

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

location_facility: Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna

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

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

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

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

location_facility: CHU de Limoges Hopital Dupuytren Service de Dermatologie

location_facility: Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia

location_facility: Klinika Onkologii Centralnego Szpitala WAM

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

location_facility: Instituto Catalan Oncologico, Servicio de Oncologia

location_facility: Orszagos Onkologiai Intezet Borgyogyaszat

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

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

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

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

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

location_facility: Azienda Ospedaliera Garibaldi, UO Oncologia Medica

location_facility: Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: Centre Eugene Marquis Departement d'Oncologie Medicale

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

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

location_facility: Dermatologische Klinik der Universitat Tubingen

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

location_facility: Hosp. Universitario de Jaen Servicio de Oncologia

location_facility: Klinik fur Dermatologie und Allergologie der RWTH Aachen

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

location_facility: Hosp. Clinic i Provincial Servicio de Oncologia

location_facility: Istituto Europeo di Oncologia, Divisione di Chirurgia Generale

location_facility: Ospedale Pierantoni, Divisione Oncologia Medica


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:
France
Poland
Hungary
United Kingdom
Spain
Turkey
Israel


acronym: Corti-TC

lead_sponsor: Nantes University Hospital

summary:
Traumatic brained injured (TBI) patients frequently suffered from glucocorticoid insufficiency that is associated with a raise in the rate of pneumonia.

In a placebo-controlled, multi-center, double-blinded trial, treatment of glucocorticoid insufficiency (hydrocortisone associated with fludrocortisone) will be assessed for prevention of post trauma pneumonia in a population of severe TBI patients.

ReferenceCitation: Asehnoune K, Roquilly A, Sebille V; Corti-TC trial group. Corticotherapy for traumatic brain-injured patients--the Corti-TC trial: study protocol for a randomized controlled trial. Trials. 2011 Oct 14;12:228. doi: 10.1186/1745-6215-12-228.

ReferenceCitation: Asehnoune K, Seguin P, Allary J, Feuillet F, Lasocki S, Cook F, Floch H, Chabanne R, Geeraerts T, Roger C, Perrigault PF, Hanouz JL, Lukaszewicz AC, Biais M, Boucheix P, Dahyot-Fizelier C, Capdevila X, Mahe PJ, Le Maguet P, Paugam-Burtz C, Gergaud S, Plaud B, Constantin JM, Malledant Y, Flet L, Sebille V, Roquilly A; Corti-TC Study Group. Hydrocortisone and fludrocortisone for prevention of hospital-acquired pneumonia in patients with severe traumatic brain injury (Corti-TC): a double-blind, multicentre phase 3, randomised placebo-controlled trial. Lancet Respir Med. 2014 Sep;2(9):706-16. doi: 10.1016/S2213-2600(14)70144-4. Epub 2014 Jul 24. Erratum In: Lancet Respir Med. 2014 Sep;2(9):e15.

sponsor_collaborators: Société Française d'Anesthésie et de Réanimation

location_facility:
Universtiy Hospital
University hospital
Saint Louis Hospital
European Hospital Georges Pompidou
University Hospital

title: Phase 3 Study of Hydrocortisone and Fludrocortisone in Glucocorticoid Insufficiency Related to Traumatic Brain Injury


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

sponsor_collaborators:
Ethicon Endo-Surgery (Europe) GmbH
Aysgarth Statistics
Physicians World GmbH

location_country:
Italy
United Kingdom
France

location_facility: Ospedale "Franchini" di Montecchio Emilia

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon


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. doi: 10.1111/j.1365-2036.2006.02879.x.

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:
Germany
Italy
France
Poland
Hungary
Russian Federation
Israel

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

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

location_facility: Azienda Ospedaliera S. Giovanni Battista Molinette

location_facility: Rostov State Medical University City Hospital # 20

location_facility: Abteilung Gastroenterologie, Charité Campus Benjamin Franklin

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

location_facility: Nizhny Novgorod Regional Clinical Hospital

location_facility: Interdisziplinäres Facharztzentrum, Zentrum für Viszerale- und Ernährungsmedizin

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

location_facility: 10 Wojskowy Szpital Kliniczny z Polikliniką

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

location_facility: Novosibirsk State Medical University City Hospital #7

location_facility: Azienda Ospedaliera Universitaria Policlinico di Torvergata

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

location_facility: St. Petersburg Mechnikov State Medical Academy

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji

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

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

location_facility: Jávorszky Ödön Kórház, Gasztroenterológiai Osztály

location_facility: Wojewódzki Szpital Specjalistyczny im. Najświętszej Maryi Panny

location_facility: State Scientific Centre of Coloproctology

location_facility: Azienda Ospedaliera "San Camillo-Forlanini"

location_facility: Szpital Specjalistyczny Św. Wojciecha- Adalberta

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

location_facility: Akademicki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

