title: Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study

acronym: TOFAST

summary: This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility:
Hopital Caremeau
Ch Dunkerque
Hopital D'Estaing
Ch Bicetre
Ch Emile Roux
Chu Rennes
Ch Annecy Genevois
Chu Nantes
Ch Montfermeil
CHU LYON
Hopital Albert Michallon
Hopital Sud
Groupe Hospitalier Saint Joseph
Clinique de l Europe
CH Le Mans
Hopital Saint Eloi
Clinique Beau Soleil
Chu Bichat Claude Bernard
Ch Saint Joseph Saint Luc
Infirmerie Protestante de Lyon
Chu de Bordeaux - Hopital Haut Leveque
Clinique Pasteur
Hopital de L'Archet
Aphp - Hopital Saint Louis
Hopital Nord
Hopital Claude Huriez
Clinique Jules Verne
Hopital Europeen Georges Pompidou
Hopital Jean Minjoz
Hopital Trousseau
Ch Valenciennes
Aphp - Hopital Beaujon
Ch Valence
Centre Hospitalier de Cahors


title: Unsupervised Clustering Evaluation of HRCT Patterns in Systemic Sclerosis-associated Interstitial Lung Disease

acronym: LUNGSCLEROCT

summary: Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. Interstitial lung disease (ILD) concerns almost 50 % of SSc patients and represents the main cause of mortality. SSc-ILD is variable: from limited forms (with asymptomatic patients) to extensive lesions. Disease course in SSc-ILD is also highly variable: patients can experience stable disease, slow or fast progression. Investigators performed unsupervised clustering analysis to classify SSc-ILD according to elementary radiological lesions on HRCT scan.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Central Hospital, Nancy, France

lead_sponsor_type: academique

status_simplified: Ongoing


title: Expectations and Beliefs of Transgender People Regarding Hormonal Treatment

summary: Hormonal treatment of gender dysphoria can have repercussions on metabolism, cardiovascular system and fertility and represents à potential oncological risk. According to the recommendations of the Endocrine society. Therefore, initial assessment and follow-up visits are necessary and must be carried out to avoid the apparition of potentially undesirable effects.

time_perspective: Prospective

intervention_type: Other


title: Is There a Link Between Inflammation and Endocrinopathies in Turner Syndrome?

summary: Liver abnormalities are common in Turner syndrome. The physiopathology of these abnormalities is unknown for the moment but their potentially serious evolution requires additional explorations.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

status_simplified: Completed


title: Attitudes of General Practitioners in Lorraine Towards Prediabetes

acronym: PréDiabMedG

summary: Screening for the risk factors of type 2 diabetes is a part of the primary prevention approach. Pre-diabetes is one of the modifiable risk factors; however, it remains under-diagnosed. Our aim was to analyse the attitudes of general practitioners in Lorraine towards prediabetes

time_perspective: Cross-Sectional

ipd_sharing: No


title: Pneumocystis Jirovecii Pneumonia in Non-HIV-infected Immunocompromised Patients : a Prognostic Observational Retrospective Monocentre Study

acronym: PnP-HIV-Free

summary: Pneumocystis jirovecii pneumonia (PjP) is a rare infectiouse disease with a high level of mortality. PjP is a classical opportunistic infection which concern HIV infected and immunocompromised patients. During the past decade, several therapeutic's progresses have been done in oncology, immunology and hematology. As a consequence, patients benefited of greater treatment efficacy but are exposed to a higher risk of opportunistic infections as PjP. The investigators hypothesis is that PjP incidence increase and its form is depending of underlying immune conditions. The investigators aim to describe its incidence, the PjP forms depending on comorbidities and to identifiy pronostics factors.

location_facility: Université de Lorraine, CHRU Nancy and APEMAC


title: Human Leucocytes Bank From COVID-19 Cured Patients With a Cellular Immunity Against SARS-CoV-2 :Raw Material for the Preparation of an Anti-SARS-CoV-2 Cellular Immunotherapy

acronym: COVIBank

summary: The SARS-CoV-2 identified in China in January 2020 is the cause of an unprecedented pandemic. The SARS-CoV-2 and each viral variant are responsible of a respiratory infectious disease, which can be asymptomatic. Nevertheless, a part of infected patients will experiment serious forms associated with a high mortality rate. Most serious forms present with lymphopenia and a functional exhaustion of speicifci T lymphocytes. Several studies showed that these quantitative and qualitative lymphocyte abnormalities are associated with unfavourable patients' outcome. The investigators hypothesized that the use of anti-viral T lymphocytes from convalescent COVID 19 donors could be helpful to improve the prognosis of COVID-19 serious forms. This study aims to demonstrate the feasibility of setting up a biobank that could allow the preservation and production of a cellular immunotherapy specific to SARS-CoV-2.

study_type: Interventional

primary_purpose: Treatment

location_facility: CHRU-Nancy - Hopitaux de Brabois - Batiment Philippe Canton


title: Study of Metabolic Connectivity in Drug-resistant Temporal Epilepsy

acronym: EPINE

summary:
18F-Fluoro-deoxy-glucose (18F-FDG) positron emission tomography (PET) has a high sensitivity for temporal lobe epilepsy (TLE), the most common form of focal epilepsy, with a detection range of 86-90% . Therefore, 18F-FDG PET is a useful tool to identify the epileptogenic zone (ETZ) in the inter-ictal phase of drug-resistant temporal epilepsy during pre-surgical evaluation . Based on stereotactic electroencephalography (SEEG) findings, a correspondence between electrical data and metabolic changes on PET was found at the group level by identifying four different patterns of TLE . As expected, hypometabolism was not limited to the EZ defined by SEEG, but underlay broader epileptic networks . Because of the different electroclinical presentations of TLE, 18F-FDG PET appears to be a very useful tool in these temporal epilepsies. Indeed, it has been recently demonstrated that a gradient of PET hypometabolism from the uninvolved area to the spreading area, then to the epileptogenic area and to the lesion area is observed with consequently a good performance of 18F-FDG PET in defining the EZ .

Therefore, it is interesting to study PET metabolism as a network and not as a combination of regional metabolic measures in epilepsy.

intervention_type: Diagnostic Test


title: Involvement of Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

acronym: MDSC-SLE

summary:
Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.

The objectives of this study is to assess the involvement of MDSC in SLE through accurate phenotypical and functional assessment, as well as characterizing their immunometabolic profile, and to identify innovative therapeutic strategies.

study_start_date_type: Anticipated

status: Not yet recruiting


title: Randomized Controlled Trial PRALIMAP-CINeCO: Comparison of Health E-coaching Versus Referral to the Usual Care System for Overweight and Obese Young Adults

acronym: PRALIMAPCINeCO

summary:
This study involves young adults from the PRALIMAP-INES trial and student volunteers from the University of Lorraine, who are overweight or obese.

For young adults from the PRALIMAP-INES trial, the proposed research is a continuation of the PRALIMAP-CINeCO research (part 1).

For students at the University of Lorraine, the proposed research is aimed at volunteer students who are overweight or obese, via the University of Lorraine's Student Health Service (SSE).

Young adults and overweight or obese students not receiving medical care at the time of the inclusion visit (4th measurement time for PRALIMAP-INES participants and 1st time for others) will be offered the chance to take part in a randomized trial comparing the acceptability of health e-coaching versus referral to standard care.

Experimental group: health e-coaching Control group: usual care system

Primary objective : To determine the effectiveness of an e-health coaching intervention using new technologies that promotes changes in eating and physical activity behavior in overweight and obese young adults aged 20, an intervention targeting the development of autonomous self-regulation.

Secondary objectives :

Determine the acceptability of health e-coaching: acceptability of new technologies (container), acceptability of personalized health e-coaching (content).
Determine the effectiveness of health e-coaching on the criteria of corpulence (BMI; body composition), changes in eating behaviors (TCA), emotion management skills and social interaction skills.
Evaluate the benefit of health e-coaching alone or combined with the previous intervention received in the PRALIMAP-INÈS trial on primary and secondary endpoints.
Evaluate and compare participation in a health promotion program over two life periods (adolescence and young adulthood) for young adults from the PRALIMAP-INÈS trial.
Evaluate the effectiveness of health e-coaching (reinforcement of autonomous self-regulation and changes in eating behaviors and physical activity practices/time spent sitting) according to the dose of intervention received by young adults (received-treatment analysis).
Determine the cost-efficiency and cost-utility ratios by means of a medico-economic evaluation based on the incremental cost of the e-coaching intervention in relation to the usual care offered by the health care system (ICER: Incremental Cost-Effectiveness Ratio).

design_allocation: Randomized

primary_purpose: Health Services Research

collaborators:
University of Lorraine
Cnam-ISTNA

sponsor_collaborators:
Central Hospital, Nancy, France
University of Lorraine
Cnam-ISTNA


title: Evaluation of Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis (SCLEROPIDEVOL Study)

acronym: SCLEROPIDEVOL

summary: Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality. Disease course in SSc-ILD is highly variable: patients can experience stable disease, slow or fast progression. Prevention of ILD progression now represents a key objective of SSc-ILD management. The understanding of the course and patterns of SSc-ILD progression is necessary, as reliable prediction tools that allow the stratification of the risk of progression. We aimed to identify the longitudinal trajectories of ILD in SSc patients using latent class mixed models and to examine their associations with SSc characteristics.


title: Resilience Trajectories Following a Preoperative Lifestyle /Behavioral Modification Program and Bariatric Surgery

acronym: ECLAIRCIE

summary:
A high prevalence of psychological trauma on one hand and of psychiatric disorders, such as depression, anxiety, suicide attempts, addictions, and eating disorders on the other hand, has been reported in patients with severe obesity seeking bariatric surgery. Some studies reported an increased prevalence of these psychiatric disorders after bariatric surgery, potentially related to weight regain. In this context, psychological resilience is a concept that brings together internal and external factors of adaptation, and whose clinical use facilitates interdisciplinary collaborative work. This research focuses on the association between resilience and success or failure of bariatric surgery in patients followed in the Specialized Obesity Center (CSO) of the Nancy University Hospital. The hypothesis is that psychological resilience before surgery promotes successful surgical treatment. This retrospective study is based on existing data from patients with severe obesity who have undergone bariatric surgery at the Nancy CSO. The main objective is to study 1) the resilience of patients with severe obesity, candidates for bariatric surgery, at the first assessment (T0), at the end of lifestyle/behavioral modifications program (T1) and at 2 years after bariatric surgery (T2), 2) the relationship between internal and external factors explaining resilience and final weight outcomes.

