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.

primary_purpose: Diagnostic

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.

ReferenceCitation: Ruiz M, Lacaille F, Berthiller J, Joly P, Dumortier J, Aumar M, Bridoux-Henno L, Jacquemin E, Lamireau T, Broue P, Rivet C, Belmalih A, Restier L, Chapuis-Cellier C, Bouchecareilh M, Lachaux A; Groupe Francophone d'Hepatologie Gastroenterologie et Nutrition Pediatriques. 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.

publisher_dissemination: Wiley

location_facility: Centre de Pédiatrie Gatien de Clocheville


title: Discovering New Insights Into Anorexia Nervosa: Influence of MicrObial DysbiosiS (DIAMOnDS)

acronym: DIAMOnDS

summary: This study will investigate the link between the gut microbiota, the occurrence of the central adiposity phenotype, and the patients' fear to regain weight in anorexia nervosa.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: Undecided

ipd_sharing_description: undecided

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Fondation de France

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


type: Registry Identifier

title: Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)

acronym: INT-METAVOSA

summary: The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fondation de France

location_facility: Service de Nutrition Clinique, Hôpital Paul Brousse (APHP)

intervention_type: Biological


title: Towards an Early Integration of Palliative Care in Oncology: Descriptive Study of Needs for Patients With Metastatic Cancer and the Adequacy of These Needs With Healthcare Facilities

acronym: BESACE

summary:
The primary objective of the study is to describe the nature and to estimate the prevalence the health needs of patients with metastatic cancer and their main caregivers, between the period from diagnosis to death.

As secondary objectives, the study aims:

to determinate the proportion of patients with an indication for palliative care according to Hui et al., and to describe the adequation of health needs and the services for them;
to study the association between clinical pathway and the indication of targeted palliative care;
to study the association between the integration of palliative care service and the adequation of health needs service of patients;
to study the factors such as the disease, the practice and the care, contribute to the patient's survivor of 1 year.

study_start_date_type: Actual

status: Active, not recruiting

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Hui D, Mori M, Watanabe SM, Caraceni A, Strasser F, Saarto T, Cherny N, Glare P, Kaasa S, Bruera E. Referral criteria for outpatient specialty palliative cancer care: an international consensus. Lancet Oncol. 2016 Dec;17(12):e552-e559. doi: 10.1016/S1470-2045(16)30577-0.

ipd_sharing: No

location_facility: Mobile palliative care and support team, Ambroise Paré hospital, APHP


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.

status: Completed

study_completion_date_type: Actual

ReferenceType: result

ReferenceCitation: Fasse L, Flahault C, Bredart 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.

oa_host_type: closed

repositories_concat: closed

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, Eon 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, Leone M, Chalumeau-Lemoine L, Garrouste M, Schlemmer B, Chevret S, Falissard B, Azoulay E. 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.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

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.

publisher_dissemination: Informa

ReferenceCitation: Fasse L, Sultan S, Flahault C, Mackinnon CJ, Dolbeault S, Bredart 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.

ReferenceType: derived

ReferenceCitation: Garrouste-Orgeas M, Flahault C, Poulain E, Evin A, Guirimand F, Fossez-Diaz V, Perruchio S, Verlaine C, Vanbesien A, Kaczmarek W, Birkui de Francqueville L, De Lariviere E, Bouquet G, Copel L, Verliac V, Marche 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.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: GCS IHFB Cognacq-Jay

sponsor_collaborators:
GCS IHFB Cognacq-Jay
Fondation de France

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

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.

status: Unknown status

design_allocation: Non-Randomized

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 Dec;177(10):1228-1236. doi: 10.1016/j.neurol.2021.04.007. Epub 2021 Jul 5.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Fondation de France

intervention_type: Diagnostic Test

status_simplified: Unknown


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.

design_allocation: Randomized

primary_purpose: Treatment

intervention_type: Procedure


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: ICU Diaries Impact of an ICU Diary on the Psychological Well-being of the Patients and Their Relatives. Mixed Multicenter Randomized Study With Blind Evaluation

acronym: ICU-diary

summary: The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.

primary_purpose: Prevention

ReferenceCitation: Flahault C, Vioulac C, Fasse L, Bailly S, Timsit JF, Garrouste-Orgeas M. "A story with gaps": An interpretative phenomenological analysis of ICU survivors' experience. PLoS One. 2022 Mar 3;17(3):e0264310. doi: 10.1371/journal.pone.0264310. eCollection 2022.

publisher_dissemination: Public Library of Science

ReferenceCitation: Garrouste-Orgeas M, Flahault C, Vinatier I, Rigaud JP, Thieulot-Rolin N, Mercier E, Rouget A, Grand H, Lesieur O, Tamion F, Hamidfar R, Renault A, Parmentier-Decrucq E, Monseau Y, Argaud L, Bretonniere C, Lautrette A, Badie J, Boulet E, Floccard B, Forceville X, Kipnis E, Soufir L, Valade S, Bige N, Gaffinel A, Hamzaoui O, Simon G, Thirion M, Bouadma L, Large A, Mira JP, Amdjar-Badidi N, Jourdain M, Jost PH, Maxime V, Santoli F, Ruckly S, Vioulac C, Leborgne MA, Bellalou L, Fasse L, Misset B, Bailly S, Timsit JF. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239. doi: 10.1001/jama.2019.9058.

oa_colors: green other

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repositories_concat: PubMed Central;orbi.ulg.ac.be

publisher_dissemination: American Medical Association

ReferenceCitation: Garrouste-Orgeas M, Flahault C, Fasse L, Ruckly S, Amdjar-Badidi N, Argaud L, Badie J, Bazire A, Bige N, Boulet E, Bouadma L, Bretonniere C, Floccard B, Gaffinel A, de Forceville X, Grand H, Halidfar R, Hamzaoui O, Jourdain M, Jost PH, Kipnis E, Large A, Lautrette A, Lesieur O, Maxime V, Mercier E, Mira JP, Monseau Y, Parmentier-Decrucq E, Rigaud JP, Rouget A, Santoli F, Simon G, Tamion F, Thieulot-Rolin N, Thirion M, Valade S, Vinatier I, Vioulac C, Bailly S, Timsit JF. The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. Trials. 2017 Nov 15;18(1):542. doi: 10.1186/s13063-017-2283-y.

lead_sponsor: Fondation Hôpital Saint-Joseph

sponsor_collaborators:
Fondation Hôpital Saint-Joseph
Fondation de France

location_facility: Medical and surgical Intensive Care unit


title: Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis

acronym: MUCO-SOPHRO

summary: The purpose of this study is to evaluate the impact of the global approach to the pain in cystic fibrosis patients with chronic or intermittent pain. The patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The results of this study will provide a new strategy of management of the patient's pain.

primary_purpose: Supportive Care


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

sponsor_collaborators:
University Hospital, Toulouse
Fondation de France

intervention_type: Drug


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: Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.

acronym: Aquavip

summary: Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve months after the end of the program, remain higher in "Plurifocal educational group" than in control group

intervention_type: Behavioral


title: Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)

acronym: HARMONIC-RT

summary: The goal of the HARMONIC-RT study is to evaluate late health and social outcomes of modern external beam radiotherapy techniques in paediatric patients, based on the setting-up of a European, long-term registry complemented by a biobank.