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

location_facility: Russian Center of Functional Surgical Gastroenterology


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.

location_country:
Germany
France
Slovakia
United Kingdom
Ukraine
Sweden

location_facility: 1218.6.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44008 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44004 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49008 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49009 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44018 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49017 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49014 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49011 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44009 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44007 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42103 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38005 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42104 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42101 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44012 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49010 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44015 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.42105 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44016 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.46004 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49001 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49015 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49013 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44006 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44017 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49012 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49005 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.49016 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44005 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44019 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.38003 Boehringer Ingelheim Investigational Site

location_facility: 1218.6.44013 Boehringer Ingelheim Investigational Site


acronym: CERTITEM

summary: Recently, early biomarkers of renal interstitial fibrosis have been identified, amongst them de novo expression of vimentin by tubular epithelial cells, which is an intermediate filament, and the translocation of beta-catenin into their cytoplasm. These markers, when present, suggest that the epithelial cell undergoes a phenomenon well known as "epithelial to mesenchymal transition" (EMT) and could behaves like a myo-fibroblast. EMT is highly instrumental in several models of tissue fibrosis, including in the kidney. Actually, it has not only been demonstrated that these markers are detectable in the renal graft at an early time point post-transplant (i.e. as soon as three months), but also that the intensity of their expression correlates with the progression of interstitial fibrosis of the graft between 3 and 12 months

ReferenceCitation: Loupy A, Aubert O, Orandi BJ, Naesens M, Bouatou Y, Raynaud M, Divard G, Jackson AM, Viglietti D, Giral M, Kamar N, Thaunat O, Morelon E, Delahousse M, Kuypers D, Hertig A, Rondeau E, Bailly E, Eskandary F, Bohmig G, Gupta G, Glotz D, Legendre C, Montgomery RA, Stegall MD, Empana JP, Jouven X, Segev DL, Lefaucheur C. Prediction system for risk of allograft loss in patients receiving kidney transplants: international derivation and validation study. BMJ. 2019 Sep 17;366:l4923. doi: 10.1136/bmj.l4923.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Prospective, Multicenter, Randomized Open Study to Evaluate the Progression of Renal Graft Fibrosis According to the Epithelial-mesenchymal Transition (EMT) in de Novo Renal Transplant Recipients Treated Either by a CNI Free Immunosuppressive Regimen With Everolimus and Enteric-coated Mycophenolate Sodium or a CNI Based Regimen With Cyclosporine and Enteric-coated Mycophenolate Sodium


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:
United Kingdom
Switzerland
France

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

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

location_facility: Centre Hospitalier Intercommunal St. Aubin les Elbeuf

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


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. doi: 10.4088/jcp.v69n0113.

location_country:
Ireland
Spain
United Kingdom
France

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: Germany Italy France Greece Sweden


title: A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer

summary: Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Hôpitaux Drôme Nord - Site de Romans-sur-Isère


title: TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study

acronym: TRENCH 1

summary:
Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD).

Primary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: Belgium France

location_facility: CHU de Clermont-Ferrand - Hôpital d'Estaing

location_facility: APHP - Hôpital Européen Georges Pompidou (HEGP)


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

collaborators:
Abbott
Corelab ISIT

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Abbott
Corelab ISIT

location_country: Switzerland Belgium France

location_facility: Centre Hospitalier les Hôpitaux de Chartres

location_facility: Hôpital Privé Institut Mutualiste Montsouris

location_facility: Centre Hospitalier Saint Joseph Saint Luc


title: Comparison of Scores for Early Brain Damage Assessment at Intensive Care Unit Admission After Out of Hospital Cardiac Arrest

summary: Even in patients with successful return of spontaneous circulation (ROSC), outcome after cardiac arrest remains poor. The overall in-hospital survival rate widely varies both worldwide and across communities, from 1 to 4 folds according to circumstances of arrest and post-resuscitation interventions. Several studies have already shown that early interventions performed after ROSC, such as treatment of the cause, targeted temperature management, optimal hemodynamic management and extra-corporeal life support in selected patients, could improve the outcome in post-cardiac arrest patients. However, the decision process regarding the allocation of these resources, in parallel with the management of patients' proxies, remains a complex challenge for physicians facing these situations. Consequently, several prediction models and scores have been developed in order to stratify the risk of unfavorable outcome and to discriminate the best candidates for post-resuscitation interventions. Overall, several scores exist, but external validation are lacking and direct comparisons are needed to assess relative interest of scoring systems. Indeed, establishing the optimal scoring system is crucial, for optimal treatment allocation and appropriate information to relatives.