The investigators are expected that non-resilient patients have more psychological vulnerabilities (psychopathology, negative life events, etc.), and have lower weight loss than resilient patients.

location_facility: Centre hospitalo-universitaire régional de Nancy


title: Relevance of Sensitization to Fenugreek in Children

summary: The prevalence of allergy to legumes is inscreasing, especially in children and for some of these legumes, little is known and there are not included in the list of priority allergen. The overall goal of this study is to improve knowledge about fenugreek allergy. The principal aim is to evaluate the prevalence of allergy to fenugreek confirmed by a positive oral food challenge in children sensitized to fenugreek. The secondary objectives are to describe the case of allergy to fenugreek (co-allergies, severity, age..), to evaluate diagnostic values of skin prick-tests and specific IgE and to compare the molecular profile of specific IgE to peanut between sensitization to fenugreek without allergy and sensitization with a confirmed allergy


title: Language and Music, Speech and the Human Beatbox: Theoretical Issues for Research in General and Applied Linguistics; Monocentric Exploratory Study

acronym: HBB

summary: Beatboxing is a form of vocal percussion primarily involving the art of mimicking drum machines, using one's mouth, lips, tongue, and voice. It may also involve vocal imitation of turntablism, and other musical instruments. To produces the different sounds, the Beatboxers use their vocal apparatus in a much wider and more complex way than its use in speech. This allows them to acquire a panel of rich and varied sounds. The Human Beatbox (HBB) is a very recent subject of study in phonetics. This study offers an exploratory study of pharyngolaryngeal articulatory behaviors using nasofibroscopy and electroglottography and an aerodynamic study in order to better understand the articulatory capacities and limits of the vocal tract.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Hopital Foch


title: Sustained Attention Abilities, Attentional Resources and Cognitive Control Mechanisms in Schizophrenia

acronym: ACCRAS

summary: Schizophrenia is a psychiatric pathology, which concerns around 1% of adult population. It is characterized by clinical symptoms combining positive and negative symptoms and thinking disorganization. Schizophrenia is also characterized by cognitive deficits, likely to play an important part in adaptation of these patients in their every-day life, and to affect their clinical symptomatology. Among them, there are deficits in sustained attention which are associated with a difficulty for these patients to maintain efficiently their cognitive activity on a source of stimulation or task. This basic attentional process is fundamental for the efficiency of the overall of cognitive processes, and so for all behaviors directed on an aim. The question of whether or not patients with schizophrenia have difficulty sustaining attention is of high relevance, in the sense that it could undermine performance on nearly any task and so provide a compelling causal explanation of many other impairments observed in these patients. Yet it has not been conclusively answered in over four decades of research. Consequently, the main objective of the protocol is to evaluate sustained attention abilities in schizophrenic patients and to better understand the specific functioning of cognitive and neural mechanisms underlying these abilities (attentional resources and cognitive control mechanisms).

status: Unknown status

lead_sponsor: University Hospital, Strasbourg, France

status_simplified: Unknown


title: SCREENING OF ADOLESCENT MENTAL SUFFERING CONSULTANT TO EMERGENCIES, MANAGEMENT AND Later MONITORING

acronym: DESPERADOS

summary:
The primary purpose is to estimate the prevalence of depression and subsyndromal states among adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they are another way of tracking this suffering, as they host many troubled teens at once for health problems and accidents sometimes iterative, reflecting their risk behaviour.

Secondary purposes are to assess the feasibility and desirability of a post-emergency medical consultation for adolescents who scored high on a self-administered questionnaire, and to assess the impact of this approach by later monitoring.

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators:
Pfizer
Fondation de France

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Pfizer
Fondation de France

location_facility: Department of paediatric emergencies, Ambroise Paré universitary hospital

intervention_type: Behavioral


title: Multiple Sclerosis and Voiding Symptoms: How to Assess?

summary:
In multiple Sclerosis (MS), storage and voiding symptoms are well described. Urodynamic patterns underlying storage symptoms are clearly defined, but the assessment of voiding phase in neurological diseases is a sensitive topic. The international continence society (ICS) recommended performing pressure flow studies to assess voiding phase. Assessments of sphincter relaxation and detrusor contractility during voiding phase are tough aims to achieve. Indeed, there is no consensus for the detrusor contractility assessment on women or on patients with neurogenic bladder. Similarly, assessment of sphincter during bladder filling and during the voiding phase is not included in ICS recommendations. In the end, it is the physicians who conclude from the non-formalized urodynamic data if there is a DSD or detrusor underactivity. In MS patients undergoing urodynamics, studies reported 43% DSD and 12% impaired contractility. These data should be interpreted with caution due to the variability of the assessment methods.

This study aims to describe the voiding phase of MS patients with standardized urodynamic evaluation and parameters.

This prospective observational study was conducted in a neuro-urology department of a French university hospital.

All the MS patients consulting for a first urodynamic evaluation without urinary treatment were included. Standardized urodynamic evaluation included an uroflowmetry, urethral pressure profile, two pressure-flow studies. If no detrusor contractility was observed during the pressure flow studies, cystometries with 100ml/min filling rate and ice water test were performed. Anal sphincter activity was recorded using surface electromyography electrodes.

Demographic data (age, sex), disease course of the MS, treatments, Expanded Disability Status Scale, urinary symptoms using the Urinary Symptom Profile and the Neurogenic Bladder Symptom Score were collected.

For assessment of detrusor contractility, the following parameters are reported: the bladder voiding efficiency; the projected isovolumetric pressure (PIP) or bladder contractility index (BCI); the Watts factor. For women, the investigators presented 3 more parameters the PIP1; the Valentini-besson-Nelson parameter k and an urodynamic cut-off proposed by Gammie et al. for DUA. Presence of Detrusor-sphincter dyssynergia was reported if there were a detrusor contraction concurrent with an involuntary contraction of the periurethral striated muscle.

ipd_sharing: Undecided

lead_sponsor: Pierre and Marie Curie University

location_facility: Department of Neuro- Urology, Hôpital Tenon


type: Other Identifier

title: Comparison of the Impact on Digestive Portage of Broad Spectrum Beta-Lactamase-Producing Enterobacteriaceae (E-ESBLs) of Proposed Treatments in Outbreaks of Childhood Urinary Tract Infection

acronym: MIKA

summary:
The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is a major public health problem. It leads more frequent prescription of penems with the risk of emergence and spread of strains producing carbapenemases, which may be resistant to all known antibiotics. A policy of savings of penems is desirable. Among the alternatives to penems, amikacin is in the foreground. It remains active on the majority of E-ESBL strains. Some risk factors for E-ESBL emergence are known: recent antibiotic therapy (particularly quinolones and cephalosporins third generation), previous hospitalization or residence in a high endemic country.

In pediatrics, E-ESBLs are primarily responsible for urinary tract infection. In France, E-ESBLs represent about 10% of the strains responsible for urinary tract infections. The Pathology Group Pediatric Infectious (GPIP) of the French Society of Pediatrics (SFP) and the Society of Infectious Pathology French Language (SPILF) have proposed different therapeutic options to treat febrile UTIs in children: amikacin intravenous; intravenous (IV) ceftriaxone or intramuscular (IM); or cefixime per-os (PO).

The objective of this study is to compare the emergence of E-ESBLs in stools of children after febrile UTIs treatment with amikacin IV versus ceftriaxone or cefixime.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Jean Verdier Hospital
Cabinet du Dr Turberg-Romain
CHI Villeneuve-Saint-Georges
157 Avenue du Général Leclerc
CHU Le Kremlin-Bicêtre
Cabinet du Dr Michot
Cabinet du Dr Romain
Cabinet du Dr Werner
Cabinet du Dr Deberdt
André Mignot Hospital
Cabinet du Dr Thollot
Centre Hospitalier de Meaux
Hospital Robert-Debré
Cabinet du Dr Cohen
13 Villa Beauséjour
Cabinet du Dr Benali
Cabinet du Dr Corrard
Antoine Beclère Hospital
Cabinet du Dr Coicadan
Cabinet du Dr Wollner


title: Severe Intraocular Infection

summary:
The host-immune reaction to infection is essential for the comprehension of the disease and the development of new therapies.

