title: Dynamics of T Cell Expression of Immune Checkpoint Molecules in Progressive Multifocal Leukoencephalopathy

acronym: ICIP

summary: Progressive multifocal leukoencephalopathy (PML) is a rare viral infection of the central nervous system (CNS) occurring in immunocompromised patients. Recovery of JC virus (JCV) specific T cell immune responses is the only available therapeutic option. JCV may use immune checkpoint inhibitory pathways to evade immune responses. The aim of this project is to determine whether T cell expression of immune checkpoint molecules is correlated to antiviral T cell responses, control of JCV replication and PML outcome. Immune checkpoint blockade by reversing T cell exhaustion may represent a therapeutic perspective for PML.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Nimes
CHU Bordeaux
CHU Montpellier
CHU de TOULOUSE


title: Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness

summary: Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode. This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up. The secondary end points are the cost and the cost/effectiveness ratio of these two approaches.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Rouen

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


summary:
Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.

Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations.

The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.

location_facility: Pulmonary & Intensive Care Department - Rouen University Hospital,

intervention_type: Device


title: Cortical Pharyngeal Area: Excitability, Facilitation and Plasticity in Healthy Subjects

summary:
The aims of this study are in four experimental sessions. The aims are:

to characterize the excitability of the cortical pharyngeal area with pharyngeal pressure and electromyograms (EMGs), at rest, in awake healthy subjects;
to study its facilitation by inspiration and deglutition; and
to study its plasticity by respiration and swallowing.

status: Completed

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

status_simplified: Completed


title: Neuromodulation of Aspiration Secondary to Stroke

summary: Aspiration could induce major respiratory affection. They are often present after stroke. The aim of this study is to facilitate swallowing recuperation in stroke patients using peripheral laryngeal stimulation and to understand its mechanisms using motor evoked potential and cortical evoked potential.

enrollment_type: Actual


title: Evoked Responses of External Anal Sphincter After Cortical and Lombo-sacral Magnetic Stimulations

summary: Anal incontinence and constipation are frequently observed in patients with neurological disease. The purpose of this study is to evaluate the neurological control of the anal sphincter in healthy subjects, patients with neurological disease by a new electrophysiological technique. This technique consists in recordings of anal sphincter responses after magnetic stimulations of the cortex and the sacral nerves.

status: Withdrawn


title: Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration

summary: the purpose of this study is to compare the oesophageal depression induced by bilateral phrenic nerve stimulation during swallowing in patients with neurological laryngeal aspiration


title: Validating an ELISpot for Early Detection of an Active Immune Response Against COVID-19

acronym: EliSpot

summary: The RT-PCR on rhino-pharynge sampling highlights the genetic material of the virus and indicates that a subject is infected with SARS-CoV-2. This test can be in about 30% of false negative cases, it does not allow to date the infection, nor to predict the asymptomatic, mild, moderate or severe evolution of the disease. In terms of public health, we need 1/ to better understand the chronology of the immune response to the virus in the general population and in contacts of index cases; 2/ To know which characteristics of the immune response are protective of future reinfections. Finally, in symptomatic subjects, we need biomarkers that predict the evolutionary mode of the disease (moderate vs. severe form).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Prevention

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Ch Grasse
Ch Cannes, Pneumologie
CH Antibes
CHU de nice

intervention_type: Other

status_simplified: Ongoing


title: Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology

acronym: KETAMINE

summary: The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)

lead_sponsor: Institut Bergonié

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

intervention_type: Drug

lead_sponsor_type: industriel


title: Plasma Coagulation Parameters and Hypercoagulability After Breast Cancer Surgery

acronym: EHC

summary: The risk of deep venous thrombosis after radical breast surgery is known. The objective of this study is to explore hypercoagulability after radical breast cancer surgery by studying several factors for haemostasis before, during and after surgery. Ultrasound Doppler examination is realised between 24 and 72 hours post-operatively. Hypercoagulability is defined by a significant increasing level of thrombin-antithrombin, D-dimer and the endogen thrombin potential.


title: Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty.

acronym: PROTOX

summary: Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could be exagerated and could produce greater postoperative opioid consumption and higher pain score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study was to evaluate, in patients with current opioid treatment, the effects of peroperative Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest


title: Impact of a Socio-aesthetic Intervention on Body Image and Quality of Life in Patients With Mastectomy or Tumorectomy for Breast Cancer.

acronym: ASE K SEIN

summary: The aim of this study is to evaluate the impact of a socio-aesthetic intervention on body image and quality of life in post-surgical patients with mastectomy or tumorectomy for breast cancer.Two groups of randomized subjects were constituted. Patients of the experimental group received 2 or 3 aesthetic care during the first post-surgical week, whereas those of the control group not. Body image, quality of life and diverse other personality variables were assessed at three different times: surgical operation day before, exit day before of hospitalization and three months afterwards. Our general hypothesis is that subjects who receive aesthetic care report levels significantly higher of corporal satisfaction and of quality of life at the end of the hospitalization and three months later than patients of the control group.

intervention_type: Behavioral


title: Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery

acronym: ROPAL 1

summary:
The purposes of this study are:

To determine the efficacy of inter pleural analgesia
To determine the plasmatic concentration of ropivacaine by inter pleural road


summary: Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: GE Healthcare


title: Study of Histological Modifications, of Pro-apoptotic Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis (Clinical and Endoscopic Remission) Taking 5-ASA

summary: Male or female, 18 years of age or older. Ulcerative Colitis described according usual criteria, diagnosed for at least 1 year. Oral maintenance treatment with 5-aminosalicylic acid (5-ASA) only for at least 3 months with a dosage of 2 to 3 g/day. Clinical remission for at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo Clinic) at the inclusion. Signed informed consent form.

lead_sponsor: Ferring Pharmaceuticals

location_facility: Hôpital Saint Antoine, Service d'hépato-Gastroentérologie


title: A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate (120 μg and 240 μg) and 2 Different Daily Doses of Minirin® Tablet (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

acronym: PALAT

summary:
To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.

To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.

To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations

ReferenceType: derived

ReferenceCitation: Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5:CD002911. doi: 10.1002/14651858.CD002911.pub3.

name: Discipline of Child and Adolescent Health; The Children's Hospital at Westmead Clinical School, University of Sydney; Westmead Australia

name: Department of Nephrology; The Children's Hospital at Westmead; Westmead Australia

family: Caldwell

full_name: Patrina HY Caldwell

given: Patrina HY

sequence: additional

name: School of Medicine; Western Sydney University; Campbelltown Australia

family: Codarini

full_name: Miriam Codarini

given: Miriam

name: c/o Cochrane Incontinence, Population Health Sciences Institute; Newcastle University; Newcastle upon Tyne UK

family: Stewart

full_name: Fiona Stewart

given: Fiona

family: Hahn

full_name: Deirdre Hahn

given: Deirdre

name: Concord Clinical School; University of Sydney; Concord Australia

family: Sureshkumar

full_name: Premala Sureshkumar

given: Premala

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Juul KV, Van Herzeele C, De Bruyne P, Goble S, Walle JV, Nørgaard JP. Desmopressin melt improves response and compliance compared with tablet in treatment of primary monosymptomatic nocturnal enuresis. Eur J Pediatr. 2013 Sep;172(9):1235-42. doi: 10.1007/s00431-013-1992-9. Epub 2013 May 16.

family: Juul

full_name: Kristian Vinter Juul

given: Kristian Vinter

sequence: first

family: Van Herzeele

full_name: Charlotte Van Herzeele

given: Charlotte

family: De Bruyne

full_name: Pauline De Bruyne

given: Pauline

family: Goble

full_name: Sandra Goble

given: Sandra

family: Walle

full_name: Johan Vande Walle

given: Johan Vande

family: Nørgaard

full_name: Jens Peter Nørgaard

given: Jens Peter

journal_name: European Journal of Pediatrics

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

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

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

location_facility: Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades


title: Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction

summary: Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.

ReferenceCitation: Manrique A, Lemarchand P, Delasalle B, Lairez O, Sportouch-Duckan C, Lamirault G, Le Corvoisier P, Neuder Y, Richardson M, Lebon A, Roncalli J, Piot C, Trochu JN, Teiger E, Hossein-Foucher C, Le Tourneau T. Predictors of ventricular remodelling in patients with reperfused acute myocardial infarction and left ventricular dysfunction candidates for bone marrow cell therapy: insights from the BONAMI trial. Eur J Nucl Med Mol Imaging. 2016 Apr;43(4):740-8. doi: 10.1007/s00259-015-3279-z. Epub 2015 Dec 15.

family: Manrique

full_name: Alain Manrique

given: Alain

family: Lemarchand

full_name: Patricia Lemarchand

given: Patricia

family: Delasalle

full_name: Béatrice Delasalle

given: Béatrice

family: Lairez

full_name: Olivier Lairez

given: Olivier

family: Sportouch-Duckan

full_name: Catherine Sportouch-Duckan

given: Catherine

family: Lamirault

full_name: Guillaume Lamirault

given: Guillaume

family: Le Corvoisier

full_name: Philippe Le Corvoisier

given: Philippe

family: Neuder

full_name: Yannick Neuder

given: Yannick

family: Richardson

full_name: Marjorie Richardson

given: Marjorie

family: Lebon

full_name: Alain Lebon

family: Roncalli

full_name: Jérome Roncalli

given: Jérome

family: Piot

full_name: Christophe Piot

given: Christophe

family: Trochu

full_name: Jean-Noel Trochu

given: Jean-Noel

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

family: Hossein-Foucher

full_name: Claude Hossein-Foucher

given: Claude

family: Le Tourneau

full_name: Thierry Le Tourneau

given: Thierry

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

version: acceptedVersion

version: submittedVersion

ReferenceCitation: Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management


summary: Determine the best strategy for proteinuria lowering in patients with proteinuria > 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.

lead_sponsor: Nantes University Hospital


title: Etude Multicentrique Ouverte Randomisée de Phase III Comparant l'Association de VELCADE®-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusqu'à l'âge de 65 Ans

summary: This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by autograft as first-line therapy, as the investigators try to compare the complete remission (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.

