title: Paternal Involvement in Psychiatric Care of Adolescents Managed for Depression or Suicide Attempt

acronym: EQIP

summary:
Parental involvement, both quantitative and qualitative, is fundamental for a good psycho-emotional development of the child. The lack of parental involvement and especially paternal involvement significantly promotes the occurrence of behavioral disorders in children and later, in adolescence, the onset of depressive symptomatology. On the other hand, parental involvement has a protective role in the occurrence of behavioral disorders and decreases the risk of suicide attempts in adolescence. The authors of these cohort studies agree on the need for research on the identification of factors determining paternal involvement in order to organize specific prevention actions and targeted interventions to promote the involvement of fathers in psychiatric care of their adolescents.

The prevention of adolescent suicide attempts appears to be a real public health issue in Reunion Island with a suicide rate among under-35s twice as high as in Reunion than in metropolitan France.

This work is a continuation of the guidelines of good practice of the High Authority of Health (HAS) which insist on the importance of "supporting the parental function by health and public action".

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Involvement of the Inositol-trisphosphate Receptor in Invasive or Migratory-type Breast Cancers

acronym: CarcIno

summary:
Breast cancer is the leading cause of female cancer and female death by cancer in France. Despite the improvement in early detection and therapeutic arsenal, the mortality of this cancer remains high with 11 886 deaths estimated in 2012. Breast cancer is most often a carcinoma born from the lobular or ductal epithelium and is classified In two main categories: non invasive and invasive. Invasive breast cancers account for 75% of the cases. They are usually ductal (75%) and more rarely lobular (25%). The cancer cells are then no longer circumscribed to the galactophoric canals or glands but have invaded neighboring tissues. If they are not treated in time, these cancers can then spread: the cancerous cells will then migrate either by the lymphatic vessels to reach the neighboring ganglia or through the blood vessels to give metastases in other tissues In the liver, lungs and bones). The mortality associated with breast cancer is not due to the growth of the primary tumor but rather to the occurrence of metastases. The study of the mechanisms leading to metastatic invasion (i.e. migration and invasion) is therefore of considerable importance. The development of metastases depends on the acquisition by the cancer cells of various capacities including that of being able to migrate, involving a remodeling of the cytoskeleton highly dependent on the intracellular calcium (Ca2 +) concentration. Several types of signals are able to induce mobilization of Ca2 + from the extracellular medium or endoplasmic reticulum (ER) reserves. At the intracellular level, some of these signals are generated by inositol (1,4,5) -trisphosphate (IP3) from the activation of G protein-coupled receptors or certain receptors with tyrosine kinase activity. Has been shown that the expression, activity and regulation of IP3R receptors (IP3Rs) are involved in the cancerous processes of many tissues, in particular in the phenomena of proliferation of breast cancer cells. Overall, altered expression and / or activity of IP3Rs can be used for the survival, growth, proliferation and migration of cancer cells.

In the laboratory, the investigator showed that regulation of the expression of subtype 3 (IP3R3) by 17β-estradiol (E2) is involved in the growth of the human mammary cancer line MCF-7. E2 triggers the release of Ca2 + in an IP3-dependent mechanism, while prolonged exposure to E2 leads to an increase in the expression of IP3R3. At the same time, the reduction in the expression of IP3R3 cancels the proliferative effect of E2 on MCF-7 cells. More recently, the investigator has established that IP3R3 regulates the proliferation of cells of the human MCF-7 mammary cancer cell line via a molecular and functional interaction with the Ca2 + -dependent BKCa potassium channel. The determination of IP3Rs, including subtype 3, as a mediator / marker of breast carcinogenesis appears to be a major clinical issue.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY

acronym: MIRESPILEPSY

summary:
Sudden and unexpected death in epilepsy (SUDEP) has become a major issue for patients with epilepsy and their physicians. SUDEP is a nontraumatic and non-drowning death in patients with epilepsy, unrelated to a documented status epilepticus, in which postmortem examination does not reveal a toxicologic or anatomic cause of death. It primarily affects young adults with drug-resistant epilepsy, with an incidence of about 0.5%/year. A recent study reported that up to 20% of patients with childhood onset drug resistant epilepsy will die of a SUDEP by the age of 45. Apart from optimizing antiepileptic drugs, no preventive treatment is available to prevent SUDEP. As underscored by the World Health Organization (WHO), there is an urgent need to develop specific therapeutic approaches to tackle this issue.

The primary objective of the proposal is to evaluate the diagnostic value of a set of circulating microRNAs pre-selected because of their implication in the regulation of molecular pathways involved in the respiratory regulation to identify patients with seizure-related respiratory dysfunction, as defined by occurrence ictal/peri-ictal pulse oxymetry < 90%.

A total of 50 patients will be included over a period of one year. Patients undergoing long-term video-EEG/SEEG monitoring will be recruited in the epilepsy monitoring unit of the Department of Functional Neurology and Epileptology, Hospices Civils de Lyon, Lyon, France.

It will be a case-control study in a cohort of patients with drug-resistant focal epilepsy undergoing long-term video-EEG monitoring, in which patients who demonstrate ictal/post-ictal hypoxemia (cases) will be compared with those without seizure-related respiratory dysfunction (controls).

status: Recruiting

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurophysiologie Clinique Hôpital La Timone

intervention_type: Genetic

status_simplified: Ongoing


title: Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta in a High Risk Population

acronym: DNA-Accreta

summary: The purpose of this study is to determine whether, in a high risk population (placenta praevia and previous caesarean or prenatal suspicion of morbidly adherent placenta (MAP)), the concentration of cell-free fetal DNA circulating in the maternal plasma is significantly increased in the subgroup of morbidly adherent placenta (MAP) cases , in order to determine if the dosage of cell-free fetal DNA circulating in the maternal plasma may be a useful biological tool to detect MAP, alone or in addition to the imagery findings (ultrasonography and RMI).

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Sekizawa A, Jimbo M, Saito H, Iwasaki M, Sugito Y, Yukimoto Y, Otsuka J, Okai T. Increased cell-free fetal DNA in plasma of two women with invasive placenta. Clin Chem. 2002 Feb;48(2):353-4.

ReferenceCitation: Jimbo M, Sekizawa A, Sugito Y, Matsuoka R, Ichizuka K, Saito H, Okai T. Placenta increta: Postpartum monitoring of plasma cell-free fetal DNA. Clin Chem. 2003 Sep;49(9):1540-1.

ReferenceCitation: Kayem G, Deneux-Tharaux C, Sentilhes L; PACCRETA group. PACCRETA: clinical situations at high risk of placenta ACCRETA/percreta: impact of diagnostic methods and management on maternal morbidity. Acta Obstet Gynecol Scand. 2013 Apr;92(4):476-82. doi: 10.1111/aogs.12078. Epub 2013 Feb 15.

ReferenceCitation: Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222. Review.

ipd_sharing: No

lead_sponsor: University Hospital, Angers

intervention_type: Biological


title: Preliminary Study of Financial Distress and Quality of Life in Patients With Advanced Cancer

acronym: DIFIC

summary:
Advanced cancer has an adverse effect in virtually all dimensions of patients' lives (physical, psychosocial, spiritual, familial, role function). One of the less frequently explored effects of cancer is its impact on personal finances and the contribution of financial-related distress to overall suffering and quality of life. Financial issues have been recently found to be the second most frequent source of distress identified by cancer patients in a community cancer center context (22%).

In the context of continuous increased health care costs, it is likely that the frequency of health care related financial problems will keep rising. The relative contribution of these adverse financial events in advanced cancer patients to overall patient distress is not well assessed and this is particularly true in France. The main objective of this work is to determine the association between financial distress and quality of life of patients with advanced cancer in a Public General Hospital and in a Comprehensive Cancer Center. A secondary objective is to characterize the frequency and intensity of financial distress reported by French cancer patients and their impact on their quality of life.

status: Completed

study_completion_date_type: Actual

primary_purpose: Supportive Care

ReferenceType: result

ReferenceCitation: Barbaret C, Brosse C, Rhondali W, Ruer M, Monsarrat L, Michaud P, Schott AM, Delgado-Guay M, Bruera E, Sanchez S, Filbet M. Financial distress in patients with advanced cancer. PLoS One. 2017 May 18;12(5):e0176470. doi: 10.1371/journal.pone.0176470. eCollection 2017.

family: Barbaret

full_name: Cécile Barbaret

given: Cécile

sequence: first

family: Brosse

full_name: Christelle Brosse

given: Christelle

sequence: additional

family: Rhondali

full_name: Wadih Rhondali

given: Wadih

family: Ruer

full_name: Murielle Ruer

given: Murielle

family: Monsarrat

full_name: Léa Monsarrat

given: Léa

family: Michaud

full_name: Patrick Michaud

given: Patrick

family: Schott

full_name: Anne Marie Schott

given: Anne Marie

family: Delgado-Guay

full_name: Marvin Delgado-Guay

given: Marvin

family: Bruera

full_name: Eduardo Bruera

given: Eduardo

family: Sanchez

full_name: Stéphane Sanchez

given: Stéphane

family: Filbet

full_name: Marilène Filbet

given: Marilène

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

location_facility: Unité de soins palliatifs Groupement Hospitalier Sud

status_simplified: Completed


title: Multifactorial Analysis of the Influence of Alcohol Marketing Stimuli Among Young Adults on the Perception of the Risks of Alcohol and According to the Types of Uses and Individual Vulnerabilities

acronym: DEPREV

summary:
Alcohol use is the second leading cause of preventable death after smoking. The Evin law was built in 1991 with the goal of reducing exposure to alcohol marketing among the youngest. But this law is currently extremely weakened, and in a press release of February 26, 2018, the French Society of Alcoology is alarmed by these developments.