The aim of the study is to describe intraocular cytokines network in aqueous humor using multiplex immunoassay, during severe intraocular infection.

location_facility: Service d'Ophtalmologie, Hôpital Michallon

location_facility: Service d'Ophtalmologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service d'Ophtalmologie, Centre Hospitalier de Mulhouse

location_facility: Service d'Ophtalmologie, Hôpital Pasteur

location_facility: Service d'Ophtalmologie, Hôpital Général de Dijon

location_facility: Service d'Ophtalmologie, Hôpital de Brabois

intervention_type: Biological


title: A Randomized Crossover Clinical Trial Regarding the Blockage of the Mineralocorticoid Receptor Using Eplerenone on the Evolution of Arterial Stiffness in Kidney Patients One Year After Transplant

acronym: EVATRAN

summary:
Cardiovascular (CV) pathologies are the leading cause of death in kidney transplant patients.Arterial stiffness is a prognostic factor for CV mortality in kidney transplantation. Despite a reduced CV risk in transplant kidney patients in comparison to patients in dialysis, CV mortality among kidney transplant patients is much higher than the general population.

After renal transplantation, the cardiac and vascular anomalies observed in chronic end-stage renal disease are partially improved because of restored normal kidney function and withdrawal from dialysis.

However, patients are exposed to immunosuppressive drugs, in particular calcineurin inhibitors, which can be associated with vascular toxicity, either directly or by promoting the appearance of hypertension, diabetes, or dyslipidemia.The pathophysiology of arterial stiffness in kidney transplantation is complex and multifactorial.

Calcineurin inhibitors are likely to play an important role in the persistence of increased arterial stiffness in transplant patients in whom renal function has been restored. Indeed, the discontinuation of anti-calcineurins in favour of other molecules .is associated with a decrease of arterial stiffness.

Preclinical work has shown that the vascular toxicity of cyclosporine is mediated by activation of the mineralocorticoid receptor in smooth muscle cells. The involvement of the mineralocorticoid receptor in the onset of arterial stiffness is also well demonstrated in non-transplanted subjects.

Blocking the mineralocorticoid receptor in patients under cyclosporine may reduce their arterial stiffness and in and consequently improve their CV prognosis.

Studies have show a good safety in kidney transplant patients. This pilot study proposes to examine, for the first time, the impact of treatment with a mineralocorticoid receptor antagonist on the evolution of arterial stiffness in renal transplant patients on calcineurin inhibitors.

lead_sponsor: Pr. Nicolas GIRERD

intervention_type: Drug

lead_sponsor_type: industriel


title: Epidemiological Study of the Progress of Puberty in Girls Followed for Cystic Fibrosis

acronym: EPIMUCO

summary:
In the general population, age of puberty, and age of menarche in girls, are closely correlated with those of their mother. The severity of chronic disease has an impact on the stature, the weight gain and the onset of puberty: age of menarche is even later that chronic illness is serious. Cystic fibrosis is one of the major chronic diseases of children.

Neonatal screening is organized since 2002, most girls with cystic fibrosis therefore currently have a very specialized and early care. Older patients were diagnosed during childhood. The optimization of the nutritional and respiratory management has allowed over the past two decades a significant improvement in the survival of these patients. Most young people reach adulthood, puberty and reproductive desire are a crucial issue in the care of these young adults.

In literature, it is often noted an age of menarche delayed an average of 2 years compared to the general population, but correlated with the age of menstruation from the mothers.

The factors involved in the conduct of cycles in the girl followed for cystic fibrosis are poorly known and there are few data on the characteristics of cycles. The menstrual irregularity and amenorrhoea episodes concern nearly half of women.

On the pathophysiological level, studies in animals show that there is a direct effect of CFTR (Cystic Fibrosis Transmembrane Regulator) on the hypothalamic pituitary gonadal and reproductive capacity in mice.

The literature data on the pubertal development, fertility and hormonal profile of these girls are for studies with low numbers and are very old. There is to date no French cohort study on this topic.

The study is a multicenter cross-sectional descriptive study for pubertal and gynecological characteristics in girls followed annually in the reference centers Cystic Fibrosis two inter-region.

lead_sponsor: University Hospital, Toulouse

location_facility:
Canton- Hôpitaux de Brabois
American Memorial Hospital
Hôpital des Enfants-Pellegrin
Hôpital de Hautepierre
Hôpital des enfants Purpan
Hôpital d'Enfants
CHU Besançon St Jacques

intervention_type: Procedure


title: Study of the Benefits of a Short Spa Treatment on the Elimination of Residual Lithic Fragments After Treatment

acronym: LITHUTHERM

summary:
Current urological therapeutic modalities are represented by extracorporeal lithotripsy (ECL), rigid (URS) or flexible (URSsple) uretero-renoscopy and percutaneous nephrolithotomy (PCNL).

They make it possible to extract the vast majority of stones by minimally invasive techniques but leave behind small residual lithic fragments (FR) that can always cause pain, infection, or promote the development of a larger stone.

A non-invasive technique that can help eliminate them would be of great benefit to many patients by avoiding painful recurrences and limiting reprocessing; combined with appropriate medical management, it would limit the rate of remote recurrences and long-term complications.

The treatment called "hydro-posturotherapy" has been developed in some spas that are approved for kidney diseases such as Vittel or Capvern. It includes several modalities: posturotherapy, lumbar percussion and hyperdiuresis.

The main objective is to compare at 3 months, on the unprepared abdomen (ASP) and the low-dose scanner without injection, the elimination of kidney stone fragments under the effect of a short spa treatment with posturotherapy, lumbar percussion and controlled hyperdiuresis compared to the recommended standard treatment. The result will be assessed in 3 categories: complete elimination (SF: "without fragments" or "stone-free"), elimination of more than 50% of the fragments; elimination of less than 50% of the fragments.

status: Terminated

lead_sponsor: GUILLEMIN Francis, MD

collaborators: Association Francaise pour la Recherche Thermale

collaborators: Conseil National des Etablissements Thermaux

intervention_type: Device


title: Cybersickness imAgiNg Olfactory Evocation

acronym: CANOE

summary:
The aim of this study is to, using fMRI, compare brain activations during olfactory imagery induced by different visual supports (words, pictures, colors and colored arrangements) in healthy subjects.

This will allow us to choose the best olfactory imagery facilitator and to assess its effect on cybersickness.

ReferenceType: background

ReferenceCitation: Fantin L, Ceyte H, Ramdane-Cherif Z, Jacquot M, Hossu G. French Vividness of Olfactory Imagery Questionnaire: A Potential Tool for Diagnosing Olfactory Loss by Assessing Olfactory Imagery? Front Psychol. 2020 Dec 21;11:606667. doi: 10.3389/fpsyg.2020.606667. eCollection 2020.


title: Biological Dating of Cerebral Ischemia With Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis

summary: The FLAG1 study will assess the diagnostic performance of biomarkers Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to identify cerebral infarction of less than 4,5 hours in a population of patients with neurological deficiency of less than 12 hours.

ReferenceType: derived

ReferenceCitation: Karakus A, Girerd N, Sanchez JC, Sabben C, Wietrich A, Lavandier K, Marchal S, Aubertin A, Humbertjean L, Mione G, Bouali S, Duarte K, Reymond S, Gory B, Richard S. Identifying patients with cerebral infarction within the time window compatible with reperfusion therapy, diagnostic performance of glutathione S-transferase-pi (GST-pi) and peroxiredoxin 1 (PRDX1): exploratory prospective multicentre study FLAG-1 protocol. BMJ Open. 2021 Aug 20;11(8):e046167. doi: 10.1136/bmjopen-2020-046167.

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 OAI-PMH doi match)

host_type: repository

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

repository_normalized: HAL

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

repository_institution: University of Geneva - Archive ouverte UNIGE

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central
unige.ch

repositories_concat: HAL;PubMed Central;unige.ch

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

location_facility:
Centre Hospitalier de Bar-Le-Duc
Hôpital Central
Centre Hospitalier de Verdun
Centre Hospitalier de Troyes
Fondation Adolphe de Rothschild

appel_a_projets: PHRCI

region: Grand Est

nom_etablissement: CHRU DE NANCY

type_etablissement: CH

titre: Datation de l'ischémie cérébrale par méthode biologique Glutathion S-Transférase-p/peroxyrédoxine 1 pour accès à la thrombolyse des infarctus cérébraux à heure incertaine

discipline_principale: autre

nom_porteur: RICHARD

prenom_porteur: Sébastien


title: Phenotypic Features and Prognostic Value of Anti-Ro52 (TRIM-21) Antibodies in Connective Tissue Diseases

summary: Anti-Ro52 autoantibodies can be detected in patients with several autoimmune diseases. Clinical significance of anti-Ro52 is controversial. The presence of anti-Ro52 may be a factor associated with disease severity (interstitial lung disease, vasculopathy) and cancers. The aim of this study is to assess interstitial lung disease and vasculopathy prevalence and severity, cancers occurence and others clinical features of connective tissue disease patients with anti-Ro52 autoantibodies.

ReferenceCitation: Ghillani P, Andre C, Toly C, Rouquette AM, Bengoufa D, Nicaise P, Goulvestre C, Gleizes A, Dragon-Durey MA, Alyanakian MA, Chretien P, Chollet-Martin S, Musset L, Weill B, Johanet C. Clinical significance of anti-Ro52 (TRIM21) antibodies non-associated with anti-SSA 60kDa antibodies: results of a multicentric study. Autoimmun Rev. 2011 Jul;10(9):509-13. doi: 10.1016/j.autrev.2011.03.004. Epub 2011 Apr 5.

