title: Evaluation of the Effect of Dextran Sulphate on Anti-Xa Activities Measured in Patients Treated With Unfractionated Heparin in Different Indications-DEXHEP

acronym: DEXHEP

summary: The measurement of anti-Xa activity is classically used for the dose adjustement of unfractionated heparin (UFH) treatment and to monitor reversal of UFH by protamine during cardiac surgery with cardiopulmonary bypass (CPB). Three categories of reagents are currently available in France for the measurement of anti-Xa activity: antithrombin-containing reagents (very little used), antithrombin-free reagents and antithrombin-free reagents with dextran sulphate. Significant differences in anti-Xa results based on the reagents used were described, particularly after protamine neutralization in CPB. Indeed, dextran sulphate, contained in some reagents, could dissociate the heparin/protamine complex contributing to the higher levels of anti-Xa with these reagents. The differences observed in these patients are likely related to the presence of platelet factor 4 (PF4) in the samples from either PF4 present in vivo in patients or released in vitro after blood collection. These differences may lead to different therapeutic attitudes, including the re-administration of protamine to neutralize heparin at the end of CBP

lead_sponsor: Rennes University Hospital

location_facility:
CHU de Dijon
Rennes University Hospital
CHU de Nancy
CHU de Lille
APHP, HOPITAL Necker enfants malades
APHP, CHU Lariboisière
CH de Versailles
CHU Bordeaux


title: Efficiency of Combined Rehabilitation Programs Including Resistance and Endurance Exercises on Functional Capacities, Quality of Life and Daily Level of Activities in Hemodialysis Patients: a Comparative Study of Current Practices.

acronym: DIALEX

summary: Hemodialysis patients display among the lowest level of daily activities and decline of functional abilities is highly correlated with mortality. Perdialytic exercise during hemodialysis procedure is now part of the patients' routine care and appears to be a solution to struggle against the functional skills decrease. Our team was able to demonstrate that beyond muscle mass, muscle strength and physical activity were essential determinants of morbidity and mortality of dialysis patients. The AIDER Santé medical team has set up an assessment of physical activities and muscle strength in the Montpellier and Nimes centers. In order to rehabilitate muscle strength and endurance, perdialytic exercise may be prescribed. Its effectiveness can be appreciated by measuring the SPPB score (Short Physical Performance Battery). Recent studies established that combined training including resistance and endurance exercises was the most effective to improve functional performance. In AIDER Santé dialysis centers, the two mainly used exercise approaches are distinguished by the time distribution of the two types of exercise: the first plans to practice both types of exercise at each session (continuous program), the second plans to alternate a week of resistance exercise with a week of endurance exercise (discontinuous program). It is established that the rehabilitation of the hemodialysis patient must include both resistance and endurance exercises, but the combination of these exercises during the same session is potentially at the origin of an interference phenomenon, limiting neuromuscular adaptations specific to each effort. Therefore, the main hypothesis of the project is that the temporal separation of resistance and endurance exercises in a discontinuous program could optimize the functional gains of combined rehabilitation and therefore be more effective than a continuous program generating a phenomenon of interference.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Montpellier

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Retrospective Study : Muscle Mass or Muscle Function as a prédictive Tools for Outtcomme in Chronic Dialysis Patients

summary:
Aim of this study is to compare the association of muscle mass and functionality with mortality among chronic haemodialysis

the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment and phyiscal activity.
the relationship between voluntary muscle strength and mortality
the relationship between voluntary muscle strength and physical activity

time_perspective: Retrospective


type: Other Identifier

title: Capsule Versus Conventional Colonoscopy in Patient Following Colorectal Surgery

summary:
The study will compare the diagnostic efficacy of the VCC (PillCam COLON 2) to standard colonoscopy in patients with prior colorectal surgery.

The hypothesis is to validate the VCC as a means of screening for colonic polyps after resection, which would avoid a colonoscopy with its associated general anesthesia and potential side effects.

status: Terminated

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: IHU Strasbourg

location_facility: Department of Hepato-Gastroenterology, Nouvel Hopital Civil

intervention_type: Device

status_simplified: Unknown


title: Evolution of Abdominal Adipose Tissue Distribution in Type 2 Diabetic Patients Treated During 6 Months With Pioglitazone or Insulin, in Association With Metformin or Sulfonylurea.

summary:
In type 2 diabetic patients with poor glycemic control despite maximum "classic" oral treatment, bed time insulin therapy may lead to a parallel increase in abdominal visceral and subcutaneous fat, whereas pioglitazone treatment should lead to a stability (or even a decrease ) in visceral and an increase in subcutaneous abdominal fat. As visceral fat mass is correlated with insulin-resistance and cardio-vascular risk, the evolution of visceral abdominal fat in type 2 diabetic patients is of great importance.

Main objective:

To compare visceral and subcutaneous abdominal fat compartment after a six-month bed time insulin or pioglitazone treatment in type 2 diabetic patients with poor glycemic control despite a maximal oral treatment with metformin and sulfonylureas.

The study hypothesis is that quantity of visceral and subcutaneous abdominal adipose tissue should differently evolute comparing a 6 month treatment with pioglitazone® (30 or 45mg/j) or NPH " bed-time " insulin (0.2u/kg/

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Hartemann-Heurtier A, Halbron M, Golmard JL, Jacqueminet S, Bastard JP, Rouault C, Ayed A, Pieroni L, Clément K, Grimaldi A. Effects of bed-time insulin versus pioglitazone on abdominal fat accumulation, inflammation and gene expression in adipose tissue in patients with type 2 diabetes. Diabetes Res Clin Pract. 2009 Oct;86(1):37-43. doi: 10.1016/j.diabres.2009.06.028. Epub 2009 Aug 15.

family: Hartemann-Heurtier

full_name: Agnès Hartemann-Heurtier

given: Agnès

sequence: first

family: Halbron

full_name: Marine Halbron

given: Marine

sequence: additional

family: Golmard

full_name: Jean-Louis Golmard

given: Jean-Louis

family: Jacqueminet

full_name: Sophie Jacqueminet

given: Sophie

family: Bastard

full_name: Jean-Philippe Bastard

given: Jean-Philippe

family: Rouault

full_name: Christine Rouault

given: Christine

family: Ayed

full_name: Amine Ayed

given: Amine

family: Pieroni

full_name: Laurence Pieroni

given: Laurence

family: Clément

full_name: Karine Clément

given: Karine

family: Grimaldi

full_name: André Grimaldi

given: André

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetes Research and Clinical Practice

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Sce de Diabétologie, hôpital de la Pitié-salpêtrière, 83bld de l'hôpital

intervention_type: Drug


title: Feasibility and Safety of Local Immunomodulation Combined With Radiofrequency Ablation for Unresectable Colorectal Liver Metastases: A Monocentric Phase I Trial

summary:
The main objective of this trial is to determine feasibility and tolerance of the human body to RFA associated with local immunomodulation carried out using a thermoreversible hydrogel combined with 2 immunomodulators, GMCSF and Mifamurtide.

The main endpoint of the study is the feasibility, the frequency and the nature of per and post-operative adverse events of the in situ injection of an immunomodulatory hydrogel after radiofrequency of unresectable colorectal liver metastases.

The secondary objective is one-year progression free survival rate.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Lemdani K, Seguin J, Lesieur C, Al Sabbagh C, Doan BT, Richard C, Capron C, Malafosse R, Boudy V, Mignet N. Mucoadhesive thermosensitive hydrogel for the intra-tumoral delivery of immunomodulatory agents, in vivo evidence of adhesion by means of non-invasive imaging techniques. Int J Pharm. 2019 Aug 15;567:118421. doi: 10.1016/j.ijpharm.2019.06.012. Epub 2019 Jun 6.

ReferenceCitation: Lemdani K, Mignet N, Boudy V, Seguin J, Oujagir E, Bawa O, Peschaud F, Emile JF, Capron C, Malafosse R. Local immunomodulation combined to radiofrequency ablation results in a complete cure of local and distant colorectal carcinoma. Oncoimmunology. 2019 Jan 10;8(3):1550342. doi: 10.1080/2162402X.2018.1550342. eCollection 2019.

location_facility: Digestive Surgery Department, Ambroise Pare University Hospital, APHP

intervention_type: Procedure

status_simplified: Ongoing


title: ANRS HC 22, PEGLIST-C, Multicenter, Randomized Controlled Trial of Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C, Non 2 or 3 Genotypes and Insulin Resistance

acronym: PEGLIST C

summary: The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie


title: Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care.

acronym: COVILLE

summary: This study is expected to provide, for the first time, data on Cov2-SARS circulation in asymptomatic children and children with moderate respiratory symptoms in order to construct the severity pyramid of this novel pathogen. This information will be essential in the coming weeks to understand the dynamics of the transmission of this pathogen at the population level and to highlight the relevance of public health interventions, particularly with regard to the systematic closure of schools and childcare facilities.

