title: Overdiagnosis of Thyroid Cancer in the Marne and Ardennes Departments of France From 1975 to 2014

acronym: OTCancer

summary:
Introduction - Incidence of thyroid cancer has increased considerably in France in recent years, but the mortality rate has declined only slightly. Part of this increased incidence could be attributable to overdiagnosis. We aimed to estimate the contribution of overdiagnosis to the incidence of papillary thyroid cancer.

Material and methods. - Incidence rates were calculated based on data from the specialised Marnes-Ardennes thyroid cancer registry, for cancers diagnosed between 1975 and 2014, by age category and by five-year period. The population was divided into two groups according to pTNM classification at diagnosis (i.e. localised or invasive). Overdiagnosis was defined as the difference in incidence rates between the invasive cancer and localised cancer groups. This rate was then divided by the incidence rate in the localised cancer group for the most recent period (2010-2014) to obtain the proportion of cancers attributable to overdiagnosis.

ReferenceCitation: Saint-Martin C, Dramé M, Dabakuyo S, Kanagaratnam L, Arveux P, Schvartz C. Overdiagnosis of thyroid cancer in the Marne and Ardennes Departments of France from 1975 to 2014. Ann Endocrinol (Paris). 2017 Feb;78(1):27-32. doi: 10.1016/j.ando.2016.07.005. Epub 2016 Sep 15.


type: Other Identifier

title: Prospective French Study on ACQUIred Haemophilia Treatment With Recombinant Factor VIIa (NovoSeven®) A Prospective Observational Study on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for the Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia

summary: This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Novo Nordisk A/S

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Behaviour and Experience of Communities Healthcare Professionals Facing the SARS CoV-2 Epidemic

acronym: COVecu

summary: The purpose of this study is to identify behaviours and experiences of communities healthcare professionals (doctors, nurses and physiotherapists) in the management of the SARS-CoV 2 epidemic by identifying the impact of the epidemic on their work, their personal life and the difficulties they had experienced.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Ongoing


title: Impact of Post-Traumatic Stress Disorder After Pregnancy Loss After 12 Weeks of Gestation (Termination of Pregnancy , Stillbirth, Late Miscarriage)

acronym: ACTRAMAT-D

summary:
In France The prevalence of Pregnancy Loss after 12 weeks of gestation is around 3%. This situation is probably associated to a risk of post-traumatic stress disorder.

As a part of the medical staff midwives are often confronted with this situation, however they can have difficulties to identify short and long term effects of a post-traumatic stress disorders.

The purpose of the present study is to estimate and analyze the prevalence of short-term (1 month) post-traumatic stress disorder in women with pregnancy loss after 12 weeks of gestation.The symptoms of post-traumatic stress disorder will be tracked using the Impact of Event Scale-revisited and the Peritraumatic Dissociative Experiences Questionnaires.The diagnosis of post-traumatic stress disorder will also be clinically confirmed by a psychiatrist during a specific consultation.

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Angers

intervention_type: Diagnostic Test


title: Influence of Sensorimotor Environment on Gambling Behavior in Pathological Gambling.

summary:
In France, the prevalence of problem gambling and risk has been estimated at 1.3%. This disorder, currently considered a behavioral addiction is characterized by a loss of control and an excessive focus on the game.

The literature on intervening psychological mechanisms in the development of the game led to think that the size of loss of control, central among players, could be understood as a reduction in control capacity but also as automatic activation behavior game.

The task of Go-Nogo, commonly used in cognitive psychology, assesses the automatic and controlled components of behavior. Furthermore, different models of the concept of addiction underline the importance of the environment associated with addiction. However, no study takes into account the interaction between the game environment and the involvement of these mechanisms.

status: Terminated

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Other

status_simplified: Unknown


title: Association of Psycho-social Traits for the Benefit of a First Respiratory Rehabilitation Course - Exploratory Study.

acronym: RESPIRSO

summary:
Respiratory Rehabilitation (RR) is based on a comprehensive multidisciplinary program of personalized and tailored care for patients with chronic respiratory diseases.

The effectiveness of RR in improving quality of life and exercise capacity has long been demonstrated in patients with chronic obstructive pulmonary disease (COPD). More recently, its interest has been highlighted in other chronic respiratory pathologies: asthma, interstitial pathologies, cancer, restrictive pathologies or pulmonary arterial hypertension. Although the efficacy of RR has been well demonstrated on the scale of a patient population, the benefits derived on an individual scale remain unpredictable and variable from one individual to another, without knowing the major determinants of this benefit.

Empirically, RR professionals suspect an association between some psychosocial characteristics and the importance of the benefit derived by patients from RR programmes. Individual personality traits and their relationship to health status, integration into a group, interaction with other group members, and the existence of anxiety or depressive symptoms may be determinants of RR benefit. These psychosocial determinants could also play a central role in the patients' adherence to the long-term rehabilitation process.

The hypothesis being tested is that there is an association between personality traits, anxiety, depressive symptoms, social support, and the benefit of an initial course of RR and the subsequent continuation of maintenance practices.

lead_sponsor: University Hospital, Tours


title: Comparison Between Left Double-lumen Tube With or Without a Carinal Hook During Lung Surgery

summary:
Most teams use a left double-lumen tube. The double-lumen tube is available with or without a carinal hook. The hook is supposed to facilitate the positioning of the tube and avoid the mobilization of the tube during surgery. The use of double-lumen tubes with a hook is large in Europe and quite unknown in US. The literature is poor, containing only few case reports.

The purpose of this research is to compare the two types of left double-lumen tube.

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Dumans-Nizard V, Parquin JF, Moyer JD, Dreyfus JF, Fischler M, Le Guen M. Left double-lumen tube with or without a carinal hook: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jun;32(6):418-24. doi: 10.1097/EJA.0000000000000201.

family: Dumans-Nizard

full_name: Virginie Dumans-Nizard

given: Virginie

sequence: first

family: Parquin

full_name: Jean-François Parquin

given: Jean-François

sequence: additional

family: Moyer

full_name: Jean-Denis Moyer

given: Jean-Denis

family: Dreyfus

full_name: Jean François Dreyfus

given: Jean François

family: Fischler

full_name: Marc Fischler

given: Marc

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Hopital Foch

intervention_type: Device


title: Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais

summary: The investigators propose to create a database at the regional level, the principle is to include all patients in whom a mutation was detected from a single platform (Lille). The creation of this regional cohort, smaller than the national cohort of Biomarkers France, will perform a more comprehensive collection of clinical data, and molecular monitoring data of patients included. To increase the completeness of the collection of information, it will not be based on voluntary prescribing clinician but will be largely carried out by CRA dedicated to this activity.

status: Unknown status

lead_sponsor: Centre Oscar Lambret

location_facility:
CHRU
Centre Oscar Lambret


title: Pilot Study of the Links Between Presbyacusis and Lexical Disorders in Patients With Alzheimer's Disease or Related Disease

acronym: LOOP

summary:
In France, Alzheimer's disease accounts for 70 to 80% of the causes of neurocognitive disorders, i.e. 600,000 to 800,000 patients. It is a neurodegenerative pathology that causes evolutionary cognitive dysfunction, mainly affecting memory functions. The inability to name familiar objects (lack of the word) is one of the most commonly noted symptoms at an early stage of the disease.

Presbyacusis, or age-related hearing loss, is the most common sensory deficit in the elderly which is manifested socially by a progressive discomfort of verbal communication. Presbyacusis remains underdiagnosed and undertreated: 2/3 of the patients are not using hearing aid.

In recent years, a link between neurocognitive disorders and hearing loss has been shown by investigating general cognition. In this study, the investigators are investigating lexical disorders.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Impact of the Arteriovenous Fistula Puncture Technique On the Hemodialysis Session For Patient and Caregiver

summary:
40000 patients are hemodialysis each year in France .

In the case of chronic care, 78% of patients have an arteriovenous fistula. In order to perform the hemodialysis session, 2 techniques of puncture of the fistula are possible:

Bevel puncture upwards then flipping the needle
or puncture bevel down. At present, there is no consensus or study on the technique of puncture fistula which generates different professional practices.

primary_purpose: Supportive Care

lead_sponsor: Poissy-Saint Germain Hospital


title: National Longitudinal Registry for Mid-Term Clinical Outcome And Procedure Efficacy Evaluation In Using A Novel Preprocedural Planning Method For Left Atrial Appendage Occlusion Guided By 3D Printing

acronym: LAA-PrintRegis

summary:
Left atrial appendage closure (LAAC) was approved by the ESC guidelines as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation in patients at high risk of bleeding (IIbB).

Although the overall LAAC benefice, in term of prevention of stroke or embolisme and decresing the anticoagulant-related risk of bleeding is already demonstrated, however the procedure success and safety, critically depends on understanding LAA anatomy and adequate pre-procedure planning.

3D-printed patient-specific adaptive and flexible LA models have demonstrated in a previous study an improving in LAAO device sizing, a better pre-procedural planning of the optimal trans-septal puncture site, by incorporating all anatomical variations and an improuving patient outcomes by reducing procedure time and number of prostheses employed per patient.

This technique is now used in several surgical centers in France and large prospective evaluation of the practice is necessary.

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure


title: AVAL Cohort Study First Step, Observational Study, After One Year

acronym: AVAL

summary:
Context: Since March 2012, several terrorist attacks have been perpetrated in France (Toulouse, Montauban, Paris, Nice ...). In March 2017, 53 french teenagers were victims in a terrorist attack in London (Westminster Bridge).
Main goal = to estimate the psycho-traumatic impact and to describe cares and management of high school students, victims of the terrorist attack in London on 2017, March the 22nd.
3 secondary objectives: 1) Clinical (occurrence of Post Traumatic Stress Disorders or other disorders); 2) Epidemiological (risk factors for developing disorders, avoiding care); 3) Preventive and therapeutic.