lead_sponsor: AfterROSC

location_facility:
CHU Cochin
CH Bethune
Aphp, Hegp
CH Cherbourg en Cotentin
Clinique Privé Claude Galien
CHU Amiens
CHU Ambroise Paré
CH La Rochelle
CH Toulon
ERASME
APHM
CHU Angers
CH Le Mans
CHU Nantes
CHU Montpellier
CHRU Nancy
CH Versailles
GHP Saint Joseph
CH Brive La Gaillard
APHP, CHU Necker
Hospices Civils Lyon
CHU Lariboisière
CHD Vendée
Hopital Privé Jacques Cartier
CHU Lille
APHP, CHU Saint Louis
CHU Créteil


title: Multicenter, Prospective Cohort of Patient With Coronary Stents Undergoing Non Cardiac Surgery or Invasive Procedures.

acronym: RECO

summary: Non cardiac surgery in patients with coronary stents is complicated with cardiovascular and hemorrhagic events associated with perioperative management of antiplatelet agents. Several guidelines have outlined the importance of maintaining antiplatelet agents throughout surgical procedures to prevent cardiovascular complications. On the other hand, interruption of antiplatelet agents is still a usual standard to avoid surgical complications. We investigate the impact of perioperative antiplatelet drugs management on these complications, through a multicenter, prospective cohort (RECO stands for "Registre des patients porteurs d'Endoprothèses Coronaires, Opérés de chirurgie non cardiaque"), including all patients with coronary stents undergoing non cardiac surgery or invasive procedures. The aim of this study is primarily to measure the incidence of cardiovascular (including stent thrombosis) and hemorrhagic complications and to identify pre and postoperative risk factors associated with these complications.

ReferenceCitation: Albaladejo P, Charbonneau H, Samama CM, Collet JP, Marret E, Piriou V, Genty C, Bosson JL. Bleeding complications in patients with coronary stents during non-cardiac surgery. Thromb Res. 2014 Aug;134(2):268-72. doi: 10.1016/j.thromres.2014.05.015. Epub 2014 May 15.

ReferenceCitation: Albaladejo P, Marret E, Samama CM, Collet JP, Abhay K, Loutrel O, Charbonneau H, Jaber S, Thoret S, Bosson JL, Piriou V. Non-cardiac surgery in patients with coronary stents: the RECO study. Heart. 2011 Oct;97(19):1566-72. doi: 10.1136/hrt.2011.224519. Epub 2011 Jul 26.

lead_sponsor: University Hospital, Grenoble


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

appel_a_projets: PHRCN

region: Bretagne

nom_etablissement: CHRU RENNES

type_etablissement: CHUR

acronyme: ROTAS

titre: Etude randomisée pour une prise en charge optimale des patients ayant un Rétrécissement Valvulaire Aortique à Bas gradient et Fraction ventriculaire d'Ejection Préservée

discipline_principale: cardiologie

nom_porteur: Galli

prenom_porteur: Elena


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).

time_perspective: Other

lead_sponsor: Gilead Sciences

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

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

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Universita degli Studi di Roma La Sapienza

location_facility: Azienda Ospedaliera Universitaria Maggiore Della Carita di Novara

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg Hospital

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

location_facility: Centre Hospitalier Bourg-en-Bresse Fleyriat

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Clinico Universitario Lozano Blesa

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

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Fundació Hospital de la Santa Creu i Sant Pau

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: South Tees Hospitals Nhs Foundation Trust

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Hospital General Universitario de Alicante

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie Westerstede

location_facility: Fondazione IRCCS Cà Grande Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: Hospital Universitari Arnau De Vilanova (Huav)

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

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

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

location_facility: Ospedali Riuniti di Ancona, Clinica Ematologica

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

location_facility: AHEPA University General Hospital of Thessaloniki

location_facility: Hospital Universitario Virgen de la Arrixaca

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

location_facility: University General Hospital of Alexandroupolis

location_facility: Centre Hospitalier Chalon sur Saône William Morey

location_facility: Centre Hospitalier Universitaire de Poitiers


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.

ipd_sharing: Undecided

sponsor_collaborators: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

location_facility: CHU de Colmar- Hopital Trousseau Medecine A


title: Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment

acronym: GRATSEC

summary:
This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.

It is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.

follow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\or from a distance relapse.

During these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.

lead_sponsor: Institut Claudius Regaud

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau