title: Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer.

summary: This multicenter, prospective, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in first-line therapy in elderly patients with metastatic colorectal cancer. Data will be collected from eligible patients for24 months.

ReferenceCitation: François E, Mineur L, Deplanque G, Laplaige P, Smith D, Gourgou S, Tanang A, Ionescu-Goga M, Veerabudun K, Lelarge Y, Kim S, Rollot F. Efficacy and Safety of Bevacizumab Combined With First-Line Chemotherapy in Elderly (≥75 Years) Patients With Metastatic Colorectal Cancer: A Real-World Study. Clin Colorectal Cancer. 2020 Sep;19(3):e100-e109. doi: 10.1016/j.clcc.2020.02.009. Epub 2020 Apr 13.

family: François

full_name: Eric François

given: Eric

family: Mineur

full_name: Laurent Mineur

given: Laurent

family: Deplanque

full_name: Gaël Deplanque

given: Gaël

family: Laplaige

full_name: Philippe Laplaige

given: Philippe

family: Smith

full_name: Denis Smith

given: Denis

family: Gourgou

full_name: Sophie Gourgou

given: Sophie

family: Tanang

full_name: Alexandre Tanang

given: Alexandre

family: Ionescu-Goga

full_name: Miruna Ionescu-Goga

given: Miruna

family: Veerabudun

full_name: Kalaivani Veerabudun

given: Kalaivani

family: Lelarge

full_name: Yoann Lelarge

given: Yoann

family: Kim

full_name: Stefano Kim

given: Stefano

family: Rollot

full_name: Florence Rollot

given: Florence

journal_name: Clinical Colorectal Cancer

lead_sponsor: Hoffmann-La Roche

location_facility: Polyclinique Du Languedoc; Chimiotherapie

location_facility: Hopital De La Croix Rousse;Hepato Gastro Entero

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

location_facility: Hopital Prive Du Vert Galant; Cons Specialisees

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Hopital Cote De Nacre; Gastro Enterologie

location_facility: Clinique Saint Francois; Oncologie Medicale

location_facility: Clinique Du Docteur Maymard; Hopital De Jour Chimiotherapie

location_facility: Clinique Du Parc; Centre de Radiotherapie Gray

location_facility: Ch De Saint Quentin; Gastro Enterologie Endoscopie

location_facility: Clinique Claude Bernard; Onco Hematologie

location_facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Clinique Sainte Catherine; Hopital De Semaine

location_facility: Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie

location_facility: Ctre Hosp Des Vals D Ardeche; Medecine C

location_facility: Hopital Saint Antoine; Oncologie Medicale

location_facility: Polyclinique Saint Come; Hopital De Jour Oncologie

location_facility: Clinique Des 4 Pavillons; Chimiotherapie

location_facility: Ch Lyon Sud; Chir Visc Sect Jules Courmont

location_facility: CH Pitie Salpetriere; Hepathologie Gastro Enterologie

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Ghi Le Raincy Montfermeil; Radiotherapie Oncologie

location_facility: Clinique sainte marie; chimiotherapie ambulatoire

location_facility: Ghi Le Raincy Montfermeil; Gastro Medecine Interne

location_facility: Hopital Prive Paul d Egine; Chimiotherapie Ambulatoire

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Ch Arrondissement De Montreuil; Medecine 1

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Polyclinique De La Louviere; Chimiotherapie

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

location_facility: Clinique D Occitanie; Chimiotherapie Ambulatoire

location_facility: Clinique Mutualiste Bonneveine; Oncologie Medicale

location_facility: Polyclinique Francheville; MED CHIMIOTHERAPIE RADIOTHERAPIE

location_facility: Medipole De Savoie; Departement Oncologie

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Clinique Pasteur; Oncologie Medicale, Hematologie

location_facility: Ch De Montelimar; Gastro Enterologie Oncologie

location_facility: Hopital Victor Jousselin; Gastro Enterologie

location_facility: Memorial France Etats Unis; Hopital De Jour

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

location_facility: Hopital Jacques Monod; Hopital De Semaine Unite 53

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

location_facility: Hopital Alpha Sante De Hayange; Medecine B

location_facility: Chi Eure Seine D Evreux; Oncologie Conventionnelle

location_facility: Hopital Joseph Ducuing; Medecine Interne

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Hopital Prive Jean Mermoz; Gastro Enterologie Hepatologie

location_facility: Hopital Prive Armand Brillard; Groupe Sein Paris Est

location_facility: Chi De Frejus Saint Raphael; Hopital De Jour

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Clinique Chir De L Orangerie; Chimiotherapie

location_facility: Ch Lyon Sud; Gastro Secteur Jules Courmont

location_facility: Centre Hospitalier Dr Duchenne; Hepato Gastro Enterologie

location_facility: Hopital Yves Le Foll; Hematologie Oncologie

location_facility: Centre Hospitalier Saint Louis; Oncologie Medicale

location_facility: Hopital Timone Adultes; Oncologie Digestive

location_facility: Clin Mut De Lyon Eugene Andre; Hopital De Jour 1er B

location_facility: Clinique Anne D Artois; Gastro Enterologie

location_facility: Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie

location_facility: Hopital De Falconaja Furiani; Hopital De Jour

location_facility: Infirmerie Protestante; Endos Digestive Coelioscopie

location_facility: Fondation Maison Sante Bagatelle; Gastro Enterologie

location_facility: Hopitaux Du Leman Site Thonon; Gastro Enterologie

location_facility: Gh Mutualiste Les Portes Du Sud; Gastro-Enterologie

location_facility: Hopital Edouard Herriot; Pavillon E Oncologie Medicale

location_facility: Hop Europeen Georges Pompidou; Gastro Enterologie

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Centre Hospitalier de La Cote Basque; Oncologie

location_facility: Hopital Saint Jean; Hospitalisation Oncologie

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: Pole Sante Republique;Oncologie Hematologie

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Polyclinique de Blois; Chimiotherapie Ambulatoire

location_facility: CH Prive Clairval; Chimiotherapie Ambulatoire


title: PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment: A Feasibility and Safety Study ODYSSEE STUDY

acronym: ODYSSEE

summary: The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order to restore the balance of their intestinal microbiome and thereby eradicate treatment-induced multidrug resistant bacteria (MDRB), infection-related complications, as well as sequelae to the gastrointestinal tract. Therefore, the investigators propose to perform a single-arm multicentre prospective fecal microbiota transplantation (FMT) trial in AML patients receiving intensive chemotherapy, and who are usually heavily treated with broad-spectrum antibiotics during aplasia that generate a profound status of dysbiosis. For this purpose, at the time of admission and AML diagnosis, patients will be requested to donate stools that will be comprehensively screened, and if deemed appropriate according to protocol criteria, conditioned and stored frozen until future processing and transplantation after aplasia completion.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Malard F, Vekhoff A, Lapusan S, Isnard F, D'incan-Corda E, Rey J, Saillard C, Thomas X, Ducastelle-Lepretre S, Paubelle E, Larcher MV, Rocher C, Recher C, Tavitian S, Bertoli S, Michallet AS, Gilis L, Peterlin P, Chevallier P, Nguyen S, Plantamura E, Boucinha L, Gasc C, Michallet M, Dore J, Legrand O, Mohty M. Gut microbiota diversity after autologous fecal microbiota transfer in acute myeloid leukemia patients. Nat Commun. 2021 May 25;12(1):3084. doi: 10.1038/s41467-021-23376-6.

family: Malard

full_name: Florent Malard

given: Florent

sequence: first

family: Vekhoff

full_name: Anne Vekhoff

given: Anne

sequence: additional

family: Lapusan

full_name: Simona Lapusan

given: Simona

family: Isnard

full_name: Francoise Isnard

given: Francoise

family: D’incan-Corda

full_name: Evelyne D’incan-Corda

given: Evelyne

family: Rey

full_name: Jérôme Rey

given: Jérôme

family: Saillard

full_name: Colombe Saillard

given: Colombe

family: Thomas

full_name: Xavier Thomas

given: Xavier

family: Ducastelle-Lepretre

full_name: Sophie Ducastelle-Lepretre

family: Paubelle

full_name: Etienne Paubelle

given: Etienne

family: Larcher

full_name: Marie-Virginie Larcher

given: Marie-Virginie

family: Rocher

full_name: Clément Rocher

given: Clément

family: Recher

full_name: Christian Recher

given: Christian

family: Tavitian

full_name: Suzanne Tavitian

given: Suzanne

family: Bertoli

full_name: Sarah Bertoli

given: Sarah

family: Michallet

full_name: Anne-Sophie Michallet

given: Anne-Sophie

family: Gilis

full_name: Lila Gilis

given: Lila

family: Peterlin

full_name: Pierre Peterlin

given: Pierre

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

family: Nguyen

full_name: Stéphanie Nguyen

given: Stéphanie

family: Plantamura

full_name: Emilie Plantamura

given: Emilie

family: Boucinha

full_name: Lilia Boucinha

given: Lilia

family: Gasc

full_name: Cyrielle Gasc

given: Cyrielle

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

location_facility:
Hopital Saint Antoine
HCL Lyon Sud
IPC
CHU Nantes


type: Other Identifier

title: Can the Use of the McGRATH® MAC Videolaryngoscope Decrease the Number of People Required for Tracheal Intubation in a Population of Patients Without Predicted Difficult Intubation?

summary: The main objective of this study is to compare the proportion of tracheal intubations for which more than one person is necessary when using the McGRATH® MAC videolaryngoscope.

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Other

ipd_sharing: Yes

ipd_sharing_description: Data will be available in the Dryad repository.

lead_sponsor: Hopital Foch

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Hemocontrol's Effectiveness in a RAndomized Controlled Trial on the Reduction of Cardiovascular Long-term EventS

acronym: HERACLES

summary: It is hypothesized that a consistent use of the Hemocontrol TM biofeedback function improves long-term cardiovascular outcome, mediated by reduced hypertension due to fluid overload and by reduced incidence of intradialytic hypotensive episodes

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_country: Italy Canada France

status_simplified: Unknown


title: Assessing the Impact of an Educational Personalized Clinical Support Device Preventive and a Referent Nurse in Surgery for Obesity With the Risk of Occurrence of Dumping Syndrome After Gastric Bypass.

acronym: IRCO

summary: The postprandial dumping syndrome is a frequent consequence of Roux-en-Y Gastric ByPass due to the rapid emptying of the stomach remnant in to the intestinal lumen. Dumping-related symptoms occur very early after eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most prominent in the early postoperative period. This syndrome very debilitating for the patient can be improved by dietary and nutritional recommendations. We hypothesize that a personalized approach based on dietary and nutritional recommendations conducted by a nurse would likely to decrease the frequency of dumping syndrome and improve the postoperative quality of life of patients in the early postoperative period.

ipd_sharing: No

lead_sponsor: University Hospital, Lille

location_facility:
Ch Boulogne-Sur-Mer
Ch de Valenciennes
CH ARRAS
Hôpital Claude Huriez, CHRU

intervention_type: Behavioral


title: Multi-center Study Evaluating Persistence of Hepatitis B Virus Replication, Long-term Prognostic Indicators and Their Clinical Relevance in Patients Co-infected With the Human Immunodeficiency Virus and Chronic Hepatitis B

acronym: COVViB

summary: The overarching purpose of this study is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses.

study_type: Observational

time_perspective: Other

ReferenceType: background

ReferenceCitation: Boyd A, Gozlan J, Miailhes P, Lascoux-Combe C, Cam MS, Rougier H, Zoulim F, Girard PM, Lacombe K. Rates and determinants of hepatitis B 'e' antigen and hepatitis B surface antigen seroclearance during long-term follow-up of patients coinfected with HIV and hepatitis B virus. AIDS. 2015 Sep 24;29(15):1963-73. doi: 10.1097/QAD.0000000000000795.

