title: Cell Therapy by Intravenous Injection of Mesenchymal Stem Cells After Stroke

acronym: ISIS

summary: The main objective of the study is to evaluate feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke (less than 6 weeks).

ReferenceCitation: Jaillard A, Hommel M, Moisan A, Zeffiro TA, Favre-Wiki IM, Barbieux-Guillot M, Vadot W, Marcel S, Lamalle L, Grand S, Detante O; (for the ISIS-HERMES Study Group). Autologous Mesenchymal Stem Cells Improve Motor Recovery in Subacute Ischemic Stroke: a Randomized Clinical Trial. Transl Stroke Res. 2020 Oct;11(5):910-923. doi: 10.1007/s12975-020-00787-z. Epub 2020 May 27.

family: Jaillard

full_name: Assia Jaillard

given: Assia

family: Hommel

full_name: Marc Hommel

given: Marc

family: Moisan

full_name: Anaick Moisan

given: Anaick

family: Zeffiro

full_name: Thomas A. Zeffiro

given: Thomas A.

family: Favre-Wiki

full_name: Isabelle M. Favre-Wiki

given: Isabelle M.

family: Barbieux-Guillot

full_name: Marianne Barbieux-Guillot

given: Marianne

family: Vadot

full_name: Wilfried Vadot

given: Wilfried

family: Marcel

full_name: Sebastien Marcel

given: Sebastien

family: Lamalle

full_name: Laurent Lamalle

given: Laurent

family: Grand

full_name: Sylvie Grand

given: Sylvie

family: Detante

full_name: Olivier Detante

given: Olivier

journal_name: Translational Stroke Research

ReferenceCitation: Hannanu FF, Goundous I, Detante O, Naegele B, Jaillard A. Spatiotemporal patterns of sensorimotor fMRI activity influence hand motor recovery in subacute stroke: A longitudinal task-related fMRI study. Cortex. 2020 Aug;129:80-98. doi: 10.1016/j.cortex.2020.03.024. Epub 2020 Apr 17.

family: Hannanu

full_name: Fabrice F. Hannanu

given: Fabrice F.

family: Goundous

full_name: Issa Goundous

given: Issa

family: Naegele

full_name: Bernadette Naegele

given: Bernadette

journal_name: Cortex

lead_sponsor: University Hospital, Grenoble

location_facility: Tissular and cell therapy unit, UniversityHospitalof Grenoble

location_facility: Neuroradiology/MRI, University Hospital of Grenoble

location_facility: Stroke Unit, University Hospital of Grenoble

intervention_type: Genetic


ReferenceType: derived

ReferenceCitation: Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.

name: Université Lille Nord de France; Lille France

name: Université Droit et Santé de Lille; Lille France

family: Staels

full_name: Bart Staels

given: Bart

sequence: first

family: Rubenstrunk

full_name: Anne Rubenstrunk

given: Anne

sequence: additional

family: Noel

full_name: Benoit Noel

given: Benoit

family: Rigou

full_name: Géraldine Rigou

given: Géraldine

family: Delataille

full_name: Philippe Delataille

given: Philippe

family: Millatt

full_name: Lesley J. Millatt

given: Lesley J.

family: Baron

full_name: Morgane Baron

given: Morgane

family: Lucas

full_name: Anthony Lucas

given: Anthony

family: Tailleux

full_name: Anne Tailleux

family: Hum

full_name: Dean W. Hum

given: Dean W.

name: Department of Hepatogastroenterology; Pitie-Salpetriere University Hospital, University Pierre et Marie Curie Paris VI; Paris France

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

name: Department of Endocrinology; l'Institut du Thorax, Nantes University Hospital; Nantes France

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

family: Hanf

full_name: Rémy Hanf

given: Rémy

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Hepatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Cariou B, Zaïr Y, Staels B, Bruckert E. Effects of the new dual PPAR α/δ agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism. Diabetes Care. 2011 Sep;34(9):2008-14. doi: 10.2337/dc11-0093. Epub 2011 Aug 4.

family: Zaïr

full_name: Yassine Zaïr

given: Yassine

family: Bruckert

full_name: Eric Bruckert

given: Eric

journal_name: Diabetes Care

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

title: Effects of the New Dual PPARα/δ Agonist GFT505 on Lipid and Glucose Homeostasis in Abdominally Obese Patients With Combined Dyslipidemia or Impaired Glucose Metabolism

location_facility:
Site n°10
Site n°13
Site n°15
Site n°14
Site n°11
Site n°30
Site n°12
Site n°37
Site n°1
Site n°16
Site n°18
Site n°39
Site n°19
Site n°17
Site n°35
Site n°32
Site n°31
Site n°2
Site n°34
Site n°36

title: A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80 mg) Orally Administered Once Daily for 35 Days in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity. A Double Blind, Parallel Group, Placebo-controlled and Randomized Study.

summary: The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 35 days.


title: Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis

location_facility:
Site n°78
Site n°42
Site n°62
Site n°60
Site n°53
Site n°17
Site n°52
Site n°35
Site n°80
Site n°91
Site n°12
Site n°51
Site n°20
Site n°64
Site n°19
Site n°61
Site n°21
Site n°31
Site n°45
Site n°36
Site n°41
Site n°79
Site n°63
Site n°10
Site n°23
Site n°14
Site n°65
Site n°82
Site n°16
Site n°39
Site n°75
Site n°38
Site n°18
Site n°13
Site n°30
Site n°11
Site n°77
Site n°1
Site n°37
Site n°74
Site n°26
Site n°50
Site n°55
Site n°33
Site n°32
Site n°34
Site n°40

title: A Pilot Study to Evaluate the Efficacy and Safety of GFT505 (80mg) Orally Administered Once Daily for 28 Days in Atherogenic Dyslipidaemic Patients With Abdominal Obesity. A Double Blind, Placebo-controlled and Randomized Study.

summary: The purpose of this study is to evaluate the efficacy of GFT505 80mg in reducing serum Triglycerides (TG) and increasing High Density Lipoprotein Cholesterol (HDL-C) levels compared with placebo in atherogenic dyslipidaemic patients with abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.


title: An Observational Study to Collect Data Characterizing Analgesia in Patients Suffering From Bone Metastasis Induced Pain

summary: Up to 180 patients with bone metastasis and requiring analgesic treatment will be followed during 4 to 10 weeks. All patients will continue to receive their cancer therapeutic treatments and be treated for pain relief exactly as they would normally be by the Investigator based on their needs. During their regular visits to the Investigator, patients will complete questionnaires and Clinical Pain Assessments.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

location_country: Belgium France

location_facility:
Institut Bordet
Hôpital La Timone
Hôpital A. Mignot
Universitair Ziekenhuis Antwerpen
Institut Curie
Centre Oscar Lambert
Cliniques Universitaires Saint Luc
ATC, CHU Sart Tilman

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients With Septic Shock. A Randomised, Double-blind, Two-Stage, Placebo Controlled Study

summary: This is a randomised, double-blind, two-stage, placebo controlled study. It is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of 3 doses of MOTREM versus placebo in adult patients with septic shock.

study_start_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Inotrem

location_country: Spain Belgium France Netherlands

location_facility: Radboudumc (there may be other sites in this country)

location_facility: Inserm Clinical Investigational Center, CHU Dupuytren (there may be other sites in this country)

location_facility: Cliniques Universitaires Saint-Luc (there may be other sites in this country)

location_facility: Hospital Clínico San Carlos, Medicina Intensiva (there may be other sites in this country)

intervention_type: Drug


title: Effects of Antioxidants Supplementation on Muscular Function of Patients Affected by Facioscapulohumeral Dystrophy (FSHD)

acronym: FSHD

summary: On the basis of published data and the investigators' results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, the investigators propose a study to test whether or not an antioxidant supplementation has a therapeutic interest for patients with FSHD. Their results have important implications for the successful implementation of rational antioxidant therapy in FSHD in which cell loss could be linked to oxidative stress.

primary_purpose: Supportive Care

ReferenceCitation: Passerieux E, Hayot M, Jaussent A, Carnac G, Gouzi F, Pillard F, Picot MC, Böcker K, Hugon G, Pincemail J, Defraigne JO, Verrips T, Mercier J, Laoudj-Chenivesse D. Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: a double-blind randomized controlled clinical trial. Free Radic Biol Med. 2015 Apr;81:158-69. doi: 10.1016/j.freeradbiomed.2014.09.014. Epub 2014 Sep 20.

family: Passerieux

full_name: Emilie Passerieux

given: Emilie

family: Hayot

full_name: Maurice Hayot

given: Maurice

family: Jaussent

full_name: Audrey Jaussent

given: Audrey

family: Carnac

full_name: Gilles Carnac

given: Gilles

family: Gouzi

full_name: Fares Gouzi

given: Fares

family: Pillard

full_name: Fabien Pillard

given: Fabien

family: Picot

full_name: Marie-Christine Picot

given: Marie-Christine

family: Böcker

full_name: Koen Böcker

given: Koen

family: Hugon

full_name: Gerald Hugon

given: Gerald

family: Pincemail

full_name: Joel Pincemail

given: Joel

family: Defraigne

full_name: Jean O. Defraigne

given: Jean O.

family: Verrips

full_name: Theo Verrips

given: Theo

family: Mercier

full_name: Jacques Mercier

given: Jacques

family: Laoudj-Chenivesse

full_name: Dalila Laoudj-Chenivesse

given: Dalila

journal_name: Free Radical Biology and Medicine

oa_host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: A double-blind randomized controlled clinical trial

lead_sponsor: University Hospital, Montpellier

location_facility: Montpellier University Hospital- Saint Eloi Hospital

intervention_type: Procedure

lead_sponsor_type: academique


title: VAgal Nerve Stimulation: safeGUARDing Heart Failure Patients

acronym: VANGUARD

summary: The purpose of the VANGUARD study is to demonstrate the safety of Vagal Nerve Stimulation for the treatment of congestive heart failure with reduced ejection fraction, and to report secondary measures of efficacy.

lead_sponsor: LivaNova

location_country: Serbia Norway Belgium France

location_facility:
Rikshospitalet
Dedinje Cardiovascular Institute
UCL St Luc
CHRU Hôpital Pontchaillou
CHU Rangueil
Hôpital Européen Georges Pompidou

intervention_type: Device


title: Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools

acronym: SOUTIEN-PC

summary: Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Limited access to the reference exam (polysomnography or PSG) delays the diagnosis and only allows screening of these disorders for a limited number of PC children. The hypothesis of our study is that connected technologies could optimize screening for sleep disorders in PC children by selecting children requiring PSG exploration and specific management.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Brest

location_facility:
CHU Angers
CHRU Brest
Fondation Ildys Ty-Yann
Kerpape
ESEAN Nantes
AP-HP Hôpital Trousseau

status_simplified: Unknown


title: Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening, in First Degree Relatives of Patients With Colorectal Neoplasia: a Prospective Randomized Study.

acronym: FAMCAP

summary: Efficacy of colonoscopy, colon capsule and fecal immunological test for colorectal cancer screening, in first degree relatives of patients with colorectal neoplasia: a prospective randomized study.

status: Recruiting

ipd_sharing: Undecided

lead_sponsor: Hôpital Edouard Herriot

location_facility: Hôpital Edouard Herriot - Hospices civils de Lyon

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris

status_simplified: Ongoing


title: Phenotypic Characterization and Array CGH Analysis in Patients With Syndromic Obesity of Unknown Etiology

acronym: REMOB

summary: Comparative genomic hybridization (CGH) array technology has been used in numerous studies on mental retardation, and few chromosomal abnormalities have been identified in patients. Because chromosomal abnormalities have still been associated with obesity, we can expect that syndromic obesity is also associated with small deletions/duplications. Characterization of deleted or duplicated loci in these obese patients would mean that these loci include genes implicated in obesity. This will permit to propose new gene(s) involved in obesity. (In french: Caractérisation phénotypique et recherche de REManiements chromosomiques chez des patients présentant une OBésité syndromique de cause non identifiée : REMOB)

ReferenceType: background

ReferenceCitation: Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3.

ReferenceCitation: Ichihara S, Yamada Y. Genetic factors for human obesity. Cell Mol Life Sci. 2008 Apr;65(7-8):1086-98. Review.

ReferenceCitation: Delrue MA, Michaud JL. Fat chance: genetic syndromes with obesity. Clin Genet. 2004 Aug;66(2):83-93. Review.

ReferenceCitation: Schoumans J, Ruivenkamp C, Holmberg E, Kyllerman M, Anderlid BM, Nordenskjöld M. Detection of chromosomal imbalances in children with idiopathic mental retardation by array based comparative genomic hybridisation (array-CGH). J Med Genet. 2005 Sep;42(9):699-705.

ReferenceCitation: Fan YS, Jayakar P, Zhu H, Barbouth D, Sacharow S, Morales A, Carver V, Benke P, Mundy P, Elsas LJ. Detection of pathogenic gene copy number variations in patients with mental retardation by genomewide oligonucleotide array comparative genomic hybridization. Hum Mutat. 2007 Nov;28(11):1124-32.

ReferenceCitation: Rosenberg C, Knijnenburg J, Bakker E, Vianna-Morgante AM, Sloos W, Otto PA, Kriek M, Hansson K, Krepischi-Santos AC, Fiegler H, Carter NP, Bijlsma EK, van Haeringen A, Szuhai K, Tanke HJ. Array-CGH detection of micro rearrangements in mentally retarded individuals: clinical significance of imbalances present both in affected children and normal parents. J Med Genet. 2006 Feb;43(2):180-6. Epub 2005 Jun 24.

ReferenceCitation: Stankiewicz P, Beaudet AL. Use of array CGH in the evaluation of dysmorphology, malformations, developmental delay, and idiopathic mental retardation. Curr Opin Genet Dev. 2007 Jun;17(3):182-92. Epub 2007 Apr 30. Review.

ReferenceCitation: Zung A, Rienstein S, Rosensaft J, Aviram-Goldring A, Zadik Z. Proximal 19q trisomy: a new syndrome of morbid obesity and mental retardation. Horm Res. 2007;67(3):105-10. Epub 2006 Oct 19.

lead_sponsor: University Hospital, Bordeaux

location_facility: Département de Génétique Hôpital Robert DEBRE Centre de Référence Maladies Rares "Anomalies du Développement & Syndromes Malformatifs"

location_facility: Département de Génétique Médicale Centre de référence anomalies du développement Centre de compétence maladies osseuses constitutionnelles Hôpital Arnaud de Villeneuve CHRU Montpellier

location_facility: Génétique Médicale HOPITAL DEBROUSSE HCL

location_facility: Centre de Génétique Hôpital d'Enfants CHU de Dijon

location_facility: Service de Génétique de médicale - Hopital des enfants - Pellegrin


title: Intervention Centered on Adolescents' Physical Activity and Sedentary Behavior (ICAPS)

acronym: ICAPS

summary: Physical activity is thought to be a key element in preventing the obesity epidemic and the associated cardiovascular and metabolic diseases. However population-based studies directed at promoting physical activity in youth have shown limited success in obesity prevention. The aim of this study is to assess whether an intervention integrating socioecological changes, which has the potential to induce sustained changes in physical activity, prevents overweight and cardiovascular risk in adolescents.

primary_purpose: Prevention

lead_sponsor: Louis Pasteur University, Strasbourg

intervention_type: Behavioral


title: Economic and Medical Evaluation of Self-monitoring of Anticoagulation in a Population of Patients Recently Fitted With a Mechanical Heart Valve Compared to Conventional Anticoagulation Follow-up

summary: To evaluate the benefit economic and medical of self-monitoring of coagulation compared with conventional follow-up of anticoagulation in a population recently fitted with mechanical heart valves.

location_facility: Pôle Cardio-Thoracique - Hôpital Cardiologique du Haut-Lévêque - CHU de Bordeaux - Avenue de Magellan


title: Sequential High-Dose Chemotherapy Combining Two Mobilization and Cyto-Reductive Treatments Followed by Three High-Dose Chemotherapy Regimens Supported by Autologous Stem Cell Transplantation

summary:
High-dose chemotherapy (HD-CT) is able to circumvent platinum-resistance of resistant/refractory germ-cell tumors (GCTs), but expectancy of cure remains low. New strategies are needed with new drugs and a sequential approach.

Patients with relapsed (but not absolutely refractory to Cisplatinum-based chemotherapy) poor-prognosis GCTs are scheduled to receive 2 cycles combining epirubicin and paclitaxel followed by 3 consecutive HD-CT supported by stem cell transplantation. One course will combine Taxol, 360 mg/m² + thiotepa, 720 mg/m², followed by two ICE regimens (Ifosfamide, 12 g/m², carboplatin, AUC 20, etoposide, 1500 mg/m²).

This phase II study is designed as a Gehan method. The main objective of the study is the complete response rate. With this aim in view, it is planned to enroll in its first step 14 patients to insure that if no complete response (CR) is noticed, study would be stopped for inefficacy (i.e., a CR rate lower than 20%). If one or more CR are noticed, protocol specified that up to 45 patients will be included in order to reduce the confidence interval (CI) of the CR rate. Secondary objectives are the overall response rate (RR), the overall survival (OS) and the progression-free survival (PFS) rates, toxicity and toxic death rate. The statistical analysis is done in terms of intent-to-treat.

design_allocation: Non-Randomized

ReferenceCitation: Lotz JP, Bui B, Gomez F, Théodore C, Caty A, Fizazi K, Gravis G, Delva R, Peny J, Viens P, Duclos B, De Revel T, Curé H, Gligorov J, Guillemaut S, Ségura C, Provent S, Droz JP, Culine S, Biron P; Groupe d'Etudes des Tumeurs Uro-Génitales (GETUG). Sequential high-dose chemotherapy protocol for relapsed poor prognosis germ cell tumors combining two mobilization and cytoreductive treatments followed by three high-dose chemotherapy regimens supported by autologous stem cell transplantation. Results of the phase II multicentric TAXIF trial. Ann Oncol. 2005 Mar;16(3):411-8. Epub 2005 Jan 19.

ReferenceCitation: Selle F, Wittnebel S, Biron P, Gravis G, Roubaud G, Bui BN, Delva R, Bay JO, Fléchon A, Geoffrois L, Caty A, Soares DG, de Revel T, Fizazi K, Gligorov J, Micléa JM, Dubot C, Provent S, Temby I, Gaulet M, Horn E, Brindel I, Lotz JP. A phase II trial of high-dose chemotherapy (HDCT) supported by hematopoietic stem-cell transplantation (HSCT) in germ-cell tumors (GCTs) patients failing cisplatin-based chemotherapy: the Multicentric TAXIF II study. Ann Oncol. 2014 Sep;25(9):1775-1782. doi: 10.1093/annonc/mdu198. Epub 2014 Jun 3.

family: Selle

full_name: F. Selle

given: F.

family: Wittnebel

full_name: S. Wittnebel

given: S.

family: Biron

full_name: P. Biron

given: P.

family: Gravis

full_name: G. Gravis

given: G.

family: Roubaud

full_name: G. Roubaud

family: Bui

full_name: B.N. Bui

family: Delva

full_name: R. Delva

given: R.

family: Bay

full_name: J.O. Bay

family: Fléchon

full_name: A. Fléchon

given: A.

family: Geoffrois

full_name: L. Geoffrois

given: L.

family: Caty

full_name: A. Caty

family: Soares

full_name: D.G. Soares

family: de Revel

full_name: T. de Revel

given: T.

family: Fizazi

full_name: K. Fizazi

given: K.

family: Gligorov

full_name: J. Gligorov

given: J.

family: Micléa

full_name: J.M. Micléa

family: Dubot

full_name: C. Dubot

given: C.

family: Provent

full_name: S. Provent

family: Temby

full_name: I. Temby

given: I.

family: Gaulet

full_name: M. Gaulet

given: M.

family: Horn

full_name: E. Horn

given: E.

family: Brindel

full_name: I. Brindel

family: Lotz

full_name: J.P. Lotz

journal_name: Annals of Oncology

location_facility: Hôpital TENON, Service d'Oncologie Médicale


title: Comparison of Standard Treatment by Continuous Positive Airway Pressure (CPAP) and CPAP Combined to a Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension: RAP Randomized Controlled Trial

acronym: RAP

summary: Investigators hypothesize that CPAP treatment for suppressing OSAS in combination with a physical activity program will optimize 24-hour blood pressure control in patients with OSA-related resistant hypertension.

lead_sponsor: AGIR à Dom

location_country: Canada France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)


title: Pilot Evaluation Study of the Feasibility of a Permanent Use in Free-life of inControl Artificial Pancreas System for the Treatment of Type 1 Diabetes

acronym: IDCLTraining

summary: A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. During this pilot study, the investigators will evaluate this new version of AP for a two-week period during which the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the clinical team with the new system and collect patient opinions on system acceptance from questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including 240 patients will be initiated. A total of 5 patients will be included in this training study over a 4-week period.

status: Terminated


type: EudraCT Number

title: Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations

acronym: AcSé

summary:
Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment.

To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the vemurafenib target gene, per cohort.

status: Active, not recruiting

ReferenceCitation: Mazieres J, Cropet C, Montané L, Barlesi F, Souquet PJ, Quantin X, Dubos-Arvis C, Otto J, Favier L, Avrillon V, Cadranel J, Moro-Sibilot D, Monnet I, Westeel V, Le Treut J, Brain E, Trédaniel J, Jaffro M, Collot S, Ferretti GR, Tiffon C, Mahier-Ait Oukhatar C, Blay JY. Vemurafenib in non-small-cell lung cancer patients with BRAF(V600) and BRAF(nonV600) mutations. Ann Oncol. 2020 Feb;31(2):289-294. doi: 10.1016/j.annonc.2019.10.022. Epub 2020 Jan 3.

family: Mazieres

full_name: J. Mazieres

family: Cropet

full_name: C. Cropet

family: Montané

full_name: L. Montané

family: Barlesi

full_name: F. Barlesi

family: Souquet

full_name: P.J. Souquet

family: Quantin

full_name: X. Quantin

given: X.

family: Dubos-Arvis

full_name: C. Dubos-Arvis

family: Otto

full_name: J. Otto

family: Favier

full_name: L. Favier

family: Avrillon

full_name: V. Avrillon

given: V.

family: Cadranel

full_name: J. Cadranel

family: Moro-Sibilot

full_name: D. Moro-Sibilot

given: D.

family: Monnet

full_name: I. Monnet

family: Westeel

full_name: V. Westeel

family: Le Treut

full_name: J. Le Treut

family: Brain

full_name: E. Brain

family: Trédaniel

full_name: J. Trédaniel

family: Jaffro

full_name: M. Jaffro

family: Collot

full_name: S. Collot

family: Ferretti

full_name: G.R. Ferretti

family: Tiffon

full_name: C. Tiffon

family: Mahier-Ait Oukhatar

full_name: C. Mahier-Ait Oukhatar

family: Blay

full_name: J.Y. Blay

title: Vemurafenib in non-small-cell lung cancer patients with BRAFV600 and BRAFnonV600 mutations


type: Other Identifier

title: Assessment by EPISPOT of Circulating Tumor Cells as an Early Predictive Marker of Response to Chemotherapy and Targeted Therapy in Patients With Metastatic Colorectal Cancer in First Line of Treatment

summary: Treatment of metastatic colorectal cancer needs chemotherapy in most of the cases. During these last years, many new chemotherapies and targeted therapies have been developed improving significantly the overall survival of patients. However, the choice of the therapeutic sequences becomes difficult due to the lack of validated predictive biomarkers of their efficiency. Indeed, only the mutation of the k-ras oncogene is a predictive factor of non-efficacy of the anti-EGFR antibodies. It is thus crucial to identify new biomarkers to propose the best personalized 1rst line therapeutic sequence. One idea would be to enumerate and characterize the circulating tumor cells (CTC) which, as it has been described in a recent study realized by Cohen et al. in patients with metastatic colorectal cancer, would give us an early evaluation of the therapeutic efficiency. In this context, the investigators have developed an innovative technology, the EPISPOT assay (patent of the University Medical Center of Montpellier), that allows the detection & characterization of viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the breast and prostate cancer. Thus, the investigators would like to perform a prospective study on a cohort of patients with metastatic colorectal cancer to confirm, with this technology, the predictive value of CTC count for the efficacy of the treatment.

primary_purpose: Other

ReferenceCitation: Cayrefourcq L, Thomas F, Mazard T, Assenat E, Assou S, Alix-Panabières C. Selective treatment pressure in colon cancer drives the molecular profile of resistant circulating tumor cell clones. Mol Cancer. 2021 Feb 8;20(1):30. doi: 10.1186/s12943-021-01326-6.

family: Cayrefourcq

full_name: Laure Cayrefourcq

given: Laure

family: Thomas

full_name: Frédéric Thomas

given: Frédéric

family: Mazard

full_name: Thibault Mazard

given: Thibault

family: Assenat

full_name: Eric Assenat

given: Eric

family: Assou

full_name: Said Assou

given: Said

family: Alix-Panabières

full_name: Catherine Alix-Panabières

given: Catherine

currency_apc_doaj: GBP

journal_name: Molecular Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: An Open-label, Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia

summary: The trial is a multi-centre, open-label, safety and tolerability extension trial to the IPH2101-101 (previously NN1975-1733) first human dose trial completed with a larger subject pool at an optimal dose level. The trial is conducted in elderly Acute Myeloid Leukemia (AML) patients over the age of 60 years, in complete remission, and who are not eligible for allogeneic stem-cell transplantation. The dose given to the individual patient will be the same as the patient received in the single dose trial IPH2101-101 and 1 mg/kg or 2 mg/kg for the 12 patients in an additional cohort.

lead_sponsor: Innate Pharma

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon


title: Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency

acronym: SCORPION

summary: Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and decreases pro-inflammatory process. There is an inverse relationship, at least in some epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence and / or activity of RA. The hypothesis of our study is that natural vitamin D supplementation in patients with RA and a vitamin D deficiency (vitamin D <30 ng / mL) improves functional disability.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Prediction of Arterial Lactate and Blood Gas Values Through the Analysis of Central Venous Blood. A Human, Prospective, Multicenter Validation Study.

acronym: PREDIGAZ

summary: Predicting arterial lactate and blood gas values with sufficient accuracy by simply analyzing central venous blood would be interesting in intensive care unit patients in whom the insertion of an arterial catheter or arterial punctures could be avoided. This prospective study aims at externally validating published mathematical models built to predict arterial values from central venous blood analysis.

ReferenceCitation: Boulain T, Garot D, Vignon P, Lascarrou JB, Benzekri-Lefevre D, Dequin PF; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Predicting arterial blood gas and lactate from central venous blood analysis in critically ill patients: a multicentre, prospective, diagnostic accuracy study. Br J Anaesth. 2016 Sep;117(3):341-9. doi: 10.1093/bja/aew261.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHU de STRASBOURG
CHU de NANTES
Chu Limoges
Hopital de La Timone
Chr D'Orleans
CHU de DIJON
CHRU de POITIERS
Chu de Garches
Ch de Versailles
CHU d'ANGERS


title: Effect of a 9-month Treatment of SPIRIVA® on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease. Validation of a New HRQoL Questionnaire Appropriate to Common Daily Practice. (TIPHON Study)

summary: The purpose of this study is to investigate the effect of a 9-month treatment of tiotropium (SPIRIVA®) 18 mcg once daily on Health Related Quality of Life and lung function in patients with a Chronic Obstructive Pulmonary Disease.

lead_sponsor: Boehringer Ingelheim

location_facility: Boehringer Ingelheim Investigational Site


title: Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.

summary:
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.

location_facility: Centre Hospitalier Universitaire Arnaud de Villeneuve


title: A Randomised Phase III Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With Carcinoma of an Unknown Primary (CUP)

summary: This is a european randomised, phase III, multi-centric study comparing a diagnostic and therapeutic strategy based on molecular analysis followed by suspected primary cancer tailored specific therapy, to an empiric strategy in patients with carcinoma of unknown primary. The purpose of this trial is to determine whether or not a strategy based on molecular analysis is effective in improving the progression free survival rates of patients with carcinoma of unknown primary (CUP).

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Denmark France Netherlands

location_facility:
Rigshospitalet
Institut Gustave Roussy
Viecuri Medical Centre Venlo


title: Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial

acronym: TOCOPROM

summary: The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.

ReferenceCitation: Mackeen AD, Seibel-Seamon J, Muhammad J, Baxter JK, Berghella V. Tocolytics for preterm premature rupture of membranes. Cochrane Database Syst Rev. 2014 Feb 27;(2):CD007062. doi: 10.1002/14651858.CD007062.pub3. Review.

ReferenceCitation: Lorthe E, Goffinet F, Marret S, Vayssiere C, Flamant C, Quere M, Benhammou V, Ancel PY, Kayem G. Tocolysis after preterm premature rupture of membranes and neonatal outcome: a propensity-score analysis. Am J Obstet Gynecol. 2017 Aug;217(2):212.e1-212.e12. doi: 10.1016/j.ajog.2017.04.015. Epub 2017 Apr 13.

ReferenceCitation: Couteau C, Haumonté JB, Bretelle F, Capelle M, D'Ercole C. [Management of preterm and prelabour rupture of membranes in France]. J Gynecol Obstet Biol Reprod (Paris). 2013 Feb;42(1):21-8. doi: 10.1016/j.jgyn.2012.10.008. Epub 2012 Nov 24. French.

ReferenceCitation: Schmitz T, Sentilhes L, Lorthe E, Gallot D, Madar H, Doret-Dion M, Beucher G, Charlier C, Cazanave C, Delorme P, Garabédian C, Azria E, Tessier V, Sénat MV, Kayem G. Preterm premature rupture of the membranes: Guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2019 May;236:1-6. doi: 10.1016/j.ejogrb.2019.02.021. Epub 2019 Mar 2. Review.

ReferenceCitation: Flenady V, Wojcieszek AM, Papatsonis DN, Stock OM, Murray L, Jardine LA, Carbonne B. Calcium channel blockers for inhibiting preterm labour and birth. Cochrane Database Syst Rev. 2014 Jun 5;(6):CD002255. doi: 10.1002/14651858.CD002255.pub2. Review.

ReferenceCitation: Lorthe E, Kayem G; TOCOPROM Study Group and the GROG (Groupe de Recherche en Obstétrique et Gynécologie). Tocolysis in the management of preterm prelabor rupture of membranes at 22-33 weeks of gestation: study protocol for a multicenter, double-blind, randomized controlled trial comparing nifedipine with placebo (TOCOPROM). BMC Pregnancy Childbirth. 2021 Sep 8;21(1):614. doi: 10.1186/s12884-021-04047-2.

family: Lorthe

full_name: Elsa Lorthe

given: Elsa

family: Kayem

full_name: Gilles Kayem

given: Gilles

family: Ancel

full_name: Pierre-Yves Ancel

given: Pierre-Yves

family: Abdoul

full_name: Hendy Abdoul

given: Hendy

family: Briand

full_name: Nelly Briand

given: Nelly

family: Lehmann

full_name: Blandine Lehmann

given: Blandine

family: Cabanne

full_name: Clémence Cabanne

given: Clémence

family: Marret

full_name: Stéphane Marret

given: Stéphane

family: Foix l’Hélias

full_name: Laurence Foix l’Hélias

given: Laurence

family: Goffinet

full_name: François Goffinet

given: François

family: Schmitz

full_name: Thomas Schmitz

given: Thomas

family: Charlier

full_name: Caroline Charlier

given: Caroline

family: Autret

full_name: Fanny Autret

given: Fanny

family: Azria

full_name: Elie Azria

given: Elie

family: Balitalike

full_name: Jadot Balitalike

given: Jadot

family: Billiemaz

full_name: Kareen Billiemaz

given: Kareen

family: Bohec

full_name: Caroline Bohec

family: Bolot

full_name: Pascal Bolot

given: Pascal

family: Bornes

full_name: Marie Bornes

given: Marie

family: Bouchghoul

full_name: Hanane Bouchghoul

name: on behalf of the TOCOPROM Study Group and the GROG (Groupe de Recherche en Obstétrique et Gynécologie)

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

title: Tocolysis in the management of preterm prelabor rupture of membranes at 22–33 weeks of gestation: study protocol for a multicenter, double-blind, randomized controlled trial comparing nifedipine with placebo (TOCOPROM)


title: Prospective Non-comparative Study to Assess the Efficacy, the Safety and the Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea Syndrome in European Population

summary: This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or respiratory comorbidities/disorders.

lead_sponsor: Seven Dreamers Europe SAS

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Phase I/II Clinical Trial Randomized, Multicentric, Open Label, Standard of Care (Silver Sulfadiazine) Controlled Aiming at Assessing Tolerance and Efficacy of Local Bacteriophage Treatment of Wound Infections Due to E. Coli or P. Aeruginosa in Burned Patients Using Pherecydes Pharma Anti-Escherichia Coli and Anti-Pseudomonas Aeruginosa Bacteriophages GMP Produced Cocktails . This Project is a European Research & Development (R&D) Project Funded by the European Commission Under the 7th Framework Programme for Research and Development Involving 7 Clinical Sites in EU.

acronym: PHAGOBURN

summary: The objective of PHAGOBURN is to assess tolerance and efficacy of local bacteriophage treatment of E. coli or P. aeruginosa wound infections in burned patients.

ReferenceCitation: Jault P, Leclerc T, Jennes S, Pirnay JP, Que YA, Resch G, Rousseau AF, Ravat F, Carsin H, Le Floch R, Schaal JV, Soler C, Fevre C, Arnaud I, Bretaudeau L, Gabard J. Efficacy and tolerability of a cocktail of bacteriophages to treat burn wounds infected by Pseudomonas aeruginosa (PhagoBurn): a randomised, controlled, double-blind phase 1/2 trial. Lancet Infect Dis. 2019 Jan;19(1):35-45. doi: 10.1016/S1473-3099(18)30482-1. Epub 2018 Oct 3.

family: Jault

full_name: Patrick Jault

given: Patrick

family: Leclerc

full_name: Thomas Leclerc

family: Jennes

full_name: Serge Jennes

given: Serge

family: Pirnay

full_name: Jean Paul Pirnay

given: Jean Paul

family: Que

full_name: Yok-Ai Que

given: Yok-Ai

family: Resch

full_name: Gregory Resch

given: Gregory

family: Rousseau

full_name: Anne Françoise Rousseau

given: Anne Françoise

family: Ravat

full_name: François Ravat

family: Carsin

full_name: Hervé Carsin

given: Hervé

family: Le Floch

full_name: Ronan Le Floch

given: Ronan

family: Schaal

full_name: Jean Vivien Schaal

given: Jean Vivien

family: Soler

full_name: Charles Soler

given: Charles

family: Fevre

full_name: Cindy Fevre

given: Cindy

family: Arnaud

full_name: Isabelle Arnaud

given: Isabelle

family: Bretaudeau

full_name: Laurent Bretaudeau

given: Laurent

family: Gabard

full_name: Jérôme Gabard

given: Jérôme

journal_name: The Lancet Infectious Diseases

lead_sponsor: Pherecydes Pharma

location_country: Belgium France Switzerland


title: Sampling of Human Microbiota in Order to Test, on a Mouse Model, Individualized Intervention Strategies During Aging

acronym: FRAGIBIOTE

summary:
Human microbial flora transfer studies in rodent models have clearly identified that age-associated microbiota dysbiosis can play a decisive role with respect to pathologies or complications linked to aging: increased intestinal permeability, in place of systemic inflammation, dysfunction of immune cells and insulin resistance.

This trial therefore aims to validate the process of ex vivo transfer to the rat of human microbiota selected from three categories of male individuals: young adults, healthy older adults and frail older adults, with the evaluation of the bacterial population of stool by analysis of the 16S rRNA gene.

primary_purpose: Basic Science


title: Results at 10 Years of the RESOLVE Study (REverse Metabolic SyndrOme by Lifestyle and Various Exercise)

summary: 10-year effect of a lifestyle intervention program (exercise, sedentary lifestyle and dietary diet) on abdominal visceral adipose tissue (primary endpoint of the RESOLVE study 10 years ago): influence of kinetics abdominal visceral adipose tissue loss in the first year of follow-up on abdominal visceral adipose tissue at 10 years

status: Not yet recruiting


title: Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events

summary:
The ANRS EP66 SEPTAVIH Study aims to screen feasibility of evaluating frailty in people living with HIV aged 70 or older, to estimate its prevalence, to analyse associated risk factors and to evaluate the impact of frailty on pejorative events.

SEPTAVIH is a French, multicentre, prospective, observational study which will include 500 HIV-infected participants

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service de Maladies Infectieuses, CHU Hôtel-Dieu


title: Impact of Thermotherapy During Childbirth on Postpartum Perineal Pain: a Multicenter Factorial Randomized Controlled Trial

acronym: PERISAFE

summary: Perineal pain is common after vaginal birth. Thermotherapy might be effective to limit postpartum perineal pain, thanks to the effects of local heating or cooling application. This study aims to evaluate the impact of thermotherapy during childbirth on postpartum perineal pain.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Louis Mourier Hospital
Cochin Hospital


title: Preventing the Risk of Osteoporotic Fracture in Premenopausal Women by a Spa Residential Physical Activity Program

acronym: ThermOs

summary:
Osteoporosis is an increasing public health problem. Involution of bone mass in women is due to a reduction in sensitivity of the bone to the mechanical stress due to the slow-down of the bone turnover after 35 years old. Osteoporosis is a silent disease combining a decrease in bone mass (quantity) and an impaired bone microarchitecture (quality) leading to an increased risk of fracture. Bone microarchitecture is an important element to be taken into account in assessing the bone properties, as demonstrated by numerous ex vivo studies.

Bone densitometry only identifies 50% of osteoporotic fractures. The other half of the fractures appears in osteopenic women. The measurement of bone mineral density is too limited to assess risk of fracture. Bone microarchitecture can be assessed through a peripheral quantitative computed tomography scan (computed tomography peripherical - pQCT). The microarchitecture data allow the calculation of bone strength index (BSI) and stress strength index (SSI) highly predictive of fracture risk. These qualitative determinants of bone fragility are the most relevant to evaluate effect of physical activity over a short period compared with bone mineral content and density, which requires several months of constraints. Biochemical markers of bone turnover, specifically those of bone resorption, are predictive of the risk of osteoporotic fracture.

Physical activity can reduce the risk of fracture up to 20-35% via direct effects on bone strength, at any age. However, response of bone varies with modalities of exercise. Repeated exercise produces greater bone adaptations than a single bout. Moreover, it has been well demonstrated since 1970 that bone responds to a dynamic stimulation, but not a static stimulation, with a dose response relationship. It has been confirmed in premenopausal women.

The effect of physical activity on microarchitectural bone parameters (porosity and density of cortical and trabecular) has not been investigated in primary prevention. This original study would highlight the effect of short-term specific physical activity on the prevention of bone fragility (qualitative) observed with age in premenopausal women.

