title: Epidemiology of Technical Procedures for the Treatment of Hepatocellular Carcinoma: Country-wide Trends From 2009 to 2019

summary:
In France, as in most countries, the incidence of primary liver cancer has increased significantly since the 1980s. In the United States, a study estimating cancer incidence and mortality rates in the coming years predicts that primary liver cancer will become the 3rd leading cause of cancer death from 2030 onwards, behind lung and pancreatic cancer, but ahead of colorectal cancer. This increase in incidence could be explained on the one hand by an increase in the incidence of chronic liver diseases, particularly those related to alcohol and metabolic steatopathies in the West, and on the other hand by improved management of the consequences of cirrhotic disease, which in turn increases the time needed for hepatocellular carcinoma (HCC) to form and develop. The management of a patient with hepatocellular carcinoma is complex because of the underlying cirrhotic disease, which hinders the development of many therapies. Thus, the patient's prognosis depends as much on the tumour extension as on the severity of the underlying chronic liver disease, and the choice of appropriate treatment is based on optimizing the balance between maximum antitumor efficacy and limited liver toxicity.

It is in this context that minimally invasive technical acts, whether local or local-regional, have developed significantly in recent years. Percutaneous tumor destruction techniques have become highly diversified with the development of microwave ablatherm, multipolar radiofrequency, or irreversible electroporation. For intra-arterial treatments, hepatic arterial chemoembolization remains the reference treatment for BCLC B stages. Alongside it, Yttrium 90 radio-embolization is booming, although its precise place remains to be defined in the therapeutic arsenal. Surgical techniques have also progressed, with the development of laparoscopic resections and improved liver transplant management. Finally, external radiotherapy is a recourse solution that can make it possible to propose a therapeutic solution in selected patients.

This multidisciplinary management of the HCC is in constant evolution and improvement, which justifies regularly carrying out an inventory of the frequency of these various technical acts at the national level. The objective of our study is to analyze the evolution, over the last 10 years and at a national level, of the various technical procedures available in the HCC therapeutic arsenal based on data from the french national PMSI database.

ReferenceCitation: Cassinotto C, Nogue E, Morell M, Panaro F, Molinari N, Guiu B. Changing trends in hepatocellular carcinoma management: Results from a nationwide database in the last decade. Eur J Cancer. 2021 Mar;146:48-55. doi: 10.1016/j.ejca.2021.01.009. Epub 2021 Feb 11.

family: Cassinotto

full_name: Christophe Cassinotto

family: Nogue

full_name: Erika Nogue

given: Erika

family: Morell

full_name: Mathieu Morell

given: Mathieu

family: Panaro

full_name: Fabrizio Panaro

given: Fabrizio

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Guiu

full_name: Boris Guiu

given: Boris

journal_name: European Journal of Cancer

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: National Surveillance of Pediatric Pertussis in Ambulatory Settings

acronym: ACTIVCOQ

summary: Since 2002, Whooping cough surveillance in pediatric private practice has been set up in France. The results of the first years, 2002-2006, have confirmed the effectiveness of the Pertussis whole-cell (Pw) vaccine and in particular the duration of protection of 9/10 years. After evaluating cases in children vaccinated with Pw vaccines, the study aims today to analyze cases in children vaccinated with Pertussis acellular (Pa) vaccines used since 2002/2003 and to assess, on an outpatient basis, the impact of new vaccine recommendations in France (in 2013, introduction of a 2 + 1 schedule - 8 weeks, 4 months and a 11-month recall - and a 6-year recall, and in 2014, update in the recommendations of exams to be prescribed based on the child's age and vaccination status).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


summary:
Colon cancer is one of the most common cancers in France with more than 36,000 new cases per year. Despite significant advances in therapeutic care, the prognosis of colon cancers with metastases remains bad. The treatment of metastatic disease is based on chemotherapy coupled with therapeutic antibodies. The most commonly used are anti-EGFR (Epidermal Growth Factor Receptor), which allowed a significant increase in patient survival. They are responsible for skin toxicity in the form of an acneiform rash which can be debilitating for patients and require discontinuation of treatment. However, this toxicity is strongly correlated with treatment efficacy. Understanding the mechanisms of cutaneous side effects of anti-EGFR is therefore a major challenge to treat and better understand the association with treatment efficacy.

The objective of this study is to investigate a link between cutaneous inflammatory response in patients treated with anti-EGFR, serum level of anti-EGFR and treatment efficacy. It will be conducted systematic consultations dermatology, skin biopsies and blood samples in patients treated with anti-EGFR. From biopsies, it will be searched by an infiltration of inflammatory cells and expression of genes involved in skin inflammation.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Poitiers University Hospital

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Seroprevalence of Hepatitis E in HIV Positive Patients in Basque Country in 2016 (VIhVhEpb): a Prospective Cohort Study

acronym: VIhVhEpb

summary: Study of seroprevalence of hepatitis E among HIV positive patient in Basque country, France in 2016.

lead_sponsor: Centre Hospitalier de la côte Basque


title: Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata.

acronym: AA

summary:
Double-blind, randomised, multi-centre study to evaluate the efficacy and safety of LH-8 cutaneous solution versus placebo in children and adolescents with moderate to severe scalp alopecia areata.

Phase 2/3 study performed in France, Germany, Bulgaria and India in 100 patients.

status: Active, not recruiting

design_allocation: Randomized

ipd_sharing: No

lead_sponsor: Legacy Healthcare SA

location_country: Germany France

location_facility: Clinical Research Center for Hair and Skin Science, Charité-Universitätsmedizin Berlin

location_facility: Centre Sabourand - Hospital Saint-Louis, 1, Avenue Claude Vellefaux


title: Human Papillomavirus DNA Testing Using Self-collected Samples for Cervical Cancer Screening: an Alternative Strategy for Unscreened Women?

summary:
Scientific Context

High-risk types of human papillomavirus (HPV) are the causative agents for cervical cancer. Cervical cancer screening strategies rely on periodic Papanicolaou (Pap) testing. It's well-known that this test has significantly contributed to the reduction of mortality and morbidity due to cervical cancer. In France, it now seems that the screening strategy could be optimized. The two main ways are to reach the 7 million underscreened women (mass screening, self-sampling for HPV DNA testing) and to improve the screening test (HPV DNA testing, computer-assisted cytology). Self-collected vaginal samples (SCVS) for HPV DNA testing could be a relevant screening option: this technique appears reliable and it could allow to reach women who are never or seldom screened. Currently, there is no French data on the SCVS for HPV DNA testing.

The goal of this study is to determine the performance and acceptability of a population-based strategy using self-collected vaginal samples for HPV DNA testing to reach women who are not participating in cervical cancer screening.

Description of the project

This project (APACHE-1) is a part of a project called APACHE. APACHE-1 will be dedicated to the SCVS technical validation and to the comparison between different transports medium. Nine hundred women will be recruited from the 20 to 65 years consultants in the Tours University Hospital (CHRU of Tours) and in the IRSA (health centre for routine medical checkup).

Each woman will collect 2 SCVS with a nylon flocked swab (Copan® microRheologics™). The first SCVS will be put in a vial which contains a liquid medium. The second SCVS will be put in a dry vial. Then during the speculum examination the physician will collect a cervical sample with a Rovers® Cervex-Brush™ and then rinse it into a vial containing PréservCyt ™. A blind HPV DNA testing and genotyping (Inno-LIPA HPV Genotyping ™ Extra) will be performed in the virology laboratory of the CHRU of Tours on all samples (SCVSs and cervical samples performed by a physician). The performance of the SCVS to detect cervical HPV infection will be assessed (gold standard test = HPV DNA testing on cervical samples collected by the physician).

In a second time (APACHE-2), the researchers will investigate to what extent offering home obtained SCVS leads to participation of unscreened women. APACHE-2 will be registered on Clinicaltrials as another project.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Tours

location_facility:
Service de Gynécologie, CHRU Tours
IRSA 37
Association Paul Metadier
IRSA 72
Service d'Orthogénie, CHRU Tours


title: Feasibility of Total Mastectomy in Ambulatory Care

acronym: AMASTEC

summary:
Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population.

The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy.

In France, Ambulatory care is developed as part of the new national health plan.

Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation.

Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Procedure


title: Cost-utility Analysis of the Use of the Paro Robotic Seal by Elderly Patients With Moderate or Severe Cognitive Disorders in Institutions: a Randomised Study.

acronym: PEPINO

summary:
Many residents from establishments for dependent elderly people (EHPAD) have memory disorders with behavioural problems such as agitation, aggression and anxiety, which make it difficult to assist them on a daily basis.

Studies have proven the beneficial effect of the therapeutic seal robot PARO® in behavioural disorders. The present project aims to complement these data with a medico-economic study. At present, the only study of this type has been carried out in Australia, and is not transposable to France.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Evaluation of the Relability and Validity of Device for the Screening of Early Pressure Ulcer in Hospitalization High-risk Patient, the Sub Epidermal Moisture During a Monocebtric Study

acronym: RELIASEM

summary: The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries. The Sub Epidermal Moister(SEM) Scanner, is a non invasive portable medical device use to complet the clinical jugement of clinician

primary_purpose: Prevention

lead_sponsor: Arjo France

intervention_type: Diagnostic Test


title: Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.

acronym: NalmeCir

summary: Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption.

status: Unknown status

status_simplified: Unknown


title: Lethal Fetal Abnormality : the Experience of Pregnancy by Parents Who Have Chosen to Carry to Term With Palliative Care.

acronym: SPAN

summary:
In France, according to current legislation, termination of pregnancy could be performed without any upper gestational age limit, if there is a strong probability that the fetus will be affected by a particularly severe and incurable disease. When there is a lethal fetal diagnosis most of parents wish to terminate their pregnancy. However, and despite some medical resistance a few of them do wish to continue pregnancy. In these situations, palliative care seems to be a good way to prepare to welcome the child and surround him until death.

The aim of the study is to describe parents' experience for a better understanding and a better care.

lead_sponsor: Hospices Civils de Lyon

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

location_facility: Équipe de psychopathologie périnatale - Service de psychopathologie du développement - Centre Hospitalier Femme-Mère-Enfant - Hospices Civils de Lyon

location_facility: Service de gynécologie-obstétrique - Centre hospitalier Lyon sud

intervention_type: Behavioral


type: Other Identifier

title: Long-term Evaluation Protocol (12 Months Postoperative) of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty Prospective, Monocentric, Randomized, Open-label Study

summary:
Total knee arthroplasty is a frequent surgery in France. It currently represents 70,000 interventions per year. The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella.

The patella belongs to the extensor system. It articulates with the femoral trochlea in which it slides. It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements.

In the case of resurfacing, the joint face of the patella is cut off; A convex polyethylene implant is sealed with cement using studs on the same face.