ReferenceCitation: Boyd A, Gozlan J, Maylin S, Delaugerre C, Peytavin G, Girard PM, Zoulim F, Lacombe K. Persistent viremia in human immunodeficiency virus/hepatitis B coinfected patients undergoing long-term tenofovir: virological and clinical implications. Hepatology. 2014 Aug;60(2):497-507. doi: 10.1002/hep.27182. Epub 2014 Jun 20.

ReferenceCitation: Lacombe K, Massari V, Girard PM, Serfaty L, Gozlan J, Pialoux G, Mialhes P, Molina JM, Lascoux-Combe C, Wendum D, Carrat F, Zoulim F. Major role of hepatitis B genotypes in liver fibrosis during coinfection with HIV. AIDS. 2006 Feb 14;20(3):419-27.

ipd_sharing_description: Data will only be made available upon official request, pending approval by the Scientific Committee.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility: Centre hospitalier universitaire de Lyon

intervention_type: Other

lead_sponsor_type: industriel


title: Combination Study of Pioglitazone and Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia Patients After Failure of a First TKIs Discontinuation Attempt in Order to Prepare a New Stop

summary:
Single-center study, prospective, phase II trial.

The study objectives are :

To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects who experience a loss of MMR following a first TKI discontinuation.
To assess survival without loss of MMR over a 12 months period following a second TKI discontinuation in subjects who achieve or maintain < MR4.5 with the combination PIO and TKI administered for at least 6 months.

lead_sponsor: Versailles Hospital

location_facility:
CHU de Rennes
Hôpital Bicêtre
CHU de Nantes
Centre Hospitalier de Versailles

intervention_type: Drug


acronym: GLAUS

summary:
Glaucoma is a progressive optical neuropathy, generally associated with ocular hypertension. The treatment aims to stabilize the visual field deficiencies by lowering the intraocular pressure. Due to the fluctuation of the visual field test and re-test measures, the European recommendations are to obtain 6 visual field tests in 2 years (or one every 4 months) in order to know if the pathology is progressing despite the current treatment (or if the treatment is necessary, in cases of intraocular hypertensions). The lack of ophthalmologists renders the monitoring of a beginning glaucoma, rarely compatible with the present recommendations. It is therefore crucial to evaluate new therapeutic alternatives, when faced to a decreasing medical demography and an increase the patient's needs.

This study should allow to validate the possibility to delegate monitoring tasks to orthoptists during glaucoma surveillance. To organize the delegation of this surveillance to orthoptists would permit a better distribution of the ophthalmologist's activities.

status: Active, not recruiting

time_perspective: Prospective

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A de Rothschild

status_simplified: Ongoing


title: Evaluation of the Efficacy of Intramuscular Islet Autograft After Extensive Pancreatectomy

acronym: AUTOGRAFTIM

summary: The liver may not be an optimal site for islet transplantation due to obstacles by an instant blood-mediated inflammatory response, and low revascularization of transplanted islets. Therefore, intramuscular islet transplantation offers an attractive alternative, based on its simplicity, enabling easier access for noninvasive graft imaging and cell explantation.

status: Recruiting

location_facility:
CHRU, Hôpital Claude Huriez
Chu Amiens Picardie
Institut Paoli Calmettes
CHU Rouen


title: Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

acronym: LaparoDAN

summary:
Gastroschisis is a rare congenital malformation consisting in a right para-umbilical defect of the abdominal wall leading to an evisceration of the abdominal content. About 25% of the cases are associated with intestinal malformation, leading to an increase in peri-natal morbidity and mortality. No prospective study has been able to definitely describe predictive factors for complicated gastroschisis on prenatal ultrasound examinations.

The aim of the current study is to prospectively look for US prenatal features predictive of complicated gastroschisis, on a national multicentric cohort.

Patients will be included during the 22 weeks of amenorrhea (WA) ultrasound examination, and pre- and postnatal clinical data will be recorded up to the 6th months of the child.

Data will then be analysed and compared in the groups of simple or complicated gastroschisis, in order to define pre-natal prognostic factors, to correlate them with specific prognosis, and to might better determine specific strategies for better care of these patients.

ReferenceType: result

ReferenceCitation: Geslin D, Clermidi P, Gatibelza ME, Boussion F, Saliou AH, Le Manac'h Dove G, Margaryan M, De Vries P, Sentilhes L, Levard G, Lardy H, Arnaud A, Leclair MD, Podevin G, Schmitt F. What prenatal ultrasound features are predictable of complex or vanishing gastroschisis? A retrospective study. Prenat Diagn. 2017 Feb;37(2):168-175. doi: 10.1002/pd.4984. Epub 2017 Jan 25.

name: Paediatric Surgery Department; University Hospital of Angers; Angers France

name: Paediatric Surgery Department; University Hospital of Lyon; Lyon France

family: Geslin

full_name: Dorothée Geslin

given: Dorothée

name: Paediatric Surgery Department; University Hospital of Nantes; Nantes France

name: Paediatric Surgery Department; Robert Debré University Hospital; Paris France

family: Clermidi

full_name: Pauline Clermidi

given: Pauline

name: Paediatric Surgery Department; University Hospital of Poitiers; Poitiers France

name: Paediatric Surgery Department; University Hospital of Rennes; Rennes France

family: Gatibelza

full_name: Marie-Eve Gatibelza

given: Marie-Eve

name: Department of Obstetrics and Gynecology; Angers University; Angers France

family: Boussion

full_name: Françoise Boussion

given: Françoise

name: Department of Obstetrics and Gynecology; University Hospital of Brest; Brest France

family: Saliou

full_name: Anne-Hélène Saliou

given: Anne-Hélène

name: Paediatric Surgery Department; Le Mans Hospital; Le Mans France

family: Le Manac'h Dove

full_name: Gaëlle Le Manac'h Dove

given: Gaëlle

family: Margaryan

full_name: Marc Margaryan

given: Marc

name: Paediatric Surgery Department; University Hospital of Brest; Brest France

family: De Vries

full_name: Philine De Vries

given: Philine

name: Department of Obstetrics and Gynecology; University Hospital of Bordeaux; Bordeaux France

family: Sentilhes

full_name: Loïc Sentilhes

given: Loïc

family: Levard

full_name: Guillaume Levard

given: Guillaume

name: Paediatric Surgery Department; University Hospital of Tours; Tours France

family: Lardy

full_name: Hubert Lardy

given: Hubert

family: Arnaud

full_name: Alexis Arnaud

given: Alexis

family: Leclair

full_name: Marc-David Leclair

given: Marc-David

family: Podevin

full_name: Guillaume Podevin

family: Schmitt

full_name: Françoise Schmitt

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Prenatal Diagnosis

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Kassa AM, Lilja HE. Predictors of postnatal outcome in neonates with gastroschisis. J Pediatr Surg. 2011 Nov;46(11):2108-14. doi: 10.1016/j.jpedsurg.2011.07.012.

family: Kassa

full_name: Ann-Marie Kassa

given: Ann-Marie

family: Lilja

full_name: Helene Engstrand Lilja

given: Helene Engstrand

journal_name: Journal of Pediatric Surgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Kuleva M, Khen-Dunlop N, Dumez Y, Ville Y, Salomon LJ. Is complex gastroschisis predictable by prenatal ultrasound? BJOG. 2012 Jan;119(1):102-9. doi: 10.1111/j.1471-0528.2011.03183.x. Epub 2011 Oct 21.

family: Kuleva

full_name: M Kuleva

given: M

journal_name: BJOG: An International Journal of Obstetrics & Gynaecology

location_facility:
University Hospital of Trousseau
University Hospital of Lens
University Hospital of René Dubos
University Hospital of Saint-Etienne
University Hospital of Reims
University Hospital of Le Mans
University Hospital of Orléans
University Hospital of Marseille
University Hospital of Robert Debré
University Hospital of Bicêtre
University Hospital of Amiens
University Hospital of Brest
University Hospital of Lille
University Hospital of Lyon
University Hospital of Clermont-Ferrand
University Hospital of Le Havre
University Hospital of Poitiers
University Hospital of Rennes
University Hospital of Angers
University Hospital of Strasbourg
University Hospital of Fort de France
University Hospital of Rouen
University Hospital of Caen
University Hospital of Montpellier
University Hospital of Toulouse
University Hospital of Nice
University Hospital of Nantes
University Hospital of Dijon
University Hospital of Nîmes
University Hospital of Bordeaux
University Hospital of Nancy
University Hospital of Besançon
University Hospital of Grenoble
University Hospital of Necker
University Hospital of Tours
University Hospital of Limoges


type: EudraCT Number

title: Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study.

acronym: HEMA-HTP

summary:
Pulmonary hypertension (PHT) patients often receive long term oral anticoagulants. If the indication is strong, in the secondary chronic thrombo-embolism pulmonary hypertension (CTE-PHT) prevention, the frequent prescription (50 to 90% of patients) contrasts with their low level of proof in the PHT. Last but not least, anticoagulants are known to be the principal cause of iatrogenic hospitalization (major bleeding).

In this study, patients are all followed during one year, to determine the annual frequency of major bleedings (according to the International Society on Thrombosis and Haemostasis (ISTH) international definition). Each event notified is validated by an independent committee for clinical events.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Grenoble
Hospices Civils de Lyon
CHU de Saint-Etienne
CHU Clermont-Ferrand


title: Performance of Diuretic Stress Test in Predicting Short Term Renal Recovery in Oliguric Critically-ill Patients

summary:
Acute kidney injury (AKI) is a common disorder and associated with high morbidity and mortality. However, distinguishing transient AKI from persistent AKI may help in individualizing treatment and limit short and long term consequences of AKI. Previous studies suggested usual urinary indices to perform poorly for separating transient from persistent AKI in an unselected population of critically ill patients. The recent KDIGO (Kidney Disease Improving Global Outcomes) guidelines underlined the need for additional strategies in estimating renal short term prognosis.

