title: Pilot Study of Evaluation of the Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

acronym: SALVADS-Fluo

summary:
Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins.

Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer.

The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area.

The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.

ReferenceCitation: Cortese S, Kerrien E, Yakavets I, Meilender R, Mastronicola R, Renard S, Leroux A, Bezdetnaya L, Dolivet G. ICG-induced NIR fluorescence mapping in patients with head & neck tumors after the previous radiotherapy. Photodiagnosis Photodyn Ther. 2020 Sep;31:101838. doi: 10.1016/j.pdpdt.2020.101838. Epub 2020 May 30.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Genetic Autopsy and Sudden Death of Young Subject

acronym: AGEMOS

summary: The purpose of the study is to better identify hereditary cardiac causes of sudden unexpected death in young subjects through Next-Generation Sequencing of autopsy tissue

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Pathology department and forensic Institute, Raymond Poincaré hospital, Garches

collaborators: Referal Center for Inherited cardiac diseases, Pitié Salpêtrière Hospital, Paris

collaborators: Clinical research Unit, Ambroise Paré Hospital, Boulogne Billancourt

collaborators: Cardiogenetic and molecular and cellular myogenetic functionnal unit Pitié Salpêtrière hospital, Paris

collaborators: Molecular and medical Virology Laboratory, Medical School, Reims

intervention_type: Genetic

lead_sponsor_type: academique

status_simplified: Unknown

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: AGEMOS

titre: Autopsie génétique et mort subite avant 40 ans

discipline_principale: médecine légale

nom_porteur: LORIN DE LA GRANDMAISON

prenom_porteur: Geoffroy


title: Intestinal Metagenome of Undernourished in Patients

acronym: INT-METAVOSA

summary: The objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition.


title: Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells

acronym: ANOPEC 3

summary: The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms.

study_type: Interventional

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Biological


acronym: EC-MOTION

summary:
The objective of the study is to investigate the exposure difference between antibiotic studied patients in intensive care with Extracorporeal Membrane Oxygenation and patients without Extracorporeal Membrane Oxygenation.

The exhibition is evaluated by population pharmacokinetic modeling.

lead_sponsor: Rennes University Hospital

intervention_type: Other


title: Methodical Search of Protective Factors During Interview of Suicidal Elderly Patients: Effect on the Proposed Care

acronym: ProFAES

summary:
Suicidal intentionality is generally stronger among the elderly, suicidal acts are more violent and are combined with a greater physical fragility. The suicide of an older adult is a situation that often leads to helplessness feelings.

Analysis of the literature reveals two types of major interventions in order to reduce suicide rate: reducing risk factors and increasing protective factors. Risk factors are well documented, particularly from studies using psychological autopsies. However, protective factors are much less studied for the elderly. Yet the identification of relevant and available protective mechanisms in a suicidal crisis is essential to effectively guide nurses and health professionals in therapeutic commitment and intervention.

status: Terminated

study_completion_date_type: Actual

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Richard-Devantoy S, Jollant F. [Suicide in the elderly: age-related specificities?]. Sante Ment Que. 2012 Autumn;37(2):151-73. doi: 10.7202/1014949ar. French.

ReferenceCitation: Conwell Y, Thompson C. Suicidal behavior in elders. Psychiatr Clin North Am. 2008 Jun;31(2):333-56. doi: 10.1016/j.psc.2008.01.004.

ReferenceCitation: Casadebaig F, Ruffin D, Philippe A. [Suicide in the elderly at home and in retirement homes in France]. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):55-64. French.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

intervention_type: Behavioral


type: Other Identifier

title: Naturalistic Clinical Studies in Several Centres of Electrodermal Hyporeactivity in Adult Patients With Primary Depression

acronym: EUDOR-A

summary: Suicide, suicide attempts and depression are major social problems. The present research program focuses on the relationship between electrodermal hyporeactivity, as measured by the ElectroDermal Orienting Reactivity (EDOR) Test, and suicide and suicide attempts with death intent in patients with a primary diagnosis of depression. Electrodermal hyporeactivity has in several publications from different laboratories repeatedly been shown to have a high sensitivity (up to 97%) and high raw specificity (up to 98%) for suicide. Such levels are unique in psychiatry. The relationship between suicidal propensity and hyporeactivity can be considered as strongly significant. Almost all evidence in the topic up today has been established in research settings with specific exclusion criteria for some secondary psychiatric and some somatic illnesses. However, it is important to study the relationship between electrodermal hyporeactivity and suicide in relatively unselected patients regarding secondary psychiatric diagnoses and somatic diagnoses in a natural clinical ward situation and milieu. A previous naturalistic study proved that a test of electrodermal hyporeactivity fits very well into the daily clinical work.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Montpellier

collaborators: EMOTRA-AB, Göteborgsvagen 74, 433 63 Sävedalen, Sweden

intervention_type: Device


title: An Adult Height Prediction Model for Congenital Adrenal Hyperplasia From a National Cohort (OPALE Model Study)

acronym: OPALE Model

summary:
Congenital Adrenal Hyperplasia (CAH) is a genetic rare disease, which alters the adrenal production of gluco and mineralo corticoïds. The treatment consists in supplementing children with hydrocortisone. Despite care for these children has improved substantially across decades, short adult height (AH) still remains an important consequence of the disease. About 20% of patients have an AH below 2 standard deviations compared to their expected AH.

In the OPALE-Model study, the investigators want to collect data from a cohort of 496 CAH French patients, born between 1970 and 1991 with a known genotype. Using their age, sex, growth, disease, bone maturation and pubertal data, the investigators will build a model which allows to predict their AH using data available at 8 years of age. The growth charts built from this cohort have shown that currently used formula to calculate the predicted AH (Bayley-Pineau's formula) is not applicable to children with CAH.

In this project, the investigators plan to compute an AH prediction model using data from children born between 1970 and 1993, and to validate the model using data from a different cohort (i.e. children born between 1994 and 1998). this choice was due to availability of data for computing the model first, and in a second stage, data from more recently born patients.

status: Completed

time_perspective: Retrospective

ReferenceCitation: Bretones P, Riche B, Pichot E, David M, Roy P, Tardy V, Kassai B, Gaillard S, Bernoux D, Morel Y, Chatelain P, Nicolino M, Cornu C; French Collaborative CAH Growth Study Group. Growth curves for congenital adrenal hyperplasia from a national retrospective cohort. J Pediatr Endocrinol Metab. 2016 Dec 1;29(12):1379-1388. doi: 10.1515/jpem-2016-0156.

lead_sponsor: Hospices Civils de Lyon

status_simplified: Completed


title: Influence of Medical and Nursing Teams Composition on Patient Mortality in Intensive Care

acronym: TEAMIC

summary: The individual characteristics and interactions of health care workers in intensive care units may influence patient safety. This study aims to quantify the influence of team familiarity among the members of medical and nursing staffs on risk of patient death.

study_start_date_type: Anticipated

location_facility: Service de Réanimation médicale, Hôpital de la Croix Rousse

appel_a_projets: PREPS

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: TEAMIC

titre: Influence de la composition d'équipe sur la mortalité des patients en réanimation

discipline_principale: anesthésiologie / réanimation

nom_porteur: GUERIN

prenom_porteur: Claude


title: Specificities of Cushing's Osteoporosis Compare to Postmenopausal Osteoporosis : pQCT Analysis in Comparison With a Group of Controls.

acronym: SOCS

summary:
Osteoporosis induced by glucocorticoids excess constitutes the main cause of secondary osteoporosis. Most of data available are provided from cohort studies of patients treated by corticosteroids, affecting among 1% of population. In contrast, very few data on osteoporosis are available in the Cushing syndrome (CS), a rare disease affecting 1 or 2 million of inhabitants, and characterized by an endogen glucocorticoid excess production. This affection is responsable of frequent fractures, occuring in 30-60% of patients (vertebral asymptomatic in 50% of case, hip, ribs). Fractures occurs often frequently above the threshold usually used for osteoporosis (T-score<-2.5), most often in the range of osteopenia. These data suggest that surface bone density isn't sufficient to characterize bone fragility, architectural factors are probably involved, and should be evaluated. The specificity of osteoporosis induced by endogen glucocorticoids excess in comparison with osteoporosis induced by estrogenic deficiency in post-menopausal women is poorly known, especially in endogen glucocorticoid excess.

A recent microarchitecture studies showed alterations of cortical compartment in patients with Cushing's syndrome, confirming by our preliminary preclinical data from a transgenic murin model of Cushing's syndrome.

In these ten last years, new radiologic tools have been developped, and are able to evaluate bone architecture. The peripheral Quantitative Computed analyses the bone architecture with distinction between cortical and trabecular compartment.