Studies focusing on the impact of alcohol marketing focus largely on young adolescents, and the links between exposure to marketing and the initiation of alcohol. But beyond these links, there has been little work on the impact of alcohol marketing in vulnerable subjects with regular alcohol consumption. Consumption of alcohol is one of the first causes of hospitalization in France (Paille and Reynaud, 2015), the damage is often restricted to notions of dependency risks, but they can appear as soon as consumptions of 1 US / d (Guerin and Laplanche, 2013) and they mainly concern 45-64 year olds. To our knowledge, there are no studies on the impact of alcohol marketing conducted on regular alcohol users, depending on how they use alcohol (use, or use disorders). mild, moderate or severe) in patients enrolled in primary care and specialized addiction care.

status: Terminated

ReferenceType: derived

ReferenceCitation: Guillou-Landreat M, Dany A, Le Reste JY, Le Goff D, Benyamina A, Grall-Bronnec M, Gallopel-Morvan K. Impact of alcohol marketing on drinkers with Alcohol use disorders seeking treatment: a mixed-method study protocol. BMC Public Health. 2020 Apr 7;20(1):467. doi: 10.1186/s12889-020-08543-6.

family: Guillou-Landreat

full_name: Morgane Guillou-Landreat

given: Morgane

family: Dany

full_name: Antoine Dany

given: Antoine

family: Le Reste

full_name: Jean Yves Le Reste

given: Jean Yves

family: Le Goff

full_name: Delphine Le Goff

given: Delphine

family: Benyamina

full_name: Amine Benyamina

given: Amine

family: Grall-Bronnec

full_name: Marie Grall-Bronnec

given: Marie

family: Gallopel-Morvan

full_name: Karine Gallopel-Morvan

given: Karine

currency_apc_doaj: GBP

journal_name: BMC Public Health

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Hypnotic Glove Anesthesia: Effects of Hypnosis on Skin Temperature Measured by Infrared Thermography

summary: Hypnotic glove anesthesia is a hypnosis technique wherein the patient, following the suggestions of the hypnotherapist, is mentally capable to create a loss of sensation in areas of the hand that would be covered by a glove. We investigated the effects of hypnotic glove anesthesia on skin temperature measured by thermography.

lead_sponsor: Claude Bernard University

location_facility:
Centre Clinical
Institut Émergences
Centre hospitalier privé Saint-Grégoire


title: Assessment of the Literacy Level of Patients With Chronic Rheumatic Diseases and Association With the Level of Knowledge and Medication Adherence: For a Better Integration of Patients' Literacy Levels Into Their Therapeutic Management.

acronym: LINK

summary: A medication non-adherence is reported in chronic rheumatic diseases, in a context of complex and long-term treatments (injectable/per os targeted therapies, biosimilar...). Understanding and integrating the patient into a shared medical decision are key factors for adherence. From this perspective, the level of literacy (an individual's ability to find, understand and use health information) must be explored in order to adapt the communication of information. These are currently insufficiently adapted to the individual understanding of patients. In practice, literacy assessment is very poorly integrated into routine care, while several tools are validated in French. In rheumatology, foreign studies have shown that literacy is positively related to knowledge level. The results remain contradictory regarding its association with medication adherence. Today, the literacy level of patients with rheumatic diseases and its impact on adherence has not been studied in France, although these evaluations would be useful to adapt interventions individually. The acceptance of patients to complete a literacy assessment questionnaire during their care should also be analysed as a condition of its deployment.

location_facility: Service de rhumatologie Hôpital Edouard Herriot


title: Tolerance and Patients' Satisfaction of Subcutaneous Infusion of Human Immunoglobulin Facilitated by Recombinant Human Hyaluronidase for Primary or Secondary Immunodeficiency

summary: Primary immunodeficiencies (PID) represent more than 150 diseases affecting the immune system. More than 50% of PIDs are due to a lack or an insufficiency in antibody production. Some of these immunodeficiencies as well as some secondary immune deficiency with deficient antibody production (especially in hematology and oncology) are responsible for repeated and/or severe infections, requiring long-term replacement therapy with intravenous polyclonal immunoglobulin. Intravenous replacement therapy is administered every 21 or 28 days in hospital. Subcutaneous administration (weekly or bi-weekly) can be initiated for patients who cannot tolerate intravenous infusions or who have difficult venous access. However, some patients experience a decrease in quality of life with these more frequent administration at home. A new treatment is available in France since 2017, which is a subcutaneous infusion of human immunoglobulin facilitated by recombinant human hyaluronidase (IGHy), administered every 3 to 4 weeks in a single abdominal site, at home. No direct data are available in adults to evaluate tolerance and satisfaction with this treatment, but we know it is a preferred option in children and adolescents.

lead_sponsor: CHU de Reims


title: Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea

summary:
The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front of the eye.

When the eye becomes opaque, the eye is not seeing and the only way to restore the visual acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). In half the cases the opacification of the cornea is secondary to dysfunction of the endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of regulating the moisture of the corneal thickness and therefore its transparency.

While the total corneal transplantation has long been the only intervention for these diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called endothelial transplant or graft lamellar later. This intervention is now experiencing significant success as it reduces very significantly the incidence of complications found after transplantation of total cornea and the visual recovery period. This type of transplant is still difficult to achieve and the best technique is not yet established.

Indeed, posterior lamellar transplantation of the cornea may be done manually or using an automated device. Manual techniques allow the preparation of grafts extremely thin but are difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may be less efficient in visual recovery.

The aim of this project is to conduct a prospective study in order to compare these two techniques in terms of postoperative visual recovery and the vitality of the graft during the first year. To date, there is no such study.

The department of Ophthalmology in the University Hospital of Rouen is one of the most famous French teams in the field of cornea transplants and receives many patients from different French regions. The recruitment of 40 patients needed to study should be done without great difficulty over a period of 18 months.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Rouen

intervention_type: Procedure


title: Impact of "Internet Tools" Consultation on Increasing Emergency Attendance

summary: Over the years, there has been an increase in the flow of emergency rooms, which is gradually leading to an overcrowding of emergency unit. This overcrowding is multifactorial with, for example, a decrease in the outpatient care in family medicine and specialized medicine, emergency services unsuitable at the level of premises ... In parallel, investigator note in recent years facilitated access to internet and especially to GAFA which is the acronym for Google, Amazon, Facebook, Apple. As a result, patients have 24-hour access to medical information via websites, blogs and social networks. This information of, often, unreliable medical information can lead to ambiguity among patients about the need for urgent or delayed intervention in the management of their symptoms. In fact, "everything becomes urgent". To date, in France, no study has evaluated the impact and prevalence of consulting a website for medical purposes before consulting an emergency service. The objective of this research will be to assess, in patients presenting in an emergency department, the prior consultation of medical information on a website, the impact on the emergency consultation decision and the relevance of this consultation.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Descriptive Study Comparing Regadenoson Versus Dipyridamole in Use as Pharmacological Stress Agent Before a Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (SPECT)

acronym: REDUCE

summary:
Myocardial perfusion scintigraphy is to evaluate coronary perfusion as well as heart muscle function. This examination takes place in two stages, one imaging at rest and one after a cardiac stress caused. This stress can be triggered as a first-line stress test. A pharmacological stress is proposed when stress test is not possible or contraindicated, Several drugs have a marketing authorization in this indication (adenosine, dipyridamole, regadenoson, dobutamine).

Among them, the regadenoson is the most recent molecule. Marketed in France since 2013, it would allow a reduction of undesirable effects compared to other agents, especially adenosine. It is simple and quick to use thanks to a single dose administration. However, its cost is nearly 30 times higher than dipyridamole. In the investigational center, dipyridamole is currently the first-line pharmacological stress agent, whereas regadenoson is reserved for a limited number of doses, the indication of which must be justified (asthmatic patient or with severe COPD). Few studies in the literature specifically compare these two pharmacological agents (examination time, cost, tolerance) and the opinion on the use of regadenoson in the service is limited.

location_facility: Lyon civil Hospital - Est Hospital Complexe - Nuclear Medicine Service


title: Study on the Prevalence of Hepatitis C In a psychiatRic Population

acronym: SaPHIR

summary:
Viral hepatitis, especially hepatitis C, is a major public health issue. Nowadays, very few studies in France have evaluated the prevalence of hepatitis C in a psychiatric environment.

In 2019, at the time of new treatments for HCV, it therefore seems essential to update the available data by estimating the prevalence of chronic active hepatitis C in psychiatric population. In addition to an update of epidemiological data, it is of high importance to assess the effectiveness of the care pathway for patients in whom chronic active hepatitis C is diagnosed, including the cascade of care, currently too inefficient despite treatments that are themselves ultra-efficient. Indeed, it is essential that once hepatitis is detected, it is formally diagnosed, then that the patient actually starts care and is adherent to treatment (take his treatment according to the prescription and until the end: this implies that the patient accepts his or her illness and understands the value of the prescribed treatments), to hope to cure the infection.

In this context, the SaPHIR study will allow to test a systematic screening of patients in an adult psychiatric environment, through rapid diagnostic tests (RDT). The objective is to promote the adherence of patients, and to assess possible obstacles in order to optimize the screening (RDTs), diagnosis (confirmation of only positive RDTs by venous sampling) and care management circuits in routine practice. In addition, the study envisages a combined HCV-HBV-HIV screening, taking into account the cross-infection risk (same mode of contamination, same risk population, frequent co-infections, more severe liver pathology in case of co-infection, etc.), thus making it possible to take care of the patient as a whole. The results of the SaPHIR study can ultimately be sent to the French health authorities to improve screening and care circuits, and their coverage by social security.

primary_purpose: Other

lead_sponsor: Nantes University Hospital

intervention_type: Diagnostic Test


title: Comparaison du Service Rendu à la Personne Atteinte d'Une Maladie d'Alzheimer et de l'Aidant Par Trois Types de Prises en Charge (Plateforme, Accueil de Jour et Groupe contrôle

acronym: COMPARSE

summary:
One of the interests of the Alzheimer Plan 2008-2010 is to provide increase support to helping families. It's also of major to involve the patient in the most active treatment possible, encouraging social inter relationship as well as cognitive and behavioural stimulation activities.

In the frame of non drug related approaches to Alzheimer disease (AD), several research projects and actions have already been conducted, but no specific study concerning the efficiency of different types of respite care structures have been conducted so far in France. The present project concerns the thematic of the frame "Development and diversification of respite care structures".