Recently, a Furosemide stress test (FST) was validated in a cohort of unselected critically ill patients. This stress test performance was found to be good in predicting capacity to identify those patients that will progress to advanced stage AKI. Additionally, FST performance was higher than those of usual renal biomarker. The limited sample size of this preliminary study however precluded adjustment for usual confounders including oliguria.

The primary objective of this study is to assess diagnostic performance of FST in differentiating transient and persistent AKI. Secondary objectives are to assess diagnostic performance of FST in predicting need for renal replacement therapy, and to confirm FST results after adjustment for confounders.

status: Terminated

primary_purpose: Diagnostic

location_facility:
CHRU de STRASBOURG
CHU de MONTPELLIER
CHU de SAINT-ETIENNE
CHU de CLERMONT-FERRAND


title: Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients

acronym: CLOT-CRANE

summary: This prospective, randomized, multicenter study is performed to determine whether prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult neurological patients with coagulation disorders (PT value less than 60%).

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)


ReferenceCitation: Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Coutre S, Loscertales J, Taylor K, Vandenberghe E, Wach M, Wagner-Johnston N, Ysebaert L, Dreiling L, Dubowy R, Xing G, Flinn IW, Owen C. Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial. Lancet Haematol. 2017 Mar;4(3):e114-e126. doi: 10.1016/S2352-3026(17)30019-4.

family: Jones

full_name: Jeffrey A Jones

given: Jeffrey A

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

family: Brown

full_name: Jennifer R Brown

given: Jennifer R

family: Awan

full_name: Farrukh T Awan

given: Farrukh T

family: Badoux

full_name: Xavier Badoux

given: Xavier

family: Coutre

full_name: Steven Coutre

given: Steven

family: Loscertales

full_name: Javier Loscertales

given: Javier

family: Taylor

full_name: Kerry Taylor

given: Kerry

family: Vandenberghe

full_name: Elisabeth Vandenberghe

given: Elisabeth

family: Wach

full_name: Malgorzata Wach

given: Malgorzata

family: Wagner-Johnston

full_name: Nina Wagner-Johnston

given: Nina

family: Ysebaert

full_name: Loic Ysebaert

given: Loic

family: Dreiling

full_name: Lyndah Dreiling

given: Lyndah

family: Dubowy

full_name: Ronald Dubowy

given: Ronald

family: Xing

full_name: Guan Xing

given: Guan

family: Flinn

full_name: Ian W Flinn

given: Ian W

family: Owen

full_name: Carolyn Owen

given: Carolyn

journal_name: The Lancet Haematology

ReferenceCitation: Jones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 02 - 06 June; Chicago, IL.

ReferenceCitation: Jones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster 7023]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May - 02 June; Chicago, IL.

ReferenceCitation: Robak T, Jones J, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 213]. 21st Congress of the European Hematology Association (EHA); 2015 09-12 June; Copenhagen, Denmark.

ReferenceCitation: Robak T, Wach M, Jones J, Owen C, Brown J, Menter A, et al. Results Of A Phase 3 Randomized Controlled Study Evaluating The Efficacy And Safety Of Idelalisib (Idela) In Combination With Ofatumumab (Ofa) For Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster LB598]. 20th Congress of the European Hematology Association (EHA); 2015 11-14 June; Vienna, Austria.

ReferenceCitation: Flinn I, Kimby E, Cotter FE, Giles FJ, Janssens A, Pulczynski EJ, et al. A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster TPS7131]. American Society of Clinical Oncology (ASCO); 2013 May 31-June 4; Chicago, IL.

ReferenceCitation: Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.

name: Oregon Health and Science University Portland OR USA

family: Gordon

full_name: Max J. Gordon

given: Max J.

family: Huang

full_name: Julie Huang

given: Julie

family: Chan

full_name: Rebecca J. Chan

given: Rebecca J.

family: Bhargava

full_name: Pankaj Bhargava

given: Pankaj

name: City of Hope National Medical Center Duarte CA USA

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
United States
Sweden
France
Poland
Ireland
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Kaiser Permanente Vallejo Medical Center

location_facility: Centre Hospitalier Universitaire Hôpital Avicenne

location_facility: Center Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Montréal

location_facility: Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi

location_facility: Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)

location_facility: Haematology and Oncology Clinics of Australia at Mater

location_facility: Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)

location_facility: The Ohio State University Medical Center

location_facility: California Cancer Associates for Research and Excellence (CCARE)

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Samodzielny Publiczny Szpital Kliniczny N1 Klinika

location_facility: Collegium Medicum Uniwersytetu Jagiellonskiego w K

location_facility: Wojewódzki Szpital Specjalistyczny im. Janusza Kor

title: A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).


title: STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

summary: In patients ≥ 60yrs with acute ST-elevation myocardial infarction randomised within 3 hours of onset of symptoms the efficacy and safety of a strategy of early fibrinolytic treatment with half-dose tenecteplase and additional antiplatelet therapy with a loading dose of 300 mg clopidogrel, aspirin and coupled with antithrombin therapy followed by catheterisation within 6-24 hours or rescue coronary intervention as required, will be compared to a strategy of primary PCI with a P2Y12 antagonist and antithrombin treatment according to local standards.

ReferenceCitation: Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.

family: Armstrong

full_name: Paul W. Armstrong

given: Paul W.

family: Gershlick

full_name: Anthony H. Gershlick

given: Anthony H.

family: Goldstein

full_name: Patrick Goldstein

given: Patrick

family: Wilcox

full_name: Robert Wilcox

given: Robert

family: Danays

full_name: Thierry Danays

given: Thierry

family: Lambert

full_name: Yves Lambert

given: Yves

family: Sulimov

full_name: Vitaly Sulimov

given: Vitaly

family: Rosell Ortiz

full_name: Fernando Rosell Ortiz

given: Fernando

family: Ostojic

full_name: Miodrag Ostojic

given: Miodrag

family: Welsh

full_name: Robert C. Welsh

given: Robert C.

family: Carvalho

full_name: Antonio C. Carvalho

given: Antonio C.

family: Nanas

full_name: John Nanas

given: John

family: Arntz

full_name: Hans-Richard Arntz

given: Hans-Richard

family: Halvorsen

full_name: Sigrun Halvorsen

given: Sigrun

family: Huber

full_name: Kurt Huber

given: Kurt

family: Grajek

full_name: Stefan Grajek

given: Stefan

family: Fresco

full_name: Claudio Fresco

given: Claudio

family: Bluhmki

full_name: Erich Bluhmki

given: Erich

family: Regelin

full_name: Anne Regelin

given: Anne

full_name: Katleen Vandenberghe

given: Katleen

family: Bogaerts

full_name: Kris Bogaerts

given: Kris

family: Van de Werf

full_name: Frans Van de Werf

given: Frans

title: Fibrinolysis or Primary PCI in ST-Segment Elevation Myocardial Infarction

ReferenceCitation: Sinnaeve PR, Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Lambert Y, Danays T, Soulat L, Halvorsen S, Ortiz FR, Vandenberghe K, Regelin A, Bluhmki E, Bogaerts K, Van de Werf F; STREAM investigators. ST-segment-elevation myocardial infarction patients randomized to a pharmaco-invasive strategy or primary percutaneous coronary intervention: Strategic Reperfusion Early After Myocardial Infarction (STREAM) 1-year mortality follow-up. Circulation. 2014 Sep 30;130(14):1139-45. doi: 10.1161/CIRCULATIONAHA.114.009570. Epub 2014 Aug 26.

name: From the Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium (P.R.S., K.V., F.V.d.W.); The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research (Canadian VIGOUR Centre), University of Alberta, Edmonton, Canada (P.W.A); NIHR, Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Trust, Leicester, United Kingdom (A.H.G.); Emergency Department and SAMU, Lille University Hospital, Lille, France (P.G.); the Department of...

publisher: Ovid Technologies (Wolters Kluwer Health)

title: ST–Segment-Elevation Myocardial Infarction Patients Randomized to a Pharmaco-Invasive Strategy or Primary Percutaneous Coronary Intervention

ReferenceCitation: Dianati Maleki N, Van de Werf F, Goldstein P, Adgey JA, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Westerhout CM, Armstrong PW. Aborted myocardial infarction in ST-elevation myocardial infarction: insights from the STrategic Reperfusion Early After Myocardial infarction trial. Heart. 2014 Oct;100(19):1543-9. doi: 10.1136/heartjnl-2014-306023. Epub 2014 Jun 10.

ReferenceCitation: Sinnaeve PR, Danays T, Bogaerts K, Van de Werf F, Armstrong PW. Drug Treatment of STEMI in the Elderly: Focus on Fibrinolytic Therapy and Insights from the STREAM Trial. Drugs Aging. 2016 Feb;33(2):109-18. doi: 10.1007/s40266-016-0345-6. Review.

location_country:
Chile
Serbia
Mexico
France
Australia
Russian Federation
Spain
Canada

location_facility: Groupe Hospitalier Sud Ile de France - CH de Melun - Service SAMU 77

location_facility: Tomsk Regional State Autonomous Healthcare Institution Emergency Care Station

location_facility: Hospital de Antequera, Unidad de Cuidados Intensivos

location_facility: Clinical Center Kragujevac, Cardiology Clinic

location_facility: Hospital Comarcal Axarquia, Unidad de Cuidados Intensivos

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Liverpool Hospital - Cardiology Department

location_facility: Hospital Serrania Ronda, Unidad de Cuidados Intensivos

location_facility: General Hospital "Dr. Laza K. Lazarevic" Sabac, Internal medicine department

location_facility: General Hospital "Sveti Luka" Smederevo, Dept of Internal Med - Cardiology Section

location_facility: Federal State Budgetary Scientific Inst "Tomsk Nat Research Med.Center of Russian Academy Sciences"

location_facility: Clinical Center of Serbia, Cardiology Clinic

location_facility: General Hospital Pancevo/Department of internal medicine - cardiology section

location_facility: General Hospital Jagodina/Intenal Medicine department

location_facility: Institute for cardiovascular diseases Dedinje, Cardiovascular research sector

location_facility: General Hospital Vrsac/Cardiology department with coronary unit

location_facility: CH Louis Pradel - Hospices civils de Lyon

location_facility: Institute for cardiovascular diseases Vojvodina - Sremska Kamenica, Cardiology Clinic

location_facility: Military Medical Academy, Clinic for Emergency Internal Medicine

location_facility: Hospital Virgen de la Victoria, Unidad de Cuidados Intensivos

location_facility: General Hospital Cuprija, Cardiology Department


title: Prevalence of Pressure Ulcers Among Critically Ill Patients and Factors Associated With Their Occurrence in the ICU

acronym: PRESSURE

summary: The prevalence of and risk factors for pressure ulcers (PUs) in critically ill patients have been poorly studied. The main objective of this study was to describe the prevalence of PUs in critically ill patients. Secondary objectives were to describe PUs, means of prevention of PUs, and factors associated with occurrence of PUs in the ICU.