ReferenceCitation: Sonneveld P, Goldschmidt H, Rosiñol L, Bladé J, Lahuerta JJ, Cavo M, Tacchetti P, Zamagni E, Attal M, Lokhorst HM, Desai A, Cakana A, Liu K, van de Velde H, Esseltine DL, Moreau P. Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials. J Clin Oncol. 2013 Sep 10;31(26):3279-87. doi: 10.1200/JCO.2012.48.4626. Epub 2013 Jul 29.

name: Pieter Sonneveld, Erasmus Medical Center, Rotterdam; Henk M. Lokhorst, Utrecht Medical Center, Utrecht, the Netherlands; Hartmut Goldschmidt, University Hospital of Heidelberg, Heidelberg, Germany; Laura Rosiñol, Joan Bladé, Hospital Clínic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona; Juan José Lahuerta, Hospital Universitario 12 de Octubre, Madrid, Spain; Michele Cavo, Paola Tacchetti, Elena Zamagni, Istituto di Ematologia Seràgnoli, Università degli Studi di...

family: Sonneveld

full_name: Pieter Sonneveld

given: Pieter

family: Goldschmidt

full_name: Hartmut Goldschmidt

given: Hartmut

family: Rosiñol

full_name: Laura Rosiñol

given: Laura

family: Bladé

full_name: Joan Bladé

given: Joan

family: Lahuerta

full_name: Juan José Lahuerta

given: Juan José

family: Cavo

full_name: Michele Cavo

given: Michele

family: Tacchetti

full_name: Paola Tacchetti

given: Paola

family: Zamagni

full_name: Elena Zamagni

given: Elena

family: Attal

full_name: Michel Attal

given: Michel

family: Lokhorst

full_name: Henk M. Lokhorst

given: Henk M.

family: Desai

full_name: Avinash Desai

given: Avinash

family: Cakana

full_name: Andrew Cakana

given: Andrew

family: Liu

full_name: Kevin Liu

given: Kevin

family: van de Velde

full_name: Helgi van de Velde

given: Helgi

family: Esseltine

full_name: Dixie-Lee Esseltine

given: Dixie-Lee

family: Moreau

full_name: Philippe Moreau

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Bortezomib-Based Versus Nonbortezomib-Based Induction Treatment Before Autologous Stem-Cell Transplantation in Patients With Previously Untreated Multiple Myeloma: A Meta-Analysis of Phase III Randomized, Controlled Trials

ReferenceCitation: Corthals SL, Kuiper R, Johnson DC, Sonneveld P, Hajek R, van der Holt B, Magrangeas F, Goldschmidt H, Morgan GJ, Avet-Loiseau H. Genetic factors underlying the risk of bortezomib induced peripheral neuropathy in multiple myeloma patients. Haematologica. 2011 Nov;96(11):1728-32. doi: 10.3324/haematol.2011.041434. Epub 2011 Jul 26.

family: Corthals

full_name: S. L. Corthals

given: S. L.

family: Kuiper

full_name: R. Kuiper

given: R.

family: Johnson

full_name: D. C. Johnson

given: D. C.

full_name: P. Sonneveld

given: P.

family: Hajek

full_name: R. Hajek

family: van der Holt

full_name: B. van der Holt

given: B.

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Moreau P, Attal M, Pégourié B, Planche L, Hulin C, Facon T, Stoppa AM, Fuzibet JG, Grosbois B, Doyen C, Ketterer N, Sebban C, Kolb B, Chaleteix C, Dib M, Voillat L, Fontan J, Garderet L, Jaubert J, Mathiot C, Esseltine D, Avet-Loiseau H, Harousseau JL; IFM 2005-01 study investigators. Achievement of VGPR to induction therapy is an important prognostic factor for longer PFS in the IFM 2005-01 trial. Blood. 2011 Mar 17;117(11):3041-4. doi: 10.1182/blood-2010-08-300863. Epub 2010 Nov 23. Erratum in: Blood. 2012 Nov 15;120(20):4274.

name: Institut Paoli-Calmettes, Marseille, France;

name: University Hospital, Lausanne, Switzerland;

name: University Hospital, Clermont-Ferrand, France;

name: University Hospital, Chalon-sur-Saône, France;

name: University Hospital Saint-Antoine, Paris, France;

name: University Hospital, Saint-Etienne, France;

name: Millenium Pharmaceuticals, Cambridge, NJ; and

name: Centre René Gauducheau, Nantes/St Herblain, France

name: for the IFM 2005-01 study investigators*


summary: Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy in multiple myeloma patients.


title: Safety and Efficacy of Pravastatin in Relapsing-remitting MS: a Double Blind Placebo Controlled Study

summary: Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is quite limited, they are not well tolerated and they have a very high cost. Recent works showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called "statins"). In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was associated with a decreased lesional activity assessed by MRI. Statins are well tolerated drugs, used for many years, with a low cost and with a putative efficacy in MS. The investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.


title: Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease

summary: Gastroesophageal reflux disease is a frequent disease and which heavily affects the patients' quality of life. To alleviate symptoms and ease the healing of lesion, patients very often need to continuously take anti-secretory drugs (Proton pump inhibitors or PPIs), which, despite their efficiency, do not cure the disease. For these PPI dependent patients, an anti-reflux surgery (fundoplication often made by coelioscopy) is a possible alternative but it has a significant morbidity rate and even an estimated post-operative mortality of 0.8% outside of expertise centres. Therefore, new therapeutic endoscopic approaches, supposed to be less invasive and less expensive than surgery have been developed during the last three years. Among them, radiofrequency (Stretta® procedure) consists in administering a high frequency current in the cardia area, in order to induce thanks to a thermal effect a sub-mucous remodelling and a modification of the compliance of the cardia regionThe aim of this project carried out in 8 French centres and 2 European centers is to assess through a randomised trial, the efficiency of radiofrequency on PPI dependent patients. The study will be carried out in 2 phases with patients who have been fully informed of the project statement, and particularly of the potential risks of the radiofrequency technique and have given their written acceptation to participate to the study.The first phase, which will last 6 to 11 weeks, will aim at making sure that patients are PPI dependent and define their needs. After this initial phase, patients will be randomised between those who will carry on with the PPI treatment or the radiofrequency treatment. The follow up after this randomisation will last one year. The first assessment of the therapeutic efficiency will be done at 6th month. The 6 additional follow up months will be required for the assessment of mid-term side effects of the treatment and the rate of symptomatic recurrences.


title: Antimicrobial Prophylaxis in Children With Isolated Vesico-Ureteral Reflux. A Randomised Prospective Study of Continuous Low Dose of Trimethoprim-Sulfamethoxazole Versus Surveillance.

summary: Randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade III or less).


title: Autograft Versus Calcium Phosphate Macroporous Bioceramics as Bone Substitute for Tibial Valgus Osteotomy

summary: The aim of the study is to compare radiological behavior of blocks of macroporous phosphocalcium as bone substitute in comparison with iliac crest autograft in tibial valgus osteotomy.

status: Unknown status


title: Analgesic Strategies in Newborns Receiving Prostaglandin Therapy

summary: This is a randomised trial comparing the efficacy of 3 different analgesic strategies in newborns on prostaglandin for ductus dependent congenital heart disease.


title: Ketamine and Postoperative Analgesia in Children

summary: The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.


title: Multicenter, Randomized, Open-Label Trial, Assessing the Efficacy of Zidovudine, Lamivudine and Nevirapine Combination Administered Twice Daily, Versus the Association of Tenofovir, Lamivudine and Nevirapine, Once Daily, in Antiretroviral Naive HIV-1 Infected Patients

summary: The study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine/lamivudine + nevirapine) in ARV-Naive HIV-1 infected subjects, with CD4 cell count below 350/µL or below 15%, whatever the viral load. Pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case of failure) will also be provided, as well as adherence rate and quality of life in respect of the treatment arms.

lead_sponsor: MEDEX

location_facility: Cisih, Clinique Medical A, Hopitaux Universitaires


title: Research Network for Neonatal Diseases Induced by Tissular Fetomaternal Alloimmunization

summary:
Problems of compatibility between a mother and her child are frequent. The most well-known case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which can induce severe anemia of the fetus.

The investigators recently proved that incompatibility between mother and child can concern an organ leading to a tissular alloimmunization. For example, neonatal membranous glomerulonephritis (a kidney disease) can result from this mechanism.