ReferenceCitation: Grenon M, Consigny M, Lemey C, Simson JP, Coulon N. Impact of a Terrorist Attack on the Mental Health of Directly Exposed French Adolescents: Study Protocol for the First Step of the AVAL Cohort Study. Front Psychiatry. 2019 Oct 25;10:744. doi: 10.3389/fpsyt.2019.00744. eCollection 2019.

family: Grenon

full_name: Marion Grenon

given: Marion

family: Consigny

full_name: Maëlys Consigny

given: Maëlys

family: Lemey

full_name: Christophe Lemey

given: Christophe

family: Simson

full_name: Jean-Pierre Simson

given: Jean-Pierre

family: Coulon

full_name: Nathalie Coulon

given: Nathalie

currency_apc_doaj: USD

journal_name: Frontiers in Psychiatry

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ipd_sharing: Yes

ipd_sharing_description: Secured email aval.france@chu-brest.fr

lead_sponsor: University Hospital, Brest

location_facility: HIA Hôpital d'Instruction des Armées Clermont Tonnerre


title: Études Observationnelles Des conséquences de l'Infection à Virus Zika au Cours de la Grossesse Pendant l'épidémie Des départements français d'Amérique de l'année 2016

acronym: ZIKA-DFA-FE

summary: The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy. This study is meant to collect, within usual care practices, clinical and paraclinical information which will allow the precise description of the consequences of ZIKV infection occurring during pregnancy.

ReferenceCitation: Funk AL, Hoen B, Vingdassalom I, Ryan C, Kadhel P, Schepers K, Gaete S, Tressières B, Fontanet A. Reassessment of the risk of birth defects due to Zika virus in Guadeloupe, 2016. PLoS Negl Trop Dis. 2021 Mar 3;15(3):e0009048. doi: 10.1371/journal.pntd.0009048. eCollection 2021 Mar.

family: Funk

full_name: Anna L. Funk

given: Anna L.

family: Hoen

full_name: Bruno Hoen

given: Bruno

family: Vingdassalom

full_name: Ingrid Vingdassalom

given: Ingrid

family: Ryan

full_name: Catherine Ryan

given: Catherine

family: Kadhel

full_name: Philippe Kadhel

given: Philippe

family: Schepers

full_name: Kinda Schepers

given: Kinda

family: Gaete

full_name: Stanie Gaete

given: Stanie

family: Tressières

full_name: Benoit Tressières

given: Benoit

family: Fontanet

full_name: Arnaud Fontanet

given: Arnaud

journal_name: PLOS Neglected Tropical Diseases

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repositories:
HAL
PubMed Central

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Hoen B, Schaub B, Funk AL, Ardillon V, Boullard M, Cabié A, Callier C, Carles G, Cassadou S, Césaire R, Douine M, Herrmann-Storck C, Kadhel P, Laouénan C, Madec Y, Monthieux A, Nacher M, Najioullah F, Rousset D, Ryan C, Schepers K, Stegmann-Planchard S, Tressières B, Voluménie JL, Yassinguezo S, Janky E, Fontanet A. Pregnancy Outcomes after ZIKV Infection in French Territories in the Americas. N Engl J Med. 2018 Mar 15;378(11):985-994. doi: 10.1056/NEJMoa1709481.

name: From INSERM Centre d’Investigation Clinique 1424 (B.H., C.C., B.T.), Service de Maladies Infectieuses et Tropicales, Dermatologie, Médecine Interne (B.H., K.S.), Cellule d’Intervention en Région (CIRE) Antilles, Santé Publique France (S.C.), Laboratoire de Microbiologie (C.H.-S.), Service de Gynécologie Obstétrique (P.K.), Centre Pluridisciplinaire de Diagnostic Prénatal (C.R.), and Pôle Parent-Enfant (E.J.), Centre Hospitalier Universitaire (CHU) de Pointe-à-Pitre/Abymes, and Université des Antilles et...

family: Schaub

full_name: Bruno Schaub

family: Ardillon

full_name: Vanessa Ardillon

given: Vanessa

family: Boullard

full_name: Manon Boullard

given: Manon

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

location_facility: CH de l'Ouest Guyanais Franck Joly (CHOG)


type: EudraCT Number

title: Development of a Fast Measurement Technique of Insulin Resistance in Human, With 123-6-deoxy-6 Iodo-D-glucose, a New Tracer of Glucose Transport

acronym: GLUCIMAG

summary:
Insulin resistance, characterised by a depressed cellular sensitivity to insulin in insulin-sensitive organs, is a central feature of the metabolic syndrome. In people with no diabetes mellitus, the presence of metabolic syndrome leads to an increase of mortality, whatever the cause, but, as a majority, cardiovascular diseases.

In patients with type 2 diabetes mellitus, the presence of a metabolic syndrome leads to an increase in major adverse cardiovascular events. The prevalence of metabolic syndrome is led to grow in a near future, because of the increase of diabetes mellitus and obesity prevalence.

Actually, there is no simple tool to measure insulin resistance. The gold standard technique remains the hyperinsulinemic euglycemic clamp. However, the complexity and length of this technique render it unsuitable for routine clinical use. Many methods or index have been proposed to assess insulin resistance in human, but none have shown enough relevance to be used in clinical use.

Within the investigators U877 INSERM team, the investigators previously performed in vivo biodistribution studies with 6-DIG (6-deoxy-6-iodo-D-glucose), a new tracer of glucose transport, radiolabelled with123 iodine, with and without insulin, on the one hand in genetically diabetic mice (db/db), consequently having a severe insulin resistance and in the other hand in rats with acquired insulin resistance after a "fructose diet".

The investigators have demonstrated that 6-DIG is able to identify in vivo slight glucose transport variations in insulin sensible organs. Then, the investigators developed a fast and simple imaging protocol with a small animal gamma camera, which allows the obtaining of an insulin resistance index for each organ, directly transferable to human.

The investigators project is to transfer to human this measurement technique, perfectly validated in animal.

The main goal of this monocentric phase I-II study is to evaluate the tolerance to the insulin resistance measurement technique with 6DIG scintigraphy, in healthy volunteers and in diabetic patients. The investigators plan to enrol 6 healthy volunteers and 6 type 2 diabetic patients.

The investigators secondary goals will be to evaluate feasibility and reproducibility of the measurement technique, to follow pharmacokinetic and to assess efficacy of 6-DIG to measure insulin resistance.

design_allocation: Non-Randomized

location_facility: Service de Biophysique et Médecine Nucléaire, CHU de Grenoble


title: Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

acronym: ESSURE

summary:
The ESSURE device is a method of permanent contraception, marketed in France since 2005. Multiple side effects have been reported by patients since 2015 and the marketing was stopped in 2017. For several months it was observed an increase in requests for withdrawal of these devices. The principal objective of this study is to evaluate clinical improvement and quality of life after ESSURE removal.

This is a multicenter retrospective descriptive study involving the gynecology department of the Croix Rousse Hospital and the gynecology department of the Lyon Sud Hospital over a period of 1 year (1 January 2017-31 December 2017).

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Gynécologie-Obstétrique - Centre Hospitalier Lyon Sud

location_facility: Service de gynécologie-Obstétrique - Hôpital de la Croix Rousse


title: Retrospective Study Comparing Radiologist Diagnostic Performance Versus Artificial Intelligence (AI) for Hip Fracture Suspicion in Elderly Patients

acronym: RAVIA

summary:
In France, femoral neck fracture is mainly detected with interpretation of pelvis/hip X-ray imaging (French Health Authority recommandation).

However, up to 10% of fractures are not identified or misdiagnosed, especially in patients admitted to the emergency department.

Indeed, radiologists may be subject to excessive work, wich cause the risk of inaccurate on X-rays diagnosis.

The Artificial intelligence (AI) begins study the detection of fratures on medical imaging.

In this retropective study, this technology developed by GLEAMER company is tested to evaluate the detection rate of hip fracture and specifically femoral neck fracture, compared to the radiologist diagnostic, in eldery patients admitted in emergency department.

AI could optimize the diagnostic performance of radiologists (increase of confidence level) and improve the efficiency of suspected fractures sorting from emergency department.

status: Active, not recruiting

ipd_sharing_description: NC


ReferenceType: background

ReferenceCitation: Schultz J, Segal N, Kolbeck J, Caldwell E, Thorsgard M, McKnite S, Aufderheide TP, Lurie KG, Yannopoulos D. Sodium nitroprusside enhanced cardiopulmonary resuscitation prevents post-resuscitation left ventricular dysfunction and improves 24-hour survival and neurological function in a porcine model of prolonged untreated ventricular fibrillation. Resuscitation. 2011 Dec;82 Suppl 2:S35-40. doi: 10.1016/S0300-9572(11)70149-6.

ReferenceCitation: Schultz J, Segal N, Kolbeck J, McKnite S, Caldwell E, Yannopoulos D. Sodium nitroprusside enhanced cardiopulmonary resuscitation (SNPeCPR) improves vital organ perfusion pressures and carotid blood flow in a porcine model of cardiac arrest. Resuscitation. 2012 Mar;83(3):374-7. doi: 10.1016/j.resuscitation.2011.07.038. Epub 2011 Aug 22.