time_perspective: Retrospective

lead_sponsor: French Society for Intensive Care

location_facility:
CHU Dijon Bourgogne
CHU Strasbourg
Hopital l'Archet
CHU d'Angers
CHU Poitiers
Grand Hopital de l'Est Francilien
Hopital Antoine Beclere
Hopital Européen Marseille
CHU Nantes
Groupe Hospitalier Sud Ile de France
Hopital Privé Claude Galien
CHU Kremlin-Bicetre
Hopital Francois Quesnay
CHU Necker Enfants Malades
Hopital Avicenne
CHU Marseille Hopital Nord
Hopital Notre-Dame de Bon Secours
Clinique de l'Union
CHU Réunion Saint Pierre
Cochin
Hopital Ambroise Pare
Hopital Mercy
HIA Desgenettes Lyon
Hopital St Louis
Hopital Privé du Vert Galan
Hopital Louis Mourier
Hôpital Saint-Esprit
CHU Henri Mondor
CHU Grenoble Alpes
Groupe Hospitalier Edouard Herriot
CHU Lapeyronie
Hopital Raymond Poincare
CHU Robert Debré
GH Diaconnesses Croix Saint Simon
HIA Béjin
Hopital Tenon
Hopital Privé du Val d'Yerres
CHU Nancy
Institut Gustave Roussy
HIA Robert Pique
Institut Mutualiste Montsouris
Hopital Delafontaine
Hopital Nord Franche Comté
Hopital Privé d'Antony
HIA Percy
CHU Pellegrin
Hopital Simone Veil
Hopital St-Andre
Hopital Saint Clair
CHU Toulouse Rangueil
Hopital Jean Bernard
Hopital Roger Salengro
Hopital de la Timone
Hopital Laennec
La Pitié Salpetriere
HEGP
HIA Clermont Tonnerre
CHU Nimes
Clinique des Cèdres
GHIRM


title: Identification of Genomic Loci Determining Susceptibility to the Development of High Myopia

acronym: ASSOMYP

summary: Compelling evidence of genetic components in high myopia has been put forward by several studies. Twin cohorts, familial linkage studies and population studies has described at least 10 loci containing genes involved in the disease development. The investigators previously demonstrated novel linkage on chromosome 7q36 and chromosome 7p15 in French families. A new approach consisting of a case-control based population association study is underway in order to recover a high number of myopic subjects avoiding the limitation of familial cases. 1.8 millions polymorphic markers will be compared with emmetropic controls in order to recover loci associated with the disease in the population.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Toulouse Hôpital Purpan
CHU Bordeaux Hôpital Pellegrin
CHU Pointe-à-Pitre
CHU Limoges Hôpital Dupuytren

intervention_type: Genetic


title: Selective Internal Radiation Therapy for Hepatocellular Carcinomas With Yttrium-90 Loaded Microspheres: Optimized Dosimetry Versus Standard Dosimetry

summary: The purpose of this study is to determine whether a treatment with Therasphere which is optimized is more efficient compared to a standard treatment for patients suffering from hepatocellular carcinomas.

ReferenceCitation: Garin E, Tselikas L, Guiu B, Chalaye J, Edeline J, de Baere T, Assenat E, Tacher V, Robert C, Terroir-Cassou-Mounat M, Mariano-Goulart D, Amaddeo G, Palard X, Hollebecque A, Kafrouni M, Regnault H, Boudjema K, Grimaldi S, Fourcade M, Kobeiter H, Vibert E, Le Sourd S, Piron L, Sommacale D, Laffont S, Campillo-Gimenez B, Rolland Y; DOSISPHERE-01 Study Group. Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Jan;6(1):17-29. doi: 10.1016/S2468-1253(20)30290-9. Epub 2020 Nov 7.

family: Garin

full_name: Etienne Garin

given: Etienne

family: Tselikas

full_name: Lambros Tselikas

given: Lambros

family: Guiu

full_name: Boris Guiu

given: Boris

family: Chalaye

full_name: Julia Chalaye

given: Julia

family: Edeline

full_name: Julien Edeline

given: Julien

family: de Baere

full_name: Thierry de Baere

given: Thierry

family: Assenat

full_name: Eric Assenat

given: Eric

family: Tacher

full_name: Vania Tacher

given: Vania

family: Robert

full_name: Corentin Robert

given: Corentin

family: Terroir-Cassou-Mounat

full_name: Marie Terroir-Cassou-Mounat

given: Marie

family: Mariano-Goulart

full_name: Denis Mariano-Goulart

given: Denis

family: Amaddeo

full_name: Giuliana Amaddeo

given: Giuliana

family: Palard

full_name: Xavier Palard

given: Xavier

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Kafrouni

full_name: Marilyne Kafrouni

given: Marilyne

family: Regnault

full_name: Hélène Regnault

given: Hélène

family: Boudjema

full_name: Karim Boudjema

given: Karim

family: Grimaldi

full_name: Serena Grimaldi

given: Serena

family: Fourcade

full_name: Marjolaine Fourcade

given: Marjolaine

family: Kobeiter

full_name: Hicham Kobeiter

given: Hicham

family: Vibert

full_name: Eric Vibert

family: Le Sourd

full_name: Samuel Le Sourd

given: Samuel

family: Piron

full_name: Lauranne Piron

given: Lauranne

journal_name: The Lancet Gastroenterology & Hepatology

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

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

location_facility:
Centre Eugène Marquis
Gustave Roussy
CHU Henri Mondor
CHU Saint Eloi


title: Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

acronym: OXYSET

summary: Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2 retention is believed to be reversal of preexisting regional hypoxic pulmonary vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and improve both urinary output and renal function.

location_facility:
CHU de la Pitié-Salpêtrière
CHU de SAINT-ETIENNE
CHU de CLERMONT-FERRAND
CHu de GRENOBLE


title: Innovation for Standard Identification for Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cance: Towards Development of Personalized Biomarkers in Clinical Oncology (PAIR HPV : Human PapillomaVirus)

acronym: PAIR HPV

summary: Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.

lead_sponsor: Institut Curie

location_facility:
Centre Jean Perrin
Institut Curie
Centre François Baclesse
CHU Besançon

intervention_type: Procedure


title: Evaluation of Trichoscopy in the Diagnosis of Tinea Capitis. Prospective, Multicenter Study (ETDT)

acronym: ETDT

summary: Waiting for a proof by mycological culture is usually necessary before starting a systemic antifungal therapy. It therefore seems to us interesting to evaluate the benefit of using dermoscopy in clinical diagnosis of Tinea Capitis.

ReferenceCitation: Zalaudek I, Argenziano G, Di Stefani A, Ferrara G, Marghoob AA, Hofmann-Wellenhof R, Soyer HP, Braun R, Kerl H. Dermoscopy in general dermatology. Dermatology. 2006;212(1):7-18. Review.

ReferenceCitation: Micali G, Lacarrubba F, Massimino D, Schwartz RA. Dermatoscopy: alternative uses in daily clinical practice. J Am Acad Dermatol. 2011 Jun;64(6):1135-46. doi: 10.1016/j.jaad.2010.03.010. Epub 2011 Feb 3. Review.

family: Micali

full_name: Giuseppe Micali

given: Giuseppe

family: Lacarrubba

full_name: Francesco Lacarrubba

given: Francesco

family: Massimino

full_name: Doriana Massimino

given: Doriana

family: Schwartz

full_name: Robert A. Schwartz

given: Robert A.

journal_name: Journal of the American Academy of Dermatology

title: Dermatoscopy: Alternative uses in daily clinical practice

ReferenceCitation: Ekiz O, Sen BB, Rifaioğlu EN, Balta I. Trichoscopy in paediatric patients with tinea capitis: a useful method to differentiate from alopecia areata. J Eur Acad Dermatol Venereol. 2014 Sep;28(9):1255-8. doi: 10.1111/jdv.12246. Epub 2013 Aug 24.

name: Department of Dermatology; School of Medicine; Mustafa Kemal University; Hatay

family: Ekiz

full_name: Ö. Ekiz

given: Ö.

family: Şen

full_name: B.B. Şen

family: Rifaioğlu

full_name: E.N. Rifaioğlu

name: Department of Dermatology; Keçiören Training and Research Hospital; Ankara Turkey

family: Balta

full_name: İ. Balta

given: İ.

journal_name: Journal of the European Academy of Dermatology and Venereology

title: Trichoscopy in Paediatric Patients with Tinea Capitis: A Useful Method to Differentiate from Alopecia Areata

ReferenceCitation: Hughes R, Chiaverini C, Bahadoran P, Lacour JP. Corkscrew hair: a new dermoscopic sign for diagnosis of tinea capitis in black children. Arch Dermatol. 2011 Mar;147(3):355-6. doi: 10.1001/archdermatol.2011.31.

family: Hughes

full_name: Rosalind Hughes

given: Rosalind

family: Chiaverini

full_name: Christine Chiaverini

given: Christine

family: Bahadoran

full_name: Philippe Bahadoran

given: Philippe

family: Lacour

full_name: Jean-Philippe Lacour

given: Jean-Philippe

journal_name: Archives of Dermatology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Corkscrew Hair: A New Dermoscopic Sign for Diagnosis of Tinea Capitis in Black Children

ReferenceCitation: Sandoval AB, Ortiz JA, Rodríguez JM, Vargas AG, Quintero DG. [Dermoscopic pattern in tinea capitis]. Rev Iberoam Micol. 2010 Sep 30;27(3):151-2. doi: 10.1016/j.riam.2010.02.003. Epub 2010 Mar 24. Spanish.

family: Crocker Sandoval

full_name: Ana Beatriz Crocker Sandoval

given: Ana Beatriz

family: Soto Ortiz

full_name: José Alfredo Soto Ortiz

given: José Alfredo

family: Mayorga Rodríguez

full_name: Jorge Mayorga Rodríguez

given: Jorge

title: Hallazgos dermoscópicos en tinea capitis

ReferenceCitation: Slowinska M, Rudnicka L, Schwartz RA, Kowalska-Oledzka E, Rakowska A, Sicinska J, Lukomska M, Olszewska M, Szymanska E. Comma hairs: a dermatoscopic marker for tinea capitis: a rapid diagnostic method. J Am Acad Dermatol. 2008 Nov;59(5 Suppl):S77-9. doi: 10.1016/j.jaad.2008.07.009.

title: Comma hairs: A dermatoscopic marker for tinea capitis

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Caen
CHRU Lille
CHU Amiens
CHU Rouen


title: Transthyretin Amyloidosis Outcomes Survey (THAOS): A Global, Multi-Center, Longitudinal, Observational Survey of Patients With Documented Transthyretin Gene Mutations or Wild-Type Transthyretin Amyloidosis.

acronym: THAOS

summary: THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin amyloidosis (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years. Patients will be followed as long as they are able to participate. The principal aims of this outcome survey are to better understand and characterize the natural history of the disease by studying a large and heterogenous patient population. Survey data may be used to develop new treatment guidelines and recommendations, and to inform and educate clinicians about the management of this disease.

