title: Impact of High-volume Veno-venous Continuous Hemofiltration in the Early Management of Septic Shock Patients With Acute Renal Failure

acronym: IVOIRE

summary: Sepsis and septic shock are still important causes of mortality in intensive care medicine. Renal replacement therapy by standard volume haemofiltration is currently used, but a higher-volume haemofiltration may improve the prognosis. The study is a prospective randomized multicenter trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU. One group will be treated by early high volume haemofiltration (70 ml/kg/h) and the second group by standard volume haemofiltration (35 ml/kg/h). The main outcome will be one-month mortality.

ReferenceCitation: Joannes-Boyau O, Honoré PM, Perez P, Bagshaw SM, Grand H, Canivet JL, Dewitte A, Flamens C, Pujol W, Grandoulier AS, Fleureau C, Jacobs R, Broux C, Floch H, Branchard O, Franck S, Rozé H, Collin V, Boer W, Calderon J, Gauche B, Spapen HD, Janvier G, Ouattara A. High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med. 2013 Sep;39(9):1535-46. doi: 10.1007/s00134-013-2967-z. Epub 2013 Jun 6.

family: Joannes-Boyau

full_name: Olivier Joannes-Boyau

family: Honoré

full_name: Patrick M. Honoré

given: Patrick M.

family: Perez

full_name: Paul Perez

given: Paul

family: Bagshaw

full_name: Sean M. Bagshaw

given: Sean M.

family: Grand

full_name: Hubert Grand

given: Hubert

family: Canivet

full_name: Jean-Luc Canivet

given: Jean-Luc

family: Dewitte

full_name: Antoine Dewitte

given: Antoine

family: Flamens

full_name: Claire Flamens

given: Claire

family: Pujol

full_name: Wilfried Pujol

given: Wilfried

family: Grandoulier

full_name: Anne-Sophie Grandoulier

given: Anne-Sophie

family: Fleureau

full_name: Catherine Fleureau

given: Catherine

family: Jacobs

full_name: Rita Jacobs

given: Rita

family: Broux

full_name: Christophe Broux

given: Christophe

family: Floch

full_name: Hervé Floch

given: Hervé

family: Branchard

full_name: Olivier Branchard

family: Franck

full_name: Stephane Franck

given: Stephane

family: Rozé

full_name: Hadrien Rozé

given: Hadrien

family: Collin

full_name: Vincent Collin

family: Boer

full_name: Willem Boer

given: Willem

family: Calderon

full_name: Joachim Calderon

given: Joachim

family: Gauche

full_name: Bernard Gauche

given: Bernard

family: Spapen

full_name: Herbert D. Spapen

given: Herbert D.

family: Janvier

full_name: Gérard Janvier

given: Gérard

location_facility: Service d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux


title: A Role for Light Therapy at Immediate Recovery From Short Duration Ambulatory Anesthesia to Prevent Dysregulation of Circadian Rest-Activity Rhythm in Patients Submitted to Colonoscopy.

acronym: LI-AMB

summary: We previously evidenced in both animal models and patients that a short duration ambulatory anesthesia impacts the circadian rest-activity biological rhythm, at least during the first 3 days. The light is the main, natural synchronisateur, of the biological cerebral clock, and is used as therapeutics in chronic disturbances of the circadian rest activity rhythm and of the sleep (Alzheimer disease for example). We would like to test for a simple and safe strategy to prevent such a long-lasting effect of anesthesia on biological clock:the increase of the light intensity at a still physiological level during the initial phase of recovery from anesthesia by using a particular artificial light of color spectrum similar to natural sun daylight.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service d'Anestésie et Réanimation - Hôpital Beaujon

location_facility: Service d'Anesthésie et Réanimation - Hôpital Pasteur

location_facility: Service d'Anesthésie et Réanimation - Hôpital de Hautepierre

location_facility: Service d'Anesthésie et Réanimation, Hôpital d'Instruction des Armées Legouest

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: EudraCT Number

title: Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing in Patients With Delayed Consolidation After Long Bone Fracture Requiring Graft Apposition or Alternative Orthobiologics

summary:
Bone grafting is widely used in hospitals to repair injured, aged or diseased skeletal tissue. In Europe, about one million patients encounter a surgical bone reconstruction annually and the numbers are increasing due to our ageing population. Bone grafting intends to facilitate bone healing through osteogenesis (i.e. bone generation) at the site of damage, but this is only attained presently by including cells capable of forming bone into the augmentation.

Bone autograft is the safest and most effective grafting procedure, since it contains patient's own bone growing cells (to enhance osteogenesis) and proteins (to enhance osteoinduction), and it providing a scaffold for the new bone to grow into (osteoconduction). However, bone autograft is limited in quantity (about 20 cc) and its harvesting (e.g. from the iliac crest) represents an additional surgical intervention, with frequent consequent pain and complications.

We hypothesize that using autologous bone marrow cells expanded in GMP facility surgically implanted with synthetic bone substitutes contribute to the resolution of the health and socioeconomic complications of delayed union or non-union after diaphyseal and metaphyseal-diaphyseal fractures with safety and efficacy.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_country: Italy Germany France Spain

location_facility: Depatment of Orthopaedic Surgery, Hôpital Henri Mondor

location_facility: Department of Orthopaedic Surgery, CHRU Tours

location_facility: Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

location_facility: Department of Orthopaedic Trauma, University of Ulm

intervention_type: Procedure

status_simplified: Completed


title: EURopean Study on Encephalitis in Intensive CAre

acronym: EURECA

summary: Prospective observational multicenter study in European ICUs. All patients admitted to the ICU for probable or confirmed Acute encephalitis (2013 IDSA - Infectious Disease Society of America criteria) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: ICUREsearch

location_country: Italy Austria India Netherlands France Spain

location_facility: Institute Of Medical Sciences Banaras Hindu University

location_facility: Fondation Opthalmologique Adolphe de Rothschild

location_facility: Centre hospitalier de Saint-Denis, Hôpital DELAFONTAINE

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Hôpitaux universitaires Est Parisien, Tenon

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: Sri Ramachandra Institute of Higher Education and Research

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

lead_sponsor_type: industriel


title: Long-term Treatment of Cancer Associated VTE: Reduced vs Full Dose of Apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis

acronym: API-CAT

summary: The main objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (symptomatic or incidental).

status: Recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country:
Italy
Austria
Switzerland
Netherlands
France
Poland
Greece
Belgium
Spain
United Kingdom

location_facility: HÔPITAL PRIVÉ ARRAS LES BONNETTES - Espace Artois Santé

location_facility: Centre of postgraduate medical education at the european health centre Otwock

location_facility: Parc Santari Sant Joan de Deu - Hospital general

location_facility: Istituto Oncologico della svizzera Italiana

location_facility: Hospital general Universitario Santa Lucia

location_facility: CHU DIJON BOURGOGNE - Hôpital François Mitterrand

location_facility: Hospital general universitario de ciudad real

location_facility: National and Kapodistrian University of Athens ALEXANDRA Hospital

location_facility: Hospital universitari Germans trias i Pujol

location_facility: Clinique de l'Infirmerie Protestante de Lyon

location_facility: Hôpital d'Instruction des Armées Clermont Tonnerre

intervention_type: Drug

status_simplified: Ongoing


type: Other Identifier

title: POLYGEN DEFI-ALPHA : Genetic Polymorphisms Study in Children With Alpha-1 Antitrypsin Deficiency, Included in the DEFI-ALPHA Cohort

acronym: Polygen

summary:
The deficiency of alpha-1 antitrypsin (DA1AT) is a genetic disorder of variable clinical expression, initially described in adults with pulmonary emphysema patients. In children, it is the second cause of neonatal cholestasis after biliary atresia and is a common indication for liver transplantation.

Several genotypes for SERPINA1 gene coding for alpha-1 anti-trypsin were identified. The main ones are M / M, M / Z, M / S and Z / Z and each genotype is closely correlated with the concentration of blood A1AT. The estimate for France suggests a prevalence of genotype deficit Z / Z of the order of 1/6054, (9982 patients), which in 11% of cases, have liver disease (prolonged neonatal jaundice). Half of them will move towards the development of cirrhosis with portal hypertension, at worst liver transplantation.

Currently, we do not know what are the clinical and genetic factors that predispose a patient A1AT deficiency develop liver damage. Recent studies have led us to think that polymorphisms in the gene SERPINA1, as well as that of the alpha-mannosidase 1 endoplasmic reticulum (Erman gene) could be a predictive marker of liver complications. Another possible candidate gene is one of the importin beta (KPNB1), a protein involved in the elimination of misfolded proteins. These data lead us to propose the study of genetic polymorphisms.

The main objective of the study is to compare the allele frequencies of these polymorphisms between (i) a cohort of A1AT deficient patients and with hepatic symptoms (portal hypertension and its complications, severe liver failure leading to transplant or not, or an indication for liver transplantation) and (ii) a cohort of A1AT deficient patients without signs of hepatic call. To build this last cohort, we will include in the genetic study the family members of deficient patients, some of whom probably carrying a deficit genotype Z / Z but without any associated clinical manifestations. This will allow us to facilitate the establishment of genotype profiles / phenotype clearly identified, which then allow a more appropriate care for children who may have such a development, we will strive to achieve a haplotype interpretation of polymorphisms found.

This study will be conducted in association with the DEFI-ALPHA study to identify clinical and biological prognostic factors such as age at diagnosis, the diagnostic mode, the results of liver biopsy (when available), the clinical course, family history, the existence of IUGR and long-term treatment.

The secondary objectives of the study are :

The measurement and interpretation of serum IL-8 in A1AT-deficient patients. Indeed, one study showed a higher IL-8 in patients with ulcerative colitis compared with healthy patients' serum. These considerations led us to hypothesize that IL-8 may be a marker of liver disease in A1AT deficiency.
Preservation of blood samples for further study of other genes, which may be in the future suspected to be associated with the occurrence of liver complications. To this end, a DNA bank will be created. It will involve the children with a deficiency of alpha-1 antitrypsin and their family of 1st and 2nd degree in civil law (parents and siblings).

This study is a continuation of the cohort DEFI-ALPHA (descriptive study of a cohort of children with DA1AT) and sought to identify the clinical and biological factors such as age at diagnosis, diagnosis mode, the result sets of the liver biopsy (when available), clinical course, family history, the presence of IUGR and long-term treatment.

The only criterion for not-inclusion is, according to the subject, the lack of consent of the child and his parents, the lack of consent of the adult patient, or the lack of consent of the witness. Demographic and clinical history data (for parents and brothers/sisters showing no DA1AT) will be collected.

Currently, the cohort of patients with DA1AT is being set up in the framework of the "Cohort DEFI-ALPHA." This multicenter project is realized with the help of french pediatric hepatology centers that regularly follow patients DA1AT. Today, over 100 patients DA1AT have already been identified, and the collection of historical data has already begun on several centers since September 2009. This study is therefore a continuation of this work.