status: Recruiting

time_perspective: Other

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

collaborators: The West German Proton Therapy Centre, Essen

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

collaborators: Princess Maxima Center for Pediatric Oncology

collaborators: National Research Council, Institute of Clinical Physiology, Italy

collaborators: Luxembourg Institute of Science and Technology

location_country: Germany Denmark Belgium France

location_facility: University Hospital Essen, The West German Proton Therapy Centre Essen


title: Morphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET Study

acronym: SEROTAMS

summary: Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult associated to a poor prognosis. MSA is clinically characterized by the association of extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. Histological and biological studies have raised the hypothesis that, beside the well known dopamine deficiency, some of the symptoms could be related to a dysfunction in serotoninergic neurotransmission. Serotonin is involved in the modulation of several functions impaired in MSA, such as mood, motricity or sleep. The recent description of an association between loss of brainstem serotonin neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role played by this neurotransmitter in the pathophysiology of this disease. Autoreceptors called 5-HT1a are strongly involved in the regulation of serotonin neurotransmission. During the last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors, such as 18F-MPPF (4-(2'-methoxyphenyl)-1-[2'-(N-2''-piridinyl)-p-fluorobenzamide]methylpiperazine), were developed. Moreover, the investigators recently demonstrated the ability of this brain functional imaging method to investigate, in healthy volunteers, the functional properties of 5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose of fluoxetine.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Bordeaux
CHU Limoges
CHU de Toulouse


title: Evaluation of the Incidence of Acute Kidney Attack by Dosing Nephrocheck® in Severe Traumatized Patients

acronym: NEPHROTRAUMA

summary: Acute Kidney Injury (AKI) is a common complication of severe traumatized patients. The diagnosis is often delayed. The Nephrocheck® test allows an earlier assessment of renal stress. The objective of our study is to determine the incidence of risk of AKI in severe traumatized patients within the first 24 hours after their admission to our trauma center. The risk of AKI is defined by a NephroCheck® test >0.3

lead_sponsor: Hospices Civils de Lyon

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: NEPHROTRAUMA

titre: Impact d'un protocole de NEPHROprotection chez des patients TRAUMAtisés graves à risque d'insuffisance rénale aiguë : un essai contrôlé randomisé multicentrique

discipline_principale: autre

nom_porteur: RIMMELE

prenom_porteur: Thomas


title: A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease

acronym: VHLSUT

summary:
VHL patients may benefit from sunitinib. This study will investigate the following objectives :

PRIMARY OBJECTIVE

To determine the objective response rate according to RECIST criteria, in VHL patients with advanced tumors or tumors untreatable by other means, and treated with sunitinib.

SECONDARY OBJECTIVES

To evaluate the safety and tolerability of sunitinib in VHL patients according to the NCI-CTC criteria Version 3.0.
To determine the following time-to-event endpoints: overall survival, time to disease progression, progression free survival, time to response and duration of response.
To evaluate quality of life in VHL patients receiving sunitinib.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale

location_facility: Hospital Saint André - Service de cancérologie


acronym: LEUCOPRO

lead_sponsor: University Hospital, Angers

summary:
Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is often difficult (germs are found only in 50% of cases). Conventional imagery is often non-specific and difficult to interpret especially in early postoperative phase. Leukocytes isolated from the patient's blood are labeled with a radiopharmaceutical technetium 99mTc-HMPAO.

The aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis infection.

location_facility: CHU CH CHRU

title: Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires.

type: EudraCT Number

source: euctr

region: Pays de la Loire

nom_etablissement: CHR ANGERS

type_etablissement: CH

acronyme: LEUCOPRO

titre: Tomoscintigraphie hybride aux leucocytes marqués dans le diagnostic des infections de prothèses vasculaires.

discipline_principale: imagerie médicale

nom_porteur: RAKOTONIRINA

prenom_porteur: Hervé


title: Predictives Factors of Cardiac Resynchronization Therapy: a Multimodal Analysis Using 2D Speckle Tracking Echocardiography Coupled With MIBG Myocardial Scintigraphy and Heart Failure Biomarkers

acronym: PREFAC-CRT

summary: Cardiac resynchronization therapy (CRT) is one of the lastest recommended treatments in patients with refractory symptomatic chronic heart failure with reduced ejection fraction (HFREF). Despite clear guidelines 20 to 40 % of implanted patients are not clinically ameliorated. They are called the "non responders". Patient selection seams to be one of the key to improve the efficiency of CRT. This protocol try to assess positive predictive factors to CRT by a multimodal approach.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
General Electrics France


title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Myotubular Myopathy and Other CentroNuclear Myopathies

acronym: NatHis-CNM

summary: This is the 2 years extension of the prospective and longitudinal study of the natural history and functional status of patients with myotubular myopathy and other centronuclear (CNM) sponsored by Dynacure including ten additional pediatric patients with mutation in MTM1 or DNM2 genes). the patients are planned to be enrolled in one year leading to an expected total number of 70 patients followed at least over 1 year period. Data from the study will be used to characterize the disease course of CNM and determine which outcome measures will be the best to assess the efficacy of potential therapies.

primary_purpose: Other

lead_sponsor: Institut de Myologie, France

sponsor_collaborators:
Institut de Myologie, France
Dynacure

location_country: Germany Italy Belgium Spain France

location_facility: Hôpital Femme Mère Enfant, CHU Lyon L'Escale

location_facility: Centre de référence neuromusculaire, CHR La Citadelle


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, Pereon 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.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

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

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

version: submittedVersion

evidence: oa repository (semantic scholar lookup)

repositories_concat: LIRIAS (KU Leuven);PubMed Central;figshare.com;ora.ox.ac.uk;orbi.ulg.ac.be;pdfs.semanticscholar.org

repositories_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

sponsor_collaborators:
Institut de Myologie, France
Institut Roche

location_country: Germany Belgium France

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

location_facility: Unité de neurologie pédiatrique - Hôpital des enfants

location_facility: Neuropédiatrie - Service de Pédiatrie 1 - CHU Hautepierre

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

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

location_facility: Centre de Référence neuromusculaire - CHR La Citadelle


title: Endothelial Function Study Before Cardiovascular Surgery in COPD and/or SAS Patients

acronym: COPD-OSAS

summary:
The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function, before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a cardiovascular surgery, by an observational physiological study.

An interim analysis will be performed when 100 patients will be included.

ReferenceCitation: Fabbri LM, Rabe KF. From COPD to chronic systemic inflammatory syndrome? Lancet. 2007 Sep 1;370(9589):797-9. doi: 10.1016/S0140-6736(07)61383-X. No abstract available.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital of Angers
Mutualist Hospital group
University Hospital of Grenoble


title: Canaux de COmmuniCAtion et Fonctionnement du CErveau: Étude Pilote en IRMf

acronym: COCACE

summary:
Communication is a social process involving individuals exchanging messages. It is usual to observe different reactions according to the manner of communication, the manner in which such information is exchanged.

In this work, it will be examined how different communication modalities cause different reactions in a person. We make the assumption that each communication modality is based on a different brain network.

lead_sponsor: University Hospital, Tours

sponsor_collaborators:
University Hospital, Tours
Kahler Communication France


title: Calcified Aortic Valve Stenosis (AVS). Markers of Fibrosis Using Cardiac Magnetic Resonance

acronym: RACINE

summary: Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are aortic valve pressure gradient and the aortic valve area. however these marker are a poor reflect of the clinical severity of AVS. The aim of the study is to validate new markers assessing cardiac fibrosis that might best or complementary markers.

location_facility: Departement of Radiology, Hopital Europeen Georges Pompidou,


title: Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

acronym: IEI-CEM

summary: The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
ANSES, France
INERIS, Verneuil-En-Halatte, France

location_facility: Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre


title: Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis ("NASH-Safety")

summary:
Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic steatohepatitis). Animal model studies confirmed that Yaq-001 reduces liver injury and prevents steatosis in these models which leads to the theoretical potential of Yaq-001 altering the microbiome and gut permeability in patients with NASH.

The purpose of this clinical trial is to study the safety and tolerability of Yaq-001 in patients with NASH. Results from this study will lead to the design of future pivotal performance and safety trials for registration purposes.

Candidate patients must be between 18-70 years old and have a clinical diagnosis of NASH, determined histologically or phenotypically, as well as meeting other clinical inclusion/exclusion criteria.