ReferenceCitation: Nativi-Nicolau J, Siu A, Dispenzieri A, Maurer MS, Rapezzi C, Kristen AV, Garcia-Pavia P, LoRusso S, Waddington-Cruz M, Lairez O, Witteles R, Chapman D, Amass L, Grogan M; THAOS Investigators. Temporal Trends of Wild-Type Transthyretin Amyloid Cardiomyopathy in the Transthyretin Amyloidosis Outcomes Survey. JACC CardioOncol. 2021 Oct 19;3(4):537-546. doi: 10.1016/j.jaccao.2021.08.009. eCollection 2021 Oct.

family: Nativi-Nicolau

full_name: Jose Nativi-Nicolau

given: Jose

family: Siu

full_name: Alfonso Siu

given: Alfonso

family: Dispenzieri

full_name: Angela Dispenzieri

given: Angela

family: Maurer

full_name: Mathew S. Maurer

given: Mathew S.

family: Rapezzi

full_name: Claudio Rapezzi

given: Claudio

family: Kristen

full_name: Arnt V. Kristen

given: Arnt V.

family: Garcia-Pavia

full_name: Pablo Garcia-Pavia

given: Pablo

family: LoRusso

full_name: Samantha LoRusso

given: Samantha

family: Waddington-Cruz

full_name: Márcia Waddington-Cruz

given: Márcia

family: Lairez

full_name: Olivier Lairez

given: Olivier

family: Witteles

full_name: Ronald Witteles

given: Ronald

family: Chapman

full_name: Doug Chapman

given: Doug

family: Amass

full_name: Leslie Amass

given: Leslie

family: Grogan

full_name: Martha Grogan

given: Martha

family: Barroso

full_name: Fabio Adrian Barroso

given: Fabio Adrian

family: Van Cleemput

full_name: Johan Van Cleemput

given: Johan

family: Fine

full_name: Nowell Fine

given: Nowell

family: Schmidt

full_name: Hartmut Schmidt

given: Hartmut

family: Gess

full_name: Burkhard Gess

given: Burkhard

family: Moelgaard

full_name: Henning Moelgaard

given: Henning

family: Planté-Bordeneuve

full_name: Violaine Planté-Bordeneuve

given: Violaine

family: Adams

full_name: David Adams

given: David

family: Inamo

full_name: Jocelyn Inamo

ReferenceCitation: González-Moreno J, Losada-López I, Cisneros-Barroso E, Garcia-Pavia P, González-Costello J, Muñoz-Beamud F, Campistol JM, Fernandez-Torron R, Chapman D, Amass L. A Descriptive Analysis of ATTR Amyloidosis in Spain from the Transthyretin Amyloidosis Outcomes Survey. Neurol Ther. 2021 Dec;10(2):833-845. doi: 10.1007/s40120-021-00267-y. Epub 2021 Jul 30.

ReferenceCitation: Gentile L, Tournev I, Amass L, Chapman D, Mazzeo A; THAOS investigators. Phenotypic Differences of Glu89Gln Genotype in ATTR Amyloidosis From Endemic Loci: Update From THAOS. Cardiol Ther. 2021 Dec;10(2):481-490. doi: 10.1007/s40119-021-00226-6. Epub 2021 Jun 19.

ReferenceCitation: Waddington-Cruz M, Wixner J, Amass L, Kiszko J, Chapman D, Ando Y; THAOS investigators. Characteristics of Patients with Late- vs. Early-Onset Val30Met Transthyretin Amyloidosis from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Neurol Ther. 2021 Dec;10(2):753-766. doi: 10.1007/s40120-021-00258-z. Epub 2021 May 22.

repository_institution: Umeå University - DiVA at Umeå University

repositories_institution: Umeå University - DiVA at Umeå University

ReferenceCitation: González-Duarte A, Barroso F, Mundayat R, Shapiro B. Blood pressure and orthostatic hypotension as measures of autonomic dysfunction in patients from the transthyretin amyloidosis outcomes survey (THAOS). Auton Neurosci. 2019 Dec;222:102590. doi: 10.1016/j.autneu.2019.102590. Epub 2019 Oct 23.

ReferenceCitation: Huber P, Flynn A, Sultan MB, Li H, Rill D, Ebede B, Gundapaneni B, Schwartz JH. A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy. Amyloid. 2019 Dec;26(4):203-209. doi: 10.1080/13506129.2019.1643714. Epub 2019 Jul 27.

ReferenceCitation: Pinto MV, Pinto LF, Dias M, Rosa RS, Mundayat R, Pedrosa RC, Waddington-Cruz M. Late-onset hereditary ATTR V30M amyloidosis with polyneuropathy: Characterization of Brazilian subjects from the THAOS registry. J Neurol Sci. 2019 Aug 15;403:1-6. doi: 10.1016/j.jns.2019.05.030. Epub 2019 May 28.

ReferenceCitation: Damy T, Kristen AV, Suhr OB, Maurer MS, Planté-Bordeneuve V, Yu CR, Ong ML, Coelho T, Rapezzi C; THAOS Investigators. Transthyretin cardiac amyloidosis in continental Western Europe: an insight through the Transthyretin Amyloidosis Outcomes Survey (THAOS). Eur Heart J. 2019 Apr 1. pii: ehz173. doi: 10.1093/eurheartj/ehz173. [Epub ahead of print]

name: Referral Center for Cardiac Amyloidosis, Department of Cardiology, Mondor Amyloidosis Network, GRC Amyloid Research Institute, Clinical Investigation Center 006, DHU A-TVB INSERM U955 all at CHU Henri Mondor, UPEC, Créteil, France

name: Department of Cardiology, Amyloidosis Center, Heidelberg University, Heidelberg, Germany

name: Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden

name: Columbia University College of Physicians and Surgeons, New York, NY, USA

name: Department of Neurology, Mondor Amyloid Network, Inserm U955-Team10, East Paris University Hospital Henri-Mondor, France

name: Department of Neurosciences, Hospital de Santo António, Centro Hospitalar do Porto, Porto, Portugal

name: Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy

ReferenceCitation: Cruz MW, Pinto MV, Pinto LF, Gervais R, Dias M, Perez C, Mundayat R, Ong ML, Pedrosa RC, Foguel D. Baseline disease characteristics in Brazilian patients enrolled in Transthyretin Amyloidosis Outcome Survey (THAOS). Arq Neuropsiquiatr. 2019 Feb;77(2):96-100. doi: 10.1590/0004-282X20180156.

name: Universidade Federal do Rio de Janeiro,  USA

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

ReferenceCitation: Rubin J, Steidley DE, Carlsson M, Ong ML, Maurer MS. Myocardial Contraction Fraction by M-Mode Echocardiography Is Superior to Ejection Fraction in Predicting Mortality in Transthyretin Amyloidosis. J Card Fail. 2018 Aug;24(8):504-511. doi: 10.1016/j.cardfail.2018.07.001. Epub 2018 Aug 17.

ReferenceCitation: Mundayat R, Stewart M, Alvir J, Short S, Ong ML, Keohane D, Rill D, Sultan MB. Positive Effectiveness of Tafamidis in Delaying Disease Progression in Transthyretin Familial Amyloid Polyneuropathy up to 2 Years: An Analysis from the Transthyretin Amyloidosis Outcomes Survey (THAOS). Neurol Ther. 2018 Jun;7(1):87-101. doi: 10.1007/s40120-018-0097-9. Epub 2018 Apr 9.

ReferenceCitation: Kristen AV, Maurer MS, Rapezzi C, Mundayat R, Suhr OB, Damy T; THAOS investigators. Impact of genotype and phenotype on cardiac biomarkers in patients with transthyretin amyloidosis - Report from the Transthyretin Amyloidosis Outcome Survey (THAOS). PLoS One. 2017 Apr 6;12(4):e0173086. doi: 10.1371/journal.pone.0173086. eCollection 2017.

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

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: Columbia University - Columbia Academic Commons

repositories_institution: Columbia University - Columbia Academic Commons

title: Impact of genotype and phenotype on cardiac biomarkers in patients with transthyretin amyloidosis – Report from the Transthyretin Amyloidosis Outcome Survey (THAOS)

ReferenceCitation: Maurer MS, Hanna M, Grogan M, Dispenzieri A, Witteles R, Drachman B, Judge DP, Lenihan DJ, Gottlieb SS, Shah SJ, Steidley DE, Ventura H, Murali S, Silver MA, Jacoby D, Fedson S, Hummel SL, Kristen AV, Damy T, Planté-Bordeneuve V, Coelho T, Mundayat R, Suhr OB, Waddington Cruz M, Rapezzi C; THAOS Investigators. Genotype and Phenotype of Transthyretin Cardiac Amyloidosis: THAOS (Transthyretin Amyloid Outcome Survey). J Am Coll Cardiol. 2016 Jul 12;68(2):161-72. doi: 10.1016/j.jacc.2016.03.596.

journal_name: Journal of the American College of Cardiology

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

title: Genotype and Phenotype of Transthyretin Cardiac Amyloidosis

ReferenceCitation: Damy T, Maurer MS, Rapezzi C, Planté-Bordeneuve V, Karayal ON, Mundayat R, Suhr OB, Kristen AV. Clinical, ECG and echocardiographic clues to the diagnosis of TTR-related cardiomyopathy. Open Heart. 2016 Feb 8;3(1):e000289. doi: 10.1136/openhrt-2015-000289. eCollection 2016.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Coelho T, Maurer MS, Suhr OB. THAOS - The Transthyretin Amyloidosis Outcomes Survey: initial report on clinical manifestations in patients with hereditary and wild-type transthyretin amyloidosis. Curr Med Res Opin. 2013 Jan;29(1):63-76. doi: 10.1185/03007995.2012.754348. Epub 2012 Dec 13.