The main hypothesis is that a spa residential program including physical activity will have greater benefits on bone cortical porosity than a spa residential program alone or physical activity alone, in premenopausal women.


title: Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon

acronym: COG AGE

summary: The aim of the study is to investigate the impact of adjuvant chemotherapy on cognitive function in patients aged over 65 and suffering from breast cancer or colon.

lead_sponsor: Centre Francois Baclesse

location_facility:
Université
INSERM
Hopital Pitié-Sapètrière
Hopital TENON
Hôpital Charles FOIX
CHU, Hôpital Bois Guillaume
Centre Henri BECQUEREL
Hopital gériatrique des Bateliers
Hopitaux universitaires
CHU
Centre François BACLESSE
Hôpital Saint-Louis
CHRU Hôpital Claude Huriez


title: Change in Brain Perfusion During Induction of General Anesthesia: Relationship Between Transcranial Doppler, Bispectral Index and Cerebral Oximetry : a Prospective Observational Study CERVO2

summary: Arterial hypotension during general anesthesia remains a factor of poor outcomes, increases the risk of myocardial infarction, acute kidney injury and 1-year mortality. Furthermore, arterial hypotension may also decrease cerebral perfusion contributing to worsen neurological outcome. It seems necessary to monitor cerebral perfusion during anesthesia and to define individual dynamic targets of blood pressure. The goal of this study is to evaluate cerebral perfusion change in adult patients with or without cardiovascular risk factors during a standardized propofol-remifentanil anesthesia induction. Cerebral perfusion will be evaluated and compared by simultaneous measurements of cerebral blood flow, cerebral oxygen saturation and neurological function with use of transcranial Doppler (TCD), Near infrared spectroscopy (NIRS) and the Bispectral index (BIS) monitoring, respectively. Those measurements will be also repeated during and after treatment of arterial hypotension episodes in both groups.

location_facility: AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care


title: A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)

summary:
The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly.

Secondary objectives are:

to characterize the global safety profile
to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule
to assess preliminary evidence of anti-lymphoma activity.

lead_sponsor: Sanofi

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 250003


ReferenceType: result

ReferenceCitation: Moreau P, Attal M, Hulin C, Arnulf B, Belhadj K, Benboubker L, Béné MC, Broijl A, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Garderet L, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Lenain P, Macro M, Mathiot C, Orsini-Piocelle F, Perrot A, Stoppa AM, van de Donk NW, Wuilleme S, Zweegman S, Kolb B, Touzeau C, Roussel M, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Fermand JP, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Zhuang S, Chiu C, Pei L, de Boer C, Smith E, Deraedt W, Kampfenkel T, Schecter J, Vermeulen J, Avet-Loiseau H, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019 Jul 6;394(10192):29-38. doi: 10.1016/S0140-6736(19)31240-1. Epub 2019 Jun 3. Erratum in: Lancet. 2019 Jun 14;:.

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Attal

full_name: Michel Attal

given: Michel

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

family: Arnulf

full_name: Bertrand Arnulf

given: Bertrand

family: Belhadj

full_name: Karim Belhadj

given: Karim

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

family: Béné

full_name: Marie C Béné

given: Marie C

family: Broijl

full_name: Annemiek Broijl

given: Annemiek

family: Caillon

full_name: Hélène Caillon

given: Hélène

family: Caillot

full_name: Denis Caillot

given: Denis

family: Corre

full_name: Jill Corre

given: Jill

family: Delforge

full_name: Michel Delforge

family: Dejoie

full_name: Thomas Dejoie

given: Thomas

family: Doyen

full_name: Chantal Doyen

given: Chantal

family: Facon

full_name: Thierry Facon

given: Thierry

family: Sonntag

full_name: Cécile Sonntag

given: Cécile

family: Fontan

full_name: Jean Fontan

given: Jean

family: Garderet

full_name: Laurent Garderet

family: Jie

full_name: Kon-Siong Jie

given: Kon-Siong

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Kuhnowski

full_name: Frédérique Kuhnowski

given: Frédérique

family: Lambert

full_name: Jérôme Lambert

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Lenain

full_name: Pascal Lenain

family: Macro

full_name: Margaret Macro

given: Margaret

ReferenceCitation: Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Béné MC, Zweegman S, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Stoppa AM, van de Donk NWCJ, Wuillème S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Krevvata M, Zhang K, de Boer C, Vara S, Kampfenkel T, Vanquickelberghe V, Vermeulen J, Avet-Loiseau H, Sonneveld P. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Oct;22(10):1378-1390. doi: 10.1016/S1470-2045(21)00428-9. Epub 2021 Sep 13.

ReferenceCitation: Hulin C, Offner F, Moreau P, Roussel M, Belhadj K, Benboubker L, Caillot D, Facon T, Garderet L, Kuhnowski F, Stoppa AM, Kolb B, Tiab M, Jie KS, Westerman M, Lambert J, Pei L, Vanquickelberghe V, De Boer C, Vermeulen J, Kampfenkel T, Sonneveld P, Van de Donk NWCJ. Stem cell yield and transplantation in transplant-eligible newly diagnosed multiple myeloma patients receiving daratumumab + bortezomib/thalidomide/dexamethasone in the phase 3 CASSIOPEIA study. Haematologica. 2021 Aug 1;106(8):2257-2260. doi: 10.3324/haematol.2020.261842.

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Roussel M, Moreau P, Hebraud B, Laribi K, Jaccard A, Dib M, Slama B, Dorvaux V, Royer B, Frenzel L, Zweegman S, Klein SK, Broijl A, Jie KS, Wang J, Vanquickelberghe V, de Boer C, Kampfenkel T, Gries KS, Fastenau J, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab for transplantation-eligible patients with newly diagnosed multiple myeloma (CASSIOPEIA): health-related quality of life outcomes of a randomised, open-label, phase 3 trial. Lancet Haematol. 2020 Dec;7(12):e874-e883. doi: 10.1016/S2352-3026(20)30356-2.

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie

location_facility: Centre Hospitalier d'Argenteuil Victor Dupouy

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: GH de l'Institut Catholique Saint Vincent

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges

location_facility: CHV André Mignot - Université de Versailles

location_facility: Institut de Cancérologie Lucien Neuwirth

title: Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma

summary: The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.


title: Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder

acronym: POLARIS

summary:
The study aims to evaluate:

the frequency of subsyndromal symptoms or disorders observed during interepisode phases in bipolar patients, particularly after a depressive episode in which these subsyndromal disorders are the most frequent
the functional impact of these disorders, factors or symptom thresholds associated with functional remission, and factors associated with symptomatic remission over a sufficient follow-up (12 months).

lead_sponsor: AstraZeneca


title: Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy

acronym: MESAMI

summary: Ischemic cardiomyopathies are a leading cause of death in both men and women. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the all damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety of injecting MSCs directly into the heart to repair and restore heart function in people who have had a heart attack and who have chronic myocardial ischemia with heart failure.

ReferenceCitation: Guijarro D, Lebrin M, Lairez O, Bourin P, Piriou N, Pozzo J, Lande G, Berry M, Le Tourneau T, Cussac D, Sensebe L, Gross F, Lamirault G, Huynh A, Manrique A, Ruidavet JB, Elbaz M, Trochu JN, Parini A, Kramer S, Galinier M, Lemarchand P, Roncalli J. Intramyocardial transplantation of mesenchymal stromal cells for chronic myocardial ischemia and impaired left ventricular function: Results of the MESAMI 1 pilot trial. Int J Cardiol. 2016 Apr 15;209:258-65. doi: 10.1016/j.ijcard.2016.02.016. Epub 2016 Feb 2.

family: Guijarro

full_name: D. Guijarro

given: D.

family: Lebrin

full_name: M. Lebrin

given: M.

family: Lairez

full_name: O. Lairez

given: O.

family: Bourin

full_name: P. Bourin

given: P.

family: Piriou

full_name: N. Piriou

given: N.

family: Pozzo

full_name: J. Pozzo

given: J.

family: Lande

full_name: G. Lande

given: G.

family: Berry

full_name: M. Berry

family: Le Tourneau

full_name: T. Le Tourneau

given: T.

family: Cussac

full_name: D. Cussac

family: Sensebe

full_name: L. Sensebe

given: L.

family: Gross

full_name: F. Gross

given: F.

family: Lamirault

full_name: G. Lamirault

family: Huynh

full_name: A. Huynh

given: A.

family: Manrique

full_name: A. Manrique

family: Ruidavet

full_name: J.B. Ruidavet

family: Elbaz

full_name: M. Elbaz

family: Trochu

full_name: J.N. Trochu

family: Parini

full_name: A. Parini

family: Kramer

full_name: S. Kramer

given: S.

family: Galinier

full_name: M. Galinier

family: Lemarchand

full_name: P. Lemarchand

family: Roncalli

full_name: J. Roncalli

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm


title: Automation of the Oxygen's Administration in Spontaneous Ventilation (FreeO2) During the Hypoxemic Acute Respiratory Distress

summary:
Aim: The purpose of this study is to evaluate the use feasibility of FreeO2 so as to deliver automatically oxygen in the emergency department in a patient population admitted for acute respiratory failure.

Hypothesis: The principal hypothesis is that FreeO2 is possible and well-accepted by nurses and medical personnel and there are advantages to use this system. In comparison with the common oxygen delivery (the rotameter), the hypothesis is that FreeO2 system will make for a better control of the oxygen saturation in function of designed target, reducing the desaturation time and hyperoxia. We think that oxygen weaning will be faster than classical way if it is automated. In addition, FreeO2 could reduce the number of intervention by nurse personnel.

ReferenceCitation: L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1). pii: 1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul.

family: L'Her

full_name: Erwan L'Her

given: Erwan

family: Dias

full_name: Patricia Dias

given: Patricia

family: Gouillou

full_name: Maelenn Gouillou

given: Maelenn

family: Riou

full_name: Anne Riou

given: Anne

family: Souquiere

full_name: Luc Souquiere

given: Luc

family: Paleiron

full_name: Nicolas Paleiron

given: Nicolas

family: Archambault

full_name: Patrick Archambault

given: Patrick

family: Bouchard

full_name: Pierre-Alexandre Bouchard

given: Pierre-Alexandre

family: Lellouche

full_name: François Lellouche

given: François

journal_name: European Respiratory Journal

oa_host_type: publisher

evidence: open (via free pdf)

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

title: Automaticversusmanual oxygen administration in the emergency department

lead_sponsor: University Hospital, Brest

location_country: Canada France

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Québec


title: Evaluation of the Efficacy of Spa Treatment for Prevention of Leg Ulcers in Advanced Chronic Venous Insufficiency.

summary: The main objective of this study is to test the hypothesis that a 3 week intensive course of spa therapy can reduce the risk of leg ulcers in patients with advanced chronic venous insufficiency (C4a-b and C5 of the CEAP classification) at one year.