Therefore, we aim to determine the specificity of osteoporosis induced by glucocorticoids excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.

status: Recruiting

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Unité de recherche GReD CNRS UMR6293 / Inserm

status_simplified: Ongoing


title: An Open Single-center, Phase I Proof of Concept Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy With Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients With a First Clinical Episode Highly Suggestive of Multiple Sclerosis

acronym: MS and EBV-CTL

summary: The etiologic mechanisms involved in multiple sclerosis (MS) are not yet fully understood. Indeed MS is a multifactorial disease involving genetic and environmental factors and Epstein-Barr-Virus (EBV) could be one of these factors. However the link between EBV infection and the immunological mechanisms underlying MS is not clear. Robust sero-epidemiological evidences support an association between EBV infection and MS, and immunological data suggest an altered/deficient immune response against this virus. In healthy individuals EBV produces a persistent infection that is tightly controlled by the immune system. In patients with MS, cellular and humoral immune studies demonstrate an altered response against the virus with a T-cell abnormal reactivity against the EBV-infected autologous B-cells, elevated humoral immune response to Epstein Barr Nuclear Antigen-1, and in the case of children, an increased EBV shedding, demonstrating frequent EBV reactivations. Thus, it has been proposed, that patients with MS present a partially inefficient control of the EBV infection. Some experimental data support the hypothesis suggesting that the presence of autoreactive EBV-B cells in the meninges of patients, probably due to an insufficient clearance of these cells by the immune system, lead to the infiltration of autoreactive T cells. Another hypothesis also suggests a deficient control of the virus, in that case during the inactive phase of the disease. Together, the above data and hypotheses lead to the notion that an immune intervention capable of restoring the host-EBV balance could be beneficial to MS patients In this project, we will assess the feasibility and safety of autologous transfer of several amounts of CD8 T cells directed against autologous EBV transformed B cell lines, in order to finally restore an efficient control of EBV in MS patients. The main objective of the project is to test the feasibility and safety of the process, while efficacy parameters will be also assessed in secondary objectives.

primary_purpose: Treatment

lead_sponsor: Nantes University Hospital


title: Influence of Surgeon-anesthesiologist Collaboration on Patient Outcomes After Pheochromocytoma Surgery

acronym: CCAP

summary: Collaboration between the surgeon and the anesthesiologist is key for delivering a safe pheochromocytoma surgery. This study aims to establish the collective performance of surgeon-anesthesiologist team by quantifying the relationship between their previous collaborations and patient complications.

location_facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

intervention_type: Procedure


title: High Intensity Preoperative Inspiratory Muscle Training (IMTHi) Effects on the Perioperative Inflammatory Reaction in Cardiac Surgery With an Associated Biocollection.

acronym: EMI HiPo

summary: This study evaluates the impact of preoperative high-intensity inspiratory muscle training (IMThi) before cardiac surgery on perioperative inflammatory response. Half participants will receive high intensity inspiratory muscle training and the others a sham inspiratory muscle therapy.

design_allocation: Randomized

ReferenceType: result

ReferenceCitation: Furon Y, Dang Van S, Blanchard S, Saulnier P, Baufreton C. Effects of high-intensity inspiratory muscle training on systemic inflammatory response in cardiac surgery - A randomized clinical trial. Physiother Theory Pract. 2023 Jan 13:1-11. doi: 10.1080/09593985.2022.2163212. Online ahead of print.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Informa

lead_sponsor: University Hospital, Angers


title: Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults

acronym: CASSANDRA

summary:
Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant.

The collection should be done as soon as possible, in the reception of vital emergencies or in the urgencies. The collection consists of the realization of a Glasgow score and a scale of Kremlin-Bicêtre for all patients by completing a standardized collection sheet. The collection of GCS and Kremlin-Bicêtre must be did at the same time. The collection sheet is filled by medical personnel trained.

The future of the patient is informed at 6 months using the Glasgow Outcome Scale- Extended, which will be made during a following consultation or by phone. Additional data will be collected on the folder (ventilation time, days of hospitalization, mortality).

lead_sponsor: Poitiers University Hospital


title: Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.

acronym: CBT

summary: This study evaluates the performance of "CRYOBEAUTY MAINS", a Cyto-selective Cryotherapy based on Difluoroethane as a treatment of Solar Lentigines in 30 volunteers. Only one application of "CRYOBEAUTY MAINS" in one hand (right or left hand according to the randomization code).

lead_sponsor: Cryobeauty

sponsor_collaborators: Cryobeauty CEISO

lead_sponsor_type: industriel


title: Peripheral Ischemia Evolution Assessed by Ultra-wide Field Angiography in Patients With Diabetic Macular Edema

summary: Patients with diabetic macular edema treated with aflibercept injections for visual impairment will be observed in standard care during 12 months. They will undergo visual assessments by Ultrawide Field angiography at baseline and at 12 months

lead_sponsor: Association Pour La Recherche En Vision Du Service D'Ophtalmologie De L'Hôpital


title: Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities

acronym: EvAd

summary: There are very few studies on emotion management in chronically ill patients. They usually include small sample size (less than 30 persons) and are not randomized controlled trials. However, emotion management is an essential coping skill in mental well-being and quality of life and is the subject of numerous studies in psychology.The investigators hypothesized that a creative and physical activities combination in chronically ill will promote the strengthening of emotion management skill. The investigators will conduct an innovating study combining quantitative and qualitative variables in a randomized controlled trial to confirm our hypothesis.

primary_purpose: Supportive Care


title: Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients

summary: The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients

lead_sponsor: BBraun Medical SAS


title: High Dosage Buprenorphine as a Drug Strategy Withdrawal Assistance of Analgesics Opioid After Failure of an Opioid Tapering-off Strategy.

acronym: SEVROP

summary:
The prevalence of analgesics opioids addiction in chronic pain patient is very difficult to know. Many studies indicated that the prevalence of addiction varied from 0% up to 50% in chronic non cancer pain patients, and from 0% up to 7.7% in cancer pain patients. Analgesics opioids use have increasingly been increased in chronic pain for 20 years. However, a long use, at least 3 months in this type of pain has not proved a large efficiency and we have noticed a habituation, tolerance and withdrawal when treatment was decreased or stopped. In current practice, patients with chronic pain, often keep their analgesics opioids despite the absence of pain relief and benefits in quality of life.

Nowadays, no withdrawal strategy is the reference in chronic non-cancer pain patients with physical opioid dependence. The most common clinical strategy is progressive decrease of analgesic opioid. But this strategy is often a failure in these patients (no data are available in literature).

It's necessary to make a prospective pilot study to assess benefits from this practice.

The primary objective of this study is to assess a new ambulatory withdrawal strategy, consisting of a temporary opioid rotation with buprenorphine in CNCP patients suffering from physical withdrawal symptoms and who have failed a conventional strategy of progressive withdrawal from their opioid analgesic treatment.

status: Active, not recruiting

intervention_type: Drug


title: Ionized Calcium and Behavioural Disorders in Older Adults (CALICO Study)

summary: The primary objective of this study is to determine whether geriatric inpatients with severe behavioral disorders exhibit higher serum ionized calcium concentration than geriatric inpatients without behavioral disorders, but no difference in serum calcium or corrected calcium concentrations. The secondary objective of this study is to determine whether the serum ionized calcium concentration is associated with behavioral and cognitive performance among geriatric inpatients.


title: Development and Evaluation of a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised

acronym: Gastrostomy

summary: The aim of the study is to improve care practice related to gastrostomy management. This a before-after study, aimed at evaluating knowledge of care givers, families and patients about gastrostomy management. The intervention includes 1) A training in a care protocol for hospital care givers, and 2) A booklet for patients, families, and outpatient care givers. The evaluation criterion is a questionnaire to assess knowledge of hospital care givers, patients, families, and outpatient care givers.

design_allocation: Non-Randomized


title: Early Detection and Paramedical Care of Sexual Difficulties in Nervous System Diseases: Example of Multiple Sclerosis and Brain Tumors

acronym: NEUROSEX

summary: This study aim to ensure that the implementation of a paramedical screening program and counseling in sexual health of patients with neurological pathologies (low-grade gliomas and Multiple Sclerosis) improves their sexual health.

appel_a_projets: PHRIP

acronyme: NEUROSEX

titre: Dépistage précoce et prise en charge paramédicale des difficultés sexuelles dans les maladies du système nerveux : l'exemple de la SEP et des tumeurs cérébrales (Approche quantitative interventionnelle prospective)

discipline_principale: neurologie

nom_porteur: LEFEBVRE

prenom_porteur: Sandrine


title: RITUX-PLUS. A Prospective Open Trial to Assess the Efficacy and Safety of a Treatment Combining Rituximab and Belimumab in Adults With Persistent Immune Thrombocytopenia.

acronym: RITUX PLUS

summary: Previous studies have shown that increase level of BAFF could promote the settlement of long-lived plasma cells in the spleen of ITP patients treated with anti-CD20. This single-center prospective pilot study, currently in phase IIa, will evaluate the efficacy of a rituximab and belimumab sequential combination treatment. Investigators plan to include 15 patients with persistent ITP over a 24-month inclusion period. Each patient will be followed for 1 year