ReferenceCitation: Lee AYS. A review of the role and clinical utility of anti-Ro52/TRIM21 in systemic autoimmunity. Rheumatol Int. 2017 Aug;37(8):1323-1333. doi: 10.1007/s00296-017-3718-1. Epub 2017 Apr 17.

ReferenceCitation: Hudson M, Pope J, Mahler M, Tatibouet S, Steele R, Baron M; Canadian Scleroderma Research Group (CSRG); Fritzler MJ. Clinical significance of antibodies to Ro52/TRIM21 in systemic sclerosis. Arthritis Res Ther. 2012 Mar 6;14(2):R50. doi: 10.1186/ar3763.

ReferenceCitation: Gunnarsson R, El-Hage F, Aalokken TM, Reiseter S, Lund MB, Garen T; Norwegian MCTD study group; Molberg O. Associations between anti-Ro52 antibodies and lung fibrosis in mixed connective tissue disease. Rheumatology (Oxford). 2016 Jan;55(1):103-8. doi: 10.1093/rheumatology/kev300. Epub 2015 Aug 28.

ReferenceCitation: Murng SHK, Thomas M. Clinical associations of the positive anti Ro52 without Ro60 autoantibodies: undifferentiated connective tissue diseases. J Clin Pathol. 2018 Jan;71(1):12-19. doi: 10.1136/jclinpath-2015-203587. Epub 2017 Jun 29.

ReferenceCitation: Reiseter S, Gunnarsson R, Mogens Aalokken T, Lund MB, Mynarek G, Corander J, Haydon J, Molberg O. Progression and mortality of interstitial lung disease in mixed connective tissue disease: a long-term observational nationwide cohort study. Rheumatology (Oxford). 2018 Feb 1;57(2):255-262. doi: 10.1093/rheumatology/kex077.

ReferenceCitation: Bauhammer J, Blank N, Max R, Lorenz HM, Wagner U, Krause D, Fiehn C. Rituximab in the Treatment of Jo1 Antibody-associated Antisynthetase Syndrome: Anti-Ro52 Positivity as a Marker for Severity and Treatment Response. J Rheumatol. 2016 Aug;43(8):1566-74. doi: 10.3899/jrheum.150844. Epub 2016 Jun 1.

location_facility:
Central Hospital
Private Hospital


title: Prospective Evaluation of 1.3-ß-D-glucan in the Peritoneal Fluid for the Diagnosis of Fungal Peritonitis in Critically Ill Patients

summary: New rapid diagnostic strategies are warranted in intra-abdominal candidiasis (IAC). A previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-Beta-D-Glucan ≤ 310pg/ml could rule out an IAC. This strategy was independent of the patient underlying conditions and Candida risk factors. This study aimed to confirm these results with a multicenter prospective study

ReferenceCitation: Novy, E.; Laithier, F.-X.; Riviere, J.; Remen, T.; Losser, M.-R.; Guerci, P.; Machouart, M. Protocol for the pBDG2 Study: Prospective Evaluation of 1.3-β-D-Glucan in the Peritoneal Fluid for the Diagnosis of Intra-Abdominal Candidiasis in Critically Ill Patients. Microbiol. Res. 2021, 12, 196-203. https://doi.org/10.3390/microbiolres12010015

ReferenceType: result

ReferenceCitation: Novy E, Laithier FX, Machouart MC, Albuisson E, Guerci P, Losser MR. Determination of 1,3-beta-D-glucan in the peritoneal fluid for the diagnosis of intra-abdominal candidiasis in critically ill patients: a pilot study. Minerva Anestesiol. 2018 Dec;84(12):1369-1376. doi: 10.23736/S0375-9393.18.12619-8. Epub 2018 Jul 9.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Edizioni Minerva Medica

ipd_sharing: Yes

ipd_sharing_description: all IPD that underlie results in a publication

location_facility:
CHR Mercy
BOUHEMAD Belaid
PILI-FLOURY Sebastien
POTTECHER Julien


title: Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2

summary:
Implantable cardioverter-defibrillators (ICD) are currently recommended (ESC guidelines 2015) for the primary prevention of sudden cardiac death (SCD) in patients with a remote myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF). Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. As a consequence, the current implantation strategy of prophylactic ICDs, based on LVEF, needs to be improved in post-MI patients. Stratification of the rhythmic risk after IDM is therefore still a major public health issue.

Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI) is a strong risk-stratifier of VT/VF risk in post- MI patients. In a recent multicenter retrospective study, the investigators showed that the presence of a critical surface of intramural scar (which is consequently neither epicardial nor endocardial) at the infarct border (measured by LGE-MRI) has a major association with the occurrence of VT/VF in post-MI patients with a LVEF≤35%.

The aim of the TVScreen 2 study is therefore to validate the relevance of the MRI criterion in a new independent cohort of patients.


title: Evaluation d'un Dispositif de Suivi téléphonique Sur la Qualité de Vie Dans Les Crises Psychogènes Non Epileptiques.

acronym: EDUQ-CPNE

summary: The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.

primary_purpose: Supportive Care

ReferenceCitation: LaFrance WC Jr, Alosco ML, Davis JD, Tremont G, Ryan CE, Keitner GI, Miller IW, Blum AS. Impact of family functioning on quality of life in patients with psychogenic nonepileptic seizures versus epilepsy. Epilepsia. 2011 Feb;52(2):292-300. doi: 10.1111/j.1528-1167.2010.02765.x. Epub 2011 Feb 7.

ReferenceCitation: Duncan R, Razvi S, Mulhern S. Newly presenting psychogenic nonepileptic seizures: incidence, population characteristics, and early outcome from a prospective audit of a first seizure clinic. Epilepsy Behav. 2011 Feb;20(2):308-11. doi: 10.1016/j.yebeh.2010.10.022. Epub 2010 Dec 30.

ReferenceCitation: Goldstein LH, Chalder T, Chigwedere C, Khondoker MR, Moriarty J, Toone BK, Mellers JD. Cognitive-behavioral therapy for psychogenic nonepileptic seizures: a pilot RCT. Neurology. 2010 Jun 15;74(24):1986-94. doi: 10.1212/WNL.0b013e3181e39658.

ReferenceCitation: Hingray C, Maillard L, Hubsch C, Vignal JP, Bourgognon F, Laprevote V, Lerond J, Vespignani H, Schwan R. Psychogenic nonepileptic seizures: characterization of two distinct patient profiles on the basis of trauma history. Epilepsy Behav. 2011 Nov;22(3):532-6. doi: 10.1016/j.yebeh.2011.08.015. Epub 2011 Oct 1.

ReferenceCitation: Howlett S, Grunewald RA, Khan A, Reuber M. Engagement in psychological treatment for functional neurological symptoms--Barriers and solutions. Psychotherapy (Chic). 2007 Sep;44(3):354-60. doi: 10.1037/0033-3204.44.3.354.

ReferenceCitation: Hubsch C, Baumann C, Hingray C, Gospodaru N, Vignal JP, Vespignani H, Maillard L. Clinical classification of psychogenic non-epileptic seizures based on video-EEG analysis and automatic clustering. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):955-60. doi: 10.1136/jnnp.2010.235424. Epub 2011 May 10.

ReferenceCitation: Jirsch JD, Ahmed SN, Maximova K, Gross DW. Recognition of psychogenic nonepileptic seizures diminishes acute care utilization. Epilepsy Behav. 2011 Oct;22(2):304-7. doi: 10.1016/j.yebeh.2011.06.031. Epub 2011 Aug 2.

ReferenceCitation: Josien E. Crises non épileptiques. EMC neurologie. 2005 ;1-9.

ReferenceCitation: LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.

ReferenceCitation: Lesser RP. Psychogenic seizures. Neurology. 1996 Jun;46(6):1499-507. doi: 10.1212/wnl.46.6.1499. No abstract available.

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ReferenceCitation: Mayor R, Howlett S, Grunewald R, Reuber M. Long-term outcome of brief augmented psychodynamic interpersonal therapy for psychogenic nonepileptic seizures: seizure control and health care utilization. Epilepsia. 2010 Jul;51(7):1169-76. doi: 10.1111/j.1528-1167.2010.02656.x. Epub 2010 Jun 18.

ReferenceCitation: Strutt AM, Hill SW, Scott BM, Uber-Zak L, Fogel TG. Motivation, psychopathology, locus of control, and quality of life in women with epileptic and nonepileptic seizures. Epilepsy Behav. 2011 Oct;22(2):279-84. doi: 10.1016/j.yebeh.2011.06.020. Epub 2011 Jul 23.

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ReferenceCitation: Benbadis SR. How many patients with pseudoseizures receive antiepileptic drugs prior to diagnosis? Eur Neurol. 1999;41(2):114-5. doi: 10.1159/000008015. No abstract available.

ReferenceCitation: Benbadis SR. A spell in the epilepsy clinic and a history of "chronic pain" or "fibromyalgia" independently predict a diagnosis of psychogenic seizures. Epilepsy Behav. 2005 Mar;6(2):264-5. doi: 10.1016/j.yebeh.2004.12.007.

ReferenceCitation: Bodde NM, Brooks JL, Baker GA, Boon PA, Hendriksen JG, Aldenkamp AP. Psychogenic non-epileptic seizures--diagnostic issues: a critical review. Clin Neurol Neurosurg. 2009 Jan;111(1):1-9. doi: 10.1016/j.clineuro.2008.09.028. Epub 2008 Nov 18.