ReferenceCitation: Carpentier PH, Maricq HR, Biro C, Ponçot-Makinen CO, Franco A. Prevalence, risk factors, and clinical patterns of chronic venous disorders of lower limbs: a population-based study in France. J Vasc Surg. 2004 Oct;40(4):650-9.

ReferenceCitation: Carpentier PH, Satger B. Randomized trial of balneotherapy associated with patient education in patients with advanced chronic venous insufficiency. J Vasc Surg. 2009 Jan;49(1):163-70. doi: 10.1016/j.jvs.2008.07.075. Epub 2008 Oct 1.

ReferenceCitation: Ernst E, Saradeth T, Resch KL. A single blind randomized, controlled trial of hydrotherapy for varicose veins. Vasa. 1991;20(2):147-52.

ReferenceCitation: Eklöf B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004 Dec;40(6):1248-52. Review.

ReferenceCitation: Rutherford RB, Padberg FT Jr, Comerota AJ, Kistner RL, Meissner MH, Moneta GL. Venous severity scoring: An adjunct to venous outcome assessment. J Vasc Surg. 2000 Jun;31(6):1307-12.

ReferenceCitation: Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54.

ReferenceCitation: Constant F, Collin JF, Guillemin F, Boulangé M. Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol. 1995 Jul;22(7):1315-20.

ReferenceCitation: Labropoulos N, Leon LR Jr. Duplex evaluation of venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):5-9. Review.

ReferenceCitation: Prandoni P, Lensing AW, Prins MH, Frulla M, Marchiori A, Bernardi E, Tormene D, Mosena L, Pagnan A, Girolami A. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med. 2004 Aug 17;141(4):249-56.

ReferenceCitation: Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15.

family: Carpentier

full_name: Patrick H. Carpentier

given: Patrick H.

family: Blaise

full_name: Sophie Blaise

given: Sophie

family: Satger

full_name: Bernadette Satger

given: Bernadette

family: Genty

full_name: Céline Genty

given: Céline

family: Rolland

full_name: Carole Rolland

given: Carole

family: Roques

full_name: Christian Roques

given: Christian

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

journal_name: Journal of Vascular Surgery

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
Cabinet médical
Hopital thermal
University Hospital Grenoble


title: Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

summary: This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).

lead_sponsor: Theranexus

location_facility:
CHU Dijon Bourgogne
CHU Grenoble Alpes
CHU Pellegrin
CHRU Lilles
University Hospital
Groupe Hospitalier Pitié Salpêtrière
Hôpital Raymond Poincaré
RespiSom


lead_sponsor: Genzyme, a Sanofi Company

source: euctr

title: A Randomized, Double-blind Phase II Trial to Assess the Efficacy and Safety of Bicalutamide (Casodex® ) Associated to ZD6474 (Zactima™ ) or to Placebo in Patients With Castration-refractory Metastatic Prostate Cancer Without Any Clinical Symptom Related to Disease Progression

summary: This randomized, double-blind phase II trial is to assess the efficacy and safety of bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression. The study is blinded, and subjects will be randomised (1:1 ratio) to either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is acceptable in this subject population where all subjects will also received bicalutamide 150 mg o.d. Subjects will continue study treatment until they reach objective biological disease progression or unacceptable toxicity or withdrawal of consent or until end of trial (which event occurs first). The end of study is fixed 12 months after the last randomised patient's first dose of study treatment.


type: Other Grant/Funding Number

title: Does Intense Weight Loss Improve Physical Performance in Obese Patients Older Than 60 Yrs Undergoing Exercise Training? Comparison Between Surgery and Standard of Care.

acronym: ELDSURG

summary: The main objective of this study is to compare the efficacy of two weight losing strategies (obesity surgery with gastric banding, and standard of care) on physical performance in elderly obese persons submitted to a physical training. Our hypothesis is that a surgery-induced weight loss in the context of a physical training (which is recommended in people 60-75 yrs losing weight) improves physical performance as compared to standard of care (3-5% weight loss).

ReferenceCitation: Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. Review. Erratum in: JAMA. 2005 Apr 13;293(14):1728.

ReferenceCitation: Chevallier JM, Zinzindohoué F, Douard R, Blanche JP, Berta JL, Altman JJ, Cugnenc PH. Complications after laparoscopic adjustable gastric banding for morbid obesity: experience with 1,000 patients over 7 years. Obes Surg. 2004 Mar;14(3):407-14.

ReferenceCitation: O'Brien PE, MacDonald L, Anderson M, Brennan L, Brown WA. Long-term outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Ann Surg. 2013 Jan;257(1):87-94. doi: 10.1097/SLA.0b013e31827b6c02. Review.

ReferenceCitation: Mittermair RP, Obermüller S, Perathoner A, Sieb M, Aigner F, Margreiter R. Results and complications after Swedish adjustable gastric banding-10 years experience. Obes Surg. 2009 Dec;19(12):1636-41. doi: 10.1007/s11695-009-9967-7.

ReferenceCitation: Chevallier JM, Paita M, Rodde-Dunet MH, Marty M, Nogues F, Slim K, Basdevant A. Predictive factors of outcome after gastric banding: a nationwide survey on the role of center activity and patients' behavior. Ann Surg. 2007 Dec;246(6):1034-9.

ReferenceCitation: Gagner M, Milone L, Yung E, Broseus A, Gumbs AA. Causes of early mortality after laparoscopic adjustable gastric banding. J Am Coll Surg. 2008 Apr;206(4):664-9. doi: 10.1016/j.jamcollsurg.2007.11.014. Epub 2008 Jan 28. Review.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU de Nantes
Hospices Civils de LYON
Hôpital louis Mourier
HEGP
CHU de LILLE
CHU de Toulouse


title: A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS)

summary: The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations.

ReferenceCitation: Rascol O, Poewe W, Lees A, Aristin M, Salin L, Juhel N, Waldhauser L, Schindler T; ADVANS Study Group. Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study. Arch Neurol. 2008 May;65(5):577-83. doi: 10.1001/archneur.65.5.577.

family: Rascol

full_name: Olivier Rascol

given: Olivier

journal_name: Archives of Neurology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations

location_country:
Austria
Netherlands
France
Spain
Germany
United Kingdom

location_facility: Hospital Clínico Universitario Vírgen de la Macarena

location_facility: Klinikum Großhadern der L.M.-Universität

location_facility: Hospital Clínico niversitario de Santiago de Compostela

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Centre Hospitalier Universitaire JB Miletrie

location_facility: Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg


title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®

acronym: Exten MenbVac

summary: This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Rouen

intervention_type: Biological


title: A 12 Week Double-blind, Randomised, Placebo-controlled, Modified Dose-escalation Trial to Investigate Safety, Efficacy, and Pharmacokinetics of BIRT 2584XX Tablets at Doses of 100, 300 and 500 mg Administered Once Daily in Patients With Moderate to Severe Psoriasis With a 12 Week Treatment Extension

summary: The purpose of this clinical study is to determine the effectiveness, pharmacokinetics and safety of several doses of BIRT 2584 XX (100mg, 300mg and 500mg) taken once daily in the treatment of moderate to severe plaque-type psoriasis. This new medicine will be compared to a so-called placebo medicine over 12 weeks with a 12 weeks treatment extension possible.

location_country:
Sweden
Netherlands
Germany
Finland
France
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: University Medical Centre Nijmegen St. Radboud West

location_facility: Royal Free Hospital, Dermatology Department,

location_facility: Eastern Canada Cutaneous Research Associates Ltd.

location_facility: Skin Therapy Research Unit, St John's Inst of Dermatolology

location_facility: Aberdeen Royal Infirmary, Department of Dermatology

location_facility: Western Infirmary, Department of Dermatology

location_facility: George Eliot Hospital, Dermatology Department

location_facility: Royal South Hants Hospital, Dept of Dermatology

location_facility: Cardiff University, Dermatology Department


title: Consequences of the COVID-19 Pandemic on Worldwide Organ Procurement and Transplantation

acronym: COVID

summary:
End-stage organ failure is estimated to affect more than 4 to 6 million persons worldwide. In 2018, transplant systems across the globe enabled around 150,000 patients to benefit from a kidney, heart, lung, liver, or other solid organ, a number that was far less than the demand. According to data from the World Health Organization, more than 1,500,000 persons live with a transplanted organ worldwide. In the US, approximately 40,000 patients receive an organ transplant every year, but 120,000 still remain waitlisted for transplantation today, with 7,600 dying annually while waiting for an organ transplant. A similar lack of organs and high death rates on the waiting list affect patients in Europe and many other countries.

As nations adjust to new realities driven by the coronavirus (COVID-19) outbreak, many health care providers, institutions and patients are concerned about the potential impact that COVID-19 will have on organ donation and transplantation. One concern is that transplant recipients may have a greater susceptibility to infection and greater viral burden. A second concern is that hospitals will lack the resources in terms of staff and equipment to care for recipients after transplantation, who often require intensive care and multispecialty management.

Because of the overwhelming healthcare system burden, a dramatic negative effect on worldwide organ donation and transplantation is anticipated, but has not been measured. Our objective was to quantify the worldwide impact of COVID-19 pandemic on organ donation and transplantation and consequences for waitlisted patients.

ReferenceCitation: Xu B, Kraemer MUG; Open COVID-19 Data Curation Group. Open access epidemiological data from the COVID-19 outbreak. Lancet Infect Dis. 2020 May;20(5):534. doi: 10.1016/S1473-3099(20)30119-5. Epub 2020 Feb 19.