ReferenceType: derived

ReferenceCitation: Mahevas M, Azzaoui I, Crickx E, Canoui-Poitrine F, Gobert D, Languille L, Limal N, Guillaud C, Croisille L, Jeljeli M, Batteux F, Baloul S, Fain O, Pirenne F, Weill JC, Reynaud CA, Godeau B, Michel M. Efficacy, safety and immunological profile of combining rituximab with belimumab for adults with persistent or chronic immune thrombocytopenia: results from a prospective phase 2b trial. Haematologica. 2021 Sep 1;106(9):2449-2457. doi: 10.3324/haematol.2020.259481.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)


title: Wake-sleep Cycle and Melatonin Secretion Dynamics Associated With 12 Hours Shift Work in French Nurses

summary: Nonstandard time-schedules work are widespread in the world of work. Shift and night work have been shown to be responsible for a desynchronization of biological rhythms, associated with melatonin secretion impairment and sleep disturbances. However, while health consequences of night and shift work are widely recognized and represent a major public health concern (High Authority of Health 2012 Recommendations and National Agency for Public Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system is affected by shift work remain poorly understood. Indeed most of the studies in the fields are cross-sectional, based on few blood or urinary samples in a single work position, in workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few studies have assessed melatonin secretion alterations in relation to objective sleep measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle recording.


title: Measuring Impact on Safety Culture in Nursing Homes, a Multifaceted Device for the Analysis of Care Associated Adverse Events

acronym: EHPAGE

summary: The Réseau QualiSanté (risk management network) hardly works on risk management in nursing homes. A model to help nursing homes managers to structure and analyze adverse events has been constructed by a working group of health professionals in the Réseau QualiSanté. Several questions appeared: is the model able to increase patient safety culture of professionals working in nursing homes? How to characterize adverse events in nursing homes? How frequent are they? The main objective of this research project EHPAGE is to measure the impact of the model to structure and analyze adverse events in nursing homes on the patient safety culture of professionals. The project combines quantitative data (questionnaire) and qualitative data (interviews).

ReferenceCitation: Teigne D, Mabileau G, Anthoine E, Lucas M, Leclere B, Moret L, Terrien N. Transcultural adaptation and psychometric study of the French version of the nursing home survey on patient safety culture questionnaire. BMC Health Serv Res. 2019 Jul 15;19(1):490. doi: 10.1186/s12913-019-4333-5.

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

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

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Springer-Nature

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: EHPAGE

titre: Impact d'un dispositif multifacette pour l'analyse et la gestion des événements indésirables associés aux soins sur la culture de sécurité en EHPAD

discipline_principale: organisation des soins

nom_porteur: MORET

prenom_porteur: Leila


title: Study of the Frequency and of the Regulatory Function of Positive T Lymphocytes Dual CD4CD8aa (DP8a) Specific to a Bacteria of the Intestinal Microbiota (Faecalibacterium Prausnitzii) in Atopic Dermatitis, Asthma and Allergic Rhinitis

acronym: Prévall-DP

summary:
The prevalence of allergic diseases (atopic dermatitis, asthma, rhinitis, conjunctivitis and food allergy) has increased dramatically in industrialized countries over the last 20-30 years.

Allergic diseases are present especially in children and young adults, but all age groups are affected, with variations across countries and age. To propose new therapies, the investigators must first understand the physiopathology.

Since their discovery the regulatory T cells have continued to be the subject of work to understand their role in maintaining immune homeostasis in the human body but also their involvement in autoimmune diseases, inflammatory diseases, transplants of solid organs or fluids and allergic diseases.

It was identified two broad classes of regulatory T cells:

T cells = natural regulators acquisition of a phenotype and a regulatory function right out of the thymus ( CD25 + / CD127 + low / FoxP3 +).
T cells induced regulators = acquisition of a phenotype and a regulatory function on the periphery depending on the cytokine micro-environment.

Phenotypic characterization of these is less obvious and even more so than during the last ten years several induced regulatory T cell populations have been described ( eg, Tr1 ).

A new subpopulation of T cells induced in patients with inflammatory bowel disease recently identified have a particular phenotype as bearing the CD4 and CD8 double marking with a regulatory phenotype.

These regulatory T cells are also induced a specific of a commensal intestinal bacterium (Faecalibacterium prausnitzii).

Regarding allergies, it has been widely demonstrated a relationship between changes of the intestinal microbiota and the occurrence of allergic diseases.

The investigators would therefore propose a cross-sectional study, single-center, controlled, single blinded to study the role of T cells called double positive induced regulators DP8 to compare the frequency and the regulatory function of specific DP8 of Faecalibacterium prausnitzii in atopic dermatitis, asthma and allergic rhinitis compared to control samples.


title: Identification Des barrières au dépistage du Cancer du Col utérin à la Réunion et Des Leviers d'amélioration

acronym: FOSFORE

summary: FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island and key levers for improvment.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Epidemiology of Hepatitis A,B and C Virus by Dried Blood Spot in Homeless Population

summary:
Social insecurity is a significant cost in human terms (health and societal), it defines evil and can be identified as difficulties accessing health and especially water.

We chose to take stock of these populations defined by difficulties accessing water as precarious setting. Subjects homeless population fall into this by accident of life, a life "homeless" or migrant subjects often illegally having only transitory access (associative or charitable structures host) the conditions precarious sanitation including drinking water or toilet. Populations of slums in the same conditions or the presence rationed water (one tap for 150 people) restricts hygiene.


acronym: THROMBONETS

summary:
Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment and mortality worldwide despite the development of revascularization therapies (intravenous Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years, neutrophil extracellular traps (NETs) have been identified as major triggers and structural factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively correlated with the infarct size and negatively correlated with electrocardiogram (ST-segment) resolution. This later study revealed that in vitro addition of DNase I accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be promising targets for improved thrombolysis in AIS.

The aim of this study is to assess the impact of NETs composition of thrombi retrieved during endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and AIS etiologies.

status: Withdrawn

ReferenceCitation: Ducroux C, Di Meglio L, Loyau S, Delbosc S, Boisseau W, Deschildre C, Ben Maacha M, Blanc R, Redjem H, Ciccio G, Smajda S, Fahed R, Michel JB, Piotin M, Salomon L, Mazighi M, Ho-Tin-Noe B, Desilles JP. Thrombus Neutrophil Extracellular Traps Content Impair tPA-Induced Thrombolysis in Acute Ischemic Stroke. Stroke. 2018 Mar;49(3):754-757. doi: 10.1161/STROKEAHA.117.019896. Epub 2018 Feb 8.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home Continuous Positive Airway Pressure or At-home Non-invasive Ventilation

acronym: APARDetp

summary: The primary objective of this study is to study the effect of therapeutic education on patient adherence for at-home continuous positive airway pressure (CPAP) or at-home non-invasive ventilation. This first study will use data already present in the Association for Home Assistance and Rehabilitation (APARD) database to compare patients who received therapeutic education with a control group who did not.

collaborators: Association pour l'Assistance et la Réhabilitation à Domicile (APARD)


title: Effects of Cyclosporine A Pretreatment of Deceased Donor on Kidney Graft Function: A Randomized Controlled Trial

acronym: Cys-A-Rein

summary: Organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. According to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints and mortality during the first year after transplantation.

ReferenceCitation: Orban JC, Fontaine E, Cassuto E, Baumstarck K, Leone M, Constantin JM, Ichai C; AzuRea network. Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial. Trials. 2018 Apr 17;19(1):231. doi: 10.1186/s13063-018-2597-4.

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

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

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

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

collaborators: Centre Hospitalier Universitaire de Nice

collaborators: Centre Hospitalier Universitaire de Nīmes

appel_a_projets: PHRCN

nom_etablissement: CHU DE CLERMONT-FERRAND

acronyme: Cis A Rein

titre: Effet de l'administration préventive de ciclosporine A chez le donneur d'organes sur la fonction des reins transplantés : étude randomisée contrôlée.

nom_porteur: CONSTANTIN

prenom_porteur: Jean Michel


acronym: TolTwiCare

summary:
The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate mandibular growth or in interception / contention.

The proposed research project will focus initially on assessing the comfort and safety of TwiCare® device. The orthopedic efficiency therefore not part of this study.

The comfort and safety of the brace will be evaluated firstly by the practitioner during the visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after the start of the port of the device, and during the control visit at 11 weeks.

location_facility: CHU de Nantes -Service d'Odontologie Restauratrice et Chirurgicale


title: Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education of Patients on Anticoagulants During a Routine Inspection by the Cardiologist.

acronym: EDUCONSULT

summary: To assess the value of a dedicated knowledge questionnaire, filled by the patient prior consultation. Indeed, it could allow to target specific shortcomings of patients first, and help the cardiologist to prioritize the other therapeutic education, targeting specifically the information provided.


title: Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure

acronym: HIGH SLEEP

summary: The aim of the study is to evaluate the impact of sleep quality on intubation rate in intensive care units patients with acute respiratory failure


title: Objective Measures of Pain Sensitivity in NREM Sleep Parasomnia

acronym: NOCISOMNIE

summary:
Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent and disabling sleep disorders characterized by arousal specifically from slow wave sleep (SWS) with dissociated brain activity that may be related to lower nociceptive state. The investigators recently reported frequent subjective complaints of chronic pain, migraine and headache during wakefulness in adult sleepwalkers. They also described frequent analgesia during severe and injuring episodes, suggesting a relationship between dissociated brain activity and nociceptive dysregulation. However, this study did not included objective nociceptive measures and the retrospective assessment of perceived pain during parasomnia episodes over a lifetime span might also introduce a recall bias.