ReferenceCitation: Cohen R, Jung C, Ouldali N, Sellam A, Batard C, Cahn-Sellem F, Elbez A, Wollner A, Romain O, Corrard F, Aberrane S, Soismier N, Creidy R, Smati-Lafarge M, Launay O, Béchet S, Varon E, Levy C. Assessment of SARS-CoV-2 infection by Reverse transcription-PCR and serology in the Paris area: a cross-sectional study. BMJ Paediatr Open. 2020 Dec 29;4(1):e000887. doi: 10.1136/bmjpo-2020-000887. eCollection 2020.

family: Cohen

full_name: Robert Cohen

given: Robert

family: Jung

full_name: Camille Jung

given: Camille

family: Ouldali

full_name: Naim Ouldali

given: Naim

family: Sellam

full_name: Aurelie Sellam

given: Aurelie

family: Batard

full_name: Christophe Batard

given: Christophe

family: Cahn-Sellem

full_name: Fabienne Cahn-Sellem

given: Fabienne

family: Elbez

full_name: Annie Elbez

given: Annie

family: Wollner

full_name: Alain Wollner

given: Alain

family: Romain

full_name: Olivier Romain

given: Olivier

family: Corrard

full_name: François Corrard

given: François

family: Aberrane

full_name: Said Aberrane

given: Said

family: Soismier

full_name: Nathalie Soismier

given: Nathalie

family: Creidy

full_name: Rita Creidy

given: Rita

family: Smati-Lafarge

full_name: Mounira Smati-Lafarge

given: Mounira

family: Launay

full_name: Odile Launay

given: Odile

family: Béchet

full_name: Stéphane Béchet

given: Stéphane

family: Varon

full_name: Emmanuelle Varon

given: Emmanuelle

family: Levy

full_name: Corinne Levy

given: Corinne

currency_apc_doaj: GBP

journal_name: BMJ Paediatrics Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Cabinet de Pédiatrie des Docteurs Ravilly et Bessa


title: Comportemental and Neuropsychologic Study of Children With Neurofibromatosis Type 1 Treated by Methylphenidate. A Double-blind Randomised Study Methylphenidate Versus Placebo

summary: Neurofibromatosis type 1 (NF1) is an autosomal dominant disorder with an estimated prevalence of 1/2190 to 1/6711. Attention deficit hyperactivity disorder (ADHD) has been reported to be common in NF1. We, the researchers at Hospices Civils de Lyon, designed a randomized, double blind, placebo controlled, crossover trial with a total follow-up duration of 9 weeks to evaluate the effect of methylphenidate (MPH) on the improvement on the simplified parents Conners' Rating Scale. In a parallel exploratory study we will compare the nature of attention deficit disorders in NF1 children to 30 ADHD NF1-free controls. Children aged 7 to 12 years are eligible when their intelligence quotient (IQ) is between 80 and 120. Fifty subjects (25 for each period) were required for testing the primary study hypothesis.

ReferenceCitation: Lion-François L, Gueyffier F, Mercier C, Gérard D, Herbillon V, Kemlin I, Rodriguez D, Ginhoux T, Peyric E, Coutinho V, Bréant V, des Portes V, Pinson S, Combemale P, Kassaï B; Réseau NF1 Rhône Alpes Auvergne-France. The effect of methylphenidate on neurofibromatosis type 1: a randomised, double-blind, placebo-controlled, crossover trial. Orphanet J Rare Dis. 2014 Sep 10;9:142. doi: 10.1186/s13023-014-0142-4.

family: Lion-François

full_name: Laurence Lion-François

given: Laurence

name: et Réseau NF1 Rhône Alpes Auvergne-France

family: Gueyffier

full_name: François Gueyffier

family: Mercier

full_name: Catherine Mercier

given: Catherine

family: Gérard

full_name: Daniel Gérard

given: Daniel

family: Herbillon

full_name: Vania Herbillon

given: Vania

family: Kemlin

full_name: Isabelle Kemlin

given: Isabelle

family: Rodriguez

full_name: Diana Rodriguez

given: Diana

family: Ginhoux

full_name: Tiphanie Ginhoux

given: Tiphanie

family: Peyric

full_name: Emeline Peyric

given: Emeline

family: Coutinho

full_name: Virginie Coutinho

given: Virginie

family: Bréant

full_name: Valentine Bréant

given: Valentine

family: des Portes

full_name: Vincent des Portes

given: Vincent

family: Pinson

full_name: Stéphane Pinson

family: Combemale

full_name: Patrick Combemale

given: Patrick

family: Kassaï

full_name: Behrouz Kassaï

given: Behrouz

journal_name: Orphanet Journal of Rare Diseases

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes


title: Impact of Ceftriaxone and/or Fluoroquinolone (FQ) Treatment on the Gut Microbiota of Hospitalized Patients.

acronym: EVOTAR

summary: Observational study of the effects of antibiotics on commensal flora. Realization of stool samples and nasal swabs before and after antibiotic therapy.


title: Randomised Comparative Prospective Study of the Treatment of Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency : ACT™ Balloon Versus Artificial Urinary Sphincter ( AMS800™)

acronym: SU-ACT

summary:
The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months.

Continence is defined by the average number of pads used per day. The social continence is defined by (0-1) pad per day

status: Unknown status

primary_purpose: Other

location_facility: Urology Department, Pitié-Salpêtrière University Hospital


title: Assessment Practices Registry in Congenital Cataract Surgery and Infantile

summary: The purpose of this observational study is to assess the therapeutic strategies in the treatment of pediatric cataracts.

status: Withdrawn

location_facility: Hospital Necker - Enfants Malades (Assistance Publique-Hôpitaux de Paris)


title: A French, Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)

acronym: Qualipec

summary:
National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.

• Study objectives include assessment of early treatment satisfaction.

lead_sponsor: Archimedes Development Ltd

lead_sponsor_type: industriel


title: Immunonutrition to Improve Quality of Life of Upper Gastrointestinal Cancer Patients Undergoing Oncological Treatment

acronym: Neoimmune

summary: The purpose of this study is to compare the health-related quality of life following dietary supplementation with an immunonutrition formulation vs an isocaloric/isoprotein control diet supplement in patients suffering from upper digestive tract neoplasia undergoing oncological treatment.

primary_purpose: Supportive Care

lead_sponsor: Nestlé

location_facility: Centre Hospitalier Régional Universitaire de Lille

intervention_type: Dietary Supplement


title: An Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-9722 (a PARP-1 and PARP-2 Inhibitor) as Single-Agent Therapy and as Combination Therapy With Temozolomide in Patients With Advanced Solid Tumors

summary: An open-label study to evaluate the safety, pharmacokinetics, and pharmacodynamics of CEP-9722 as single-agent therapy and as combination therapy with temozolomide in patients with advanced solid tumors.

lead_sponsor: Cephalon

location_country:
United Kingdom
France


title: Comparison of Monotherapy With Protracted Superpotent Topical Steroids to Superpotent Topical Steroids Associated With Methotrexate in Bullous Pemphigoid

acronym: BP/MTX

summary: This controlled multi-center randomized clinical trial, with direct individual benefit, will compare efficacy and safety of two strategies in non-localized BP care: a combined regimen using initial superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months (current standard of care). The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.


title: Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital Cytomegalovirus Infection

acronym: INFECSMELL

summary: CMV lesions were found in the olfactory system of children with congenital CMV infection but no study has hitherto examined the impact of congenital CMV infection on olfaction. So the investigators propose in this study to assess the proportion of children with olfactory deficits among children with congenital CMV infection. Second this study will also evaluate performances of a new olfactory test, based on discrimination of binary odorant mixtures.

time_perspective: Cross-Sectional

lead_sponsor: Institut Pasteur

location_facility:
Hopital Bicêtre
Robert Debré Hospital


title: Assessment of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer

summary:
With 4,600 new cases in France in 2012, ovarian cancer is the seventh most common cancer in women and the fourth cause of mortality by cancer. Despite a high response rate to initial treatment, most patients will relapse within 2 years. No standard treatment has yet been established for patients with recurrent ovarian cancer.

Most patients with such recurrences are currently treated with new combinations of systemic chemotherapy. A repeated laparotomy with complete cytoreduction is also an option that several authors have used to obtain median survival rates of more than 30 months.

Twenty five percent of patients experiencing relapse present with platinum-resistant recurrence, occurring less than 6 months after chemotherapy completion. Recently, Pujade et al. showed that adding bevacizumab to chemotherapy significantly improves progression-free survival (PFS) in this subgroup of patients with poor prognoses (16.6 months versus 13.3 months in women treated with chemotherapy alone). Three case control studies have compared systemic chemotherapy and CRS (Cytoreduction Surgery) alone versus CRS plus HIPEC in patients with recurrent disease. They showed significantly improved results with the addition of HIPEC. In the French registry that included 474 patients with recurrence and peritoneal carcinomatosis, the median PFS was 13.8 months for platinum-resistant patients and 13 months for platinum-sensitive patients. Our hypothesis is that surgery would reduce the tumor burden and consequently the number of platinum-resistant tumor clones and that HIPEC would control the microscopic residual disease by increasing the tumor cell cytotoxicity.

We assume that adding a locoregional treatment to an "Aurelia-like" systemic treatment would improve the PFS. We aim to assess the benefit of adding surgery and HIPEC to the treatment of first or second platinum-resistant recurrence compared to chemotherapy + bevacizumab.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier Universitaire L'Archet II

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Hôpital Européen Georges Pompidou - APHP

location_facility: Centre Hospitalier Universitaire Hautepierre

location_facility: Centre Hospitalier Universitaire Jean Minjoz

location_facility: Centre Hospitalier Universitaire de St Etienne

location_facility: Institut de Cancérologie de Lorraine - Alexis Vautrin


title: A Phase II Study of MK 2206 in Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma

acronym: AKTIL

summary: The purpose of this study is to evaluate the antitumor efficacy and the safety of MK 2206 in patients with relapsed or refractory diffuse large B cell lymphoma.