ReferenceCitation: Bodde NM, Brooks JL, Baker GA, Boon PA, Hendriksen JG, Mulder OG, Aldenkamp AP. Psychogenic non-epileptic seizures--definition, etiology, treatment and prognostic issues: a critical review. Seizure. 2009 Oct;18(8):543-53. doi: 10.1016/j.seizure.2009.06.006. Epub 2009 Aug 13.

ReferenceCitation: Carton S, Thompson PJ, Duncan JS. Non-epileptic seizures: patients' understanding and reaction to the diagnosis and impact on outcome. Seizure. 2003 Jul;12(5):287-94. doi: 10.1016/s1059-1311(02)00290-x.

ReferenceCitation: Cuthill FM, Espie CA. Sensitivity and specificity of procedures for the differential diagnosis of epileptic and non-epileptic seizures: a systematic review. Seizure. 2005 Jul;14(5):293-303. doi: 10.1016/j.seizure.2005.04.006.

ReferenceCitation: Duncan R, Oto M. Psychogenic nonepileptic seizures in patients with learning disability: comparison with patients with no learning disability. Epilepsy Behav. 2008 Jan;12(1):183-6. doi: 10.1016/j.yebeh.2007.09.019.

ReferenceCitation: Fiszman A, Alves-Leon SV, Nunes RG, D'Andrea I, Figueira I. Traumatic events and posttraumatic stress disorder in patients with psychogenic nonepileptic seizures: a critical review. Epilepsy Behav. 2004 Dec;5(6):818-25. doi: 10.1016/j.yebeh.2004.09.002.

ReferenceCitation: Goldstein LH, Deale AC, Mitchell-O'Malley SJ, Toone BK, Mellers JD. An evaluation of cognitive behavioral therapy as a treatment for dissociative seizures: a pilot study. Cogn Behav Neurol. 2004 Mar;17(1):41-9. doi: 10.1097/00146965-200403000-00005.

ReferenceCitation: Guillemin F. Primer: the fallacy of subgroup analysis. Nat Clin Pract Rheumatol. 2007 Jul;3(7):407-13. doi: 10.1038/ncprheum0528.

ReferenceCitation: Hall-Patch L, Brown R, House A, Howlett S, Kemp S, Lawton G, Mayor R, Smith P, Reuber M; NEST collaborators. Acceptability and effectiveness of a strategy for the communication of the diagnosis of psychogenic nonepileptic seizures. Epilepsia. 2010 Jan;51(1):70-8. doi: 10.1111/j.1528-1167.2009.02099.x. Epub 2009 Apr 27.

ReferenceCitation: Iriarte J, Parra J, Urrestarazu E, Kuyk J. Controversies in the diagnosis and management of psychogenic pseudoseizures. Epilepsy Behav. 2003 Jun;4(3):354-9. doi: 10.1016/s1525-5050(03)00113-6.

ReferenceCitation: LaFrance WC Jr, Barry JJ. Update on treatments of psychological nonepileptic seizures. Epilepsy Behav. 2005 Nov;7(3):364-74. doi: 10.1016/j.yebeh.2005.07.010. Epub 2005 Sep 16.

ReferenceCitation: LaFrance WC Jr, Miller IW, Ryan CE, Blum AS, Solomon DA, Kelley JE, Keitner GI. Cognitive behavioral therapy for psychogenic nonepileptic seizures. Epilepsy Behav. 2009 Apr;14(4):591-6. doi: 10.1016/j.yebeh.2009.02.016. Epub 2009 Feb 20.

ReferenceCitation: LaFrance WC Jr, Alper K, Babcock D, Barry JJ, Benbadis S, Caplan R, Gates J, Jacobs M, Kanner A, Martin R, Rundhaugen L, Stewart R, Vert C; NES Treatment Workshop participants. Nonepileptic seizures treatment workshop summary. Epilepsy Behav. 2006 May;8(3):451-61. doi: 10.1016/j.yebeh.2006.02.004. Epub 2006 Mar 15.

ReferenceCitation: LaFrance WC Jr, Syc S. Depression and symptoms affect quality of life in psychogenic nonepileptic seizures. Neurology. 2009 Aug 4;73(5):366-71. doi: 10.1212/WNL.0b013e3181b04c83.

ReferenceCitation: LaFrance WC Jr, Blum AS, Miller IW, Ryan CE, Keitner GI. Methodological issues in conducting treatment trials for psychological nonepileptic seizures. J Neuropsychiatry Clin Neurosci. 2007 Fall;19(4):391-8. doi: 10.1176/jnp.2007.19.4.391.

ReferenceCitation: LaFrance WC Jr, Devinsky O. The treatment of nonepileptic seizures: historical perspectives and future directions. Epilepsia. 2004;45 Suppl 2:15-21. doi: 10.1111/j.0013-9580.2004.452002.x.

ReferenceCitation: Lawton G, Mayor RJ, Howlett S, Reuber M. Psychogenic nonepileptic seizures and health-related quality of life: the relationship with psychological distress and other physical symptoms. Epilepsy Behav. 2009 Jan;14(1):167-71. doi: 10.1016/j.yebeh.2008.09.029. Epub 2008 Nov 6.

ReferenceCitation: Lesser RP. Treating psychogenic nonepileptic seizures: easier said than done. Ann Neurol. 2003 Mar;53(3):285-6. doi: 10.1002/ana.10542. No abstract available.

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ReferenceCitation: Mrabet H, Mrabet A, Zouari B, Ghachem R. Health-related quality of life of people with epilepsy compared with a general reference population: a Tunisian study. Epilepsia. 2004 Jul;45(7):838-43. doi: 10.1111/j.0013-9580.2004.56903.x.

ReferenceCitation: Oto M, Conway P, McGonigal A, Russell AJ, Duncan R. Gender differences in psychogenic non-epileptic seizures. Seizure. 2005 Jan;14(1):33-9. doi: 10.1016/j.seizure.2004.02.008.

ReferenceCitation: Oxman AD, Guyatt GH. A consumer's guide to subgroup analyses. Ann Intern Med. 1992 Jan 1;116(1):78-84. doi: 10.7326/0003-4819-116-1-78.

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ReferenceCitation: Racine AD, Alderman EM, Avner JR. Effect of telephone calls from primary care practices on follow-up visits after pediatric emergency department visits: evidence from the Pediatric Emergency Department Links to Primary Care (PEDLPC) randomized controlled trial. Arch Pediatr Adolesc Med. 2009 Jun;163(6):505-11. doi: 10.1001/archpediatrics.2009.45.

ReferenceCitation: Ramachandran K, Husain N, Maikhuri R, Seth S, Vij A, Kumar M, Srivastava N, Prabhakaran D, Airan B, Reddy KS. Impact of a comprehensive telephone-based disease management programme on quality-of-life in patients with heart failure. Natl Med J India. 2007 Mar-Apr;20(2):67-73.

ReferenceCitation: Reuber M, Fernandez G, Bauer J, Helmstaedter C, Elger CE. Diagnostic delay in psychogenic nonepileptic seizures. Neurology. 2002 Feb 12;58(3):493-5. doi: 10.1212/wnl.58.3.493.

ReferenceCitation: Reuber M. Psychogenic nonepileptic seizures: answers and questions. Epilepsy Behav. 2008 May;12(4):622-35. doi: 10.1016/j.yebeh.2007.11.006. Epub 2007 Dec 27.

ReferenceCitation: Reuber M, Howlett S, Khan A, Grunewald RA. Non-epileptic seizures and other functional neurological symptoms: predisposing, precipitating, and perpetuating factors. Psychosomatics. 2007 May-Jun;48(3):230-8. doi: 10.1176/appi.psy.48.3.230.

ReferenceCitation: Reuber M, Mitchell AJ, Howlett S, Elger CE. Measuring outcome in psychogenic nonepileptic seizures: how relevant is seizure remission? Epilepsia. 2005 Nov;46(11):1788-95. doi: 10.1111/j.1528-1167.2005.00280.x.

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ReferenceCitation: Szaflarski JP, Hughes C, Szaflarski M, Ficker DM, Cahill WT, Li M, Privitera MD. Quality of life in psychogenic nonepileptic seizures. Epilepsia. 2003 Feb;44(2):236-42. doi: 10.1046/j.1528-1157.2003.35302.x.

ReferenceCitation: Szaflarski JP, Szaflarski M, Hughes C, Ficker DM, Cahill WT, Privitera MD. Psychopathology and quality of life: psychogenic non-epileptic seizures versus epilepsy. Med Sci Monit. 2003 Apr;9(4):CR113-8.

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sponsor_collaborators:
Central Hospital, Nancy, France
Dr Coraline HINGRAY
Pr Raymund SCHWAN
Dr Vincent LAPREVOTE
Dr Jean Pierre VIGNAL
Pr Hervé VESPIGNANI
Dr Anne THIRIAUX
Dr Delphine RAUCHER CHENE
Dr Martine LEMESLE
Dr Benoît TROJAK
Pr Edouard HIRSCH
Pr Pierre Vidailhet
Dr Dominique Mastelli

location_facility:
Chu Nancy
Chu Reims
Chu Dijon
Chu Strasbourg


title: "Evaluation of the Impact of an Oral and Practical Presentation of Intrauterine Devices by a Health Professional on Women's Opinion as a Possible Contraceptive Method"

acronym: EPODIU

summary:
Contraception among women in France has evolved considerably and has become a frequent reason for consultation in general practice in view of the growing shortage of gynaecologists practising in towns.