The aims of the present study are to measure objective pain sensitivity in patients with NREM parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS, and 3) wakefulness.

Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the nociceptive threshold. During the recovery sleep following the sleep deprivation, the investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive responses.

The investigators hypothesized a lower nociceptive threshold during wakefulness in sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This study may help to better understand the etiology and mechanisms underlying the clinical enigma of the nociceptive dysregulation in NREM sleep parasomnias.

primary_purpose: Basic Science


title: Evaluation of the Effectiveness and Security of the Prophylactic Platelet Transfusion in Thrombocytopenic Patients Requiring the Placement of a Central Venous Catheter

acronym: PLATCAT

summary: PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion


title: Advanced Breast Cancer and Lifestyle Exercise Study

acronym: ABLE

summary: About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The physical, biological, psychological and clinical benefits of physical activity (PA) during treatment in patients with localized breast cancer have been widely demonstrated. Numerous studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of PA in patients with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.

ReferenceCitation: Delrieu L, Touillaud M, Perol O, Morelle M, Martin A, Friedenreich CM, Mury P, Dufresne A, Bachelot T, Heudel PE, Fervers B, Tredan O, Pialoux V. Impact of Physical Activity on Oxidative Stress Markers in Patients with Metastatic Breast Cancer. Oxid Med Cell Longev. 2021 Jul 16;2021:6694594. doi: 10.1155/2021/6694594. eCollection 2021.

evidence: open (via page says license)

publisher_dissemination: Wiley

ReferenceCitation: Delrieu L, Pialoux V, Perol O, Morelle M, Martin A, Friedenreich C, Febvey-Combes O, Perol D, Belladame E, Clemencon M, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Touillaud M, Tredan O, Fervers B. Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study. JMIR Mhealth Uhealth. 2020 Jan 28;8(1):e12306. doi: 10.2196/12306.

publisher_dissemination: JMIR Publications

ReferenceCitation: Delrieu L, Vallance JK, Morelle M, Fervers B, Pialoux V, Friedenreich C, Dufresne A, Bachelot T, Heudel PE, Tredan O, Perol O, Touillaud M. Physical activity preferences before and after participation in a 6-month physical activity intervention among women with metastatic breast cancer. Eur J Cancer Care (Engl). 2020 Jan;29(1):e13169. doi: 10.1111/ecc.13169. Epub 2019 Sep 30.

evidence: oa journal (via publisher name)

publisher_dissemination: Hindawi

ReferenceCitation: Delrieu L, Perol O, Fervers B, Friedenreich C, Vallance J, Febvey-Combes O, Perol D, Canada B, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Tredan O, Touillaud M, Pialoux V. A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2018 Aug 30;7(8):e10487. doi: 10.2196/10487.

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
Claude Bernard University


title: BetaLACTA® Test-guided Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections Diagnosed in Intensive Care Unit - BLUE¬-CarbA Study

acronym: BLUE-CarbA

summary:
The emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably intensivists, to prescribe more carbapenems, particularly in the most fragile patients such as ICU patients. Unfortunately, the increased carbapenem consumption favored the emergence of carbapenem resistance mechanisms. Moreover, several preliminary results suggest that carbapenem could markedly impact the human intestinal microbiota, Thus, reduction of carbapenem exposure is widely desired both by national and international antibiotic plans. Therefore, the use of rapid diagnostic tests evaluating bacterial resistance to reduce inappropriate exposure to carbapenems could be a relevant solution. Due to its good diagnostic performance, the betaLACTA® test could meet these objectives.

Experimental plan :

Randomized, open-labeled non-inferiority clinical trial involving an in vitro diagnostic medical device (close to a phase III study), comparing two parallel groups:

Experimental group: early carbapenems de-escalation since the second dose, guided by results of the betaLACTA® test performed directly on the bacterial pellet from the microbiological sample positive on direct examination.
Control group: carbapenems de-escalation guided by definitive results of the antibiotic susceptibility test obtained 48 to 72h after microbiological sampling (reference strategy).

ReferenceCitation: Garnier M, Gallah S, Vimont S, Benzerara Y, Labbe V, Constant AL, Siami S, Guerot E, Compain F, Mainardi JL, Montil M, Quesnel C; BLUE-CarbA study group.. Multicentre randomised controlled trial to investigate usefulness of the rapid diagnostic betaLACTA test performed directly on bacterial cell pellets from respiratory, urinary or blood samples for the early de-escalation of carbapenems in septic intensive care unit patients: the BLUE-CarbA protocol. BMJ Open. 2019 Feb 19;9(2):e024561. doi: 10.1136/bmjopen-2018-024561.

publisher_dissemination: British Medical Journal

location_facility: Anesthesiology and Critical Care Medicine Department

acronyme: BLUE CarbA

titre: Utilisation du bêtaLACTA® test sur examen direct positif à Bacille à Gram Négatif pour la désescalade précoce de l'antibiothérapie probabiliste par carbapénèmes au cours des infections respiratoires, urinaires et bactériémies en réanimation.

nom_porteur: QUESNEL

prenom_porteur: Christophe


title: Search for Restenosis Markers in Lower Limb Arteritis

acronym: FEMIA

summary:
The initial hypothesis of this work is that the genesis and the evolution of the atheromatous plaque are partly controlled at the molecular level and in particular by the microRNAs through their role as regulator of the genes.

The study of the tissue and serum profile over time of specific microRNAs involved in the regulation of atheromatous plaque correlated with clinical data and restenosis imaging will allow to define biological markers of restenosis in the patient with an arteritis of the lower limbs .

This study is a pioneer in the field and it would be imprudent to conclude that a biomarker would be used clinically at the end of this work alone. Nevertheless this study will make a major advance in this topic, in vivo intervention studies with inhibition or over-expression of microRNA will obviously be necessary to confirm the use of these as biomarkers of arteritis of the lower limbs.

Regular assay of reliable biomarkers in arterial patients will ultimately suggest early management to best adapt surgical and medical treatment.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's Disease

acronym: NoISE-PD

summary: Impulse control disorders encountered in Parkinson's disease (PD) are induced by dopaminergic medications and their frequency is estimated to be nearly 20%, mainly under dopaminergic agonists (AD).

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear

acronym: EPISIO

summary: The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.

lead_sponsor: Hopital Foch


title: Measurement of Contractile Activity and Distensibility of the Esophago-gastric Junction, of the Esophagus and of the Pylorus: Normal Values in Controls Under General Anesthesia (NormaFLIP Study)

acronym: NormaFLIP

summary: Impedance planimetry using Endoscopic Functional Lumen Imaging Probe (EndoFLIP) device is a promising diagnostic tool to assess esophageal, esophago-gastric junction and pylorus function. It allows the measurement of esophageal and pylorus distensibility as well as contractile activity in response to distension. Examination is useful performed under sedation. General anesthesia might affect distensibility values. The aim of this study is to normal values for esophageal, esophago-gastric junction and pylorus distensibility in controls during an upper gastro-intestinal endoscopy performed under general anesthesia.

location_facility: Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot


title: Myelodysplasic Syndromes and Risk Factors for Infection : A Case / Control Study

acronym: MYRIFIC

summary:
Myelodysplastic Syndromes (MDS) are characterized by quantitative and qualitative bone marrow failure and by a disorder of the medullary production which is a pre-leukemic state which can evolve into acute myeloid leukemia.

The risk of leukemic transformation is estimated by the score IPSS (International Prognostic Score System). We distinguish the MDS of low risk (IPSS<1) and those of high risk of leukemic transformation (IPSS=1,5).

Besides the risk of leukemic transformation, MDS much be complicated of infections which could be life-threatening.

The risk of developing first infection after the diagnosis of MDS of high risk is probably influenced by anamnestic (disease duration, comorbidities), clinical (veinous central catheter, previous hospitalization), biological (neutropenia, lymphopenia, serum ferritin) and therapeutics (demethylating agent, lenalidomide, erythropoietin, G-CSF, transfusions, anti-infectious preventive treatment) factors. Their identification will allow for improved targeting of the population which is is likely to benefit from anti-infective prophylaxis Primary objective is to identify risk factors associated with first acute episode of infection in patients with MDS, by comparing index cases and matched control cases who did not develop infection episode since diagnosis.