A platform is defined in the Alzheimer Plan as a "diversified range of despite structures according to patients' needs and informal caregivers' expectations" providing several objectives:

Two objectives targeting the informal caregivers:

offer spare time or tutored
inform, support and accompany

Two objectives targeting the patients:

encourage maintain of the patient social life and relationships and work together towards his/her psychological and emotional well-being
contribute to improve functional cognitive and sensory capacities

The study COMPARSE suggests to compare for the patient - informal caregiver couple, the impact of three different groups of patient care on health profit; resit platform (P), the day care group (D), the control group without access to a respite structure (C).

primary_purpose: Health Services Research

lead_sponsor: Department of Clinical Research and Innovation

intervention_type: Behavioral

lead_sponsor_type: industriel


title: Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Domomedecine Plateform

acronym: MULTIDOM

summary: Pancreatic cancer is a rapidly developing cancer with a poor prognosis. The mFOLFIRINOX protocol has become the standard medical treatment for this pathology. However, mFOLFIRINOX is the cause of severe toxicities including leukoneutropenia, thrombocytopenia, diarrhea, nausea-vomiting, anorexia, asthenia, weight loss and peripheral sensory neuropathy. Therefore, its indication is limited to patients in good general condition. In practice, it is often interrupted upon the occurrence of hematological and/or clinical grade 3-4 toxicities, Remote patient tele-monitoring of symptoms (Patient Reported Outcomes), body weight, circadian rhythms, sleep and activity would allow the identification of early warning signals reflecting deterioration or improvement in the health of these fragile patients, and trigger proactive interventions, while they are outside the hospital. Thus, the MultiDom study proposes a comprehensive tele-monitoring and telecare strategy that would complement standard of care over a 7-weeks period to 42 consenting patients. The patients receive neoadjuvant or first line chemotherapy with mFOLFIRINOX for advanced or metastatic pancreatic cancer at one of four centres in Ile-de-France region (France).

ReferenceCitation: Bouchahda M, Komarzynski S, Ulusakarya A, Attari A, Duprès A, Breda G, Fritsch A, Adam R, Lévi F (2020) Improving FOLFIRINOX safety in pancreatic cancer patients through multidimensional remote monitoring and proactive care using a domomedecine mobile platform. J Clin Oncol 38: TPS4673.

ReferenceCitation: Lévi F, Komarzynski S, Huang Q, Young T, Ang Y, Fuller C, Bolborea M, Brettschneider J, Fursse J, Finkenstädt B, White DP, Innominato P. Tele-Monitoring of Cancer Patients' Rhythms during Daily Life Identifies Actionable Determinants of Circadian and Sleep Disruption. Cancers (Basel). 2020 Jul 17;12(7). pii: E1938. doi: 10.3390/cancers12071938.

ReferenceCitation: Innominato P, Komarzynski S, Karaboué A, Ulusakarya A, Bouchahda M, Haydar M, Bossevot-Desmaris R, Mocquery M, Plessis V, Lévi F. Home-Based e-Health Platform for Multidimensional Telemonitoring of Symptoms, Body Weight, Sleep, and Circadian Activity: Relevance for Chronomodulated Administration of Irinotecan, Fluorouracil-Leucovorin, and Oxaliplatin at Home-Results From a Pilot Study. JCO Clin Cancer Inform. 2018 Dec;2:1-15. doi: 10.1200/CCI.17.00125.

ipd_sharing: Undecided

lead_sponsor: Ramsay Générale de Santé

intervention_type: Device


title: Effect of the Intervention of Biofields Therapy on Warts of the Hands and Feet in Adults: a Prospective, Randomized, Double-blind Trial

acronym: MAGNETIK

summary:
Traditionally, healers are willing to look after, two out of three French citizens have already appealed to them at least once during their lives. Many healers in good faith are exercising their magnetism as a "gift" often inherited from elders. Now, they create interest of doctors who do not hesitate in some cases to ensure their cooperation, to implicitly recognize their mysterious talents. Some serious studies have examined these practices: Several studies have been conducted on the influence of biofield therapies in pain, depression and fatigue in cancer disease. The investigators propose a study of the effect of magnetism on the wart disease whose cure is objectively assessable.

Sixty-two subjects in total would be included, comparing 2 proportions observed: the proportion of healing in the group treated with a "real" biofield therapist (recognized and affiliated to the National Group for Alternative Medicine in France) to the proportion of healing in the group treated with a "fake" biofield therapist (someone assessed as not having capacity to magnetize). The "fake" biofield therapist, placebo, has been trained to replicate gestures during a training validated by an independent recognized biofield therapist.

ReferenceCitation: Gaillard C, Allain L, Legros H, Brucato S, Desgue Y, Rouillon C, Peyro-Saint-Paul L, Dompmartin A. Real versus sham proximal biofield therapy in the treatment of warts of the hands and feet in adults: study protocol for a randomized controlled trial (MAGNETIK study). Trials. 2017 Jun 7;18(1):263. doi: 10.1186/s13063-017-1994-4.

family: Gaillard

full_name: Cathy Gaillard

given: Cathy

family: Allain

full_name: Laure Allain

given: Laure

family: Legros

full_name: Hélène Legros

given: Hélène

family: Brucato

full_name: Sylvie Brucato

given: Sylvie

family: Desgue

full_name: Yohann Desgue

given: Yohann

family: Rouillon

full_name: Christophe Rouillon

given: Christophe

family: Peyro-Saint-Paul

full_name: Laure Peyro-Saint-Paul

family: Dompmartin

full_name: Anne Dompmartin

given: Anne

journal_name: Trials

lead_sponsor: University Hospital, Caen


title: Impact Of A Training Program And Organization On The Management Of Stroke In The Acute Phase (AVC-II)

acronym: AVC-II

summary:
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region, France (AVC69) (Porthault et al. 2013) the investigators observed that only a small percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of patients reached hospital through an emergency department instead of going directly to a stroke unit. Among those patients, only 2% were finally thrombolysed. A significant part of patients arrived in the emergency department too late to be thrombolysed. However, among the subset of ischemic stroke patients who reach emergency department less than 3 hours after symptoms onset, and who had no clinical or radiological exclusion criteria for thrombolysis, only 15 % were thrombolysed. The hypothesis was that an intervention designed to improve ED professional's knowledge and skills and to develop together efficient clinical pathway would decrease door-to imaging time and consequently door-to needle time and eventually improve overall thrombolysis rate.

The investigators have conducted a cluster randomized controlled stepped wedge trial. All adult patients with suspected stroke arriving in one of the participating ED were included in the study along five successive four-month periods. The program featured: development of written materials (booklets) and video (film), and one day session of standardized training for trainers, at least one nurse and one physician of all EDs, with formal presentation to improve knowledge, and simulation to improve skills for using the "FAST" tool (nurses) and the "NIHSS" score (ED physicians). Additionally, a clinical pathway was developed to adapt general evidence based guidelines to the local organization. The primary outcome is the door-to imaging time.

ReferenceCitation: Haesebaert J, Nighoghossian N, Mercier C, Termoz A, Porthault S, Derex L, Gueugniaud PY, Bravant E, Rabilloud M, Schott AM; AVC II Trial group. Improving Access to Thrombolysis and Inhospital Management Times in Ischemic Stroke: A Stepped-Wedge Randomized Trial. Stroke. 2018 Feb;49(2):405-411. doi: 10.1161/STROKEAHA.117.018335. Epub 2018 Jan 10.

name: From the EA7425, Laboratoire HeSPeR, Lyon, France (J.H., A.T., E.B., A.-M.S.) and CNRS, UMR 5558, LBBE, Equipe Biostatistique-Santé (C.M., M.R.) Université Lyon 1, Villeurbanne, France; Pôle IMER (J.H., A.T., E.B., A.-M.S.), Stroke Center, Hôpital Pierre Wertheimer (N.N., L.D.), Service de Biostatistique et Bioinformatique (C.M., M.R.), and PAM Urgences Réanimation Médicales, Hôpital Edouard Herriot (S.P., P.-Y.G.), Hospices Civils de Lyon, France.

family: Haesebaert

full_name: Julie Haesebaert

given: Julie

family: Nighoghossian

full_name: Norbert Nighoghossian

given: Norbert

family: Mercier

full_name: Catherine Mercier

given: Catherine

family: Termoz

full_name: Anne Termoz

family: Porthault

full_name: Sylvie Porthault

family: Derex

full_name: Laurent Derex

given: Laurent

family: Gueugniaud

full_name: Pierre-Yves Gueugniaud

given: Pierre-Yves

family: Bravant

full_name: Estelle Bravant

given: Estelle

family: Rabilloud

full_name: Muriel Rabilloud

given: Muriel

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

family: Saligari

full_name: Elisabeth Saligari

given: Elisabeth

family: Cailler

full_name: Samira Cailler

given: Samira

family: Hénniche

full_name: Adeline Hénniche

given: Adeline

family: Prost

full_name: Sylvain Prost

given: Sylvain

family: Fournier

full_name: Carole Fournier

given: Carole

family: Le Loch

full_name: Jean-Baptiste Le Loch

given: Jean-Baptiste

family: Roncoroni

full_name: Cécile Roncoroni

given: Cécile

family: Verbois

full_name: Frédéric Verbois

given: Frédéric

family: Debas

full_name: Olivier Debas

given: Olivier

family: Tesniere

full_name: Marc Tesniere

given: Marc

family: Bontemps

full_name: Béatrice Bontemps

given: Béatrice

family: Lavignon

full_name: Jean-Pierre Lavignon

given: Jean-Pierre

family: Rimet

full_name: Mathilde Rimet

given: Mathilde

family: Trinquet

full_name: Patricia Trinquet

publisher: Ovid Technologies (Wolters Kluwer Health)

location_facility: Groupement Hospitalier Edouard Herriot - Urgences Médicales et Psychiatriques Adultes - Pavillon N, 5 Place d'Arsonval