In case of non-resurfacing, the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea.

Both methods have advantages and disadvantages. For some implants, it is recommended to resurface the patella because the implant is not very tolerant with the native patella. Other implants have been designed to be better adapted to the preservation of patellar cartilage.

There is currently no evidence that one method is superior to the other on new generation implants known as "patellar friendly".

It seems necessary to compare both methods in terms of long-term postsurgery results.


title: Isolation and Establishment of Gustatory Cell Lines in Patients Operated on for Cancer of the Mobile Tongue - ImmortTasteCELL

summary:
In terms of incidence, cancer of the tongue is one of the leading cancers in France. Moreover, this cancer is associated with physiological complications ranging from swallowing disorders to loss of taste. Following surgery, impaired perception of food taste may lead to cachexia. It is therefore necessary to carry out research in the field of impaired taste, notably with regard to the regeneration of taste buds. However, there is currently no available functional model of taste bud cells.

It is therefore necessary to obtain a cell line of human taste cells. These immortalised human cells will allow us to better orient our investigations for applications in humans: search for and characterisation of "taste modifiers" synthesised using organic chemistry, able to trigger the perception of food in cases of taste loss or taste impairment.

Moreover, given recent studies conducted by the investigating team proposing the existence of a fatty taste and its implication in obesity, the work of the team could be oriented towards the synthesis of lipid-receptor agonists, by analogy with artificial sweeteners instead of sugar. The availability of these chemical molecules would lead to a reduction in lipid intake as these agents contain no (or very few) calories. They will act as an organoleptic decoy.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Digital Intervention Promoting Physical Activity Among Obese People Randomized Controlled Trial: Assessing the Effects of a Digital Intervention to Promote Physical Activity in Patients With Obesity and/or Type 2 Diabetes Mellitus

acronym: DIPPAO

summary:
Overweight and obesity are today considered among the most important health risks facing humanity with more than one in two adults overweight or obese in western countries. In addition, Type 2 diabetes mellitus (T2DM) is a common comorbidity associated with overweight and obesity and counts for 5% of the French population under 65 years of age and 15% in people over 65 years old. Despite the accumulation of scientific evidence supporting the benefits of physical activity, obese and diabetic people remain insufficiently active and current programs struggle to engage and sustain physical activity of patients over long periods of time. It is therefore urgent to develop interventions that can effectively change individuals' behavior. In this context, "e-health" interventions and gamification appear to be a particularly promising avenue to improve physical activity and reduce attrition rates of current programs.

This clinical trial aim to test the effectiveness of a digital intervention based on gamification and teamwork in comparison to a supervised physical activity program. The investigators hypothesized that the intervention will be efficient by the development of a self-determined motivation through the process of gamification on the one hand. On the other hand, through the in-group collaboration with other people who share the same stigmatized criteria that will help participants to overcome weight stigmas, acting generally as physical activity barriers.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Device


title: Evaluation of the Management of Acute Appendicitis Before Emergency Department in Children: a Prospective Study

summary:
Acute appendicitis is the first visceral surgical emergency in pediatrics with about 30,000 cases in children having been described in France.

It concerns 0.3% of children under 15 with a maximum frequency between 8 and 13 years of age. Acute appendicitis has a significant morbidity rate of 8% and a mortality rate under 0.1%.

10 to 25% of the children admitted to emergency rooms for abdominal pain have appendicitis.

In 20 to 30% of the cases, the initial symptoms are atypical, which explains the difficulty in diagnosing.

The purpose of our study is to evaluate the quality of general practitioners in the diagnosis of acute appendicitis, its severity and the diagnostic criteria used.

Furthermore, it is not as easy to evaluate pain or examine a complaint in children as it is in adults.

Appendicectomy is the treatment of choice for all acute appendicitis. The importance of early diagnosis and treatment is, therefore, essential. Many predictive diagnostic scores have been studied over the years. The Pediatric Appendicitis Score (PAS) using typical symptoms of acute appendicitis and biological items was published in 2002. Nowadays, it is still considered as a reference and has been validated by other studies.

Most of the patients suffering from abdominal pain first consult their general practitioner.

lead_sponsor: University Hospital, Limoges


title: Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients (ECENVIR Study)

acronym: ECENVIR

summary:
Asthma is one of the most prevalent chronic respiratory diseases, with potential lifethreatening impacts. Indeed, asthma is still responsible for about a thousand deceases per year in France, and constitutes a public health problem in our country as in many countries in the world. The economic burden of asthma is also very high, in terms of health care, and indirect costs including lost work and lost school days.

A few international and French studies have shown a positive clinical impact of Medical Indoor Environment Counselors (MIECs) visiting homes of asthma patients, mainly pediatrics. It has been proposed that MIECs could contribute to reduce patient exposure to many allergens and irritants, among them, house dust mite allergens, formaldehyde or molds. Most of the studies that show a significant decrease of hospitalization or visit in an emergency ward for asthma are monocentric and study the eviction of 1 such identified risk factor. By contrast, meta-analysis underline that additional studies are needed to evaluate the effectiveness of these interventions in adults, in a multicentric and controlled manner, with both clinical, environmental and economical endpoints.

primary_purpose: Supportive Care

lead_sponsor: Rennes University Hospital

location_facility:
Chalon
Macon Hospital
Marseille European Hospital
Aix-en-Provence Hospital
Reims University Hospital
Dijon University Hospital
Chauny Hospital
Grenoble University Hospital
Rouen University Hospital
Vire Hospital
Marseille University Hospital
Strasbourg UH
Lille UH
Caen University Hospital
Nantes University Hospital
Bordeaux University Hospital


lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

acronym: AAPIX

type: EudraCT Number

source: euctr

title: Evaluation of the Biological Response to Clopidogrel in Patients With Ischemic Stroke : Role of Platelet alpha2-adrenergic Receptors

summary:
Ischemic stroke (AIC) is the leading cause of non-traumatic disability in adults, the second leading cause of dementia and the third leading cause of death in France.

Clopidogrel is one of the recommended first line in the secondary prevention of AIC non cardioembolic origin. However recurrences occur in approximately 9% of patients receiving clopidogrel. Some studies in patients with coronary artery disease have made the connection between these treatment failures and non-biological response to clopidogrel. This non-biological response is found for approximately 30% to 50% of patients. Several mechanisms may explain this non-response. The most accepted mechanism is pharmacokinetic. Indeed, clopidogrel is a prodrug that requires intestinal absorption by P-glycoprotein (PGP) and a transformation by hepatic cytochrome into active metabolites. The genetic polymorphism of proteins involved in these two steps explain the low plasma concentration of active metabolites and thus the low efficacy of clopidogrel in some patients.

A new pharmacodynamic hypothesis suggests the involvement of platelet alpha 2-adrenergic receptors. The activation of these receptors potentiates signaling pathway P2Y12 receptor (channel inhibited by clopidogrel) and helps reduce platelet aggregation inhibiting response to clopidogrel.


title: Observatory of Screening Aneurysms of the Abdominal Aorta During Echocardiography. National Epidemiological Survey

summary:
Study of the prevalence of Abdominal Aortic Aneurysms (AAA) (> 3 cm) in patients with echocardiography (transthoracic or) during a specific day, with cardiologists in France.

This is a cross-sectional epidemiological investigation, assembling evidence from a routine ultrasound screening for AAA at the waning of echocardiograms performed during a specific day.

The study will be offered a list of centers selected by the Scientific Committee in the complete list of locations being in France, the subsidiary of echocardiography Echocardiography of French Society of Cardiology. These centers will be 500 in number representative of the French centers, geographically and by type of centers.

ReferenceType: background

ReferenceCitation: Jaussi A, Fontana P, Mueller XM. Imaging of the abdominal aorta during examination of patients referred for transthoracic echocardiography. Schweiz Med Wochenschr. 1999 Jan 23;129(3):71-6.

ReferenceCitation: Kertai MD, Boersma E, Westerhout CM, van Domburg R, Klein J, Bax JJ, van Urk H, Poldermans D. Association between long-term statin use and mortality after successful abdominal aortic aneurysm surgery. Am J Med. 2004 Jan 15;116(2):96-103.

ReferenceCitation: Roshanali F, Mandegar MH, Yousefnia MA, Mohammadi A, Baharvand B. Abdominal aorta screening during transthoracic echocardiography. Echocardiography. 2007 Aug;24(7):685-8.

ReferenceCitation: Schwartz KV, Rashkow AM, Akella MS. Detection of Abdominal Aortic Aneurysm During Routine Echocardiography. Echocardiography. 1996 Jan;13(1):71-74.

ReferenceCitation: Seelig MH, Malouf YL, Klingler PJ, Oldenburg WA, Atkinson EJ. Clinical utility of routine screening for abdominal aortic aneurysm during echocardiography. Vasa. 2000 Nov;29(4):265-8.

ReferenceCitation: Spittell PC, Ehrsam JE, Anderson L, Seward JB. Screening for abdominal aortic aneurysm during transthoracic echocardiography in a hypertensive patient population. J Am Soc Echocardiogr. 1997 Sep;10(7):722-7.

ReferenceType: result

ReferenceCitation: Aboyans V, Bataille V, Bliscaux P, Ederhy S, Filliol D, Honton B, Kurtz B, Messas E, Mohty D, Brochet E, Kownator S; investigators of the E2T3A study. Effectiveness of screening for abdominal aortic aneurysm during echocardiography. Am J Cardiol. 2014 Oct 1;114(7):1100-4. doi: 10.1016/j.amjcard.2014.07.024. Epub 2014 Jul 18.

family: Aboyans

full_name: Victor Aboyans

given: Victor

sequence: first

family: Bataille

full_name: Vincent Bataille

given: Vincent

sequence: additional

family: Bliscaux

full_name: Pascale Bliscaux

given: Pascale

family: Ederhy

full_name: Stéphane Ederhy

given: Stéphane

family: Filliol

full_name: Didier Filliol

given: Didier

family: Honton

full_name: Benjamin Honton

given: Benjamin

family: Kurtz

full_name: Baptiste Kurtz

given: Baptiste

family: Messas

full_name: Emmanuel Messas

given: Emmanuel

family: Mohty

full_name: Dania Mohty

given: Dania

family: Brochet

full_name: Eric Brochet

given: Eric

family: Kownator

full_name: Serge Kownator

given: Serge

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The American Journal of Cardiology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Effectiveness of Screening for Abdominal Aortic Aneurysm During Echocardiography

lead_sponsor: French Cardiology Society


title: ALZHEIMER'S CAREGIVER Accompaniment

acronym: ACCAIDANT

summary: Initiatives have been taken hotline in France and abroad for other conditions, they provide support to patients and their caregivers.

lead_sponsor: University Hospital, Bordeaux


title: Evaluation of Difficulties and Obstacles to the Integration in Community of Children With Type 1 Diabetes Before Primary School, Followed by the Diabetology Department of Lyon Pediatric Hospital.

acronym: DIABECO

summary:
The incidence of type 1 diabetes is increasing worldwide and in France, including among young children.