Over a period of 30 months, the total number of potentially includable subjects is estimated at about 400 in this study (100 patients and 300 related to the first degree such as parents, brothers and sisters).

This study will be promoted by the Hospices Civils de Lyon. Authorization of the competent authority and the ethical committee will be obtained as well as informed consent from families before blood sampling.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Joly P, Ruiz M, Garin R, Karatas E, Lachaux A, Restier L, Belmalih A, Renoux C, Lombard C, Dechomet M, Bouchecareilh M. A Particular SORL1 Micro-haplotype May Prevent Severe Liver Disease in a French Cohort of Alpha 1-Antitrypsin-deficient Children. J Pediatr Gastroenterol Nutr. 2021 Sep 1;73(3):e68-e72. doi: 10.1097/MPG.0000000000003125.

family: Joly

full_name: Philippe Joly

given: Philippe

sequence: first

family: Ruiz

full_name: Mathias Ruiz

given: Mathias

sequence: additional

family: Garin

full_name: Roman Garin

given: Roman

family: Karatas

full_name: Esra Karatas

given: Esra

family: Lachaux

full_name: Alain Lachaux

given: Alain

family: Restier

full_name: Lioara Restier

given: Lioara

family: Belmalih

full_name: Abdelouahed Belmalih

given: Abdelouahed

family: Renoux

full_name: Céline Renoux

given: Céline

family: Lombard

full_name: Christine Lombard

given: Christine

family: Dechomet

full_name: Magali Dechomet

given: Magali

family: Bouchecareilh

full_name: Marion Bouchecareilh

given: Marion

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Pediatric Gastroenterology & Nutrition

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Ruiz M, Lacaille F, Berthiller J, Joly P, Dumortier J, Aumar M, Bridoux-Henno L, Jacquemin E, Lamireau T, Broué P, Rivet C, Belmalih A, Restier L, Chapuis-Cellier C, Bouchecareilh M, Lachaux A; Groupe Francophone d'Hépatologie Gastroentérologie et Nutrition Pédiatriques. Liver disease related to alpha1-antitrypsin deficiency in French children: The DEFI-ALPHA cohort. Liver Int. 2019 Jun;39(6):1136-1146. doi: 10.1111/liv.14035. Epub 2019 Feb 1.

name: Hépatologie, Gastroentérologie et Nutrition pédiatriques Hôpital Femme Mère Enfant, Hospices Civils de Lyon Lyon France

name: Faculté de Médecine Lyon‐Est Université Claude Bernard Lyon 1 Lyon France

name: Gastroentérologie Hépatologie et Nutrition pédiatriques, Hôpital Universitaire Necker‐Enfants Malades Paris France

family: Lacaille

full_name: Florence Lacaille

given: Florence

name: Unité de support méthodologique du groupement Est, Pôle Information Médicale Evaluation Recherche Hospices Civils de Lyon Lyon France

family: Berthiller

full_name: Julien Berthiller

given: Julien

name: Inter‐university Laboratory of Human Movement Science University Lyon ‐ University Claude Bernard Lyon 1 Villeurbanne France

name: Laboratoire de Biochimie et biologie moléculaire Grand‐Est Hôpital Edouard Herriot, Hospices Civils de Lyon Lyon France

name: Hépatologie Hôpital Edouard Herriot, Hospices Civils de Lyon Lyon France

family: Dumortier

full_name: Jérôme Dumortier

given: Jérôme

name: Gastroentérologie, Hépatologie et Nutrition pédiatrique, Centre d'investigation clinique CHU Lille University of Lille Lille France

family: Aumar

full_name: Madeleine Aumar

given: Madeleine

name: Gastroentérologie, Hépatologie et Nutrition pédiatriques CHU Rennes Rennes France

family: Bridoux‐Henno

full_name: Laure Bridoux‐Henno

given: Laure

name: Pediatric Hepatology and Pediatric Liver Transplantation Unit and National Reference Centre for Rare Pediatric Liver Diseases, Hepatinov Bicêtre Universitary Hospital, University of Paris‐Sud, Assistance Publique‐Hôpitaux de Paris Le Kremlin Bicêtre France

name: Inserm, UMR‐S1174 University of Paris‐Sud Orsay France

family: Jacquemin

full_name: Emmanuel Jacquemin

given: Emmanuel

name: Gastroentérologie Hépatologie et Nutrition pédiatriques Bordeaux France

family: Lamireau

full_name: Thierry Lamireau

given: Thierry

name: Gastroentérologie, Hépatologie Nutrition, Diabétologie pédiatriques, Maladies héréditaires du métabolisme, CHU Toulouse Toulouse France

family: Broué

full_name: Pierre Broué

given: Pierre

name: Laboratoire d’Immunologie Centre de Biologie Sud, Hospices Civils de Lyon Lyon France

name: INSERM, UMR1053 Bordeaux Research In Translational Oncology University Bordeaux BaRITOn Bordeaux France

name: Groupe Francophone d’Hépatologie Gastroentérologie et Nutrition Pédiatriques

title: Liver disease related to alpha1‐antitrypsin deficiency in French children: The DEFI‐ALPHA cohort

location_facility: Centre de Pédiatrie Gatien de Clocheville


title: MecoExpo Study Protocol

acronym: MecoExpo

summary:
The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie region to commonly used pesticides. These pesticides were selected in a pilot study (the Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators of pesticide use and the presence of pesticide in the environment in Picardie.

These substances (or their metabolites) will be measured in the each newborn's meconium (the first faeces after birth) and each newborn's mother's hair in the Picardie region during the study period. The mother's exposure will also be assessed using a retrospective questionnaire (filled out within a few days of the delivery).

Thus, the MecoExpo project will enable the investigators to:

evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and clinical parameters measured at birth (term, length, weight, etc.).
map pesticide exposure across the Picardie region.
create a meconium bank in Picardie (the first ever meconium bank in France).

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CH Peronne
CH Chauny
Groupe Santé Victor Pauchet
CH Beauvais
CH Abbeville
CH Chateau-Thierry
Groupe Hospitalier Public Sud Oise
Clinique Saint Come
CH Compiegne
CHU Amiens
CH Laon


title: Randomized, Double-Blind, Phase III Trial Olaparib vs. Placebo Patients With Advanced FIGO Stage IIIB-IV High Grade Serious or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer Treated Standard First-Line Treatment

summary: Randomized, Double-Blind, Phase III Trial of Olaparib vs. Placebo in Patients with Advanced FIGO Stage IIIB - IV High Grade Serous or Endometrioid Ovarian, Fallopian Tube, or Peritoneal Cancer treated with standard First-Line Treatment, Combining Platinum-Taxane Chemotherapy and Bevacizumab Concurrent with Chemotherapy and in Maintenance.

status: Active, not recruiting

ReferenceType: result

ReferenceCitation: Ray-Coquard I, Pautier P, Pignata S, Pérol D, González-Martín A, Berger R, Fujiwara K, Vergote I, Colombo N, Mäenpää J, Selle F, Sehouli J, Lorusso D, Guerra Alía EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marmé F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.

name: From Centre Léon Bérard (I.R.-C., D.P.), Health Services and Performance Research Lab (EA 7425 HESPER), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de...

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Pautier

full_name: Patricia Pautier

given: Patricia

family: Pignata

full_name: Sandro Pignata

given: Sandro

family: Pérol

full_name: David Pérol

given: David

family: González-Martín

full_name: Antonio González-Martín

given: Antonio

family: Berger

full_name: Regina Berger

given: Regina

family: Fujiwara

full_name: Keiichi Fujiwara

given: Keiichi

family: Vergote

full_name: Ignace Vergote

given: Ignace

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: Mäenpää

full_name: Johanna Mäenpää

given: Johanna

family: Selle

full_name: Frédéric Selle

given: Frédéric

family: Sehouli

full_name: Jalid Sehouli

given: Jalid

family: Lorusso

full_name: Domenica Lorusso

given: Domenica

family: Guerra Alía

full_name: Eva M. Guerra Alía

given: Eva M.

family: Reinthaller

full_name: Alexander Reinthaller

given: Alexander

family: Nagao

full_name: Shoji Nagao

given: Shoji

family: Lefeuvre-Plesse

full_name: Claudia Lefeuvre-Plesse

given: Claudia

family: Canzler

full_name: Ulrich Canzler

given: Ulrich

family: Scambia

full_name: Giovanni Scambia

given: Giovanni

family: Lortholary

full_name: Alain Lortholary

family: Marmé

full_name: Frederik Marmé

given: Frederik

family: Combe

full_name: Pierre Combe

family: de Gregorio

full_name: Nikolaus de Gregorio

given: Nikolaus

repository_institution: Tampere University - Tampere University Institutional Repository

ReferenceCitation: Fujiwara K, Fujiwara H, Yoshida H, Satoh T, Yonemori K, Nagao S, Matsumoto T, Kobayashi H, Bourgeois H, Harter P, Mosconi AM, Vazquez IP, Reinthaller A, Fujita T, Rowe P, Pujade-Lauraine E, Ray-Coquard I. Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial. J Gynecol Oncol. 2021 Sep;32(5):e82. doi: 10.3802/jgo.2021.32.e82.

name: Saitama Medical University International Medical Center, Saitama, Japan.

name: Jichi Medical University Hospital, Tochigi, Japan.

name: University of Tsukuba Hospital, Ibaraki, Japan.

name: National Cancer Center Hospital, Tokyo, Japan.

name: Ehime University Hospital, Ehime, Japan.

name: Kagoshima University Hospital, Kagoshima, Japan.

name: Centre Jean Bernard – Clinique Victor Hugo, GINECO, Le Mans, France.

name: Ospedale Santa Maria della Misericordia, Perugia, Italy.

name: Hospital Universitario Central de Asturias, Oviedo, Spain.

name: Medical University Vienna, Vienna, Austria.

name: Medical Oncology, Université Paris Descartes, Paris, France.

name: Centre Léon BERARD and University Claude Bernard Lyon I, GINECO, Lyon, France.

publisher: Asian Society of Gynecologic Oncology; Korean Society of Gynecologic Oncology and Colposcopy

location_country: Italy Austria Sweden Finland France Japan Belgium Spain Denmark Germany Monaco

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez

location_facility: Centre Catherine de Sienne - Group confluent

location_facility: Kagoshima University Medical And Dental Hospital

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

location_facility: Charité - Universitätsmedizin Berlin (CVK)

location_facility: Istituto Nazionale Tumori - IRCCS Pascale

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne

location_facility: Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble

location_facility: Institut Curie - Hopital Claudius Régaud

location_facility: Hôpital de la Milétrie - CHU de Poitiers - Pôle Régional de Cancérologie


title: Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients

acronym: STARHE

summary:
By 2030, hepatocellular carcinoma (HCC) will become the second leading cause of cancer-related death, accounting for more than one million deaths per year according to the World Health Organization.

To this date, screening for hepatocellular carcinoma in France remains uniform for all patients, based solely on a liver ultrasound every 6 months. This strategy has three main limitations: lack of personalisation, low compliance, relatively poor performance of the ultrasound.