intervention_type: Drug

lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: ZITHROSHU

type: EudraCT Number

source: euctr

title: Azithromycin in Post Diarrheal Haemolytic and Uremic Syndrome

summary: Post diarrheal hemolytic and uremic syndrome (D+HUS) is the first etiology of acute renal failure in children less than 5 years old in France. Previous works highlighted a mortality rate of 2 % and a prevalence of renal sequelae at one year after D+HUS onset in 25 % of patients D+HUS is a consequence of a gastrointestinal infection with shiga toxin (Stx) producing E.coli (STEC). The most frequent straight is E.coli O157H7. The sequence of STEC induced HUS is now well known. Typically, digestive symptoms appear five days following STEC ingestion. STEC colonize the intestinal mucosa, adhere to the enterocyte and cause a typical attaching/effacing lesion and inflammation. Then, diarrhea and vomiting occurred. D+HUS occurs in about 10% of patients and is a consequence of Stx systemic absorption. Indeed, Stx are released in the gastrointestinal tract, then after transferred to the systemic circulation. At the cellular level, Stx binds the globotriosylceramide (Gb3Cer) localized at the surface of the endothelial and epithelial cells of target organs. Following binding to Gb3Cer, the A subunits of Stx are internalized and trigger the activation of the apoptotic program leading to cell death. In addition, Stx are also able to enhance the production and the release of pro inflammatory factor (IL-1, TNFα, IL-6). Cytokines locally produced by Stx-stimulated cells can amplify the inflammatory processes and the prothrombotic state leading to the constitution of the microangiopathic lesions of HUS. To this day, management of D+HUS involves supportive care mainly based on fluid management, dialysis and red blood cells transfusions. Specific therapies used in D+HUS (plasma infusion, antithrombotic and anti inflammatory agents) failed to improve the course of D+HUS. The use of antibiotics remains not recommended while meta-analysis clearly showed that the use of bactericidal antibiotics could worse the course of D+HUS. In vitro experimentations highlighted that some classes of antibiotics like fluoroquinolones dramatically increase the production and the release of Stx before bacterial lysis and worsen the outcome of D+HUS in animal models. By contrast, azythromycin, a bacteriostatic antibiotic of the macrolides family blocking the protein synthesis in bacteria, has a strong inhibitory effect on Stx production and release by STEC as well as it inhibits the in vitro growth of STEC strains. In addition, azithromycin is able to inhibit the Stx-induced production of inflammatory cytokines which are considered to be essential for the development of D+HUS. Consistently the use of azithromycin in animal models of D+HUS dramatically improved the survival rate. Preliminary data on humans with D+HUS treated with azithromycin highlighted a lower prevalence of severe gastrointestinal involvement than in control patients. All these data supported the hypothesis that azithromycin should have a beneficial effect on D+HUS and should improve the short and long term outcome and deserves to be formally demonstrated in human with D+HUS.


summary:
Fibromyalgia affects 0.7 to 3.3% of the adult population and 7-10 times more women than men. In France, the prevalence is 1.6% according to a French study conducted in 2009 and published in 2011 by Serge Perrot et al.

The definition of fibromyalgia was recently amended with particular consideration of cognitive and somatic symptoms, factors not involved in the initial criteria of the ACR classification. Several factors are in favor of a malfunction of the central modulation of pain and poorer performance noxious inhibitory controls descendants (DNIC: diffuse noxious inhibitory controls) have been demonstrated. In fibromyalgia patients, the DNIC (diffuse noxious inhibitory controls) are altered with less pain inhibition than controls. Dysfunction of the central pain modulation is widely described in the literature and contributes to pain complained of fibromyalgia.

According to the Recommendations of the European League Against Rheumatism (EULAR) 2006, antidepressants have a genuine analgesic efficacy in controlled studies. Milnacipran is an antidepressant known and used in major depressive disorder according to its marketing authorization but is also part of the molecules used in the treatment of chronic neuropathic pain and fibromyalgia according to the recommendations of the EULAR. A review included five double-blind studies on 4,000 participants who took 100 mg or 200 mg milnacipran or placebo over a period of 8 weeks to 24 weeks. A moderate response was obtained for 40% of participants treated for each dose of milnacipran on the criteria of "at least 30% pain relief" Impression and global change. Substantial improvement with milnacipran compared to placebo has been shown.

To date, the link between the weakening of DNIC in fibromyalgia and effectiveness of drug treatment has not been shown.

This study aims to assess the degree of impairment of DNIC in fibromyalgia patients may be predictive of the efficacy of milnacipran.

ReferenceCitation: Macian N, Pereira B, Shinjo C, Dubray C, Pickering G. Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial. Trials. 2015 Apr 3;16:134. doi: 10.1186/s13063-015-0659-4.

family: Macian

full_name: Nicolas Macian

given: Nicolas

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Shinjo

full_name: Coralie Shinjo

given: Coralie

family: Dubray

full_name: Claude Dubray

given: Claude

family: Pickering

full_name: Gisèle Pickering

given: Gisèle


title: To Assess the Tolerance of Intraperitoneal (IP) Nivolumab After Extensive Debulking Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Ovarian Carcinoma, Through a Phase Ib/II Study Including Patients at 3 Dose-levels for Nivolumab

acronym: ICONIC

summary:
Spread pattern, the lack of alternative treatments, and emerging data on the activity of anti-Programmed death ligand 1 (PDL1) targeted checkpoint inhibitor therapy in gynecological cancers provide the rationale for this investigation.

Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) are likely to increase the tumor-antigen expression and the mutational load. As a result, it would be interesting to combine this approach with immunotherapy. Moreover, Intraperitoneal (IP) infusion will directly target the peritoneal cavity and potentially enhance the immune response. Indeed some recent papers indicate that the peritoneum could be considered as a lymphoid organ, involving "milky spots", thus able to produce a better immune response when immunotherapy is given by IP route rather than intravenous (IV) route.

The investigating team in Lyon, France is one of the major groups for HIPEC research in Europe (Pr O. Glehen et al) - Reference center for the tumors of the peritoneum (French National Cancer Institute).

The aim of this study is to assess in this I/II phase study, the feasibility of extensive debulking surgery and HIPEC followed by Intraperitoneal (IP) nivolumab dose escalation in patients with advanced ovarian carcinoma.

study_start_date_type: Anticipated


title: Cost-utility Analysis Treatment of Bartholin's Abscess : Word Catheter Versus Incision-drainage.

acronym: BARTHO-KT

summary: Bartholin's gland abscess is a condition requiring emergency consultation. Placement of a Word catheter, which is a minor technique used in France as a treatment of bartholin's Abscess, can be done in an emergency room without hospitalization. Actually, incision-drainage, which is the most widespread treatment in France, is performed on day surgery with or without overnight hospitalization. Our hypothesis is that the use of Word catheter compared to incision-drainage would not modify the quality of life of the patients but would allow a saving of up to 3 M€ per year in France.

location_facility:
Chu Poitiers
Chu Lille
Chu Angers
Rennes University Hospital
Ch Antoine Beclere
CHU CAEN
Chu Cochin
Nancy University Hospital
Chu Nantes
Chu Toulouse
Chu Estaing
Institut Franco Britannique
Chi Poissy
Chu Caremeau
Bordeaux University Hospital
Ch Kremlin Bicetre
Chu Robert Debre


title: Assessment of the "Appui Parental": A Program of Early Support to Parenthood

summary:
In so-called at risk families, the child-parent attachment relationship is more difficult to set up and this can be a barrier to social and emotional development of young children. To help parents build and sustain this relationship, and to prevent child development disorders, many parenting programs have been created, usually with frequent home visits by early childhood professionals. In France, therapeutic interventions at home are little used and they are not evaluated.

In Montpellier, an action of this type has been conducted since 2001 by the "Conseil Départemental de l'Hérault" in collaboration with the University Hospital of Montpellier including, in addition to home visits, supervision of professionals: the Appui Parental Program.

Before extending this action to other areas of Herault, the "Conseil Départemental de l'Hérault", the "Abri Languedocien" and the University Hospital of Montpellier are conducting an assessment to know the effectiveness of the program for families under care.

This 3-year multicenter prospective study includes 88 children aged 1 to 20 months from families meeting vulnerability criteria previously defined, 44 benefiting Appui Parental program (experimental group) and 44 benefiting a regular support (control group).

A paediatric examination on the basis of the Denver scale, parental questionnaires, questionnaires to professionals and an a video of infant-parent interactions are used. The data, collected at baseline and 18 months later, will be compared.

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier


title: Randomised Phase III Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over Intergroup Trial: Ffcd, Gercor, Gerico, Unicancer-gi

acronym: ADAGE

summary:
Colorectal cancer occurs mainly in elderly patients. Recent estimation showed that in France more than 50% of the patients diagnosed with a colorectal cancer are 70 years old or more. Adjuvant chemotherapy has demonstrated a benefit on disease-free survival and overall survival after a stage III colon cancer resection. Nevertheless adjuvant chemotherapy is poorly used in elderly patients. Prognostic improvement with chemotherapy based on 5FU is suggested by a post-hoc analysis of randomized prospective clinical trial. But elderly patients in this study were highly selected and patients older than 80 represented only 0.7% of the total population. Thus, there is still a concern about the benefit of adjuvant 5FU-based chemotherapy in very elderly unselected patients.

The recommended treatment for stage III adjuvant chemotherapy is a combination of fuoropyrimidine and oxaliplatin. Nevertheless oxaliplatin did not demonstrated survival advantage in elderly patients.

Altogether there are still two matters of debate:

First, is there a benefit of fluoropyrimidine-based adjuvant chemotherapy for unfit elderly patients?
Second, is there a benefit of oxaliplatin-based adjuvant chemotherapy for fit elderly patients? The aim of this randomized phase III study is to evaluate the benefit for disease-free survival of adjuvant chemotherapy in elderly patient and which chemotherapy.

The elderly patient population will be dichotomized into two groups according to physician's choice after a multidisciplinary evaluation involving a geriatrician, with two different randomization assignments. The patients with an expected life-expectancy below 4 years according Lee score are excluded of this study.