The purpose of this network is to detect and study neonatal diseases induced by tissular fetomaternal alloimmunization. The detection of these diseases will be performed by the mother's serum analysis.

lead_sponsor: University Hospital, Limoges


title: Follow-up of Patients With Curative-Intent Surgical Resection for NSCLC : CT Scanning Versus 18 FDG Imaging.

summary: The guidelines and institutional practices recommended more frequent visits the two years following curative-intent therapy for non-small cell lung cancer (NSCLC).No international consensus is published concerning follow-up of resected NSCLC patients.Recent studies have outlined that positron emission tomography (PET) scanning may be accurate in early detection of recurrences by comparison to computed tomography (CT). The aim of this study is to compare follow-up by conventional methods versus PET. Patients are randomly assigned to two arms. In the first arm, thorax CT with liver and adrenal gland sections, abdominal ultrasonography and nuclear bone scintigraphy are performed every 6 months after surgery for two years. In the second arm, PET scanning is only. For brain metastasis detection, CT is performed in the two arms. Recurrences are detected during scheduled or unscheduled procedure in asymptomatic patients. PET and CT are interpreted separately by two nuclear physicians and two radiologists. The direct cost of follow-up procedure is determined in the two groups. The calculated sample is composed of 60 patients in each arm to detect significant difference. The Ethics Committee of Universitary Hospital of Limoges approves the study.


title: Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units.

acronym: PLASCOSSA

summary:
COVID-19 (Corona Virus Disease 2019) hospitalized patients evolution is marked by the risk of worsening of the respiratory system during the second week of the disease. To date, treatments are currently being evaluated and none of them have shown to be effective in the care of these patients. The use of convalescent plasma is a passive immunotherapy. It has often been used in respiratory virus epidemic situations (during the 1918 or 2009 influenza pandemic, or during SARS-CoV-1 or MERS-CoV pandemic). Effects reported in literature are in favour of a beneficial impact of transfusion of these plasma without serious adverse effects reported.

PlasCoSSA is a randomized, controlled, triple-blinded, parallel clinical trial. This study tests the efficacy of convalescent plasma transfusion therapy in the early care of COVID-19 hospitalized patients outside intensive care units.

ReferenceType: background

ReferenceCitation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.

family: Huang

full_name: Chaolin Huang

given: Chaolin

family: Wang

full_name: Yeming Wang

given: Yeming

family: Li

full_name: Xingwang Li

given: Xingwang

family: Ren

full_name: Lili Ren

given: Lili

family: Zhao

full_name: Jianping Zhao

given: Jianping

family: Hu

full_name: Yi Hu

given: Yi

family: Zhang

full_name: Li Zhang

given: Li

family: Fan

full_name: Guohui Fan

given: Guohui

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Cheng

full_name: Zhenshun Cheng

given: Zhenshun

family: Yu

full_name: Ting Yu

given: Ting

family: Xia

full_name: Jiaan Xia

given: Jiaan

family: Wei

full_name: Yuan Wei

given: Yuan

family: Wu

full_name: Wenjuan Wu

given: Wenjuan

family: Xie

full_name: Xuelei Xie

given: Xuelei

family: Yin

full_name: Wen Yin

given: Wen

full_name: Hui Li

given: Hui

full_name: Min Liu

given: Min

family: Xiao

full_name: Yan Xiao

given: Yan

family: Gao

full_name: Hong Gao

given: Hong

family: Guo

full_name: Li Guo

full_name: Jungang Xie

given: Jungang

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

name: Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Pulmonary Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Infectious Disease, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Emergency Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

title: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China

ReferenceCitation: Ahn DG, Shin HJ, Kim MH, Lee S, Kim HS, Myoung J, Kim BT, Kim SJ. Current Status of Epidemiology, Diagnosis, Therapeutics, and Vaccines for Novel Coronavirus Disease 2019 (COVID-19). J Microbiol Biotechnol. 2020 Mar 28;30(3):313-324. doi: 10.4014/jmb.2003.03011. Review.

ReferenceCitation: Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.

ReferenceCitation: Zhang B, Liu S, Tan T, Huang W, Dong Y, Chen L, Chen Q, Zhang L, Zhong Q, Zhang X, Zou Y, Zhang S. Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Chest. 2020 Jul;158(1):e9-e13. doi: 10.1016/j.chest.2020.03.039. Epub 2020 Mar 31.

ReferenceCitation: Walls AC, Park YJ, Tortorici MA, Wall A, McGuire AT, Veesler D. Structure, Function, and Antigenicity of the SARS-CoV-2 Spike Glycoprotein. Cell. 2020 Apr 16;181(2):281-292.e6. doi: 10.1016/j.cell.2020.02.058. Epub 2020 Mar 9. Erratum in: Cell. 2020 Dec 10;183(6):1735.

ReferenceCitation: Zhang JS, Chen JT, Liu YX, Zhang ZS, Gao H, Liu Y, Wang X, Ning Y, Liu YF, Gao Q, Xu JG, Qin C, Dong XP, Yin WD. A serological survey on neutralizing antibody titer of SARS convalescent sera. J Med Virol. 2005 Oct;77(2):147-50.

ReferenceCitation: Subbarao K, McAuliffe J, Vogel L, Fahle G, Fischer S, Tatti K, Packard M, Shieh WJ, Zaki S, Murphy B. Prior infection and passive transfer of neutralizing antibody prevent replication of severe acute respiratory syndrome coronavirus in the respiratory tract of mice. J Virol. 2004 Apr;78(7):3572-7.

ReferenceCitation: Ko JH, Seok H, Cho SY, Ha YE, Baek JY, Kim SH, Kim YJ, Park JK, Chung CR, Kang ES, Cho D, Müller MA, Drosten C, Kang CI, Chung DR, Song JH, Peck KR. Challenges of convalescent plasma infusion therapy in Middle East respiratory coronavirus infection: a single centre experience. Antivir Ther. 2018;23(7):617-622. doi: 10.3851/IMP3243. Epub 2018 Jun 20.

ReferenceCitation: Guo L, Ren L, Yang S, Xiao M, Chang, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.

ReferenceCitation: Thevarajan I, Nguyen THO, Koutsakos M, Druce J, Caly L, van de Sandt CE, Jia X, Nicholson S, Catton M, Cowie B, Tong SYC, Lewin SR, Kedzierska K. Breadth of concomitant immune responses prior to patient recovery: a case report of non-severe COVID-19. Nat Med. 2020 Apr;26(4):453-455. doi: 10.1038/s41591-020-0819-2.

ReferenceCitation: Bouadma L, Lescure FX, Lucet JC, Yazdanpanah Y, Timsit JF. Severe SARS-CoV-2 infections: practical considerations and management strategy for intensivists. Intensive Care Med. 2020 Apr;46(4):579-582. doi: 10.1007/s00134-020-05967-x. Epub 2020 Feb 26.

ReferenceCitation: To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.

ReferenceCitation: Liu L, Wei Q, Lin Q, Fang J, Wang H, Kwok H, Tang H, Nishiura K, Peng J, Tan Z, Wu T, Cheung KW, Chan KH, Alvarez X, Qin C, Lackner A, Perlman S, Yuen KY, Chen Z. Anti-spike IgG causes severe acute lung injury by skewing macrophage responses during acute SARS-CoV infection. JCI Insight. 2019 Feb 21;4(4). pii: 123158. doi: 10.1172/jci.insight.123158. eCollection 2019 Feb 21.

ReferenceCitation: Tirado SM, Yoon KJ. Antibody-dependent enhancement of virus infection and disease. Viral Immunol. 2003;16(1):69-86. Review.

ReferenceCitation: Chaichana P, Okabayashi T, Puiprom O, Sasayama M, Sasaki T, Yamashita A, Ramasoota P, Kurosu T, Ikuta K. Low levels of antibody-dependent enhancement in vitro using viruses and plasma from dengue patients. PLoS One. 2014 Mar 18;9(3):e92173. doi: 10.1371/journal.pone.0092173. eCollection 2014.

ReferenceCitation: Houser KV, Broadbent AJ, Gretebeck L, Vogel L, Lamirande EW, Sutton T, Bock KW, Minai M, Orandle M, Moore IN, Subbarao K. Enhanced inflammation in New Zealand white rabbits when MERS-CoV reinfection occurs in the absence of neutralizing antibody. PLoS Pathog. 2017 Aug 17;13(8):e1006565. doi: 10.1371/journal.ppat.1006565. eCollection 2017 Aug.

ReferenceCitation: van Griensven J, Edwards T, de Lamballerie X, Semple MG, Gallian P, Baize S, Horby PW, Raoul H, Magassouba N, Antierens A, Lomas C, Faye O, Sall AA, Fransen K, Buyze J, Ravinetto R, Tiberghien P, Claeys Y, De Crop M, Lynen L, Bah EI, Smith PG, Delamou A, De Weggheleire A, Haba N; Ebola-Tx Consortium. Evaluation of Convalescent Plasma for Ebola Virus Disease in Guinea. N Engl J Med. 2016 Jan 7;374(1):33-42. doi: 10.1056/NEJMoa1511812.

ReferenceCitation: Dufour-Gaume F, Delaune D, Martinaud C, Sailliol A. Early and repeated use of plasma for the management of Ebola patients: Reflection around a case. Transfus Clin Biol. 2017 Feb;24(1):5-8. doi: 10.1016/j.tracli.2016.08.005. Epub 2016 Sep 14.

ReferenceCitation: Tirumalai RS, Chan KC, Prieto DA, Issaq HJ, Conrads TP, Veenstra TD. Characterization of the low molecular weight human serum proteome. Mol Cell Proteomics. 2003 Oct;2(10):1096-103. Epub 2003 Aug 13.

ReferenceCitation: Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.

ReferenceCitation: Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Jun 25;58(7):1131-1134. doi: 10.1515/cclm-2020-0198.

ReferenceCitation: Sperry JL, Guyette FX, Brown JB, Yazer MH, Triulzi DJ, Early-Young BJ, Adams PW, Daley BJ, Miller RS, Harbrecht BG, Claridge JA, Phelan HA, Witham WR, Putnam AT, Duane TM, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Rosengart MR, Forsythe RM, Billiar TR, Yealy DM, Peitzman AB, Zenati MS; PAMPer Study Group. Prehospital Plasma during Air Medical Transport in Trauma Patients at Risk for Hemorrhagic Shock. N Engl J Med. 2018 Jul 26;379(4):315-326. doi: 10.1056/NEJMoa1802345.