Risk stratification models have been developed for chronic hepatitis C, alcoholic cirrhosis and non-alcoholic steatohepatitis (NASH) including clinical and biological parameters but no analysis of the liver parenchyma which is the physiopathological substrate of hepatocarcinogenesis.

The advent of new artificial intelligence techniques could revolutionize the approach and lead to a personalised radiological screening strategy.

Deep learning, a subclass of machine learning, is a popular area of research that can help humans performing certain tasks by automatically identifying new image features not defined by humans.

The hypothesis of this study is that the non-tumor cirrhotic liver parenchyma is rich in structural information reflecting the severity of the hepatopathy, its carcinological risk and the process of hepatocarcinogenesis. Its analysis combined with clinical and biological data, which have already been studied to stratify the risk of hepatocarcinogenesis, will allow to define a very high-risk population, particularly in the context of Hepatitis C Virus (HCV) eradication and Hepatitis B Virus (HBV) control.

Consequently, this study proposes to design prospectively a deep learning model for stratification of the risk of hepatocarcinogenesis by including clinical, biological and radiological ultrasound parameters.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceType: background

ReferenceCitation: Cadier B, Bulsei J, Nahon P, Seror O, Laurent A, Rosa I, Layese R, Costentin C, Cagnot C, Durand-Zaleski I, Chevreul K; ANRS CO12 CirVir and CHANGH groups. Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States. Hepatology. 2017 Apr;65(4):1237-1248. doi: 10.1002/hep.28961. Epub 2017 Feb 8.

ReferenceCitation: Costentin CE, Layese R, Bourcier V, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Lédinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Riachi G, Calès P, Péron JM, Alric L, Bourlière M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grangé JD, Attali P, Bacq Y, Wartelle C, Dao T, Thabut D, Pilette C, Silvain C, Christidis C, Nguyen-Khac E, Bernard-Chabert B, Zucman D, Di Martino V, Sutton A, Letouzé E, Imbeaud S, Zucman-Rossi J, Audureau E, Roudot-Thoraval F, Nahon P; ANRS CO12 CirVir Group. Compliance With Hepatocellular Carcinoma Surveillance Guidelines Associated With Increased Lead-Time Adjusted Survival of Patients With Compensated Viral Cirrhosis: A Multi-Center Cohort Study. Gastroenterology. 2018 Aug;155(2):431-442.e10. doi: 10.1053/j.gastro.2018.04.027. Epub 2018 May 3.

ReferenceCitation: Ioannou GN, Green P, Kerr KF, Berry K. Models estimating risk of hepatocellular carcinoma in patients with alcohol or NAFLD-related cirrhosis for risk stratification. J Hepatol. 2019 Sep;71(3):523-533. doi: 10.1016/j.jhep.2019.05.008. Epub 2019 May 28.

ReferenceCitation: Audureau E, Carrat F, Layese R, Cagnot C, Asselah T, Guyader D, Larrey D, De Lédinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Riachi G, Calès P, Péron JM, Alric L, Bourlière M, Mathurin P, Blanc JF, Abergel A, Chazouillères O, Mallat A, Grangé JD, Attali P, d'Alteroche L, Wartelle C, Dao T, Thabut D, Pilette C, Silvain C, Christidis C, Nguyen-Khac E, Bernard-Chabert B, Zucman D, Di Martino V, Sutton A, Pol S, Nahon P; ANRS CO12 CirVir group. Personalized surveillance for hepatocellular carcinoma in cirrhosis - using machine learning adapted to HCV status. J Hepatol. 2020 Dec;73(6):1434-1445. doi: 10.1016/j.jhep.2020.05.052. Epub 2020 Jun 29.

ReferenceCitation: Kitamura S, Iishi H, Tatsuta M, Ishikawa H, Hiyama T, Tsukuma H, Kasugai H, Tanaka S, Kitamura T, Ishiguro S. Liver with hypoechoic nodular pattern as a risk factor for hepatocellular carcinoma. Gastroenterology. 1995 Jun;108(6):1778-84.

ReferenceCitation: Tarao K, Hoshino H, Shimizu A, Ohkawa S, Harada M, Nakamura Y, Ito Y, Tamai S, Okamoto N. Patients with ultrasonic coarse-nodular cirrhosis who are anti-hepatitis C virus-positive are at high risk for hepatocellular carcinoma. Cancer. 1995 Mar 15;75(6):1255-62.

ReferenceCitation: Caturelli E, Castellano L, Fusilli S, Palmentieri B, Niro GA, del Vecchio-Blanco C, Andriulli A, de Sio I. Coarse nodular US pattern in hepatic cirrhosis: risk for hepatocellular carcinoma. Radiology. 2003 Mar;226(3):691-7. Epub 2003 Jan 24.

ReferenceCitation: Dana J, Agnus V, Ouhmich F, Gallix B. Multimodality Imaging and Artificial Intelligence for Tumor Characterization: Current Status and Future Perspective. Semin Nucl Med. 2020 Nov;50(6):541-548. doi: 10.1053/j.semnuclmed.2020.07.003. Epub 2020 Aug 2. Review.

ReferenceCitation: Yala A, Schuster T, Miles R, Barzilay R, Lehman C. A Deep Learning Model to Triage Screening Mammograms: A Simulation Study. Radiology. 2019 Oct;293(1):38-46. doi: 10.1148/radiol.2019182908. Epub 2019 Aug 6.

ReferenceCitation: Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouché O, François E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2020 Mar;69(3):531-539. doi: 10.1136/gutjnl-2018-316407. Epub 2019 May 17.

family: Dohan

full_name: Anthony Dohan

given: Anthony

family: Gallix

full_name: Benoit Gallix

given: Benoit

family: Guiu

full_name: Boris Guiu

given: Boris

family: Le Malicot

full_name: Karine Le Malicot

given: Karine

family: Reinhold

full_name: Caroline Reinhold

given: Caroline

family: Soyer

full_name: Philippe Soyer

given: Philippe

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

family: Barbier

full_name: Emilie Barbier

given: Emilie

family: Boige

full_name: Valérie Boige

given: Valérie

family: Taieb

full_name: Julien Taieb

given: Julien

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: François

full_name: Eric François

given: Eric

family: Phelip

full_name: Jean-Marc Phelip

given: Jean-Marc

family: Borel

full_name: Christian Borel

given: Christian

family: Faroux

full_name: Roger Faroux

given: Roger

family: Seitz

full_name: Jean-Francois Seitz

given: Jean-Francois

family: Jacquot

full_name: Stéphane Jacquot

given: Stéphane

family: Ben Abdelghani

full_name: Meher Ben Abdelghani

given: Meher

family: Khemissa-Akouz

full_name: Faiza Khemissa-Akouz

given: Faiza

family: Genet

full_name: Dominique Genet

ReferenceCitation: Savadjiev P, Chong J, Dohan A, Agnus V, Forghani R, Reinhold C, Gallix B. Image-based biomarkers for solid tumor quantification. Eur Radiol. 2019 Oct;29(10):5431-5440. doi: 10.1007/s00330-019-06169-w. Epub 2019 Apr 8. Review.

ReferenceCitation: LeCun Y, Bengio Y, Hinton G. Deep learning. Nature. 2015 May 28;521(7553):436-44. doi: 10.1038/nature14539. Review.

ReferenceCitation: European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu. Corrigendum to "EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma" [J Hepatol 69 (2018) 182-236]. J Hepatol. 2019 Apr;70(4):817. doi: 10.1016/j.jhep.2019.01.020. Epub 2019 Feb 7.

location_facility: Groupement Hospitalier Nord, Hôpital de la Croix-Rousse

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot


title: High Resolution PET Imaging of Microglial Activation in Parkinson's Disease (PD) With a New Tracer [18F]DPA-714

acronym: INFLAPARK

summary:
There is accumulating evidence suggesting that inflammatory processes, through microglial activation, would play a key role in the neurodegenerative process of Parkinson's disease (PD). It is considered that microglial activation would be part of self-propelling cycle of neuroinflammation that fuels the progressive dopaminergic neurodegeneration. It is however hard to evidence microglial activation in vivo, especially in the substantia nigra: first, the investigators need very high resolution imaging tools and then, the only ligand available to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous results.

18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to explore the topography and intensity of microglial activation in several different groups of PD patients: 1) de novo, drug-naïve subjects (n = 6); 2) non-fluctuating treated patients ("honeymoon") (n = 10); 3) advanced drug-responsive patients motor fluctuations (wearing-off or dyskinesia) (n = 6); 4) patients with LRRK2 gene mutation (n = 6); and 5) related to healthy patients carriers of the mutation LRRK2(n = 6). PET imaging will be performed with a new generation tomography having a very high resolution.

This study might reveal significant neuroinflammatory process in the midbrain of PD patients and will determine if such process is present in both sporadic and genetic forms of PD. The results of this study might provide a new biomarker of disease pathological progression and help as identifying subjects who might most benefit from a specific anti-inflammatory drug.

primary_purpose: Basic Science

ReferenceCitation: Lavisse S, Goutal S, Wimberley C, Tonietto M, Bottlaender M, Gervais P, Kuhnast B, Peyronneau MA, Barret O, Lagarde J, Sarazin M, Hantraye P, Thiriez C, Remy P. Increased microglial activation in patients with Parkinson disease using [(18)F]-DPA714 TSPO PET imaging. Parkinsonism Relat Disord. 2021 Jan;82:29-36. doi: 10.1016/j.parkreldis.2020.11.011. Epub 2020 Nov 17.

family: Lavisse

full_name: Sonia Lavisse

given: Sonia

family: Goutal

full_name: Sébastien Goutal

given: Sébastien

family: Wimberley

full_name: Catriona Wimberley

given: Catriona

family: Tonietto

full_name: Mattéo Tonietto

given: Mattéo

family: Bottlaender

full_name: Michel Bottlaender

given: Michel

family: Gervais

full_name: Philippe Gervais

family: Kuhnast

full_name: Bertrand Kuhnast

given: Bertrand

family: Peyronneau

full_name: Marie-Anne Peyronneau

given: Marie-Anne

family: Barret

full_name: Olivier Barret

family: Lagarde

full_name: Julien Lagarde

family: Sarazin

full_name: Marie Sarazin

given: Marie

family: Hantraye

full_name: Philippe Hantraye

family: Thiriez

full_name: Claire Thiriez

given: Claire

family: Remy

full_name: Philippe Remy

journal_name: Parkinsonism & Related Disorders

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Increased microglial activation in patients with Parkinson disease using [18F]-DPA714 TSPO PET imaging


title: Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions_COVID-19

acronym: REMPAR-EHPAD

summary: REMPAR EHPAD study addresses environmental and managerial factors associated with an outbreak of COVID 19 in French Long Term Care Institutions in the spring of 2020. The survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501) and qualitative interviews with facility directors (n=21).

time_perspective: Retrospective

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes


title: Tolerance of Nasal High Frequency Percussive Ventilation Versus Nasal CPAP in Neonatal Respiratory Distress in Term and Preterm (> 33 Weeks of Gestation) Neonates

acronym: TONIPEP

summary:
Respiratory distress is the main cause of morbimortality in preterm and term neonates. In most of the case, these babies required the use of positive end expiratory pressure (PEEP) delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.