Intrauterine devices (IUDs) are the leading reversible contraceptive method used in the world, but only 20.7% of women in France were using them in 2010.

In practice, in France, use of the IUD is still "reserved" for older women or those who have already had children, despite medical recommendations.

In this study the investigator will investigate whether clear information about the mode of action and insertion/withdrawal of IUDs would dispel these misconceptions of patients.

lead_sponsor: Raincy Montfermeil Hospital Group


title: Effectiveness of an Early Intervention Aiming at Promoting Healthy Diet, Lifestyle and Growth of Children Living in Situation of Social Disadvantage : the prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

acronym: ECAIL

summary: The purpose of this study is to conduct a randomized controlled trial among 800 socially disadvantaged pregnant women and their families to test the effectiveness of a multi-component home visitation nutrition program, compared to usual care, in promoting healthy feeding practices, lifestyle behaviors and growth in young children.

primary_purpose: Prevention

lead_sponsor: French Red Cross

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

collaborators: Association Française de Pédiatrie Ambulatoire

location_facility: Valenciennes Hospital, Monaco Hospital maternity


title: Early Detection of Severe Apnea-bradycardia in Preterm Infants Using Algorithm Fusion

acronym: INTEM

summary:
Apnea-bradycardia is a frequent phenomenon in preterm infants which has been associated with short term complications and alterations in neurodevelopment. Duration and amplitude of the bradycardias depend on the time delay between the beginning of the bradycardia and the intervention of the nurse.

The purpose of the study is to test a new method set for early detection of bradycardia in preterm infants.

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Ministry of Health, France

location_facility:
Tours University Hospital
Rennes University Hospital
Nantes University Hospital


title: Molecular Characterization and Cellular Infection Capacity of Urinary Viral Particles Isolated From SARS-CoV-2 and Association With Proximal Tubular Dysfunction, in Hospitalized Patients With COVID-19

acronym: CovUrinePTD

summary: The primary goal is to detect Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) urine viral particles in patients in intensive care units, hospitalized for coronavirus Coronavirus Disease-19 (COVID-19) infection, and correlate the presence of the virus in the urine with proximal tubular dysfunction (defined by the association of at least 2 abnormalities: tubular proteinuria, renal phosphate leak, uricosuria, normoglycemic glycosuria, amino aciduria)

ReferenceCitation: Kormann R, Jacquot A, Alla A, Corbel A, Koszutski M, Voirin P, Garcia Parrilla M, Bevilacqua S, Schvoerer E, Gueant JL, Namour F, Levy B, Frimat L, Oussalah A. Coronavirus disease 2019: acute Fanconi syndrome precedes acute kidney injury. Clin Kidney J. 2020 Jun 8;13(3):362-370. doi: 10.1093/ckj/sfaa109. eCollection 2020 Jun.


title: Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis. A Randomized Trial Comparing Two Periodicities of Ultrasonographic Surveillance: 3-month vs 6-month

summary: Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors is currently recommended, but the best periodicity is unknown.This randomized trial is aimed to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.

ReferenceCitation: Ganne-Carrie N, Nahon P, Chaffaut C, N'Kontchou G, Layese R, Audureau E, Chevret S; CIRRAL group; ANRS CO12 CirVir group. Impact of cirrhosis aetiology on incidence and prognosis of hepatocellular carcinoma diagnosed during surveillance. JHEP Rep. 2021 Mar 26;3(3):100285. doi: 10.1016/j.jhepr.2021.100285. eCollection 2021 Jun.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

publisher_dissemination: Elsevier

ReferenceCitation: Nery F, Chevret S, Condat B, de Raucourt E, Boudaoud L, Rautou PE, Plessier A, Roulot D, Chaffaut C, Bourcier V, Trinchet JC, Valla DC; Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire. Causes and consequences of portal vein thrombosis in 1,243 patients with cirrhosis: results of a longitudinal study. Hepatology. 2015 Feb;61(2):660-7. doi: 10.1002/hep.27546. Epub 2015 Jan 5.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Trinchet JC, Chaffaut C, Bourcier V, Degos F, Henrion J, Fontaine H, Roulot D, Mallat A, Hillaire S, Cales P, Ollivier I, Vinel JP, Mathurin P, Bronowicki JP, Vilgrain V, N'Kontchou G, Beaugrand M, Chevret S; Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire (GRETCH). Ultrasonographic surveillance of hepatocellular carcinoma in cirrhosis: a randomized trial comparing 3- and 6-month periodicities. Hepatology. 2011 Dec;54(6):1987-97. doi: 10.1002/hep.24545.

collaborators:
Ministry of Health, France
UNICANCER

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


title: Translating Molecular Classifications and Genetic Alterations of Hepatocellular Carcinoma in Clinical Care (MUTHEC Project)

acronym: MUTHEC

summary: The MUTHEC project aims to describe the mutational and transcriptomic landscape of HCC treated by curative treatments (resection, radio frequency ablation, transplantation) as well as advanced HCC together with the analysis of circulating tumor DNA.

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

appel_a_projets: PRTK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: MUTHEC

titre: Transfert des classifications moléculaires et génétiques des carcinomes hépatocellulaires en pratique clinique (projet MUTHEC)

discipline_principale: cancer

nom_porteur: TRINCHET

prenom_porteur: Jean-Claude


title: WELL-being Improvement Following a SOphrology Intervention in Hospital Staff

acronym: So-Well

summary:
Work stress and psychosocial risks are a major public health problem. Health-care workers (HCW) are particularly at risk. Moreover, non-HCW staff of hospitals can also be at risk, with working environment described as the main risk factor. The University Hospital (CHU) of Clermont-Ferrand is one of the 3 CHUs in France with more than 10% absenteeism, and the first CHU for duration of sick leave. The political orientations favor an approach to improve the quality of life at work.

Sophrology is a psychocorporal method used as a therapeutic technique or experienced as a philosophy of life. It is an exclusively verbal and non-tactile method. It combines a set of techniques that will act both on the body and on the mind through breathing exercises, muscle relaxation and mental imagery (or visualization). It allows to find a state of well-being and to activate all physical and psychological potential in order to acquire a better knowledge of oneself. NLP is a set of communication and self-transformation techniques that focuses on reactions rather than the origins of behaviors. NLP associated with sophrology proposes above all to mobilize the resources of the unconscious.

Neurolinguistic programming (NLP) strategies are effective in the improvement in mental (anxiety and depression), physical, and social health, both in the general population, in individuals with social/psychological problems or in patients, both in hospital settings or outside hospital. Similary, sophrology also demonstrated some benefits on symptoms of patients. However, these approaches have never been provided in the workplace for the benefits of workers at risk of stress-related disorders.

This protocol may permit improvements of stress-related outcomes. Putative short-term benefits: This protocol may incidentally detect cardiac disorders. Any abnormality discovered will not be covered by promotor's insurance (our exploratory study cannot lead to such event) and will be supported by health insurance.

In general, the investigators aim to demonstrate the effectiveness of a workplace sophrology / NLP intervention for HCW at risk of stress-related disorders. Stress and well-being will be the target of the intervention, and will be measured both in a subjective (questionnaire) and objective (biomarkers).

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Centre National de la Recherche Scientifique, France


title: Tuberculosis Cohort Avicenne Hospital

acronym: COTB-AVC

summary:
Tuberculosis represents the second highest death rate from an infectious disease in the world, just after COVID-19. The most affected department of France is Seine-Saint-Denis. Since 2005, this department with difficult socio-economic conditions has the highest incidence rate in metropolitan France, higher than that of Paris. In 2012, the reporting rate was 10 times higher among people born abroad compared to those born in France, with the highest rates found among people born in sub-Saharan Africa and Asia.

It is proposed to constitute for the first time in France a cohort of patients with tuberculosis disease to better understand the characteristics of patients with unfavorable treatment outcomes and ultimately, to propose solutions to obtain better control of tuberculosis. This study would recruit all patients with tuberculosis disease for at least 4 years associated with 1 year of follow-up for a total duration of the study of at least 5 years.

location_facility:
Hôpital Avicenne
Hopital Avicenne


type: Registry Identifier

title: Impact of a Truthful Information Concerning Chemotherapy on Chemotherapy Prescription at the End of Life : a Randomized Controlled Study in Non-curable Lung Cancer Patients

acronym: HIPPOCRATE

summary:
Patients with metastatic cancer have a substantial symptom burden and may receive aggressive care at the end of life. There is evidence that the use of chemotherapy near the end of life is not related to its likelihood of providing benefit and the overuse of aggressive anticancer therapies near the end of life may result in more toxicity than clinical benefit. Moreover, proposing new lines of treatment after successive therapeutic failures may be a way of avoiding discussion of prognosis and advance care planning. It has been proposed that systems not providing overly aggressive care near the end of life would be the ones in which less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the first consultation between patient and oncologist is ruled in France by the first "Plan Cancer" and the "Dispositif d'annonce" (announcement planning). Oncologists are supposed to explain the diagnosis of cancer and to present a treatment plan. In routine practice for metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and its side effects are explained. The use of chemotherapy has been associated with the worsening of two major competitive life-threatening conditions for cancer patients: cachexia and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is hardly explained in routine practice.