ReferenceCitation: Chen L, Li X, Chen M, Feng Y, Xiong C. The ACE2 expression in human heart indicates new potential mechanism of heart injury among patients infected with SARS-CoV-2. Cardiovasc Res. 2020 May 1;116(6):1097-1100. doi: 10.1093/cvr/cvaa078. Erratum in: Cardiovasc Res. 2020 Oct 1;116(12):1994.

ReferenceCitation: Recalcati S. Cutaneous manifestations in COVID-19: a first perspective. J Eur Acad Dermatol Venereol. 2020 May;34(5):e212-e213. doi: 10.1111/jdv.16387.

ReferenceCitation: Wu F, Peng Z, Park PW, Kozar RA. Loss of Syndecan-1 Abrogates the Pulmonary Protective Phenotype Induced by Plasma After Hemorrhagic Shock. Shock. 2017 Sep;48(3):340-345. doi: 10.1097/SHK.0000000000000832.

ReferenceCitation: Whitney JE, Zhang B, Koterba N, Chen F, Bush J, Graham K, Lacey SF, Melenhorst JJ, Teachey DT, Mensinger JL, Yehya N, Weiss SL. Systemic Endothelial Activation Is Associated With Early Acute Respiratory Distress Syndrome in Children With Extrapulmonary Sepsis. Crit Care Med. 2020 Mar;48(3):344-352. doi: 10.1097/CCM.0000000000004091.

ReferenceCitation: Garraud O, Heshmati F, Pozzetto B, Lefrere F, Girot R, Saillol A, Laperche S. Plasma therapy against infectious pathogens, as of yesterday, today and tomorrow. Transfus Clin Biol. 2016 Feb;23(1):39-44. doi: 10.1016/j.tracli.2015.12.003. Epub 2016 Jan 6. Review.

ReferenceCitation: Dinsdale RJ, Hazeldine J, Al Tarrah K, Hampson P, Devi A, Ermogenous C, Bamford AL, Bishop J, Watts S, Kirkman E, Dalle Lucca JJ, Midwinter M, Woolley T, Foster M, Lord JM, Moiemen N, Harrison P. Dysregulation of the actin scavenging system and inhibition of DNase activity following severe thermal injury. Br J Surg. 2020 Mar;107(4):391-401. doi: 10.1002/bjs.11310. Epub 2019 Sep 10.

ReferenceCitation: Squizzato A, Hunt BJ, Kinasewitz GT, Wada H, Ten Cate H, Thachil J, Levi M, Vicente V, D'Angelo A, Di Nisio M. Supportive management strategies for disseminated intravascular coagulation. An international consensus. Thromb Haemost. 2016 May 2;115(5):896-904. doi: 10.1160/TH15-09-0740. Epub 2015 Dec 17. Review.

ReferenceCitation: Di Nisio M, Thachil J, Squizzato A. Management of disseminated intravascular coagulation: a survey of the International Society on Thrombosis and Haemostasis. Thromb Res. 2015 Aug;136(2):239-42. doi: 10.1016/j.thromres.2015.05.022. Epub 2015 May 23.

ReferenceCitation: Garraud O, Malot S, Herbrecht R, Ojeda-Uribe M, Lin JS, Veyradier A, Payrat JM, Liu K, Corash L, Coppo P. Amotosalen-inactivated fresh frozen plasma is comparable to solvent-detergent inactivated plasma to treat thrombotic thrombocytopenic purpura. Transfus Apher Sci. 2019 Dec;58(6):102665. doi: 10.1016/j.transci.2019.10.007. Epub 2019 Nov 5.

ReferenceCitation: van Griensven J, De Weiggheleire A, Delamou A, Smith PG, Edwards T, Vandekerckhove P, Bah EI, Colebunders R, Herve I, Lazaygues C, Haba N, Lynen L. The Use of Ebola Convalescent Plasma to Treat Ebola Virus Disease in Resource-Constrained Settings: A Perspective From the Field. Clin Infect Dis. 2016 Jan 1;62(1):69-74. doi: 10.1093/cid/civ680. Epub 2015 Aug 10.

ReferenceCitation: Brown JF, Dye JM, Tozay S, Jeh-Mulbah G, Wohl DA, Fischer WA 2nd, Cunningham CK, Rowe K, Zacharias P, van Hasselt J, Norwood DA, Thielman NM, Zak SE, Hoover DL. Anti-Ebola Virus Antibody Levels in Convalescent Plasma and Viral Load After Plasma Infusion in Patients With Ebola Virus Disease. J Infect Dis. 2018 Jul 13;218(4):555-562. doi: 10.1093/infdis/jiy199.

ReferenceCitation: Di Minno G, Navarro D, Perno CF, Canaro M, Gürtler L, Ironside JW, Eichler H, Tiede A. Pathogen reduction/inactivation of products for the treatment of bleeding disorders: what are the processes and what should we say to patients? Ann Hematol. 2017 Aug;96(8):1253-1270. doi: 10.1007/s00277-017-3028-4. Epub 2017 Jun 18. Review.

ReferenceCitation: Ahn JY, Sohn Y, Lee SH, Cho Y, Hyun JH, Baek YJ, Jeong SJ, Kim JH, Ku NS, Yeom JS, Roh J, Ahn MY, Chin BS, Kim YS, Lee H, Yong D, Kim HO, Kim S, Choi JY. Use of Convalescent Plasma Therapy in Two COVID-19 Patients with Acute Respiratory Distress Syndrome in Korea. J Korean Med Sci. 2020 Apr 13;35(14):e149. doi: 10.3346/jkms.2020.35.e149.

ReferenceCitation: Duan K, Liu B, Li C, Zhang H, Yu T, Qu J, Zhou M, Chen L, Meng S, Hu Y, Peng C, Yuan M, Huang J, Wang Z, Yu J, Gao X, Wang D, Yu X, Li L, Zhang J, Wu X, Li B, Xu Y, Chen W, Peng Y, Hu Y, Lin L, Liu X, Huang S, Zhou Z, Zhang L, Wang Y, Zhang Z, Deng K, Xia Z, Gong Q, Zhang W, Zheng X, Liu Y, Yang H, Zhou D, Yu D, Hou J, Shi Z, Chen S, Chen Z, Zhang X, Yang X. Effectiveness of convalescent plasma therapy in severe COVID-19 patients. Proc Natl Acad Sci U S A. 2020 Apr 28;117(17):9490-9496. doi: 10.1073/pnas.2004168117. Epub 2020 Apr 6.

ReferenceCitation: Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

ReferenceCitation: Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6.

ReferenceCitation: Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8.

ReferenceCitation: Mair-Jenkins J, Saavedra-Campos M, Baillie JK, Cleary P, Khaw FM, Lim WS, Makki S, Rooney KD, Nguyen-Van-Tam JS, Beck CR; Convalescent Plasma Study Group. The effectiveness of convalescent plasma and hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral etiology: a systematic review and exploratory meta-analysis. J Infect Dis. 2015 Jan 1;211(1):80-90. doi: 10.1093/infdis/jiu396. Epub 2014 Jul 16. Review.

ReferenceCitation: Shi Y, Wang Y, Shao C, Huang J, Gan J, Huang X, Bucci E, Piacentini M, Ippolito G, Melino G. COVID-19 infection: the perspectives on immune responses. Cell Death Differ. 2020 May;27(5):1451-1454. doi: 10.1038/s41418-020-0530-3. Epub 2020 Mar 23.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Chang L, Yan Y, Wang L. Coronavirus Disease 2019: Coronaviruses and Blood Safety. Transfus Med Rev. 2020 Apr;34(2):75-80. doi: 10.1016/j.tmrv.2020.02.003. Epub 2020 Feb 21. Review.

ReferenceCitation: Hashem AM, Hassan AM, Tolah AM, Alsaadi MA, Abunada Q, Damanhouri GA, El-Kafrawy SA, Picard-Maureau M, Azhar EI, Hindawi SI. Amotosalen and ultraviolet A light efficiently inactivate MERS-coronavirus in human platelet concentrates. Transfus Med. 2019 Dec;29(6):434-441. doi: 10.1111/tme.12638. Epub 2019 Nov 6.

ReferenceCitation: Lin L, Hanson CV, Alter HJ, Jauvin V, Bernard KA, Murthy KK, Metzel P, Corash L. Inactivation of viruses in platelet concentrates by photochemical treatment with amotosalen and long-wavelength ultraviolet light. Transfusion. 2005 Apr;45(4):580-90.

ReferenceCitation: Chang L, Zhao L, Gong H, Wang L, Wang L. Severe Acute Respiratory Syndrome Coronavirus 2 RNA Detected in Blood Donations. Emerg Infect Dis. 2020 Jul;26(7):1631-1633. doi: 10.3201/eid2607.200839. Epub 2020 Jun 21.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility:
HIA Bégin
HIA Laveran
HIA Percy
HIA Sainte Anne


title: Analysis of the Coagulopathy Developed by COVID-19 Infected Patients: Thrombin Generation Potential in COVID-19 Infected Patients

acronym: COVID-TGT

summary: Increased D-dimers at admission of COVID-19 infected patients entering hospital due to a severe disease is a risk factor for death. Understanding this acquired coagulopathy is a prerequisite before specific interventional studies. The study investigators aim to apply a normalized and automated thrombin generation test (TGT), developed for testing the thrombotic risk (triggered by 5 pM Tissue Factor, with a purified thrombomodulin (TM) challenge) and to study its association with survival.