ReferenceCitation: Schultz JC, Segal N, Caldwell E, Kolbeck J, McKnite S, Lebedoff N, Zviman M, Aufderheide TP, Yannopoulos D. Sodium nitroprusside-enhanced cardiopulmonary resuscitation improves resuscitation rates after prolonged untreated cardiac arrest in two porcine models. Crit Care Med. 2011 Dec;39(12):2705-10. doi: 10.1097/CCM.0b013e31822668ba.

ReferenceCitation: Yannopoulos D, Matsuura T, Schultz J, Rudser K, Halperin HR, Lurie KG. Sodium nitroprusside enhanced cardiopulmonary resuscitation improves survival with good neurological function in a porcine model of prolonged cardiac arrest. Crit Care Med. 2011 Jun;39(6):1269-74. doi: 10.1097/CCM.0b013e31820ed8a6.

acronym: SICARE

source: euctr

title: SNPeCPR Pour la prIse en Charge Des Arrêts CaRdiaques Extrahospitaliers

summary: Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic resuscitation survival after cardiac arrest remains low (1-8%) and has not changed significantly over the past five decades.It has recently been shown that the combination of different non-invasive therapies, cardiopulmonary resuscitation with mechanical CPR with automated compression / decompression and an impedance threshold device, can increase the rate of return of spontaneous circulation and short and long term survival after cardiac arrest.We propose to study a new cardiopulmonary resuscitation called SNPeCPR (Sodium nitroprusside enhanced cardiopulmonary resuscitation), which includes two components:a) a mechanical component: cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold deviceb) a pharmacological component: sodium nitroprusside, an effective arterial vasodilator that decrease vascular resistance, and improve flow in vital organs.Our hypothesis is that SNPeCPR should improve the return of spontaneous circulation rate during cardiac arrest.


title: A Cohort Study to Assess the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections

acronym: UTOPIE

summary:
Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive in France, as 65%-85% of children below 11 years are being treated, frequently with Proton Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection rate but data in pediatry are scarce, especially in community medecine. Recently a study conducted in England brought up controversial results suggesting that the use of PPIs can be associated with a reduced risk of community acquired pneumonia.

Our study was aimed to assess, on a population-based database, the association between PPI prescription and community infections in children of 11 years or under.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

summary:
Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible.

The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.

lead_sponsor: Poitiers University Hospital


title: Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant

acronym: CoQualSEP

summary: Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

ReferenceCitation: Planche V, Moisset X, Morello R, Dumont E, Gibelin M, Charré-Morin J, Saubusse A, Mondou A, Reuter F, Defer G, Pelletier J, Brochet B, Clavelou P. Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study. J Neurol Sci. 2017 Nov 15;382:148-154. doi: 10.1016/j.jns.2017.10.008. Epub 2017 Oct 6.

family: Planche

full_name: Vincent Planche

given: Vincent

family: Moisset

full_name: Xavier Moisset

given: Xavier

family: Morello

full_name: Remy Morello

given: Remy

family: Dumont

full_name: Emilie Dumont

given: Emilie

family: Gibelin

full_name: Marion Gibelin

family: Charré-Morin

full_name: Julie Charré-Morin

given: Julie

family: Saubusse

full_name: Aurore Saubusse

given: Aurore

family: Mondou

full_name: Audrey Mondou

given: Audrey

family: Reuter

full_name: Françoise Reuter

given: Françoise

family: Defer

full_name: Gilles Defer

given: Gilles

family: Pelletier

full_name: Jean Pelletier

given: Jean

family: Brochet

full_name: Bruno Brochet

family: Clavelou

full_name: Pierre Clavelou

given: Pierre

journal_name: Journal of the Neurological Sciences

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Clermont-Ferrand


title: Health in Smart Rurality: Impact on Coordination of Care of Telemonitoring and Data Centralization of Frailty Patients

summary:
Chronic diseases are frequent (around 10% of the total population and 30% after 60 years) and accelerate age-related functional decline. Concerning cross-border patients, use of health services can be delayed given the distances, the lack of rapid road access and the limited availability of public transport and the complex organization of coordinated care.

One of the ways to reduce acute exacerbations and preserve the quality of life of patients is to detect warning signs early. One of the ways to do this is to use new communication technologies.

lead_sponsor: Université de Reims Champagne-Ardenne


title: Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC

summary: The addition of chemotherapy to lung cancer surgery is now considered as the standard of care. Solid data support postoperative chemotherapy but only few results are available in the preoperative setting. To define which timing of perioperative chemotherapy offers the best survival improvement, the IFCT 0002 study is conducted in France.

ReferenceType: result

ReferenceCitation: Westeel V, Quoix E, Puyraveau M, Lavolé A, Braun D, Laporte S, Bigay-Game L, Pujol JL, Ozenne G, Rivière A, Douillard JY, Lebeau B, Debieuvre D, Poudenx M, David P, Molinier O, Zalcman G, Lemarié E, Morin F, Depierre A, Milleron B; Intergroupe Francophone de Cancérologie Thoracique. A randomised trial comparing preoperative to perioperative chemotherapy in early-stage non-small-cell lung cancer (IFCT 0002 trial). Eur J Cancer. 2013 Aug;49(12):2654-64. doi: 10.1016/j.ejca.2013.04.013. Epub 2013 Jun 1.

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Puyraveau

full_name: Marc Puyraveau

given: Marc

family: Lavolé

full_name: A. Lavolé

given: A.

family: Braun

full_name: Denis Braun

given: Denis

family: Laporte

full_name: Silvy Laporte

given: Silvy

family: Bigay-Game

full_name: Laurence Bigay-Game

given: Laurence

family: Pujol

full_name: Jean-Louis Pujol

given: Jean-Louis

family: Ozenne

full_name: Gervais Ozenne

given: Gervais

family: Rivière

full_name: Alain Rivière

given: Alain

family: Douillard

full_name: Jean-Yves Douillard

given: Jean-Yves

family: Lebeau

full_name: Bernard Lebeau

given: Bernard

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Poudenx

full_name: Michel Poudenx

given: Michel

family: David

full_name: Philippe David

given: Philippe

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Lemarié

full_name: Etienne Lemarié

given: Etienne

family: Morin

full_name: Franck Morin

given: Franck

family: Depierre

full_name: Alain Depierre

family: Milleron

full_name: Bernard Milleron

journal_name: European Journal of Cancer

ReferenceCitation: de Fraipont F, Levallet G, Creveuil C, Bergot E, Beau-Faller M, Mounawar M, Richard N, Antoine M, Rouquette I, Favrot MC, Debieuvre D, Braun D, Westeel V, Quoix E, Brambilla E, Hainaut P, Moro-Sibilot D, Morin F, Milleron B, Zalcman G; Intergroupe Francophone de Cancérologie Thoracique. An apoptosis methylation prognostic signature for early lung cancer in the IFCT-0002 trial. Clin Cancer Res. 2012 May 15;18(10):2976-86. doi: 10.1158/1078-0432.CCR-11-2797. Epub 2012 Mar 20.

publisher: American Association for Cancer Research (AACR)

title: An Apoptosis Methylation Prognostic Signature for Early Lung Cancer in the IFCT-0002 Trial

ReferenceCitation: Mouillet G, Monnet E, Milleron B, Puyraveau M, Quoix E, David P, Ducoloné A, Molinier O, Zalcman G, Depierre A, Westeel V; Intergroupe Francophone de Cancérologie Thoracique (IFCT). Pathologic complete response to preoperative chemotherapy predicts cure in early-stage non-small-cell lung cancer: combined analysis of two IFCT randomized trials. J Thorac Oncol. 2012 May;7(5):841-9. doi: 10.1097/JTO.0b013e31824c7d92.

title: Pathologic Complete Response to Preoperative Chemotherapy Predicts Cure in Early-Stage Non–Small-Cell Lung Cancer: Combined Analysis of Two IFCT Randomized Trials

ReferenceCitation: Levallet G, Bergot E, Antoine M, Creveuil C, Santos AO, Beau-Faller M, de Fraipont F, Brambilla E, Levallet J, Morin F, Westeel V, Wislez M, Quoix E, Debieuvre D, Dubois F, Rouquette I, Pujol JL, Moro-Sibilot D, Camonis J, Zalcman G; Intergroupe Francophone de Cancérologie Thoracique (IFCT). High TUBB3 expression, an independent prognostic marker in patients with early non-small cell lung cancer treated by preoperative chemotherapy, is regulated by K-Ras signaling pathway. Mol Cancer Ther. 2012 May;11(5):1203-13. doi: 10.1158/1535-7163.MCT-11-0899. Epub 2012 Mar 12.

title: High TUBB3 Expression, an Independent Prognostic Marker in Patients with Early Non–Small Cell Lung Cancer Treated by Preoperative Chemotherapy, Is Regulated by K-Ras Signaling Pathway

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique


title: Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study.

acronym: OPEN

summary: osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.


title: Effect and Tolerance of a Probiotic-based Medical Device (Lactiplus®) Administered to Patients With Irritable Bowel Syndrome

acronym: Lactiplus

summary:
This is an observational, open, longitudinal, multicentre study conducted in France.

The study plans to enrol 119 patients with irritable bowel syndrome who will be included by about 50 general practitioners or gastroenterologists consulting in private offices. The treatment, Lactiplus® is a medical device, in the form of capsules containing L. gasseri LA806. The main objective of the study is to assess the effect of a 4-week treatment with the medical device on abdominal pain.

lead_sponsor: PiLeJe

location_facility: General practitioners or gastroenterologists consulting in french private offices


type: Registry Identifier

title: Interest of Azithromycin With or Without Hydroxychloroquine for the Treatment of COVID-19 Pneumonia : a Retrospective Observational Study

acronym: AZITHROVID

summary:
During COVID-19 epidemic, hydroxychloroquine was proposed and authorized as a possible key agent in the treatment of COVID-19 hospitalized pneumonia, including in France. Gautret et al. proposed the combination regimen with azithromycin. However only one study reported the interest of azithromycin alone.