Type 1 diabetes has consequences for integration in community, especially on the management of hypoglycemia and hyperglycemia, mealtimes, participation in sporting activities and school trips.

This works' purpose is to describe obstacles and difficulties to the integration in community before primary school (day care center, childminder, and nursery school) of a complete sample of children with type 1 diabetes followed in the Diabetology Department of Lyon Pediatric Hospital, at the start of the school year 2018-2019. The investigating team will carry out a descriptive study, using different questionnaires addressed to the professionals (nursery school directors, day care nursery directors, childminders, school doctors, pediatricians and doctors of child and maternal protection centers) and to the parents of children with type 1 diabetes. These different questionnaires will help to take into account different points of view, in order to identify all the obstacles to integration of children with type 1 diabetes in community.

Through this work, secondary information actions through training and/or information leaflets will be carried out in order to facilitate the reception of these children in the community.

time_perspective: Cross-Sectional

location_facility: Service d'endocrinologie pédiatrique Hôpital Femme mère enfant


title: Use of the Thrombectomy Device ReVive™ SE in the Acute Treatment of Stroke

acronym: REVIVE SE

summary: The last marketed thrombectomy devices, named stentretriever, permit a better and faster recanalization in patient with a stroke. The REVIVETM SE is a device designed to restore the brain perfusion in patient with an intracranial artery occlusion. The REVIVETM Se device is not widely use in Europe and in France. The objective of this study is to assess the interest of using this device in the standard care of ischemic stroke in the radiology unit of the hospital Pierre Wertheimer, Lyon. The medical care will not be modified but data will be collected in order to determine whether or not this device is useful for the practice of the radiology unit.

location_facility: Hospices Civils de Lyon - Neuroradiology unit


title: Suicidal Risk Factors Associated With Opioid Analgesics Use : a Pharmacoepidemiological Study

acronym: SANTE

summary:
There is an increase in prescriptions for analgesics opioids and overdose mortality in France.

In the United States, the consumption of opioid analgesics is associated with excess mortality, especially suicide. In France, the investigator team showed retrospectively a link between history of suicide attempt (SA) and use of analgesics in general elderly population.

It is important to determine if there is a link between the prescription of opioid analgesics and suicide attempts, in a longitudinal study in general population.

The originality of the project lies in:

the absence of a French epidemiological study on the link between opioid analgesics and suicide attempt / mortality despite the context of "opioid crisis",
taking into account the terms of consumption of care

time_perspective: Retrospective

lead_sponsor: University Hospital, Montpellier


title: Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for Teenagers and Young Adults With Cancer

acronym: PREVAPAJA

summary: About 700 new cases of cancer are recorded each year among TYAC aged 15 to 25 years old in Rhône-Alpes region (France); more than 200 are treated and supported within the TYAC Department of the Institute of Hematology and Oncology Pediatrics (Centre Léon Bérard-Civil Hospice of Lyon). These patients survive from their disease in 80% of cases; they have six times more likely to develop a risk of second primary cancer (SCP) than their peers. This risk of SCP is multifactorial and varies depending on the type of first cancer, treatment received and the prevalence of risk factors (smoking, overweight, sedentary lifestyle, environmental exposures...). This project aims to implement a clinical program based on adapted physical activity (APA) and cancer prevention recommendations for TYAC during the active treatment period (4-6 months). The methodology used series of assessments of APA sessions and information meetings dedicated to cancer prevention and SCP risk recommendations. It mobilizes regularly the health care team of TYAC Department, TYAC associations, sports structures and associations involved in cancer prevention at the regional level. Assessment of TYAC satisfaction regarding the project, benefits in terms of exercise practice, and knowledge improvement on cancer prevention recommendations, are assessed throughout the program.

ReferenceCitation: Carretier J, Boyle H, Duval S, Philip T, Laurence V, Stark DP, Berger C, Marec-Bérard P, Fervers B. A Review of Health Behaviors in Childhood and Adolescent Cancer Survivors: Toward Prevention of Second Primary Cancer. J Adolesc Young Adult Oncol. 2016 Jun;5(2):78-90. doi: 10.1089/jayao.2015.0035. Epub 2015 Dec 1. Review.

ReferenceCitation: Duval S, Carretier J, Boyle H, Philip T, Berger C, Marec-Bérard P, Fervers B. [Life style and occupational factors and prevention of second primary cancers after childhood and adolescent cancer: Current state of knowledge]. Bull Cancer. 2015 Jul-Aug;102(7-8):665-73. doi: 10.1016/j.bulcan.2015.03.017. Epub 2015 May 1. Review. French.

lead_sponsor: Centre Leon Berard


title: Intravoxel Incoherent Motion Prognostic Value in the Initial Evaluation of Patients With Acute Ischemic Strokes Using 3 Tesla Magnetic Resonance Imaging

acronym: IMPROVES

summary:
Ischemic strokes are the first cause of handicap in adult people, the second cause of dementia and the third cause of death in France. Brain Magnetic Resonance (MR) initial assessment is mandatory to get the right diagnosis, to exclude hemorrhagic lesions and to determine the best treatment.

The conventional diffusion weighted imaging sequence is used to establish the diagnosis and to estimate the volume of ischemic lesions. The perfusion weighted imaging sequences are also used to assess the diffusion-perfusion mismatch which is supposed to be the ischemic penumbra corresponding to territories that could be saved with appropriate treatments.

IntraVoxel Incoherent Motion (IVIM) is a multi-b diffusion sequence which allows to extract four quantitative variables (D, D*, f, ADC) related to the true molecular diffusion and correlated to the microvascular perfusion.

It's a quick sequence with no need of contrast injection and allowing a perfect coregistration with the true diffusion. It has been validated in many pathologies but not in acute strokes.

The feasibility of this sequence in acute ischemic strokes has already been assessed with interesting results.

The study aims to assess the correlation between the quantitative values of IVIM at initial MR exam and the modified Rankin Scale (mRS) score 3 months after an acute ischemic stroke.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Retrospective Evaluation of the Management of Children's Deep Neck Infections at the Montpellier Hospital

summary: To descride the clinical presentation, diagnosis, management and complications of children with a deep neck infection. A retrospective chart review was conducted at the Montpellier hospital in France. All children aged less than 18 years who had been admitted with a diagnosis of cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses between January 2015 and December 2017 were included. The investigators collected the demographic, biological, radiological data and treatment received of the patients to the admision. The results of the bacteriological samples were collected. The investigators compared our results to those of the 10-year cohort. The investigators wish to compare the duration of hospitalization and the duration of the fever enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage


title: Relationship Between Sleep EEG, Intraoperative EEG and Postoperative Cognitive Dysfunction

acronym: SOMEDYSPO

summary:
The challenge of new recommendations and better adapted practices is pushing to operate patients who are getting older and more fragile. In this context, there is an inevitable increase in the risks associated with care and in particular perioperative neurological complications, of which postoperative cognitive dysfunction (POCD) is the most common.

The interest of perioperative cerebral monitoring and in particular electroencephalography (EEG) to reduce neurological and cognitive damage in surgery has been the subject of abundant research and corresponds to a crucial issue.

From the literature and preliminary results obtained in our clinical research unit, it appears that there is also a relationship between certain characteristics of the peroperative EEG (signal strength and burst suppression) and the occurrence of postoperative cognitive dysfunction (PCOD).

In this context, quantitative analysis of the preoperative sleep EEG and the EEG obtained during general anesthesia could allow the identification of a simple to use biomarker of susceptibility or fragility. To our knowledge, there is no preoperative evaluation strategy using EEG analysis to detect a predisposition to POCD.

The main goal of this observational clinical study is to extend the traditional use of per-operative EEG with pre-operative and post-operative sleep EEG for the detection and prediction of early post-operative cognitive dysfunction.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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


title: Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving Continuous Positive Airway Pressure (CPAP) Compliance in Low Cardiovascular Risk Sleep Apnea Patients

summary:
Targeted population:

Sleep apnea patients at low cardiovascular risk newly treated by CPAP

Hypothesis:

Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.

lead_sponsor: Fédération Française de Pneumologie

location_facility: Respiratory physician in private practice


title: Rehabilitation After Admission in Intensive Care Unit for COVID-19: an Observational Study

acronym: RECOVER

summary:
France and especially the region "Grand Est" have been severely impacted by the COVID-19 pandemic. The first affected patients gradually began leaving the hospitalization sector and some of them required rehabilitation before returning home.

Because it has only been studied for few months, COVID 19 possible impairment remain unknown, especially in patients who required admission in ICU and needed rehabilitation.

In order to better understand the impact of the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient in rehabilitation center for Post-Covid-19 rehabilitation after ICU.

The purpose of this study was to describe the impairments and functional independency in patients addressed to a rehabilitation center after an ICU stay for COVID 19 and to explore the factors associated with their evolution.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
Hopital Legouest
CHR Metz Thionville
Etablissement de santé Filieris


title: Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group

acronym: POP-REMIND

summary:
Crohn's disease (CD), a chronic inflammatory process in intestinal segments leads to tissue damage. More than two thirds of CD patients need intestinal resection. Symptomatic clinical recurrence occurs in 60% by 10 years. The principal factors affecting postoperative recurrence are active smoking, penetrating disease, perianal lesions history, prior intestinal resection, small bowel resection extent, and prophylaxis treatment absence.

Ileocolonoscopy within one year of surgery can predict clinical recurrence risk.

Different therapies are proposed after surgery, to prevent post-operative recurrence : Thiopurines, 6-mercaptopurine (positive for clinical and endoscopic postoperative recurrence prevention), Anti-tumour necrosis factor therapy (anti-TNF), the most effective therapy.

Intestinal microbiota acts as a central factor in the CD pathogenesis, and fecal stream role is clearly shown. Various changes in luminal flora with a possible link to local inflammation was also demonstrated. Bacteria associated with postoperative recurrence could be more pathogenic as adherent invasive E coli (AIEC), which could be a pathogen in CD through several mechanisms including increased mucosal colonization, adherence, replication and induction of TNF secretion. Alternatively, postoperative CD recurrence could be linked to a protective commensal species lack, such as Faecalibacterium prausnitzii.

Microscopic inflammation occurs as early as 8 days after anastomosis in the neoterminal ileum mucosa. IL6, IL10 and TGFb levels, measured in neoterminal ileum early after surgery are associated with different rates of postoperative recurrence. It suggests cytokines implication in postoperative recurrence. T cells are major players in the intestinal immune response. The presence at time of surgery and persistence of disease inducing T cell clonal expansions could play an important role in post-operative recurrence.