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU de Limoges
CHU de Bordeaux
CHU de Nimes


title: Characterization of Kidney Involvement in COVID-19 Disease: a French Multi-center Prospective Observational Study

acronym: COVKID

summary:
Novel coronavirus disease (COVID-19) is a newly discovered contagious disease caused by SARS-CoV-2 virus, primarily manifesting as an acute respiratory illness with pneumonia, but can affect multiple organs such as kidney, heart, digestive tract, blood and nervous system. In previous reports of SARS and MERS-CoV infections, acute kidney injury was described in 5 to 15% of patients and was associated with a high mortality rate (60-90%). Recent reports showed renal abnormalities in COVID-9 infected patients. A recent Chinese study also reported that acute kidney injury was an independent risk factor for mortality. However, the exact mechanism of kidney involvement remains unclear: sepsis-related cytokine storm or direct cellular injury from the virus. Also, kidney involvement has not yet been well characterized: heavy albuminuria, hematuria or interstitial nephropathy alone.

A recent study identified viral RNA in kidney tissue and another study succeeded isolating SARS-CoV-2 from the urine sample of an infected patient. These data suggest that the kidney might be a target of this novel coronarivus.

The sponsor suggests characterizing kidney involvement in SARS-CoV-2 infection.

Study objectives are:

To give an accurate characterization of kidney involvement in COVID-19
To investigate the physiopathologic mechanism of kidney involvement in SARS-CoV-2 infection
To identify risk factors for kidney involvement in in SARS-CoV-2 infection
To evaluate the impact of kidney involvement in in SARS-CoV-2 infection
To assess the long-term health effect of kidney injury on survivors of in SARS-CoV-2 infection

ipd_sharing: No

ipd_sharing_description: no data sharing plan has been established

location_facility: Centre hospitalier d'Antibes Juan les pins


title: CESAR (Randomized Therapeutic Study of Steroid vs. Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura)

summary: Henoch-Schonlein purpura is a leucocytoclastic systemic vasculitis involving small vessels with the deposition of immune complexes containing IgA. It is characterized by the association of skin, joint and gastrointestinal manifestations. Even though the evolution is usually simple, some patients, especially adults, may have severe visceral involvement including heart, lung, brain and renal disease. The best treatment is currently unknown. This study will test the safety and efficacy of steroids associated or not with cyclosphosphamide to treat the acute lesions and to prevent the development of chronic lesions.

ReferenceType: result

ReferenceCitation: Pillebout E, Thervet E, Hill G, Alberti C, Vanhille P, Nochy D. Henoch-Schönlein Purpura in adults: outcome and prognostic factors. J Am Soc Nephrol. 2002 May;13(5):1271-8.

ReferenceCitation: Pillebout E, Alberti C, Guillevin L, Ouslimani A, Thervet E; CESAR study group. Addition of cyclophosphamide to steroids provides no benefit compared with steroids alone in treating adult patients with severe Henoch Schönlein Purpura. Kidney Int. 2010 Sep;78(5):495-502. doi: 10.1038/ki.2010.150. Epub 2010 May 26.

family: Pillebout

full_name: Evangéline Pillebout

given: Evangéline

family: Alberti

full_name: Corinne Alberti

given: Corinne

family: Guillevin

full_name: Loic Guillevin

given: Loic

family: Ouslimani

full_name: Amel Ouslimani

given: Amel

family: Thervet

full_name: Eric Thervet

given: Eric

family: the CESAR study group

full_name: the CESAR study group

journal_name: Kidney International

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Decompressive Craniectomy In Malignant Middle Cerebral Artery Infarcts : A Sequential Design, Multicenter, Randomized, Controlled Trial

acronym: DECIMAL

summary: The purpose of this study is to determine if patients with malignant middle cerebral artery infarction have a better clinical outcome after early decompressive surgery compared to standard medical management.

ReferenceCitation: Vahedi K, Hofmeijer J, Juettler E, Vicaut E, George B, Algra A, Amelink GJ, Schmiedeck P, Schwab S, Rothwell PM, Bousser MG, van der Worp HB, Hacke W; DECIMAL, DESTINY, and HAMLET investigators. Early decompressive surgery in malignant infarction of the middle cerebral artery: a pooled analysis of three randomised controlled trials. Lancet Neurol. 2007 Mar;6(3):215-22.

location_facility: Hôpital Lariboisière, Assistance Publique - Hôpitaux de Paris


title: Comparison of the Success Rate of a Procedure With Peeling of Limiting the Intern of the Retina Versus a Traditional Procedure Without Peeling of Limiting, at Patients Presenting a Macular Hole.

summary:
Rational of the study: for macular holes larger than 400 µm the rate of failure is of more than 20%. It is for these eyes that it is necessary to show the benefit of internal limiting membrane (ILM) peeling in term of vision and success rate. In order to test the benefit of this gesture, it is necessary to make a randomized study.

Primary objective: To show that the percentage of success (anatomical closing, confirmed by OCT) at third postoperative month is higher in the ILM peeling group.

Design of the study: Randomized multicentric study, in parallel groups, with individual benefit for the patient.

Tested Hypothesis: The success rate of the surgery of idiopathic macular holes larger than 400 µm is increased by the peeling of the MLI.

Awaited results: To show that the success rate of the surgery of idiopathic macular holes larger than 400 µm is improved by ILM peeling. This category could then have a success rate similar to the small holes. If this difference is not proven, it will remain no justification to continue this procedure which represents little risk but which is not either without consequence.

location_facility: Service d'Ophtalmolgie de l'Hôpital Lariboisière


summary: The study hypothesis is the involvement of the couple CX3CR1/CX3CL1 in occurrence of endothelial injury in preeclampsia. According to this hypothesis, Carriers of the I249 allele who express less CX3CR1 shoud be protected against this risk. The main objective of the study is the search of an association between CX3CR1 V249I polymorphism and preeclampsia. The secondary aims are the search of an association with the most severe forms of preeclampsia and endothelial injury.

time_perspective: Retrospective


title: Evaluation of the Success Rate of a Procedure Without Strict Positioning Post Surgical Versus With Positioning Face Towards the Strict Ground, at Patients Presenting a Macular Hole. Study of Non-Inferiority.

summary:
Rational of the study: There are arguments to think that the closure of macular holes can be obtained without a strict positioning under certain conditions, i.e. hole size ≤ 400 µm, if the patient avoids the position laid down on the back. In order to be able to confirm these observations, it is necessary to make a randomized study with an adequate number of patients.

Aim of the study: To show that the percentage of success (anatomical closure confirmed by OCT) is not lower in the group without positioning.

Tested Hypothesis: The absence of strict positioning is "at least as effective" on the success of the surgery of small macular holes as the imposition of a strict positioning.

Expected results: To show that the success rate of the surgery of the idiopathic macular holes of 400 µm or less is not decreased by the replacement of a strict positioning (face-down 22h/24) by a simple instruction of avoiding the position laid down on the back, thus avoiding the patients this painful part of the treatment and allowing a reduction in the duration of hospitalization and consequently a reduction in the cost of the treatment.


summary: To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.

lead_sponsor: Association Européenne de Recherche en Oncologie


summary: The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.


summary: To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.


title: A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel

summary: The purpose of this study is to evaluate whether or not the addition of Herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel.

lead_sponsor: ARCAGY/ GINECO GROUP


title: A Double-blind Randomized Trial of Interpectoral Nerve Block (Pecs 1 and 2) With Ropivacaine Versus Placebo Before Breast Cancer Surgery: Effects on Acute Postoperative Pain. (MIRs 04)

summary: Compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery.

lead_sponsor: Institut Curie

location_facility:
Hopital Tenon
Institut Curie
Institut de Cancérologie de Lorraine
Centre Jean Perrin


title: Pilot Feasibility Study: Inflammation and Presence of M2 Macrophages Explorations With[18F]-DPA-714 PET/CT in Triple Negative Breast Cancers

acronym: EITHICS

summary: This phase II study is assessing the correlation between M1/M2 macrophage polarization determined by tumor immunohistochemistry analysis and [18F]DPA-714 PET/CT binding (qualitative and texture analysis) in patients with operable triple negative breast cancer.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cacerologie de l'ouest - site Paul Papin


title: Analysis of Four Biological Parameters at Diagnosis of Adult Acute Lymphoblastic Leukaemia: DNA Index, Percentage of Cells in S-Phase, CD45 Fluorescence Index, and Protein P16: Prognostic Study in Patients Enrolled in a Multicentric Trial

summary:
Adult acute lymphoblastic leukemia treatment approaches relie on risk stratification, including cytogenetics. We want to study at diagnosis several blast cells parameters on frozen samples of GRAALL protocols enrolled patients:

A CD45-DNA double staining analysed by flow cytometry will allow mesurement for each blastic clone of DNA ploidy, percentage of cells in S-phase, CD45 fluorescence index.
The proteine P16 metabolic way, involved in cell cycle regulation, will be studied by Western Blot analysis.

The comparison between these parameters, and main haematological data, will be followed by a prognostic analysis, based on blast corticosensibility in vivo, chimiosensibility, complete remission, and survival.

Combination of the studied parameters will allow to appreciate a clonal diversity. This will help to predict, at diagnosis, high probability of resistance to treatment.

lead_sponsor: University Hospital, Angers


title: Assessment of Metabolomic and Proteomic Phenotyping Associated With Amniotic Fluid Embolism

acronym: AMNIOPROFIL

summary:
Amniotic fluid embolism is a serious complication of the peri-partum period that is associated with high maternal mortality rate, ranging from 20 to 40%.

The pathophysiology of amniotic fluid embolism remains poorly known at this time.