Retrospective study reporting the impact of the anti-infective agents used during the pandemic in a tertiary care hospital, using azithromycin with or without hydroxychloroquine.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Does Therapeutic Education Improve Heart Failure Patient Quality of Life?

acronym: ETIC

summary:
Use lay language. Background: Heart failure is an increasingly frequent current pathology due to the population aging and the improvement of acute and chronic heart failure management. Heart failure patients have a poor quality of life because of their symptoms (asthenia, dyspnea…) and frequent hospitalizations. Heart failure is an expensive disease: 1.5 % of the health expenses, 85 % in hospital cost with 200 000 hospitalizations in France per year. Previous studies were multidisciplinary interventions and not realistic in a daily practice for a general practitioner. The aim of this project is to integrate therapeutic education for heart failure patients in a current practice. The patient becomes competent to manage his disease and to identify acute heart failure signs.

Main objective: Improve therapeutic education efficiency on life quality of heart failure patients in general practice.

Second objectives: Describe heart failure patient's hospitalizations.

Methods: Cluster randomized controlled clinical trial comparing intervention and control groups with a follow through for 19 months for each patient. A therapeutic education program will be proposed to the heart failure patients in primary care. The intervention group GP will follow a workshop concerning the therapeutic education concepts and the intervention.

Endpoints: Life quality evaluation (SF-36 and Minnesota scales) and number of hospitalizations of patients in each group.

Population: Heart failure patients in stages I, II, and III of NYHA in primary care. Cluster randomized surgeries in Auvergne (France).

Expected results: The therapeutic education allows the patients to improve their quality of life, to be able to detect their illness signs worsening in a early manner, and to contact their doctor if needed. This would limit the acute heart failure due to treatment adaptation or life habits.

ReferenceCitation: Vaillant-Roussel H, Laporte C, Pereira B, De Rosa M, Eschalier B, Vorilhon C, Eschalier R, Clément G, Pouchain D, Chenot JF, Dubray C, Vorilhon P. Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial. BMC Fam Pract. 2016 Jul 19;17:80. doi: 10.1186/s12875-016-0473-4.

family: Vaillant-Roussel

full_name: Hélène Vaillant-Roussel

given: Hélène

full_name: Catherine Laporte

given: Catherine

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: De Rosa

full_name: Marion De Rosa

given: Marion

family: Eschalier

full_name: Bénédicte Eschalier

given: Bénédicte

family: Vorilhon

full_name: Charles Vorilhon

given: Charles

full_name: Romain Eschalier

given: Romain

family: Clément

full_name: Gilles Clément

given: Gilles

family: Pouchain

full_name: Denis Pouchain

family: Chenot

full_name: Jean-François Chenot

given: Jean-François

family: Dubray

full_name: Claude Dubray

given: Claude

full_name: Philippe Vorilhon

currency_apc_doaj: GBP

journal_name: BMC Family Practice

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Vaillant-Roussel H, Laporte C, Pereira B, Tanguy G, Cassagnes J, Ruivard M, Clément G, Le Reste JY, Lebeau JP, Chenot JF, Pouchain D, Dubray C, Vorilhon P. Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial. BMC Fam Pract. 2014 Dec 24;15:208. doi: 10.1186/s12875-014-0208-3.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand


title: Prevention of Cardio-embolic Stroke Using Anti-vitamin K and Direct Oral Anticoagulants. A Model of Action in Burgundy.

acronym: AOD

summary: Stroke is a major public health problem as it is very frequent (140,000 cases/year in France), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading cause of handicap). Ischemic cardio-embolic stroke accounts for around 25% of ischemic strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial fibrillation (CAAF) is the leading non-atheromatous cause. The aim of this study is to optimise the secondary prevention of CAAF-related stroke identified at the University Hospital of Dijon Burgundy in the framework of the recommendations of the '2010-2014 stroke plan' and the Compulsory Consultation at the 6th month (Directive DGOS//2015/262 of the 3rd August 2015)


title: Benefit of Carbohydrate Deficient Transferrin to Detect Chronic Alcohol Abuse in the Elderly. A French Multicentered Prospective Interventional Study.

acronym: Caesar

summary:
Alcohol misuse affects 5 million people in France. Even though the elderly are also concerned by this pathology, there is not much information about chronic alcohol misuse of this population in particular.

Biological markers like gamma-glutamyltranspeptidase (GGT), mean corpuscular volume (MCV) and carbohydrate deficient transferrin (CDT) are usually used to detect alcohol abuse. As a biological marker of alcohol misuse, the specificity of the CDT is known to be superior to the GGT as well.

However, when it comes to the elderly, alcoholism diagnosis tools are based on research of younger populations.

This study aims to evaluate the benefit of the CDT to detect chronic alcohol use in the elderly.

ReferenceCitation: Henni A, Bideau C, Routon X, Berrut G, Cholet J. [Prevalence and issues of screening for alcohol consumption among elderly inpatients admitted to acute geriatric inpatient unit]. Geriatr Psychol Neuropsychiatr Vieil. 2013 Mar;11(1):33-41. doi: 10.1684/pnv.2013.0397. French.

ReferenceCitation: Mundle G, Ackermann K, Munkes J, Steinle D, Mann K. Influence of age, alcohol consumption and abstinence on the sensitivity of carbohydrate-deficient transferrin, gamma-glutamyltransferase and mean corpuscular volume. Alcohol Alcohol. 1999 Sep-Oct;34(5):760-6.

ReferenceCitation: Hermansson U, Helander A, Huss A, Brandt L, Rönnberg S. The Alcohol Use Disorders Identification Test (AUDIT) and carbohydrate-deficient transferrin (CDT) in a routine workplace health examination. Alcohol Clin Exp Res. 2000 Feb;24(2):180-7.

ReferenceCitation: Anton RF, Lieber C, Tabakoff B; CDTect Study Group. Carbohydrate-deficient transferrin and gamma-glutamyltransferase for the detection and monitoring of alcohol use: results from a multisite study. Alcohol Clin Exp Res. 2002 Aug;26(8):1215-22.

ReferenceCitation: Schwan R, Albuisson E, Malet L, Loiseaux MN, Reynaud M, Schellenberg F, Brousse G, Llorca PM. The use of biological laboratory markers in the diagnosis of alcohol misuse: an evidence-based approach. Drug Alcohol Depend. 2004 Jun 11;74(3):273-9.

ReferenceCitation: Allen JP, Litten RZ, Anton RF, Cross GM. Carbohydrate-deficient transferrin as a measure of immoderate drinking: remaining issues. Alcohol Clin Exp Res. 1994 Aug;18(4):799-812. Review.

ReferenceCitation: Bortolotti F, De Paoli G, Tagliaro F. Carbohydrate-deficient transferrin (CDT) as a marker of alcohol abuse: a critical review of the literature 2001-2005. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Sep 1;841(1-2):96-109. Epub 2006 May 24. Review.

ReferenceCitation: Salaspuro M. Carbohydrate-deficient transferrin as compared to other markers of alcoholism: a systematic review. Alcohol. 1999 Nov;19(3):261-71. Review.

ReferenceCitation: WHO Expert Committee on Problems Related to Alcohol Consumption. WHO Expert Committee on Problems Related to Alcohol Consumption. Second report. World Health Organ Tech Rep Ser. 2007;(944):1-53, 55-7, back cover.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

location_facility:
Reseau d'Appui aux Generalistes (RAG)
GHRMSA


title: A FRENCH SURVEY OF THE DIAGNOSTIC AND THERAPEUTIC MANAGEMENT OF ELDERLY PEOPLE WITH HISTOLOGICALLY/CYTOLOGICALLY CONFIRMED LUNG CANCER.

summary: Management of lung cancer remains very controversial for elderly patients (pts) and they are often excluded from clinical trials. We present here a survey performed about the management of lung cancer pts aged 70 or more in France. All pts aged 70 or more with histo/cytologically proved lung cancer diagnosed between sept 02 and oct 03 in participating centers were recorded and their characteristics, the diagnostic procedures, therapeutic management and survival were analysed.


title: CESIR-U2 : Influence of Drugs Use and Health Status

summary:
In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram.

When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization > 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance.

This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility.

This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization < 24 hours) that represent around 73% of accidents.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Pellegrin
CH de Perigueux


title: Study of the Value of Using a Honey Dressing Compared to the Use of a Standard Dressing on the Toe Amputation Wound in the Diabetic Patient

acronym: MELIDIAB

summary:
Numerous scientific publications in France and internationally have described the healing, anti-bacterial, anti-oxidant, anti-inflammatory and immuno-modulating properties of honey.

Honey is effective in the management of many infected or uninfected post-surgical wounds.

This study focuses on post surgical wounds after toe amputation in diabetic patients.

The main objective of this study is to compare the rate of epidermisation at six months for these wounds, between honey dressing and other dressing devices used according to the french Haute Autorité de Santé (HAS) recommendations

lead_sponsor: Centre Hospitalier Metropole Savoie


title: Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers to the Optimal Care Pathway for Parkinson Disease Patients

acronym: ECOSO-ICAREPD

summary:
According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients.