Eligible patients will be randomly assigned to receive standard of care treatment plus Yaq-001, or standard of care treatment plus placebo).

The treatment lasts for 48 weeks. During treatment, the patient will have 6 study visits. At all the visits, the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. On two occasions the patient will have a liver Multiscan and on three occasions the patient will have a liver Fibroscan.

70 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

status: Withdrawn

lead_sponsor: Yaqrit Ltd

collaborators: Servicio Madrileño de Salud, Madrid, Spain

collaborators: Hospital Universitari Vall d'Hebron Research Institute

collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna

collaborators: Institut d'Investigacions Biomèdiques August Pi i Sunyer

location_country:
Italy
Portugal
United Kingdom
Switzerland
Spain
France

location_facility: Hospital Ramon y Cajal, Department of Gastroenterology and Hepatology

location_facility: Hospital Beaujon, Hepatology and Liver Intensive Care,

location_facility: Inselspital Universitaet Bern, Department for Visceral Surgery and Medicine

location_facility: Royal Free Hospital, Institute of Liver and Digestive Disease

location_facility: Azienda Ospedaliera di Padova, Hepatic Emergencies Unit

location_facility: Policlinico S.Orsola Malpighi, Department of Medical and Surgical Sciences

location_facility: Hospital Clinic of Barcelona , Liver Unit,

intervention_type: Device


title: Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients

acronym: HAD-Covid

summary: To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period (2020 and 2021) with those no Covid period (2022)

location_facility:
CH Vichy
University hopistal, Lyon
CH Périgueux
University hospital, Clermont-Ferrand
CH Moulins
CH Rodez
CH Grenoble
CH Cannes
CH Aurillac
Centre Jean Perrin
CH Le Puy-en-Velay


title: Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale

acronym: TELEBARIA

summary:
Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation.

This study will assess a new care pathway in which the patients are follow-up according to the weight evolution measured by the patient using a connected scale.

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Ministry of Health, France

location_facility:
Hop Claude Huriez Chu Lille
Ch Boulogne-Sur-Mer - Boulogne Sur Mer

appel_a_projets: PREPS

region: Hauts-de-France

nom_etablissement: CHR LILLE

acronyme: TELEBARIA

titre: Evaluation d'un parcours de soins personnalisé après chirurgie bariatrique basé sur le suivi de l'évolution pondérale à l'aide d'une balance connectée  Etude multicentrique randomisée

discipline_principale: chirurgie viscérale et digestive

nom_porteur: Pattou

prenom_porteur: Francois


title: Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.

acronym: APT'x

summary: Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Clermont-Ferrand, CHU Site Gabriel-Montpied


title: Spironolactone and Perioperative Atrial Fibrillation Occurrence in Cardiac Surgery Patients: a Multicenter Randomized, Double-blind Study. The ALDOCURE Trial

acronym: ALDOCURE

summary:
Study hypothesis : Pre-operative aldosterone receptor blockade may reduce post-operative atrial fibrillation (POAF) occurrence within 5 days after coronary artery bypass graft surgery (CABG) ± aortic valve replacement (AVR) without any heart failure or any mitral surgery.

Primary efficacy criterion : occurrence of POAF occurring from randomization and within 5 days after surgery, assess, in a standardized manner, by continuous ECG monitoring (during the ICU stay) or Holter-ECG monitoring (during the stepdown unit stay).

Primary objective: To establish whether pre-operative administration of spironolactone leads to a reduction in POAF incidence occurring from randomization and within 5 days after surgery, compared with placebo, in patients referred for on-pump elective CABG surgery ± AVR without heart failure.

Study design : Phase III drug trial - Randomized, double blind, multicentre, prospective study.

ReferenceCitation: Alexandre J, Ollitrault P, Fischer MO, Fellahi JL, Rozec B, Cholley B, Dolladille C, Chequel M, Allouche S, Legallois D, Saplacan V, Buklas D, Beygui F, Parienti JJ, Milliez P. Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: Rationale and design of the ALDOCURE trial. Am Heart J. 2019 Aug;214:88-96. doi: 10.1016/j.ahj.2019.04.023. Epub 2019 May 9.

lead_sponsor: University Hospital, Caen

sponsor_collaborators:
University Hospital, Caen
Ministry of Health, France

location_facility:
Gaillard
CHU Caen

appel_a_projets: PHRCN

region: Normandie

nom_etablissement: CHU DE CAEN NORMANDIE

acronyme: ALDOCURE

titre: Effets du blocage du récepteur aux minéralocorticoïdes sur la survenue de fibrillation auriculaire en période péri-opératoire de chirurgie cardiaque : essai randomisé multicentrique en double aveugle.

discipline_principale: pharmacologie

nom_porteur: Alexandre

prenom_porteur: Joachim


title: Evaluation of the Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations of Poor Prognosis

acronym: RAPAMALYMPH

summary:
To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period.

The success rate is determined by volume reduction superior to 1/5e of the initial volume measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.

location_facility:
Hôpital Jeanne de Flandres, CHU
Hu Robert Debre Aphp - Paris


title: Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy

acronym: MITOX

summary:
The aim of the present study is to compare Resting Energy Expenditure (REE) between normal fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced thermogenesis (DIT) and body composition between NFD vs HFD.

This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids, 45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 % lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry ). 36 included MID subjects will be included in this study. Main evaluation criteria and second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.


title: Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies: the Model of an Oral Glucose Load

acronym: HYPOSOMNPARK

summary: Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It is a major complain and represents a socially relevant problem as unintended episodes of sleep can also occur while driving for example. Arterial hypotension is frequently observed in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness is known to occur preferentially when patients are having arterial hypotension whatever the cause (i.e. postprandial period, administration of hypotensive medication such as dopamine agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness. We have observed this association in an on-going epidemiological survey Hyperglycaemia induced by oral glucose load - a standardized model simulating food intake during a meal - provokes arterial hypotension in the majority of Parkinson's disease patients with dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated by this fall in blood pressure.

sponsor_collaborators:
University Hospital, Toulouse
Ministry of Health, France

location_facility: UHBordeaux UHToulouse


title: Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

acronym: MEC ORL

summary: The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.

ReferenceCitation: Villard A, Breuskin I, Casiraghi O, Asmandar S, Laplace-Builhe C, Abbaci M, Moya Plana A. Confocal laser endomicroscopy and confocal microscopy for head and neck cancer imaging: Recent updates and future perspectives. Oral Oncol. 2022 Apr;127:105826. doi: 10.1016/j.oraloncology.2022.105826. Epub 2022 Mar 19.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Effects of Inspiratory Muscle Training Combined With a Pulmonary Rehabilitation Program Versus a Program of Pulmonary Rehabilitation Alone on Dyspnea: a Randomized Trial

acronym: IMT

summary: The purpose of this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP > 60 cmH2O).

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Ministry of Health, France

location_facility:
Brest University Hospital
Hospital of Morlaix


title: What Should be the Best Physiotherapy Early After Stroke ?

acronym: AMOBES

summary: This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.

ReferenceCitation: Yelnik AP, Quintaine V, Andriantsifanetra C, Wannepain M, Reiner P, Marnef H, Evrard M, Meseguer E, Devailly JP, Lozano M, Lamy C, Colle F, Vicaut E; AMOBES Group. AMOBES (Active Mobility Very Early After Stroke): A Randomized Controlled Trial. Stroke. 2017 Feb;48(2):400-405. doi: 10.1161/STROKEAHA.116.014803. Epub 2016 Dec 22.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

location_facility: Service de Neurologie - Hôpital Lariboisière


title: Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects: Longitudinal Multicentric Study

acronym: POLLAIR

summary: Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea in older subjects.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Saint-Etienne
Hospices Civiles de Lyon


title: Prospective Follow-up of a Multicentric Cohort of Children With Prenatal Discovery of Mild Isolated Cerebral Ventriculomegaly. Evaluation at 2 and 5 Years.

summary:
Isolated uni or bilateral mild cerebral ventriculomegaly represents the most frequent "minor" cerebral anomalies discovered by antenatal echography. There are not French data making it possible to specify the incidence and the prevalence of this pathology and international data of the prevalence are very heterogeneous, going, according to the published series, of 1.48 to 22 per 1000 births.