ReferenceCitation: Anderson RM, Heesterbeek H, Klinkenberg D, Hollingsworth TD. How will country-based mitigation measures influence the course of the COVID-19 epidemic? Lancet. 2020 Mar 21;395(10228):931-934. doi: 10.1016/S0140-6736(20)30567-5. Epub 2020 Mar 9.

ReferenceCitation: Ahn C, Amer H, Anglicheau D, Ascher NL, Baan CC, Battsetset G, Bat-Ireedui B, Berney T, Betjes MGH, Bichu S, Birn H, Brennan D, Bromberg J, Caillard S, Cannon RM, Cantarovich M, Chan A, Chen ZS, Chapman JR, Cole EH, Cross N, Durand F, Egawa H, Emond JC, Farrero M, Friend PJ, Geissler EK, Ha J, Haberal MA, Henderson ML, Hesselink DA, Humar A, Jassem W, Jeong JC, Kaplan B, Kee T, Kim SJ, Kumar D, Legendre CM, Man K, Moulin B, Muller E, Munkhbat R, Od-Erdene L, Perrin P, Rela M, Tanabe K, Tedesco Silva H, Tinckam KT, Tullius SG, Wong G. Global Transplantation COVID Report March 2020. Transplantation. 2020 Oct;104(10):1974-1983. doi: 10.1097/TP.0000000000003258.

ReferenceCitation: Zhang X. Epidemiology of Covid-19. N Engl J Med. 2020 May 7;382(19):1869. doi: 10.1056/NEJMc2005157. Epub 2020 Mar 27.

ReferenceCitation: Martino F, Plebani M, Ronco C. Kidney transplant programmes during the COVID-19 pandemic. Lancet Respir Med. 2020 May;8(5):e39. doi: 10.1016/S2213-2600(20)30182-X. Epub 2020 Apr 16.

ReferenceCitation: Akalin E, Azzi Y, Bartash R, Seethamraju H, Parides M, Hemmige V, Ross M, Forest S, Goldstein YD, Ajaimy M, Liriano-Ward L, Pynadath C, Loarte-Campos P, Nandigam PB, Graham J, Le M, Rocca J, Kinkhabwala M. Covid-19 and Kidney Transplantation. N Engl J Med. 2020 Jun 18;382(25):2475-2477. doi: 10.1056/NEJMc2011117. Epub 2020 Apr 24.

ReferenceCitation: Coates PT, Wong G, Drueke T, Rovin B, Ronco P; Associate Editors, for the Entire Editorial Team. Early experience with COVID-19 in kidney transplantation. Kidney Int. 2020 Jun;97(6):1074-1075. doi: 10.1016/j.kint.2020.04.001. Epub 2020 Apr 9.

ReferenceCitation: Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344.

ReferenceCitation: Omer SB, Malani P, Del Rio C. The COVID-19 Pandemic in the US: A Clinical Update. JAMA. 2020 May 12;323(18):1767-1768. doi: 10.1001/jama.2020.5788.

ReferenceCitation: Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. Erratum in: Lancet Infect Dis. 2020 Sep;20(9):e215.

ReferenceCitation: Levin A, Tonelli M, Bonventre J, Coresh J, Donner JA, Fogo AB, Fox CS, Gansevoort RT, Heerspink HJL, Jardine M, Kasiske B, Köttgen A, Kretzler M, Levey AS, Luyckx VA, Mehta R, Moe O, Obrador G, Pannu N, Parikh CR, Perkovic V, Pollock C, Stenvinkel P, Tuttle KR, Wheeler DC, Eckardt KU; ISN Global Kidney Health Summit participants. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet. 2017 Oct 21;390(10105):1888-1917. doi: 10.1016/S0140-6736(17)30788-2. Epub 2017 Apr 20. Review.

family: Levin

full_name: Adeera Levin

given: Adeera

family: Tonelli

full_name: Marcello Tonelli

given: Marcello

family: Bonventre

full_name: Joseph Bonventre

given: Joseph

family: Coresh

full_name: Josef Coresh

given: Josef

family: Donner

full_name: Jo-Ann Donner

given: Jo-Ann

family: Fogo

full_name: Agnes B Fogo

given: Agnes B

family: Fox

full_name: Caroline S Fox

given: Caroline S

family: Gansevoort

full_name: Ron T Gansevoort

given: Ron T

family: Heerspink

full_name: Hiddo J L Heerspink

given: Hiddo J L

family: Jardine

full_name: Meg Jardine

given: Meg

family: Kasiske

full_name: Bertram Kasiske

given: Bertram

family: Köttgen

full_name: Anna Köttgen

given: Anna

family: Kretzler

full_name: Matthias Kretzler

given: Matthias

family: Levey

full_name: Andrew S Levey

given: Andrew S

family: Luyckx

full_name: Valerie A Luyckx

given: Valerie A

family: Mehta

full_name: Ravindra Mehta

given: Ravindra

family: Moe

full_name: Orson Moe

given: Orson

family: Obrador

full_name: Gregorio Obrador

given: Gregorio

family: Pannu

full_name: Neesh Pannu

given: Neesh

family: Parikh

full_name: Chirag R Parikh

given: Chirag R

family: Perkovic

full_name: Vlado Perkovic

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Aubert O, Yoo D, Zielinski D, Cozzi E, Cardillo M, Dürr M, Domínguez-Gil B, Coll E, Da Silva MI, Sallinen V, Lemström K, Midtvedt K, Ulloa C, Immer F, Weissenbacher A, Vallant N, Basic-Jukic N, Tanabe K, Papatheodoridis G, Menoudakou G, Torres M, Soratti C, Hansen Krogh D, Lefaucheur C, Ferreira G, Silva HT Jr, Hartell D, Forsythe J, Mumford L, Reese PP, Kerbaul F, Jacquelinet C, Vogelaar S, Papalois V, Loupy A. COVID-19 pandemic and worldwide organ transplantation: a population-based study. Lancet Public Health. 2021 Oct;6(10):e709-e719. doi: 10.1016/S2468-2667(21)00200-0. Epub 2021 Aug 30.

lead_sponsor: Paris Translational Research Center for Organ Transplantation


title: Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable

summary: To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.

ReferenceCitation: Fournel P, Vergnenégre A, Robinet G, Léna H, Gervais R, Le Caer H, Souquet PJ, Chavaillon JM, Bozonnat MC, Daurès JP, Chouaid C, Martel-Lafay I; GFPC and IFCT Team. Induction or consolidation chemotherapy for unresectable stage III non-small-cell lung cancer patients treated with concurrent chemoradiation: a randomised phase II trial GFPC - IFCT 02-01. Eur J Cancer. 2016 Jan;52:181-7. doi: 10.1016/j.ejca.2015.10.072. Epub 2015 Dec 12.

family: Fournel

full_name: Pierre Fournel

given: Pierre

family: Vergnenégre

full_name: Alain Vergnenégre

given: Alain

family: Robinet

full_name: Gilles Robinet

given: Gilles

family: Léna

full_name: Hervé Léna

given: Hervé

family: Gervais

full_name: Radj Gervais

given: Radj

family: Le Caer

full_name: Hervé Le Caer

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Chavaillon

full_name: Jean-Michel Chavaillon

given: Jean-Michel

family: Bozonnat

full_name: Marie-Cécile Bozonnat

given: Marie-Cécile

family: Daurès

full_name: Jean-Pierre Daurès

given: Jean-Pierre

family: Chouaid

full_name: Christos Chouaid

given: Christos

family: Martel-Lafay

full_name: Isabelle Martel-Lafay

given: Isabelle

full_name: P. Fournel

given: P.

family: Talabard

full_name: J.N. Talabard

full_name: A. Vergnenégre

given: A.

family: Melloni

full_name: B. Melloni

given: B.

family: Decroisette

full_name: C. Decroisette

given: C.

family: Clavére

full_name: P. Clavére

full_name: G. Robinet

given: G.

family: Bayle

full_name: S. Bayle

given: S.

family: Labat

full_name: J.P. Labat

full_name: H. Léna

given: H.

family: Belleguic

full_name: C. Belleguic

family: Benchalal

full_name: M. Benchalal

given: M.

title: Induction or consolidation chemotherapy for unresectable stage III non-small-cell lung cancer patients treated with concurrent chemoradiation: a randomised phase II trial GFPC – IFCT 02-01

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique


title: Characterization of the Interruptions of the GAA Expansion and Study of Their Influence on the Severity of Friedreich's Ataxia : INTREP-AF

acronym: INTREP-AF

summary:
Friedreich's ataxia (FA) is the most frequent recessive genetic ataxia with an estimated prevalence of 1/50 000. The first symptoms appear around the age of 10 years with a progressive course and the need for an armchair 10- 15 years after the first symptoms. More rarely the disease can present with a late onset (after the age of 25) with a picture characterized by spastic paraparesis and slower progression ("LOFA" for "Late Onset Friedreich Ataxia" or VLOFA for "Very Late Appearance of Friedreich's ataxia ").

AF is caused in 96% of cases by an expansion of GAAN triplets (N> 100 repeats) located in intron 1 of the FXN gene, present on the two alleles, and, in the rest of the cases, by an associated expansion a point mutation or a deletion in trans. During molecular diagnostics, it is not uncommon to find the presence of interruptions within the GAA expansion. This results in the absence and / or the shift of peak (s) within the chromatogram.

To date, only the partial correlation between the size of the expansion and the age of onset of Friedreich's ataxia has been established. In particular, very atypical forms of AF with a late onset (after the age of 25) are in particular explained by the low number of repetitions in the expansion, typically between 100 and 500 repetitions. However, the presence of an interruption could stabilize the size of the expansion and, therefore, be mainly associated with expansions of small sizes and therefore with a late onset of the disease.

The objective of this study is therefore to analyse and caracterize the presence and the type of interruptions of the GAA expansions in a group of patients with FA ; this data will be correlated with the age at onset of FA.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions Using International Pharmacovigilance Database

acronym: RAFALE

summary: Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase.

time_perspective: Cross-Sectional

ReferenceCitation: Dressler D, Potter H. Molecular mechanisms in genetic recombination. Annu Rev Biochem. 1982;51:727-61. Review.