ReferenceCitation: Thieblemont C, Gisselbrecht C. Second-line treatment paradigms for diffuse large B-cell lymphomas. Curr Oncol Rep. 2009 Sep;11(5):386-93. Review.

ReferenceCitation: Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, Sonneveld P, Gisselbrecht C, Cahn JY, Harousseau JL, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med. 1995 Dec 7;333(23):1540-5.

ReferenceCitation: Gisselbrecht C, Glass B, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Ketterer N, Shpilberg O, Hagberg H, Ma D, Brière J, Moskowitz CH, Schmitz N. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010 Sep 20;28(27):4184-90. doi: 10.1200/JCO.2010.28.1618. Epub 2010 Jul 26. Erratum in: J Clin Oncol. 2012 May 20;30(15):1896.

ReferenceCitation: Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Fermé C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2005 Jun 20;23(18):4117-26. Epub 2005 May 2.

ReferenceCitation: Lignon J, Sibon D, Madelaine I, Brice P, Franchi P, Briere J, Mounier N, Gisselbrecht C, Faure P, Thieblemont C. Rituximab, dexamethasone, cytarabine, and oxaliplatin (R-DHAX) is an effective and safe salvage regimen in relapsed/refractory B-cell non-Hodgkin lymphoma. Clin Lymphoma Myeloma Leuk. 2010 Aug;10(4):262-9. doi: 10.3816/CLML.2010.n.055.

ReferenceCitation: Coiffier B. Fourteen years of high-dose CHOP (ACVB regimen): preliminary conclusions about the treatment of aggressive-lymphoma patients. Hamilton Fairley Award Lecture, European Society for Medical Oncology Meeting, Lisbon, November 21, 1994. Ann Oncol. 1995 Mar;6(3):211-7. Review.

ReferenceCitation: Wilson WH, Dunleavy K, Pittaluga S, Hegde U, Grant N, Steinberg SM, Raffeld M, Gutierrez M, Chabner BA, Staudt L, Jaffe ES, Janik JE. Phase II study of dose-adjusted EPOCH and rituximab in untreated diffuse large B-cell lymphoma with analysis of germinal center and post-germinal center biomarkers. J Clin Oncol. 2008 Jun 1;26(16):2717-24. doi: 10.1200/JCO.2007.13.1391. Epub 2008 Mar 31.

ReferenceCitation: Dupuis J, Itti E, Rahmouni A, Hemery F, Gisselbrecht C, Lin C, Copie-Bergman C, Belhadj K, El Gnaoui T, Gaillard I, Kuhnowski F, Meignan M, Haioun C. Response assessment after an inductive CHOP or CHOP-like regimen with or without rituximab in 103 patients with diffuse large B-cell lymphoma: integrating 18fluorodeoxyglucose positron emission tomography to the International Workshop Criteria. Ann Oncol. 2009 Mar;20(3):503-7. doi: 10.1093/annonc/mdn671. Epub 2008 Dec 11.

ReferenceCitation: Shipp MA. Molecular signatures define new rational treatment targets in large B-cell lymphomas. Hematology Am Soc Hematol Educ Program. 2007:265-9. Review.

ReferenceCitation: Altomare DA, Testa JR. Perturbations of the AKT signaling pathway in human cancer. Oncogene. 2005 Nov 14;24(50):7455-64. Review.

ReferenceCitation: Hennessy BT, Smith DL, Ram PT, Lu Y, Mills GB. Exploiting the PI3K/AKT pathway for cancer drug discovery. Nat Rev Drug Discov. 2005 Dec;4(12):988-1004. Review.

ReferenceCitation: Steelman LS, Stadelman KM, Chappell WH, Horn S, Bäsecke J, Cervello M, Nicoletti F, Libra M, Stivala F, Martelli AM, McCubrey JA. Akt as a therapeutic target in cancer. Expert Opin Ther Targets. 2008 Sep;12(9):1139-65. doi: 10.1517/14728222.12.9.1139 . Review.

ReferenceCitation: Sarbassov DD, Ali SM, Sabatini DM. Growing roles for the mTOR pathway. Curr Opin Cell Biol. 2005 Dec;17(6):596-603. Epub 2005 Oct 13. Review.

ReferenceCitation: Gupta M, Ansell SM, Novak AJ, Kumar S, Kaufmann SH, Witzig TE. Inhibition of histone deacetylase overcomes rapamycin-mediated resistance in diffuse large B-cell lymphoma by inhibiting Akt signaling through mTORC2. Blood. 2009 Oct 1;114(14):2926-35. doi: 10.1182/blood-2009-05-220889. Epub 2009 Jul 29.

ReferenceCitation: Hay N. The Akt-mTOR tango and its relevance to cancer. Cancer Cell. 2005 Sep;8(3):179-83. Review.

ReferenceCitation: Weil RJ. Incorporating molecular tools into early-stage clinical trials. PLoS Med. 2008 Jan 22;5(1):e21. doi: 10.1371/journal.pmed.0050021. Review.

ReferenceCitation: Kawauchi K, Ogasawara T, Yasuyama M, Otsuka K, Yamada O. The PI3K/Akt pathway as a target in the treatment of hematologic malignancies. Anticancer Agents Med Chem. 2009 Jun;9(5):550-9. Review.

ReferenceCitation: Testa JR, Bellacosa A. AKT plays a central role in tumorigenesis. Proc Natl Acad Sci U S A. 2001 Sep 25;98(20):10983-5. Review.

ReferenceCitation: Hasselblom S, Hansson U, Olsson M, Torén L, Bergström A, Nilsson-Ehle H, Andersson PO. High immunohistochemical expression of p-AKT predicts inferior survival in patients with diffuse large B-cell lymphoma treated with immunochemotherapy. Br J Haematol. 2010 May;149(4):560-8. doi: 10.1111/j.1365-2141.2010.08123.x. Epub 2010 Mar 1.

ReferenceCitation: Uddin S, Hussain AR, Siraj AK, Manogaran PS, Al-Jomah NA, Moorji A, Atizado V, Al-Dayel F, Belgaumi A, El-Solh H, Ezzat A, Bavi P, Al-Kuraya KS. Role of phosphatidylinositol 3'-kinase/AKT pathway in diffuse large B-cell lymphoma survival. Blood. 2006 Dec 15;108(13):4178-86. Epub 2006 Aug 31.

ReferenceCitation: Wanner K, Hipp S, Oelsner M, Ringshausen I, Bogner C, Peschel C, Decker T. Mammalian target of rapamycin inhibition induces cell cycle arrest in diffuse large B cell lymphoma (DLBCL) cells and sensitises DLBCL cells to rituximab. Br J Haematol. 2006 Sep;134(5):475-84.

ReferenceCitation: Reeder CB, Gornet MK, Habermann TM, et al.: A phase II trial of the oral mTOR inhibitor Everolimus (RAD001) in relapsed aggressive Non-Hodgkin Lymphoma (NHL), in (ed 110; Abstract 121), 2007

ReferenceCitation: Johnson PB, Ansell SM, Colgan JP, et al.: Phase II trial of the oral mTOR inhibitor everolimus (RAD001) for patients with relapsed or refractory lymphoma, in (ed 25, No. 18S, Abstract 8055), 2007

ReferenceCitation: Smith SM, van Besien K, Karrison T, Dancey J, McLaughlin P, Younes A, Smith S, Stiff P, Lester E, Modi S, Doyle LA, Vokes EE, Pro B. Temsirolimus has activity in non-mantle cell non-Hodgkin's lymphoma subtypes: The University of Chicago phase II consortium. J Clin Oncol. 2010 Nov 1;28(31):4740-6. doi: 10.1200/JCO.2010.29.2813. Epub 2010 Sep 13.

ReferenceCitation: Woehrer S, Hejna M, Skrabs C, Drach J, Zielinski CC, Jaeger U, Raderer M. Rituximab, Ara-C, dexamethasone and oxaliplatin is safe and active in heavily pretreated patients with diffuse large B-cell lymphoma. Oncology. 2005;69(6):499-502. Epub 2006 Jan 16.

ReferenceCitation: Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE, Lam W, McBride K, Wride K, Pietronigro D, Takeshita K, Ervin-Haynes A, Zeldis JB, Habermann TM. Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2008 Oct 20;26(30):4952-7. doi: 10.1200/JCO.2007.15.3429. Epub 2008 Jul 7.

ReferenceCitation: Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. Epub 2004 Dec 21.

ReferenceCitation: Robertson MJ, Kahl BS, Vose JM, de Vos S, Laughlin M, Flynn PJ, Rowland K, Cruz JC, Goldberg SL, Musib L, Darstein C, Enas N, Kutok JL, Aster JC, Neuberg D, Savage KJ, LaCasce A, Thornton D, Slapak CA, Shipp MA. Phase II study of enzastaurin, a protein kinase C beta inhibitor, in patients with relapsed or refractory diffuse large B-cell lymphoma. J Clin Oncol. 2007 May 1;25(13):1741-6. Epub 2007 Mar 26.