This study proposes to examine in a monocentric interventional prospective randomized trial, the impact of a particular way for the oncologist to present chemotherapy at the diagnosis stage on the easiness of timely chemotherapy interruption at the end of life. The main objective is to determine whether or not the explanation of the potential role of anticancer chemotherapy in worsening life-threatening conditions impacts the proportion of patients receiving chemotherapy in the last 30 days of life compared with usual presentation. Secondary objectives are to determine the impact of this communication strategy on overall survival and other indicators of aggressiveness of care and palliative care resources use.

The hypothesis is that the intervention will allow 15% of patients receiving anticancer therapy during the last 30 days of life, as compared to 30% in the control group.

The investigators expect that the intervention evaluated in this study will reduce the rate of patients receiving chemotherapy during the last 30 days of life hopefully improving the quality of end of life care. A secondary objective is overall survival and this study will therefore verify that the intervention arm is not associated with poorer overall survival. But more probably investigators expect patients in the intervention arm to have an improved overall survival mainly link to a decrease in harms due to chemotherapy given near the end of life and to better palliative care. In effect the hypothesis is that showing the life-threatening risks associated with chemotherapy and thus reducing for patients the importance of this treatment will leave room for improved palliative care as shown notably by earlier and more frequent referral to palliative care specialists. If this trial is positive, it will prove the capital role of patient-doctor communication in cancer care and that few differences in communication strategy could improve end of life care and maybe even survival. The impact on the oncology community would be major since the intervention could be easily transposed in all practices at no additional cost. It would also emphasize the importance of communication skills and human relationship in the very technical field of medical oncology.

ReferenceCitation: Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.

oa_host_type: repository

repository_institution: Queensland University of Technology - QUT ePrints

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

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

unpaywall_oa_status: green

publisher_dissemination: Wiley

collaborators: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne


acronym: MesoPDT

lead_sponsor: University Hospital, Lille

summary:
Malignant pleural mesothelioma (MPM) is an aggressive tumour with poor prognosis (median survival <13 months), and high resistance to chemotherapy. Extended pleurectomy/decortication (eP/D) is a debulking surgery of MPM but cannot be considered as a curative treatment. Therefore it has been suggested that eP/D may be of interest if combined with intra-operative treatment and adjuvant therapies.

Photodynamic Therapy (PDT) is an innovative treatment based on the rationale that tumour cells, if previously treated with photosensitizing drugs (Photofrin), will die when exposed to light at a particular wavelength. Interestingly PDT might also stimulate anti-tumour immune response through the release of tumour antigens and induced inflammation.

PDT was tested in phase I-II trials for MPM in combination with EPP or eP/D, and chemotherapy. US studies from J Friedberg et al found very promising survival results in MPM when combining eP/D, but not EPP, intra-operative PDT and chemotherapy (cisplatin-pemetrexed), with a median overall survival of 31.7 months.

However, the definitive value of intra-pleural PDT combined to eP/D in the treatment of MPM still need to be validated. The same multimodal treatment has been established in Lille, the French national expert centre for MPM, with the help of our american colleagues. Therefore, this phase II trial proposes to patients to benefit from the combination of eP/D, intra-operative PDT then chemotherapy by cisplatin-pemetrexed and prophylactic radiotherapy.

Primary endpoint is the feasibility for the patients to have the full multimodal treatment of MPM including intrapleural PDT without unacceptable or unexpected grade III-IV toxicities. Secondary endpoints are PFS, OS, ORR, and quality of life. If the feasibility of such treatment would be confirmed in France, a multicentric, randomized trial comparing this experimental treatment vs control arm (same multimodal treatment without PDT) is planned.

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

title: Pilot Study of the Feasibility of Intrapleural Photodynamic Therapy in a Multimodal Treatment Combining Extended Pleurectomy/Decortication, Adjuvant Chemotherapy and Prophylactic Radiotherapy in Patients With Malignant Pleural Mesothelioma

type: EudraCT Number

source: euctr

appel_a_projets: PHRCK

region: Hauts-de-France

nom_etablissement: CHR LILLE

acronyme: MESOPDT

titre: Essai clinique randomisé de phase II évaluant un traitement multimodal incluant une pleurectomie/décortication étendue (eP/D), une thérapie photodynamique intra-opératoire et une chimiothérapie adjuvante dans le mésothéliome pleural malin

discipline_principale: thoracic oncology

nom_porteur: SCHERPEREEL

prenom_porteur: Arnaud


title: Prospective Longitudinal Study on Health and Diet (Etude Longitudinale Prospective Alimentation et Santé)

acronym: ELPAS

summary: We hypothesize that Family Dietary Coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.

ReferenceCitation: Paineau DL, Beaufils F, Boulier A, Cassuto DA, Chwalow J, Combris P, Couet C, Jouret B, Lafay L, Laville M, Mahe S, Ricour C, Romon M, Simon C, Tauber M, Valensi P, Chapalain V, Zourabichvili O, Bornet F. Family dietary coaching to improve nutritional intakes and body weight control: a randomized controlled trial. Arch Pediatr Adolesc Med. 2008 Jan;162(1):34-43. doi: 10.1001/archpediatrics.2007.2.

lead_sponsor: Centre d'Etudes et de Documentation du Sucre

collaborators: Ministry of Higher Education and Research, France


title: Beta-Blocker Continuation Versus Interruption in Patients With Congestive Heart Failure Hospitalized for Heart Failure Worsening (B-CONVINCED)

acronym: BConvinced

summary:
The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission.

162 patients will be randomized in cardiology centers in France. Clinical status (primary endpoint) will be evaluated with a standardized questionnaire 3 days after hospital admission.

location_facility: Les Etablissements Hospitaliers du Bessin

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire La Milétrie

location_facility: Centre Hospitalier Universitaire Hautepierre

location_facility: Centre Hospitalier Universitaire Potcaillou


title: InductOs® in Real World Spine Surgery; A Retrospective, French, Multi-centric, Study

acronym: InductOR

summary:
It is a phase IV, national, multicenter, observational, retrospective study collecting data from patient medical files in French spinal centers.

The aim of the study is to describe the real world use of InductOs in Spine fusion in France.

Approximately 10 French centers will enroll 400 patients. The retrospective review of records will focus on patients who have undergone a spinal fusion surgery. Patient should be considered for enrollment if he/she has been treated with InductOs between January 1, 2011 and 31st December 2012.

lead_sponsor: Medtronic Spinal and Biologics

location_facility: Clinique Du Parc à Saint -Priest en Jarez

location_facility: CHU de Bordeaux- Centre Universitaire Pellegrin

location_facility: Centre Hospitalier Universitaire Nice - Hôpital Pasteur


title: Functional and Phenotypic Characteristics of Blood Neutrophils in Cystic Fibrosis

acronym: MUCO-PNN

summary: The purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of Pseudomonas aeruginosa chronic infection, treatment with CFTR modulators and acute exacerbation on blood neutrophils phenotype and function.

primary_purpose: Basic Science

ReferenceCitation: Adib-Conquy M, Pedron T, Petit-Bertron AF, Tabary O, Corvol H, Jacquot J, Clement A, Cavaillon JM. Neutrophils in cystic fibrosis display a distinct gene expression pattern. Mol Med. 2008 Jan-Feb;14(1-2):36-44. doi: 10.2119/2007-00081.Adib-Conquy.

ReferenceCitation: Bonvillain RW, Painter RG, Adams DE, Viswanathan A, Lanson NA Jr, Wang G. RNA interference against CFTR affects HL60-derived neutrophil microbicidal function. Free Radic Biol Med. 2010 Dec 15;49(12):1872-80. doi: 10.1016/j.freeradbiomed.2010.09.012. Epub 2010 Sep 24.

ReferenceCitation: Bouayad D, Pederzoli-Ribeil M, Mocek J, Candalh C, Arlet JB, Hermine O, Reuter N, Davezac N, Witko-Sarsat V. Nuclear-to-cytoplasmic relocalization of the proliferating cell nuclear antigen (PCNA) during differentiation involves a chromosome region maintenance 1 (CRM1)-dependent export and is a prerequisite for PCNA antiapoptotic activity in mature neutrophils. J Biol Chem. 2012 Sep 28;287(40):33812-25. doi: 10.1074/jbc.M112.367839. Epub 2012 Jul 30.

ReferenceCitation: Bruijnzeel PL, Uddin M, Koenderman L. Targeting neutrophilic inflammation in severe neutrophilic asthma: can we target the disease-relevant neutrophil phenotype? J Leukoc Biol. 2015 Oct;98(4):549-56. doi: 10.1189/jlb.3VMR1214-600RR. Epub 2015 May 14.

ReferenceCitation: Bulloch MN, Hanna C, Giovane R. Lumacaftor/ivacaftor, a novel agent for the treatment of cystic fibrosis patients who are homozygous for the F580del CFTR mutation. Expert Rev Clin Pharmacol. 2017 Oct;10(10):1055-1072. doi: 10.1080/17512433.2017.1378094. Epub 2017 Sep 22.

ReferenceCitation: Chiara AD, Pederzoli-Ribeil M, Burgel PR, Danel C, Witko-Sarsat V. Targeting cytosolic proliferating cell nuclear antigen in neutrophil-dominated inflammation. Front Immunol. 2012 Oct 9;3:311. doi: 10.3389/fimmu.2012.00311. eCollection 2012.

ReferenceCitation: Cantin A. Cystic fibrosis lung inflammation: early, sustained, and severe. Am J Respir Crit Care Med. 1995 Apr;151(4):939-41. doi: 10.1164/ajrccm.151.4.7697269. No abstract available.