Secondary objectives are to explore nature and severity of infectious episodes, number of recurrences during 1 year of follow up and survival at 6 and 12 months

lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronyme: MYRIFIC

titre: Facteurs de risque des complications infectieuses aigues dans les syndromes myélodysplasiques de haut risque : une étude cas - témoin

discipline_principale: hématologie infectieux

nom_porteur: TOMA

prenom_porteur: Andrea


title: Relation Entre diabète Gestationnel et Adipocytokines Inflammatoires Chez Des mères obèses et Leur Nouveau-né à l'Accouchement

acronym: ADIPOGEST

summary: ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and C-reactive protein in obese women and their newborn at delivery whether exposed or not to Gestational Diabetes Mellitus (GDM)

sponsor_collaborators: Centre Hospitalier Universitaire de la Réunion


title: Prevalence of Asymptomatic Thrombosis in Multiple Myeloma

summary:
Malignant hemopathies, such as solid cancers, increase the risk of venous and arterial thromboembolic events. The incidence of symptomatic venous thromboembolic events is particularly high in myeloma, linked to the usual risk factors for venous thromboembolic disease, biological risk factors specific to myeloma, and especially to its treatments.

The prevalence of asymptomatic venous thromboembolic events and arterial events are not known to date and remain important data for planning a possible randomized study to determine the most suitable thromboprophylaxis in these patients.


title: Objective Markers of Pain Perception in Pediatric Emergency

acronym: TAMALOU

summary: Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief rests on the oral communication of the young patient, who does not always able to it (difficult to verbalize, fear of the hospital, problem mental development ...). There is no way in which pain can be apprehended objectively, immediately and effectively. To advance our knowledge of this problem, several approaches have been studied as from functional magnetic resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters. However, all these approaches have their limitations: although fMRI presents interesting performances, it allows only a retrospective analysis, and cannot adapt to the clinical context of the young patient for example. EEG-based approaches and autonomic parameters show interesting results but suffer from perfectible sensitivity to muscle activation for EEG whereas the vegetative parameters to stress. In this context, our working hypothesis considers that the search for markers of painful perception must be based on a neurophysiological approach, based on the combined analysis of the EEG and autonomic responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic (cardiovascular, skin, pupillary) responses induced by sutures in children who can communicate their pain according to whether they cause pain or not.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


acronym: Physios

summary:
The environment of the ICU and operating room allows the multi continuous monitoring of patients in critical situations. The physician anesthesiologist is working more and more in an environment where he receives a multitude of information from both the patient's medical history but also measured data in real time to its physiological situation. It is sometimes difficult for practitioners to consider all of the information by identifying a course of action. A decision support and a degree of automation can increase security along the lines of what has been observed in many processes and industries like aviation.

The goal of this project is to establish initially a database of physiological parameters. We want to use patient data to model physiological processes in order to advance towards the creation of "physios" program,

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Study of the Psychometric Properties of the Scale of Well-being at Work: The Serenat Study

acronym: SERENAT

summary: The main objective of this work is to explore the psychometric properties of scale of well-being at work called "Serenat" in order to validate it. Secondary objectives are to study the influence of socio-demographic characteristics of the subjects on the results of Serenat and to describe the results on subjects monitored among an adult psychiatric population.

primary_purpose: Screening

ReferenceCitation: Andrea H, Bultmann U, Beurskens AJ, Swaen GM, van Schayck CP, Kant IJ. Anxiety and depression in the working population using the HAD Scale--psychometrics, prevalence and relationships with psychosocial work characteristics. Soc Psychiatry Psychiatr Epidemiol. 2004 Aug;39(8):637-46. doi: 10.1007/s00127-004-0797-6.

ReferenceCitation: Stansfeld S, Candy B. Psychosocial work environment and mental health--a meta-analytic review. Scand J Work Environ Health. 2006 Dec;32(6):443-62. doi: 10.5271/sjweh.1050.

ReferenceCitation: Melchior M, Caspi A, Milne BJ, Danese A, Poulton R, Moffitt TE. Work stress precipitates depression and anxiety in young, working women and men. Psychol Med. 2007 Aug;37(8):1119-29. doi: 10.1017/S0033291707000414. Epub 2007 Apr 4.

ReferenceCitation: Servant D, Drumez E, Raynal S, Demarty AL, Salembier A, Deschepper MH, Bizet MA, Pisanu-Zimny A, Culem JB, Labreuche J, Duhamel A, Vaiva G. [Elaboration and psychometric properties of a well-being scale at work. The Serenat study among employees in occupational medicine unit]. Rev Epidemiol Sante Publique. 2019 Sep;67(5):303-309. doi: 10.1016/j.respe.2019.05.011. Epub 2019 Jun 28. French.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

repositories_concat: HAL

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

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Lille


summary:
Venous thromboembolism (VTE) is a common and potentially fatal disease. It is considered a chronic disease with a recurrence rate of 30% at 10 years.

Reduce the risk of recurrence is a serious public health issue. For this it is necessary to identify patients at high risk of recurrence. However, until now, only 50% of recurrences are in the presence of known risk factors, suggesting that there are still yet unidentified risk factors.

The assumption behind this project is that there are specifically associated genetic polymorphisms to the risk of VTE recurrence.

The aim of our project is to identify these polymorphisms from genome-wide data MARTHA cohort. This cohort is composed of 1542 subjects from the Marseille region with at least one episode of VTE documented. Patients in the cohort MARTHA have all been genotyped for approximately 500,000 polymorphisms.

The investigators want to achieve a case-control study nested in the cohort MARTHA. Subjects with recurrent VTE (the case) will be compared to subjects with only one episode of VTE (the controls). The allelic frequencies of polymorphisms previously genotyped 500,000 will be compared between cases and controls. The identification of these new genetic variants associated with VTE recurrence should allow us to improve the pathophysiological knowledge of the disease, reduce the frequency of episodes and focus research on new therapeutic approaches.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


title: Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy

acronym: SPECTROBEVA

summary:
No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment.

These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

acronyme: SPECTROBEVA

titre: Etude prospective de biomarqueurs spectroscopiques prédictifs de la survie à 6 mois pour les patients traités par bévacizumab  en première rechute de glioblastomes après échec de radiochimiothérapie

discipline_principale: autre

nom_porteur: CONSTANS

prenom_porteur: Jean-Marc


title: Prevention of Diseases Induced by Chlamydia Trachomatis

acronym: i-PREDICT

summary:
The main objective of the study is to determine whether early screening and treating young women (<25 years of age) for genital Chlamydia Trachomatis (Ct) infection reduces the cumulative incidence of pelvic inflammatory disease (PID) over 24 months.

As secondary objectives, the study aims

To determine the baseline prevalence and the incidence of Ct infection;
To improve knowledge on natural history of Ct infection in young women such as the rate and timing of progression to PID (at the beginning of the infection, at the end, throughout the course of infection), as well as the incidence of reinfections with Ct;
To investigate the relation between host immuno-genetic factors and the clearance, persistence and development of late complications (PID) as an explanation for the inter-individual heterogeneity in the susceptibility to and course of Ct infection.

ReferenceCitation: Tamarelle J, Thiebaut ACM, Sabin B, Bebear C, Judlin P, Fauconnier A, Rahib D, Meaude-Roufai L, Ravel J, Morre SA, de Barbeyrac B, Delarocque-Astagneau E; i-Predict study group. Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial. Trials. 2017 Nov 13;18(1):534. doi: 10.1186/s13063-017-2211-1.

collaborators: National Reference Center (NRC) for Chlamydia infections, UMR1181

acronyme: PIDPrev

titre: Dépistage précoce et traitement des infections à Chlamydia trachomatis chez les jeunes femmes pour prévenir les infections génitales hautes : un essai de prévention randomisé.

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: DELAROCQUE ASTAGNEAU

prenom_porteur: Elisabeth


title: Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers

acronym: PHOTOFLUO

summary:
The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence.

This Spectrofluorometer must be initially validated in healthy volunteers. In the long term, it will be used clinically to measure residual photosensitivity of patients who received a photosensitizer in photodynamic therapy.

primary_purpose: Health Services Research

lead_sponsor: Institut de Cancérologie de Lorraine


title: Hypermetabolism in the Elderly Lung Cancer Patient

acronym: HELP

summary: Aging and cancer are two conditions associated with extensive metabolic changes that can cause malnutrition. However, the clinical features and the underlying mechanisms leading to malnutrition are different in these two cases. We therefore wonder how age can influence the metabolic response to cancer.