ReferenceCitation: Casasnovas RO, Meignan M, Berriolo-Riedinger A, Bardet S, Julian A, Thieblemont C, Vera P, Bologna S, Brière J, Jais JP, Haioun C, Coiffier B, Morschhauser F; Groupe d'étude des lymphomes de l'adulte (GELA). SUVmax reduction improves early prognosis value of interim positron emission tomography scans in diffuse large B-cell lymphoma. Blood. 2011 Jul 7;118(1):37-43. doi: 10.1182/blood-2010-12-327767. Epub 2011 Apr 25.

family: Casasnovas

full_name: René-Olivier Casasnovas

given: René-Olivier

family: Meignan

full_name: Michel Meignan

given: Michel

name: Centre Georges-Francois Leclerc, Dijon, France;

family: Berriolo-Riedinger

full_name: Alina Berriolo-Riedinger

given: Alina

family: Bardet

full_name: Stéphane Bardet

family: Julian

full_name: Anne Julian

given: Anne

family: Thieblemont

full_name: Catherine Thieblemont

family: Vera

full_name: Pierre Vera

given: Pierre

name: CHU Nancy, Vandoeuvre les Nancy, France;

family: Bologna

full_name: Serge Bologna

given: Serge

family: Brière

full_name: Josette Brière

given: Josette

family: Jais

full_name: Jean-Philippe Jais

given: Jean-Philippe

family: Haioun

full_name: Corinne Haioun

name: Hopital Lyon Sud, Pierre Bénite, France; and

family: Coiffier

full_name: Bertrand Coiffier

given: Bertrand

name: Hopital Claude Huriez and EA 4481 GRIIOT, Lille 2 University, Lille, France

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Juweid ME, Stroobants S, Hoekstra OS, Mottaghy FM, Dietlein M, Guermazi A, Wiseman GA, Kostakoglu L, Scheidhauer K, Buck A, Naumann R, Spaepen K, Hicks RJ, Weber WA, Reske SN, Schwaiger M, Schwartz LH, Zijlstra JM, Siegel BA, Cheson BD; Imaging Subcommittee of International Harmonization Project in Lymphoma. Use of positron emission tomography for response assessment of lymphoma: consensus of the Imaging Subcommittee of International Harmonization Project in Lymphoma. J Clin Oncol. 2007 Feb 10;25(5):571-8. Epub 2007 Jan 22.

ReferenceCitation: Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-López A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. Review. Erratum in: J Clin Oncol 2000 Jun;18(11):2351.

ReferenceCitation: Meignan M, Itti E, Gallamini A, Haioun C. Interim 18F-fluorodeoxyglucose positron emission tomography in diffuse large B-cell lymphoma: qualitative or quantitative interpretation--where do we stand? Leuk Lymphoma. 2009 Nov;50(11):1753-6. doi: 10.3109/10428190903308056.

ReferenceCitation: Meignan M, Gallamini A, Haioun C, Polliack A. Report on the Second International Workshop on interim positron emission tomography in lymphoma held in Menton, France, 8-9 April 2010. Leuk Lymphoma. 2010 Dec;51(12):2171-80. doi: 10.3109/10428194.2010.529208. Epub 2010 Nov 15.

location_facility:
Centre Henri Mondor
Hôpital Necker
CHU de Nantes
CHU St Eloi
Centre Hospitalier LYON SUD
Institut Paoli Calmettes
CHRU
Centre Leon Berard
Institut Bergonié
Centre Henri Becquerel
CHU
Institut Gustave Roussy
Hôpital Saint-Louis


title: Randomized, Double-blind, Placebo and Comparator-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

summary:
3. RATIONALE FOR BF2.649 IN NARCOLEPSY Narcolepsy is a disabling syndrome affecting the generation and organizations of sleep and wakefulness, first described by Westphal and Gelineau in 19th century. Excessive Daytime Sleepiness (EDS) and cataplexy are two main symptoms of narcolepsy. Other symptoms referred to as auxiliary symptoms are hypnagogic and hypnopompic hallucinations, sleep paralysis, dyssomnia and automatic behaviour. The prevalence of narcolepsy is estimated around 25 per 100 000 in Causasian population. It is often extremely incapacitating, interfering with every aspect of life, in work and social settings.

Several breakthroughs in the understanding of physiopathology of narcolepsy have recently shown that most narcoleptic patients display a strongly decreased CSF level of orexins, a group of hypothalamic peptides with wake-promoting activity. It was also found that sporadic narcolepsy in dogs, mice and humans may also be related to a deficiency in the production of orexin ligands. Narcolepsy may be a neurodegenerative or autoimmune disorder resulting in a loss of hypothalamic neurons containing the orexin [Baumann CR & Bassetti CL Lancet Neurol. 2005 ; Dauvilliers Y et al, Clin Neurophysiol. 2003 ].

In accordance with guidelines published by the European task force [Billiard M et al, Eur J Neurol. 2006] , management of narcolepsy with or without cataplexy relies on several classes of drugs, namely stimulants for EDS, antidepressants for cataplexy and hypnosedative drugs for disturbed nocturnal sleep. The first line pharmacological treatment of EDS and irresistible episodes of sleep rely on Modafinil, 100-400 mg/day, given in two doses, one in the morning and one early in the afternoon, the need for amphetamines and amphetamine-like stimulants (e.g. methylphenidate) has been decreased. Sodium oxybate and antidepressants are main drug therapies of cataplexy.

BF2.649, an H3R inverse agonist promotes significantly vigilance in mice knock out for the orexin gene, a reliable model of narcolepsy, whereas the animals remain calm, a difference with treatment by amphetamine-like drugs which induce psychomotor excitation. In addition, BF2.649 shows a significant inhibitory effect on the occurrence of narcolepsy episodes during the dark period. These narcolepsy episodes are to be compared to cataplexy episodes in human [Chemelli et al., Cell 1999] 11. In agreement, Modafinil, in humans, does not show any effects on cataplexy, even if it improves wakefulness by an ill-defined mechanism. Thus anticataplectic drugs, such as antidepressants, are given in addition to Modafinil to narcoleptic patients.

Taken together, the preclinical and clinical results provide a compelling rationale for this study to verify and confirm, under randomized double-blind and placebo-controlled conditions, the safety and efficacy of escalating dose of BF2.649 in the treatment of EDS and cataplexy in narcolepsy.

It is on the basis of preclinical studies, and on the observation of the first included patients, that the doses to be administered were determined.

ReferenceCitation: Fronczek R, Middelkoop HA, van Dijk JG, Lammers GJ. Focusing on vigilance instead of sleepiness in the assessment of narcolepsy: high sensitivity of the Sustained Attention to Response Task (SART). Sleep. 2006 Feb;29(2):187-91.

lead_sponsor: Bioprojet


title: Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase in Relapse After Allogeneic Stem Cell Transplantation

summary: The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.

design_allocation: Non-Randomized

lead_sponsor: Poitiers University Hospital


title: Phase II, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of TRO40303 for Reduction of Reperfusion Injury in Patients Undergoing Percutaneous Coronary Intervention for Acute Myocardial Infarction

summary:
Objectives of the phase 2 prospective, multicenter, randomized, double-blind, placebo-controlled study is to assess safety and efficacy of TRO40303 administered just before balloon inflation during percutaneous coronary intervention (PCI) for limitation of infarct size in patients treated for acute myocardial infarction (AMI).

The study is being conducted in 9 centres in Sweden, Denmark, Norway and France. One hundred eighty patients will be included. It will last one month per patient and its overall duration will be 11 months.

The efficacy will be assessed by infarct size expressed as area under the curve for creatine kinase and troponin I (blood sampling at D1, D2 and D3), and also evaluated by Cardiac Magnetic Resonance.

Safety will be assessed by

clinic evaluation,
blood samples (hematology, biochemistry, renal and hepatic function),
Recording and follow-up of major adverse events occurring during the first 48h after reperfusion (death, heart failure, AMI, stroke, recurrent ischemia, the need for repeat revascularization, renal or hepatic, vascular complication and bleeding).
ECG
Recording cardiac events during one month after AMI
Follow-up of global left ventricular function by Echocardiography at D3 and D30.

Demographic and medical history at inclusion and non-cardiac events occurring during the first 30 days will be recorded. TRO40303 plasma concentration will be assessed at 15 min, 6h, and 12h post the end of administration.

Sample size calculation assuming a reduction of 35% of the AUC for Troponin I release, for a statistical power of 85% and a probability of type I error of 0.05.

Main analysis: between-group comparisons of AUCs for serum troponin I and CK release will be performed using O'Brien's method for multiple endpoints testing.

Secondary analysis: comparisons of the CMR criteria described above will be performed using mixed model of ANCOVA.

All analyses will be performed on the Full Analysis Set and Per protocol populations.

Safety analysis: A comparison of the incidence of cumulative adverse clinical events between the groups will be performed by Fisher's exact tests.

Subjects will undergo primary PCI and receive concomitant medications according to current standard of care.

After coronary angiography is performed but just before balloon inflation is performed, patients who meet the enrollment criteria will be randomly assigned to either the control group or the TRO40303 group. Randomization is ensured by taking the treatment units in ascending and consecutive order in each strata (anterior/posterior as determined on ECG). Just before balloon inflation, ideally less than 5 minutes, and with a maximum of 15 minutes before balloon inflation and stenting, the patients in the TRO40303 group will receive an intravenous slow-bolus (35 mL/min) injection of 6 mg/kg of TRO40303 injected in peripheral IV. The patients in the control group will receive an equivalent volume of the placebo. Patients will be hospitalized for as long as there is a medical indication. CMR and echocardiography will accordingly be conducted as in/out patient between day 3 (ideally) and 5. A follow-up visit will be conducted one month after PCI.