The prognostic of ventriculomegaly remains dubious : the studies have small populations, are for the majority retrospectives with a short and often vague follow-up. The announced rate of after-effects varies between 0 and 48 %.

The objective of this study is to evaluate the neuropsychological development until the 5 years age of the children for whom a prenatally diagnosis of mild isolated ventriculomegaly was carried (absence of another cerebral or extra-cerebral anomaly in imagery and a negative aetiology). This prospective cohort will be compared with children for whom no neurological anomaly was prenatally detected.

The children diagnosed for an mild isolated cerebral ventriculomegaly will be identified by the investigators among medical files of the Centers of Prenatal Diagnosis (CPDPN) of the UH of Angers and the UH of Nantes. The patient inclusion will be done at the 2 years age after parental agreement, with a follow-up at 5 years. The control children will be included under the same conditions after having ensured of the normality of the echographies of 22 and 30 gestational weeks. The follow-up of these 2 cohorts will be based on the 2 years obligatory paediatric examination, and on the network "Naitre ensemble" set up in the Pays de la Loire Loire. In addition to the clinical routine examinations, standardized neuropsychological examinations will be done (Brunet Lezine Revised score at 2 years, NEPSY at 5 years and ASQ at 2 and 5 years).

This study will allow to compare the neuropsychological development at school age of the children diagnosed for a foetal mild, apparently isolated, cerebral ventriculomegaly from children not presenting any foetal anomaly, to evaluate the incidence of the mild isolated ventriculomegaly, to identify the predictive factors of the neuropsychological anomalies in the children diagnosed for ventriculomegaly and to compare (in the children diagnosed for ventriculomegaly), the neuropsychological development at the school age of the children having a ventricular atrium between 10 and 12 mm with those having a ventricular atrium between 12,1 and 15 mm.

This study will allow to define the neuropsychological morbidity of the foetal mild isolated cerebral ventriculomegaly and will allow to define the best clinical and educational follow up of these children and their family.

sponsor_collaborators:
University Hospital, Angers
Ministry of Health, France

location_facility:
UH of Angers
UH of Nantes


title: Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.

summary: Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.

ReferenceCitation: Chaix C, Durand-Zaleski I, Alberti C, Brun-Buisson C. Control of endemic methicillin-resistant Staphylococcus aureus: a cost-benefit analysis in an intensive care unit. JAMA. 1999 Nov 10;282(18):1745-51. doi: 10.1001/jama.282.18.1745.

ReferenceCitation: Girou E, Pujade G, Legrand P, Cizeau F, Brun-Buisson C. Selective screening of carriers for control of methicillin-resistant Staphylococcus aureus (MRSA) in high-risk hospital areas with a high level of endemic MRSA. Clin Infect Dis. 1998 Sep;27(3):543-50. doi: 10.1086/514695.

ReferenceCitation: Camus C, Bellissant E, Sebille V, Perrotin D, Garo B, Legras A, Renault A, Le Corre P, Donnio PY, Gacouin A, Le Tulzo Y, Thomas R. Prevention of acquired infections in intubated patients with the combination of two decontamination regimens. Crit Care Med. 2005 Feb;33(2):307-14. doi: 10.1097/01.ccm.0000152224.01949.01.

ReferenceCitation: Camus C, Bellissant E, Legras A, Renault A, Gacouin A, Lavoue S, Branger B, Donnio PY, le Corre P, Le Tulzo Y, Perrotin D, Thomas R. Randomized comparison of 2 protocols to prevent acquisition of methicillin-resistant Staphylococcus aureus: results of a 2-center study involving 500 patients. Infect Control Hosp Epidemiol. 2011 Nov;32(11):1064-72. doi: 10.1086/662180. Epub 2011 Sep 29.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Ministry of Health, France

location_facility: Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou

location_facility: Service de Réanimation Médicale - Hôpital Bretonneau


title: Cytochrome P450 2E1 and Iron Overload

summary: The aim of the study is to determine, in patients presenting hepatic iron overload (genetic haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.

location_facility: Unité d'Investigation Clinique - Hôpital Pontchaillou


title: Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients

acronym: ASAP

summary: Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

lead_sponsor: MicroPort CRM

sponsor_collaborators:
MicroPort CRM
Sorin Group France SAS


title: A Phase I and Phase II Study of the Efficacy and Safety of Maintenance Treatment With Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes Who Achieved Hematological Response to Azacitidine

summary: A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who achieved a hematological response after 6 cycles of azacitidine. After approval by an independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an open label randomized phase II study designed to characterize the efficacy, safety, and tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of azacitidine.

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
EpiCept Corporation

location_facility: Centre Hospitalier Universitaire de STRASBOURG

location_facility: Hôpital Edouard Heriot, dpt Hématologie Clinique

location_facility: Hopital Purpan Service d'Hématologie Clinique


title: Vaccine Attitudes and Practices of Hospital Specialists

acronym: SPECIVAC

summary: This study aims to evaluate the perceptions and knowledge of hospital specialists regarding vaccine recommendations targeting their patients, to study their behavior with respect to these recommendations and to quantify their vaccine hesitancy.

collaborators: Innovative clinical research network in vaccinology (I-REIVAC)

collaborators: Observatoire Régionale de la santé ORS-PACA

location_facility: Service d'Hygiène, Epidémiologie et Prévention, Groupement Hospitalier Edouard Herriot et Unité de recherche clinique ne Immunologie du centre hospitalier Lyon Sud

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: SpeciVac

titre: Attitudes et pratiques de vaccination des médecins spécialistes hospitaliers

discipline_principale: organisation des soins

nom_porteur: LAUNAY

prenom_porteur: Odile


title: Phase II Evaluating the Efficacy of the Dual Inhibition of Phosphoinositide 3 Kinase (PI3K)/Akt /Mammalian Target Of Rapamycine (mTOR) Signaling Pathway by PF-05212384 (PKI-587) for Patients With Myeloid Neoplasm Secondary to Chemo-radiotherapy (t-AML/MDS) or de Novo Relapsed or Refractory AML.

acronym: LAM-PIK

summary: Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384 (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
Fondation ARC
National Cancer Institute, France

location_facility:
Hôpital Saint-Louis
Institut Curie - Hôpital René Huguenin
Institut Paoli Calmette
Hôpital Cochin
CHU de Toulouse


title: Interest of Low-dose Landiolol Administration After Cardiac Surgery for the Prevention of Postoperative Atrial Fibrillation

acronym: LANDIPROTEC

summary:
Postoperative atrial fibrillation (POAF) is a common complication that occurs in 30-50% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. During the perioperative period, the discontinuation of beta-blocker treatment is known to be a risk factor for developing POAF in patient undergoing cardiac surgery. Early beta-blocker reintroduction is associated with lower incidence of POAF. Unfortunately, side effects of currently available beta-blockers (including esmolol), such as low blood pressure and excessive bradycardia and/or their extended duration of action, limit their use in the post-operative period especially for prevention.

Landiolol, an ultra-short acting injectable beta-blocker, offers the advantage of significantly limiting low blood pressure events while increasing therapeutic efficacy in the treatment of POAF in cardiac and non-cardiac surgery. Landiolol, when used at low dose in the postoperative period, has been showed to reduce the incidence of POAF with no increased incidence of side effect as compared to standard of care. The limitation is that these promising data come from single center studies with limited samples and conducted exclusively in Japanese population. If landiolol is approved for use in the treatment of atrial fibrillation in non-Asian patients, there are no data on the prevention of POAF in cardiac surgery.