We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy (NIRS).

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de Néonatalogie - Maternité - Hôpital Pellegrin

intervention_type: Device


title: Sub-thalamic Nucleus Stimulation in Parkinson Disease: Comparison of a Two-steps Electrophysiological Approach Under Local and General Anesthesia and a One-step Approach Under General Anesthesia

acronym: PARKEO

summary:
Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology. This study is a prospective, randomized and monocentric study to compare two DBS procedures with or without electrophysiology.

A better control of targeting and trajectory is necessary before not using electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei without the need of electrophysiology.

Two groups of patients will be followed: a first group of patients with a procedure under general anesthesia alone without electrophysiological stimulation and a second smaller group of patients with a first step of electrode implantation under awake surgery with electrophysiological stimulation followed by a second step under general anesthesia for the implantation of stimulator.

Clinical results will be assessed at 6 months after implantation.

primary_purpose: Other

ReferenceCitation: Bronstein JM, Tagliati M, Alterman RL, Lozano AM, Volkmann J, Stefani A, Horak FB, Okun MS, Foote KD, Krack P, Pahwa R, Henderson JM, Hariz MI, Bakay RA, Rezai A, Marks WJ Jr, Moro E, Vitek JL, Weaver FM, Gross RE, DeLong MR. Deep brain stimulation for Parkinson disease: an expert consensus and review of key issues. Arch Neurol. 2011 Feb;68(2):165. doi: 10.1001/archneurol.2010.260. Epub 2010 Oct 11. Review.

ReferenceCitation: Cuny E, Guehl D, Burbaud P, Gross C, Dousset V, Rougier A. Lack of agreement between direct magnetic resonance imaging and statistical determination of a subthalamic target: the role of electrophysiological guidance. J Neurosurg. 2002 Sep;97(3):591-7.

ReferenceCitation: Ferrara J, Diamond A, Hunter C, Davidson A, Almaguer M, Jankovic J. Impact of STN-DBS on life and health satisfaction in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Mar;81(3):315-9. doi: 10.1136/jnnp.2009.184127. Epub 2009 Sep 1.

ReferenceCitation: Kenney C, Simpson R, Hunter C, Ondo W, Almaguer M, Davidson A, Jankovic J. Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. J Neurosurg. 2007 Apr;106(4):621-5.

ReferenceCitation: Kleiner-Fisman G, Herzog J, Fisman DN, Tamma F, Lyons KE, Pahwa R, Lang AE, Deuschl G. Subthalamic nucleus deep brain stimulation: summary and meta-analysis of outcomes. Mov Disord. 2006 Jun;21 Suppl 14:S290-304. Review.

ReferenceCitation: Limousin P, Krack P, Pollak P, Benazzouz A, Ardouin C, Hoffmann D, Benabid AL. Electrical stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 1998 Oct 15;339(16):1105-11.

ReferenceCitation: Maltête D, Navarro S, Welter ML, Roche S, Bonnet AM, Houeto JL, Mesnage V, Pidoux B, Dormont D, Cornu P, Agid Y. Subthalamic stimulation in Parkinson disease: with or without anesthesia? Arch Neurol. 2004 Mar;61(3):390-2.

ReferenceCitation: Engelhardt J, Caire F, Damon-Perrière N, Guehl D, Branchard O, Auzou N, Tison F, Meissner WG, Krim E, Bannier S, Bénard A, Sitta R, Fontaine D, Hoarau X, Burbaud P, Cuny E. A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease. Stereotact Funct Neurosurg. 2021;99(3):230-240. doi: 10.1159/000511424. Epub 2020 Nov 30.

family: Engelhardt

full_name: Julien Engelhardt

given: Julien

family: Caire

full_name: François Caire

given: François

family: Damon-Perrière

full_name: Nathalie Damon-Perrière

given: Nathalie

family: Guehl

full_name: Dominique Guehl

given: Dominique

family: Branchard

full_name: Olivier Branchard

given: Olivier

family: Auzou

full_name: Nicolas Auzou

given: Nicolas

family: Tison

full_name: François Tison

family: Meissner

full_name: Wassilios G. Meissner

given: Wassilios G.

family: Krim

full_name: Elsa Krim

given: Elsa

family: Bannier

full_name: Stéphanie Bannier

given: Stéphanie

family: Bénard

full_name: Antoine Bénard

given: Antoine

family: Sitta

full_name: Rémi Sitta

given: Rémi

family: Fontaine

full_name: Denys Fontaine

given: Denys

family: Hoarau

full_name: Xavier Hoarau

given: Xavier

family: Burbaud

full_name: Pierre Burbaud

given: Pierre

family: Cuny

full_name: Emmanuel Cuny

given: Emmanuel

journal_name: Stereotactic and Functional Neurosurgery

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

title: A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson’s Disease


title: Obtaining Vascular Access (Venous or Intraosseous) During Cardiac Arrest in Out-of-hospital Care: Delays and Failure Risk Factors

acronym: ACCIO

summary: the international recommendations don't explain the place of the intraosseous infusion in the reanimation of adult cardiac arrest; the goal of this preliminary study is to inform the delay for obtaining a vascular access by evaluation of a current strategy (using intraosseous infusion after one peripheral venous access failure) and to determine the potential failure risk factors of venous access.


title: Total Hip Prosthesis Assisted by Computer Based on Pre-operative EOS Imaging

acronym: NAVEOS

summary: Computer assistance in prosthetic hip surgery is able to improve the accuracy of the surgery: Associating hip navigation and EOSTM imaging pre-operatively could simplify the procedure of hip navigation in lateral decubitus while maintaining the accuracy of the technique

location_facility: Unité d'orthopédie-traumatologie, membre supérieur CHU Pellegrin


title: Prospective Study of the Natural History of Patients With Type 2 and 3 Spinal Muscular Atrophy

acronym: NatHis-SMA

summary: NatHis-SMA is a prospective, longitudinal and interventional study of the natural history of patients with type 2 and 3 Spinal Muscular Atrophy (SMA). The purpose of this study is to characterize the disease course over 2 years and identify prognostic variables of the disease and biomarkers of SMA progression, as well as determine the best outcome measures for further therapeutics approaches.

ReferenceCitation: Chabanon A, Seferian AM, Daron A, Péréon Y, Cances C, Vuillerot C, De Waele L, Cuisset JM, Laugel V, Schara U, Gidaro T, Gilabert S, Hogrel JY, Baudin PY, Carlier P, Fournier E, Lowes LP, Hellbach N, Seabrook T, Toledano E, Annoussamy M, Servais L; NatHis-SMA study group. Prospective and longitudinal natural history study of patients with Type 2 and 3 spinal muscular atrophy: Baseline data NatHis-SMA study. PLoS One. 2018 Jul 26;13(7):e0201004. doi: 10.1371/journal.pone.0201004. eCollection 2018.

family: Chabanon

full_name: Aurélie Chabanon

given: Aurélie

family: Seferian

full_name: Andreea Mihaela Seferian

given: Andreea Mihaela

family: Daron

full_name: Aurore Daron

given: Aurore

family: Péréon

full_name: Yann Péréon

given: Yann

family: Cances

full_name: Claude Cances

given: Claude

family: Vuillerot

full_name: Carole Vuillerot

given: Carole

family: De Waele

full_name: Liesbeth De Waele

given: Liesbeth

family: Cuisset

full_name: Jean-Marie Cuisset

given: Jean-Marie

family: Laugel

full_name: Vincent Laugel

given: Vincent

family: Schara

full_name: Ulrike Schara

given: Ulrike

family: Gidaro

full_name: Teresa Gidaro

given: Teresa

family: Gilabert

full_name: Stéphanie Gilabert

family: Hogrel

full_name: Jean-Yves Hogrel

given: Jean-Yves

family: Baudin

full_name: Pierre-Yves Baudin

given: Pierre-Yves

family: Carlier

full_name: Pierre Carlier

family: Fournier

full_name: Emmanuel Fournier

family: Lowes

full_name: Linda Pax Lowes

given: Linda Pax

family: Hellbach

full_name: Nicole Hellbach

given: Nicole

family: Seabrook

full_name: Timothy Seabrook

given: Timothy

family: Toledano

full_name: Elie Toledano

given: Elie

family: Annoussamy

full_name: Mélanie Annoussamy

given: Mélanie

family: Servais

full_name: Laurent Servais

given: Laurent

currency_apc_doaj: USD

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

location_facility: Centre de Référence neuromusculaire - CHR La Citadelle

location_facility: Centre de référence Maladies Neuromusculaires Nantes-Angers - Hôtel Dieu

location_facility: Maladie Neuromusculaire de l'enfant - Service Maladies infectieuses et neurologie infantile - Hôpital Roger Salengro

location_facility: Universitätsklinikum Essen (AöR) - Klinik für Kinderheilkunde I - Sozialpädiatrisches Zentrum

location_facility: Neuropédiatrie - Service de Pédiatrie 1 - CHU Hautepierre

location_facility: Unité de neurologie pédiatrique - Hôpital des enfants

location_facility: Service de Rééducation Pédiatrique Infantile " L'Escale " - Hôpital Femme Mère Enfant

location_facility: Reference centre for neuromuscular diseases - UZ Leuven - Department of Pediatrics - University Hospitals Leuven


title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients - Sarilumab Trial - CORIMUNO-19 - SARI

acronym: CORIMUNO-SARI

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Sarilumab administration to patients enrolled in the CORIMUNO-19 cohort. Sarilumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Sarilumab will receive standard of care. Outcomes of Sarilumab-treated patients will be compared with outcomes of standard of care-treated patients as well as with outcomes of patients treated with other immune modulators.