Some biological tumour abnormalities are more frequently observed in elderly (i.e. mismatch repair deficiency), therefore an evaluation of specific biological prognostic factors is needed in elderly population.

ReferenceCitation: Aparicio T, Francois E, Cristol-Dalstein L, Carola E, Maillard E, Paillaud E, Retornaz F, Faroux R, André T, Bedenne L, Seitz JF. PRODIGE 34-FFCD 1402-ADAGE: Adjuvant chemotherapy in elderly patients with resected stage III colon cancer: A randomized phase 3 trial. Dig Liver Dis. 2016 Feb;48(2):206-7. doi: 10.1016/j.dld.2015.11.023. Epub 2015 Dec 2.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Groupe Hospitalier de la Rochelle Ré-Aunis

location_facility: Institut de Cancérologie de Bourgogne - GRRECC

location_facility: Centre d'Oncologie et de Radiothérapie du Pays-Basque

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Importance of Multidimensional Assessments in Accompanying Schooling of Children With Mild to Moderate Intellectual Disability.

acronym: EVAL'ID

summary:
The EVAL'ID study aims to demonstrate the value of a multidimensional assessment in accompanying schooling of children with Intellectual Disability. The study will be performed in the Rhône department (France) in children aged from 5 to 13 years with mild to moderate Intellectual Disability , and attending school either at ULIS (Unités Localisées pour l'Inclusion Scolaire, which enables disabled children to attend regular schools), or IME (Instituts Médico-Educatifs, which are special schools mandated to accommodate children and young people with Intellectual Disability at any level of disability). A multidimensional assessment encompasses the assessment of academic, cognitive, behavioral and adaptive skills of the children, with validated and reliable neuropsychological batteries, called ID Kit (Intellectual Deficiency assessment Kit), which includes the following scales : the Wechsler Intelligence Scale for Children 4th edition (WISC-IV), the Vineland Adaptive Behavioral Scale II, the GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger, which is the French translation of the Nisonger Child Behavior Rating Form), and an academic skills rating form (GEVA-SCO). A comparison of the children neuropsychological profiles according to the type of school they attend, will be perform.

The project consists of three phases:

Stage 1: Collection of information from each child records at MDPH (Departmental Administration for Disabled Persons), IME, ULIS schools, including the assessments that were performed, and from a survey of both caregivers and parents regarding their respective perception and knowledge of the child's disability
Stage 2: All the children who were not previously assessed with the ID kit will be further evaluated using these tests. The results of these assessments will be shared with parents and caregivers.
Stage 3: A survey regarding the perception and knowledge of the child's disability will be carried out again among caregivers and parents.

time_perspective: Cross-Sectional


title: 50% Nitrous Oxide and 50% Oxygen (MEOPA) Conscious Sedation Versus Placebo in Fiberoptic Bronchoscopy : Randomized, Double Blind, Placebo-Controlled Study

summary:
Fiberoptic bronchoscopy may generate pain, anxiety or cough and dyspnea. It may then induce discomfort and then run down its yield. Systematic local anaesthesia does not always suffice and FOB may be conducted under general anaesthesia. Premixed nitrous oxide and oxygen (MEOPA) could be efficient to avoid general anesthesia risks and to reduce organizational costs. Nitrous oxide induces anaelgesia and anxiolysis when administered in oxygen at a 50% concentration.

MEOPA is being delivered in France for every short painful medical in-patients procedure since 2001. At a concentration of 50% in oxygen, and delivered through a facial mask, it produces a conscious sedation useful during endoscopy. MEOPA safety is due to its short term effect, which ends 5 minutes after cessation of inhalation. It therefore allows ambulatory medicine.

Two randomized double blind controlled studies were driven in fiberoptic bronchoscopy (Fauroux 2004, Atassi 2005) and showed its efficacy on pain control and sedation.

We will perform our Study to estimate MEOPA efficacy in term of pain control (Visual Analogic Scale (VAS)), anxiety control (COVI Scale), cough and number of general anaesthesias, comparing FOB under MEOPA and Oxygen (double blind, randomized, placebo-controlled study.


title: Operation of the Groupe Hospitalier Paris Saint-Joseph Clinical Ethical Reflection Assistance Group During the COVID-19

acronym: ETHICOVID

summary:
Between March and May 2020, Ile-de-France hospitals faced an influx of patients infected with the COVID 19 virus. Faced with the scale of the pandemic, the aggressiveness of this pathology, severe respiratory complications and the shortage of resuscitation beds , the teams had to make difficult decisions on the therapeutic strategy, the orientation of patients in the event of respiratory distress and their intensive care status. To do this, each establishment reflected in an emergency context on procedures for collegial deliberation and assistance in ethical reflection, based on the recommendations of the National Consultative Ethics Committee and learned societies such as the French Society. of Anesthesia and Resuscitation or the French Society of Support and Palliative Care.

Some hospitals had already institutionalized the ethical approach upstream of the health crisis. For example, the Groupe d'Aide à la Réflexion Éthique Clinique (GAREC) was created in November 2005 within the Paris Saint-Joseph Hospital Group. GAREC is a collegial and multidisciplinary entity, made up of 8 members who intervene at the request of caregivers when a clinical situation turns out to be ethically complex. He gives an advisory opinion, the decision belonging to the referring physician.

At the start of the COVID period, GAREC changed its structure, organization and operation in order to respond to the multiple issues posed by the complexity of the health situation.

This study seeks to analyze the adaptation mechanisms put in place by this group during the epidemic period as well as the nature of the benefit provided to the caregivers who requested it, to the patients and to their relatives.

Adaptation mechanisms: during the COVID period, GAREC was extended to other paramedical professions (psychologists, nurses), thus increasing from 8 to 15 members. It has set up 2 weekly meetings, an on-call duty and on-call duty. The requests were made easier: they could be done by phone, by email, day or night. Several questions emerge: What were the motivations for enlarging the group? How were the members integrated into this group? What were its operating methods? How and by whom was it seized? For what purpose? Were the intervention teams multidisciplinary?
Nature of the benefit provided by GAREC: it will be approached by semi-structured interviews via a qualitative research method.

This work is part of a broader reflective perspective:

What representation of ethics underlies this device?
Does the institutionalization of ethics help to enhance or make invisible what ethics owes to daily healthcare practices?
To what extent does the institutionalization of clinical ethics make health institutions more human and virtuous?
Under what conditions can a device like GAREC go beyond the role of ethical guarantor and transform the institution and nursing practices in the service of a collective reflective approach? This study will be carried out on patient data usually collected as part of their care and on data collected through semi-structured interviews with healthcare professionals. As such, it fits into the perspective of grounded theory.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Population-based Cancer Observatory of the French Region Sud-Provence-Alpes-Côte d'Azur Recruiting Incident Cases of Cancer Since 2005

acronym: cancer observ

summary:
Cancer is the leading cause of death in Western countries. In France cancer control plans (National screening programmes) and recommendations for the management of cancer patients (multidisciplinary team meetings), have been implemented. Evaluating the effectiveness of these policies aiming for improved prevention and management is essential. However to conduct such an evaluation, a baseline reference requiring ongoing, reliable and complete data collection is necessary and can be used for epidemiological research.

There is no cancer registry in the French Region Sud-Provence-Alpes-Côte d'Azur. In view of this situation, the regional Health Agency appointed the public health department of the Nice Côte d'Azur University and the Centre for computerized pathology data collection (CRISAP-PACA) to develop a Cancer Observatory. Since 2005, the public health department collects data concerning invasive and in situ cancers from all the histopathology labs in the French Region Sud-Provence-Alpes-Côte d'Azur, gathered in the CRISAP-PACA, and transmits incidence cancer rates to the regional Health Agency. In 2007, a quality control procedure, comparing a random sample of data collected by the Cancer Observatory with pathology lab reports, confirmed the validity of the collected data with fewer than 3% in disagreement with the report's conclusions. In 2008, the estimated completeness of cancer records collected from histopathology laboratories was higher than 90% for new cases of breast and colorectal cancer within the age range concerned by the screening programme. Since 2012, public and private hospitals treating cancer patients as well as the regional cancer network ONCOPACA, coordinating multiple team meetings, have been contacted to transmit to the public health department cases of cancer without histological diagnosis. In addition, patients with cancer have been geolocated to study the influence of environmental exposures on the occurrence of cancers (patients living near of waste incinerator, highways).

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Interest of Oral Corticosteroids in the Treatment of Chronic Subdural Hematomas. Prospective Randomized Multicenter Trial

acronym: hemacort

summary: The chronic subdural hematoma is a common disease in the population over 60 years. For example, in patients over 70 years, it occurs every year 7 new cases per 100,000 people. A chronic subdural hematoma is an accumulation of blood in the intracranial space between brain membrane (dura mater) and the brain. The origin of blood in this area follows a minor brain injury, which causes the rupture of small vessels in the area. During its evolution, the volume of the hematoma increases. After a few weeks, the amount of fluid build-up can compress the brain. That's when clinical symptoms occur: persistent headaches, neurological deficits, seizures, impaired consciousness, cognitive functions (memory loss, impaired intellectual function, or hallucinations, etc.). The compression of the brain may cause impairment of consciousness resulting in more severe cases coma and death. At this stage, a neurosurgical intervention is necessary. Recurrences are numerous (15 to 25% recurrence over six months after neurosurgery). That is why in France, about 20% of medical teams administer a postoperative treatment with corticosteroids to reduce the risk of recurrence. Until now, the potential benefit of this treatment has not yet been confirmed by a clinical study. So the purpose of this research.


title: Idiopathic Scoliosis Surgery in Adolescents ; Earnings a Multidisciplinary Management of Pain and Quality of Life

acronym: SQUAD

summary:
Around the scoliosis surgery, the pain (pre or post operative, physical, psychological, fantasy or real) is a major concern for adolescents and their families. She is also a key concern of caregivers, both its assessment and management is complex. this pain involved predominantly in the quality of life of these teenagers today who will become the adults of tomorrow.