It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Toulouse


title: Performances of Immunoassays Based on the Detection of Antibodies Directed Against Mycobacterium Tuberculosis Antigen for the Diagnosis of Active Tuberculosis in Adults

acronym: MycoTB

summary: TB remains a health problem in France with about 5,000 new cases per year. Development of new screening tests is a priority for TB. The main objective of the study is to evaluate performances of innovative blood tests to identify active tuberculosis in adults patients living in low-prevalence country. Adult patients with possible TB from will be tested for the presence of antibodies directed against M. tuberculosis selected antigens. Positive and negative predictive values will be established based on TB culture results.

location_facility: University Hospital Montpellier Department of microbiology


title: CHEMO RESISTANCE TO PLATINUM COMPOUNDS AND NOTCH PATHWAYS IN PATIENTS RECEIVING NEOADJUVANT CHEMOTHRERAPY FOR LOCALLY ADVANCED ADENOCARCINOMA OF THE LUNG.

acronym: NOTCH

summary: Every year in France, 30.000 deaths are due to lung cancer and 39.500 new cases of this disease are diagnosed (INCa 2014). Patients suffering from locally advanced non-small-cell lung cancer (NSCLC), stage IIIa, usually undergo a multimodality treatment including chemotherapy with platinum compounds before surgery (called neoadjuvant chemotherapy or induction chemotherapy). The reason of this combined modality treatment is the really poor prognosis of patients presenting a disease already spread to lymph nodes (classified N2 when the lymph node under the carina is affected). Up till now, the five-year survival of patients who underwent surgical resection of N2 NSCLC does not exceed 15%


title: Effects of a Multidisciplinary Outpatient Rehabilitation Program on Physical Capacity and Quality of Life in Patients With Ehlers-Danlos Syndrome.

summary: The management of patients with Ehlers-Danlos syndrome (EDS) is still underdeveloped in healthcare institutions in France. Although multidisciplinary management through exercise rehabilitation has demonstrated its benefits in many chronic pathologies, it has not been evaluated for EDS. As a result, to date there is no evidence of its effectiveness in patients with EDS. The objective of this study is therefore to objectively evaluate the effectiveness of such a treatment on the different dimensions of these patients' health.

status: Enrolling by invitation

lead_sponsor: Hakimi Adrien


title: Evaluation of the Effects of LUNII on Pre-operative Anxiety and on the Post-operative Period in Children With Cleft Lip and Palate Admitted for Alveolar Bone Graft: Pilot Study

acronym: LUNII

summary:
The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.

The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Adjustment of Adopted Adolescents in Their Families

acronym: EEAA

summary: The adjustment of adopted adolescents has been studied in the U.S. and England, but few other European countries have conducted research into this topic. As countries differ greatly in their cultural practices, a comparative study of the adjustment of internationally adopted teenagers in 4 European countries (France, Italy, Spain, Norway) is planned. The adjustment of teens and their families will be studied in relation to the openness of communication related to adoption within the families.

lead_sponsor: Centre Hospitalier St Anne


title: Cardiac Biomarkers and Mortality in Critically Ill Patients With SARS-CoV-2 (COVID-19) : COROBIOCHIC

acronym: COROBIOCHIC

summary:
Objective: To assess the prognostic value of high-sensitive cardiac troponin T (hs-cTnT) and N-terminal pro brain natriuretic peptide (NT-proBNP) at ICU admission in patients with coronavirus disease 2019 (COVID-19).

Design: Multicenter retrospective observational cohort study Setting: Three ICUs at three hospitals in Occitanie, France. Patients: Adults (≥ 18 years old) with laboratory-confirmed COVID-19 and at least one hs-cTnT measurement at ICU admission, from March 9, 2020, to May 9, 2020.

lead_sponsor: University Hospital, Montpellier


title: Single-center Study, Transversal, Controlled and Not Randomized, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women

summary: In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility remains " unexplained" . Among the causes of female infertility , there are the eating disorders, as well as sexual disorders , these two cases may be linked. In addition, data from the literature seem to suggest that beyond a diagnosis of eating disorders, the feeding behavior of infertile women is more often disturbed than the general population. Moreover, the notions of desire for a child and maternal representations seem essential to address in the comprehensive care of women with infertility but also TCA integrating all conflicting issues reactivated at the time of motherhood. However, little work has been done on this subject. Thus, we propose a study on the desire for children and the eating disorders to infertile women, to update epidemiological data, but also to better characterize this particular patient population. Perspectives of this work are to improve screening measures and support through a joint work of doctors reproductive and psychiatrists.

lead_sponsor: Nantes University Hospital


title: Concordance of Capillary Blood Biological Samples Analyzed in Delocalized Biology With Conventional Venous Biological Blood Samples Analyzed at the Biology Laboratory

acronym: CAPIVEIN

summary: The main objectives are to evaluate the concordance between the results of natremia, kalaemia and blood sugar levels obtained 1) by capillary puncture, analysed on a delocalized resuscitation machine GEM 4000 (Werfen) and 2) by venous sampling, analysed on the machine of the standard biology laboratory Gen. 2 COBAS (Roche).

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting

acronym: NEPAL

summary:
The frequency of neurological and psychiatric complaints for participants taking rilpivirine, elvitegravir, or dolutegravir reaches on average 20-30% during clinical trials. The inclusion and exclusion criteria for enrolling people living with HIV are at times so selective and the subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and ambiguous that one cannot extrapolate these particular research results to practicing medicine. These adverse events negatively affect the patient's quality of life and ultimately his or her good adherence to treatments.

This study aims at assessing the prevalence and at describing the neurological and psychiatric adverse events related to these drugs.


title: Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen

acronym: QUATTROTURBO

summary:
ANRS HC 33 is a pilot study to assess efficacy and safety of a DCV 3DAA therapy with Asunaprevir, Daclatasvir and BMS-791325 in HCV genotype 4-infected patients after failure of pegylated Interferon-Ribavirin regimen.

Proportion of patients with cirrhosis will be limited to 50% of all patients included, cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse elastometry ≥ 14 kPa or a Fibrotest® result > 0,75.

status: Withdrawn

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Bio-clinical Evolutive Dynamic in Patients Suffering From Communitary Septic Shock (Biosepsis)

acronym: BIOSEPSIS

summary: Septic shock is a frequent pathology responsible for over 30000 deaths/year in France. Its outcome has not been improved despite the knowledge on inflammatory processes; a reason for these lack of results may lay on the lack of data on the precise dynamics of inflammatory and anti-inflammatory cascades and their consequences. We intend to achieve accurate monitoring of the inflammatory process on a small group of non-immunocompromised patients. Our goal is to obtain quality data, repeated over time, by limiting the technical variability.

lead_sponsor: University Hospital, Grenoble


title: Amélioration Des Techniques d'étude de la Micro-cirulation cutanée Chez Des Sujets Sains

acronym: MICROTEC

summary: Current stimulation induces microvascular dilation in human skin. The investigators aimed to study (1) whether the current vasodilation is amplified after two segmental current stimulation as compared to one stimulation; (2) whether this amplification relies on prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover trial is conducted in Angers, France.

primary_purpose: Basic Science

ReferenceCitation: Mahé G, Abraham P, Humeau-Heurtier A, Gascoin L, Lefthériotis G, Durand S. Evidence for a vasomotor cyclo-oxygenase dependent mechanism of sensitization at the cutaneous level. Br J Clin Pharmacol. 2015 Aug;80(2):185-92. doi: 10.1111/bcp.12623. Epub 2015 May 26.

name: Biologie Neurovasculaire et Mitochondriale Intégrée (BNMI) - Unité mixte UMR CNRS 6214 / INSERM U 1083; Faculté de Médecine; Angers France

name: Laboratory of Vascular Investigations; University Hospital of Angers; France

name: CHU Rennes; Imagerie cœur-vaisseaux; F-35033 Rennes France

name: INSERM; Clinical Investigation Center CIC 1414; F-34043 Rennes France

name: Université de Rennes 1; F-34043 Rennes France

family: Mahé

full_name: G. Mahé

given: G.

family: Abraham

full_name: P. Abraham

given: P.

name: LARIS - Laboratoire Angevin de Recherche en Ingénierie des Systèmes; Université d'Angers; 62 avenue Notre-Dame du Lac 49000 Angers France

family: Humeau-Heurtier

full_name: A. Humeau-Heurtier

given: A.

family: Gascoin

full_name: L. Gascoin

given: L.

family: Lefthériotis

full_name: G. Lefthériotis

name: Université du Maine, EA 4334, Motricité, Interactions, Performance; LUNAM Université; Le Mans 72085 Cedex 9 France

family: Durand

full_name: S. Durand

given: S.

journal_name: British Journal of Clinical Pharmacology

oa_colors: green hybrid

evidence: open (via free article)

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

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

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Angers


title: Implementation of a National Register of Children and Adults Presenting Prader-Willi Syndrome

summary:
Prader-Willi Syndrome (PWS) is a rare syndrome with a prevalence of 15 to 20 000 at birth. PWS represents a large fraction of mental retardation syndromes due to a genetic cause and the most frequent cause of genetic obesity. The majority of the patients are seen by paediatricians. This syndrome is responsible for severe physical, psychological and social impairments.

The diversity and the severity of the manifestations of this disease explain the requirement of multidisciplinary care which deserve specific evaluation. Today the follow-up and management of a great proportion of these patients are greatly insufficient if not absent.