The main objective is to define a classification of ileal Crohn's Disease based on data integration on a large cohort of patients.

primary_purpose: Basic Science

ReferenceCitation: Sokol H, Brot L, Stefanescu C, Auzolle C, Barnich N, Buisson A, Fumery M, Pariente B, Le Bourhis L, Treton X, Nancey S, Allez M, Seksik P; REMIND Study Group Investigators. Prominence of ileal mucosa-associated microbiota to predict postoperative endoscopic recurrence in Crohn's disease. Gut. 2020 Mar;69(3):462-472. doi: 10.1136/gutjnl-2019-318719. Epub 2019 May 29.

ReferenceCitation: Auzolle C, Nancey S, Tran-Minh ML, Buisson A, Pariente B, Stefanescu C, Fumery M, Marteau P, Treton X, Hammoudi N; REMIND Study Group Investigators, Jouven X, Seksik P, Allez M. Male gender, active smoking and previous intestinal resection are risk factors for post-operative endoscopic recurrence in Crohn's disease: results from a prospective cohort study. Aliment Pharmacol Ther. 2018 Nov;48(9):924-932. doi: 10.1111/apt.14944. Epub 2018 Aug 20.

name: Department of Gastroenterology; Hôpital Saint-Louis; APHP; INSERM U1160; University Denis Diderot; Paris France

family: Auzolle

full_name: Claire Auzolle

given: Claire

name: Department of Gastroenterology; Lyon Sud Hospital; Hospices Civils de Lyon; Lyon France

family: Nancey

full_name: Stephane Nancey

given: Stephane

family: Tran-Minh

full_name: My-Linh Tran-Minh

given: My-Linh

name: Université Clermont Auvergne; Inserm U1071; M2iSH, 3iHP; CHU Clermont-Ferrand; Service de Médecine de l'Appareil Digestif Clermont-Ferrand; Clermont-Ferrand France

family: Buisson

full_name: Anthony Buisson

given: Anthony

name: Department of Gastroenterology; Claude Huriez Hospital; University of Lille 2; Lille France

family: Pariente

full_name: Benjamin Pariente

name: Hôpital Beaujon; Service de Gastroentérologie; MICI et Assistance Nutritive; Clichy France

family: Stefanescu

full_name: Carmen Stefanescu

given: Carmen

name: Department of Hepatogastroenterology; Amiens University Hospital; Amiens France

family: Fumery

full_name: Mathurin Fumery

given: Mathurin

name: Gastroenterology; Sorbonne Universités; AP-HP, Hospital Saint-Antoine; Paris France

family: Marteau

full_name: Philippe Marteau

given: Philippe

family: Treton

full_name: Xavier Treton

given: Xavier

family: Hammoudi

full_name: Nassim Hammoudi

given: Nassim

family: Jouven

full_name: Xavier Jouven

family: Seksik

full_name: Philippe Seksik

family: Allez

full_name: Matthieu Allez

given: Matthieu

journal_name: Alimentary Pharmacology & Therapeutics

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Allez M, Auzolle C, Le Bourhis L, Seksik P. Editorial: predicting recurrence of Crohn's disease after surgical resection-Close to a crystal ball. Authors' reply. Aliment Pharmacol Ther. 2018 Nov;48(10):1157-1158. doi: 10.1111/apt.14998.

family: Le Bourhis

full_name: Lionel Le Bourhis

given: Lionel

name: Gastroenterology Department; Saint-Antoine Hospital; Paris France

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

title: Editorial: predicting recurrence of Crohn's disease after surgical resection-Close to a crystal ball. Authors’ reply

ReferenceCitation: Le Baut G, O'Brien C, Pavli P, Roy M, Seksik P, Tréton X, Nancey S, Barnich N, Bezault M, Auzolle C, Cazals-Hatem D, Viala J, Allez M; REMIND GROUP, Hugot JP, Dumay A. Prevalence of Yersinia Species in the Ileum of Crohn's Disease Patients and Controls. Front Cell Infect Microbiol. 2018 Sep 21;8:336. doi: 10.3389/fcimb.2018.00336. eCollection 2018.

journal_name: Frontiers in Cellular and Infection Microbiology

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

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

ReferenceCitation: Allez M, Auzolle C, Ngollo M, Bottois H, Chardiny V, Corraliza AM, Salas A, Perez K, Stefanescu C, Nancey S, Buisson A, Pariente B, Fumery M, Sokol H, Tréton X, Barnich N, Seksik P, Le Bourhis L; REMIND Study Group. T cell clonal expansions in ileal Crohn's disease are associated with smoking behaviour and postoperative recurrence. Gut. 2019 Nov;68(11):1961-1970. doi: 10.1136/gutjnl-2018-317878. Epub 2019 Feb 12.

title: T cell clonal expansions in ileal Crohn’s disease are associated with smoking behaviour and postoperative recurrence

ReferenceCitation: Hammoudi N, Cazals-Hatem D, Auzolle C, Gardair C, Ngollo M, Bottois H, Nancey S, Pariente B, Buisson A, Treton X, Fumery M, Bezault M, Seksik P, Le Bourhis L; REMIND Study Group Investigators, Flejou JF, Allez M. Association Between Microscopic Lesions at Ileal Resection Margin and Recurrence After Surgery in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Jan;18(1):141-149.e2. doi: 10.1016/j.cgh.2019.04.045. Epub 2019 Apr 28.

journal_name: Clinical Gastroenterology and Hepatology

title: Association Between Microscopic Lesions at Ileal Resection Margin and Recurrence After Surgery in Patients With Crohn’s Disease

ReferenceCitation: Fumery M, Seksik P, Auzolle C, Munoz-Bongrand N, Gornet JM, Boschetti G, Cotte E, Buisson A, Dubois A, Pariente B, Zerbib P, Chafai N, Stefanescu C, Panis Y, Marteau P, Pautrat K, Sabbagh C, Filippi J, Chevrier M, Houze P, Jouven X, Treton X, Allez M; REMIND study group investigators. Postoperative Complications after Ileocecal Resection in Crohn's Disease: A Prospective Study From the REMIND Group. Am J Gastroenterol. 2017 Feb;112(2):337-345. doi: 10.1038/ajg.2016.541. Epub 2016 Dec 13.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Postoperative Complications after Ileocecal Resection in Crohn’s Disease: A Prospective Study From the REMIND Group

ReferenceCitation: Khaloian S, Rath E, Hammoudi N, Gleisinger E, Blutke A, Giesbertz P, Berger E, Metwaly A, Waldschmitt N, Allez M, Haller D. Mitochondrial impairment drives intestinal stem cell transition into dysfunctional Paneth cells predicting Crohn's disease recurrence. Gut. 2020 Nov;69(11):1939-1951. doi: 10.1136/gutjnl-2019-319514. Epub 2020 Feb 28.

title: Mitochondrial impairment drives intestinal stem cell transition into dysfunctional Paneth cells predicting Crohn’s disease recurrence

location_facility:
Clermont-Ferrand Hospital
Saint Antoine Hospital
SART Tilman Hospital
Kremlin-Bicêtre Hospital
Henri Mondor Hospital
Hôpital Nord, CHU Marseille
Saint Louis Hospital
Beaujon Hospital
Strasbourg Hospital
South Lyon Hospital
Nantes Hospital
Lille Hospital
Archet 2 Hospital
Montpellier Hospital
Amiens Hospital
Haut-levêque Hospital
Brabois Hospital


title: Personal Recovery of Young Adults With Severe Anorexia Nervosa During Adolescence: a Pilot Qualitative Study

acronym: ANAPR

summary:
A growing qualitative literature about personal recovery process in mental disorders emerges. However in Anorexia Nervosa (AN), it remains few understood, especially in severe AN during adolescence.

This pilot study seeks to enhance understanding of recovery from AN in France and support the dissemination of the PR paradigm among the French mental health community working with AN, as a complement to the medical approach.

A qualitative research according to Interpretative Phenomenological Analysis (IPA) method was conducted .Five young women hospitalized ten years before for a severe AN during their adolescence were interviewed with a semi-structured face-to-face interview on recovery process.

ReferenceCitation: Khalsa SS, Portnoff LC, McCurdy-McKinnon D, Feusner JD. What happens after treatment? A systematic review of relapse, remission, and recovery in anorexia nervosa. J Eat Disord. 2017 Jun 14;5:20. doi: 10.1186/s40337-017-0145-3. eCollection 2017. Review.

ReferenceCitation: Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.

ReferenceCitation: Strober M, Freeman R, Morrell W. The long-term course of severe anorexia nervosa in adolescents: survival analysis of recovery, relapse, and outcome predictors over 10-15 years in a prospective study. Int J Eat Disord. 1997 Dec;22(4):339-60.

ReferenceCitation: Leamy M, Bird V, Le Boutillier C, Williams J, Slade M. Conceptual framework for personal recovery in mental health: systematic review and narrative synthesis. Br J Psychiatry. 2011 Dec;199(6):445-52. doi: 10.1192/bjp.bp.110.083733. Review.

ReferenceCitation: Wollburg E, Meyer B, Osen B, Löwe B. Psychological change mechanisms in anorexia nervosa treatments: how much do we know? J Clin Psychol. 2013 Jul;69(7):762-73. doi: 10.1002/jclp.21945. Epub 2013 Jan 24. Review.

ReferenceCitation: Espíndola CR, Blay SL. Anorexia nervosa's meaning to patients: a qualitative synthesis. Psychopathology. 2009;42(2):69-80. doi: 10.1159/000203339. Epub 2009 Feb 19. Review.

ReferenceCitation: Noordenbos G, Seubring A. Criteria for recovery from eating disorders according to patients and therapists. Eat Disord. 2006 Jan-Feb;14(1):41-54.

ReferenceCitation: Westwood LM, Kendal SE. Adolescent client views towards the treatment of anorexia nervosa: a review of the literature. J Psychiatr Ment Health Nurs. 2012 Aug;19(6):500-8. doi: 10.1111/j.1365-2850.2011.01819.x. Epub 2011 Sep 27. Review.

ReferenceCitation: Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. Epub 2007 Sep 14.

ReferenceCitation: Jenkins J, Ogden J. Becoming 'whole' again: a qualitative study of women's views of recovering from anorexia nervosa. Eur Eat Disord Rev. 2012 Jan;20(1):e23-31. doi: 10.1002/erv.1085. Epub 2011 Mar 10.

lead_sponsor: Institut Mutualiste Montsouris


title: Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

acronym: IMAP

summary:
According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough.

Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.

