Search Results - "Plattner, Valérie"
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A randomized controlled phase III study comparing hadrontherapy with carbon ions versus conventional radiotherapy - including photon and proton therapy - for the treatment of radioresistant tumors: the ETOILE trial
Published in BMC cancer (23-05-2022)“…Some cancers such as sarcomas (bone and soft tissue sarcomas) and adenoid cystic carcinomas are considered as radioresistant to low linear energy transfer…”
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How the new European data protection regulation affects clinical research and recommendations?
Published in Therapie (01-02-2019)“…Clinical research on human subjects or their data is confronted with conflicting requirements with, on one hand, the principle of open science (transparency…”
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Stenting of Long Femoro-popliteal Lesions (TASC C and D): A Pilot Study on the Feasibility of the Local Delivery of Paclitaxel and Its Effectiveness to Prevent Restenosis STREAMER (STent REstenosis And Medicaments Release)
Published in Annals of vascular surgery (01-01-2017)Get full text
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The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop
Published in Therapie (01-01-2015)“…In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to…”
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Primary endpoint adjudication: comparison between the expert committee and the regulatory MedDRA® coding in the MITRA‐FR study
Published in European journal of heart failure (01-02-2022)Get full text
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Laparoscopic pyloromyotomy for hypertrophic pyloric stenosis: a prospective, randomized controlled trial
Published in Journal of pediatric surgery (01-04-2007)“…Abstract Background Several authors have reported on laparoscopic pyloromyotomy (LP) since the technique was originally described in 1990, but its benefits…”
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Exploratory clinical trials: implementation modes & guidelines, scope and regulatory framework
Published in Therapie (01-05-2009)“…The working group focused on defining exploratory trials on medicinal products and developing recommendations for their implementation in France (notably…”
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A randomized controlled phase III study comparing hadrontherapy with carbon ions versus conventional radiotherapy – including photon and proton therapy – for the treatment of radioresistant tumors: the ETOILE trial
Published in BMC cancer (23-05-2022)“…Background: Some cancers such as sarcomas (bone and soft tissue sarcomas) and adenoid cystic carcinomas are considered as radioresistant to low linear energy…”
Get full text
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Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies — The Pre-Optimon study
Published in Contemporary clinical trials (01-01-2011)“…Abstract Context Good Clinical Practice regulates monitoring activities in clinical research. Due to question and design diversity, and limited resources,…”
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Unstented Tubularized Incised Plate Urethroplasty Combined with Foreskin Reconstruction for Distal Hypospadias
Published in European urology (01-10-2004)“…Background and aim: Urethral stent has recently been proven to be unnecessary for normal healing in an animal model of tubularized incised plate (TIP)…”
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Unstented tubularized incised plate urethroplasty conlbined with foreskin reconstruction for distal hypospadias
Published in European urology (2004)Get full text
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Clinical Trials Legislation - preparing for the revision of the European Directive Scheduled for 2011
Published in Therapie (01-07-2010)“…The aim of the Round Table was to make recommendations with regard to the imminent revision of the European Directive on clinical drug trials (2001/20/CE)…”
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Early effect of hyaluronic acid intra-articular injections on serum and urine biomarkers in patients with knee osteoarthritis: An open-label observational prospective study
Published in Journal of orthopaedic research (01-05-2012)“…The aim of the study was to investigate the effect of hyaluronic acid (HA) intra articular injections (IA) on osteoarthritis (OA) biomarkers in patients with…”
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Traitement laparoscopique du reflux gastro-œsophagien chez l'enfant
Published in Hepato-gastro (01-03-2000)Get full text
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