The definition and diagnosis of amniotic fluid embolism is only clinical, based on different scores, the most used of which is the score proposed by the United Kingdom Obstetric Surveillance System (UKOSS). This score supports the diagnosis of amniotic fluid embolism in the event of acute maternal collapse associated with one or more of the following features: cardiac rhythm problems, acute fetal compromise, respiratory distress, maternal hemorrhage, coagulopathy, convulsions, premonitory symptoms (restlessness, numbness, tingling, agitation, etc.). ) seizure, in the absence of any other clear cause. Amniotic fluid embolism is a differential diagnosis of maternal collapse.

Determining specific biological markers for this disease would be very useful in order to be able to affirm the diagnosis and refute other diagnostic hypotheses with certainty. The detection of amniotic cells in the blood or bronchoalveolar lavage fluid seems to be of little help. The assay of plasma tryptase does not confirm the diagnosis of amniotic embolism, but is useful for ruling out the diagnosis of anaphylactic shock. The dosage of the complement lacks sensitivity and specificity to be useful in the diagnosis of amniotic fluid embolism. The maternal plasma assay of IGFBP-1 ("Insulin Growth Factor Binding Protein" type 1) has been proposed for the biological diagnosis of amniotic embolism. IGFBP-1 is present in high concentration in amniotic fluid, while its concentration is low in maternal plasma. High levels of IGFBP-1 in maternal blood would therefore make it possible to establish the diagnosis of amniotic fluid embolism with excellent sensitivity and specificity according to previous data collected from 25 patients. However, no study has confirmed this result to date. Other markers have also been suggested (zinc-coproporphyrin in particular), but to date, no specific marker for this disease has been formally identified.

Metabolic phenotyping consists in the identification of subtle and coordinated metabolic variations associated with various pathophysiological stimuli. Different analytical methods, such as nuclear magnetic resonance, allow the simultaneous quantification of a large number of metabolites. Statistical analyses of these spectra thus lead to the discrimination between samples and the identification of a metabolic phenotype corresponding to the effect under study. This approach allows the extraction of candidate biomarkers and the recovery of perturbed metabolic networks, driving to the generation of biochemical hypotheses (pathophysiological mechanisms, diagnostic tests, therapeutic targets,...).. It is thus possible to obtain biochemical characterizations of human biological samples (also called "metabolic profile or signature") which can be compared in order to identify distinctive elements of certain pathophysiological states, establishing a metabolic phenotype of the pathological state studied. This analysis can be supplemented by a study of the proteome (proteomics), in order to identify one or more biological markers associated with a disease.

The aim of this study is to determine the metabolic and proteomic phenotyping in three groups of women: women for whom the diagnosis of amniotic fluid embolism was retained according to the UKOSS clinical criteria (Group AFE), women admitted for prophylactic elective cesarean section (Group Control 1), women presenting acute collapse or shock in the peri- partum for which the diagnosis of amniotic fluid embolism has been excluded (severe hemorrhage, SEPSIS, pulmonary embolism for example; Group Control 2)

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'anesthésie réanimation Hôpital de la Croix Rousse

location_facility: Service d'anesthésie réanimation Centre Hospitalier Lyon-Sud

location_facility: Service Anesthésie Réanimation CHU de Hautepierre, Strasbourg

location_facility: Service Anesthésie réanimation - Centre Hospitalier Hôpital Femme Mère Enfant - Groupement Hospitalier Est - Hospices Civils de Lyon

intervention_type: Biological


title: Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery: Comparing Continuous Infusion of Local Anesthetic With Systemic Multimodal Analgesia

summary: This trial examines the analgesia of the fibula free flap donor site by peri-neuronal catheter in oro-pharyngeal carcinoma surgery by comparing continuous infusion of a local anesthetic with systemic multimodal analgesia.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Isolated Pelvic and Limb Perfusion With 1mg TNFa in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle

summary: This study looks at isolated pelvic perfusion and limbs' girdle with 1 mg tumor necrosis factor alpha (TNFa) in the treatment of locally advanced sarcoma of the pelvis and limbs' girdle.


title: Is Invasive Pulmonary Aspergillosis a Common Complication of Severe Influenza ?

acronym: ASPERGIGRIPP

summary:
Invasive pulmonary aspergillosis (IPA) has been reported in critically ill patients with influenza infection with a highly variable incidence between 1 to 21%. Studies investigating IPA in critically ill patients with influenza infection suffer limitations in their methods. It remains unknown whether patients with influenza are more at risk of IPA than other patients hospitalized in intensive care unit and whether patients with influenza who develop IPA have specific risk factors for this infection.

Our study aims to determine the incidence of IPA in a large multicenter cohort and to identify risk factors for IPA in these patients.

lead_sponsor: University Hospital, Brest

location_facility:
CHU de NANTES
CHR
CHU de Rennes
CHRU de Brest


title: Randomized Trial Of Platelet Transfusion Policies After Blood Stem Cells Transplantation In Young Children: Reduction Of Number Of Single Platelet Concentrate Donors Per Child


title: MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE.

summary: MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY (BEC REGIMEN) FOLLOWED BY STANDARD RADIOTHERAPY (70 Gy / 7 WEEKS) VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE (UCNT).


title: Noninvasive 3D Mapping in Persistent Atrial Fibrillation, to Describe Modifications of the Arrhythmogenic Substrate After Pulmonary Vein Isolation and Identify Potential Predicting Factors of Ablation Success

acronym: CRYOVEST

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. It is a major cause of ischemic stroke and heart failure. Intravascular cardiac ablation of the left atrium by catheter delivery is an efficient treatment to restore sinus rhythm. AF ablation is a class IIa treatment for patients with symptomatic persistent AF refractory or intolerant to antiarrhythmic medication. There are still many debates considering the ablation strategy. The pulmonary veins remain the cornerstone of AF ablation therapy, even in persistent AF. There is a large electrical remodeling occurring in the left atrium between paroxysmal AF, early persistent AF and long-standing persistent AF. However, no multicentric and randomized study has demonstrated so far the interest of targeting other left atrial substrate, such as rotors or focal sources.

Our study aims to describe with a noninvasive mapping system the arrhythmogenic substrate of persistent AF > 6 months pre- and post-cardioversion, and after pulmonary vein isolation.

lead_sponsor: University Hospital, Rouen

location_facility:
Groupe Hospitalier du Havre
Dieppe Hospital
Rouen University Hospital
Caen University Hospital


title: Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse

summary: This is a phase II study to determine the antitumor activity of Vinorelbine and Cyclofosfamide association among patients with refractory tumours or in relapse with rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas or medulloblastomas.


title: Interest of a Reirradiation With Concomitant Chemotherapy After Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area: a Multicentric Phase III Randomized Trial

summary: Interest of a reirradiation with concomitant chemotherapy after salvage surgery for recurrence of head and cancer in irradiated area : a multicentric Phase III randomized trial


title: A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.

acronym: POLYAMAL

summary: The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery.

location_facility:
CHRU Brest La Cavale Blanche
CHU Nantes Hôtel Dieu
CHU Nancy Hôpital Brabois
CHD Vendée


title: SFOP-OS94: Multicentric Randomised Phase III Trial Comparing Efficacy of Preoperative High-Dose Methotrexate Plus Doxorubicin to Efficacy of High-Dose Methotrexate Plus Etoposide and Ifosfamide, in Children and Adolescents Osteosarcoma

summary: The purpose of this study is to compare two preoperative chemotherapy regimens based on high-dose methotrexate courses given alternately either with doxorubicin or with etoposide-ifosfamide.

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

name:
Laboratory of Experimental Oncology, Pharmacogenomics and Pharmacogenetics Research Unit, IRCCS Istituto Ortopedico Rizzoli,
      Bologna, Italy

family: Hattinger

full_name: Claudia Maria Hattinger

given: Claudia Maria

family: Patrizio

full_name: Maria Pia Patrizio

given: Maria Pia

family: Magagnoli

full_name: Federica Magagnoli

given: Federica

family: Luppi

full_name: Silvia Luppi

given: Silvia

family: Serra

full_name: Massimo Serra

given: Massimo

journal_name: Expert Opinion on Emerging Drugs

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Le Deley MC, Guinebretière JM, Gentet JC, Pacquement H, Pichon F, Marec-Bérard P, Entz-Werlé N, Schmitt C, Brugières L, Vanel D, Dupoüy N, Tabone MD, Kalifa C; Société Française d'Oncologie Pédiatrique (SFOP). SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients. Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30.


title: Randomized, Comparative Study to Evaluate the Effects of Cosmetic Balm on Xerosis and Associated Signs and Symptoms, Induced by Systemic Anticancer Treatments in Subjects Receiving Targeted Educational Action Compared to a Control Group

summary:
Xerosis is one of the most common adverse events in patients treated with new cancer therapies and chemotherapies, such as multi-kinase inhibitors and more specifically, immunological checkpoint inhibitors used in the treatment of several cancers.

Xerosis appears as a result of a deterioration of the stratum corneum which results in a reduction of the hydric power of the skin. It reaches the trunk and limbs, with an incidence of 4-35%, and gradually disappears after the end of treatment.

Preventive targeted educational action is essential before initiation of cancer treatment. Once the xerosis is installed, the management is based on the use of emollients to contribute to the hydric correction of the skin. In the case of inflammation or associated infection, the administration of topical corticosteroids and / or local or oral antibiotic therapy is prescribed.

The aim of this study is to evaluate the efficacy of the cosmetic product (balm) on the improvement of xerosis induced by systemic anticancer treatments, in participants receiving targeted educational action compared to a control group.

Clinical, biological and biometrological assessments will be performed to characterized the effects in both induced xerosis and associated signs and symptoms.

Each group will include 40 participants.

time_perspective: Other

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility: Institut Universitaire du Cancer Toulouse- Oncopole


summary: To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3.