name:
Centre for the Study of Amyloidoses, Hospital Santo António
PortoPortugal

name:
Division of Cardiology, Columbia University Medical Center, New York-Presbyterian Hospital
New York, NYUSA

name:
Department of Public Health and Clinical Medicine, Umeå University
UmeåSweden

title: THAOS – The Transthyretin Amyloidosis Outcomes Survey: initial report on clinical manifestations in patients with hereditary and wild-type transthyretin amyloidosis

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Malaysia
Romania
Belgium
Denmark
Taiwan
France
Japan
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
Portugal
Germany
United States
Italy
Brazil
Mexico
Cyprus
Israel
Spain
Turkey

location_facility: Instituto De Investigaciones Medicas Dr Alfredo Lanari

location_facility: Hospital Italiano de Buenos Aires (HIBA)

location_facility: Istanbul University,Istanbul Faculty of Medicine,Department of Neurology

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Montefiore Medical Center-Jack D. Weiler Hospital

location_facility: Samsung Medical Center, Sungkyunkwan University School of Medicine

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica (Ftgm)

location_facility: University of Chicago Medical Center IRB

location_facility: Comitato Etico Indipendente dell Azienda

location_facility: Vanderbilt University School of Medicine

location_facility: University of Pennsylvania - Perelman Center for Advanced Medicine

location_facility: Instituto Nacional de Ciencia Medicas y Nutricion Salvador Zubiran

location_facility: Comitato di Bioetica della Fondazione IRCCS Policlinico S. Matteo

location_facility: University of Maryland School of Medicine

location_facility: Instituto Dante Pazzanese De Cardiologia

location_facility: Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria

location_facility: Peters Township Health and Wellness Pavillion

location_facility: AOU Policlinico G. Martino - Messina - Dr. Vita

location_facility: University of Alberta Foothills Medical Centre

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Washington University School of Medicine

location_facility: Alexandrovska University Hospital Clinic of Neurology

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz KöR

location_facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Pavia - Prof. Merlini

location_facility: Hospital de Rehabilitacion y Traumatologia Virgen de las Nieves

location_facility: University Medical Center, Johannes Gutenberg-University Mainz

location_facility: Institut Clinic de Nefrologia i Urologia - ICNU, Hospital Clinic i Provincial de Barcelona

location_facility: Cardiology Clinic at Montefiore Hutchinson Campus

location_facility: Institutul De Cardiologie Prof. Dr. C. C. Iliescu Spitalului Fundeni

location_facility: Hospital Universitário Clementino Fraga Filho -HUCFF Universidade Federal do Rio de Janeiro

location_facility: The University of Utah Health Sciences Center

location_facility: Karolinska University Hospital, Huddinge

location_facility: Unidade Clinica de Paramiloidose-Centro Hospitalar Porto,EPE-Hospital Geral Santo Antonio

location_facility: AOU Policlinico G. Martino - Messina - Comitato Etico Scientifico

location_facility: University of California - San Francisco, UCSF Department of Neurology

location_facility: Azienda Ospedaliero-Universitaria di Careggi

location_facility: Toronto General Hospital-University Health Network

location_facility: Universitatsklinikum Muenster - Transplant Hepatology

location_facility: Fondazione Policlinico Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Penn Presbyterian Medical Center-University of Pennsylvania

location_facility: Cyprus Institute of Neurology and Genetics


lead_sponsor: University Hospital, Brest

acronym: ESPER

location_facility:
HIA Clermont Tonnerre Brest
CH Morlaix
CHRU Brest
Polyclinique de Keraudren

source: euctr

title: Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV

summary: This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood loss using two dosage regimens (standard and extended) after a surgery during total hip arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for prophylaxis of thrombosis.


title: Effect of the Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Obstructive Sleep Apnea Patients With Resistant Hypertension

acronym: POP-ART

summary:
Resistant hypertension is defined as uncontrolled blood pressure (BP ≥ 140/90mmHg) despite the current use of three or more antihypertensive drugs at full doses, including a diuretic. Obstructive Sleep Apnea (OSA) is at high risk for cardiovascular morbidity and is highly prevalent in patients with resistant hypertension.

The prospective observational POP-ART study will assess the efficacy of continuous positive airway pressure (CPAP) treatment on BP in patients with resistant hypertension and collect data from usual care.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinique des Eaux Claires, Groupe Hospitalier Mutualiste


title: Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714

acronym: NICAD

summary: The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) scores).

ReferenceCitation: Schmidt C, Wolff M, Weitz M, Bartlau T, Korth C, Zerr I. Rapidly progressive Alzheimer disease. Arch Neurol. 2011 Sep;68(9):1124-30. doi: 10.1001/archneurol.2011.189. Review.

ReferenceCitation: Soto ME, Andrieu S, Arbus C, Ceccaldi M, Couratier P, Dantoine T, Dartigues JF, Gillette-Guyonnet S, Nourhashemi F, Ousset PJ, Poncet M, Portet F, Touchon J, Vellas B. Rapid cognitive decline in Alzheimer's disease. Consensus paper. J Nutr Health Aging. 2008 Dec;12(10):703-13.

ReferenceCitation: Helmer C, Andrieu S, Pérès K, Orgogozo JM, Vellas B, Dartigues JF; REAL.fr Group. Predictive value of 6-month decline in ADAS-cog for survival without severe Alzheimer's disease. Dement Geriatr Cogn Disord. 2007;23(3):168-74. Epub 2007 Jan 11.

ReferenceCitation: Lo RY, Jagust WJ; Alzheimer's Disease Neuroimaging Initiative. Vascular burden and Alzheimer disease pathologic progression. Neurology. 2012 Sep 25;79(13):1349-55. Epub 2012 Sep 12.

lead_sponsor: University Hospital, Tours

location_facility:
University Hospital of Rennes
University Hospital of Tours
university hospital of Nantes
University hospital of Caen


title: Prospective Multicenter Study in Patients With a Tumor Benign Ovarian Presumed on the Use of Algorithms Such as Roma and RMI (Risk of Malignancy Index) and Tumor Markers Such as CA125 (Cancer Antigen 125) and HE4 (Human Epididymal Protein 4)

acronym: TORCH

summary:
Ovarian cancer is the fifth leading cause of cancer death in women worldwide. Most of these cancers are manifested in the form of an ovarian cyst. Practitioners are faced with two main difficulties. The first is to establish an early diagnosis. The second is to differentiate a benign tumor, a malignant tumor.

To date, there is only one biological tumor marker routinely performed before an ovarian cyst, the CA-125 (cancer antigen 125). Unfortunately, many studies have been performed and show a sensitivity and specificity unsatisfactory in view of the severity of the disease.

The principal investigator therefore propose to evaluate a new tumor marker, as well as its use in algorithms to help differentiate benign from malignant tumors, and allow earlier diagnosis in cases of ovarian cancer.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CH de Saint Nazaire
Centre Hospitalier de Cholet
CHU de Nantes
CHD Vendée


title: Multicenter, Randomized, Double-blind, Two-period, Placebo Controlled, Forced-titration Proof of Concept Crossover Study to Compare QGC001 With Placebo in Patients With Grade I or II Essential Hypertension

summary: 2QG1 is a Phase IIa study aiming to assess the blood pressure lowering effect of 4-week administration of QGC001 oral doses in patients with grade I or II essential hypertension compared to placebo, to assess the safety and tolerability, to obtain preliminary PK information for QGC001 given as multiple oral doses and to determine preliminary PD profile of QGC001 multiple oral doses on plasma and urine hormones, which will be compared to that of placebo.

ReferenceCitation: Azizi M, Courand PY, Denolle T, Delsart P, Zhygalina V, Amar L, Lantelme P, Mounier-Vehier C, De Mota N, Balavoine F, Llorens-Cortes C. A pilot double-blind randomized placebo-controlled crossover pharmacodynamic study of the centrally active aminopeptidase A inhibitor, firibastat, in hypertension. J Hypertens. 2019 Aug;37(8):1722-1728. doi: 10.1097/HJH.0000000000002092.

family: Azizi

full_name: Michel Azizi

given: Michel

family: Courand

full_name: Pierre-Yves Courand

given: Pierre-Yves

family: Denolle

full_name: Thierry Denolle

given: Thierry

family: Delsart

full_name: Pascal Delsart

given: Pascal

family: Zhygalina

full_name: Valentina Zhygalina

given: Valentina

family: Amar

full_name: Laurence Amar

given: Laurence

family: Lantelme

full_name: Pierre Lantelme

given: Pierre

family: Mounier-Vehier

full_name: Claire Mounier-Vehier

given: Claire

family: De Mota

full_name: Nadia De Mota

given: Nadia

family: Balavoine

full_name: Fabrice Balavoine

given: Fabrice

family: Llorens-Cortes

full_name: Catherine Llorens-Cortes

given: Catherine

journal_name: Journal of Hypertension

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Quantum Genomics SA

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse


title: PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure.

acronym: PROVE-SAS-AHF

summary:
The prevalence of sleep-disordered breathing is common in patients with stable chronic heart failure (up to 83%). Basically, the SAS is divided into two categories: central SAS (CSAS) and obstructive SAS (OSAS). The two can coexist. In patients with CHF, the presence of SAS is associated with higher mortality.

CHF is associated with a high rate of re-hospitalization and significant morbidity and mortality and is considered as a major medical and economic problem. To date, few studies have investigated the prevalence, severity, persistence and the role of SAS during cardiac decompensation. For different pathophysiological considerations, it is assumed that SAS is exacerbated during AHF. Therefore SAS is not conventionally screened during this phase. This assumption has been questioned recently by some studies which showed stability of the type of SAS and its severity between the decompensation episode and the stable HF.

Our hypothesis is that SAS during an AHF episode of CHF will remain stable both in terms of severity and type at three months of decompensation. Thus early polygraphy may be reliable for identifying HF patients with SAS.

primary_purpose: Screening

lead_sponsor: French Cardiology Society

location_facility:
Chu Saint Etienne
Hôpital Henri Mondor
Hôpital BICHAT
Chu Pitie Salpetriere


ReferenceCitation: Armstrong TS, Cao Y, Scheurer ME, Vera-Bolaños E, Manning R, Okcu MF, Bondy M, Zhou R, Gilbert MR. Risk analysis of severe myelotoxicity with temozolomide: the effects of clinical and genetic factors. Neuro Oncol. 2009 Dec;11(6):825-32. doi: 10.1215/15228517-2008-120.