ReferenceCitation: CORIMUNO-19 Collaborative group. Sarilumab in adults hospitalised with moderate-to-severe COVID-19 pneumonia (CORIMUNO-SARI-1): An open-label randomised controlled trial. Lancet Rheumatol. 2021 Nov 17. doi: 10.1016/S2665-9913(21)00315-5. [Epub ahead of print]

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Hermine

full_name: Olivier Hermine

given: Olivier

family: Tharaux

full_name: Pierre-Louis Tharaux

given: Pierre-Louis

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

family: Porcher

full_name: Raphael Porcher

given: Raphael

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Bureau

full_name: Serge Bureau

given: Serge

family: Dougados

full_name: Maxime Dougados

given: Maxime

family: Tibi

full_name: Annick Tibi

given: Annick

family: Azoulay

full_name: Elie Azoulay

family: Cadranel

full_name: Jacques Cadranel

given: Jacques

family: Emmerich

full_name: Joseph Emmerich

given: Joseph

family: Fartoukh

full_name: Muriel Fartoukh

given: Muriel

family: Guidet

full_name: Bertrand Guidet

given: Bertrand

family: Humbert

full_name: Marc Humbert

given: Marc

family: Lacombe

full_name: Karine Lacombe

given: Karine

family: Mahevas

full_name: Matthieu Mahevas

family: Pene

full_name: Frédéric Pene

given: Frédéric

family: Pourchet-Martinez

full_name: Valérie Pourchet-Martinez

given: Valérie

family: Schlemmer

full_name: Frédéric Schlemmer

family: Yazdanpanah

full_name: Yazdan Yazdanpanah

given: Yazdan

family: Baron

full_name: Gabriel Baron

given: Gabriel

family: Perrodeau

full_name: Elodie Perrodeau

given: Elodie

location_facility:
HEGP
Cochin Aphp
Kremlin Bicetre hospital APHP
NECKER Hospital


title: Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients

summary:
Critically ill and intubated patients on mechanical ventilation (IMV) often present retention of respiratory secretions, increasing the risk of respiratory infections and associated morbidity. Endotracheal suctioning (ETS) is the main strategy to prevent mucus retention, but its effects are limited to the first bronchial bifurcation.

Mechanical in-exsufflation devices (MI-E) are a non-invasive chest physiotherapy (CPT) technique that aims to improve mucus clearance in proximal airways by generating high expiratory flows and simulating cough. Currently there are no studies that have specifically assessed the effects of MI-E in critically ill and intubated patients. Thus, the aims of this study are to evaluate efficacy and safety of MI-E to improve mucus clearance in critically ill and intubated patients.

ReferenceCitation: Konrad F, Schreiber T, Brecht-Kraus D, Georgieff M. Mucociliary transport in ICU patients. Chest. 1994 Jan;105(1):237-41.

ReferenceCitation: American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64.

ReferenceCitation: Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schönhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19. Review.

family: Gosselink

full_name: R. Gosselink

given: R.

family: Bott

full_name: J. Bott

given: J.

family: Johnson

full_name: M. Johnson

given: M.

family: Dean

full_name: E. Dean

given: E.

family: Nava

full_name: S. Nava

given: S.

family: Norrenberg

full_name: M. Norrenberg

family: Schönhofer

full_name: B. Schönhofer

given: B.

family: Stiller

full_name: K. Stiller

given: K.

family: van de Leur

full_name: H. van de Leur

given: H.

family: Vincent

full_name: J. L. Vincent

given: J. L.

journal_name: Intensive Care Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Guérin C, Bourdin G, Leray V, Delannoy B, Bayle F, Germain M, Richard JC. Performance of the coughassist insufflation-exsufflation device in the presence of an endotracheal tube or tracheostomy tube: a bench study. Respir Care. 2011 Aug;56(8):1108-14. doi: 10.4187/respcare.01121.

family: Guerin

full_name: C. Guerin

given: C.

family: Bourdin

full_name: G. Bourdin

given: G.

family: Leray

full_name: V. Leray

given: V.

family: Delannoy

full_name: B. Delannoy

family: Bayle

full_name: F. Bayle

given: F.

family: Germain

full_name: M. Germain

family: Richard

full_name: J.-C. Richard

journal_name: Respiratory Care

publisher: Daedalus Enterprises

publisher_dissemination: Daedalus Enterprises

publisher_group: Daedalus Enterprises

title: Performance of the CoughAssist Insufflation-Exsufflation Device in the Presence of an Endotracheal Tube or Tracheostomy Tube: A Bench Study

ReferenceCitation: Gómez-Merino E, Sancho J, Marín J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83.

ReferenceCitation: Martínez-Alejos R, Martí JD, Li Bassi G, Gonzalez-Anton D, Pilar-Diaz X, Reginault T, Wibart P, Ntoumenopoulos G, Tronstad O, Gabarrus A, Quinart A, Torres A. Effects of Mechanical Insufflation-Exsufflation on Sputum Volume in Mechanically Ventilated Critically Ill Subjects. Respir Care. 2021 Sep;66(9):1371-1379. doi: 10.4187/respcare.08641. Epub 2021 Jun 8.

location_facility: Polyvalent ICU. Centre medico-chirurgicale Magellan 2.


title: Impulsivity and Parkinson's Disease : a Neuropsychology With Magnetic Resonance Imaging Study

summary: This study aims to characterize the nature of impulsivity in Parkinson's Disease (PD).

lead_sponsor: Poitiers University Hospital

location_facility:
Chu de Poitiers
Pascal DERKINDEREN
Marc VERIN


title: Corneal Biomechanics and Continuous IOP Monitoring Using Soft Contact Lenses in Glaucomatous Patients

acronym: BIOLENS

summary:
Ocular hypertension and its fluctuations is a major risk factor of glaucoma onset and progression. In normal eyes, IOP presents a circadian rhythm, but in glaucomatous eyes IOP circadian rhythm is altered and varied widely between patients. To date, the only way to evaluate 24 hour IOP fluctuations is a regular GAT-IOP measurement during a 24-hour hospitalization. This method is expensive and does not reflect physiological conditions because it requires IOP measurements during sleeping periods that may potentially produce artifacts.

Sensimed AG has developed a new medical device SENSIMED Triggerfish® that enables a 24-hour continuous monitoring of IOP fluctuations. As any IOP measurements methods, this medical device might be influenced by corneal properties of the cornea as central corneal thickness, keratometry or biomechanics. We, therefore, investigate the corneal lens tolerance, potential modifications of corneal parameters after a 24-hour wear of the lens, and its influence on data collected during the whole period of analysis. Then we will also analyze the influence of corneal parameters on continuous IOP fluctuations measured with the contact sensor and finally the correlation between data collected and the rate of progression (severity) of glaucoma evaluated with visual field test or optic nerve head damages.

location_facility: Service d'ophtalmologie Hôpital Pellegrin


title: Level of Expression and Prognostic Value of CXCL4, CXCL4L1 and CXCR3 in Renal Cell Carcinoma

acronym: ChemoRenCan

summary:
Despite novel treatment options, Renal Cell Carcinoma (RCC) has been characterized by a constant increase in its mortality and consequently requires an important involvement in translational research.

The aim of this study is to evaluate the interest of CXCL4, CXCL4L1 and CXCR3 as biomarkers in localized, locally advanced or metastatic RCC. Indeed these chemokines have shown anti-angiogenic and anti-tumor properties in experimental models and may be particularly interesting for prognostic and predictive purposes.

ReferenceCitation: Belot A, Grosclaude P, Bossard N, Jougla E, Benhamou E, Delafosse P, Guizard AV, Molinié F, Danzon A, Bara S, Bouvier AM, Trétarre B, Binder-Foucard F, Colonna M, Daubisse L, Hédelin G, Launoy G, Le Stang N, Maynadié M, Monnereau A, Troussard X, Faivre J, Collignon A, Janoray I, Arveux P, Buemi A, Raverdy N, Schvartz C, Bovet M, Chérié-Challine L, Estève J, Remontet L, Velten M. Cancer incidence and mortality in France over the period 1980-2005. Rev Epidemiol Sante Publique. 2008 Jun;56(3):159-175. doi: 10.1016/j.respe.2008.03.117. Epub 2008 Jun 10.

ReferenceCitation: Raynal G, Bernhard JC. [Premature death from urologic cancer: the kidneys at the forefront]. Prog Urol. 2007 Apr;17(2):260-1. French.

ReferenceCitation: Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999 Aug;17(8):2530-40.

ReferenceCitation: Margulis V, Sánchez-Ortiz RF, Tamboli P, Cohen DD, Swanson DA, Wood CG. Renal cell carcinoma clinically involving adjacent organs: experience with aggressive surgical management. Cancer. 2007 May 15;109(10):2025-30.

ReferenceCitation: Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70.

ReferenceCitation: Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24.

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203.

ReferenceCitation: Escudier B, Pluzanska A, Koralewski P, Ravaud A, Bracarda S, Szczylik C, Chevreau C, Filipek M, Melichar B, Bajetta E, Gorbunova V, Bay JO, Bodrogi I, Jagiello-Gruszfeld A, Moore N; AVOREN Trial investigators. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet. 2007 Dec 22;370(9605):2103-11.

ReferenceCitation: Ravaud A, Wallerand H, Culine S, Bernhard JC, Fergelot P, Bensalah K, Patard JJ. Update on the medical treatment of metastatic renal cell carcinoma. Eur Urol. 2008 Aug;54(2):315-25. doi: 10.1016/j.eururo.2008.04.056. Epub 2008 May 5. Review.

ReferenceCitation: Maione TE, Gray GS, Petro J, Hunt AJ, Donner AL, Bauer SI, Carson HF, Sharpe RJ. Inhibition of angiogenesis by recombinant human platelet factor-4 and related peptides. Science. 1990 Jan 5;247(4938):77-9.

ReferenceCitation: Jouan V, Canron X, Alemany M, Caen JP, Quentin G, Plouet J, Bikfalvi A. Inhibition of in vitro angiogenesis by platelet factor-4-derived peptides and mechanism of action. Blood. 1999 Aug 1;94(3):984-93.

ReferenceCitation: Lasagni L, Francalanci M, Annunziato F, Lazzeri E, Giannini S, Cosmi L, Sagrinati C, Mazzinghi B, Orlando C, Maggi E, Marra F, Romagnani S, Serio M, Romagnani P. An alternatively spliced variant of CXCR3 mediates the inhibition of endothelial cell growth induced by IP-10, Mig, and I-TAC, and acts as functional receptor for platelet factor 4. J Exp Med. 2003 Jun 2;197(11):1537-49.

ReferenceCitation: Eisman R, Surrey S, Ramachandran B, Schwartz E, Poncz M. Structural and functional comparison of the genes for human platelet factor 4 and PF4alt. Blood. 1990 Jul 15;76(2):336-44.

ReferenceCitation: Struyf S, Burdick MD, Proost P, Van Damme J, Strieter RM. Platelets release CXCL4L1, a nonallelic variant of the chemokine platelet factor-4/CXCL4 and potent inhibitor of angiogenesis. Circ Res. 2004 Oct 29;95(9):855-7. Epub 2004 Sep 30.

ReferenceCitation: Struyf S, Burdick MD, Peeters E, Van den Broeck K, Dillen C, Proost P, Van Damme J, Strieter RM. Platelet factor-4 variant chemokine CXCL4L1 inhibits melanoma and lung carcinoma growth and metastasis by preventing angiogenesis. Cancer Res. 2007 Jun 15;67(12):5940-8.

ReferenceCitation: Pan J, Burdick MD, Belperio JA, Xue YY, Gerard C, Sharma S, Dubinett SM, Strieter RM. CXCR3/CXCR3 ligand biological axis impairs RENCA tumor growth by a mechanism of immunoangiostasis. J Immunol. 2006 Feb 1;176(3):1456-64.