The three main objectives of this project are

to identify, compare and combine predictive markers of Alzheimer's disease
to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
to study the ability of different neuroimaging techniques to follow the evolution of this pathology.

design_allocation: Non-Randomized

ReferenceCitation: Chételat G. [Neuroimaging Alzheimer's disease: early diagnosis, monitoring, and mechanism understanding]. Med Sci (Paris). 2011 Feb;27(2):193-8. doi: 10.1051/medsci/2011272193. Epub 2011 Mar 8. French.

ReferenceCitation: Mevel K, Grassiot B, Chételat G, Defer G, Desgranges B, Eustache F. [The default mode network: cognitive role and pathological disturbances]. Rev Neurol (Paris). 2010 Nov;166(11):859-72. doi: 10.1016/j.neurol.2010.01.008. Epub 2010 Mar 11. Review. French.

ReferenceCitation: La Joie R, Fouquet M, Mézenge F, Landeau B, Villain N, Mevel K, Pélerin A, Eustache F, Desgranges B, Chételat G. Differential effect of age on hippocampal subfields assessed using a new high-resolution 3T MR sequence. Neuroimage. 2010 Nov 1;53(2):506-14. doi: 10.1016/j.neuroimage.2010.06.024. Epub 2010 Jun 16.

family: La Joie

full_name: Renaud La Joie

given: Renaud

family: Fouquet

full_name: Marine Fouquet

given: Marine

family: Mézenge

full_name: Florence Mézenge

given: Florence

family: Landeau

full_name: Brigitte Landeau

given: Brigitte

family: Villain

full_name: Nicolas Villain

given: Nicolas

family: Mevel

full_name: Katell Mevel

given: Katell

family: Pélerin

full_name: Alice Pélerin

given: Alice

family: Eustache

full_name: Francis Eustache

given: Francis

family: Desgranges

full_name: Béatrice Desgranges

given: Béatrice

family: Chételat

full_name: Gaël Chételat

given: Gaël

journal_name: NeuroImage

oa_host_type: repository

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

ReferenceCitation: Villain N, Landeau B, Groussard M, Mevel K, Fouquet M, Dayan J, Eustache F, Desgranges B, Chételat G. A simple way to improve anatomical mapping of functional brain imaging. J Neuroimaging. 2010 Oct;20(4):324-33. doi: 10.1111/j.1552-6569.2010.00470.x.

family: Groussard

full_name: Mathilde Groussard

given: Mathilde

family: Dayan

full_name: Jacques Dayan

given: Jacques

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

title: A Simple Way to Improve Anatomical Mapping of Functional Brain Imaging

location_facility:
University Hospital Pontchaillou
University Hospital Roger Salengro
University Hospital Côte de Nacre
University Hospital Rouen
University Hospital Tours


title: French Observatory on the Management of Cardiogenic Shock in 2016

acronym: FRENSHOCK

summary:
Cardiogenic shock (CS) is defined as an organ hypoperfusion secondary to low cardiac output. Catches diagnostic management, and therapeutic monitoring of these patients remain highly variable from one center to another and even from one doctor to another within the same team. The management protocols are often not standardized or non-existent.

It appears therefore necessary to make an inventory of the management practices of the CS in France in 2016, prerequisite to a common work of standardization of practices and the creation of specialized networks to support these complex patients.

ReferenceCitation: Reynolds HR, Hochman JS. Cardiogenic shock: current concepts and improving outcomes. Circulation. 2008 Feb 5;117(5):686-97. doi: 10.1161/CIRCULATIONAHA.106.613596. Review.

ReferenceCitation: Aissaoui N, Puymirat E, Tabone X, Charbonnier B, Schiele F, Lefèvre T, Durand E, Blanchard D, Simon T, Cambou JP, Danchin N. Improved outcome of cardiogenic shock at the acute stage of myocardial infarction: a report from the USIK 1995, USIC 2000, and FAST-MI French nationwide registries. Eur Heart J. 2012 Oct;33(20):2535-43. doi: 10.1093/eurheartj/ehs264. Epub 2012 Aug 26.

ReferenceCitation: Jeger RV, Radovanovic D, Hunziker PR, Pfisterer ME, Stauffer JC, Erne P, Urban P; AMIS Plus Registry Investigators. Ten-year trends in the incidence and treatment of cardiogenic shock. Ann Intern Med. 2008 Nov 4;149(9):618-26.

ReferenceCitation: Thiele H, Allam B, Chatellier G, Schuler G, Lafont A. Shock in acute myocardial infarction: the Cape Horn for trials? Eur Heart J. 2010 Aug;31(15):1828-35. doi: 10.1093/eurheartj/ehq220. Epub 2010 Jul 7. Review.

ReferenceCitation: Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Böhm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) trial investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet. 2013 Nov 16;382(9905):1638-45. doi: 10.1016/S0140-6736(13)61783-3. Epub 2013 Sep 3.

ReferenceCitation: Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Böhm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock. N Engl J Med. 2012 Oct 4;367(14):1287-96. doi: 10.1056/NEJMoa1208410. Epub 2012 Aug 26.

ReferenceCitation: Sleeper LA, Reynolds HR, White HD, Webb JG, Dzavík V, Hochman JS. A severity scoring system for risk assessment of patients with cardiogenic shock: a report from the SHOCK Trial and Registry. Am Heart J. 2010 Sep;160(3):443-50. doi: 10.1016/j.ahj.2010.06.024.

ReferenceCitation: Katz JN, Stebbins AL, Alexander JH, Reynolds HR, Pieper KS, Ruzyllo W, Werdan K, Geppert A, Dzavik V, Van de Werf F, Hochman JS; TRIUMPH Investigators. Predictors of 30-day mortality in patients with refractory cardiogenic shock following acute myocardial infarction despite a patent infarct artery. Am Heart J. 2009 Oct;158(4):680-7. doi: 10.1016/j.ahj.2009.08.005.

ReferenceCitation: Thiele H, Ohman EM, Desch S, Eitel I, de Waha S. Management of cardiogenic shock. Eur Heart J. 2015 May 21;36(20):1223-30. doi: 10.1093/eurheartj/ehv051. Epub 2015 Mar 1. Review.

ReferenceCitation: De Backer D, Biston P, Devriendt J, Madl C, Chochrad D, Aldecoa C, Brasseur A, Defrance P, Gottignies P, Vincent JL; SOAP II Investigators. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med. 2010 Mar 4;362(9):779-89. doi: 10.1056/NEJMoa0907118.

ReferenceCitation: McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. Erratum in: Eur Heart J. 2013 Jan;34(2):158.

ReferenceCitation: Mebazaa A, Nieminen MS, Packer M, Cohen-Solal A, Kleber FX, Pocock SJ, Thakkar R, Padley RJ, Põder P, Kivikko M; SURVIVE Investigators. Levosimendan vs dobutamine for patients with acute decompensated heart failure: the SURVIVE Randomized Trial. JAMA. 2007 May 2;297(17):1883-91.

ReferenceCitation: Felker GM, Benza RL, Chandler AB, Leimberger JD, Cuffe MS, Califf RM, Gheorghiade M, O'Connor CM; OPTIME-CHF Investigators. Heart failure etiology and response to milrinone in decompensated heart failure: results from the OPTIME-CHF study. J Am Coll Cardiol. 2003 Mar 19;41(6):997-1003.

ReferenceCitation: Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34.

ReferenceCitation: Dzavik V, Sleeper LA, Cocke TP, Moscucci M, Saucedo J, Hosat S, Jiang X, Slater J, LeJemtel T, Hochman JS; SHOCK Investigators. Early revascularization is associated with improved survival in elderly patients with acute myocardial infarction complicated by cardiogenic shock: a report from the SHOCK Trial Registry. Eur Heart J. 2003 May;24(9):828-37.

ReferenceCitation: Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29.

journal_name: European Heart Journal

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: O'Connor CM, Gattis WA, Uretsky BF, Adams KF Jr, McNulty SE, Grossman SH, McKenna WJ, Zannad F, Swedberg K, Gheorghiade M, Califf RM. Continuous intravenous dobutamine is associated with an increased risk of death in patients with advanced heart failure: insights from the Flolan International Randomized Survival Trial (FIRST). Am Heart J. 1999 Jul;138(1 Pt 1):78-86.

ReferenceCitation: Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5.

ReferenceCitation: Delmas C, Puymirat E, Leurent G, Elbaz M, Manzo-Silberman S, Bonello L, Gerbaud E, Bataille V, Levy B, Lamblin N, Bonnefoy E, Henry P, Roubille F; FRENSHOCK investigators. Design and preliminary results of FRENSHOCK 2016: A prospective nationwide multicentre registry on cardiogenic shock. Arch Cardiovasc Dis. 2019 May;112(5):343-353. doi: 10.1016/j.acvd.2019.02.001. Epub 2019 Apr 11.

family: Delmas

full_name: Clément Delmas

given: Clément

family: Puymirat

full_name: Etienne Puymirat

given: Etienne

family: Leurent

full_name: Guillaume Leurent

given: Guillaume

family: Elbaz

full_name: Meyer Elbaz

given: Meyer

family: Manzo-Silberman

full_name: Stéphane Manzo-Silberman

given: Stéphane

family: Bonello

full_name: Laurent Bonello

given: Laurent

family: Gerbaud

full_name: Edouard Gerbaud

given: Edouard

family: Bataille

full_name: Vincent Bataille

given: Vincent

family: Levy

full_name: Bruno Levy

given: Bruno

family: Lamblin

full_name: Nicolas Lamblin

family: Bonnefoy

full_name: Eric Bonnefoy

given: Eric

family: Henry

full_name: Patrick Henry

given: Patrick

family: Roubille

full_name: François Roubille

given: François

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

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


title: Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.

acronym: CYST-GEN

summary:
The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics.

The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.

ReferenceCitation: Lee KS, Sekhar A, Rofsky NM, Pedrosa I. Prevalence of incidental pancreatic cysts in the adult population on MR imaging. Am J Gastroenterol. 2010 Sep;105(9):2079-84. doi: 10.1038/ajg.2010.122. Epub 2010 Mar 30.

ReferenceCitation: Farrell JJ, Fernández-del Castillo C. Pancreatic cystic neoplasms: management and unanswered questions. Gastroenterology. 2013 Jun;144(6):1303-15. doi: 10.1053/j.gastro.2013.01.073. Review.

ReferenceCitation: Terris B, Ponsot P, Paye F, Hammel P, Sauvanet A, Molas G, Bernades P, Belghiti J, Ruszniewski P, Fléjou JF. Intraductal papillary mucinous tumors of the pancreas confined to secondary ducts show less aggressive pathologic features as compared with those involving the main pancreatic duct. Am J Surg Pathol. 2000 Oct;24(10):1372-7.