Teams strongly lack information on the natural history of this severe disease and on the factors involved in its evolution and the outcome of these patients throughout life. The present project is to implement a register in the whole country for children and adult patients

ReferenceCitation: Pacoricona Alfaro DL, Lemoine P, Ehlinger V, Molinas C, Diene G, Valette M, Pinto G, Coupaye M, Poitou-Bernert C, Thuilleaux D, Arnaud C, Tauber M. Causes of death in Prader-Willi syndrome: lessons from 11 years' experience of a national reference center. Orphanet J Rare Dis. 2019 Nov 4;14(1):238. doi: 10.1186/s13023-019-1214-2.

family: Pacoricona Alfaro

full_name: Dibia Liz Pacoricona Alfaro

given: Dibia Liz

family: Lemoine

full_name: Perrine Lemoine

given: Perrine

family: Ehlinger

full_name: Virginie Ehlinger

given: Virginie

family: Molinas

full_name: Catherine Molinas

family: Diene

full_name: Gwénaëlle Diene

given: Gwénaëlle

family: Valette

full_name: Marion Valette

family: Pinto

full_name: Graziella Pinto

given: Graziella

family: Coupaye

full_name: Muriel Coupaye

given: Muriel

family: Poitou-Bernert

full_name: Christine Poitou-Bernert

given: Christine

family: Thuilleaux

full_name: Denise Thuilleaux

given: Denise

family: Arnaud

full_name: Catherine Arnaud

family: Tauber

full_name: Maithé Tauber

given: Maithé

journal_name: Orphanet Journal of Rare Diseases

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

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

title: Causes of death in Prader-Willi syndrome: lessons from 11 years’ experience of a national reference center


title: Ibuprofen and Renal Function in Premature Infants

summary:
Purpose of the study:

To evaluate renal function maturation within the first month of life in very premature infants.
To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.

ReferenceCitation: Gournay V, Roze JC, Kuster A, Daoud P, Cambonie G, Hascoet JM, Chamboux C, Blanc T, Fichtner C, Savagner C, Gouyon JB, Flurin V, Thiriez G. Prophylactic ibuprofen versus placebo in very premature infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2004 Nov 27-Dec 3;364(9449):1939-44.

ReferenceCitation: Desandes R, Jellimann JM, Rouabah M, Haddad F, Desandes E, Boubred F, Semama DS, Vieux R, Hascoët JM. Echocardiography as a guide for patent ductus arteriosus ibuprofen treatment and efficacy prediction. Pediatr Crit Care Med. 2012 May;13(3):324-7. doi: 10.1097/PCC.0b013e31822882b5.

family: Desandes

full_name: Roxane Desandes

given: Roxane

family: Jellimann

full_name: Jean-Marc Jellimann

given: Jean-Marc

family: Rouabah

full_name: Mahmoud Rouabah

given: Mahmoud

family: Haddad

full_name: Fouad Haddad

given: Fouad

full_name: Emmanuel Desandes

given: Emmanuel

family: Boubred

full_name: Farid Boubred

given: Farid

family: Semama

full_name: Denis S. Semama

given: Denis S.

family: Vieux

full_name: Rachel Vieux

given: Rachel

family: Hascoët

full_name: Jean-Michel Hascoët

given: Jean-Michel

journal_name: Pediatric Critical Care Medicine

title: Echocardiography as a guide for patent ductus arteriosus ibuprofen treatment and efficacy prediction*

ReferenceCitation: Vieux R, Hascoet JM, Merdariu D, Fresson J, Guillemin F. Glomerular filtration rate reference values in very preterm infants. Pediatrics. 2010 May;125(5):e1186-92. doi: 10.1542/peds.2009-1426. Epub 2010 Apr 5.

family: Hascoet

full_name: Jean-Michel Hascoet

family: Merdariu

full_name: Dana Merdariu

given: Dana

family: Fresson

full_name: Jeanne Fresson

given: Jeanne

family: Guillemin

full_name: Francis Guillemin

given: Francis

journal_name: Pediatrics

publisher: American Academy of Pediatrics (AAP)

publisher_dissemination: American Academy of Pediatrics (AAP)

publisher_group: American Academy of Pediatrics (AAP)

publisher_normalized: American Academy of Pediatrics (AAP)

title: Glomerular Filtration Rate Reference Values in Very Preterm Infants

ReferenceCitation: Vieux R, Desandes R, Boubred F, Semama D, Guillemin F, Buchweiller MC, Fresson J, Hascoet JM. Ibuprofen in very preterm infants impairs renal function for the first month of life. Pediatr Nephrol. 2010 Feb;25(2):267-74. doi: 10.1007/s00467-009-1349-9. Epub 2009 Nov 10.

full_name: Denis Semama

given: Denis

location_facility:
CHU
Maternite Regionale Universitaire
AP-HM (Néonatologie)


title: Contribution du Cervelet Dans l'Adaptation Sensori-motrice Via Les Oscillations Gamma : le Cas de la Dystonie

acronym: GAMMA

summary: Dystonia, a disabling disease with uncontrolled movement disorders was considered to be a manifestation of basal ganglia dysfunction, yet there is accumulating evidence from animal and human experiments that the cerebellum plays a prominent role in the pathophysiology of dystonia. Our recent results suggest a deficient cerebellar sensory encoding in dystonia, resulting in a decoupling of the motor component from the afferent information flow resulting from changes in the environment. An overall loss of gabaergic-mediated inhibition is at the forefront in dynamic changes in neural circuitry described in dystonia. In the mature brain gabaergic control the generation of temporal synchronies and oscillations in the glutamatergic neurons. Taken these all together with the results of a pilot experiment, the investigators hypothesize that deficient synchronies in the fast gamma range are one of the key mechanisms leading to abnormal communication inside the cerebello-cortical network in dystonia. The investigators aim first to demonstrate it by means of MEG (Magneto encepholography) recordings allowing to reconstruct the spatio-temporal dynamics of gamma oscillations in the nodes of the cerebello-cortical network. The investigators then aim to re-establish (if lost) or boost (if decreased) the defective synchronies by applying to the cerebellum at high gamma frequency a non invasive transcranial alternative current stimulation.

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


title: Study of the Impact of an Intervention Performed by a Clinical Pharmacist on Patients at Risk of Pneumococcal Infection at the End of Hospitalization

acronym: IP-VAC

summary:
In France, Streptococcus pneumoniae is the leading agent involved in community-acquired bacterial pneumopathies and bacterial meningitis. The frequency of these infections is increasing in at-risk subjects. Paradoxically, pneumococcal vaccination coverage in this type of patient is limited at the national level, even though the French High Council for Public Health (HCSP) has been extending the 13-valent conjugate and 23-valent non-conjugate double vaccination in this target population since March 2017.

These patients generally benefit from regular medical follow-up involving several health professionals in hospital or outpatient clinics. In spite of this, one of the factors identified as a hindrance to pneumococcal vaccination is the absence of a proposal from the doctor.

We would like to assess compliance with the recommendations for pneumococcal vaccination according to the High Council of Public Health (HCSP) in at-risk patients leaving hospital. We also wish to measure the potential impact of an intervention by the clinical pharmacist on the application of these recommendations.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry

acronym: DREPAMASSE

summary:
Three methods are actually used in newborn screening for sickle cell disease (SCD) in France: isoelectric focusing, high performance liquid chromatography and capillary electrophoresis. New technologies are currently under development such as Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS) using the SpOtOn Diagnostics Reagent Kit available in United Kingdom only.

Zentech company (Liège, Belgium) is developing a package for SCD newborn screening using MS/MS technology. The main objective of the present study will be to compare this new technique with the technique actually used in the hospital center of Lille (sub-contractor for SCD newborn screening of Lyon) and the haemoglobin analysis to test its accuracy (sensitivity and specificity).

lead_sponsor: Hospices Civils de Lyon

location_facility: Groupement Hospitalier Est - Hospices Civils de Lyon


title: Evaluation of the Satisfaction of Patients With Conization Under Local Anesthesia, Prospective Study

acronym: ESCAL

summary:
In France, screening involves a routine test of papanicolaou in women aged 25 to 65 years. In the case of an abnormal Pap smear discovery, the diagnostic strategy is based in most cases in colscopy to allow cervical biopsies if necessary to obtain a histological diagnosis of high quality cervical intraepithelial neoplasia (CIN) (2- 3) which, if persistent, can cause cervical cancer. Their results, also in the case of the persistence of a low-level lesion or of a cyto-histological discordance, indicate conization. Conization is a procedure performed by resection of the diathermic grip, allowing a simple and fast gesture compatible with a load under local anesthesia. In order to simplify the overall cost of the patient, more and more conizations of Montpellier and Nimes take place under local anesthesia. .

The main objective of our study is to evaluate the overall satisfaction of patients in the case of conisation under local anesthesia.