The objective of this multicenter, double-blind, randomized, placebo- controlled phase III trial is to confirm that landiolol postoperative infusion is associated with lower incidence of POAF without excess of adverse events as compared to standard of care in a non-Asian population after cardiac surgery with sternotomy.

lead_sponsor: CMC Ambroise Paré

location_facility:
Hôpital Privé Jacques Cartier
CMC Ambroise Paré
Centre Cardiologique du Nord


title: Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage

acronym: MIVAR

summary:
Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality.

Intravenous Milrinone, because of vasodilatory properties could be a therapeutic option. We hypothesize that intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months.

This is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).

ReferenceCitation: Lasocki S, Bruckert V, Campfort M, Leger M, Rineau E. Restrictive transfusion targets the heart now! Insight from the REALITY study. Anaesth Crit Care Pain Med. 2021 Apr;40(2):100854. doi: 10.1016/j.accpm.2021.100854. Epub 2021 Mar 27. No abstract available.

location_facility:
Hôpital Gui de Chauliac
CHU Nantes
Hôpital Gabriel Montpied
CHU Rennes
Hôpital de Hautepierre
CHU Angers

acronyme: MIVAR

titre: Milrinone pour le traitement du VAsospasme dans l'hémoRragie méningée

discipline_principale: anesthesiology / resuscitation

nom_porteur: LASOCKI

prenom_porteur: Sigismond


title: Safety and Tolerability of Yaq-001 in Patients With Cirrhosis ("CARBALIVE-SAFETY")

summary:
In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut into the blood and cause harm. This study looks into a new way to lower the leakage of bacterial fragments into the blood.

Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have the ability to bind these bacterial fragments and so confine them to the gut. The purpose of this clinical trial is to test the product Yaq-001 for the first time in patients with cirrhosis.

This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it helps improve the overall health status of the cirrhotic patients.

Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis for any cause. Only postmenopausal women or with surgical sterilisation are eligible. Additional inclusion and exclusion criteria of medical nature will be determined with the investigator at the screening visit, by means of standard care routines plus an additional test to assess the bowel transit time.

Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001, or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to better understand how safe and tolerable Yaq-001 really is.

The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study doctor 5 times. At all the visits the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital.

56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

primary_purpose: Device Feasibility

sponsor_collaborators: Institut d'Investigacions Biomèdiques August Pi i Sunyer

sponsor_collaborators: Hospital Universitari Vall d'Hebron Research Institute

sponsor_collaborators: IRCCS Azienda Ospedaliero-Universitaria di Bologna

sponsor_collaborators: Servicio Madrileño de Salud, Madrid, Spain

location_facility: Hospital Ramon y Cajal, Department of Gastroenterology and Hepatology

location_facility: Hospital Beaujon, Hepatology and Liver Intensive Care,

location_facility: Royal Free Hospital, Institute of Liver and Digestive Disease

location_facility: Azienda Ospedaliera di Padova, Hepatic Emergencies Unit

location_facility: Inselspital Universitaet Bern, Department for Visceral Surgery and Medicine,

location_facility: Policlinico S.Orsola Malpighi, Department of Medical and Surgical Sciences

location_facility: Hospital Clinic of Barcelona , Liver Unit,


title: Recherche de Marqueurs Pronostiques électro-physiologiques précoces Chez l'Aphasique après un Accident Vasculaire cérébral.APHA-TMS

acronym: APHA-TMS

summary: The purpose of this study is to study, among the aphasic person, if motor function ( studied by Motor Evoked Potentials) performed within the first 14 days after a stroke can predict a good recovery from aphasia 6 months of the initial episode.

ReferenceCitation: Dickey, L., A. Kagan, et al. (2010).

ReferenceCitation: El Hachioui, H., H. F. Lingsma, et al. (2013).

ReferenceCitation: Fadiga L, Craighero L, Buccino G, Rizzolatti G. Speech listening specifically modulates the excitability of tongue muscles: a TMS study. Eur J Neurosci. 2002 Jan;15(2):399-402. doi: 10.1046/j.0953-816x.2001.01874.x.

ReferenceCitation: Meister IG, Wilson SM, Deblieck C, Wu AD, Iacoboni M. The essential role of premotor cortex in speech perception. Curr Biol. 2007 Oct 9;17(19):1692-6. doi: 10.1016/j.cub.2007.08.064. Epub 2007 Sep 27.

ReferenceCitation: Meister IG, Sparing R, Foltys H, Gebert D, Huber W, Topper R, Boroojerdi B. Functional connectivity between cortical hand motor and language areas during recovery from aphasia. J Neurol Sci. 2006 Sep 25;247(2):165-8. doi: 10.1016/j.jns.2006.04.003. Epub 2006 Jun 5.

ReferenceCitation: Meister IG, Buelte D, Staedtgen M, Boroojerdi B, Sparing R. The dorsal premotor cortex orchestrates concurrent speech and fingertapping movements. Eur J Neurosci. 2009 May;29(10):2074-82. doi: 10.1111/j.1460-9568.2009.06729.x. Epub 2009 May 9.

ReferenceCitation: Tokimura H, Tokimura Y, Oliviero A, Asakura T, Rothwell JC. Speech-induced changes in corticospinal excitability. Ann Neurol. 1996 Oct;40(4):628-34. doi: 10.1002/ana.410400413.

lead_sponsor: University Hospital, Bordeaux


title: Impact of COVID-19 Pandemic in Perinatal Mental Health

summary: Introduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: The study and handling of the data will follow all national required data protection standards. Each researcher (or team of researchers) involved will submit the project to their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.

ReferenceCitation: Yu N, Li W, Kang Q, Xiong Z, Wang S, Lin X, Liu Y, Xiao J, Liu H, Deng D, Chen S, Zeng W, Feng L, Wu J. Clinical features and obstetric and neonatal outcomes of pregnant patients with COVID-19 in Wuhan, China: a retrospective, single-centre, descriptive study. Lancet Infect Dis. 2020 May;20(5):559-564. doi: 10.1016/S1473-3099(20)30176-6. Epub 2020 Mar 24.

ReferenceCitation: World Health Organization (2020). WHO guidelines on Intrapartum care for a positive childbirth experience and Interim guidance on Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf

ReferenceCitation: Royal College of Obstetricians & Gynaecologists: Coronavirus (COVID-19) infection and pregnancy https://www.rcog.org.uk/globalassets/documents/guidelines/2020-04-03-coronavirus-covid-19-infection-in-pregnancy.pdf

ReferenceCitation: Hahn-Holbrook J, Cornwell-Hinrichs T, Anaya I. Economic and Health Predictors of National Postpartum Depression Prevalence: A Systematic Review, Meta-analysis, and Meta-Regression of 291 Studies from 56 Countries. Front Psychiatry. 2018 Feb 1;8:248. doi: 10.3389/fpsyt.2017.00248. eCollection 2017.

ReferenceCitation: Shorey S, Chee CYI, Ng ED, Chan YH, Tam WWS, Chong YS. Prevalence and incidence of postpartum depression among healthy mothers: A systematic review and meta-analysis. J Psychiatr Res. 2018 Sep;104:235-248. doi: 10.1016/j.jpsychires.2018.08.001. Epub 2018 Aug 3.

ReferenceCitation: Caparros-Gonzalez RA. [Maternal and neonatal consequences of coronavirus COVID-19 infection during pregnancy: a scoping review]. Rev Esp Salud Publica. 2020 Apr 17;94:e202004033. Spanish.