ReferenceCitation: Crippa S, Fernández-Del Castillo C, Salvia R, Finkelstein D, Bassi C, Domínguez I, Muzikansky A, Thayer SP, Falconi M, Mino-Kenudson M, Capelli P, Lauwers GY, Partelli S, Pederzoli P, Warshaw AL. Mucin-producing neoplasms of the pancreas: an analysis of distinguishing clinical and epidemiologic characteristics. Clin Gastroenterol Hepatol. 2010 Feb;8(2):213-9. doi: 10.1016/j.cgh.2009.10.001. Epub 2009 Oct 14.

ReferenceCitation: Marchegiani G, Mino-Kenudson M, Sahora K, Morales-Oyarvide V, Thayer S, Ferrone C, Warshaw AL, Lillemoe KD, Fernández-Del Castillo C. IPMN involving the main pancreatic duct: biology, epidemiology, and long-term outcomes following resection. Ann Surg. 2015 May;261(5):976-83. doi: 10.1097/SLA.0000000000000813.

ReferenceCitation: Tanaka M, Fernández-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.

ReferenceCitation: Brugge WR, Lewandrowski K, Lee-Lewandrowski E, Centeno BA, Szydlo T, Regan S, del Castillo CF, Warshaw AL. Diagnosis of pancreatic cystic neoplasms: a report of the cooperative pancreatic cyst study. Gastroenterology. 2004 May;126(5):1330-6.

ReferenceCitation: Serikawa M, Sasaki T, Fujimoto Y, Kuwahara K, Chayama K. Management of intraductal papillary-mucinous neoplasm of the pancreas: treatment strategy based on morphologic classification. J Clin Gastroenterol. 2006 Oct;40(9):856-62.

ReferenceCitation: Bournet B, Kirzin S, Carrère N, Portier G, Otal P, Selves J, Musso C, Suc B, Moreau J, Fourtanier G, Pradère B, Lazorthes F, Escourrou J, Buscail L. Clinical fate of branch duct and mixed forms of intraductal papillary mucinous neoplasia of the pancreas. J Gastroenterol Hepatol. 2009 Jul;24(7):1211-7. doi: 10.1111/j.1440-1746.2009.05826.x. Epub 2009 May 19.

ReferenceCitation: Sugiyama M, Izumisato Y, Abe N, Masaki T, Mori T, Atomi Y. Predictive factors for malignancy in intraductal papillary-mucinous tumours of the pancreas. Br J Surg. 2003 Oct;90(10):1244-9.

ReferenceCitation: Kanno A, Satoh K, Hirota M, Hamada S, Umino J, Itoh H, Masamune A, Asakura T, Shimosegawa T. Prediction of invasive carcinoma in branch type intraductal papillary mucinous neoplasms of the pancreas. J Gastroenterol. 2010 Sep;45(9):952-9. doi: 10.1007/s00535-010-0238-0. Epub 2010 Apr 10.

ReferenceCitation: Crippa S, Salvia R, Warshaw AL, Domínguez I, Bassi C, Falconi M, Thayer SP, Zamboni G, Lauwers GY, Mino-Kenudson M, Capelli P, Pederzoli P, Castillo CF. Mucinous cystic neoplasm of the pancreas is not an aggressive entity: lessons from 163 resected patients. Ann Surg. 2008 Apr;247(4):571-9. doi: 10.1097/SLA.0b013e31811f4449.

ReferenceCitation: Cizginer S, Turner BG, Bilge AR, Karaca C, Pitman MB, Brugge WR. Cyst fluid carcinoembryonic antigen is an accurate diagnostic marker of pancreatic mucinous cysts. Pancreas. 2011 Oct;40(7):1024-8. doi: 10.1097/MPA.0b013e31821bd62f. Erratum in: Pancreas. 2013 May;42(4):728. Turner, Brian [corrected to Turner, Brian G].

ReferenceCitation: Sahora K, Mino-Kenudson M, Brugge W, Thayer SP, Ferrone CR, Sahani D, Pitman MB, Warshaw AL, Lillemoe KD, Fernandez-del Castillo CF. Branch duct intraductal papillary mucinous neoplasms: does cyst size change the tip of the scale? A critical analysis of the revised international consensus guidelines in a large single-institutional series. Ann Surg. 2013 Sep;258(3):466-75. doi: 10.1097/SLA.0b013e3182a18f48.

ReferenceCitation: Wu BU, Sampath K, Berberian CE, Kwok KK, Lim BS, Kao KT, Giap AQ, Kosco AE, Akmal YM, Difronzo AL, Yu W, Ngor EW. Prediction of malignancy in cystic neoplasms of the pancreas: a population-based cohort study. Am J Gastroenterol. 2014 Jan;109(1):121-9; quiz 130. doi: 10.1038/ajg.2013.334. Epub 2013 Oct 1.

ReferenceCitation: Grobmyer SR, Cance WG, Copeland EM, Vogel SB, Hochwald SN. Is there an indication for initial conservative management of pancreatic cystic lesions? J Surg Oncol. 2009 Oct 1;100(5):372-4. doi: 10.1002/jso.21260.

ReferenceCitation: Huang ES, Turner BG, Fernandez-Del-Castillo C, Brugge WR, Hur C. Pancreatic cystic lesions: clinical predictors of malignancy in patients undergoing surgery. Aliment Pharmacol Ther. 2010 Jan 15;31(2):285-94. doi: 10.1111/j.1365-2036.2009.04173.x. Epub 2009 Oct 21.

ReferenceCitation: Crippa S, Bassi C, Salvia R, Malleo G, Marchegiani G, Rebours V, Levy P, Partelli S, Suleiman SL, Banks PA, Ahmed N, Chari ST, Fernández-Del Castillo C, Falconi M. Low progression of intraductal papillary mucinous neoplasms with worrisome features and high-risk stigmata undergoing non-operative management: a mid-term follow-up analysis. Gut. 2017 Mar;66(3):495-506. doi: 10.1136/gutjnl-2015-310162. Epub 2016 Jan 7.

ReferenceCitation: Springer S, Wang Y, Dal Molin M, Masica DL, Jiao Y, Kinde I, Blackford A, Raman SP, Wolfgang CL, Tomita T, Niknafs N, Douville C, Ptak J, Dobbyn L, Allen PJ, Klimstra DS, Schattner MA, Schmidt CM, Yip-Schneider M, Cummings OW, Brand RE, Zeh HJ, Singhi AD, Scarpa A, Salvia R, Malleo G, Zamboni G, Falconi M, Jang JY, Kim SW, Kwon W, Hong SM, Song KB, Kim SC, Swan N, Murphy J, Geoghegan J, Brugge W, Fernandez-Del Castillo C, Mino-Kenudson M, Schulick R, Edil BH, Adsay V, Paulino J, van Hooft J, Yachida S, Nara S, Hiraoka N, Yamao K, Hijioka S, van der Merwe S, Goggins M, Canto MI, Ahuja N, Hirose K, Makary M, Weiss MJ, Cameron J, Pittman M, Eshleman JR, Diaz LA Jr, Papadopoulos N, Kinzler KW, Karchin R, Hruban RH, Vogelstein B, Lennon AM. A combination of molecular markers and clinical features improve the classification of pancreatic cysts. Gastroenterology. 2015 Nov;149(6):1501-10. doi: 10.1053/j.gastro.2015.07.041. Epub 2015 Aug 4.

ReferenceCitation: Al-Haddad MA, Kowalski T, Siddiqui A, Mertz HR, Mallat D, Haddad N, Malhotra N, Sadowski B, Lybik MJ, Patel SN, Okoh E, Rosenkranz L, Karasik M, Golioto M, Linder J, Catalano MF. Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. Endoscopy. 2015 Feb;47(2):136-42. doi: 10.1055/s-0034-1390742. Epub 2014 Oct 14.

ReferenceCitation: Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. Epub 2007 Dec 4.

ReferenceCitation: Boustière C, Veitch A, Vanbiervliet G, Bulois P, Deprez P, Laquiere A, Laugier R, Lesur G, Mosler P, Nalet B, Napoleon B, Rembacken B, Ajzenberg N, Collet JP, Baron T, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2011 May;43(5):445-61. doi: 10.1055/s-0030-1256317. Epub 2011 May 4.

ReferenceCitation: Dumonceau JM, Polkowski M, Larghi A, Vilmann P, Giovannini M, Frossard JL, Heresbach D, Pujol B, Fernández-Esparrach G, Vazquez-Sequeiros E, Ginès A; European Society of Gastrointestinal Endoscopy. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2011 Oct;43(10):897-912. doi: 10.1055/s-0030-1256754. Epub 2011 Aug 12.

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: CHU NANTES Institut des Maladies de l'Appareil Digestif

intervention_type: Genetic


title: Benefit From a Proximity-incentive Strategy Based on Vaginal Self-sampling for Women Who do Not Participate to Cervical Cancer Screening in Aude and Hérault [French Departments]: an Interventional Research to Reduce Social and Territorial Inequalities.

acronym: RIDECA

summary:
In France, cervical cancer screening is based on a cervical smear for women aged 25 to 30 years and on High Risk- HPV (HR-HPV) testing for women aged 30 to 65 years. One of the main concerns in France is poor attendance to this screening program, up to 40% of women, which led French Health Authorities to implement population-based organized cervical cancer screening (DO CCU), based on remind letters, starting in 2019.

Our project is a complementary strategy to DO CCU based on direct proposal of a vaginal self-sample device for HR-HPV testing to non-attendee women while attending health care centers. Our hypothesis is that contacting under-screened women directly and proposing them a self-sample device to be used at home will increase their participation to cervical cancer screening.

This project will be held in the Departments of Hérault and Aude, which are among those in the region of Occitanie (south of France) with the lowest participation to cervical cancer screening.

Women aged 50 to 65 years with no cervical smear and/or gynecological examination for more than three years, will be recruited in two sites: in a mobile unit for breast cancer screening implemented in the whole Department of Hérault and in a Medical and Social Care located in a particularly deprived area of Aude (Limoux-Quillan). In each site, non attendee-women will be proposed by a trained mid-wife, a vaginal self-sample device to perform at home and send back by mail to the laboratory of the Hospital of Montpellier, which will perform HR-HPV testing. Women with positive HR-HPV DNA test will be asked to perfom a cervical smear and completion of follow-up will be monitored.

The primary objective of this study will be to evaluate attendance of under-screened women to vaginal self-sampling for cervical cancer screening, i.e. the number of women who accepted a self-sample device among women to whom it has been proposed.

A second objective will be to analyse psycho-social factors associated with cervical cancer screening in this population of non-attendee women, i.e. their socio-economic environment and the way women perceive and are implicated in cervical cancer screening. This secondary objective will be based on a specific questionnaire at recruitment and on semi-directive phone interviews in a sub-group of women. The efficacy of this screening strategy (number of women who performed vaginal self sample and sent it to the laboratory, and number of women who completed follow-up in case of a positive HR-HPV test) will also be monitored.