The goal is to promote local anesthesia for the management of congested patients, which simplifies overall management, reduces cost and reduces complications associated with general anesthesia.


title: Accelerometers' Validity in Counting Number of Steps in the Elderly Subjects Before Discharge From Rehabilitation Units, Having Reached Their Maximal Walking Ability After Physiotherapy. Comparison of the Accuracy of 3 Accelerometer Positions: Wrist, Ankle, Hip

acronym: VAPODAGE

summary: Accelerometers enhance physical activity. Nevertheless, their validity (ability to accurately count steps) is not known in an elderly frail population ready for discharge from a rehabilitation unit. The objective was to assess accelerometers' validity for counting steps (10 meters), in comparison with the gold standard: steps counted by 2 physicians blind to accelerometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). The second objective was to evaluate the best position of the accelerometer: wrist, ankle, hip.


title: Impact of the Covid-19 Pandemic on the Epidemiology of Respiratory Syncytial Virus

acronym: IPCoVRS

summary: The magnitude of seasonal RSV epidemics brings each year new logistical challenges for the hospitalization of young infants with bronchiolitis that overwhelm hospital capacities and lead to specific winter plans with deprogramming and mobilization of human and logistical resources. The Covid-19 pandemic has changed the way winter epidemics are presented. For example, the seasonal RSV epidemic was shifted by several months in Lyon, with an impression of a lower incidence of hospitalized cases, with a population of older children and with fewer signs of clinical severity. This is largely attributable to the widespread use of barrier gestures and social distancing measures, known as "non-pharmacological interventions" or NPI. Given the magnitude of the reduction of the RSV epidemic, it is legitimate to analyze the benefits of NPIs to draw lessons for maintaining preventive measures around RSV-vulnerable populations; moreover, new preventive pharmacological interventions are soon to be marketed, whether they are particularly refined and long half-life anti-RSV monoclonal antibodies, RSV vaccines for mothers or for newborns and infants. In this perspective, it is crucial to properly define the populations at risk of severe disease to establish a legitimate hierarchy in the implementation of different preventive strategies. The study of the RSV epidemic is a high potential model because of the convergence of epidemiological, virological, and pharmacological knowledge. However, the study of the impact of the pandemic on the epidemiology of rhinovirus also seems promising because, for reasons unknown to date, it seems that the pandemic did not have the same reducing impact on the rhinovirus epidemic; in the latter case, the interest is to confirm the resistance of this virus and to look for more fundamental explanations, for example, on viral interactions.

ReferenceCitation: Casalegno JS, Ploin D, Cantais A, Masson E, Bard E, Valette M, Fanget R, Targe SC, Myar-Dury AF, Doret-Dion M, Massoud M, Queromes G, Vanhems P, Claris O, Butin M, Pillet S, Ader F, Bin S, Gaymard A, Lina B, Morfin F; VRS study group in Lyon, Javouhey E, Gillet Y. Characteristics of the delayed respiratory syncytial virus epidemic, 2020/2021, Rhône Loire, France. Euro Surveill. 2021 Jul;26(29). doi: 10.2807/1560-7917.ES.2021.26.29.2100630.

apc_source: doaj

name: Université Claude Bernard Lyon 1, Lyon, France

name: Centre International de Recherche en Infectiologie (CIRI), Laboratoire de Virologie et Pathologie Humaine - VirPath Team, INSERM U1111, CNRS UMR5308, École Normale Supérieure de Lyon, Lyon, France

name: Centre national de référence des virus des infections respiratoires (dont la grippe), Hôpital de la Croix-Rousse, Lyon, France

name: Hospices Civils de Lyon, Hôpital de la Croix-Rousse, Centre de Biologie Nord, Institut des Agents Infectieux, Laboratoire de Virologie, Lyon, France

family: Casalegno

full_name: Jean-Sebastien Casalegno

given: Jean-Sebastien

name: Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Service de Réanimation Pédiatrique et d’Accueil des Urgences, Bron, France

family: Ploin

full_name: Dominique Ploin

given: Dominique

name: Groupe Immunité des Muqueuses et Agents Pathogènes (GIMAP) EA-3064, Faculté de Médecine de Saint-Etienne, Campus Santé-Innovations de Saint-Etienne, Saint-Priest-en-Jarez, France

name: Centre Hospitalier Universitaire de Saint-Étienne, Service des Urgences Pédiatriques, Saint-Priest-en-Jarez, France

family: Cantais

full_name: Aymeric Cantais

given: Aymeric

family: Masson

full_name: Elsa Masson

given: Elsa

family: Bard

full_name: Emilie Bard

given: Emilie

family: Valette

full_name: Martine Valette

given: Martine

family: Fanget

full_name: Remi Fanget

given: Remi

name: Hospices Civils de Lyon, Département d’Information Médicale, Lyon, France

family: Targe

full_name: Sandrine Couray Targe

given: Sandrine Couray

family: Myar-Dury

full_name: Anne-Florence Myar-Dury

given: Anne-Florence

name: Hospices Civils de Lyon, Service de Gynécologie-Obstétrique, Hôpital Femme-Mère-Enfant, Bron, France

family: Doret-Dion

full_name: Muriel Doret-Dion

given: Muriel

family: Massoud

full_name: Mona Massoud

given: Mona

family: Queromes

full_name: Gregory Queromes

given: Gregory

name: Centre International de Recherche en Infectiologie (CIRI), Public Health, Epidemiology and Evolutionary Ecology of Infectious Diseases (PHE3ID) INSERM U1111, CNRS UMR5308, École Normale Supérieure de Lyon, Lyon, France

name: Hospices Civils de Lyon, Centre Hospitalier Édouard Herriot, Service Hygiène, Épidémiologie et Prévention, Lyon, France

family: Vanhems

full_name: Philippe Vanhems

given: Philippe

name: Hospices Civils de Lyon, Hôpital Femme-Mère-Enfant, Service de Néonatologie et de Réanimation Néonatale, Bron, France

family: Claris

full_name: Olivier Claris

given: Olivier

name: Hospices Civils de Lyon, Pôle IMER, Unité de Recherche Clinique, Lyon, France

family: Butin

full_name: Marine Butin

given: Marine

name: Centre Hospitalier Universitaire de Saint-Étienne, Laboratoire de Virologie, Saint-Priest-en-Jarez, France

family: Pillet

full_name: Sylvie Pillet

given: Sylvie

name: Hospices Civils de Lyon, Hôpital de la Croix-Rousse, Service des Maladies Infectieuses et Tropicales, Lyon, France

family: Ader

full_name: Florence Ader

given: Florence

family: Bin

full_name: Sylvie Bin

family: Gaymard

full_name: Alexandre Gaymard

given: Alexandre

family: Lina

full_name: Bruno Lina

given: Bruno

family: Morfin

full_name: Florence Morfin

family: Javouhey

full_name: Etienne Javouhey

given: Etienne

family: Gillet

full_name: Yves Gillet

given: Yves

publisher: European Centre for Disease Control and Prevention (ECDC)

location_facility: Groupement Hospitalier EST - Hospices Civils de Lyon


title: PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor: a Prospective, Randomized Monocentric Clinical Trial

acronym: PREMAPESSAIRE

summary:
In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases.

After 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%.

A pessary is a silicone ring encircling the cervix. It was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies.

The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective.

To evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened preterm labor.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders

acronym: HATS

summary: Several epidemiological studies in large cohorts suggest a strong association between sleep duration, complaint of insomnia and risk of hypertension.These findings suggest an important role of sleep quality in development of hypertension. Principal limitations of these studies are the cross-sectional study design, self-report sleep duration and poor measurement of blood pressure. The investigators propose to study an insomniac population with complete evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement of hypertension.

time_perspective: Other

location_facility: centre du sommeil et de la vigilance, Hotel Dieu


title: Alcohol and Women : Screening in General Medicine.

summary: The alcohol consumption of adults has been decreasing in France since the sixties. When focusing on the particular case of women, this trend goes on the opposite direction. In addition, the impact of drinking alcohol involves an increased severity in women in comparison to men. Furthermore, women consult less often doctors about their alcohol problem due to stigmatisation. Finally, as alcohol consumption is a major public health issue (second preventable cause of death), the aim of this study is to propose an earlier screening of women with alcohol use disorders (AUD) in general medicine.


title: Incidence and Characteristics of Pulmonary Embolism in COVID-19 Patients Hospitalized for Acute Respiratory Syndrome

acronym: COVID-EP

summary:
Multicentric case-control study that is aims at:

evaluating the prevalence of pulmonary embolism among a large population of consecutive patients admitted for COVID-19 pneumonia into two large university hospitals in Paris, France: Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and Hôpital Européen Georges Pompidou (HEGP)
and identifying the characteristics associated with pulmonary embolism by using a nested case control study design within the patients who underwent either unenhanced computed tomograpghy (CT) or CT pulmonary angiogram (CTPA) evaluation.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

name: From the State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (W.G., W.L., J.H., R.C., C.T., T.W., S.L., Jin-lin Wang, N.Z., J.H., W.L.), the Departments of Thoracic Oncology (W.L.), Thoracic Surgery and Oncology (J.H.), and Emergency Medicine (Z.L.), First Affiliated Hospital of Guangzhou Medical University, and Guangzhou Eighth People’s Hospital,...

family: Guan

full_name: Wei-jie Guan

given: Wei-jie

family: Ni

full_name: Zheng-yi Ni

given: Zheng-yi

family: Hu

full_name: Yu Hu

given: Yu

family: Liang

full_name: Wen-hua Liang

given: Wen-hua

family: Ou

full_name: Chun-quan Ou

given: Chun-quan

family: He

full_name: Jian-xing He

given: Jian-xing

family: Liu

full_name: Lei Liu

given: Lei

family: Shan

full_name: Hong Shan

given: Hong

family: Lei

full_name: Chun-liang Lei

given: Chun-liang

family: Hui

full_name: David S.C. Hui

given: David S.C.

family: Du

full_name: Bin Du

given: Bin

family: Li

full_name: Lan-juan Li

given: Lan-juan

family: Zeng

full_name: Guang Zeng

given: Guang

family: Yuen

full_name: Kwok-Yung Yuen

given: Kwok-Yung

family: Chen

full_name: Ru-chong Chen

given: Ru-chong

family: Tang

full_name: Chun-li Tang

given: Chun-li

family: Wang

full_name: Tao Wang

given: Tao

full_name: Ping-yan Chen

given: Ping-yan

family: Xiang

full_name: Jie Xiang

given: Jie

full_name: Shi-yue Li

given: Shi-yue

full_name: Jin-lin Wang

given: Jin-lin

full_name: Zi-jing Liang

given: Zi-jing

family: Peng

full_name: Yi-xiang Peng

given: Yi-xiang

ReferenceCitation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.