ReferenceCitation: Moraes EV, Toledo OR, David FL, Godoi BN, Monteiro KA, Deluqui TC, Teixeira TW, Carvalho AL, Avelino MM. Implications of the clinical gestational diagnosis of ZIKV infection in the manifestation of symptoms of postpartum depression: a case-control study. BMC Psychiatry. 2019 Jun 26;19(1):199. doi: 10.1186/s12888-019-2157-9.

ReferenceCitation: Dos Santos Oliveira SJG, Dos Reis CL, Cipolotti R, Gurgel RQ, Santos VS, Martins-Filho PRS. Anxiety, depression, and quality of life in mothers of newborns with microcephaly and presumed congenital Zika virus infection: a follow-up study during the first year after birth. Arch Womens Ment Health. 2017 Jun;20(3):473-475. doi: 10.1007/s00737-017-0724-y. Epub 2017 Apr 21. No abstract available.

ReferenceCitation: Lebel C, MacKinnon A, Bagshawe M, Tomfohr-Madsen L, Giesbrecht G. Elevated depression and anxiety symptoms among pregnant individuals during the COVID-19 pandemic. J Affect Disord. 2020 Dec 1;277:5-13. doi: 10.1016/j.jad.2020.07.126. Epub 2020 Aug 1. Erratum In: J Affect Disord. 2021 Jan 15;279:377-379.

ReferenceCitation: Wu, Y. T., Zhang, C., Liu, H., Duan, C. C., Li, C., Fan, J. X., ... & Guo, Y. (2020). Perinatal Depression of Women Along with 2019 Novel Coronavirus Breakout in China. Available at SSRN: https://ssrn.com/abstract=3539359 or http://dx.doi.org/10.2139/ssrn.3539359

ReferenceCitation: Thomason, M.E., Graham, A., VanTieghem, M.R. (2020). The COPE-IS: Coronavirus Perinatal Experiences - Impact Survey. Available on the Open Science Framework (OSF) at https://osf.io/uqhcv/.

ReferenceCitation: Thomason, M.E., Graham, A., Smyser, C.D., Rogers, C.E. (2020). The COPE-IU: Coronavirus Perinatal Experiences - Impact Update. Available on the Open Science Framework (OSF) at https://osf.io/uqhcv/

ReferenceCitation: Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems

ReferenceCitation: Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

ReferenceCitation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

ReferenceCitation: Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The PTSD Checklist for DSM-5 (PCL-5) - Extended Criterion A [Measurement instrument]. Available from https://www.ptsd.va.gov/

ReferenceCitation: Bracken-Roche D, Bell E, Macdonald ME, Racine E. The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Syst. 2017 Feb 7;15(1):8. doi: 10.1186/s12961-016-0164-6. Erratum In: Health Res Policy Syst. 2017 Apr 3;15(1):29.

ReferenceCitation: Wilson CA, Gomez-Gomez I, Parsons J, Costa R, Mesquita A, Vousoura E, Contreras-Garcia Y, Levy D, Mateus V, Christoforou A, Felice E, Dikmen-Yildiz P, Dominguez-Salas S, Motrico E. The Mental Health of Women with Gestational Diabetes During the COVID-19 Pandemic: An International Cross-Sectional Survey. J Womens Health (Larchmt). 2022 Sep;31(9):1232-1240. doi: 10.1089/jwh.2021.0584. Epub 2022 Jul 19.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: University of Porto - Open Repository of the University of Porto

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Gomez-Baya D, Gomez-Gomez I, Dominguez-Salas S, Rodriguez-Dominguez C, Motrico E. The influence of lifestyles to cope with stress over mental health in pregnant and postpartum women during the COVID-19 pandemic. Curr Psychol. 2022 Jun 15:1-20. doi: 10.1007/s12144-022-03287-5. Online ahead of print.

ReferenceCitation: Motrico E, Bina R, Dominguez-Salas S, Mateus V, Contreras-Garcia Y, Carrasco-Portino M, Ajaz E, Apter G, Christoforou A, Dikmen-Yildiz P, Felice E, Hancheva C, Vousoura E, Wilson CA, Buhagiar R, Cadarso-Suarez C, Costa R, Devouche E, Ganho-Avila A, Gomez-Baya D, Gude F, Hadjigeorgiou E, Levy D, Osorio A, Rodriguez MF, Saldivia S, Gonzalez MF, Mattioli M, Mesquita A; Riseup-PPD-COVID-19 Group. Impact of the Covid-19 pandemic on perinatal mental health (Riseup-PPD-COVID-19): protocol for an international prospective cohort study. BMC Public Health. 2021 Feb 17;21(1):368. doi: 10.1186/s12889-021-10330-w.

repository_institution: Universidad de Coimbra - Estudo Geral

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Cyprus University of Technology - Ktisis at Cyprus University of Technology

lead_sponsor: University of Minho

collaborators: Mackenzie Presbiterian University, São Paulo, Brazil

collaborators: Instituto de Saude Publica da Universidade do Porto

collaborators: Instituto de Investigação Biomédica de Malaga. Spain

collaborators: Universidad Nacional de Educación a Distancia

location_country:
Cyprus
Albania
Portugal
Israel
United Kingdom
Brazil
Malta
Spain
Greece
Turkey
Chile
Bulgaria
France

location_facility:
Universidad de Concepción
King'S College London
Groupe Hospitalier du Havre
Kırklareli Üniversitesi
Beder College University
University of Malta
Universidad Loyola Andalucia
Sofia University
University of Athens
Bar-Ilan University
Universidade do Minho
European University Cyprus
Universidade Presbiteriana Mackenzie


title: Evaluation de la COagulopathie et de la Dysfonction enDOthéliale Comme Facteur prédictif de la gravité de l'Infection Par SARS-CoV-2 / COVID-19

acronym: SARCODO

summary:
On 30 January 2020, WHO declared the SARS-CoV-2 outbreak as a public health emergency of international concern. Compared to SARS-CoV, which caused an outbreak of SARS in 2003, SARS-CoV-2 has a higher transmission capacity. Although the clinical manifestations of SARS-CoV-2 are dominated by respiratory symptoms, some patients have severe cardiovascular damage. In addition, patients with underlying cardiovascular disease may be at increased risk of death. Therefore, understanding the impairments caused by SARS-CoV-2 to the cardiovascular system and the underlying mechanisms is of the utmost importance.

Circulating endothelial cells (CECs) are generally considered markers of lesions and may be non-invasive markers of pulmonary vascular dysfunction during SARS-CoV-2 infection. Another marker of endothelial activation could be circulating extracellular vesicles. They could also be involved in the spread of the virus. Thus this project proposes to study different aspects of the diagnosis and pathophysiology of SARS-CoV-2. We propose to fully study activation state of coagulation and endothelium on a plasma and cellular side in patients diagnosed with SARS-CoV-2/COVID19. The different forms of the disease will be included: without lung disease, with a more or less severe lung disease, i.e. having evolved or not towards acute respiratory distress syndrome (ARDS). Extensive research of biomarkers will be compared to the detection of the virus in the respiratory tract as well as in the blood. This work will contribute to a better description of disease pathophysiology and should allow us to identify a patient profile in whom preventive or curative anticoagulant therapy could be considered.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
National Research Agency, France

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Cochin


title: Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications

acronym: GLUTADIAB

summary: Experimental data suggest that glutamine catabolism in involved in the activation of macrophages by generating TCA(Tricarboxylic acid) intermediates that promote the pro-inflammatory polarization of macrophages. The project investigates the possible link between glutaminolysis, monocytes polarization and diabetes related cardiovascular complications in humans

location_facility:
Diabétologie - Hôpital Lariboisière
Diabetologie Bichat

appel_a_projets: PRTS

acronyme: GlutaDiab

titre: Impact du métabolisme de la glutamine dans les complications cardio-vasculaires dans le diabète

nom_porteur: ROUSSEL

prenom_porteur: Ronan


title: Clinical and Multi-omics Cross-phenotyping of Patients With Autoimmune and Auto-inflammatory Diseases

acronym: TRANSIMMUNOM

summary: The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases.