The number of women to be recruited is 300 for each site. The total estimated duration of the project is 48 months, including 24 months for women's recruitment.

Expected results from this project are:

An increase in participation to cervical cancer screening of non-attendee women aged 50 to 65 years in the Departments of Hérault and Aude.
Women's education about cervical cancer screening through discussion with the midwife during recruitment and information tools developed for the project
Information of local health staff and community-based associations about cervical cancer screening and the place of HR-HPV testing.
Identification of psycho-social factors and potential barriers to compliance to cervical cancer screening.
Identification of organizational and practical difficulties that must be overcome to improve preventive actions towards deprived populations.

primary_purpose: Screening

location_facility: Arnaud de Villeneuve Hospital, clinical trials Department


title: Return to Sport and Functional Assessment After Surgery for Chronic Lateral Ankle Instability

acronym: CAIRTS

summary: Real-life, observational, monocentric, prospective, longitudinal study, carried out at the European Center for Sports Rehabilitation (CERS), France.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Prospective Multicenter Cohort of Patients With Inflammatory Bowel Disease Treated by Infliximab or Vedolizumab During COVID-19 Pandemic

summary: Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells

lead_sponsor: Nantes University Hospital


title: Investigation on Early Detection and Active Management of Supra-ventricular Arrhythmia With Telecardiology

acronym: SETAM

summary:
This study investigates if the early detection and treatment of supraventricular arrhythmia (SVA) may help to prevent the progression of the arrhythmia and improve the clinical outcome.

The primary endpoint investigates the delay to implement treatment in two groups of patients :

Active group: Patients followed by telecardiology.
Control group: Patients followed in the conventional manner.

It is assumed that the delay to implement treatment will be higher in the Control group.

lead_sponsor: Biotronik France

location_facility: Groupe Hospitalier de l'Institut catholique de Lille

location_facility: Intercommunal General Hospital LE RAINCY- MONTFERMEIL

location_facility: Centre Hospitalier Départemental Les Oudairies


title: Prospective Assessment of Dasatinib Management Among CP-CML Patients With Dasatinib Initiation in a Real Life Setting: DasaREALISE.

summary: This is a prospective, non-interventional study conducted in CP-CML patients receiving dasatinib who are enrolled by a sample of hematologists in France.

lead_sponsor: Bristol-Myers Squibb


title: EValuation of REsidual Platelet REactivity After Acute Coronary Syndrome in HIV-infected Patients. The EVERE2ST-HIV Study.

summary:
Elevated on-treatment platelet reactivity is an independent risk factor of major adverse cardiovascular events following percutaneous coronary intervention or ACS. People living with HIV patients have a higher risk of recurrent events after ACS than people without HIV.

The investigators hypothesized that this increased risk is driven by higher platelet reactivity.

Using a nested case-control study design, HIV-infected and HIV-uninfected patients with a first episode of Acute Coronary Syndrome (ACS) treated with percutaneous coronary intervention were matched for age, sex, known diabetes mellitus and anti-platelet therapy.

The primary end-point was the residual platelet reactivity (RPA) on dual antiplatelet therapy assessed by light transmission aggregometry (LTA, 20µM ADP).

The study was conducted in a two large public university hospitals in central Paris, France.

ReferenceCitation: Parodi G, Marcucci R, Valenti R, Gori AM, Migliorini A, Giusti B, Buonamici P, Gensini GF, Abbate R, Antoniucci D. High residual platelet reactivity after clopidogrel loading and long-term cardiovascular events among patients with acute coronary syndromes undergoing PCI. JAMA. 2011 Sep 21;306(11):1215-23. doi: 10.1001/jama.2011.1332.

ReferenceCitation: Boccara F, Mary-Krause M, Teiger E, Lang S, Lim P, Wahbi K, Beygui F, Milleron O, Gabriel Steg P, Funck-Brentano C, Slama M, Girard PM, Costagliola D, Cohen A; Prognosis of Acute Coronary Syndrome in HIV-infected patients (PACS) Investigators. Acute coronary syndrome in human immunodeficiency virus-infected patients: characteristics and 1 year prognosis. Eur Heart J. 2011 Jan;32(1):41-50. doi: 10.1093/eurheartj/ehq372. Epub 2010 Oct 21.

ReferenceCitation: Lang S, Mary-Krause M, Cotte L, Gilquin J, Partisani M, Simon A, Boccara F, Bingham A, Costagliola D; French Hospital Database on HIV-ANRS CO4. Increased risk of myocardial infarction in HIV-infected patients in France, relative to the general population. AIDS. 2010 May 15;24(8):1228-30. doi: 10.1097/QAD.0b013e328339192f.

ReferenceCitation: Triant VA, Lee H, Hadigan C, Grinspoon SK. Increased acute myocardial infarction rates and cardiovascular risk factors among patients with human immunodeficiency virus disease. J Clin Endocrinol Metab. 2007 Jul;92(7):2506-12. Epub 2007 Apr 24.

ReferenceCitation: Friis-Møller N, Weber R, Reiss P, Thiébaut R, Kirk O, d'Arminio Monforte A, Pradier C, Morfeldt L, Mateu S, Law M, El-Sadr W, De Wit S, Sabin CA, Phillips AN, Lundgren JD; DAD study group. Cardiovascular disease risk factors in HIV patients--association with antiretroviral therapy. Results from the DAD study. AIDS. 2003 May 23;17(8):1179-93.

ReferenceCitation: Kaplan RC, Kingsley LA, Sharrett AR, Li X, Lazar J, Tien PC, Mack WJ, Cohen MH, Jacobson L, Gange SJ. Ten-year predicted coronary heart disease risk in HIV-infected men and women. Clin Infect Dis. 2007 Oct 15;45(8):1074-81. Epub 2007 Sep 12.

ReferenceCitation: Patel P, Hanson DL, Sullivan PS, Novak RM, Moorman AC, Tong TC, Holmberg SD, Brooks JT; Adult and Adolescent Spectrum of Disease Project and HIV Outpatient Study Investigators. Incidence of types of cancer among HIV-infected persons compared with the general population in the United States, 1992-2003. Ann Intern Med. 2008 May 20;148(10):728-36.

ReferenceCitation: Savès M, Chêne G, Ducimetière P, Leport C, Le Moal G, Amouyel P, Arveiler D, Ruidavets JB, Reynes J, Bingham A, Raffi F; French WHO MONICA Project and the APROCO (ANRS EP11) Study Group. Risk factors for coronary heart disease in patients treated for human immunodeficiency virus infection compared with the general population. Clin Infect Dis. 2003 Jul 15;37(2):292-8. Epub 2003 Jul 7.

ReferenceCitation: Grinspoon SK. Metabolic syndrome and cardiovascular disease in patients with human immunodeficiency virus. Am J Med. 2005 Apr;118 Suppl 2:23S-28S. Review.

ReferenceCitation: Capeau J. From lipodystrophy and insulin resistance to metabolic syndrome: HIV infection, treatment and aging. Curr Opin HIV AIDS. 2007 Jul;2(4):247-52. doi: 10.1097/COH.0b013e3281e66919.

ReferenceCitation: Triant VA, Meigs JB, Grinspoon SK. Association of C-reactive protein and HIV infection with acute myocardial infarction. J Acquir Immune Defic Syndr. 2009 Jul 1;51(3):268-73. doi: 10.1097/QAI.0b013e3181a9992c.

ReferenceCitation: Mangili A, Polak JF, Quach LA, Gerrior J, Wanke CA. Markers of atherosclerosis and inflammation and mortality in patients with HIV infection. Atherosclerosis. 2011 Feb;214(2):468-73. doi: 10.1016/j.atherosclerosis.2010.11.013. Epub 2010 Nov 17.

ReferenceCitation: Coll B, Parra S, Alonso-Villaverde C, Aragonés G, Montero M, Camps J, Joven J, Masana L. The role of immunity and inflammation in the progression of atherosclerosis in patients with HIV infection. Stroke. 2007 Sep;38(9):2477-84. Epub 2007 Aug 2.

ReferenceCitation: Kaplan RC, Kingsley LA, Gange SJ, Benning L, Jacobson LP, Lazar J, Anastos K, Tien PC, Sharrett AR, Hodis HN. Low CD4+ T-cell count as a major atherosclerosis risk factor in HIV-infected women and men. AIDS. 2008 Aug 20;22(13):1615-24. doi: 10.1097/QAD.0b013e328300581d.

ReferenceCitation: Torre D, Pugliese A. Platelets and HIV-1 infection: old and new aspects. Curr HIV Res. 2008 Sep;6(5):411-8. Review.

ReferenceCitation: Satchell CS, Cotter AG, O'Connor EF, Peace AJ, Tedesco AF, Clare A, Lambert JS, Sheehan GJ, Kenny D, Mallon PW. Platelet function and HIV: a case-control study. AIDS. 2010 Mar 13;24(5):649-57. doi: 10.1097/QAD.0b013e328336098c.

ReferenceCitation: Boccara F, Mary-Krause M, Teiger E, et al. HIV-infected patients have an increased risk of recurrent ischemic events as compared to the general population after an acute coronary syndrome. Paper presented at: American Heart Association; November 15th, 2011, 2011; Orlando, USA.

ReferenceCitation: Baker JV, Neuhaus J, Duprez D, Kuller LH, Tracy R, Belloso WH, De Wit S, Drummond F, Lane HC, Ledergerber B, Lundgren J, Nixon DE, Paton NI, Neaton JD; INSIGHT SMART Study Group. Changes in inflammatory and coagulation biomarkers: a randomized comparison of immediate versus deferred antiretroviral therapy in patients with HIV infection. J Acquir Immune Defic Syndr. 2011 Jan 1;56(1):36-43. doi: 10.1097/QAI.0b013e3181f7f61a.

ReferenceCitation: Scaradavou A. HIV-related thrombocytopenia. Blood Rev. 2002 Mar;16(1):73-6. Review.

ReferenceCitation: von Hentig N, Förster AK, Kuczka K, Klinkhardt U, Klauke S, Gute P, Staszewski S, Harder S, Graff J. Platelet-leucocyte adhesion markers before and after the initiation of antiretroviral therapy with HIV protease inhibitors. J Antimicrob Chemother. 2008 Nov;62(5):1118-21. doi: 10.1093/jac/dkn333. Epub 2008 Aug 27.

ReferenceCitation: Corrales-Medina VF, Simkins J, Chirinos JA, Serpa JA, Horstman LL, Jy W, Ahn YS. Increased levels of platelet microparticles in HIV-infected patients with good response to highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2010 Jun;54(2):217-8. doi: 10.1097/QAI.0b013e3181c8f4c9.