ReferenceCitation: Klatte T, Seligson DB, Leppert JT, Riggs SB, Yu H, Zomorodian N, Kabbinavar FF, Strieter RM, Belldegrun AS, Pantuck AJ. The chemokine receptor CXCR3 is an independent prognostic factor in patients with localized clear cell renal cell carcinoma. J Urol. 2008 Jan;179(1):61-6. Epub 2007 Nov 13.

ReferenceCitation: Kattan MW, Reuter V, Motzer RJ, Katz J, Russo P. A postoperative prognostic nomogram for renal cell carcinoma. J Urol. 2001 Jul;166(1):63-7.

ReferenceCitation: Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol. 2002 Jan 1;20(1):289-96.

ReferenceCitation: Zisman A, Pantuck AJ, Wieder J, Chao DH, Dorey F, Said JW, deKernion JB, Figlin RA, Belldegrun AS. Risk group assessment and clinical outcome algorithm to predict the natural history of patients with surgically resected renal cell carcinoma. J Clin Oncol. 2002 Dec 1;20(23):4559-66.

ReferenceCitation: Bensalah K, Pantuck AJ, Crepel M, Verhoest G, Méjean A, Valéri A, Ficarra V, Pfister C, Ferrière JM, Soulié M, Cindolo L, De La Taille A, Tostain J, Chautard D, Schips L, Zigeuner R, Abbou CC, Lobel B, Salomon L, Lechevallier E, Descotes JL, Guillé F, Colombel M, Belldegrun AS, Patard JJ. Prognostic variables to predict cancer-related death in incidental renal tumours. BJU Int. 2008 Nov;102(10):1376-80. doi: 10.1111/j.1464-410X.2008.07847.x. Epub 2008 Aug 22.

ReferenceCitation: Furniss D, Harnden P, Ali N, Royston P, Eisen T, Oliver RT, Hancock BW; National Cancer Research Institute Renal Clinical Studies Group. Prognostic factors for renal cell carcinoma. Cancer Treat Rev. 2008 Aug;34(5):407-26. doi: 10.1016/j.ctrv.2007.12.008. Epub 2008 Apr 28. Review.

intervention_type: Biological


title: Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.

acronym: EPI-ENDO

summary:
Biventricular pacing is a validated treatment for patients suffering from heart failure resistant to medical treatment. However, up to 30% of the patients are non responsive to this strategy using the coronary sinus approach to pace the Left Ventricle (LV).

It has been demonstrated that the magnitude of the improvement was highly dependant on the LV pacing site. The coronary sinus approach rarely offers more than 1 or 2 potential pacing sites. Resynchronisation using a transeptal approach to pace the left ventricle on the cardiology has been shown feasible on small series. We therefore would like to compare these two approached in a randomised prospective study to confirm the hypotheses that endocardial LV pacing by offering multiple choices for the pacing sites reduces the number of non responders and is associated with greater hemodynamic benefit when compared to the conventional coronary sinus approach.


title: Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter

acronym: EvaMAP

summary:
Monophasic action potential (MAP) recording plays an important role in a more direct view of human myocardial electrophysiology under both physiological and pathological conditions. The MAP method represents a very useful tool for an electrophysiological research in cardiology. Its crucial importance lies in the fact that it enables the study of the action potential (AP) of myocardial cell in vivo and, therefore, the study of the dynamic relation of this potential with all the organism variables what can be particularly helpful in the case of arrhythmias.

Hundred and fifty patients will be included to explore mapping capabilities in cardiac chambers in patients suffering from regular or fibrillating tachycardia's with the following inclusion plan: i) Atrial fibrillation at a total of 50 patients ii) Ventricular fibrillation or patients at high risk of sudden cardiac death at a total of 50 patients iii) Junctional tachycardia at a total of 50 patients. We will focus on cardiac activation (depolarization and repolarization) in this population.

status: Suspended

location_facility: Hôpital cardiologique du Haut-Lévêque, Cardiac arrhythmias department


title: Decision-making and Emotion Recognition in Essential Tremor

acronym: EMOTREM

summary: The present study aims at investigating cognitive functions requiring orbitofrontal control, namely decision-making and facial emotion recognition. The investigators hypothesize that decision-making and facial emotion recognition are impaired in patients with essential tremor (ET) due to frontal lobe dysfunction which may have consequences in daily social life.

location_facility: CHU de Bordeaux, Hôpital du Haut-Lévêque

intervention_type: Behavioral


title: Early Detection of Diabetic Cardiomyopathy by Analysis of Myocardial Deformations by Two-dimensional Speckle Tracking Strain Echocardiography and Relationship to Micro-angiopathy

acronym: ECHO-DIAB

summary: Despite careful monitoring of patients with diabetes, it is so far difficult to predict the occurrence of cardiac events in the evolution. As shown by various studies conducted in patients with diabetes, cardiac involvement can be detected by abnormalities of diastolic or systolic functions using non-invasive investigations such as echocardiography. For 4 years, the evaluation technique of myocardial deformations by two-dimensional speckle tracking strain by echocardiography is the subject of high hopes in the earlier detection of still asymptomatic cardiomyopathies. In the present study, the investigators hypothesized that this technique would improve the detection of myocardial contraction abnormalities in patients with insulin-dependent diabetes mellitus (IDDM), and would establish their association with micro-angiopathy, frequently encountered in these patients.

location_facility: Hôpital Cardiologique du Haut-Lévêque, Service de Cardiologie et Maladies Vasculaires


title: The Fami-Life Study: Protocol of a Prospective Multicenter Observational Mixed Study of Psychological Consequences of Grieving Families in French Palliative Care Units on the Behalf of the F.R.I.P.C Research Network

acronym: FAMI-LIFE

summary: The purpose of this study is to assess the incidence and risk factors of prolonged grief in family members of patients died in French palliative care units and to explore experience of bereaved families to build a scientifically valid management prevention program.

ReferenceCitation: Fasse L, Flahault C, Brédart A, Dolbeault S, Sultan S. Describing and understanding depression in spouses of cancer patients in palliative phase. Psychooncology. 2015 Sep;24(9):1131-7. doi: 10.1002/pon.3777. Epub 2015 Feb 24.

name: Institut Gustave Roussy; 114 rue E. Vaillant Villejuif France

name: Université Paris Descartes; LPPS EA 4057, IUPDP Paris France

family: Fasse

full_name: Léonor Fasse

given: Léonor

name: Institut Curie; 26 rue d'Ulm Paris France

family: Flahault

full_name: Cécile Flahault

given: Cécile

family: Brédart

full_name: Anne Brédart

given: Anne

family: Dolbeault

full_name: Sylvie Dolbeault

given: Sylvie

name: Université de Montréal & CHU Sainte-Justine; Montréal Canada

family: Sultan

full_name: Serge Sultan

given: Serge

journal_name: Psycho-Oncology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Kentish-Barnes N, Chaize M, Seegers V, Legriel S, Cariou A, Jaber S, Lefrant JY, Floccard B, Renault A, Vinatier I, Mathonnet A, Reuter D, Guisset O, Cohen-Solal Z, Cracco C, Seguin A, Durand-Gasselin J, Éon B, Thirion M, Rigaud JP, Philippon-Jouve B, Argaud L, Chouquer R, Adda M, Dedrie C, Georges H, Lebas E, Rolin N, Bollaert PE, Lecuyer L, Viquesnel G, Léone M, Chalumeau-Lemoine L, Garrouste M, Schlemmer B, Chevret S, Falissard B, Azoulay É. Complicated grief after death of a relative in the intensive care unit. Eur Respir J. 2015 May;45(5):1341-52. doi: 10.1183/09031936.00160014. Epub 2015 Jan 22.

family: Kentish-Barnes

full_name: Nancy Kentish-Barnes

given: Nancy

family: Chaize

full_name: Marine Chaize

given: Marine

family: Seegers

full_name: Valérie Seegers

given: Valérie

family: Legriel

full_name: Stéphane Legriel

given: Stéphane

family: Cariou

full_name: Alain Cariou

given: Alain

family: Jaber

full_name: Samir Jaber

given: Samir

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Floccard

full_name: Bernard Floccard

given: Bernard

family: Renault

full_name: Anne Renault

family: Vinatier

full_name: Isabelle Vinatier

given: Isabelle

family: Mathonnet

full_name: Armelle Mathonnet

given: Armelle

family: Reuter

full_name: Danielle Reuter

given: Danielle

family: Guisset

full_name: Olivier Guisset

given: Olivier

family: Cohen-Solal

full_name: Zoé Cohen-Solal

given: Zoé

family: Cracco

full_name: Christophe Cracco

given: Christophe

family: Seguin

full_name: Amélie Seguin

ReferenceCitation: Flahault C, Dolbeault S, Sankey C, Fasse L. Understanding grief in children who have lost a parent with cancer: How do they give meaning to this experience? Results of an interpretative phenomenological analysis. Death Stud. 2018 Sep;42(8):483-490. doi: 10.1080/07481187.2017.1383951. Epub 2018 Jan 24.

name: Laboratory of Psychopathology and Health Process, Paris Descartes University, IUPDP, Paris, France

name: UPO, Curie Institute, IUPDP, Paris, France

name: Laboratory of Psychology, Relational Dynamics and Identity Process, University of Burgundy, Dijon, France

ReferenceCitation: Fasse L, Sultan S, Flahault C, Mackinnon CJ, Dolbeault S, Brédart A. How do researchers conceive of spousal grief after cancer? A systematic review of models used by researchers to study spousal grief in the cancer context. Psychooncology. 2014 Feb;23(2):131-42. doi: 10.1002/pon.3412. Epub 2013 Sep 30. Review.

name: Université Paris Descartes; LPPS EA 4057, IUPDP; Paris France

name: Department of Educational and Counseling Psychology; McGill University; Montréal Québec Canada

name: Palliative Care Research; SMBD Jewish General Hospital; Montréal Québec Canada

name: Psychosocial Oncology Program; Montreal General Hospital; Montréal Québec Canada

name: Université Paris-Sud and Université Paris Descartes; UMR-S0669; Paris France

ReferenceCitation: Garrouste-Orgeas M, Flahault C, Poulain E, Evin A, Guirimand F, Fossez-Diaz V, Perruchio S, Verlaine C, Vanbésien A, Kaczmarek W, Birkui de Francqueville L, De Larivière E, Bouquet G, Copel L, Verliac V, Marché V, Mathias C, Gracia D, Mhalla A, Michonneau-Gandon V, Poupardin C, Touzet L, Ranchou G, Guastella V, Richard B, Bienfait F, Sonrier M, Michel D, Ruckly S, Bailly S, Timsit JF. The Fami-life study: protocol of a prospective observational multicenter mixed study of psychological consequences of grieving relatives in French palliative care units on behalf of the family research in palliative care (F.R.I.P.C research network). BMC Palliat Care. 2019 Dec 9;18(1):111. doi: 10.1186/s12904-019-0496-4.