To date in France, no study aims to describe and evaluate the effect of a multidisciplinary approach and its impact on the quality of life of these young people made.

The present study wish to prevent, anticipate and limit the short, medium and long-term morbidity. Focus will be on pain and its management, on preparing for surgery, hospitalization, follow-up after surgery, rehabilitation until recovery.

Help teens reclaim their bodies after the changes caused by the intervention is a major issue.

This study believe that support good quality, adapted to patient needs will limit operating and postoperative pain in the medium and long term.

Medical team developed special attention around the teenagers that are operated for scoliosis (teen groups and parent groups, interview before the operation and counseling, physiotherapy support ...).

The present study would systematize data collections in order to have a comprehensive and accurate assessment of the care.

The qualitative research will focus on the multidisciplinary care in an effort to evaluate the whole course of these teenagers, their experience and to identify efforts to put in place to optimize the current care.

lead_sponsor: University Hospital, Toulouse


title: Assessment of Women's Insight and Understanding of Non-invasive Prenatal Testing (NIPT) During Their First Trimester Ultrasound

summary:
Down's syndrome is the leading cause for mental retardation in France. Screening for this chromosomal abnormality is systematically proposed during pregnancy.

Until April 2017, prenatal screening for Down's syndrome was based on a combined screening test which included fetal ultrasound markers and maternal serum hormone levels prescribed after the first trimester ultrasound. Depending on this screening result, women that presented a higher risk of ill fetuses could benefit from invasive procedures (amniocentesis or trophoblastic biopsy) in order to have a karyotype and make certain diagnosis. The latter procedure involved risks of complications such as miscarriages, infections and water break.

A new screening procedure is available since 2017. It relies on detecting an extra 21 chromosome in cell-free DNA by a simple maternal blood test, called noninvasive prenatal screening (NIPT). This screening test is highly efficient with a detection of 99 % of fetuses affected by Down's syndrome and therefore enables practitioners to avoid 95% of invasive samples. NIPT implies to proceed to a diagnosis test as well (amniocentesis and trophoblastic biopsy) to obtain karyotype and confirm diagnosis.

Few studies show a concerning level of Down's syndrome screening general strategy. There is a clear lack of understanding of the information provided by the health professional during the first trimester ultrasound. Women report feeling uninformed and confused about French screening strategy. Nevertheless, high quality insight is essential to ensure validity of women's consent to perform Down's syndrome screening and quality of provided health care.

Since introduction of NIPT, no study has been carried out to assess women's prior knowledge to NIPT for Down's syndrome. Main objective of the study is therefore to evaluate women's information and understanding of Down's syndrome screening using NIPT. Secondary objectives stand in collecting modalities of the provided information by the doctor performing the first ultrasound and assess patient's satisfaction regarding this information.

Understanding of this new screening strategy by pregnant women is a key issue in decision making. This observational study is intended for all pregnant patients from 11 to 17 + 6 WA (weeks of amenorrhea) expecting a single baby, consulting in the obstetrics and gynecology department of the University Hospital of Reims for their 1st trimester ultrasound. Participation to the study will not change patient's medical care. The doctor who carries out the ultrasound will not be aware of the patient's participation in the study. Concordant results with literature using the experience of what was done for Down's syndrome screening prior to NIPT are expected. Communication on this matter to the lay public is scarce. Level of knowledge regarding NIPT before the consultation is expected to be insufficient. The absolute necessity of upstream information (brochure provided by secretaries, information disclosed throughout the three month pregnancy consultation, booklet delivered with initial documents ....) to enhance patient's comprehension and satisfaction will be highlighted.


title: Psychological Effect of the pancréatectomy: a Feeling of Strangeness

acronym: REPPSE

summary:
The cancer of the pancreas represents 1,8 % of cancers in France, with 9040 new cases in 2011 (France). This cancer is known to be of dark forecast. Indeed, of late clinical expression, is diagnosed most of the time at a late stage . For that reason, the cancer of the pancreas is considered as the one who presents the least good prognosis for survival. He affects more frequently the men than the women (rate of incidence of 7,7 against 4,7 cases for 100 000). Between 1980 and 2005, the incidence increased by 3,8 % at the women, by 2,0 % at the men (INCA Source, on 2012). The number of cases of cancer of the pancreas in the world is estimated at 278 684, with 266 669 deaths a year (Cancer Incidence and Mortality Worldwide - Globocan, on 2008).

In these cases of very grave cancers, the surgery represents the unique treatment to curative aim, although always not warning of a risk of relapse, and susceptible of entrainer to complications. Thus the pancréatectomy establishes a modality of specific treatment. Remaining the ultimate chance of cure, it is only rarely possible. Indeed, only 10 in 20 % of the cancers of the pancreas exocrines can be handled by surgery when the latter establish 95 % of the cases of pancreatic cancer.

To date, the psychosomatic approach goes away from the search for the causes to be interested more and more in the psychological consequences of the somatic disorders, what we wish to study in the present search.

Once the surgical indication was put, one of the key elements in the psychological plan is the uncertainty as for the outcome of the ablation, as well as the consequences psychopathologiques which ensue from it. The mutilation of an organ, whatever it is, can have an impact on the identity of the person constituting at the same time a physical and narcissistic wound, while having psychological effect at the sick person such as of the anxiety, a depression, or another a state of post-traumatic stress.

More exactly, a study was able to show a positive relation between cancer of the pancreas and depression in a retrospective study. A review of literature concerning the specific relations between depression and cancer of the pancreas was also realized. Besides, 50 % of the patients have a significant level of anxiety and 15 % of depression. A study was nevertheless able to bring to light that the depression does not affect the survival of the patient. Finally, a study was also able to find a decrease marked with the quality of life of the patients during the next first 6 months the operation.

Various studies so studied the quality of life of the patients reached of a cancer of the pancreas in particular in comment surgery. It is also advisable to specify that besides the depression and the quality of life, the strategies of adaptation of the patients having undergone a pancréatectomy were also the object of studies. However, none documented, to date, the specific psychological consequences described clinically by certain patients, in particular the feeling of confusion and strangeness felt, and it in association with the possible presence of a state of post-traumatic stress in several weeks of the operation.

lead_sponsor: Institut Paoli-Calmettes


title: Chemsex Among Men Who Have Sex With Men : Perceived Risks and Coping Strategies, a Qualitative Study.

acronym: Chemsex

summary:
The research hypothesis is that access to prevention and harm and risk reduction associated with the use of psychoactive substances in a sexual context is insufficient for MSM practicing chemsex. This would lead to a lack of awareness of the risks taken and insufficient or inadequate strategies to protect themselves.

This qualitative study has a comprehensive objective. The aim is to identify the risks perceived by MSM practicing Chemsex and their coping strategies. The study is based on individual semi-directed interviews and focus group. The criteria for inclusion are: an age greater than or equal to 18 years, being a man having sex with men and having used psychoactive substances in a sexual context at least once in the past 12 months. Participants were recruited through a gay geo-social networking app on mobile phones on a voluntary basis. At the same tim+e, flyers presenting the study are also distributed to the "chemsex" consultations at the Montpellier University Hospital in France as well as to an association fighting against AIDS in Montpellier.

Data are subjected to an inductive method analysis, bringing out by constant comparison conceptualizing categories illustrating the experience and making it possible to identify and understand the risks felt and the coping strategies.

ipd_sharing_description: NC


title: Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients: a Prospective, Randomized, Multicenter Study

acronym: EXTUB-OBESE

summary: Mechanical ventilation is the first artificial support used in intensive care. After a period of invasive mechanical ventilation, patients should be separated from the ventilator (weaning period of mechanical ventilation). If weaning and extubation (removal of the tracheal tube) are successful in approximately 80 to 90% of resuscitation patients, 10 to 20% will develop acute respiratory failure (ARF) in the days following extubation. Obesity concerns 20 to 30% of resuscitation admissions in France. The pathophysiological changes in the obese patient explain the over-risk of desaturation and ARF in the post-extubation period. In order to decrease the incidence of extubation failure (need for reintubation within 48-72h post-extubation) of the most fragile patients, it is recommended in intensive care unit to prophylactically use various ventilatory support strategies and / or oxygenation, among which noninvasive ventilation (NIV) and oxygen therapy, which can be administered in two ways: High-Flow Humidified Nasal Oxygen Therapy (HFNO) or standard oxygen therapy. These strategies have never been compared in the obese post-extubation critically ill patient. Our hypothesis is that NIV is superior to oxygen to prevent the development of ARF in obese extubated patients in intensive care unit.

primary_purpose: Prevention

location_facility: Centre Hospitalier Universitaire Saint Eloi


title: Cell Therapy in Critical Limb Ischemia by Implantation of Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells

acronym: CLI

summary:
Study drug and dosage form : Umbilical cord-derived mesenchymal stem cells (HB-MSC1)

Dose and route of administration : 60 × 106 cells or 120 x 106 cells to be injected as 30 individual intramuscular injections, once at V0 within 48 hours to 2 weeks maximum after the revascularization procedure.

Comparator, dose and route of administration : Placebo, injected as 30 individual intramuscular injections, once at V2 within 48 hours to 2 weeks maximum after the revascularization procedure.

Study centers : 3 centers in France

Study objectives :

Primary: Evaluation of the feasibility and systemic and local tolerance of an implantation, via intramuscular route, of allogenic HB-MSC1, associated with a revascularization procedure, in patients suffering from critical limb ischemia (CLI).

Secondary: Preliminary evaluation of efficacy and dose effect relationship of the MSC implantation in hemodynamic, anatomical and functional terms.

Exploratory: Constitution of a serum bank of the patients included in the study for inflammation and auto immunity biomarkers analysis

Study design : This will be a multicenter Phase IIa study, consisting in a first, open-label, ascending dose feasibility and safety stage followed by a randomized placebo-controlled feasibility, safety and preliminary efficacy stage.


title: Effects of Proteins Fraction Derived From Milk on Bone Mineral Density and Bone Metabolism in Healthy Postmenopausal Women

summary:
Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis is a serious public health problem that is responsible for approximately 3 million women with osteoporosis in France, with approximately 150,000 cases per year occurring in vertebral fractures, of which only one third would be diagnosed and 50,000 hip fractures (causing death in 20% of cases). The frequency of the disease increases with age, particularly among women: 10% among women aged 60 years and 20% among women aged 65 and 40% among women aged 75. At menopause, oestrogen deficiency causes alterations of the immune system, decreased bone formation, microarchitectural deterioration and a decrease in bone mass. Various factors may contribute to this decrease in bone density such as diet, lifestyle, or the genetic background.