ReferenceCitation: Nordlund D, Heiberg E, Carlsson M, Fründ ET, Hoffmann P, Koul S, Atar D, Aletras AH, Erlinge D, Engblom H, Arheden H. Extent of Myocardium at Risk for Left Anterior Descending Artery, Right Coronary Artery, and Left Circumflex Artery Occlusion Depicted by Contrast-Enhanced Steady State Free Precession and T2-Weighted Short Tau Inversion Recovery Magnetic Resonance Imaging. Circ Cardiovasc Imaging. 2016 Jul;9(7). pii: e004376. doi: 10.1161/CIRCIMAGING.115.004376.

name: From the Cardiac MR Group, Department of Clinical Physiology (D.N., E.H., M.C., A.H.A., H.E., H.A.) and Department of Cardiology (S.K., D.E.), Skåne University Hospital, Lund University, Sweden; Department of Radiology, Odense University Hospital, Denmark (E.-T.F.); Section for Interventional Cardiology, Division of Cardiovascular and Pulmonary Diseases, Department of Cardiology, Oslo University Hospital, Ullevaal, Norway (P.H.); Department of Cardiology B, Oslo University Hospital Ullevål, and...

family: Nordlund

full_name: David Nordlund

given: David

family: Heiberg

full_name: Einar Heiberg

given: Einar

family: Carlsson

full_name: Marcus Carlsson

given: Marcus

family: Fründ

full_name: Ernst-Torben Fründ

given: Ernst-Torben

family: Hoffmann

full_name: Pavel Hoffmann

given: Pavel

family: Koul

full_name: Sasha Koul

given: Sasha

family: Atar

full_name: Dan Atar

given: Dan

family: Aletras

full_name: Anthony H. Aletras

given: Anthony H.

family: Erlinge

full_name: David Erlinge

family: Engblom

full_name: Henrik Engblom

given: Henrik

family: Arheden

full_name: Håkan Arheden

given: Håkan

journal_name: Circulation: Cardiovascular Imaging

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Engblom H, Tufvesson J, Jablonowski R, Carlsson M, Aletras AH, Hoffmann P, Jacquier A, Kober F, Metzler B, Erlinge D, Atar D, Arheden H, Heiberg E. A new automatic algorithm for quantification of myocardial infarction imaged by late gadolinium enhancement cardiovascular magnetic resonance: experimental validation and comparison to expert delineations in multi-center, multi-vendor patient data. J Cardiovasc Magn Reson. 2016 May 4;18(1):27. doi: 10.1186/s12968-016-0242-5.

family: Tufvesson

full_name: Jane Tufvesson

given: Jane

family: Jablonowski

full_name: Robert Jablonowski

given: Robert

family: Jacquier

full_name: Alexis Jacquier

given: Alexis

family: Kober

full_name: Frank Kober

given: Frank

family: Metzler

full_name: Bernhard Metzler

given: Bernhard

journal_name: Journal of Cardiovascular Magnetic Resonance

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Tufvesson J, Carlsson M, Aletras AH, Engblom H, Deux JF, Koul S, Sörensson P, Pernow J, Atar D, Erlinge D, Arheden H, Heiberg E. Automatic segmentation of myocardium at risk from contrast enhanced SSFP CMR: validation against expert readers and SPECT. BMC Med Imaging. 2016 Mar 5;16:19. doi: 10.1186/s12880-016-0124-1.

location_facility:
Hôpital Henri Mondor
Hôpital La Timone
Haukeland University Hospital
Larsen
Odense University Hospital
Oslo University Hospital
Aarhus University Hospital
Hôpital Nord Marseille
Karolinska University Hospital
Skane University Hospital
Hôpital Européen Georges Pompidou


title: Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) of the Motor or Prefrontal Cortex in Peripheral Neuropathic Pain: a Multicenter Randomized Placebo Controlled Trial

acronym: TRANSNEP

summary:
This study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain intensity, quality of life, sleep, neuropathic symptoms, return to work, in patients with peripheral neuropathic pain.

The medical device of study: transcranial magnetic stimulator (TMS).

ReferenceCitation: Attal N, Poindessous-Jazat F, De Chauvigny E, Quesada C, Mhalla A, Ayache SS, Fermanian C, Nizard J, Peyron R, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain. 2021 Jul 1. pii: awab208. doi: 10.1093/brain/awab208. [Epub ahead of print]

name: INSERM U 987, CETD, Hôpital Ambroise Paré, APHP, 92100 Boulogne-Billancourt, France

name: UVSQ, Paris Saclay University, 78000 Versailles, France

family: Attal

full_name: Nadine Attal

given: Nadine

family: Poindessous-Jazat

full_name: Frédérique Poindessous-Jazat

given: Frédérique

name: Pain, Palliative and Supportive Care Department, UIC22 and EA3826, University Hospital Nantes, 44000 Nantes, France

family: De Chauvigny

full_name: Edwige De Chauvigny

given: Edwige

name: INSERM U1028 & CETD, CHU Bellevue, 42100 Saint Etienne, France

family: Quesada

full_name: Charles Quesada

given: Charles

name: Clinical Neurophysiology Unit, Hôpital Henri Mondor, APHP, 94000 Creteil, France

family: Mhalla

full_name: Alaa Mhalla

given: Alaa

name: EA 4391, Paris Est Creteil University, 94000 Creteil, France

family: Ayache

full_name: Samar S Ayache

given: Samar S

family: Fermanian

full_name: Christophe Fermanian

given: Christophe

family: Nizard

full_name: Julien Nizard

given: Julien

family: Peyron

full_name: Roland Peyron

given: Roland

family: Lefaucheur

full_name: Jean-Pascal Lefaucheur

given: Jean-Pascal

family: Bouhassira

full_name: Didier Bouhassira

given: Didier

journal_name: Brain

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_facility: Pain evaluation and treatement center, CHU Ambroise Paré


title: QUILAM : Development and Validation of a Self-administered QUestionnaire to Identify Levers of Adhesion Behavior to Patient's Medication in Order to Adapt the Educational Monitoring

acronym: QUILAM

summary:
Medication non-adherence is an economic problem and a major public health challenge. Factors influencing medication adherence can be modelled according to five dimensions: disease, medication, patient and its close relatives, demographic and socioeconomic factors and health care system. A tool is needed to qualify medication adherence in order to adapt tailored support for individual patients to promote and optimize adherence to therapy.

The objective of this work is to present the preliminary results of QUILAM project which is divided into 3 phases: 1. Development of a tool to assess barriers to medication adherence in chronic patient (COPD, Heart failure, Type 2 diabetes) ; 2. Validation of the instrument (especially against clinical criteria) ; 3. Evaluation of the sensitivity of the tool during educational interventions.

lead_sponsor: University Hospital, Grenoble


title: Multicentric Prospective Study to Screen Inborn Errors of Metabolism in Non-immune Hydrops Fetalis by Massively Parallel Sequencing

acronym: ANAMETAB-PRO

summary:
A fetal hydrops, also called a fetal anasarca, is the buildup of fluid in the serosa and / or fetal subcutaneous tissue. The diagnosis is made by ultrasound, possibly from the first trimester of pregnancy.

The etiologies of hydrops can be immune or non-immune. The historically classic immune causes are linked to fetal-maternal alloimmunizations in erythrocyte blood groups. The implementation of systematic prevention of these anti rhesus immunizations since the 1970s has significantly reduced the incidence of immune hydrops Non-immune hydrops (NIH) now represent 90% of fetal hydrops. Known causes of NIH can be classified in several ways depending on the mechanism or organ involved.

The prognosis for NIH is closely linked to the cause. Fetal anemia due to maternal-fetal infections can heal spontaneously or give rise to in utero transfusions. Cardiac rhythm abnormalities are accessible to medical treatment. Chylothorax compressions may benefit from in utero drainage, but chromosomal or metabolic causes cannot benefit from antenatal care. The term of pregnancy in which the hydrops is discovered also has an impact on survival, which however remains poor.

In France, certain pathologies can be considered as particularly serious without the possibility of treatment and give rise to a request for medical termination of pregnancy. This possibility is subject to acceptance by two practitioners who are members of a multidisciplinary prenatal diagnostic center (CPDPN). This preliminary multidisciplinary reflection participates in the development of prenatal counseling with the greatest precision in diagnostic hypotheses. This prenatal advice is essential for a couple on the decision to make a pregnancy in progress but also for future pregnancies, given the 25% risk of recurrence due to the autosomal recessive mode of transmission.

Thus the current screening strategy for inherited metabolic diseases on amniotic fluid is fragmented. The resulting subdiagnosis explains the objective of the study of using the new high throughput sequencing techniques (NGS) in this indication. This approach should make it possible to reduce the number of cases classified as idiopathic, to allow the parents concerned to receive suitable genetic counseling with a view to new pregnancies, and to refine the knowledge of the prenatal epidemiology of these pathologies.

status: Recruiting

location_facility:
Hôpital Le Bocage
Hôpital Archet 2
Hopital Lyon Sud
CHU Limoges
CHU Pellegrin
APHP Trousseau
CHU Marseille Timone
Hopital Croix Rousse
CHU Saint Etienne
CHU Montpellier
Hôpital d'Estaing
CHU Besançon
CHU Grenoble
CHU de Nancy Brabois,
Hôpital Paule de Viguier;
Hopital Nord
Hôpital Femme Mère Enfant

intervention_type: Diagnostic Test


title: Comparison of Three Assisting Devices to Power Manual Wheelchairs in Patients With Spinal Cord Injury : Assessment of Biomechanical, Physiological and Functional Properties.

acronym: PAPAW

summary: The purpose of this study is to compare three assisting devices to propel personal wheelchairs (Servomatic A©, Servomatic B© and E.Motion©) to the standard personal manual wheelchair in patients with spinal cord injury.