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


title: Role of Retina in Mechanisms of Illusions and Visual Hallucinations Observed in Idiopathic Parkinson's Disease

summary:
Parkinson's disease is characterized not only by motor symptoms but also by psycho-behavioral symptoms including Visual Hallucinations (VH) and illusions (I), that are generally associated with a severe functional impairment and a bad prognosis for patients. Visual Hallucinations are defined by a visual perception without any real objet to perceive, whereas illusions are defined by a wrong perceptions of an object that is really present. In most of studies investigating the pathophysiology of VH in PD, no difference is made between VH and I, however different mechanisms could lead to the emergence of these two phenomenon, with different prognosis.

Investigator hypothesize that illusions could be related to a visual impairment, maybe at the retinal level, known to be impaired in PD, whereas Visual hallucinations would be due to a more widespread impairment affecting higher levels visuo-perceptive and cognitive functions.

ReferenceCitation: Marques A, Beze S, Lambert C, Bonamy L, de Chazeron I, Rieu I, Chiambaretta F, Durif F. Psycho-sensory modalities of visual hallucinations and illusions in Parkinson's disease. Rev Neurol (Paris). 2021 Jul 5. pii: S0035-3787(21)00590-7. doi: 10.1016/j.neurol.2021.04.007. [Epub ahead of print]

family: Marques

full_name: A. Marques

given: A.

family: Beze

full_name: S. Beze

given: S.

family: Lambert

full_name: C. Lambert

given: C.

family: Bonamy

full_name: L. Bonamy

given: L.

family: de Chazeron

full_name: I. de Chazeron

given: I.

family: Rieu

full_name: I. Rieu

family: Chiambaretta

full_name: F. Chiambaretta

given: F.

family: Durif

full_name: F. Durif

journal_name: Revue Neurologique

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Diagnostic Test


title: Post Operative Analgesia After Wrist Fracture Surgery Under Regional Anesthesia: Randomized Trial, Open Study, With Evaluation of the Endpoint and Patient Blind (PROBE Design), Evaluating the Equivalence Between Ultrasound-guided Nerve Bloc and Local Infiltration

acronym: BNINF

summary:
Distal radial fracture reparations by volar plating are often managed under regional anaesthesia, but are associated with severe pain when the block ends. Acute post-operative pain may delay rehabilitation, and even be a risk factor for the development of chronic pain. The use of opioids and the inevitable opioid-related side effects further decrease patient satisfaction. A multimodal approach to pain management should include local or regional analgesia technique when possible. In the case of wrist fractures, two methods are available: peripheral nerve block by the anaesthesiologist or surgical site local infiltration by the surgeon with a long-acting local aesthetic. Both techniques are commonly used for the management of postoperative pain after diverse orthopaedic surgeries.

The purpose of this study was to determine the equivalence between ultrasound-guided peripheral nerve block and local infiltration by the surgeon for short-term postoperative analgesia after surgical reparation of isolated closed wrist fractures by volar plating under regional anaesthesia. The quality of postoperative pain, patient satisfaction and adverse events were recorded for the first 48 hours following surgery.


title: Effects of a Physical Rehabilitation Program Using the Nintendo Wii on Children With Osteogenesis Imperfecta (OI) Is Nintendo Wii an Effective Intervention for Children With Osteogenesis Imperfecta

summary:
Children with osteogenesis imperfecta are described as extremely sedentary and therefore fatigable, which strongly impacts their daily activities. The physical rehabilitation of these children is a fundamental aspect of treatment.

It has been shown that playing Wii console causes the same increase in energy expenditure than practicing moderate exercise, while ensuring user safety. This type of physical exercise with this type of fun game console might have a role in the treatment of OI children on the physical side but also on the psychological side.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Residual Immune Activation in HIV-infected Patients on Successful cART: Association Between Inflammasome Activation in Monocytes by Circulating Metabolites and Non AIDS Defining Comorbidities

acronym: InflammoVIH

summary:
The clinical challenges confronting patients with HIV has shifted over the past 10 years from acquired immunodeficiency syndrome to chronic diseases including atherosclerosis, neurocognitive disorders, and osteoporosis. Chronic low grade inflammation and monocyte activation have been consistently associated with comorbidities in HIV patients. Indeed, recent studies indicate that inflammatory mediators including IL-6, IL-1, sCD14 and s CD163 produced by monocytes, but not T-cell activation, predict Non-AIDS-related events in virologically suppressed HIV-infected persons treated with combined antiretroviral therapy (cART), highlighting the important role of monocyte activation in the occurrence of comorbidities in cART-treated HIV infected patients. Yet, the underlying molecular pathways of persistent monocyte activation in cART treated HIV-infected patients remains incompletely characterized. Our preliminary results: 1/ establish a link between the activation of the inflammasome, the increased of pyrimidine-derived metabolites and the cardiovascular risk in a cohort of elderly patients; 2/ show that treated HIV-patients are characterized by increased soluble IL-1b or IL-18 in their blood suggesting that the inflammasome pathway is activated.

Objectives: In this study we will characterize the molecular pathways underlying persistent monocyte activation in treated HIV patients, through the implication of the activation of the inflammasome machinery: 1. Characterization of NOD like Receptor (NLR) expression in monocytes for IL-1b and IL-18 secretion (inflammasome activation); 2. Characterization of circulating metabolites that active the inflammasome machinery; 3. Evaluation of the link between the activation of the inflammasome, the increased of circulating metabolites and the non-AIDS related comorbidities.

ReferenceCitation: Furman D, Chang J, Lartigue L, Bolen CR, Haddad F, Gaudilliere B, Ganio EA, Fragiadakis GK, Spitzer MH, Douchet I, Daburon S, Moreau JF, Nolan GP, Blanco P, Déchanet-Merville J, Dekker CL, Jojic V, Kuo CJ, Davis MM, Faustin B. Expression of specific inflammasome gene modules stratifies older individuals into two extreme clinical and immunological states. Nat Med. 2017 Feb;23(2):174-184. doi: 10.1038/nm.4267. Epub 2017 Jan 16.

ReferenceCitation: Ozanne A, Duffau P, Dauchy FA, Rigothier C, Terrien C, Lazaro E, Cazanave C, Lawson-Ayayi S, Bonnet F, Blanco P, Wittkop L, Pellegrin I; CIADIS sub-study in the ANRS CO3 Aquitaine cohort study group. Activation, senescence and inflammation markers in HIV patients: association with renal function. AIDS. 2017 May 15;31(8):1119-1128. doi: 10.1097/QAD.0000000000001461.

ReferenceCitation: Duffau P, Wittkop L, Lazaro E, le Marec F, Cognet C, Blanco P, Moreau JF, Dauchy FA, Cazanave C, Vandenhende MA, Bonnet F, Thiebaut R, Pellegrin I; ANRS CO3 Aquitaine Cohort Study Group. Association of immune-activation and senescence markers with non-AIDS-defining comorbidities in HIV-suppressed patients. AIDS. 2015 Oct 23;29(16):2099-108. doi: 10.1097/QAD.0000000000000807.

ReferenceCitation: Wittkop L, Bitard J, Lazaro E, Neau D, Bonnet F, Mercie P, Dupon M, Hessamfar M, Ventura M, Malvy D, Dabis F, Pellegrin JL, Moreau JF, Thiébaut R, Pellegrin I; Groupe d'Epidémiologie Clinique du SIDA en Aquitaine. Effect of cytomegalovirus-induced immune response, self antigen-induced immune response, and microbial translocation on chronic immune activation in successfully treated HIV type 1-infected patients: the ANRS CO3 Aquitaine Cohort. J Infect Dis. 2013 Feb 15;207(4):622-7. doi: 10.1093/infdis/jis732. Epub 2012 Nov 29.


title: Cognitive Auditory Evoked Potential After Cardiac Arrest: Interest of Mismatch negativiTY: The CAPACITY Study

acronym: CAPACITY

summary: Determination of vital and functional outcome in comatose survivors after cardiac arrest is principally based on the identification of predictors of non-awakening, using by clinical, biological and electrophysiological tools. In patients without presence of non-awakening predictors, it would be of interest to identify predictive criteria of awakening. The presence of mismatch negativity during the cortical auditory-evoked potential could contribute to further progress in neurological prognostication of these patients. However, at this time, its prognostic value has been insufficiently studied and the optimal time of realization remains unknown.

location_facility: Lariboisière Hospital - Medical and toxicology unit

location_facility: Dr Stéphane LEGRIEL - Intensive Care Unit


title: Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.

acronym: KTAP

summary: Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment. Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The investigators hypothesized bilateral continuous transverse abdominal plan block would reduce ventilatory impairment following abdominal surgery.

lead_sponsor: Pierre and Marie Curie University

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS

summary: This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.

ReferenceCitation: Stingl K, Schippert R, Bartz-Schmidt KU, Besch D, Cottriall CL, Edwards TL, Gekeler F, Greppmaier U, Kiel K, Koitschev A, Kühlewein L, MacLaren RE, Ramsden JD, Roider J, Rothermel A, Sachs H, Schröder GS, Tode J, Troelenberg N, Zrenner E. Interim Results of a Multicenter Trial with the New Electronic Subretinal Implant Alpha AMS in 15 Patients Blind from Inherited Retinal Degenerations. Front Neurosci. 2017 Aug 23;11:445. doi: 10.3389/fnins.2017.00445. eCollection 2017.

ReferenceCitation: Edwards TL, Cottriall CL, Xue K, Simunovic MP, Ramsden JD, Zrenner E, MacLaren RE. Assessment of the Electronic Retinal Implant Alpha AMS in Restoring Vision to Blind Patients with End-Stage Retinitis Pigmentosa. Ophthalmology. 2018 Mar;125(3):432-443. doi: 10.1016/j.ophtha.2017.09.019. Epub 2017 Oct 27.

ipd_sharing: Undecided

ipd_sharing_description: If data are shared, this will only be done in a pseudonymized manner.

lead_sponsor: Retina Implant AG

location_facility: Centre Hospitalier Universitaire La Milétrie de Poitiers


title: A Prospective, Randomized, Multi-Center Comparison of the CYPHER Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients With Intra-Des Restenosis

acronym: CRISTAL

summary: A Prospective, Randomized, Multi-Center Comparison of the Cypher Select™ Sirolimus-Eluting Stent and Balloon Re-Angioplasty for Treatment of Patients with Intra-Des Restenosis.