ReferenceCitation: Lorenzon R, Mariotti-Ferrandiz E, Aheng C, Ribet C, Toumi F, Pitoiset F, Chaara W, Derian N, Johanet C, Drakos I, Harris S, Amselem S, Berenbaum F, Benveniste O, Bodaghi B, Cacoub P, Grateau G, Amouyal C, Hartemann A, Saadoun D, Sellam J, Seksik P, Sokol H, Salem JE, Vicaut E, Six A, Rosenzwajg M, Bernard C, Klatzmann D. Clinical and multi-omics cross-phenotyping of patients with autoimmune and autoinflammatory diseases: the observational TRANSIMMUNOM protocol. BMJ Open. 2018 Aug 30;8(8):e021037. doi: 10.1136/bmjopen-2017-021037.

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: British Medical Journal

location_facility: CIC Paris-Est, Hôpital PITIE SALPETRIERE


summary: The project aims to precisely quantify the postprandial amino acid utilization of egg proteins in vivo in humans, and also to assess their satiating power, in relation with nutrient postprandial waves and incretin secretions. For that purpose, 2 independent studies are conducted. The first one is realized using stable isotopes on 8 volunteers ingesting an egg test meal. The second one is a cross over design performed on 30 volunteers to compare the satiating effect of 2 equivalent snacks: whole eggs or cottage cheese.

ReferenceCitation: Fromentin C, Tome D, Nau F, Flet L, Luengo C, Azzout-Marniche D, Sanders P, Fromentin G, Gaudichon C. Dietary proteins contribute little to glucose production, even under optimal gluconeogenic conditions in healthy humans. Diabetes. 2013 May;62(5):1435-42. doi: 10.2337/db12-1208. Epub 2012 Dec 28.

evidence: open (via crossref license)

publisher_dissemination: American Diabetes Association

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

location_facility:
Centre de recherche sur Volontaires
Centre de recherche sur volontaires

intervention_type: Dietary Supplement


title: Study of the Agreement Between Two Methods of Measuring Brachial Systolic Pressure (SFATI or Auscultatory) in Pregnant Women With or Without Blood Pressure Disorders and Search for Markers of Arterial Stiffness in Pre-eclampsia.

acronym: SFATI GROPE

summary: The investigators hypothesize that the Systolic Foot-to-Apex Time Interval (SFATI) method is an accurate means of measuring systolic blood pressure in pregnant women at a risk of pre-eclampsia. As the presence of arterial calcifications only changes the concordance between the SFATI method and the auscultatory reference method if calcifications are very severe, it should make it possible to identify, at an early stage, those women with a higher risk of developing pre-eclampsia. This is a transversal study with monocentric prospective recruitment to evaluate a non-CE (Conformité Européenne) -marked medical device in a diagnostic situation.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Phase I Study of AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer

acronym: NANOCOL

summary:
This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method.

Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Gustave Roussy
Centre Hospitalier Lyon Sud


title: Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.

acronym: EXEPUMP

summary: The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.

sponsor_collaborators:
University Hospital, Caen
Eli Lilly and Company

location_facility: Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen


title: Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test

acronym: HeMO

summary: Colorectal cancer screening by faecal occult blood test (FOBT) is a high public health priority. The interest of guaiac tests (G-FOBT) is limited by their poor sensitivity, while the superiority of I-FOBT in comparison with G-FOBT is now established. Nevertheless automated quantitative I-FOBTs have not been compared, and the optimal number of samples and threshold is not yet fixed. The aim of this study is to compare the performances of the 2 more well-known I-FOBTs with automated analyzers (magstream by Fujirebio, and OC Sensor by Eiken) for different positivity thresholds and numbers of samples in general average risk population. Patients will performed a two samples Magstream, a two samples OC Sensor and Hemoccult II. In case of a positive test, a colonoscopy will be performed. Sensitivity and specificity for detection of cancer and advanced neoplasias will be compared between tests using ratio of sensitivities (RSN) and ratio of false positives (RFP) according to number of samples and positivity threshold.

primary_purpose: Screening

ReferenceCitation: Raginel T, Puvinel J, Ferrand O, Bouvier V, Levillain R, Ruiz A, Lantieri O, Launoy G, Guittet L. A population-based comparison of immunochemical fecal occult blood tests for colorectal cancer screening. Gastroenterology. 2013 May;144(5):918-25. doi: 10.1053/j.gastro.2013.01.042. Epub 2013 Feb 1.

sponsor_collaborators:
University Hospital, Caen
National Cancer Institute, France
Ligue contre le cancer, France

location_facility:
Adoc18 - Irsa
ADECA


title: Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock

acronym: LevoHeartShock

summary: Cardiogenic shock (CS) mortality remains high (40%). Despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS. Based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. Inotropic agents increase myocardial contractility, thereby increasing cardiac output. Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. It may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing cAMP or calcium concentration. At present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. Our hypothesis is that the early use of levosimendan, by enabling the discontinuation of dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.

lead_sponsor: Central Hospital, Nancy, France

location_facility: APHP -Lariboisière Hospital (Cardiology department)

location_facility: APHP, Lariboisière Hospital (intensive care unit and toxicology)

location_facility: CHU Montpellier, Arnaud de Villeneuve Hospital

location_facility: APHP, La Pitié Salpêtrière (medical intensive care unit)

location_facility: Hospices Civils de Lyon - Louis Pradel Hospital

region: Grand Est

nom_etablissement: CHRU DE NANCY

acronyme: LevoHeartShock

titre: Effet de l'utilisation précoce du levosimendan versus placebo en plus d'une stratégie conventionnelle d'utilisation des inotropes sur un critère composite de morbidité-mortalité dans le choc cardiogénique

nom_porteur: LEVY

prenom_porteur: Bruno


title: Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors. Comparison of the Taking of Kidney by cœliosurgery (Pure or " Hand-assisted "), by cœliosurgery Assisted by Robot and by the Classic Technique of Open Donor Nephrectomy.

acronym: DOVIREIN

summary:
The main objective of this multicentre study is to conduct the evaluation of cost-efficiency of various techniques of kidney taking with regard the quality of life of the kidney living donors.

It will allow to compare three techniques of taking (open donor nephrectomy, cœliosurgery pure or " hand-assisted " and cœliosurgery assisted by robot) and to determine their respective advantages in quality of life, then their medico-economic consequences in a cost-efficiency approach from the point of view of the society.

The evaluation will concern the donor and the receiver followed three months after the taking.

The open donor nephrectomy will be the technique of reference with which will be compared the two others.

ReferenceCitation: Achit H, Guillemin F, Karam G, Ladriere M, Baumann C, Frimat L, Hosseini K, Hubert J. Cost-effectiveness of four living-donor nephrectomy techniques from a hospital perspective. Nephrol Dial Transplant. 2020 Nov 1;35(11):2004-2012. doi: 10.1093/ndt/gfz143.

publisher_dissemination: Oxford University Press

location_facility:
CHU Lyon Sud
CHU Pasteur
Hôpital Necker
CHU Hôpital de la Conception
Hôpital Saint-Louis
Hôpital Tenon
CHU Brabois
Hôpital Pitié Salpêtrière
CHU Henri Mondor
CMC Foch
Hôpital Charles Nicolle
CHU Lapeyronie
CHU Hôpital Michallon de Grenoble
Hôpital Edouard Herriot de Lyon
CHU Côte de Nacre de CAEN
CHU Bicêtre
CHU Saint Jacques de Besançon
CHU Saint Etienne
CHU Hautepierre
Hôpital de Rangueil
CHU Hôtel Dieu
CHU Bretonneau
CHU Montpied de Clermont-Ferrand
Hôpital Claude Huriez


title: Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)

acronym: HYPO-ECMO

summary:
A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C) during 24 hours ± 1h versus normothermia (36°C≤ T°C ≤37°C), comparative open trial will be conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO.