ReferenceCitation: Guillon B, Van-Hecke G, Iddir J, Pellegrini N, Beghoul N, Vaugier I, Figère M, Pradon D, Lofaso F. Evaluation of 3 pushrim-activated power-assisted wheelchairs in patients with spinal cord injury. Arch Phys Med Rehabil. 2015 May;96(5):894-904. doi: 10.1016/j.apmr.2015.01.009. Epub 2015 Jan 22.

family: Guillon

full_name: Bruno Guillon

given: Bruno

family: Van-Hecke

full_name: Gary Van-Hecke

given: Gary

family: Iddir

full_name: Jérome Iddir

given: Jérome

family: Pellegrini

full_name: Nadine Pellegrini

family: Beghoul

full_name: Nabil Beghoul

given: Nabil

family: Vaugier

full_name: Isabelle Vaugier

given: Isabelle

family: Figère

full_name: Marjorie Figère

given: Marjorie

family: Pradon

full_name: Didier Pradon

family: Lofaso

full_name: Frédéric Lofaso

given: Frédéric

journal_name: Archives of Physical Medicine and Rehabilitation

title: Evaluation of 3 Pushrim-Activated Power-Assisted Wheelchairs in Patients With Spinal Cord Injury

location_facility: Physical Medicine and Rehabilitation, Raymond Poincaré Hospital


title: Eight-year Outcome and Health Care After Severe Traumatic Brain Injury in the Parisian Area

summary:
The objective of the protocol is to pursue the long-term follow-up of a large cohort of severe traumatic brain injury patients. This outcome is to be described in terms of activity, participation, quality of life, socio-professional outcome, economical consequences and impact on caregivers, and in relation to health care provision.

Secondary objectives are to measure the impact on outcome of several predictive factors; to evaluate evolution of patients since the last (four-year) evaluation.


ReferenceCitation: Bernard L, Arvieux C, Brunschweiler B, Touchais S, Ansart S, Bru JP, Oziol E, Boeri C, Gras G, Druon J, Rosset P, Senneville E, Bentayeb H, Bouhour D, Le Moal G, Michon J, Aumaître H, Forestier E, Laffosse JM, Begué T, Chirouze C, Dauchy FA, Devaud E, Martha B, Burgot D, Boutoille D, Stindel E, Dinh A, Bemer P, Giraudeau B, Issartel B, Caille A. Antibiotic Therapy for 6 or 12 Weeks for Prosthetic Joint Infection. N Engl J Med. 2021 May 27;384(21):1991-2001. doi: 10.1056/NEJMoa2020198.

name: From the Division of Infectious Diseases (L.B., G.G.), Orthopedic Unit (J.D., P.R.), and INSERM Centre d’Investigation Clinique 1415 (B.G., A.C.), University Hospital, and University of Tours and University of Nantes, INSERM, SPHERE (Methods in Patient-Centered Outcomes and Health Research) Unité 1246 (B.G., A.C.), Tours, the Division of Infectious Diseases, University Hospital, Rennes (C.A.), the Orthopedic Unit, University Hospital, Amiens (B.B.), the Orthopedic Unit (S.T.), the Division of Infectious...

family: Bernard

full_name: Louis Bernard

given: Louis

family: Arvieux

full_name: Cédric Arvieux

given: Cédric

family: Brunschweiler

full_name: Benoit Brunschweiler

given: Benoit

family: Touchais

full_name: Sophie Touchais

given: Sophie

family: Ansart

full_name: Séverine Ansart

given: Séverine

family: Bru

full_name: Jean-Pierre Bru

given: Jean-Pierre

family: Oziol

full_name: Eric Oziol

given: Eric

family: Boeri

full_name: Cyril Boeri

given: Cyril

family: Gras

full_name: Guillaume Gras

given: Guillaume

family: Druon

full_name: Jérôme Druon

given: Jérôme

family: Rosset

full_name: Philippe Rosset

given: Philippe

family: Senneville

full_name: Eric Senneville

family: Bentayeb

full_name: Houcine Bentayeb

given: Houcine

family: Bouhour

full_name: Damien Bouhour

given: Damien

family: Le Moal

full_name: Gwenaël Le Moal

given: Gwenaël

family: Michon

full_name: Jocelyn Michon

given: Jocelyn

family: Aumaître

full_name: Hugues Aumaître

given: Hugues

family: Forestier

full_name: Emmanuel Forestier

given: Emmanuel

family: Laffosse

full_name: Jean-Michel Laffosse

given: Jean-Michel

family: Begué

full_name: Thierry Begué

given: Thierry

family: Chirouze

full_name: Catherine Chirouze

given: Catherine

family: Dauchy

full_name: Fréderic-Antoine Dauchy

given: Fréderic-Antoine

family: Devaud

full_name: Edouard Devaud

given: Edouard

family: Martha

full_name: Benoît Martha

given: Benoît

family: Burgot

full_name: Denis Burgot

given: Denis

location_facility: Service de médecine interne et de maladies infectieuses, CHU de BREST

location_facility: Service de Chirurgie Orthopédique et Traumatologique, APHP Hôpital Antoine Béclère

location_facility: Service de pneumologie - maladies infectieuses et tropicales, CH de ST QUENTIN

location_facility: Service de chirurgie orthopédique et traumatologique, CHU d'AMIENS

location_facility: Service de médecine interne, CH de BEZIERS

location_facility: Service de Maladies Infectieuses, CHU de LIMOGES

location_facility: Service des maladies infectieuses et tropicales, CH de CLERMONT-FERRAND

location_facility: Service de Maladies Infectieuses et de Médecine Tropicale, Hôpital Pellegrin, CHU de Bordeaux

location_facility: Service des maladies infectieuses et tropicales, CHU de BESANCON

location_facility: Centre de chirurgie orthopédique et de la main, CHRU de STRASBOURG

location_facility: Service des maladies infectieuses et tropicales - médecine interne, CH de CHAMBERY

location_facility: Service de Médecine Interne et de Maladies Infectieuses, CHRU de TOURS

location_facility: Service des maladies infectieuses et tropicales, CHU d'ANGERS

location_facility: Service des maladies infectieuses et tropicales Hôtel-Dieu, CHU de Nantes

location_facility: Service de Maladies Infectieuses, CHU de REIMS

location_facility: Service de chirurgie orthopédique, CH de VERSAILLES

location_facility: Service de chirurgie orthopédique et traumatologique, CH de BOURG EN BRESSE

location_facility: Centre de vaccinations internationales et de médecine des voyages du Tonkin

location_facility: Service des maldies infectieuses, CH d'ANNECY

location_facility: Service de Chirurgie Orthopédique et traumatologie, hôpital Trousseau

location_facility: Service des Maladies Infectieuses, CHU de RENNES

location_facility: Département de Médecine Interne et Maladies Infectieuses, hôpital privé d'Antony

location_facility: Service de Médecine Interne et Immunologie Clinique, APHP Hôpital Antoine Béclère

location_facility: Service des Maladies Infectieuses et tropicales, CHU de NANCY

location_facility: Service de Chirurgie orthopédique Hôpital Lariboisière

location_facility: Service des maladies infectieuses et tropicales, CHU de CAEN

location_facility: Service des Maladies Infectieuses et tropicales, CHU de MONTPELLIER

location_facility: Service de chirurgie orthopédique et traumatologique, Polyclinique de BLOIS

location_facility: Service des maladies infectieuses et tropicales CH Saint-Jean

location_facility: Service des maladies infectieuses CH Gustave Dron

location_facility: Service de médecine interne, rhumatologie, Centre Hospitalier Chalon sur Saône William Morey

location_facility: Unité de Traumatologie -Orthopédie septique, CHRU de LILLE

location_facility: Service de médecine interne, maladies infections et tropicales, CHU de POITIERS

location_facility: Service de Maladies Infectieuses, CH de BOURG EN BRESSE

title: Multicentric Study, of Non Inferiority, Randomized, Opened, to Evaluate the Two Durations Effectiveness of Antibiotherapy (6 Weeks Versus 12 Weeks) in the Treatment of Osteo-articular Prostheses Infections, With Prosthetic Change (in 1 Time or 2 Long Times) or Not (Articular Washing)

summary:
The study is a prospective, open randomized, non-inferiority trial with two parallel groups, comparing 6 weeks versus 12 weeks of antibiotic treatment following surgery procedure (debridement and retention, 1-stage or 2 stage exchange).

The duration of the treatment antibiotic of prosthetic joint infections is only based on experts' opinion ; this one varies from 6 weeks to several months according to the customs of the influencer.

The principal aim of this study is to explore the efficacy and safety of 6 weeks versus 12 weeks antibiotic therapy duration, both associated with surgical procedure (debridement and retention of implant, one-stage or two stages exchange), in PJI treatment.

The study concerns 410 men or women of more than 18 years include in 34 centres in France.

The duration of the study is of 4 years.


title: Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma in a Post-intensive Care Rehabilitation Unit

acronym: POHER II

summary:
Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure.

The primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (HO) in patients admitted to a post intensive care rehabilitation unit (PICRU) after a severe neurologic trauma.

The CT scan at 5 weeks of admission is considered as the gold standard. CT scan reader will be blinded to clinical data.

location_facility: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP


title: Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients

summary:
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device.