ReferenceCitation: Chevalier B, Moulichon R, Teiger E, Brunel P, Metzger JP, Pansieri M, Carrie D, Stoll HP, Wittebols K, Spaulding C, Fajadet J; Cristal Investigators. One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents. J Interv Cardiol. 2012 Dec;25(6):586-95. doi: 10.1111/j.1540-8183.2012.00769.x. Epub 2012 Sep 20.

family: CHEVALIER

full_name: BERNARD CHEVALIER

given: BERNARD

family: MOULICHON

full_name: ROBERT MOULICHON

given: ROBERT

family: TEIGER

full_name: EMMANUEL TEIGER

given: EMMANUEL

family: BRUNEL

full_name: PHILIPPE BRUNEL

given: PHILIPPE

family: METZGER

full_name: JEAN-PHILIPPE METZGER

given: JEAN-PHILIPPE

family: PANSIERI

full_name: MICHEL PANSIERI

given: MICHEL

family: CARRIE

full_name: DIDIER CARRIE

given: DIDIER

family: STOLL

full_name: HANS-PETER STOLL

given: HANS-PETER

family: WITTEBOLS

full_name: KRISTEL WITTEBOLS

given: KRISTEL

family: SPAULDING

full_name: CHRISTIAN SPAULDING

given: CHRISTIAN

family: FAJADET

full_name: JEAN FAJADET

given: JEAN

journal_name: Journal of Interventional Cardiology

title: One-Year Results of the CRISTAL Trial, a Randomized Comparison of Cypher Sirolimus-Eluting Coronary Stents versus Balloon Angioplasty for Restenosis of Drug-Eluting Stents

lead_sponsor: Cordis Corporation

location_facility:
Unite de Cardiologie Interventionelle
Centre Cardiologique du Nord


title: Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy

acronym: MSA-DOUL

summary:
Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder. MSA is dominated by autonomic/urogenital failure which may be associated with either Parkinsonism (MSA-P subtype) or with cerebellar ataxia (MSA-C subtype). The prognostic of this disease is bad because it ended with the patient's death few years later. No neuroprotective treatment has shown a real efficacy. 50% of patients suffering of MSA frequently experienced painful sensation. The origin of this pain is unknown. In Parkinson disease (PD) ; arguments suggest the implication of dopamine neuromediator pathway in integration and modulation of pain. Several studies suggest the existence of various influences with dopamine implication in the appearance of painful sensation and that would be inhibitory. That's why observed painful symptoms in MSA and PD could be due to a decrease of pain appearance threshold, secondary to a lost of control of sensitizes centres, to Parkinson control.

It is interesting to determine if MSA as PD is responsible for a decrease of pain threshold and to characterise the levodopa effect on the patient's pain threshold. Better physiopathology knowledge of pain in MSA is necessary to improve the therapeutic care. Because the efficacy of others treatments is low, it's important to improve the research for a better comfort of patients with a better understanding, analysing and treating of the pain.

lead_sponsor: University Hospital, Toulouse


title: Use of MEOPA for Elderly With Dementia.

summary:
Acute pain is frequent in elderly especially in geriatrics acute care units where painful procedures are often occurring.

MEOPA represents an alternative to opioïd therapy to prevent procedural pain during the treatment of pressure ulcers.

In this study, cognitive impairment and dementia do not limit the use of MEOPA. The new approach in the management of acute procedural pain provides effective and safe analgesia in frail old patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Gerontology department, Nice University Hospital


title: Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium

summary: Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard.

status: Withdrawn

lead_sponsor: University Hospital, Lille

location_facility: ICU, Calmette Hospital, University Hospital of Lille

intervention_type: Radiation


title: Phase 1-2 Study of Onapristone in Patients With Progesterone Receptor Expressing Cancers

summary: This is a multi-center, open-label, randomized, parallel group two-stage phase 1 study with a phase 2 expansion component in pts with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma. Stage 1: Six dose cohorts, 5 using the extended release tablet (ER) formulation (10 mg BID, 20 mg BID, 30 mg BID, 40 mg BID, 50 mg BID) and 1 using the immediate-release (IR) tablet formulation 100 mg QD will be randomized in parallel. After enrollment of 36 patients in Stage 1, a dose of 50 mg BID was determined to be the RP2D. Stage 2: An additional 10 patients with recurrent or metastatic APRpos uterine endometrioid adenocarcinoma (Stage 2a) will be enrolled at the RP2D. Based on the response in Stage 2a, the cohort will be further expanded by up to 19 more patients to a total of 29 patients to confirm the efficacy and safety profile of onapristone in this selected patient population (Stage 2b).

ReferenceCitation: Cottu PH, Bonneterre J, Varga A, Campone M, Leary A, Floquet A, Berton-Rigaud D, Sablin MP, Lesoin A, Rezai K, Lokiec FM, Lhomme C, Bosq J, Bexon AS, Gilles EM, Proniuk S, Dieras V, Jackson DM, Zukiwski A, Italiano A. Phase I study of onapristone, a type I antiprogestin, in female patients with previously treated recurrent or metastatic progesterone receptor-expressing cancers. PLoS One. 2018 Oct 10;13(10):e0204973. doi: 10.1371/journal.pone.0204973. eCollection 2018.

family: Cottu

full_name: Paul H. Cottu

given: Paul H.

family: Bonneterre

full_name: Jacques Bonneterre

given: Jacques

family: Varga

full_name: Andrea Varga

given: Andrea

family: Campone

full_name: Mario Campone

given: Mario

family: Leary

full_name: Alexandra Leary

given: Alexandra

family: Floquet

full_name: Anne Floquet

given: Anne

family: Berton-Rigaud

full_name: Dominique Berton-Rigaud

given: Dominique

family: Sablin

full_name: Marie-Paule Sablin

given: Marie-Paule

family: Lesoin

full_name: Anne Lesoin

family: Rezai

full_name: Keyvan Rezai

given: Keyvan

family: Lokiec

full_name: François M. Lokiec

given: François M.

family: Lhomme

full_name: Catherine Lhomme

given: Catherine

family: Bosq

full_name: Jacques Bosq

family: Bexon

full_name: Alice S. Bexon

given: Alice S.

family: Gilles

full_name: Erard M. Gilles

given: Erard M.

family: Proniuk

full_name: Stefan Proniuk

given: Stefan

family: Dieras

full_name: Veronique Dieras

given: Veronique

family: Jackson

full_name: David M. Jackson

given: David M.

family: Zukiwski

full_name: Alexander Zukiwski

given: Alexander

family: Italiano

full_name: Antoine Italiano

given: Antoine

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

location_facility:
Institut Curie Oncologie Medicale
Institut Gustave Roussy
Centre Oscar Lambret


title: Epidemiology of Aging of People With Disabilities - Gerontological Sector "Rumilly-Annecy-Saint-Julien-Pays de Gex-Bellegarde" : Description of the Population in an Attempt to Identify Ways to Implement to Meet the Needs in Aging

acronym: PHV

summary:
Heterogeneous modalities of aging lead to describe three categories of elderly patients: 1-healthy without frailty, 2- healthy with frailty, 3- patients with chronic disease(s) and frailty. Frail people have a high risk of losing functional independence and as a consequence they require more help for day to day life. It is known in elderly that physical activities, nutrition, social environment are important to maintain functional independence.

For patients with disabilities, less is known about the occurence of dependance with aging. That is of growing importance because life expectancy of disabled patients has increased a lot during last decades, and because caregivers, often parents, also become elderly and frail.

So the investigators will require tools to anticipate prevention and supportive needs for this specific population.

The goal of this study is to evaluate if the participants (disabled patients over 40 years old) of a well-defined region in the south-east of France (400000 inhabitants), and to assess their needs, using the Functional Autonomy Measurement System (SMAF) developed for assessment of the elderly, by Rejean Hebert & Nicole Dubuc's team in Sherbrooke University (Quebec/Canada).

primary_purpose: Health Services Research

ReferenceCitation: Ahmed N, Mandel R, Fain MJ. Frailty: an emerging geriatric syndrome. Am J Med. 2007 Sep;120(9):748-53.

ReferenceCitation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56.

ReferenceCitation: Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. Review.

ReferenceCitation: Rubenstein LZ, Josephson KR, Wieland GD, English PA, Sayre JA, Kane RL. Effectiveness of a geriatric evaluation unit. A randomized clinical trial. N Engl J Med. 1984 Dec 27;311(26):1664-70.

ReferenceCitation: Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet. 1993 Oct 23;342(8878):1032-6.

ReferenceCitation: Stuck AE, Egger M, Hammer A, Minder CE, Beck JC. Home visits to prevent nursing home admission and functional decline in elderly people: systematic review and meta-regression analysis. JAMA. 2002 Feb 27;287(8):1022-8. Review.

ReferenceCitation: Carlsen WR, Galluzzi KE, Forman LF, Cavalieri TA. Comprehensive geriatric assessment: applications for community-residing, elderly people with mental retardation/developmental disabilities. Ment Retard. 1994 Oct;32(5):334-40.

ReferenceCitation: Pinsonnault E, Dubuc N, Desrosiers J, Delli-Colli N, Hébert R. Validation study of a social functioning scale: The social-SMAF (social-Functional Autonomy Measurement System). Arch Gerontol Geriatr. 2009 Jan-Feb;48(1):40-4. Epub 2007 Dec 3.

ReferenceCitation: Dubuc N, Hébert R, Desrosiers J, Buteau M, Trottier L. Disability-based classification system for older people in integrated long-term care services: the Iso-SMAF profiles. Arch Gerontol Geriatr. 2006 Mar-Apr;42(2):191-206. Epub 2005 Aug 25.

ReferenceCitation: Gervais P, Hébert R, Lamontagne J, Tousignant M. [Implementation of functional autonomy measurement system: barriers and facilitators in PISE-Dordogne project]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Dec;9(4):417-28. French.

ReferenceCitation: Vellas BJ, Wayne SJ, Romero L, Baumgartner RN, Rubenstein LZ, Garry PJ. One-leg balance is an important predictor of injurious falls in older persons. J Am Geriatr Soc. 1997 Jun;45(6):735-8.

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility: ADTP Site de Cran-Gevrier (Entreprises Adaptées)

location_facility: FAM Résidence Leirens - Armée du Salut Monnetier Mornex

location_facility: SAVS - Association Départementale des Infirmes Moteurs Cérébraux

location_facility: Association "Nous aussi" - Foyer d'hébergement - SATTHAV


title: Enfuvirtide for the Initial Phase of Antiretroviral Therapy in HIV-infected Patients With High Risk of Clinical Progression : ANRS 130 APOLLO

summary:
HIV infection is diagnosed late in a substantial proportion of patients having an increased risk of clinical progression (AIDS, new AIDS-defining event or death). The currently recommended antiretroviral therapy has suboptimal activity in this setting and potent quadruple-drug therapy has not been sufficiently evaluated. Enfuvirtide may be an appropriate candidate as the fourth antiretroviral agent, regarding its activity, its parenteral administration avoiding gastrointestinal symptoms that often lead to interruption of treatment, the lack of pharmacokinetic interactions and the absence of systemic toxicity.

The aim of this study is to investigate, in a comparative intensification trial, the immunological benefit of adding enfuvirtide for 6 months to a conventional antiretroviral therapy in HIV-1 infected and severely immunosuppressed patients, naïve of any antiretroviral treatment.

We postulate that addition of enfuvirtide to a first-line antiretroviral therapy consisting in emtricitabine/tenofovir combined with either efavirenz or lopinavir/r may improve immunological restoration, measured as the proportion of patients with more than 200 CD4 cells per mm3 after 24 weeks of antiretroviral therapy.

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

location_facility: Service des Maladies Infectieuses A Hôpital Bichat-Claude Bernard