ReferenceCitation: Ulmann G, Jouinot A, Tlemsani C, Curis E, Kousignian I, Neveux N, Durand JP, Goldwasser F, Cynober L, De Bandt JP. Lean Body Mass and Endocrine Status But Not Age Are Determinants of Resting Energy Expenditure in Patients with Non-Small Cell Lung Cancer. Ann Nutr Metab. 2019;75(4):223-230. doi: 10.1159/000504874. Epub 2019 Dec 19.

publisher_dissemination: S. Karger AG

lead_sponsor: University of Paris 5 - Rene Descartes


title: Kinetics of Serum β-D-glucan During Peritonitis With Candida in Resuscitation

summary: Intraabdominal fungal infections with Candida are constantly increasing. Their diagnosis and treatment is difficult. Morbidity and mortality are high. Β-D-Glucan has been proposed as a marker of systemic fungal infection in candidemia. Moreover, its kinetics is associated with therapeutic success. On the other hand, there are no data on intraabdominal infections that are much more frequent. The objective of the study is to evaluate the initial levels of β-D-glucan and its daily kinetics during the treatment of fungal peritonitis in resuscitation compared to a control group with a yeast-free peritonitis.


title: Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis

acronym: VOPRABIO

summary: Aortic valve pathology is the third most common cardiovascular disease after coronary artery disease and hypertension, which is responsible for severe morbidity and mortality in elderly patients and requires surgical treatment in its most severe form of progression. The purpose of this study is to find a link between arterial stiffness and degenerative aortic stenosis. If this link is established, arterial stiffness may become a medical therapeutic target in order to delay the evolution of the disease.


title: Evaluation of the Emergence of the Resistance to Linezolid in Staphylococcus Epidermidis and Risk Factors Analysis : a Mono-centric Case-control Study

acronym: ELiCSIR

summary:
Understanding the emergence of linezolid-resistance in Staphylococci has been allowed in the past years through the discovery of the clonal dissemination of a chromosomal cassette carrying a modified crf gene. New mutations have even been described. Though, clinical evidences are still lacking, especially concerning the factors associated to this emergence. It could seriously become quite problematic to eliminate one of the last therapeutic weapon at our disposal for the treatment of severe or complicated infections caused by resistant strains of Staphylococci and Enterococci.

We aim to describe the mechanisms that permitted to this resistance to become clinically significant, concerning meticillin-resistant Staphyloccocus epidermidis strains causing blood stream infections in ICU patients, and show the clinical risk factors associated with it through a case-control study on patients hospitalized in two ICUs of our hospital between 2011 and 2016.

time_perspective: Other

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Contribution of the Perfusion Scanner in the Prediction of the Tumor Control of Patients With Hepatocellular Carcinoma Treated With Sorafenib.

acronym: HCC-CTPerf

summary:
Hepatocellular carcinoma (HCC) is a hypervascular tumor. The reference treatment of advanced forms of stage C according to the Barcelona classification (BCLC C) is sorafenib, a multi-target tyrosine kinase inhibitor with predominant anti-angiogenic action. In order not to underestimate the efficacy of sorafenib, scannographic evaluation of the tumor response should be performed with mRECIST criteria that are significantly better correlated with survival. These criteria take into account the tumor size and also the modification of the tumor contrast enhancement after anti-angiogenic treatment. It seems appropriate to evaluate tumor control rather than tumor response since sorafenib is more stable than tumor response.

This evaluation will be made according to the mRECIST criteria after 3 months of treatment since the progression-free survival is of the order of 3 to 4 months. The determination of early predictive criteria for the response to sorafenib would optimize the management of advanced HCCs. Indeed, sorafenib only improves overall survival by 3 months in selected patients, and with undesirable effects and a significant cost. Predictive biological criteria have already been studied, such as alpha foeto-protein (AFP), whose early decrease with sorafenib is associated with better overall survival. The same applies to the early reduction at 4-6 weeks of tumor arterial contrast according to mRECIST criteria. The perfusion scanner appears to be an accessible and reproducible choice imaging technique for assessing tumor vasculature. In metastatic kidney cancers, it was demonstrated that some criteria for tumor perfusion prior to treatment with sorafenib were predictive of better control of the disease and even a better tumor response according to the RECIST 1.1 criteria. The determination of pre-therapeutic tumor perfusion criteria in order to predict tumor control or even overall survival has never been studied in advanced CHCs. On the other hand, an early variation in the criteria for tumor perfusion under treatment would tend to be correlated with the tumor response and even with overall progression-free survival.

Therefore, the study of tumor vascularization by the perfusion scanner could make it possible to demonstrate early predictive criteria for tumor control under sorafenib in order to optimize the management of patients with advanced HCC.


acronym: CONCORDE

summary: Bipolar disorders are common psychiatric disorders characterized by severe and recurrent symptomatic periods (Major Depressive Episode, mania, hypomania) and interictal periods characterized by persistent residual symptoms, impaired functioning and quality of life. In addition, the prognosis of bipolar disorder is aggravated by an increased risk of suicide and a high frequency of somatic comorbidities. Poor adherence is one of the major factors influencing the course of the disorder and one of the causes of ineffective treatments. Considering that between 20 and 60% of patients with bipolar disorder have problems with adherence. Adherence is modulated by a number of socio-demographic, clinical and neuropsychological factors. It is also modulated by the knowledge, beliefs and In addition, studies have shown that the reasons attributed to poor adherence are different depending on whether questioning patients or healthcare professionals. This fault diagnosis, assessment of the causes and "fit" into the reasons associated with poor adherence is an aggravating factor of the problem. However, this factor seems modifiable by better training of professionals. A team from Newcastle University in England has developed a training program for all health professionals to improve the diagnosis and understanding of compliance issues in bipolar patients and provide simple tools to fight against patients with this problem. The investigators assume that this training will improve medication adherence among outpatients by trained professionals.


title: Etude Des Traumatismes Sportifs Lors Des Cours d'éducation Physique et Sportive Chez Les collégiens Dans le Sud de l'Ile de La Reunion

acronym: TsColEPS

summary: TsColEPS aims at identifying individual determinants of sport injuries during physical activity lessons in secondary school at reunion Island.


title: Comparison of the Use of Energy Substrates and Hormonal Regulation of Blood Sugar During Exercise of Increasing Intensity Between Children With Type 1 Diabetes and Non-diabetic Control Children.

acronym: DIABSPORT

summary: The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas. A lot of factors modify blood glucose. The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Connectivity and Social Cognition in Adolescent Girls With Borderline Personality Disorder, a Pilot Study

acronym: EEG-NIRS

summary: The disruption of social cognition associated with borderline personality disorder (BPD), and more specifically categorization of facial emotions, remains largely under-studied, despite the high frequency of this pathology in the clinical population. The first results differ from the observations made in adults and this confirms the relevance of studying this theme specifically in adolescence. On the cognitive level, there is a disturbance of the detection and the categorization of the facial emotions in the TPL. The characteristics of this disturbance and its possible association with an attack on the connectivity of the brain remain unknown in adolescence. No functional imaging studies are published in adolescent TPL. This pilot bimodal functional imaging study EEG-NIRS aims to collect preliminary and feasibility data to support a response to upcoming PHRC competitions and eventually offer a science thesis opportunity.


acronym: CAPADO

summary:
French Guiana is the French territory where the prevalence of HIV is highest. in order to determine the knowledge attitudes, beliefs, and practices among the target group of teenagers attending the public school system a survey was conducted in 2011. schools and classrooms were randomly selected, and a structured questionnaire was administered. Descriptive statistics were obtained and multivariate logistic regression was used to determine predictors of main outcomes such as age at first sex.

the results will be used to guide prevention of HIV and sexually transmitted infections though the school system.

lead_sponsor: Centre Hospitalier de Cayenne


title: Cervical Cancer in French Guiana: Screening Between 2006-2011. Description of the Population With Invasive Cervical Cancer Between 2003-2008

acronym: DepCol

summary: Given that cervical cancer is the second most frequent cancer among women in french guiana the aim of the study was to determine the screening rate among women living in French Guiana. Cervical smears are read in 2 laboratories which allowed us to compute screening rates per 100 women-years. overall the screening activity was 23.5-25.8 smears per 100 women-years. between 2006 and 2011 54% of women were screened. These baseline figures will allow to evaluate present efforts to increase the screening rate for this frequent cancer in French Guiana.


title: Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy

acronym: PRELOAD-CRRT

summary:
Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. New diagnostic methods are now available with high reliability to identify hypovolemia as the underlying cause of hypotension, among which change in cardiac index during passive leg raising may be the less affected by restrictive validity criteria. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.

The aim of this study is then to identify, among hypotensive episodes occurring during renal replacement therapy in Intensive Care Unit patients, the percentage of episodes related to preload dependence as identified by passive leg raising.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de réanimation médicale- Hôpital de la Croix-Rousse


title: Usefulness of Non EPI-DWI-MRI / CT 3D Static Co-registration Prior to Surgery of Cholesteatomas

summary:
Cholesteatoma is a destructive and expanding pathologic condition consisting of keratin pearl arising from a squamous epithelium in the middle ear and/or mastoid process. Evolution consists in a destruction of the ossicles as well as their possible spread through the base of the skull into the brain. Surgical treatment is required to prevent infectious or functional complications. A recurrence after surgery occurs in approximately 10% of patients and rarely affects initial site. Surgical treatment is the only care option for recurrent cholesteatoma. Various locations such as surgical approach cavity, mastoid, hypotympanum are seen. Temporal bone CT is performed prior to surgery for added information on bone erosions especially of ossicules, tegmen tympani, facial nerve canal of internal ear. Due high anatomical resolution and complex anatomy, temporal bone CT is usually displayed with Magnetic Resonance Imaging (MRI) in operating room to help surgical guidance .