The hypothesis to be tested by this clinical investigation is that patients indicated for an ICD with cardiac resynchronization therapy respond as well to LV only pacing as to BiV pacing.

ReferenceCitation: Boriani G, Kranig W, Donal E, Calo L, Casella M, Delarche N, Lozano IF, Ansalone G, Biffi M, Boulogne E, Leclercq C; B-LEFT HF study group. A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial. Am Heart J. 2010 Jun;159(6):1052-1058.e1. doi: 10.1016/j.ahj.2010.03.008.

family: Boriani

full_name: Giuseppe Boriani

given: Giuseppe

family: Kranig

full_name: Wolfgang Kranig

given: Wolfgang

family: Donal

full_name: Erwan Donal

given: Erwan

family: Calo

full_name: Leonardo Calo

given: Leonardo

family: Casella

full_name: Michela Casella

given: Michela

family: Delarche

full_name: Nicolas Delarche

given: Nicolas

family: Lozano

full_name: Ignacio Fernandez Lozano

given: Ignacio Fernandez

family: Ansalone

full_name: Gerardo Ansalone

given: Gerardo

family: Biffi

full_name: Mauro Biffi

given: Mauro

family: Boulogne

full_name: Eric Boulogne

given: Eric

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

journal_name: American Heart Journal

title: A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: The Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial

lead_sponsor: Abbott Medical Devices

location_facility: Department of Cardiology - CHU Pontchaillou


title: Clinical and Microbiological Impact of Respiratory Viral Infections in the Short and Medium Term in Infants (<24 Months) With Cystic Fibrosis.

acronym: PREVIMUC

summary:
Respiratory Viral Infections (RVI) are particularly frequent in young children. Old data mention the deleterious role of some viruses such as the Respiratory Syncytial Virus in young children with cystic fibrosis (CF). However, recent epidemiological data on RVI in CF children are rare and the impact of most frequent viruses such as human rhinoviruses is usually not correctly evaluated.

The aim of this study is to assess the frequency of lower and upper RVI during a 1 year follow-up in CF infants and to evaluate the impact of RVI at a clinical, microbiological and therapeutic level.

Our hypothesis is that frequent and/or clinically severe RVIs have the worst impact in the short term and without any particular link with a specific virus as previously described.

location_facility: Cystic Fibrosis Pediatric Reference Centrer, Hospices Civils de Lyon


title: Relevance of a Web-mediated Follow up in Patients Having a Lymphoma With a High Risk of Relapse in Complete or Partial Response

summary:
Lymphoma is the 6th cancer in terms of incidence in France where approximately 11,000 new cases are diagnosed each year. Most types of lymphomas occur at all ages with a predominance in elderly subjects.

With the continuous improvement of the diagnostic techniques and the treatments, the prognosis of lymphomas is constantly improving. However, 20-40% of patients relapse most often within 2 or 3 years after the end of treatment.

The current standard follow up includes a clinical examination and a biological check-up every 3 months for 2 years, then every 6 months up to 5 years and an imaging every 6 months. However, the interest of this systematic surveillance by imaging is controversial.

The use of new information and communication technologies, can improve the clinical follow-up of patients. To date, access to the Internet and portable technologies is sufficiently broad and democratized to envisage the use of this type of remote surveillance in the field of health. In particular to facilitate the dissemination of information between the patient and the physician. It is thus possible to imagine using this flow of information to generate alerts.

Strengthening the clinical follow-up in this indication, in which routine imaging has not demonstrated their interest, in particular by the implementation of remote monitoring completed by the patient, may present an advantage in terms of effectiveness and precocity of care. In this pathology, up to 40% of patients relapse early (within 2 to 3 years), in the vast majority of cases symptomatically (less than 2% asymptomatic relapse discovered by imaging). Finally the CT scan every 6-month , which generates radiation costs and exposures for a relatively low benefit, is performed in symptomatic patients since several weeks.

The aim of this study is to evaluate the interest of a web-mediated follow up using a score based on the dynamics and the association of clinical and biological signs to alert the physician of a possible recurrence of the patients treated for a lymphoma in complete or partial response.

lead_sponsor: Weprom

location_facility: Centre Hospitalier Universitaire Jean Minjoz

location_facility: Institut d'Hématologie de Basse Normandie


title: Influence of Pravastatin on Carotid Artery Structure and Function in HIV-infected Patients Under Antiretroviral Therapy

summary:
The advent of new antiretroviral agents, in particular Highly Active Antiretroviral Therapy (HAART), spectacularly reduced HIV-associated morbidity and mortality. However, new complications have appeared in HIV-infected patients treated by with HAART such as dyslipidemia, insulin resistance, diabetes mellitus, and related cardiovascular complications including acute coronary syndromes, peripheral vascular disease, and stroke have been reported.

A linear association has been proved between increased intima-media thickness of the common carotid artery (CCA-IMT), aortic stiffness (pulse wave velocity [aPWV]) and incidence of cardiovascular events suggesting that IMT and aPWV could be considered as an early marker of atherosclerosis. The progression of IMT has been shown to be predictive of cardiovascular events. Case control and longitudinal studies but not all have suggested an increase CCA-IMT in HIV-infected patients under HAART compared with non-HIV infected patients with different progression.

The aim of this study was to examine the effects of pravastatin on CCA-IMT and aortic stiffness in dyslipidemic HIV-infected patients receiving HAART by using a high-resolution echotracking system.

Patients in the pravastatin group were consecutively recruited in four department of infectious diseases if they fulfilled the following criteria : (1) HIV-infected treated with HAART for > 12 months 2) with dyslipidemia, defined as fasting serum LDL cholesterol > 160 mg/dL before initiation of pravastatin, (3) treated with pravastatin > 12 months and one more coronary risk factor. The patients in the control group were selected consecutively in the same departments among 1) HIV-infected patients treated with HAART > 12 months 2) fasting serum LDL cholesterol > 160 mg/dL 3) without lipid-lowering drugs and one more coronary risk factor. Cases and control patients were matched for age, gender and tobacco consumption.

Using data from Mercie et al., inclusion of 42 patients in pravastatin and control groups was the minimum sample size needed for detection of a 6.5% difference in CCA-IMT, in a two-sided test (a = 0.05, b = 0.20).

The protocol of the study, sponsored by the French Society of Cardiology was approved by the Committee for the Protection of Human Subjects in Biomedical Research of Pitié-Salpétrière University hospital in Paris. Written informed consent to participate in the study was obtained from each patient.

lead_sponsor: Saint Antoine University Hospital

location_facility: Department of Pharmacology and INSERM U652, Hôpital Européen Georges Pompidou


title: Evaluation of a Marine OXYgen Carrier (HEMO2Life®) for hypOthermic Kidney Graft Preservation Before Transplantation (OXYOP): 4 Years Follow-up

summary: 4 years follow-up of the oxyop study.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication.

lead_sponsor: University Hospital, Brest


title: Evaluation of 2 Interferon γ Assays (QuantiFERON TB Gold In-Tube® and T-SPOT.TB®) in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT

summary: The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube® and T-SPOT.TB® for the diagnosis of latent tuberculosis in HIV infected antiretroviral naive patients: 80 originated from low TB prevalence countries, without any active TB; 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB.

location_facility: Service des Maladies Infectieuses B Hopital Bichat


title: Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria

acronym: IGUS

summary: Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
University Hospital
Saint louis Hospital
Regional University Hospital
University hospital


title: Effect of Magnesium on Stress in Fibromyalgia: Randomized Double-blind Placebo Controlled Trial

acronym: SeMAFor

summary:
Fibromyalgia affects an average of 2% of the French population. Data from the literature report that low levels of magnesium could be associated with fibromyalgia. However, no study to date has investigated the effect of oral magnesium administration on stress in fibromyalgia.

This trial therefore aims to evaluate whether magnesium could improve stress and the various disorders that contribute to the complexity of fibromyalgia, including pain, cognition, sleep disorders and quality of life.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.

acronym: WII

summary: The purpose of this study is to evaluate changes in strategies of hemiparetic upper limb movement in chronic stroke patients following rehabilitation using the "Nintendo Wii". The investigators hypothesize that patients will increase their use of compensatory strategies following this rehabilitation.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Behavioral


title: Phase Ib Trial of Multiple-ascending Doses of EMD 1201081 in Combination With 5-FU/Cisplatin and Cetuximab in First-line Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_facility: Clinical Research Unit and Pharmacology Lab EA 3035 Institut Claudius Regaud


title: Phase II Randomised Clinical Trial Evaluating an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI) Versus an EGFR-TKI Combined With an Anti-oestrogen Treatment (Fulvestrant) in Women With Advanced Stage Non-squamous Lung Cancer

acronym: LADIE

summary:
Lung Cancer is to become the first cause of death related to cancer in France as it's already the case in United States. At Present, Lung Cancer in women and in men is treated similarly. Nevertheless, numerous studies shows that lung cancer in women has specificities : at the time of the diagnosis female patients are younger, there are less clinical signs, clinical stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker . Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response rate to chemotherapy is better. Prognosis is better

Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above.

One hypothesis is that there are different genetic anomalies in women. Some studies show an increase of EGFR mutation and HER2 expression and a decrease of expression of repair enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to tabagism and to chemotherapy.
Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual cycle, hormone replacement therapy. Estrogens would have a deleterious effect on cancer incidence and on survival of lung cancer in women. Cellular and animal models show that ER pathway is activated in lung cancer and participates in oncogenesis.
Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer cell lines and mouse models.

EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib) and in women with EGFR mutations (with gefitinib). In this study, the use of these two treatment will be in accordance with their market authorisations.

The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates its breakdown. It has a market authorisation in breast cancer. Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways .

ReferenceCitation: Mazieres J, Barlesi F, Rouquette I, Molinier O, Besse B, Monnet I, Audigier-Valette C, Toffart AC, Renault PA, Fraboulet S, Hiret S, Mennecier B, Debieuvre D, Westeel V, Masson P, Madroszyk-Flandin A, Pichon E, Cortot AB, Amour E, Morin F, Zalcman G, Moro-Sibilot D, Souquet PJ. Randomized Phase II Trial Evaluating Treatment with EGFR-TKI Associated with Antiestrogen in Women with Nonsquamous Advanced-Stage NSCLC: IFCT-1003 LADIE Trial. Clin Cancer Res. 2020 Jul 1;26(13):3172-3181. doi: 10.1158/1078-0432.CCR-19-3056. Epub 2020 Mar 6.

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Rouquette

full_name: Isabelle Rouquette

given: Isabelle

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Besse

full_name: Benjamin Besse

given: Benjamin

family: Monnet

full_name: Isabelle Monnet

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: Toffart

full_name: Anne-Claire Toffart

given: Anne-Claire

family: Renault

full_name: Patrick Aldo Renault

given: Patrick Aldo

family: Fraboulet

full_name: Séverine Fraboulet

given: Séverine

family: Hiret

full_name: Sandrine Hiret

given: Sandrine

family: Mennecier

full_name: Bertrand Mennecier

given: Bertrand

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Masson

full_name: Philippe Masson

given: Philippe

family: Madroszyk-Flandin

full_name: Anne Madroszyk-Flandin

given: Anne

family: Pichon

full_name: Eric Pichon

family: Cortot

full_name: Alexis B. Cortot

given: Alexis B.

family: Amour

full_name: Elodie Amour

given: Elodie

family: Morin

full_name: Franck Morin

given: Franck

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

publisher: American Association for Cancer Research (AACR)

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques


type: Registry Identifier

title: AROPE : Early Ovarian Reserve Decreased : Impact of Exposure to Persistent Endocrine Disruptors and Organic Solvents

acronym: AROPE

summary:
Early ovarian reserve decreased is one of the main causes of infertility for women after 35 years. The relationship between this decreased and exposure to chemicals, including persistent endocrine disruptors or organic solvents, has been little studied. However, several in vivo or in vitro experimental studies suggested that these chemicals may impaired ovarian function.

The main objective is to study the relationship between early ovarian reserve decreased and exposure to persistent organic pollutants.

The secondary objectives are to study the relationship between early ovarian reserve decreased and exposure to organic solvents and heavy metals.

Multicenter case-control study. This project will permit to increase the knowledge concerning the etiology of early decreased ovarian reserve. Considering that exposure of interest are frequent, the results may be important in a public health perspective. If associations are observed in this study, the results may encouraged prevention strategy.

lead_sponsor: Rennes University Hospital

location_facility:
Cabinet de Gynécologie Malakoff
Brest university hospital
Clinique Mutualiste de La Sagesse
Rennes university hospital
Nantes university hospital


title: GFAP Auto-immunity : a French Cohort Study

acronym: GFAP

summary:
Glial fibrillary acidic protein (GFAP)-Immunoglobulin G (IgG) have recently been described as a biomarker of a novel inflammatory central nervous system (CNS) disorder, termed autoimmune GFAP astrocytopathy. Thus far, four major clinical series have been published (two from Mayo Clinic USA, one from Italy and one from China). GFAP-IgG detected in serum or in cerebrospinal fluid, by tissue-based assay and confirmed by cell-based assay, are associated with encephalitis or meningoencephalitis of acute or subacute onset, less frequently with myelitis or optic disk edema. The characteristic MRI feature is brain linear perivascular radial gadolinium enhancement in the white matter perpendicular to the ventricle, consistent with the immunohistochemical staining pattern of GFAP in rodent brain sections. Approximately 20% of reported cases are associated with a neoplasm (ovarian teratoma mostly). Coexisting neural autoantibodies are described in some patients, N-methyl-D-aspartate (NMDA)-receptor (R)-IgG mostly, followed by aquaporin 4 (AQP4)-IgG. The disease is usually corticosteroid responsive although relapse can occur. In contrast, Chinese patients display poorer outcomes. Pathophysiology is not well understood but the intracellular antigen location makes GFAP-IgG unlikely pathogenic whereas animal models and neuropathologic data suggest a T-cell immune-mediated disorder.

The aim of the investigators is to report the first French cohort of patients GFAP-IgG positive. Investigators retrospectively assessed clinical, immunological and radiological features, treatment response and outcomes.


title: Ketamine-propofol Versus Ketamine Alone for Procedural Sedation in Adults : a Blinded, Randomized Controlled Trial

summary:
Using Ketamine for procedural sedation in adults is often uncomfortable for emergency physicians because of the significant proportion of patients experimenting recovery agitation. The investigators believe that combining propofol to ketamine, the proportion of recovery agitation will be significantly lowered.

The objectives of this double-blinded, randomized controlled trial are to compare the proportion of recovery agitation in adults receiving procedural sedation with ketamine-propofol versus ketamine alone, and to compare the proportion of other classical procedural sedation side-effects and parameters such as respiratory depression, hypotension, sedation duration, time of recovery, procedural failures, and levels of satisfaction.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature

acronym: Phoenix

summary:
The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. However, treatments were stopped in January 2012 at the request of the French drug agency. Therefore, a protocol amendment divided the study in two study periods.

Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement

lead_sponsor: Eli Lilly and Company

location_country: France Netherlands

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


title: The Primordial Dwarfisms: Diagnosis, Identification of the Molecular Basis of Seckel Syndrome and Microcephalic Osteodysplastic Primordial Dwarfism Type II (MOPDII).

acronym: NANPIM

summary: The purpose of this study si to define morphological and epidemiological parameters and identify new symptoms in French patients with Seckel syndrome (SCKL) or microcephalic osteodysplastic primordial dwarfism type II (MOPDII).

location_facility: Medical Genetics Department and INSERM U781, Necker-Enfants Malades Hospital


summary: The purpose of this study is to evaluate the antipsoriatic effect of 5 different combinations of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in compared to Daivobet® gel in order to explore/find other safe and effective combination of the two components.

lead_sponsor: LEO Pharma

location_facility: Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD)


type: EudraCT Number

title: An Open, Prospective, Single Arm Study Investigating Efficacy and Safety of Human Hepatitis B Immunoglobulin Zutectra in Liver Transplanted Patients - the ZEUS Study

acronym: ZEUS

summary:
Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral antiviral medication. In the first 6 months after liver transplantation, patients receive treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody concentrations above 100 IU/L, the level considered safe for preventing hepatitis B reinfection.

Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the 'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure'. The purpose of this study is to show that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can prevent hepatitis B reinfection.

Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of patients and is more convenient for patients compared to intravenous treatment that must take place in the hospital setting.

Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy and Spain. Patients who are eligible for the study will receive treatment with Zutectra for 24 weeks.

During the study, the safety and effectiveness of Zutectra will be assessed by checking for symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs antibodies and hepatitis B surface antigen (HBsAg).

primary_purpose: Prevention

lead_sponsor: Biotest

location_country:
Italy
United Kingdom
France
Spain

location_facility: Fondazione Policlinico Tor-Vergata U.O.C.

location_facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Liver and Multivisceral Transplant Center, University of Modena and Reggio Emilia

location_facility: Azienda Ospedialera Universitaria di Padova

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda-Chirurgia

location_facility: Azienda ospedaliera "G. Brutzu" di Cagliari

location_facility: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari


title: Identification of Occupational Exposures in Acute Hematologic Malignancy

acronym: RHELYPRO

summary: Lymphoid hemopathies are a group of malignant haematological disorders characterized by clonal proliferation of cells of the lymphoid line. Non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) are the most frequently encountered features of lymphoid hemopathies. Duriong the last 35 years the prevalence of these pathologies has increased in France but also in most industrialized countries. This increased can't be solely explained by demographic changes and improvements in diagnostic techniques. As a result, the involvement of environmental and professional factors is strongly suspected. Studies have shown that these diseases are associated with some professions or type of activity, including agricultural occupations, and other sectors such as agriculture, printing, woodworking. Some organic solvents and pesticides have been suspected of being risk factors of hematologic malignancies. Based on cohort studies and case-control studies, some of them have been identified by the International Cancer Research Center as associated with the occurrence of NHL with a sufficient or limited level of evidence. One of the difficulties encountered in the analysis of the literature has been the permanent evolution of the international classification of lymphoid hemopathies over the past 30 years. The old epidemiological studies are therefore difficult to interpret. Lymphoid hemopathies cover a range of different conditions, thus it is likely that carcinogens involved vary according to the type of hemopathy. Finally, environmental and occupational exposures to various chemicals and biological agents have evolved over time. The aim of this study is firstly to develop and validate a questionnaire to identify and quantify exposures to nuisances (substances and agents) suspected of being associated with the occurrence of NHL, MM and LLC. In a second time, this questionnaire will be used as a support for the realization of a subsequent case-control study to improve epidemiological knowledge on these diseases.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHRU Lille
Fernand Widal hospital
CHU Toulouse
Service de pathologie professionelle
CHU Bordeaux
CHU H. Mondor