ReferenceCitation: Baker J, Ayenew W, Quick H, Hullsiek KH, Tracy R, Henry K, Duprez D, Neaton JD. High-density lipoprotein particles and markers of inflammation and thrombotic activity in patients with untreated HIV infection. J Infect Dis. 2010 Jan 15;201(2):285-92. doi: 10.1086/649560.

ReferenceCitation: Daali Y, Ancrenaz V, Bosilkovska M, Dayer P, Desmeules J. Ritonavir inhibits the two main prasugrel bioactivation pathways in vitro: a potential drug-drug interaction in HIV patients. Metabolism. 2011 Nov;60(11):1584-9. doi: 10.1016/j.metabol.2011.03.015. Epub 2011 May 6.

ReferenceCitation: Collet JP, Cayla G, Cuisset T, Elhadad S, Rangé G, Vicaut E, Montalescot G. Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: rationale and design of the assessment with a double randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and clopidogrel after DES implantation, and (2) treatment interruption versus continuation, 1 year after stenting (ARCTIC) study. Am Heart J. 2011 Jan;161(1):5-12.e5. doi: 10.1016/j.ahj.2010.09.029.

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Cayla

full_name: Guillaume Cayla

family: Cuisset

full_name: Thomas Cuisset

given: Thomas

family: Elhadad

full_name: Simon Elhadad

given: Simon

family: Rangé

full_name: Grégoire Rangé

given: Grégoire

family: Vicaut

full_name: Eric Vicaut

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

journal_name: American Heart Journal

title: Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: Rationale and design of the Assessment with a double Randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and Clopidogrel after DES implantation, and (2) Treatment Interruption versus Continuation, 1 year after stenting (ARCTIC) study

ReferenceCitation: Silvain J, Bellemain-Appaix A, Barthélémy O, Beygui F, Collet JP, Montalescot G. Optimal use of thienopyridines in non-ST-elevation acute coronary syndrome following CURRENT-OASIS 7. Circ Cardiovasc Interv. 2011 Feb 1;4(1):95-103. doi: 10.1161/CIRCINTERVENTIONS.109.910406.

ReferenceCitation: Silvain J, Collet JP, Nagaswami C, Beygui F, Edmondson KE, Bellemain-Appaix A, Cayla G, Pena A, Brugier D, Barthelemy O, Montalescot G, Weisel JW. Composition of coronary thrombus in acute myocardial infarction. J Am Coll Cardiol. 2011 Mar 22;57(12):1359-67. doi: 10.1016/j.jacc.2010.09.077.

ReferenceCitation: Hulot JS, Collet JP, Cayla G, Silvain J, Allanic F, Bellemain-Appaix A, Scott SA, Montalescot G. CYP2C19 but not PON1 genetic variants influence clopidogrel pharmacokinetics, pharmacodynamics, and clinical efficacy in post-myocardial infarction patients. Circ Cardiovasc Interv. 2011 Oct 1;4(5):422-8. doi: 10.1161/CIRCINTERVENTIONS.111.963025. Epub 2011 Oct 4.

name: From Université Pierre et Marie Curie-Paris 6, INSERM UMR S 956, Pharmacology Department, Pitié-Salpêtrière University Hospital, Paris, France (J.-S.H., F.A.); the Cardiovascular Research Center, Mount Sinai School of Medicine, New York, NY (J.-S.H.); Institut de Cardiologie, INSERM CMR937, Pitié-Salpêtrière Hospital (AP-HP) 75013, and Université Pierre et Marie Curie, Paris, France (J.-P.C., G.C., J.S., A.B.-A., G.M.); and the Department of Genetics and Genomics Sciences, Mount Sinai School of...

family: Hulot

full_name: Jean-Sébastien Hulot

given: Jean-Sébastien

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Allanic

full_name: Frédérick Allanic

given: Frédérick

family: Bellemain-Appaix

full_name: Anne Bellemain-Appaix

given: Anne

family: Scott

full_name: Stuart A. Scott

given: Stuart A.

title: CYP2C19But NotPON1Genetic Variants Influence Clopidogrel Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy in Post–Myocardial Infarction Patients

ReferenceCitation: Silvain J, Cayla G, Hulot JS, Finzi J, Kerneis M, O'Connor SA, Bellemain-Appaix A, Barthélémy O, Beygui F, Collet JP, Montalescot G. High on-thienopyridine platelet reactivity in elderly coronary patients: the SENIOR-PLATELET study. Eur Heart J. 2012 May;33(10):1241-9. doi: 10.1093/eurheartj/ehr407. Epub 2011 Nov 7.


title: Assessment of the Production of Uremic Toxins by the Gut Microbiota of Patients With Chronic Kidney Disease: in Vitro Test

acronym: GUTCOL

summary: Chronic renal failure (CKD) affects 3 million people in France and is characterized by the accumulation of uremic toxins (UTs) such as p-cresyl sulfate (PCS) and indoxyl sulfate (IS) which participate in cardiovascular complications and disturbance of the carbohydrate metabolism associated with CKD. These UTs are not eliminated by dialysis due to their high affinity for albumin and alternative strategies to dialysis must be developed to decrease the production of TUs in patients not yet in dialysis. The dysregulation of the intestinal microbiota observed during CKD increases the generation of UTs in the intestine, by the transformation of amino acids derived from proteins (such as tyrosine and tryptophan transformed respectively into PCS and, IS). Thus, modulation of the intestinal microbiota seems to be an attractive target for reducing the production of UTs and the comorbidities associated with CKD. Some studies have demonstrated the potential interest of probiotics in lowering the plasma concentration of UTs, but the effects remain unclear. In order to test the interest of probiotics during CKD, the investigators have, in collaboration with the Nestlé laboratory and the ProDigest platform, the possibility of testing probiotics using a human intestine simulator before the investigation of experimental and human models. For this the investigators would need a collection of fresh stools. The fresh stools will be instilled in artificial intestine to test the efficacy of selected probiotics on UTs production.

lead_sponsor: Hospices Civils de Lyon


title: Comparison of Two Antimicrobial Therapy Duration (6 Weeks Versus 12 Weeks)for Spondylodiscitis

acronym: DTS

summary:
Duration of antimicrobial therapy for spondylodiscitis is not standardized; it could vary from 6 weeks to several months depending on the medical habits. The study hypothesis is that a 6 weeks antimicrobial therapy is not inferior to a 12 weeks.

We run a prospective multi-centric, non inferiority open label trial, randomised in two parallel groups.

The main objective is to compare the efficacy of two durations of antibiotherapy, 6 weeks versus 12 weeks, on the rate of cure in this indication.

The study concerns 400 patients more than 18 years, 70 centres in France are involved.

The duration of the study is 4 years.

ReferenceType: derived

ReferenceCitation: Desoutter S, Cottier JP, Ghout I, Issartel B, Dinh A, Martin A, Carlier R, Bernard L; Duration of Treatment for Spondylodiscitis Study Group. Susceptibility Pattern of Microorganisms Isolated by Percutaneous Needle Biopsy in Nonbacteremic Pyogenic Vertebral Osteomyelitis. Antimicrob Agents Chemother. 2015 Dec;59(12):7700-6. doi: 10.1128/AAC.01516-15. Epub 2015 Oct 5.

family: Desoutter

full_name: Sophie Desoutter

given: Sophie

family: Cottier

full_name: Jean-Philippe Cottier

family: Ghout

full_name: Idir Ghout

given: Idir

family: Issartel

full_name: Bertrand Issartel

given: Bertrand

family: Dinh

full_name: Aurélien Dinh

given: Aurélien

family: Martin

full_name: Arnaud Martin

given: Arnaud

family: Carlier

full_name: Robert Carlier

given: Robert

family: Bernard

full_name: Louis Bernard

given: Louis

name: the Duration of Treatment for Spondylodiscitis Study Group

journal_name: Antimicrobial Agents and Chemotherapy

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

ReferenceCitation: Zervou FN, Zacharioudakis IM, Mylonakis E. ACP Journal Club. 6 weeks of antibiotics was noninferior to 12 weeks for clinical cure in pyogenic vertebral osteomyelitis. Ann Intern Med. 2015 May 19;162(10):JC7. doi: 10.7326/ACPJC-2015-162-10-007.

family: Zervou

full_name: Fainareti N. Zervou

given: Fainareti N.

family: Zacharioudakis

full_name: Ioannis M. Zacharioudakis

given: Ioannis M.

family: Mylonakis

full_name: Eleftherios Mylonakis

given: Eleftherios

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

ReferenceCitation: Bernard L, Dinh A, Ghout I, Simo D, Zeller V, Issartel B, Le Moing V, Belmatoug N, Lesprit P, Bru JP, Therby A, Bouhour D, Dénes E, Debard A, Chirouze C, Fèvre K, Dupon M, Aegerter P, Mulleman D; Duration of Treatment for Spondylodiscitis (DTS) study group. Antibiotic treatment for 6 weeks versus 12 weeks in patients with pyogenic vertebral osteomyelitis: an open-label, non-inferiority, randomised, controlled trial. Lancet. 2015 Mar 7;385(9971):875-82. doi: 10.1016/S0140-6736(14)61233-2. Epub 2014 Nov 5.


title: Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities

acronym: VISTA CARE

summary: The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.

lead_sponsor: University Hospital, Grenoble


title: Non Invasive Diagnosis of Gastric Precancerous Lesions by GastroPanel Blood Test in Patients With Increased Gastric Cancer Risk : a French Multicenter Study

acronym: GASTRO-PRA

summary:
Despite the declining incidence, gastric cancer (GC) remains the second leading cause of cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases per year. It is now well demonstrated that patients with H. pylori infection, atrophic gastritis and intestinal metaplasia, have a high risk of developing GC. It is therefore important to detect these pre-neoplastic lesions at an early stage to improve patients prognosis.

Thus, the aim of this project is to investigate the possible screening of gastric precancerous lesions by a blood test (GastroPanel®) in France, in patients with oesophagogastroduodenoscopy (EGD) prescription.


title: Changes in the Consumption of Psychoactive Substances by People Incarcerated at the Villeneuve-Lès-Maguelone Prison During Containment Linked to COVID-19.

summary:
The SARS-CoV 2 pandemic started in China in December 2019, then reached France on January 24, 2020.

On March 14, France moved into phase 3 of the epidemic threshold with the implementation of containment measures on March 17 Measures were put in place by N.Belloubet (French Minister of Justice) from March 17, including suspension of visiting rooms and activities in detention.

Containment provides boredom and isolation with many potential consequences: sleep disturbance, anxiety, PTSD, depression, suicide, addictive behavior and violence.

However,prisoners have a higher prevalence of substance use disorders than the general population.

What will have been the impact of the confinement on the consumption of psychoactive substances by prisoners at the Villeneuve Les Maguelone prison.

Anonymous questionnaire from the start
Collection of socio-demographic data
Collection of consumption data before and during containment
Collection of monitoring data