Imaging especially using MRI is the cornerstone for diagnosis in asymptomatic patients. Since 2006, non echo planar imaging (EPI) Diffusion weighted imaging (DWI) Magnetic resonance imaging (MRI) (sequences has shown high accuracy to depict recurrent cholesteatoma. If EPI sequences had a high rate of diffeomorphic atefacts whereas non EPI sequences using either HAlf-Fourier acquisition Single-shot Turbo spin-Echo (HASTE) or Fast-spin-echo demonstrates less magnetic susceptibility artifacts. Multimodality fusion between NonEPI-DWI-MRI and computerized tomography (CT) is a rational promising tool to rise the performance for cholesteatomas delineation. The performances of NonEPI-DWI-MRI in assessing lesion spread and volume are still unknown and needs further investigations. The aim of the study is to assess the DWI-MRI/CT fusion feasibility, reproducibility and the accuracy prior to surgery propectively compared to surgical findings.

location_facility: Hôpital de La Timone - Assistance Publique Hôpitaux de Marseille


title: The Potential Impact of Aging Stereotypes in the Assessment of Memory Deficits and Screening for Prodromal State of Alzheimer's Disease

acronym: AGING

summary: Because of the lengthening of life expectancy, more and more people are concerned with the effects of aging on their mental faculties (e.g., memory decline) and with the possibility of getting Alzheimer's Disease (AD) or other forms of dementia. This increasing awareness of AD has already resulted in a growing demand for neuropsychological testing. AD's research also emphasizes the need for early screening to improve the prediction of the disease progression and the efficacy of any future therapy. Such a drive to screen for pre-dementia raises the challenging issue of frontline identification of individuals in the preclinical or early clinical stages of AD. Mild Cognitive Impairment (MCI) is typically considered to be the prodromal state of AD, and is therefore at the core of the drive for early screening. Moreover, Pre-MCI so called SCI (Subjective Cognitive Impairment) can precede AD for 15 years. However, many individuals diagnosed with MCI do not convert to AD, some remaining stable and others even reversing back to normal (with rates of reversion to normal varying from 4.5% to as high as 53%). This over-diagnosis bias, which has been largely overlooked, is at the core of the present project at the interface of human and life sciences. Here, we argue that an important source of overdiagnosis in the prodromal state of AD comes from negative aging stereotypes (e.g., the culturally shared beliefs that aging inescapably causes severe cognitive decline and diseases such as AD) that permeate neuropsychological screening. There is ample evidence in the laboratory that such stereotypes contribute to the differences observed in the healthy population between younger and older adults in explicit memory tasks. Additionally, three pilot (lab) studies specifically conducted for the present ANR project showed that the threat of being judged stereotypically undermines the controlled use of memory of healthy older adults and simultaneously intensifies their automatic response tendencies, resulting in impaired memory performance. The present proposal goes several steps further by examining for the first time whether aging stereotypes are powerful enough to implicitly permeate the clinical neuropsychological testing and thus inflate memory deficits in older adults judged "at risk" (based on either epidemiological criteria or memory complaints), resulting in false-positive detection of SCI and MCI. This provocative hypothesis will be tested while 1) using biomarkers of neurodegeneration to distinguish false-positives from true MCI, and 2) using biomarkers of stress to examine whether and how aging stereotypes can lead to acute physiological stress during neuropsychological testing. This innovative project has the potential to offer new recommendations to improve the diagnosis accuracy of prodromal state of AD, with positive consequences for older people's wellbeing.

ReferenceCitation: Gauthier K, Morand A, Dutheil F, Alescio-Lautier B, Boucraut J, Clarys D, Eustache F, Girard N, Guedj E, Mazerolle M, Paccalin M, de la Sayette V, Zarea A, Huguet P, Michel BF, Desgranges B; AGING consortium; Regner I. Ageing stereotypes and prodromal Alzheimer's disease (AGING): study protocol for an ongoing randomised clinical study. BMJ Open. 2019 Oct 7;9(10):e032265. doi: 10.1136/bmjopen-2019-032265.

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

intervention_type: Diagnostic Test


title: Pain in Oncolgy: Evaluation of a Non Invasive Monitoring Device (ANI). A Monocentric Prospective Study

acronym: ANIONCO

summary:
l'ANI (Analgesia Nociception Index

The main objective of the research is to estimate the Analgesia Nociception Index (ANI) as a parameter giving the possibility of measuring the pain in painful metastatic cancer. The parameter ANI is compared with visual analogical scale (VAS) score.


title: Psychological Intervention modifiEs Outcome of Patients With implAntable Cardioverter dEfibrillator: The PEACE Study

acronym: PEACE

summary: This study aims to investigate whether follow-up with a psychologist has an impact on the outcome of patients with an implantable automated defibrillator.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation) Evaluation of Individual Genetic Susceptibility in Severe Gastro-enteritis Rotavirus: Role of HBGA Polymorphisms & Biotechnology Improvement of RVA Vaccines

acronym: Gastrovimc

summary: The GASTROVIM research explores the links between individual genetic susceptibility, genetic variability of rotavirus strains and effectiveness of immunization with the rotavirus vaccination: a clinical investigation to assess glycan attachment specificity, toward rotavirus vaccine improvement.

lead_sponsor: Nantes University Hospital

appel_a_projets: PRTS

acronyme: GASTROVIM

titre: Spécificité d'attachement sur les glycannes, vers une amélioration des vaccins rotavirus

nom_porteur: GRAS-LE GUEN

prenom_porteur: Christèle


title: Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke

acronym: ROTEMPredict

summary:
Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy.

The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.

lead_sponsor: University Hospital, Caen


title: Analysis of Transcriptomic Profile of Graft-versus-host Disease (GHVD) After Allogeneic Grafting of Hematopoietic Stem Cells

summary:
Graft-versus-host disease (GVHD) is a frequent and severe complication of hematopoietic stem cell transplantation (HSC), and is responsible for significant early mortality despite prophylactic strategies developed in recent decades, Especially since it is resistant to first-line treatment.

The present diagnosis is difficult, non-specific and is based on the combination of an evocative clinical context (CSH allograft, time to appearance before J100, characteristic clinical manifestations), suggestive anatomo-pathological analysis (predominantly inflammatory infiltrate Lymphocyte, mucosal edema and presence of apoptotic bodies), and the exclusion of any differential diagnosis (in particular serology / negative viral PCR).

However, to date there is no molecular characterization of this manifestation, and therefore no specific treatment.

The nCounter® nanostring technology allows the rapid and simple analysis of the simultaneous expression of a group of genes (up to 800 on the same sample), from a very small amount of RNA, and from samples with difficulty Such as fabrics already fixed to formaldehyde and included in paraffin. It allows the detection of a "molecular signature" of the tissue analyzed.

No transcriptomic analysis has ever been performed on human tissues with GVHD.


title: Prospective Study With Biological Assessment: Evolution of Coagulation Activity in Non Valvular Atrial Fibrillation Patients Under Apixaban

acronym: ECAN

summary: Apixaban is a potent, oral, selective reversible direct inhibitor of factor Xa with a favorable efficacy and safety profile in the prevention of non valvular (NV) atrial fibrillation (AF). It has been shown, including by our group, that D-dimers levels (molecular marker of coagulation activity) are predictive of the events (including mortality) in patient with AF independently of the antithrombotic treatment. The aim of the study is to evaluate the changes in plasma levels of biomarkers of coagulation activation: D-dimers, prothrombin fragments F1+2, von Willebrand factor (vWF) and thrombin-antithrombin complexes (TAT) in response to apixaban treatment in patients with NVAF.

lead_sponsor: Hopital Lariboisière

location_facility: Department of Cardiology Lariboisiere Hospital


summary:
The deaf children showed deficits in speech processing and temporality. They badly apprehend temporal concepts and perceptions of deficit so the acoustic phenomena marking the time course linguistically. Their prediction capabilities and anticipation multisensory events are thereby affected, thus impacting their ability to adapt to multiple and complex interaction possibilities that arise during a conversation.The project aim it is to measure the impact of a musical rhythmic stimulation of neuronal activity and the temporal prediction capabilities of older deaf children 5 to 8 years and its impact on their language skills in a conversational task. A matched control group of age will be examined for each of the proposed tasks.

We first measure the capacity to anticipate a situation of language interaction. For this purpose, we will use an alternate naming paradigm with a virtual partner, already developed and tested in children with normal hearing. This paradigm approaches the conversational situation while allowing control of the time parameter of speech (speed of trade) and by controlling the bias (temporal) inherent linguistic programming difficulties of children in a spontaneous conversation situations .

Then we will couple behavioral measurements with measurements of eye movements and the electroencephalogram (EEG) in deaf children. For this, we use a dialog observation task already developed for normal hearing children. This task will allow us firstly to analyze the anticipation level of speaking turns by analyzing eye movements (which "precedes" the speaker). Secondly, it will allow us to study the effects of manipulation of the acoustic parameters of auditory evoked potentials (AEP) and the oscillatory activity of the motor system (EEG, mu rhythm and beta). The audiomoteur coupling would seem to be the key point of anticipatory processes and convergence in conversational interaction will also be studied using cortico-cortical coherence techniques to assess the dynamics of connectivity between remote networks (system here auditory and motor system).


title: Epidémie de Chikungunya à l'île de La Réunion : Effet à Dix Ans de l'Infection Sur la qualité de Vie Dans la Cohorte TELECHIK

acronym: QoLCHIK

summary: QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK cohort by comparing scores of SF-36 health survey.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


summary: The support of help to the prevention of sores include a big diversity of devices. The clinical experiment of these support comes up against the problem of the large number of factors participants in the genesis of bedsores. Nevertheless, it seems to be interesting to estimate the incidence of bedsores in these supports, with control of other factors

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEP

acronym: SURV-SEP

summary:
The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two randomised, placebo phase-controlled III international studies, organized by the pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.

Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of a physician experienced in the treatment of the disease.

It has proved effective to reduce the number of relapses in patients with recurring-remitting MS and reduce the number of patients who have relapses during treatment.

The objective of the study is to observe, in real conditions, on the one hand the tolerance and the other evolution, clinical and radiologic disease in patients already treated by dimethyl-fumarate and collect long-term safety data.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmique Adolphe de Rothschild


title: Body Perception and Complex Regional Pain Syndrome : a Case-control Study

acronym: SDRC

summary:
In CRPS, perturbation of body image and pseudo-neglect syndrome of the body part affected are frequently found. Pain and sensory perturbation seems to modify the way patients perceived their body part affected.

Does a local body image perturbation can affect the balanced of the global self-awareness?

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Etude de Validation de la Version française d'un Questionnaire " Ask Suicide-Screening Questions " (ASQ) Dans Une Population de Patients Adolescents Pris en Charge en unité d'Urgences pédiatriques

acronym: ASQ-Fr

summary: The ASQ-Fr study aims at validating the French version of Ask Suicide-Screening Questions composed of 5 items in adolescents managed in pediatric emergency department. Therefore, use of this brief valid screening instrument could assess the risk for suicide in pediatric patients and then improve the prevention of suicidal tendencies in this population.

location_facility: Centre Hospitalier Universitaire de La Réunion


title: Nutritional Assessment of Locally Advanced Head and Neck Cancer Patients Who Underwent Exclusive or Adjuvant Radiotherapy or Chemo-radiotherapy

acronym: NUTRINECK

summary: Radiotherapy and chemotherapy are standard treatment of head and neck cancer alone or associated to surgical treatment. Early (during treatment or the following weeks) and late side effects contribute to malnutrition in this population at risk. In this context, nutritional support adapted by dietary monitoring and enteral nutrition (nasogastric tube or gastrostomy) are often necessary. The early identification of the patients with high malnutrition risk and requiring enteral nutrition is necessary to improve the tolerance and efficacy of treatment. This prospective study research the factors of malnutrition during head and neck radiotherapy.

lead_sponsor: Centre Henri Becquerel


title: Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy

acronym: NEUTROSTROKE

summary:
Clinical and experimental data suggest that neutrophil activation and extravasation are deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil recruitment in AIS patients were negative. Recently, an experimental study has shown that neutrophil activation and transmigration begin immediately after the occlusion. Inhibition of neutrophil recruitment several hours after the start of ischemia appears therefore too late to have a clinical relevance.

The objective is to study the time dependent impact of neutrophils in AIS and the predominant mediators in each time point to identify the appropriate therapeutic target and time window.

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild


acronym: AIRWAY

summary:
Oro-tracheal intubation is performed daily in anesthesia and in the ICU. When a patient is intubated, the endotracheal tube must be inserted into the trachea to the right depth. If the tube is not deep Inserted enough there is a risk of accidental extubation and trauma to the vocal cords by the balloon. If the tube is inserted too far there is a risk of selective intubation into the right or left mainstem bronchus, which can lead to contralateral lung atelectasis and hypoxemia.

The purpose of this study is to determine whether there is a correlation between the measurement of the airway of an adult population and criteria that would be easily accessible in daily clinical practice: the height of the patient and the size of their feet.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Epidemiological Surveillance of Rotavirus Gastroenteritis With a Perspective of Vaccination

acronym: Rotavirus

summary:
Epidemiological studies have shown the diversity of resistance genotypes and the evolution of their prevalence in the paediatric population. This large study conducted in a context of very low vaccination coverage will generate more precise data on the natural epidemiological evolution of rotavirus, notably the G9 genotype, which has appeared relatively recently.
This study will allow us to identify and document rare or unusual strains of human or animal origin. The complete genetic characterization of these strains will also make it possible to study their ability to recombine and to assess the risk of emergence. Among these still rare strains, the investigators are particularly monitoring G12 rotavirus, whose ability to recombine raises the risk of emergence.
For at least one of the centres taking part in the study, the paediatric population studied will be given strong vaccination coverage. It will be extremely interesting to compare the results obtained in the vaccinated population with non-vaccinated children to assess the impact of this vaccination on the distribution of rotavirus genotypes

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Understand the Behavior and the Knowledges of Patients Enrolled Into SIOUX Study

acronym: COM-Patient

summary: The purpose of this study is to contribute to the evaluation of SIOUX study by adding data about the choices of the observant patients, the mis-observant ones or the protocol deviations.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Caregivers Confronted With the Withdrawal of Artificial Nutrition at the End of Life: Perception and Experienced Difficulties

acronym: PERCEPAL

summary: Withdrawing artificial nutrition in palliative care is an issue that often leads to ethical dilemmas among health care providers, despite clinical guidelines.

sponsor_collaborators: Centre Hospitalier Régional Metz-Thionville


title: The Incidence of Invasive Aspergillosis in Acute Myeloid Leukemia

acronym: IA-AML

summary: Patients with acute myeloid leukemia (AML) are at risk to develop severe infections whose invasive aspergillosis (IA). These infections are leading to an important morbidity and mortality. Antifungal prophylaxis is recommended by posaconazole for AML patients during neutropenia induced by induction chemotherapy. Their application is not uniform.

lead_sponsor: University Hospital, Brest


title: MRI Sequences Optimization in Healthy Subjects

acronym: OSS-IRM

summary:
Magnetic resonance imaging (MRI) is a noninvasive and non-ionizing (no use of X-rays) imaging modality. Today it is considered an anatomical and functional exploration reference technique. Since its inception around 1985, this technology is constantly evolving.

Many advances in MRI require constant adaptations of radiological practices. The morphological image is now associated with functional and parametric information (infusion, diffusion spectroscopy, etc ...). In parallel, work combining acquisition and post-processing of data also open new applications (tractography, functional MRI, etc ....). Thus, more and more procedures are necessary to "integrate" these techniques for the diagnosis and adapt to new demands of clinicians.

The type of sequence and its associated parameters allow to directly influence the contrast of images, to characterize tissue compared to another and, ultimately, to highlight morphological or functional abnormality. Image quality can be optimized on each MRI, depending on the time available for the acquisition on the one hand, and on the desired resolution and contrast, on the other hand. For each sequence, it is therefore necessary to find a compromise that will optimize the diagnostic quality of the examination.

This optimization requires a phase focusing on healthy volunteers. It is therefore important that researchers and physicists could design on healthy volunteers, the best settings of all parameters for an image or spectrum. Indeed, it is always necessary to properly optimize every parameter choices before beginning a study of a cohort of patients.

In this context, the main objective of this study is to optimize sequences and imaging protocols to evaluate and validate the choice of parameters in healthy volunteers.

lead_sponsor: Rennes University Hospital


title: Predictive Interest of Serum Phosphorus Level in the Early Diagnosis of Acute Renal Insufficiency in Post-operative Immediate at Patients Having Benefited From a Cardiac Surgery.

acronym: PhosphoIRA

summary: Cardiac surgery associated acute kidney injury is an independent factor of morbidity and mortality . Despite its delayed elevation, serum creatinine (Cr) remains the goal standard to diagnose AKI. Hyperphosphatemia is well-know in case of AKI because of its excretion decrease. Moreover, serum phosphorus (Ph) is daily measure d after cardiac surgery since its variation may lead to cardiac dysfunction. In case of AKI, Ph may reflect the decrease of renal function in this context. Consequently, the purpose of this study is to evaluate the predictibility of Ph to detect both AKI induction and in a second time, renal recovery.

lead_sponsor: University Hospital, Montpellier


title: Constitution of a Biobank to Optimize in Vitro an Antioxydant Treatment for Diaphragm Dysfunction Induced by Mechanical Ventilation

acronym: BOTAN

summary:
This non-interventional study focuses on mechanical ventilation used in intensive care unit to supplement ventilatory function in patients. Mechanical ventilation can "paradoxically" be at the origin of complications that can be life-threatening in patients. This muscular pathology is called ventilation-induced diaphragmatic dysfunction (DDIV).

Diaphragmatic muscle collected during a digestive surgery for a benign or malignant tumor of the liver requiring surgical excision in contact with the diaphragm from the care will be conserved. The diaphragm biopsy from the care will be retained for biobanking to obtain myoblast in culture which will differentiate in Diaphragm fiber. Then these fibers will be submitted under mechanical stress condition similar to those imposed in vivo by mechanical ventilation to validate in human a model in vitro of diaphragm dysfunction induced by mechanical ventilation. Then the second part of the study will be to evaluate with this model, the efficiency of an antioxidant therapy.