According to prospective studies, an overexpression of 135% of hip fractures is expected at European level in 50 years. Therefore, it is interesting to develop new prevention approaches aimed at maintaining the healthy aging population. Nutritional researches can consider setting up a real prevention.

Studies suggest that specific milk protein fraction contain factors able to promote bone formation, inhibit bone resorption in vitro. In animal model, they showed that the specific fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption. Furthermore, in human volunteers, a supplementation with the specific milk protein fraction maintains balanced bone remodelling and increase bone mineral density. For example, in healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p<0.05).

The objective of this study is to assess the efficacy of daily consumption of the milk proteins fraction on bone mineral density improvement in healthy postmenopausal women.

lead_sponsor: Soredab

intervention_type: Dietary Supplement


title: Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes From a 10 Year Follow-up Linking Datasets Between Patient Medical Records and Patient Claims: the ESTHYM Study

acronym: ESTHYM

summary:
A retrospective, systematic study of reimbursed healthcare costs over a 10 year period in patients suffering from Familial Chylomicronaemia Syndromes (FCS) or Multifactorial Chylomicronaemia Syndromes (MCS) in order to establish the relative healthcare burden of both syndromes by linking the Hospices Civils de Lyon (HCL) registry of FCS or MCS patients and data obtained from FCS or MCS patients followed in Paris, Nantes and Lyon to the French National Health System (NHS) healthcare claims database, the Système National d'Information Inter-Régimes de l'Assurance Maladie (SNIIR-AM).

A probabilistic approach will be used to link databases. This linkage will be based on the following variables: age, gender, date of discharge of any hospitalization, date of any imaging procedure.

This study will help to describe, in real life, the management of severe hyperglyceridaemia in France. In addition, the descriptive results will help obtain a better understanding of the patients suffering from this disease, the burden of the disease and the healthcare consumption linked to this disease. Even if this consumption of care has been relatively unexplored until this point, it is not negligible. The potential of merging genomics and claims data for cardiovascular research could help to identify ways to optimize disease

time_perspective: Retrospective

ReferenceCitation: Belhassen M, Van Ganse E, Nolin M, Bérard M, Bada H, Bruckert E, Krempf M, Rebours V, Valero R, Moulin P. 10-Year Comparative Follow-up of Familial versus Multifactorial Chylomicronemia Syndromes. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1332-e1342. doi: 10.1210/clinem/dgaa838.

name: PELyon, PharmacoEpidemiology Lyon, Lyon, France

family: Belhassen

full_name: Manon Belhassen

given: Manon

name: Department of Pneumology, Croix-Rousse University Hospital, Lyon, France

name: HESPER 7425, Health Services and Performance Research, Claude Bernard Lyon 1 University, Lyon, France

family: Van Ganse

full_name: Eric Van Ganse

given: Eric

family: Nolin

full_name: Maeva Nolin

given: Maeva

family: Bérard

full_name: Marjorie Bérard

given: Marjorie

name: Department of Endocrinology Louis Pradel University Hospital, Hospices Civils de Lyon, INSERM UMR 1060 Carmen, Claude Bernard Lyon 1 University, Lyon, France

family: Bada

full_name: Hanane Bada

given: Hanane

name: Department of Endocrinology, Pitié Salpêtrière University Hospital, APHP, Paris, France

family: Bruckert

full_name: Eric Bruckert

name: Department of Endocrinology, Nantes University Hospital, Nantes, France

family: Krempf

full_name: Michel Krempf

given: Michel

name: Department of gastroenterology pancreatology, Beaujon University Hospital, AP-HP, Clichy, France

family: Rebours

full_name: Vinciane Rebours

given: Vinciane

name: Department of Nutrition, Metabolic Diseases and Endocrinology, Aix Marseille Univ, APHM, INSERM, INRAE, C2VN, University Hospital La Conception, Marseille, France

name: Department of Endocrinology, APHM University Hospital, Marseille, France

family: Valero

full_name: René Valero

given: René

family: Moulin

full_name: Philippe Moulin

given: Philippe

journal_name: The Journal of Clinical Endocrinology & Metabolism

oa_host_type: repository

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

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

lead_sponsor: Hospices Civils de Lyon


title: INTERNATIONAL VALIDATION STUDY OF THE ALGOPLUS SCALE IN FIVE LANGUAGES

acronym: ALGOPLUS LE

summary:
Acute pain is responsible for unnecessary suffering. Among elderly patients, acute pain is frequent and underestimated, especially when these patients have cognitive disorders. The expression of pain is then modified and the conventional tools for evaluating pain cannot be used. Thus the existence of pain must be detected on the basis of a behavioural assessment.

It is nonetheless necessary to have the assistance of standardised and validated tools. In France, the Doloplus Group has proposed a scale called Doloplus, validated in January 1999, and is now proposing a new scale for acute pain, Algoplus that has been validated in French (4). Doloplus has been recently translated and validated in 5 languages and an identical methodology will be used in this protocol.

Internationally, although several teams are working on the development of scales that can be used for non-communicating elderly subjects, there is as yet no validated tool for acute pain assessment.

Considering 1- the lack of tools at an international level and 2- the frequent request from many practitioners worldwide, the Doloplus group has offered to validate the Algoplus® scale in 5 foreign languages, English, German, Spanish, Italian, Portuguese. A rigorous methodology with the help of a statistician will be used in this validation process.


title: Development of a Risk Score to Predict the Vacuum Extraction Failure

acronym: FADS

summary:
Safe operative vaginal delivery requires a careful assessment of the clinical situation.

During the pushing efforts, the complexity of the delivery can lead to choose between an operative vaginal delivery attempt and a caesarean section straightaway. An emergency caesarean section for failed operative vaginal delivery is associated with a higher fetal and maternal morbidity, compared to a successful operative vaginal delivery and to a caesarean section straightaway.

The objective of this study was to develop a risk score of failed vacuum extraction leading to an emergency caesarean section.

This score could be an objective tool to help the obstetricians to choose between a vacuum extraction attempt and a caesarean section straightaway.

The investigators included patients who benefited from a vacuum extraction attempt in the Regional Teaching Hospital of Besançon (France) between January 2010 and December 2015. Patients were separated into two groups : the vacuum extraction failure group and the vacuum extraction success group.

The investigators selected maternal, fetal and labor characteristics which could influence success or failure of the vacuum extraction and compared them between the two groups.

The score was developed with the characteristics which significantly influence the vacuum extraction failure.

ReferenceCitation: Verhoeven CJ, Nuij C, Janssen-Rolf CR, Schuit E, Bais JM, Oei SG, Mol BW. Predictors for failure of vacuum-assisted vaginal delivery: a case-control study. Eur J Obstet Gynecol Reprod Biol. 2016 May;200:29-34. doi: 10.1016/j.ejogrb.2016.02.008. Epub 2016 Mar 2.

ReferenceCitation: Miot S, Riethmuller D, Deleplancque K, Teffaud O, Martin M, Maillet R, Schaal JP. [Cesarean section for failed vacuum extraction: risk factors and maternal and neonatal outcomes]. Gynecol Obstet Fertil. 2004 Jul-Aug;32(7-8):607-12. French.

ReferenceCitation: Palatnik A, Grobman WA, Hellendag MG, Janetos TM, Gossett DR, Miller ES. Predictors of Failed Operative Vaginal Delivery in a Contemporary Obstetric Cohort. Obstet Gynecol. 2016 Mar;127(3):501-506. doi: 10.1097/AOG.0000000000001273.

ReferenceCitation: Alexander JM, Leveno KJ, Hauth JC, Landon MB, Gilbert S, Spong CY, Varner MW, Caritis SN, Meis P, Wapner RJ, Sorokin Y, Miodovnik M, O'Sullivan MJ, Sibai BM, Langer O, Gabbe SG; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Failed operative vaginal delivery. Obstet Gynecol. 2009 Nov;114(5):1017-1022. doi: 10.1097/AOG.0b013e3181bbf3be.

ReferenceCitation: Langeron A, Mercier G, Chauleur C, Varlet MN, Patural H, Lima S, Seffert P, Chêne G. [Failed forceps extraction: risk factors and maternal and neonatal morbidity]. J Gynecol Obstet Biol Reprod (Paris). 2012 Jun;41(4):333-8. doi: 10.1016/j.jgyn.2011.11.001. Epub 2012 Jan 9. French.

ReferenceCitation: Gopalani S, Bennett K, Critchlow C. Factors predictive of failed operative vaginal delivery. Am J Obstet Gynecol. 2004 Sep;191(3):896-902.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Investigation of the Therapeutic Value of Transcranial Stimulation With Direct Current on Language Disorders in Semantic Dementia

acronym: STIM-SD

summary:
Within the spectrum of fronto-temporal lobar degeneration (FTLD) semantic dementia (SD) causes profound language dysfunction. SD damages semantic processing typically in the temporal poles (anterior temporal lobes, ATL). It is an early onset disease (often before 65 years of age) affecting about 4000 patients in France and for which no validated treatment is available.

For several years a growing number of studies have explored the effects of transcranial stimulation (TCS) on aphasic patients following stroke. Several studies have targeted left-sided language areas and/or homotopical right-sided regions with excitatory or inhibitory TCS, respectively, according to the principle of inter-hemispheric inhibition. In addition, repetitive multi-day TCS has provided evidence for long-lasting language effects (>6 months) presumably linked to stimulation-induced neuroplasticity. Such investigations have provided promising results and have demonstrated that the stimulation site is a determining factor by showing that stimulation of cortical areas belonging to the language network usually results in more convincing effects than stimulating areas outside that network. Despite these findings the use of TCS in degenerative language diseases, such as primary progressive aphasias including SD, has only been explored in few small cohort studies and, surprisingly, they have not targeted language-related cortices.