ReferenceCitation: Ribrag V, Koscielny S, Bosq J, Leguay T, Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Le Gouill S, Ojeda-Uribe M, Mariette C, Cornillon J, Cartron G, Verge V, Chassagne-Clément C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G. Rituximab and dose-dense chemotherapy for adults with Burkitt's lymphoma: a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Jun 11;387(10036):2402-11. doi: 10.1016/S0140-6736(15)01317-3. Epub 2016 Apr 11.

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

family: Koscielny

full_name: Serge Koscielny

given: Serge

family: Bosq

full_name: Jacques Bosq

given: Jacques

family: Leguay

full_name: Thibaut Leguay

given: Thibaut

family: Casasnovas

full_name: Olivier Casasnovas

given: Olivier

family: Fornecker

full_name: Luc-Mathieu Fornecker

given: Luc-Mathieu

family: Recher

full_name: Christian Recher

given: Christian

family: Ghesquieres

full_name: Hervé Ghesquieres

given: Hervé

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Girault

full_name: Stéphane Girault

given: Stéphane

family: Gouill

full_name: Steven Le Gouill

given: Steven Le

family: Ojeda-Uribe

full_name: Mario Ojeda-Uribe

given: Mario

family: Mariette

full_name: Clara Mariette

given: Clara

family: Cornillon

full_name: Jerome Cornillon

given: Jerome

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

family: Verge

full_name: Veronique Verge

given: Veronique

family: Chassagne-Clément

full_name: Catherine Chassagne-Clément

given: Catherine

family: Dombret

full_name: Hervé Dombret

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

family: Lamy

full_name: Thierry Lamy

given: Thierry

family: Tilly

full_name: Hervé Tilly

family: Salles

full_name: Gilles Salles

given: Gilles

journal_name: The Lancet


title: A Randomized Study of Unmodified Versus Leuko-Reduced Allogeneic Red Blood Cells Transfusion During Surgery in Cancer Patients

summary: There is evidence to suggest that red blood cell concentrate (RBC) transfusion may have immunomodulatory effects. The aim of this randomized single-center trial is to compare immune responses in patients undergoing cancer surgery and given either an unmodified RBC (UN-RBC) or a leuko-reduced RBC (LR-RBC) transfusion perioperatively.


title: Treatment Protocol for High-Risk PNET Brain Tumors in Children With Surgery, Sequential Chemotherapy, Conventional and High-Dose With Peripheral Blood Stem Cell Transplantation and Radiation Therapy

summary: The purpose of this study is to evaluate the efficacy of the combination of surgery, conventional chemotherapy, sequential high-dose chemotherapy with peripheral blood stem cell transplantation and reduced dose radiation therapy in high-risk PNET brain tumors.


title: Prevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor Genotonorm (Registered) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-term Corticosteroid Therapy. Extension of the Study Beyond Three Years

summary:
To evaluate the effect of increasing the growth hormone dose on the statural response
To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4 years after the diagnosis

ReferenceCitation: David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.

family: David

full_name: Hélène David

given: Hélène

family: Aupiais

full_name: Camille Aupiais

given: Camille

family: Louveau

full_name: Baptiste Louveau

given: Baptiste

family: Quartier

full_name: Pierre Quartier

given: Pierre

family: Jacqz-Aigrain

full_name: Evelyne Jacqz-Aigrain

given: Evelyne

family: Carel

full_name: Jean-Claude Carel

given: Jean-Claude

family: Simon

full_name: Dominique Simon

given: Dominique

journal_name: The Journal of Clinical Endocrinology & Metabolism

evidence: open (via free article)

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

lead_sponsor: Pfizer


title: Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.

summary: To assess the effect of long-term treatment by Genotonorm on linear growth

title: Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis


title: Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome

summary: This is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the treated group will be followed within 6 months, the untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months after the end of the treatment period.


title: The DIAMET Study: Peripheral and Coronary Endothelial Dysfunction in Type 2diabetic Patients- Evaluation of Reversibility Following 3 Months of Metformin Treatment

summary: Peripheral and coronary endothelial dysfunction in type 2 diabetic patients may be influenced by therapeutics. Using Radial flow monitoring and myocardial perfusion magnetic resonance imaging, we designed a controlled randomized double blind study to test the hypothesis that endothelial dysfunction will be reversed following 3 months of Metformin administration vs gliclazide. 30 patients will be included.


title: Remission Evaluation Before Intensified Treatment in Lymphoma: Impact of Positron Emission Tomography (PET) Using Fluorine-18-Floro-Deoxyglucose (FDG) in the Therapeutic Prescription. Medico-Economic Randomised Study

acronym: TEPELY

summary: This randomised study aimed at evaluating the medical and economical impact of positron emission tomography (PET) using fluorine-18-fluoro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin's lymphoma or with large B and P cell non-Hodgkin's lymphoma. The median progression free survival, the costs and the quality of life are compared between two groups : Group 1: the results of conventional staging and of the PET are known before stem cell transplantation. Group 2: only the results of conventional staging before stem cell transplantation are known before stem cell transplantation.


summary:
Pallidal stimulation is effective in patients with generalised idiopathic dystonia. The aim of this study is to:

evaluate the efficacy and safety of this treatment in patients with idiopathic generalised dystonia, 3 years after surgery and
assess the recurrence of the motor symptoms after the switch off.

ReferenceCitation: Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tézenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destée A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere


title: Comparison of Clinical, Molecular and Metabolic Characteristics of PD Patients With and Without Parkin Mutation

summary: Parkinson's disease is a frequent neurodegenerative disorder. Genetic forms of the disease have been recently identified. The monogenic form due to parkin mutation is responsible for many familial cases and sporadic forms. However, the relationship between the mutation and the genotype of patients is not fully established. The aim of this study is to compare clinical, metabolic and neuropsychological characteristics obtained in patients with parkin mutation with those of patients without parkin mutation.


summary: Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia.

lead_sponsor: Marie-laure Welter


summary: Basal ganglia are involved in the control of motor, cognitive and emotional behaviours. The aim of this study is to precisely evaluate patients with basal ganglia focal lesions both with or without loss of psychic-self activation.


title: Assessement of the Diagnostic Interest in Insulin Resistance of the Specific and Quantitative ELISA Assay of a Plasma Biomarker of Cellular Glucose Capture: the Secreted IRAP Protein (Regulated Amino Peptidase Insulin)

acronym: IRAP-IR

summary:
There is currently no reliable, diagnostic tests of insulin resistance other than the hyperinsulinemic euglycemic clamp which, due to its constraints and cost, is reserved for research. The insulin-Regulated aminopeptidase (IRAP) protein is a direct marker of insulin-dependent glucose cell capture and thus it blood concentration seems to be a good diagnostic test of insulin resistance.

The purpose of this study is to assess a plasma essay of IRAP protein for evaluation of insulin resistance during an oral glucose tolerance test (OGTT).

lead_sponsor: University Hospital, Grenoble

location_facility: CRNH Rhône-Alpes et Centre Hospitalier LYON Sud

location_facility: Endocrinologie-Diabétologie-Nutrition et CIC, CHU DE MONTPELLIER

location_facility: Inserm CIC1406, clinical research center, Grenoble Alpes university hospital

location_facility: Service de Nutrition clinique et CRNH Auvergne

intervention_type: Diagnostic Test


title: Efficacy and Safety of Preventive Mechanical Ventilation in Adults With Guillain Barré Syndrome

summary: The purpose of this study is to determine whether early mechanical ventilation can prevent hospital acquired pneumonia in adults with Guillain Barré Syndrome.

ReferenceCitation: Sharshar T, Chevret S, Bourdain F, Raphaël JC; French Cooperative Group on Plasma Exchange in Guillain-Barré Syndrome. Early predictors of mechanical ventilation in Guillain-Barré syndrome. Crit Care Med. 2003 Jan;31(1):278-83.

ReferenceCitation: Chevrolet JC, Deléamont P. Repeated vital capacity measurements as predictive parameters for mechanical ventilation need and weaning success in the Guillain-Barré syndrome. Am Rev Respir Dis. 1991 Oct;144(4):814-8.

ReferenceCitation: Melone MA, Heming N, Meng P, Mompoint D, Aboab J, Clair B, Salomon J, Sharshar T, Orlikowski D, Chevret S, Annane D. Early mechanical ventilation in patients with Guillain-Barré syndrome at high risk of respiratory failure: a randomized trial. Ann Intensive Care. 2020 Sep 30;10(1):128. doi: 10.1186/s13613-020-00742-z.

family: Melone

full_name: Marie-Anne Melone

given: Marie-Anne

family: Heming

full_name: Nicholas Heming

given: Nicholas

family: Meng

full_name: Paris Meng

given: Paris

family: Mompoint

full_name: Dominique Mompoint

family: Aboab

full_name: Jerôme Aboab

given: Jerôme

family: Clair

full_name: Bernard Clair

given: Bernard

family: Salomon

full_name: Jerôme Salomon

family: Sharshar

full_name: Tarek Sharshar

given: Tarek

family: Orlikowski

full_name: David Orlikowski

given: David

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Annane

full_name: Djillali Annane

given: Djillali

currency_apc_doaj: GBP

journal_name: Annals of Intensive Care

oa_colors: green gold

evidence: oa journal (via doaj)

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: University of Versailles


title: Phase II Study Evaluating the Efficacy of Bevacizumab (Avastin@) in Hepatocellular Carcinoma Not Amenable to Curative Treatment

summary: Primary liver cancer (hepatocellular carcinoma) is the fifth most common malignant disorder, with an increasing incidence in Europe and the USA as a result of the high prevalence of hepatitis C. Most patients are not suitable for potentially curative treatment. There is no standard palliative treatment for patients with advanced hepatocellular carcinoma (HCC), as no drug has been demonstrated to be efficient in this disease in terms of survival. The use of anti-vascular agents might be a promising approach in view of the highly vascular nature of this tumor. The aim of this phase II trial is to evaluate the potential benefit of bevacizumab in terms of disease control rate, progression-free and overall survival in adult patients with advanced primary liver cancer. Bevacizumab is an angiogenesis inhibitor already successfully used in patients with colorectal and renal cancers.