ReferenceCitation: Baden LR, Rubin EJ. Covid-19 - The Search for Effective Therapy. N Engl J Med. 2020 May 7;382(19):1851-1852. doi: 10.1056/NEJMe2005477. Epub 2020 Mar 18.

ReferenceCitation: Chen T, Wu D, Chen H, Yan W, Yang D, Chen G, Ma K, Xu D, Yu H, Wang H, Wang T, Guo W, Chen J, Ding C, Zhang X, Huang J, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study. BMJ. 2020 Mar 26;368:m1091. doi: 10.1136/bmj.m1091. Erratum in: BMJ. 2020 Mar 31;368:m1295.

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

name: Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Pulmonary Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Infectious Disease, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Emergency Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

title: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Tang N, Li D, Wang X, Sun Z. Abnormal coagulation parameters are associated with poor prognosis in patients with novel coronavirus pneumonia. J Thromb Haemost. 2020 Apr;18(4):844-847. doi: 10.1111/jth.14768. Epub 2020 Mar 13.

ReferenceCitation: Han H, Yang L, Liu R, Liu F, Wu KL, Li J, Liu XH, Zhu CL. Prominent changes in blood coagulation of patients with SARS-CoV-2 infection. Clin Chem Lab Med. 2020 Jun 25;58(7):1116-1120. doi: 10.1515/cclm-2020-0188.

ReferenceCitation: Tang N, Bai H, Chen X, Gong J, Li D, Sun Z. Anticoagulant treatment is associated with decreased mortality in severe coronavirus disease 2019 patients with coagulopathy. J Thromb Haemost. 2020 May;18(5):1094-1099. doi: 10.1111/jth.14817. Epub 2020 Apr 27.

ReferenceCitation: Marietta M, Ageno W, Artoni A, De Candia E, Gresele P, Marchetti M, Marcucci R, Tripodi A. COVID-19 and haemostasis: a position paper from Italian Society on Thrombosis and Haemostasis (SISET). Blood Transfus. 2020 May;18(3):167-169. doi: 10.2450/2020.0083-20. Epub 2020 Apr 8.

ReferenceCitation: Akima S, McLintock C, Hunt BJ. RE: ISTH interim guidance to recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 Aug;18(8):2057-2058. doi: 10.1111/jth.14853. Epub 2020 Jul 15.

ReferenceCitation: Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH; Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950-2973. doi: 10.1016/j.jacc.2020.04.031. Epub 2020 Apr 17. Review.

ReferenceCitation: Oudkerk M, Büller HR, Kuijpers D, van Es N, Oudkerk SF, McLoud T, Gommers D, van Dissel J, Ten Cate H, van Beek EJR. Diagnosis, Prevention, and Treatment of Thromboembolic Complications in COVID-19: Report of the National Institute for Public Health of the Netherlands. Radiology. 2020 Oct;297(1):E216-E222. doi: 10.1148/radiol.2020201629. Epub 2020 Apr 23.

ReferenceCitation: Léonard-Lorant I, Delabranche X, Séverac F, Helms J, Pauzet C, Collange O, Schneider F, Labani A, Bilbault P, Molière S, Leyendecker P, Roy C, Ohana M. Acute Pulmonary Embolism in Patients with COVID-19 at CT Angiography and Relationship to d-Dimer Levels. Radiology. 2020 Sep;296(3):E189-E191. doi: 10.1148/radiol.2020201561. Epub 2020 Apr 23.

ReferenceCitation: Grillet F, Behr J, Calame P, Aubry S, Delabrousse E. Acute Pulmonary Embolism Associated with COVID-19 Pneumonia Detected with Pulmonary CT Angiography. Radiology. 2020 Sep;296(3):E186-E188. doi: 10.1148/radiol.2020201544. Epub 2020 Apr 23.

ReferenceCitation: Poissy J, Goutay J, Caplan M, Parmentier E, Duburcq T, Lassalle F, Jeanpierre E, Rauch A, Labreuche J, Susen S; Lille ICU Haemostasis COVID-19 Group. Pulmonary Embolism in Patients With COVID-19: Awareness of an Increased Prevalence. Circulation. 2020 Jul 14;142(2):184-186. doi: 10.1161/CIRCULATIONAHA.120.047430. Epub 2020 Apr 24.

ReferenceCitation: Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.

ReferenceCitation: Helms J, Tacquard C, Severac F, Leonard-Lorant I, Ohana M, Delabranche X, Merdji H, Clere-Jehl R, Schenck M, Fagot Gandet F, Fafi-Kremer S, Castelain V, Schneider F, Grunebaum L, Anglés-Cano E, Sattler L, Mertes PM, Meziani F; CRICS TRIGGERSEP Group (Clinical Research in Intensive Care and Sepsis Trial Group for Global Evaluation and Research in Sepsis). High risk of thrombosis in patients with severe SARS-CoV-2 infection: a multicenter prospective cohort study. Intensive Care Med. 2020 Jun;46(6):1089-1098. doi: 10.1007/s00134-020-06062-x. Epub 2020 May 4.

ReferenceCitation: Middeldorp S, Coppens M, van Haaps TF, Foppen M, Vlaar AP, Müller MCA, Bouman CCS, Beenen LFM, Kootte RS, Heijmans J, Smits LP, Bonta PI, van Es N. Incidence of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 2020 Aug;18(8):1995-2002. doi: 10.1111/jth.14888. Epub 2020 Jul 27.

ReferenceCitation: Lodigiani C, Iapichino G, Carenzo L, Cecconi M, Ferrazzi P, Sebastian T, Kucher N, Studt JD, Sacco C, Bertuzzi A, Sandri MT, Barco S; Humanitas COVID-19 Task Force. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020 Jul;191:9-14. doi: 10.1016/j.thromres.2020.04.024. Epub 2020 Apr 23.

ReferenceCitation: Revel MP, Parkar AP, Prosch H, Silva M, Sverzellati N, Gleeson F, Brady A; European Society of Radiology (ESR) and the European Society of Thoracic Imaging (ESTI). COVID-19 patients and the radiology department - advice from the European Society of Radiology (ESR) and the European Society of Thoracic Imaging (ESTI). Eur Radiol. 2020 Sep;30(9):4903-4909. doi: 10.1007/s00330-020-06865-y. Epub 2020 Apr 20.

ReferenceCitation: PROTECT Investigators for the Canadian Critical Care Trials Group and the Australian and New Zealand Intensive Care Society Clinical Trials Group, Cook D, Meade M, Guyatt G, Walter S, Heels-Ansdell D, Warkentin TE, Zytaruk N, Crowther M, Geerts W, Cooper DJ, Vallance S, Qushmaq I, Rocha M, Berwanger O, Vlahakis NE. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med. 2011 Apr 7;364(14):1305-14. doi: 10.1056/NEJMoa1014475. Epub 2011 Mar 22.

ReferenceCitation: Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Nicol P, Vicaut E, Turpie AG, Yusen RD; EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study. Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial. Ann Intern Med. 2010 Jul 6;153(1):8-18. doi: 10.7326/0003-4819-153-1-201007060-00004.

title: Extended-Duration Venous Thromboembolism Prophylaxis in Acutely Ill Medical Patients With Recently Reduced Mobility

ReferenceCitation: Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

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

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

title: Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients

ReferenceCitation: Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

repository_institution: The University of Queensland - Queensland's institutional digital repository

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

title: Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients

ReferenceCitation: Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM; APEX Investigators. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534-44. doi: 10.1056/NEJMoa1601747. Epub 2016 May 27.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: St George's University of London - St George's Online Research Archive


title: Collection and Analysis of the Clinical and Biological Characteristics of Patients Treated at Nîmes Carémeau University Hospital, for Giant Cells ARTEitis (Horton's Disease), for Diagnosis and During Long-term Follow-up

acronym: CARTECEL

summary:
Giant cell arteritis (GCA) or Horton's disease: frequent large vessel vasculitis (cephalic) (incidence estimated at 9 per 100,000 in France), potentially responsible for blindness.

Treatment: corticosteroid therapy, which is effective in the vast majority of cases.

Clinical problem: relapse; 36% to 44% of patients have a relapse that occurs in the first year for many patients, requiring a re-escalation of corticosteroid therapy, with its consequences:

Cumulative dose of corticosteroid therapy that causes cardiovascular and infectious morbidity.
Requires additional immunosuppressive treatment.


title: Metformin Use in Chronic Kidney Disease: The CKD-Met Study

acronym: CKD-Met

summary:
Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit.

Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD) patients.

The aim of the study is to describe the use and side-effects of metformin in CKD patients in routine practice.

ReferenceCitation: Coliche V, Koppe L, Laville M, Nouvier M, Pelletier S, Trolliet P, Fouque D. Metformin misuse in chronic kidney disease. Diabetes Metab. 2020 Sep;46(4):337-339. doi: 10.1016/j.diabet.2018.07.005. Epub 2018 Jul 24.

family: Coliche

full_name: V. Coliche

given: V.

family: Koppe

full_name: L. Koppe

given: L.

family: Laville

full_name: M. Laville

given: M.

family: Nouvier

full_name: M. Nouvier

family: Pelletier

full_name: S. Pelletier

given: S.

family: Trolliet

full_name: P. Trolliet

given: P.

family: Fouque

full_name: D. Fouque

given: D.

journal_name: Diabetes & Metabolism

location_facility: Claude Bernard University, Lyon, France, Lyon Sud university hospital