This project proposes the application of multi-day repetitive TCS with direct current (tDCS) in a large population of SD patients (N=60). It is built on a exploratory investigation of our team which has used three single tDCS sessions in a double-blind sham-controlled study. Excitatory and inhibitory tDCS to the left and right temporal pole, respectively, demonstrated highly significant transient effects (20 min) on semantic processing in 12 SD patients, providing 'proof of concept' and the rationale for this project. The aim here consists of using repetitive multi-day tDCS for a potential therapeutic outcome leading to long-lasting semantic improvement via neuroplasticity. The project is grounded on 2 hypotheses: i) tDCS to temporal poles (left-excitatory, right-inhibitory) reactivates semantic processing in SD, ii) repetitive tDCS during ten days could induce neuroplasticity and therapeutic language improvement.

ReferenceCitation: Sanches C, Levy R, Benisty S, Volpe-Gillot L, Habert MO, Kas A, Ströer S, Pyatigorskaya N, Kaglik A, Bourbon A, Dubois B, Migliaccio R, Valero-Cabré A, Teichmann M. Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial. Trials. 2019 Nov 20;20(1):632. doi: 10.1186/s13063-019-3613-z.

family: Sanches

full_name: Clara Sanches

given: Clara

family: Levy

full_name: Richard Levy

given: Richard

family: Benisty

full_name: Sarah Benisty

given: Sarah

family: Volpe-Gillot

full_name: Lisette Volpe-Gillot

given: Lisette

family: Habert

full_name: Marie-Odile Habert

given: Marie-Odile

family: Kas

full_name: Aurelie Kas

given: Aurelie

family: Ströer

full_name: Sébastian Ströer

given: Sébastian

family: Pyatigorskaya

full_name: Nadya Pyatigorskaya

given: Nadya

family: Kaglik

full_name: Anna Kaglik

given: Anna

family: Bourbon

full_name: Angelina Bourbon

given: Angelina

family: Dubois

full_name: Bruno Dubois

family: Migliaccio

full_name: Raffaella Migliaccio

given: Raffaella

family: Valero-Cabré

full_name: Antoni Valero-Cabré

given: Antoni

family: Teichmann

full_name: Marc Teichmann

given: Marc

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

repository_normalized: dnet

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

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

location_facility: Département de Neurologie - Centre des maladies neurologiques, cognitives et comportementales


title: FERTilité féminine, Agents ENvironnementaux et Stress OXydant

acronym: FERTENOX

summary:
Synthetic products used in industrial, pharmaceutical, agro-alimentary or agricultural fields are found in our environment. Thus, humans could be simultaneously exposed to several of these pollutants. Furthermore, these environmental agents exert or could exert adverse actions on fertility, by altering gamete and embryo quality through endocrine disruptor effects or through increase in oxidative stress in gonads (cellular pathway known to be involved in several human reproductive pathologies).

In this context, the objectives of the present project are to obtain descriptive and analytical data on woman and oocyte exposure to several environmental agents (bisphenols, ethynylestradiol and glyphosate). The relation between these pollutant measures in follicular fluid and urine (from women receiving follow-up of in vitro fertilization (IVF) protocol in the University hospital of Tours, France) and the oocyte quality, the IVF and pregnancy successes will be studied. Several oxidative stress biomarkers in blood and follicular fluid will be also measured for these women, who will complete a questionnaire on their lifestyles. Finally, thanks to in vitro approaches, the effects and the mechanisms of action (including oxidative stress) of these pollutants (alone or in cocktails) will be studied on granulosa cells from these patients.

status: Not yet recruiting

lead_sponsor: University Hospital, Tours

location_facility: Department of Reproductive Medicine and Biology, Univesity Hospital, Tours


title: Study of Kinetics and Efficacy of the Immune Response Against COVID-19 Among Hospital Staff

acronym: IMMUNO-COVID

summary:
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff.

A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic.

Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool.

Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding.

The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: PAncreatic Adenocarcinoma in Hospital

acronym: APACH

summary:
Few data are currently available in the literature on pancreatic adenocarcinoma in France. About 8,000 new cases each year in France. The 5-year survival for all stages combined is <5%. This is the only digestive cancer in which mortality / incidence ratio is 98%.

Epidemiological characteristics at diagnosis, the impact on the survival of recent advances related to surgery, adjuvant chemotherapy and new standard forms of adjuvant chemotherapy (FOLFIRINOX) are mispriced in real life.

The development of new drugs and the development of Phase II and III require a better understanding of the state of this disease in the country.

The main objective is to describe the characteristics of the pancreatic adenocarcinoma at diagnosis in France and make an inventory of diagnostic practices and support.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_country: Belgium France

location_facility:
Chicas
Hôpital des chanaux
CH Roubaix
CH Chambery
CH Dourdan
CHI Poissy Saint Germain
CH Pontoise
CH Haut Anjou
CH Blois
Centre Hospitalier de Bigorre
CHBA de Vannes
CH Melun
Centre Hospitalier de Perpignan
CH Bayeux
CH Chalons en champagne
Centre Hospitalier de Lagny
CH de la Fontaine
CH Compiègne Noyon
CH de la région d'Annecy
CH Chartres
CH Châteauroux
CH du Mans
CH Avignon
CH Sainte Musse
CH Quimper
CH d'Aubenas
CHIAP
CH Valenciennes
CH Forcilles
Centre hospitalier départemental Vendée
Lens
CH Draguignan
Centre Hospitalier Côté de lumière
CHIV Villeneuve Saint-Georges
CH de Bourges
CH sud francilien
Centre Hospitalier Montelimar
Centre hospitalier Yves Le Foll
HPA Castres Mazamet
CH Robert Ballanger
CHI Créteil
CH Montfermeil
CH Dreux
CH Bagnols sur Ceze
CH Béziers
CH Saint Camille
CH Bourg en Bresse
CHR de Mercy-Metz
CH Auch
CHG Oloron
CH Gonesse
CH Saint Quentin
CH de Jolimont
CH Nord Deux Sèvres
Ch Cholet
Centre Hospitalier de Meaux
CH Gabriel Martin
CH de Creil
CHR Orléans
CHAM
CH Simone Veil
CH Montauban
CH Tourcoing
CH François Mitterand
CH Angoulême
CH Niort


title: Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke

acronym: PREVENTION AVC

summary:
Stroke is a growing disease. It is the first pathology responsible for acquired handicap, the second of dementia and the second cause of death in the world. In France, they are the leading cause of death in women and the third cause in men. Sequelae and disabilities also represent a significant financial cost for health insurance.

The early management of the treatment improves the patient's vital and functional prognosis. The ability of the patient to identify the signs of stroke requiring urgent consultation and proper orientation are therefore crucial for further management.

The most common signs that patients must recognize are muscle weakness or sudden paralysis of an arm, leg or half of the body, asymmetry of the face, tingling, numbness of a hemi-body, speech or understanding, loss of vision of an eye or hemifield, disorder of the coordination of a hemi-body. The variety of clinical pictures complicates primary prevention.

In this context, a 2010-2014 National Stroke Action Plan was undertaken with the aim, among other things, of developing information to prevent stroke and to limit its sequelae. In this plan, the attending physician must improve prevention in high-risk patients and be a link between the city and the hospital for follow-up.

Several questions arise:

Are patients who are regularly followed by a general practitioner better educated on the signs of stroke / TIA and thus more able to give an appropriate warning?
What is the profile of patients who have not been affected by the different modes of primary prevention?
What are the effective means of information and those desired


title: Establish an Evaluation Scale for the Quality of Primary Care in Multi-professional Health Centres and Homes Integrating the Point of View of Patients in Complex Care Situations and Their Caregivers.

summary: The prevalence of multimorbid patients and complex care is increasing in France and elsewhere in the world. It concerns 60% of the over 65 years old. Comprehensive care, the involvement of the patient and his caregivers appear as the solutions for the management of these new care situations. The structures of multi-professional grouping, developing a coordinated exercise (GECO), appear as the privileged place to take care of these patients. These structures become the main place of exercise in France (improved working conditions for professionals, financial incentives, public policy, etc.); they have shown their ability to formulate patient care protocols, to produce coordinated exercise, to better involve the patient and caregivers in their care. The question of improving the quality of care arises. To date, there is no data on the subject apart from some evaluations mainly medico-economic. The patient's place in the evaluation showed his interest with the existence of a proven correlation between patient satisfaction in particular and his compliance and health outcomes.

lead_sponsor: University Hospital, Brest

location_facility:
Pôle de santé de Lanmeur
Maison de santé de Châteauneuf-du-Faou
Maison de santé de Bannalec
Maison de santé de Coray
Maison de santé de Trébeurden


title: The Influence of the Perceived Workload on Performance During High Fidelity Simulation in Surgical Specialty ( Including Anesthesia) and Nurses

summary:
High-fidelity simulation (HFS) is a learning method extensively used for training of surgical specialty (including anesthesia) and nurses. It has a beneficial effect on knowledge of algorithms, team working, early warning scores, and communication. Various skills can be learned using a standardized simulation programs.

The complexity of instructional design may produce cognitive overload, high stress level and anxiety. This may increase fatigue, facilitate errors, and is associated with inferior task performance which may impede memorization of learned skills resulting in inefficient learning/simulation failure. Subjectively reported scales can accurately identify the level of perceived workload and mental demand in individuals during simulation tasks. One example is the National Aeronautics and Space Administration (NASA)-TLX - the most accepted subjective measure of human workload in various industries including medicine.

Surgical specialty (including anesthesia) and nurses training curriculum in Lyon, France, includes several HFS scenarios with a large panel of critical events. The investigators aim to evaluate the effect of burden of workload and stress perceived by surgical specialty (including anesthesia) residents and nurses during HFS on the learning performance, and to grade different learning scenarios by their difficulty.

lead_sponsor: Claude Bernard University