ReferenceCitation: Boige V, Malka D, Bourredjem A, Dromain C, Baey C, Jacques N, Pignon JP, Vimond N, Bouvet-Forteau N, De Baere T, Ducreux M, Farace F. Efficacy, safety, and biomarkers of single-agent bevacizumab therapy in patients with advanced hepatocellular carcinoma. Oncologist. 2012;17(8):1063-72. doi: 10.1634/theoncologist.2011-0465. Epub 2012 Jun 15.

family: Boige

full_name: Valérie Boige

given: Valérie

family: Malka

full_name: David Malka

family: Bourredjem

full_name: Abderrahmane Bourredjem

given: Abderrahmane

family: Dromain

full_name: Clarisse Dromain

given: Clarisse

family: Baey

full_name: Charlotte Baey

given: Charlotte

family: Jacques

full_name: Nathalie Jacques

given: Nathalie

family: Pignon

full_name: Jean‐Pierre Pignon

given: Jean‐Pierre

family: Vimond

full_name: Nadege Vimond

given: Nadege

family: Bouvet‐Forteau

full_name: Nathalie Bouvet‐Forteau

family: De Baere

full_name: Thierry De Baere

given: Thierry

family: Ducreux

full_name: Michel Ducreux

given: Michel

name: eLaboratory of Translational Research, Institut Gustave‐Roussy, Villejuif, France

family: Farace

full_name: Françoise Farace

given: Françoise

journal_name: The Oncologist

title: Efficacy, Safety, and Biomarkers of Single‐Agent Bevacizumab Therapy in Patients with Advanced Hepatocellular Carcinoma


title: Relation Between Maternal Iodine Status and Prenatal Foetal Thyroid Dimension

summary: Mother with severe Iodine deficiency are more likely to have neonates with further poor mental development . In order to select population which could benefit from iodine supplementation, ioduria has been tested but cannot be routinely practised. Strong background data suggest that iodine status could be antenatally correlated with foetal thyroid volume. The aim of that study is to examine correlation between these two parameter in a population of 130 healthy pregnant women.

ReferenceCitation: Luton D, Alberti C, Vuillard E, Ducarme G, Oury JF, Guibourdenche J. Iodine deficiency in northern Paris area: impact on fetal thyroid mensuration. PLoS One. 2011 Feb 16;6(2):e14707. doi: 10.1371/journal.pone.0014707.

family: Luton

full_name: Dominique Luton

given: Dominique

family: Alberti

full_name: Corinne Alberti

given: Corinne

family: Vuillard

full_name: Edith Vuillard

given: Edith

family: Ducarme

full_name: Guillaume Ducarme

given: Guillaume

family: Oury

full_name: Jean François Oury

given: Jean François

family: Guibourdenche

full_name: Jean Guibourdenche

given: Jean

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Iodine Deficiency in Northern Paris Area: Impact on Fetal Thyroid Mensuration


title: Microcirculation cutanée et Vasodilatation Induite Par la Pression Non-Nociceptive Chez Les diabètiques

summary: Vascular and neurological mechanisms are both likely to be involved in foot ulcer. We recently reported on the hand an original transient pressure-induced vasodilation (PIV) during a 5 mmHg/min increase of pressure strain using laser Doppler flowmetry. This physiological response to non noxious external local pressure strain is a widely protective cutaneous mechanism. The impairment of PIV in diabetic subjects may be relevant to the high prevalence of foot ulcer that occurs in these individuals. The aim of the project is to analyse the different physiopathological processes involved in PIV impairment in diabetic subjects as compared to matched controls.

ReferenceCitation: Koïtka A, Legrand-Fernandez MS, Abraham P, Fizanne L, Fromy B, Sigaudo-Roussel D, Saumet JL. Low skin temperature impairs the cutaneous vasodilator response to local progressive pressure strain. Microvasc Res. 2004 Mar;67(2):203-6.

ReferenceCitation: Koïtka A, Abraham P, Bouhanick B, Sigaudo-Roussel D, Demiot C, Saumet JL. Impaired pressure-induced vasodilation at the foot in young adults with type 1 diabetes. Diabetes. 2004 Mar;53(3):721-5.


title: A Double-Blind, Placebo-Controlled, Randomized, Clinical Study of the Effects of Betaserc® 24 mg (1 Tablet b.i.d Over 3 Months) on Vestibular Compensation Following Vestibular Neurotomy in Patients With Disabling Menière's Disease

summary: This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in patients suffering from disabling Menière's disease.

lead_sponsor: Solvay Pharmaceuticals


title: Phase II Study Comparing Radiochemotherapy With the Folfox 4 Regimen Versus Radiochemotherapy With 5FU-Cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Esophageal Cancer

summary:
The primary objectives of this study are to assess the feasibility (completion of full treatment) in both arms and to assess endoscopic complete response rate in both arms.

The secondary objective of this study is to assess the toxicity profile of each arm using the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).

lead_sponsor: Sanofi


title: Phase 1 Study of Motor Cortex Stimulation in the Treatment of Advanced Parkinson Disease

summary: The purpose of this study is to determine whether motor cortex stimulation, a mildly invasive surgical procedure, is safe and effective in advanced stage Parkinsonian patients who display side effects with dopaminergic treatment.

primary_purpose: Educational/Counseling/Training

ReferenceCitation: Drouot X, Oshino S, Jarraya B, Besret L, Kishima H, Remy P, Dauguet J, Lefaucheur JP, Dollé F, Condé F, Bottlaender M, Peschanski M, Kéravel Y, Hantraye P, Palfi S. Functional recovery in a primate model of Parkinson's disease following motor cortex stimulation. Neuron. 2004 Dec 2;44(5):769-78.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Neurosurgical Department Henri Mondor Hospital


title: LOW CYCLO: A Multicenter, Prospective, Randomized Study Evaluating the Benefit, on Renal Function, of Two Doses of Ciclosporine: Low Dose Versus Usual Dose, in Association With Mycophenolate and Corticoïds, in de Novo Cardiac Transplant

summary:
Primary Objective:

Evaluation of the benefit on renal function of one year of a low dose of ciclosporine versus the usual dose

Secondary Objective:

To evaluate the immunosuppressive efficacy and tolerance of the treatment

Study Duration:

Twelve months for each patient

Study Treatment: Ciclosporine

Group A: low dose >= 130 µg/l < T0 ciclosporinemia < 200 µg/l; Group B: standard dose >= 200 µg/l < T0 ciclosporinemia < 300 µg/l.

Study Visits:

One visit every 15 days, for the first three months; then 1 visit every month, for 6 months; and 1 visit at 9 and 12 months.

Associated Treatments:

Mycophenolate (Cellcept®), 3g a day
Corticoids, as used for transplanted patients

Randomization: Randomization will occur when it is decided that ciclosporine will be introduced.

ReferenceCitation: Boissonnat P, Gaillard S, Mercier C, Redonnet M, Lelong B, Mattei MF, Mouly-Bandini A, Pattier S, Sirinelli A, Epailly E, Varnous S, Billes MA, Sebbag L, Ecochard R, Cornu C, Gueyffier F. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial. Trials. 2012 Dec 3;13:231. doi: 10.1186/1745-6215-13-231.

family: Boissonnat

full_name: Pascale Boissonnat

given: Pascale

family: Gaillard

full_name: Ségolène Gaillard

given: Ségolène

family: Mercier

full_name: Catherine Mercier

given: Catherine

family: Redonnet

full_name: Michel Redonnet

family: Lelong

full_name: Bernard Lelong

given: Bernard

family: Mattei

full_name: Marie-Françoise Mattei

given: Marie-Françoise

family: Mouly-Bandini

full_name: Annick Mouly-Bandini

given: Annick

family: Pattier

full_name: Sabine Pattier

given: Sabine

family: Sirinelli

full_name: Agnès Sirinelli

given: Agnès

family: Epailly

full_name: Eric Epailly

given: Eric

family: Varnous

full_name: Shaida Varnous

given: Shaida

family: Billes

full_name: Marc-Alain Billes

given: Marc-Alain

family: Sebbag

full_name: Laurent Sebbag

given: Laurent

family: Ecochard

full_name: René Ecochard

given: René

family: Cornu

full_name: Catherine Cornu

family: Gueyffier

full_name: François Gueyffier

given: François

journal_name: Trials

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


title: A Randomized Phase III Study Comparing Intravenous Versus Subcutaneous Administration of Amifostine in Prevention of Xerostomia for Patients Receiving Radiotherapy for Head and Neck Carcinomas

summary: Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer. Salivary flow will be evaluated during few years after the treatment by a clinical evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.

ReferenceCitation: Bardet E, Martin L, Calais G, Tuchais C, Bourhis J, Rhein B, Feham N, Alphonsi M. Preliminary data of the GORTEC 2000-02 phase III trial comparing intravenous and subcutaneous administration of amifostine for head and neck tumors treated by external radiotherapy. Semin Oncol. 2002 Dec;29(6 Suppl 19):57-60.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility: Centre Régional de Lutte contre le Cancer de Nantes-Atlantique