ReferenceCitation: Moslehi JJ, Salem JE, Sosman JA, Lebrun-Vignes B, Johnson DB. Increased reporting of fatal immune checkpoint inhibitor-associated myocarditis. Lancet. 2018 Mar 10;391(10124):933. doi: 10.1016/S0140-6736(18)30533-6.

family: Moslehi

full_name: Javid J Moslehi

given: Javid J

family: Salem

full_name: Joe-Elie Salem

given: Joe-Elie

family: Sosman

full_name: Jeffrey A Sosman

given: Jeffrey A

family: Lebrun-Vignes

full_name: Bénédicte Lebrun-Vignes

given: Bénédicte

family: Johnson

full_name: Douglas B Johnson

given: Douglas B

journal_name: The Lancet

oa_colors: green hybrid

version: acceptedVersion

ReferenceCitation: Moslehi JJ, Salem JE, Sosman JA, Lebrun-Vignes B, Johnson DB. Reporting of immune checkpoint inhibitor-associated myocarditis - Authors' reply. Lancet. 2018 Aug 4;392(10145):384-385. doi: 10.1016/S0140-6736(18)31556-3.

title: Reporting of immune checkpoint inhibitor-associated myocarditis – Authors' reply

ReferenceCitation: Salem JE, Manouchehri A, Moey M, Lebrun-Vignes B, Bastarache L, Pariente A, Gobert A, Spano JP, Balko JM, Bonaca MP, Roden DM, Johnson DB, Moslehi JJ. Cardiovascular toxicities associated with immune checkpoint inhibitors: an observational, retrospective, pharmacovigilance study. Lancet Oncol. 2018 Dec;19(12):1579-1589. doi: 10.1016/S1470-2045(18)30608-9. Epub 2018 Nov 12.

family: Manouchehri

full_name: Ali Manouchehri

given: Ali

family: Moey

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.


title: Elderly Cancer Patient: ELCAPA Cohort Survey

acronym: ELCAPA

summary:
The management of older patients with cancer has become a major public health concern in Western countries because of the aging of the population and steady increase in cancer incidence with advancing age. Cancer treatment of aged patients is complex due to comorbidities, polypharmacy and functional status. The heterogeneity of the older population in terms of comorbidities and functional status may explain the difficulty in establishing management recommendations.

Study hypothesis is that a geriatric consultation using Geriatric Assessment (GA) can evaluate patient's resource and strengths, in order to help oncologist to define the most effective treatment. The GA developed by geriatricians and recommended by the International Society of Geriatric Oncology (SIOG), is a multidimensional assessment of general health status; comorbidities; functional status; nutritional, cognitive, psychological, and social parameters; and medications. The GA uses validated geriatric scales to produce an inventory of problems, which can then serve to develop an individualized geriatric intervention plan; it may be an important step in selecting elderly patients for cancer screening and treatment.

The objectives are:

To assess the role of GA for decision making process for older patients with cancer
To identify geriatric and oncologic factors associated with overall survival, treatment feasibility, toxicities, morbidities
To develop and/or validate screening tests for frailty in geriatric oncology
To develop and validate frailty classifications

Method: The ELCAPA (ELderly CAncer PAtient) survey is a French multicentric prospective study that includes all patients age 70 years or older who has a diagnosis of solid cancer or hematologic malignancies in French hospitals

ReferenceCitation: Martinez-Tapia C, Diot T, Oubaya N, Paillaud E, Poisson J, Gisselbrecht M, Morisset L, Caillet P, Baudin A, Pamoukdjian F, Broussier A, Bastuji-Garin S, Laurent M, Canouï-Poitrine F. The obesity paradox for mid- and long-term mortality in older cancer patients: a prospective multicenter cohort study. Am J Clin Nutr. 2020 Sep 5. pii: nqaa238. doi: 10.1093/ajcn/nqaa238. [Epub ahead of print]

name: IMRB-EA 7376 CEpiA (Clinical Epidemiology and Ageing Unit), Paris-Est Créteil University (UPEC), Créteil, France

family: Martinez-Tapia

full_name: Claudia Martinez-Tapia

given: Claudia

family: Diot

full_name: Thomas Diot

given: Thomas

name: Public Health Department, Public Assistance—Paris Hospitals (AP-HP), Henri-Mondor Hospital, Créteil, France

family: Oubaya

full_name: Nadia Oubaya

given: Nadia

family: Paillaud

full_name: Elena Paillaud

given: Elena

family: Poisson

full_name: Johanne Poisson

given: Johanne

name: Onco-Geriatric Department, Public Assistance—Paris Hospitals (AP-HP), Georges-Pompidou European Hospital (HEGP), Paris, France

family: Gisselbrecht

full_name: Mathilde Gisselbrecht

given: Mathilde

name: Oncogeriatrics Coordination Unit, Curie Institute, Paris, France

family: Morisset

full_name: Laure Morisset

given: Laure

family: Caillet

full_name: Philippe Caillet

given: Philippe

name: Clinical Research Unit (URC Mondor), Public Assistance—Paris Hospitals (AP-HP), Henri-Mondor Hospital, Créteil, France

family: Baudin

full_name: Aurélie Baudin

given: Aurélie

name: Coordination Unit in Geriatric Oncology, Geriatric Department, Public Assistance—Paris Hospitals (AP-HP), Avicenne Hospital, Bobigny, France

family: Pamoukdjian

full_name: Fréderic Pamoukdjian

given: Fréderic

name: Department of Geriatrics, Public Assistance—Paris Hospitals (AP-HP), Henri-Mondor Hospital/Emile Roux Hospital, Créteil, France

family: Broussier

full_name: Amaury Broussier

given: Amaury

family: Bastuji-Garin

full_name: Sylvie Bastuji-Garin

given: Sylvie

name: Internal Medicine and Geriatric Department, Public Assistance—Paris Hospitals (AP-HP), Henri-Mondor Hospital, Créteil, France

family: Laurent

full_name: Marie Laurent

given: Marie

family: Canouï-Poitrine

full_name: Florence Canouï-Poitrine

given: Florence

journal_name: The American Journal of Clinical Nutrition

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


title: Validation of the French Version of the Pain Sensitivity Questionnaire

acronym: PSQ-F

summary: The Pain Sensitivity Questionnaire (PSQ) is a tool created in 2009 by Dr. R. Ruscheweyh in Germany. It aims at identifying the natural sensitivity to pain, through a set of 17 simple questions. These questions simulate daily life situations likely to induce pain of various intensities. The internal validity of the tool had been demonstrated both for the original version in German, and then for its English version. The external validity had also been demonstrated by correlation to real nociceptive stimulations applied to healthy volunteers (German version), and to patients before surgery (English version). A French validation of the questionnaire is needed, in order to integrate it in pain research programs in French-speaking countries.

ReferenceCitation: Dualé C, Bauer U, Storme B, Eljezi V, Ruscheweyh R, Eschalier S, Dubray C, Guiguet-Auclair C. Transcultural adaptation and French validation of the Pain Sensitivity Questionnaire. Can J Anaesth. 2019 Oct;66(10):1202-1212. doi: 10.1007/s12630-019-01377-w. Epub 2019 Apr 24.

ReferenceCitation: Duale C, Leray V, Giron F, Boulliau S, Macian N, Ruscheweyh R, Dubray C, Giraudet F. The Added Value of Sensitivity to Nonnoxious Stimuli to Predict an Individual's Sensitivity to Pain. Pain Physician. 2021 Sep;24(6):E783-E794.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Assessment and Follow-up of Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Nivolumab Under the French Temporary Authorization for Use (ATU) Program

acronym: CLINIVO

summary: Our study sought to examine nivolumab efficacy and safety in advanced NSCLC patients treated under the Temporary Authorization for Use (ATU, compassionate use) setting and describe their long-term clinical characteristics, notably the treatments they received after nivolumab discontinuation. The profile of these patients shows greater conformity to that of a non-selected population, yet the clinical data collection does not reflect "real life" conditions and stops when treatment ends, which does not enable us to get an overview of post-immunotherapy treatments.

location_facility:
CH Le Mans
Clinique Saint Joseph
CHU d'Angers
CH de Pau
Centre Jean Perrin
CHU de Clermont-Ferrand
CHI Toulon La Seyne Sur Mer
CHRU de Tours
CHU Bretagne Atlantique
CH de Pontoise
CH de Blois
CHI de Créteil
NHC CHRU de Strasbourg
CHU de Besançon
CHR Saint-Omer
Hôpital Tenon APHP
CH Annecy Genevois
Hôpital Paul Brousse APHP
ICL Lucien Neuwirth
Hôpital Bicêtre APHP
HIA Val de Grâce
CHU de Bordeaux
CH Argenteuil
Hôpital Avicenne APHP
ICO René Gauducheau
CH de Valence
CH de Saint-Brieuc
Hôpital Foch
Gustave Roussy
CH d'Avignon
CH du Pays d'Aix
CHU de Caen
Hôpital Pradel HCL
Hôpital Saint Louis APHP
CHU Toulouse
Hôpital Nord-Ouest
CHU Grenoble Alpes
HP Clairval
CHU de Nantes
CHU Nîmes
Hôpital Saint Joseph
CH Briançon
Polyclinique de Limoges
HP Robert Schumann
Centre d'Oncologie de Gentilly
CHD Vendée
CHU d'Amiens-Picardie
CH de la Côte Basque
CH Alpes Léman
Institut Daniel Hollard
GRH Mulhouse Sud-Alsace
Nice CLCC
Hegp Aphp
HIA Saint Anne
CH de Belfort Montbéliard
Centre Georges-François Leclerc
Centre Léon Bérard
HIA Percy
HIA Begin
CHRU de Lille
CH Métropole Savoie
CH de Dax
CHU de Limoges
CH de Mont-De-Masan
CHR d'Orléans
Hôpital Nord APHM
CH de Versailles
CH Lyon-Sud HCL
Clinique du Rambot
Institut Sainte Catherine
Clinique des Cèdres
Caen CLCC