ReferenceCitation: Gerber DE, Grossman SA, Zeltzman M, Parisi MA, Kleinberg L. The impact of thrombocytopenia from temozolomide and radiation in newly diagnosed adults with high-grade gliomas. Neuro Oncol. 2007 Jan;9(1):47-52. Epub 2006 Nov 15.

ReferenceCitation: George JN, Raskob GE, Shah SR, Rizvi MA, Hamilton SA, Osborne S, Vondracek T. Drug-induced thrombocytopenia: a systematic review of published case reports. Ann Intern Med. 1998 Dec 1;129(11):886-90. Review.

ReferenceCitation: Kuter DJ, Rummel M, Boccia R, Macik BG, Pabinger I, Selleslag D, Rodeghiero F, Chong BH, Wang X, Berger DP. Romiplostim or standard of care in patients with immune thrombocytopenia. N Engl J Med. 2010 Nov 11;363(20):1889-99. doi: 10.1056/NEJMoa1002625.

ReferenceCitation: Molineux G. The development of romiplostim for patients with immune thrombocytopenia. Ann N Y Acad Sci. 2011 Mar;1222:55-63. doi: 10.1111/j.1749-6632.2011.05975.x. Review.

ReferenceCitation: Sure D, Dunn I, Norden A, Anderson WS. Intracerebral hemorrhage secondary to thrombocytopenia in a patient treated with temozolomide. Clin Neurol Neurosurg. 2010 Oct;112(8):741-2. doi: 10.1016/j.clineuro.2010.04.005.

ReferenceCitation: Mutter N, Stupp R. Temozolomide: a milestone in neuro-oncology and beyond? Expert Rev Anticancer Ther. 2006 Aug;6(8):1187-204. Review.

ReferenceCitation: Oh J, Kutas GJ, Davey P, Morrison M, Perry JR. Aplastic anemia with concurrent temozolomide treatment in a patient with glioblastoma multiforme. Curr Oncol. 2010 Aug;17(4):124-6.

ReferenceCitation: Le Rhun E, Devos P, Houillier C, Cartalat S, Chinot O, Di Stefano AL, Lepage C, Reyns N, Dubois F, Weller M. Romiplostim for temozolomide-induced thrombocytopenia in glioblastoma: The PLATUM trial. Neurology. 2019 Nov 5;93(19):e1799-e1806. doi: 10.1212/WNL.0000000000008440. Epub 2019 Oct 4.

family: Le Rhun

full_name: Emilie Le Rhun

given: Emilie

family: Devos

full_name: Patrick Devos

given: Patrick

family: Houillier

full_name: Caroline Houillier

given: Caroline

family: Cartalat

full_name: Stéphanie Cartalat

given: Stéphanie

family: Chinot

full_name: Olivier Chinot

given: Olivier

family: Di Stefano

full_name: Anna Luisa Di Stefano

given: Anna Luisa

family: Lepage

full_name: Clément Lepage

given: Clément

family: Reyns

full_name: Nicolas Reyns

given: Nicolas

family: Dubois

full_name: François Dubois

given: François

family: Weller

full_name: Michael Weller

given: Michael

journal_name: Neurology

oa_host_type: repository

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

host_type: repository

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

version: submittedVersion

acronym: PLATUM

location_facility: AP-HM,Hôpital La Timone, AP-HM, Marseille

location_facility: CHRU de Lille, Hôpital Roger Salengro,Clinique de Neurochirurgie

location_facility: Hôpital Neurologique Pierre Wertheimer, Lyon,

location_facility: AH-HP, Hôpital Pitié-Salpêtrière, Service de Neurologie 2

title: Secondary Prophylaxis Use of Romiplostim for the Prevention of Thrombocytopenia Induced by Temozolomide in Newly Diagnosed Glioblastoma Patients

summary:
Chemotherapy used in the treatment of primitive tumors of the central nervous system has a particularly important platelet toxicity compared to chemotherapy used for treatment of other tumors. Chemotherapy postponed for toxicity is often due to thrombocytopenia (TP). The TP and/or the other anomalies of coagulation, which can be spontaneous (Rogers, 2004) or induced (Gerber, 2006) can have dramatic consequences:

specifically neurological (intratumoral bleeding with particularly important neovascularization) with a functional aggravation and sometimes involvement of vital prognosis,
digestive (Garcia-Rodiguez, 2001) in patients receiving long term treatment with corticoids (potential gastric toxicity).

The encouraging results from the EORTC/NCIC trial by Stupp (median survival among patients with newly diagnosed glioblastoma is 14.6 months with an estimated 5-year survival of 9, 8%), has changed the standard of care of these patients (Stupp et al., 2009). Patients with newly diagnosed, histologically confirmed glioblastoma receive radiotherapy (2 Gy given 5 days per week for 6 weeks, for a total of 60 Gy) plus continuous daily Temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant Temozolomide (TMZ) (150 to 200 mg per square meter for 5 days during each 28-day cycle). The Stupp regimen is currently the treatment of reference for glioblastoma and is used as a basis in various clinical studies with new agents.

This study aims to evaluate Romiplostim for the treatment of TP secondary to initial TMZ chemotherapy of glioblastomas.


title: Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)

acronym: FIV-INOPK

summary:
The original mechanism of action of myo-inositol and preliminary results available in the literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the risk of OHSS in PCOS patients.

The aim of the study is to demonstrate that administration of myo-inositol decreases the incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS supported in IVF patients.

location_facility:
CHI de Créteil
CH de Saint Nazaire
CHU de Nantes
CHD Vendée


title: Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department

acronym: MEMOPROPO

summary: The purpose of this study is to determine the incidence of recall in patients managed in emergency department with a procedural sedation protocol using propofol in a population of 250 .

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility:
Groupe Hospitalier Est Réunion
CHU de La Réunion
CHU de la Réunion
Centre Hospitalier Gabriel Martin


acronym: DAPTOREA

summary:
Treatment of infections in critically ill patients remains a significant challenge to intensivists world-wide with persisting high mortality and morbidity. Compelling evidence suggests that source control of the pathogen and appropriate antibiotic therapy remain the most important interventions to improve patients' outcome, the latter including the administration of a suitable molecule at an optimized dosage regimen.

Daptomycin is the first representative of a new family of antibiotics, the cyclic lipopeptides. Its bactericidal effect against Gram-positive bacteria, including meticillin-resistant strains, and its low renal toxicity, make it a useful antibiotic in critically ill patients having infections due to resistant Gram positive strains.

Unfortunately, no PK study has been performed in infected critically ill patients without renal replacement therapy. A vast array of pathophysiological changes can occur in infected critically ill patients, leading to changes in volume of distribution and clearance of antibiotics in these patients, which may affect the antibiotic concentration at the target site.

It is therefore important to better characterize daptomycin PK in infected patients with various degrees of renal failure in order to define optimal dosing regimens.

This project aims to identify optimal daptomycin administration schemes in critical care patients with various degrees of renal impairment

lead_sponsor: Poitiers University Hospital

location_facility: Lasocki S, University Hospital of Angers

location_facility: Asehnoune K, University Hospital of Nantes

location_facility: Ferrandiere M, University Hospital of Tours


title: Correlation Between Microbiota Biodiversity of HIV Seropositive Patients With Their Clinical and Immunological Status (ANRS EP 55 MICROGUT).

acronym: MICROGUT

summary: The bacterial diversity of HIV patients digestive microbiota seropositive is poorly understood, it remains to be defined.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: IHU Méditerranée Infection; Hôpital Nord, AP-HM

location_facility: Service de Médecine Interne et Immunologie Clinique


acronym: CURTAXEL

summary: Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic castration resistant. Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial).

lead_sponsor: Centre Jean Perrin

location_facility:
Centre Hospitalier Emile Roux
Centre Jean Perrin
Institut Jean Godinot
Clinique de la Chataigneraie


title: Efficacy of Collagen-elastin Dermal Substitute in the Treatment of Loss of Cutaneous Substances With Skin Grafts

acronym: MATRIGREFFE

summary:
In reconstructive surgery , most losses of cutaneous substance require the use of a thin skin graft . This technique allows epidermization of the defect by applying a thin layer of autologous epidermis. It does not reconstitute the injured skin. Transplants cause retractile scars, adherent to the deep plan, that may require revision surgery . Since a decade , dermal matrices are mainly used in burned skin centers . The collagen -elastin matrix has the advantage to set up in the same operation that the skin graft and contain elastic fibers , two assets which improve the results of skin grafting.

Objective:

Evaluation of the clinical efficacy of the addition of a dermal matrix to skin graft on Skin Foldability, at day 360.

Methodology:

This is a multicenter randomized study (CHU Caen , Amiens, Rouen and Lille)

Conduct of the study :

The transplant will be performed according to the protocol defined between inter -region surgeons. The implementation of the dermal matrix will be in the same surgical technique as thin skin graft ( group 1 ) or the thin skin graft will be performed alone ( group 2) time .

Evaluation Criteria Main : Skin Foldability ( Uf ) assessed grafted site will be compared to the opposite side ungrafted evaluated at Day 360 . Quantitative data will be measured by a cutometer Skin Elasticity Meter 580 (Courage and Khazaba Electronic GmbH).

To achieve the main objective, it is planned to compare the ratio between Uf graft site and the opposite healthy site between two groups: skin + matrix graft , or skin graft only. Thus, the Wilcoxon test for independent samples will be used to settle bilateral formulation between the null hypothesis ( there is no difference between the two groups ) and the alternative hypothesis ( there is a difference between the two groups ) . In determining the overall risk of first species to 5% and the power of this test to detect the 90% expected under the alternative hypothesis difference should be the main criterion for evaluating at least 59 patients in each group so 118 patients total.

Prospect If the contribution of a dermal matrix in loss of skin substances improves skin pliability and reduces pain , functional and aesthetic sequelae grafts thin skin , the dermal matrix may be proposed as a complementary treatment in these indications.

lead_sponsor: University Hospital, Rouen

location_facility:
CHU de Caen
CHU de Lille
CHU d'Amiens
UH Rouen


title: Study of the Cerebral Metabolism in Patients With Refractory Chronic Cluster Headache Treated by Occipital Nerve Stimulation

acronym: MET-ONS

summary:
The occipital nerve stimulation (ONS) is used to treat patients with refractory primary chronic headache but its mechanism of action (MoA) remains unknown. Different hypothesis have been suggested in particular a specific action on cerebral generators involved in different types of primary headaches or a non specific action on pain modulatory network.