The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between 33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality in comparison with the normothermia group (36°C≤ T°C ≤37°C).

ReferenceCitation: Levy B, Girerd N, Amour J, Besnier E, Nesseler N, Helms J, Delmas C, Sonneville R, Guidon C, Rozec B, David H, Bougon D, Chaouch O, Walid O, Herve D, Belin N, Gaide-Chevronnay L, Rossignol P, Kimmoun A, Duarte K, Slutsky AS, Brodie D, Fellahi JL, Ouattara A, Combes A; HYPO-ECMO Trial Group and the International ECMO Network (ECMONet). Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Clinical Trial. JAMA. 2022 Feb 1;327(5):442-453. doi: 10.1001/jama.2021.24776. Erratum In: JAMA. 2023 Apr 11;329(14):1226.

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

repositories_concat: HAL;PubMed Central;oskar-bordeaux.fr

ReferenceCitation: Jacquot A, Lepage X, Merckle L, Girerd N, Levy B. Protocol for a multicentre randomised controlled trial evaluating the effects of moderate hypothermia versus normothermia on mortality in patients with refractory cardiogenic shock rescued by venoarterial extracorporeal membrane oxygenation (VA-ECMO) (HYPO-ECMO study). BMJ Open. 2019 Oct 14;9(10):e031697. doi: 10.1136/bmjopen-2019-031697.

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

location_facility: CHU Bordeaux - Groupe Hospitalier SaintAndré

location_facility: CHU Toulouse Hôpital - Pierre Paul Riquet

location_facility: CHU Clermont-Ferrand -Hopital G. Montpied

acronyme: HYPO ECMO

titre: Effets de l'hypothermie modérée sur la mortalité des patients en choc cardiogénique traités par ECMO artério-veineuse

discipline_principale: anesthésiologie / réanimation


title: Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study

acronym: ALPHO

summary:
The main objective of this study is to compare pholcodine exposure in patients having presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine exposure in matched anaesthetised patients with injection of NMBA, who did not present with an anaphylactic reaction (controls).

The secondary objectives of the study are:

To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.
To study the concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.
To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.
To study the association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.
To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to (at least) one NMBA.

sponsor_collaborators:
Central Hospital, Nancy, France
Zambon SpA
Laboratoires URGO
THE BOOTS COMPANY PLC
Pierre Fabre Medicament
LABORATOIRE HEPATOUM
Biocodex
Sanofi
Laboratoires Bouchara-Recordati
GlaxoSmithKline
ALLIANCE PHARMACEUTICALS LIMITED
BELL SONS & COMPANY
PINEWOOD LABORATORIES LIMITED
THORNTON & ROSS & Ross Ltd
ERNEST JACKSON & Co. Ltd

location_facility:
CHU d' ANGERS
CHU de Poitiers
AP-HP- Hôpital Bichat
AP-HP Paris TENON
Fondation Hôpital St Joseph
CHU de MONTPELLIER
CHU de Rouen
CHRU de Nancy
CHU de Dijon
CHU de Toulouse
CHU de Strasbourg
CHRU de Lille
CHU de Saint Etienne
CHU de Besançon
CHU de NANTES
CHU de Nice
CHU de Reims
CHU de TOURS
AP-HM
CHU de Bordeaux
CHU de Caen
CHU de Clermont-Ferrand
CHU de Limoges
Hospices Civils de Lyon


title: Interest of MR Urography in the Evaluation of Functional Consequences of Urinary Tract in Children and Adults

summary: The objective of functional Uro MR is to add to an initial morphological phase, based on T2 and T1 weighted MR sequences, a sequential contrast-enhanced acquisition allowing to obtain functional semi-quantitative parameters from time-intensity curves from ROIs placed on the aorta, renal parenchyma and cavities. If the equivalence with the renal scintigraphy is demonstrated, it would be possible to have both the morphological and functional approach of an obstructed kidney in one MR examination, without exposure to diagnostic irradiation.

location_facility:
AP-HP Bicêtre
Chu Angers
Fondation LENVAL
Chu Poitiers
Chu Tours
Chu Reims
Ap-Hm Marseille
Chu Rennes
AP-HP Robert Debré
AP-HP Saint Vincent de Paul
Chu Strasbourg
AP-HP Trousseau
Chru Lille
Chu Rouen
CHU NANCY Hôpital Brabois enfant
Chu Bordeaux


title: Occupational Respiratory Allergies and Gene-environment Interactions

acronym: ARPEIGE

summary:
The purpose is to compare clinical, functional, professional and socio-economical characteristics of patients with occupational asthma and work aggravated asthma.

Secondary purposes are:

to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide and cytology of induced expectoration;
to estimate medical-social becoming of diagnosed work-related asthma after one year;
to establish a biobank of blood samples of individuals with work related asthma for measurement of cytokines and search for genetic polymorphisms associated with asthma.

location_facility: Centre de consultation de pathologies professionnelles, Hôpital côte de Nacre - CHU de Caen

location_facility: Centre de consultation de pathologies professionnelles, Centre Hospitalier Intercommunal de Créteil

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Purpan - CHU de Toulouse

location_facility: Centre de consultation de pathologies professionnelles, Centre Hospitalier Lyon-Sud

location_facility: Centre de consultation de pathologies professionnelles, immeuble Tourville - CHU de Nantes

location_facility: Centre de consultation de pathologies professionnelles, AP-HP groupe hospitalier Cochin

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Fernand-Widal

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Civil - CHU de Strasbourg

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Lyautey - CHU de Strasbourg

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Michallon - CHU de Grenoble

location_facility: Centre de consultation de pathologies professionnelles, CHRU Nancy

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Pellegrin - CHU de Bordeaux


acronym: OptimaCC

summary: The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction will be compared, by following cardiac index evolution as main criteria. The study is a pilot pathophysiological study, randomized, double blind and multicenter.

ReferenceCitation: Takagi K, Blet A, Levy B, Deniau B, Azibani F, Feliot E, Bergmann A, Santos K, Hartmann O, Gayat E, Mebazaa A, Kimmoun A. Circulating dipeptidyl peptidase 3 and alteration in haemodynamics in cardiogenic shock: results from the OptimaCC trial. Eur J Heart Fail. 2020 Feb;22(2):279-286. doi: 10.1002/ejhf.1600. Epub 2019 Aug 31.

evidence: open (via free article)

ReferenceCitation: Levy B, Clere-Jehl R, Legras A, Morichau-Beauchant T, Leone M, Frederique G, Quenot JP, Kimmoun A, Cariou A, Lassus J, Harjola VP, Meziani F, Louis G, Rossignol P, Duarte K, Girerd N, Mebazaa A, Vignon P; Collaborators. Epinephrine Versus Norepinephrine for Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. 2018 Jul 10;72(2):173-182. doi: 10.1016/j.jacc.2018.04.051.

location_facility:
CHU de BESANCON / Hôpital Jean Minjoz
CHU Toulouse
CH de MULHOUSE
CHU de DIJON
Chru Tours
CHU de LIMOGES Hôpital Dupuytren
CHU de STRASBOURG / NHC
Chr Metz Thionville
Nancy Brabois university hospital
APHM Hôpital NORD
AP-HP-Hôpital Cochin

title: Optimizing the Use of Vasopressor After Coronary Reperfusion in Cardiogenic Shock Secondary to Myocardial Infarction. Pathophysiological Study Comparing the Efficacy and Cardio-circulatory Tolerability of Epinephrine and Norepinephrine