The aim of this study, using the chronic cluster headache as a model, is to determine the changes in cerebral metabolism induced by ONS to precise its MoA in the treatment of primary chronic headache.

primary_purpose: Health Services Research

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Département d'Evaluation et Traitement de la Douleur - Pôle Neurosciences Cliniques - Centre Hospitalo-Universitaire de Nice

intervention_type: Radiation


title: STUDY OF PREFERENCES IN MEN FACED WITH THE DIFFERENT TREATMENT OPTIONS FOR LOCALIZED PROSTRATE CANCER WITH A GOOD OR INTERMEDIATE PROGNOSIS

acronym: CALIPSO

summary:
This study will be based on two questionnaires

One specific questionnaire that has already been developed from social sciences interviews conducted in men who have been treated for localized prostrate cancer, with a good or intermediate prognosis. This questionnaire comprises 11 pairs of scenarios. Each scenario gathers in a random manner, the modalities of 7 possible characteristics of the management strategy for localized prostrate cancer, with a good or intermediate prognosis:

the risk of death at 5 years (modalities: 5%, 15%),
the risk of impotence (modalities: 0%, 25%, 50%, 75%),
the presence of urinary leaks (modalities: no protection during the day, one protection pad per day, several protection pads per day),
the duration and frequency of care provided (modalities: 2 days of care in your whole life, 7 days of care in your whole life, 5 half-days of care per week for 8 weeks, every 3 months for 2 years then every 6 months for life),
ablation of the prostate (modalities: Yes, No),
the existence of possible treatments in case of aggravation or recurrence (modalities: Yes, No),
the nature of the technology used (modalities: innovative technology, standard technology).

The objective is to ask each participant of the study for each pair of scenarios, to choose from the two scenarios (binary-choice survey), the scenario he prefers.

The "Spielberger Inventory Trait" scale to evaluate stable characteristics in the propensity to anxiety in study participants.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
Hôpital TENON
CHU de TOURS
CHU de DIJON
Clinique St Marie


title: Prospective Multicentric, Randomized, Open-labeled, in Parallel Groups, Study to Assess the Benefit/Risk of an Induction Treatment With Anti-Thymocyte Globulins (ATG) Versus Basiliximab in Kidney Transplant Patients Displaying Low Immunological Risk But High Susceptibility to Delayed Graft Function.

acronym: PREDICT-DGF

summary: The primary objective of the following randomized open label trial is to demonstrate how low immunological risk patients (no anti HLA immunization and first kidney transplantation) but diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from induction with ATG for preventing delayed graft function compared to Basiliximab.

ReferenceCitation: Chapal M, Foucher Y, Marguerite M, Neau K, Papuchon E, Daguin P, Morélon E, Mourad G, Cassuto E, Ladrière M, Legendre C, Giral M. PREventing Delayed Graft Function by Driving Immunosuppressive InduCtion Treatment (PREDICT-DGF): study protocol for a randomized controlled trial. Trials. 2015 Jun 23;16:282. doi: 10.1186/s13063-015-0807-x.

family: Chapal

full_name: Marion Chapal

given: Marion

family: Foucher

full_name: Yohann Foucher

given: Yohann

family: Marguerite

full_name: Monique Marguerite

given: Monique

family: Neau

full_name: Karine Neau

given: Karine

family: Papuchon

full_name: Emmanuelle Papuchon

given: Emmanuelle

family: Daguin

full_name: Pascal Daguin

given: Pascal

family: Morélon

full_name: Emmanuel Morélon

given: Emmanuel

family: Mourad

full_name: Georges Mourad

given: Georges

family: Cassuto

full_name: Elisabeth Cassuto

given: Elisabeth

family: Ladrière

full_name: Marc Ladrière

given: Marc

family: Legendre

full_name: Christophe Legendre

given: Christophe

family: Giral

full_name: Magali Giral

given: Magali

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Nantes University Hospital

location_facility:
Nantes Universitary hospital
Universitary hospital of Lyon
Universitary hospital of Nice
Necker Hospital


title: Changes in Cutaneous, Digestive and Urinary Bacterial Flora Among Patients With Pelvic Bedsores: a Prospective Pilot Study

acronym: EscaFlor

summary: The main objective of this study is to characterize the evolution (over a period of 28 days) of superficial and deep bacterial skin flora in patients with stage 3 or 4 sacral pressure ulcers (bedsores). Changes in terms of pathogenic, potentially pathogenic and non-pathogenic bacterial species at the intra-individual and population levels.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: Laboratoire d'Etude et de Recherche en Environnement et Santé, Unité Biodiagnostic, UNIMES

location_facility: Unité U1047 "Bacterial virulence and infectious diseases", UFR de Médecine

intervention_type: Biological


title: Multicenter Clinical Study Evaluating the Functional Prognosis and Quality of Life at Least 2 Years in Patients Treated With Decompressive Craniectomy for Malignant Sylvian Ischemic Stroke

summary: The objective of this protocol is to evaluate the quality of life and functional disability in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien stroke who received a decompressive craniotomy in the acute phase. Patients who have given their consent to be evaluated at least two years after their stroke and their operation in a single visit by clinical examination and procurement of standardized scales. Will be measured the quality of life through scale SIS3.0, residual disability by the Rankin scale. The quality of life of the carer will be assessed through scales and Zarit carer version of SIS3.0. The existence of predictive parameters of long-term evolution will be searched in determining the existence of a correlation between demographic data and baseline characteristics of the stroke on and the evolution of the quality of life.

location_facility:
CHU Angers
CHU de Brest
CHU Bretonneau
CH R U Pontchaillou


title: Prospective, Comparative (5 Groups), Non-randomized, Multicenter, Physiopathological Study, Evaluating Pharmacokinetic Characteristics of Serum Hepcidin Level in Response to Iron Oral Intake in Order to Evaluate Their Interest to Discriminate Patients With Dysmetabolic Hepatosiderosis or Ferroportin Disease.

summary:
The diagnosis of iron overload is a common problem. It is important to optimize the diagnosis to ensure support for patients and their relatives especially regarding genetic disease.

Iron overload revealed by a high level of serum ferritin and confirmed by the presence of an excessive amount of iron in the liver is a frequent situation. In a lot of case there is no increase in serum iron and transferrin saturation. This situation may arise in particular in patients with:

a genetic iron overload related to mutation in the ferroportine gene, leading to a ferroportin disease. The diagnosis is based on the sequencing of the gene,
a dysmetabolic hepatosiderosis, the most frequent situation , where iron overload is associated with abnormalities in the metabolism of carbohydrates and fats, whereas no genetic cause is identified.

However, patients often have similar biological signs and despite the implementation of strict algorithm regarding the diagnostic procedure, it appears that a large number of patients are tested for the mutation in the ferroportin gene, and that mutation is not found in most cases. It is therefore essential to optimize the diagnosis process by introducing additional criteria.

The investigators' hypothesis, based on the known elements, is that the response to a single dose of iron will modulate differently the iron parameters measured in serum, including hepcidin level which controls iron metabolism and metals associated with iron. This could be helpful for diagnosis procedure in patients with ferroportin disease or dysmetabolic hepatosiderosis.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Montpellier
CHU Limoges
CHU Pontchaillou
CHU Clermont-Ferrand


title: Haploidentical NK-cell Infusion in Bad Prognosis AML Patients: Evaluation of Feasibility and Antitumoral Effect

acronym: NK

summary: Leukemia cells can be killed by natural killer (NK) from HLA-I mismatched donor. The proposed study plans to realize an adoptive anti-leukaemic immunotherapy by infusion of HLA-I mismatched NK cells to treat poor prognosis acute myeloid leukemia patients. NK cells will be selected from HLA mismatch familial donor peripheral mononuclear cells by purification protocol. Before NK-infusion, patients received immunosuppressive chemotherapy.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service d'Hématologie adultes du Pr. Hermine - Hôpital Necker Enfants Malades

location_facility: Service d'Hématologie Clinique du Pr. Leblond- Hôpital Pitié salpêtrière

location_facility: Service d'Hématologie oncologie du Pr. Mohty -Hôpital Saint Antoine

location_facility: Service d'Hématologie Clinique du Pr. Cordonnier-Hôpital Henri Mondor


title: Accuracy of a Portable International Normalized Ratio Monitor in a Population Aged 75 Years Old and Over

acronym: AGINR

summary:
Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the treatment of thromboembolic disorders, which are among the most costly diseases in terms of public health resources. According to the Agence française de sécurité sanitaire des produits de santé (AFSSAPS), it was estimated at about 900,000 the number of patients treated with VKA in 2008 (more than 1% of the French population). VKA are at the origin of many adverse effects, given their narrow therapeutic window. They are the cause of the death of approximately 5000 patients per year. The use of this therapy is a priority axis of reflection for the Haute Autorité de Santé.

The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people, is particularly affected by this problem.

University hospitals of our interregion, given their very substantial regional referral activity, are actually involved in managing VKA adverse side effects.

Elderly population constitutes the majority of prescriptions. The main objective of this study is to compare INR of people older than 75 years measured by traditional method with those measured by capillary method with INRatio2 supply.

The secondary objective is to show that this measure is not affected by the presence or absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as to test the variability of INR measurement between different hospital.

ReferenceCitation: Manoussakis MN, Tzioufas AG, Silis MP, Pange PJ, Goudevenos J, Moutsopoulos HM. High prevalence of anti-cardiolipin and other autoantibodies in a healthy elderly population. Clin Exp Immunol. 1987 Sep;69(3):557-65.

ReferenceCitation: Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001 Nov;86(5):516-21.

ReferenceCitation: Bazzan M, Montaruli B, Vaccarino A, Fornari G, Saitta M, Prandoni P. Presence of low titre of antiphospholipid antibodies in cancer patients: a prospective study. Intern Emerg Med. 2009 Dec;4(6):491-5. doi: 10.1007/s11739-009-0316-6. Epub 2009 Sep 26.

ReferenceCitation: Sène D, Piette JC, Cacoub P. Antiphospholipid antibodies, antiphospholipid syndrome and infections. Autoimmun Rev. 2008 Feb;7(4):272-7. doi: 10.1016/j.autrev.2007.10.001. Epub 2007 Oct 23. Review.

ReferenceCitation: Quéméneur T, Lambert M, Hachulla E, Dubucquoi S, Caron C, Fauchais AL, Devulder B, Hatron PY. Significance of persistent antiphospholipid antibodies in the elderly. J Rheumatol. 2006 Aug;33(8):1559-62.

ReferenceCitation: Perry SL, Samsa GP, Ortel TL. Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies. Thromb Haemost. 2005 Dec;94(6):1196-202.

lead_sponsor: University Hospital, Caen

location_facility: Centre hospitalier régional universitaire de Lille

location_facility: Centre hospitalier régional universitaire de Rouen

location_facility: Centre hospitalier régional universitaire d'Amiens

location_facility: Centre hospitalier régional universitaire de Caen