ReferenceCitation: Dibbert B, Weber M, Nikolaizik WH, Vogt P, Schoni MH, Blaser K, Simon HU. Cytokine-mediated Bax deficiency and consequent delayed neutrophil apoptosis: a general mechanism to accumulate effector cells in inflammation. Proc Natl Acad Sci U S A. 1999 Nov 9;96(23):13330-5. doi: 10.1073/pnas.96.23.13330.

ReferenceCitation: Downey DG, Bell SC, Elborn JS. Neutrophils in cystic fibrosis. Thorax. 2009 Jan;64(1):81-8. doi: 10.1136/thx.2007.082388.

ReferenceCitation: Fadok VA, Bratton DL, Henson PM. Phagocyte receptors for apoptotic cells: recognition, uptake, and consequences. J Clin Invest. 2001 Oct;108(7):957-62. doi: 10.1172/JCI14122. No abstract available.

ReferenceCitation: Futosi K, Mocsai A. Tyrosine kinase signaling pathways in neutrophils. Immunol Rev. 2016 Sep;273(1):121-39. doi: 10.1111/imr.12455.

ReferenceCitation: Gilroy DW, Lawrence T, Perretti M, Rossi AG. Inflammatory resolution: new opportunities for drug discovery. Nat Rev Drug Discov. 2004 May;3(5):401-16. doi: 10.1038/nrd1383. No abstract available.

ReferenceCitation: Hayes E, Pohl K, McElvaney NG, Reeves EP. The cystic fibrosis neutrophil: a specialized yet potentially defective cell. Arch Immunol Ther Exp (Warsz). 2011 Apr;59(2):97-112. doi: 10.1007/s00005-011-0113-6. Epub 2011 Feb 11.

ReferenceCitation: Khan TZ, Wagener JS, Bost T, Martinez J, Accurso FJ, Riches DW. Early pulmonary inflammation in infants with cystic fibrosis. Am J Respir Crit Care Med. 1995 Apr;151(4):1075-82. doi: 10.1164/ajrccm/151.4.1075.

ReferenceCitation: Koenderman L, Chilvers ER. Future treatment in patients with chronic obstructive pulmonary disease: to reverse or not to reverse steroid resistance-that is the question. J Allergy Clin Immunol. 2014 Aug;134(2):323-4. doi: 10.1016/j.jaci.2014.04.030. Epub 2014 Jun 13. No abstract available.

ReferenceCitation: Laval J, Touhami J, Herzenberg LA, Conrad C, Taylor N, Battini JL, Sitbon M, Tirouvanziam R. Metabolic adaptation of neutrophils in cystic fibrosis airways involves distinct shifts in nutrient transporter expression. J Immunol. 2013 Jun 15;190(12):6043-50. doi: 10.4049/jimmunol.1201755. Epub 2013 May 20.

ReferenceCitation: Leliefeld PH, Koenderman L, Pillay J. How Neutrophils Shape Adaptive Immune Responses. Front Immunol. 2015 Sep 14;6:471. doi: 10.3389/fimmu.2015.00471. eCollection 2015.

ReferenceCitation: Mantovani A, Cassatella MA, Costantini C, Jaillon S. Neutrophils in the activation and regulation of innate and adaptive immunity. Nat Rev Immunol. 2011 Jul 25;11(8):519-31. doi: 10.1038/nri3024.

ReferenceCitation: Martin C, Ohayon D, Alkan M, Mocek J, Pederzoli-Ribeil M, Candalh C, Thevenot G, Millet A, Tamassia N, Cassatella MA, Thieblemont N, Burgel PR, Witko-Sarsat V. Neutrophil-Expressed p21/waf1 Favors Inflammation Resolution in Pseudomonas aeruginosa Infection. Am J Respir Cell Mol Biol. 2016 May;54(5):740-50. doi: 10.1165/rcmb.2015-0047OC.

ReferenceCitation: McKeon DJ, Condliffe AM, Cowburn AS, Cadwallader KC, Farahi N, Bilton D, Chilvers ER. Prolonged survival of neutrophils from patients with Delta F508 CFTR mutations. Thorax. 2008 Jul;63(7):660-1. doi: 10.1136/thx.2008.096834. No abstract available.

ReferenceCitation: Meijer L, Nelson DJ, Riazanski V, Gabdoulkhakova AG, Hery-Arnaud G, Le Berre R, Loaec N, Oumata N, Galons H, Nowak E, Gueganton L, Dorothee G, Prochazkova M, Hall B, Kulkarni AB, Gray RD, Rossi AG, Witko-Sarsat V, Norez C, Becq F, Ravel D, Mottier D, Rault G. Modulating Innate and Adaptive Immunity by (R)-Roscovitine: Potential Therapeutic Opportunity in Cystic Fibrosis. J Innate Immun. 2016;8(4):330-49. doi: 10.1159/000444256. Epub 2016 Mar 18.

ReferenceCitation: Moriceau S, Kantari C, Mocek J, Davezac N, Gabillet J, Guerrera IC, Brouillard F, Tondelier D, Sermet-Gaudelus I, Danel C, Lenoir G, Daniel S, Edelman A, Witko-Sarsat V. Coronin-1 is associated with neutrophil survival and is cleaved during apoptosis: potential implication in neutrophils from cystic fibrosis patients. J Immunol. 2009 Jun 1;182(11):7254-63. doi: 10.4049/jimmunol.0803312.

ReferenceCitation: Moriceau S, Lenoir G, Witko-Sarsat V. In cystic fibrosis homozygotes and heterozygotes, neutrophil apoptosis is delayed and modulated by diamide or roscovitine: evidence for an innate neutrophil disturbance. J Innate Immun. 2010;2(3):260-6. doi: 10.1159/000295791. Epub 2010 Mar 10.

ReferenceCitation: Ohayon D, De Chiara A, Chapuis N, Candalh C, Mocek J, Ribeil JA, Haddaoui L, Ifrah N, Hermine O, Bouillaud F, Frachet P, Bouscary D, Witko-Sarsat V. Cytoplasmic proliferating cell nuclear antigen connects glycolysis and cell survival in acute myeloid leukemia. Sci Rep. 2016 Oct 19;6:35561. doi: 10.1038/srep35561.

ReferenceCitation: Peranzoni E, Zilio S, Marigo I, Dolcetti L, Zanovello P, Mandruzzato S, Bronte V. Myeloid-derived suppressor cell heterogeneity and subset definition. Curr Opin Immunol. 2010 Apr;22(2):238-44. doi: 10.1016/j.coi.2010.01.021. Epub 2010 Feb 17.

ReferenceCitation: Pillay J, Kamp VM, van Hoffen E, Visser T, Tak T, Lammers JW, Ulfman LH, Leenen LP, Pickkers P, Koenderman L. A subset of neutrophils in human systemic inflammation inhibits T cell responses through Mac-1. J Clin Invest. 2012 Jan;122(1):327-36. doi: 10.1172/JCI57990. Epub 2011 Dec 12.

ReferenceCitation: Pillay J, Ramakers BP, Kamp VM, Loi AL, Lam SW, Hietbrink F, Leenen LP, Tool AT, Pickkers P, Koenderman L. Functional heterogeneity and differential priming of circulating neutrophils in human experimental endotoxemia. J Leukoc Biol. 2010 Jul;88(1):211-20. doi: 10.1189/jlb.1209793. Epub 2010 Apr 16.

ReferenceCitation: Pillay J, Tak T, Kamp VM, Koenderman L. Immune suppression by neutrophils and granulocytic myeloid-derived suppressor cells: similarities and differences. Cell Mol Life Sci. 2013 Oct;70(20):3813-27. doi: 10.1007/s00018-013-1286-4. Epub 2013 Feb 20.

ReferenceCitation: Rossi AG, Sawatzky DA, Walker A, Ward C, Sheldrake TA, Riley NA, Caldicott A, Martinez-Losa M, Walker TR, Duffin R, Gray M, Crescenzi E, Martin MC, Brady HJ, Savill JS, Dransfield I, Haslett C. Cyclin-dependent kinase inhibitors enhance the resolution of inflammation by promoting inflammatory cell apoptosis. Nat Med. 2006 Sep;12(9):1056-64. doi: 10.1038/nm1468. Epub 2006 Sep 3. Erratum In: Nat Med. 2006 Dec;12(12):1434. Dosage error in article text.

ReferenceCitation: Scapini P, Marini O, Tecchio C, Cassatella MA. Human neutrophils in the saga of cellular heterogeneity: insights and open questions. Immunol Rev. 2016 Sep;273(1):48-60. doi: 10.1111/imr.12448.

ReferenceCitation: Uhel F, Azzaoui I, Gregoire M, Pangault C, Dulong J, Tadie JM, Gacouin A, Camus C, Cynober L, Fest T, Le Tulzo Y, Roussel M, Tarte K. Early Expansion of Circulating Granulocytic Myeloid-derived Suppressor Cells Predicts Development of Nosocomial Infections in Patients with Sepsis. Am J Respir Crit Care Med. 2017 Aug 1;196(3):315-327. doi: 10.1164/rccm.201606-1143OC.

ReferenceCitation: Warbrick E. A functional analysis of PCNA-binding peptides derived from protein sequence, interaction screening and rational design. Oncogene. 2006 May 11;25(20):2850-9. doi: 10.1038/sj.onc.1209320.

ReferenceCitation: Witko-Sarsat V. Neutrophils in the innate immunity conundrum of cystic fibrosis: a CFTR-related matter? J Innate Immun. 2013;5(3):195-6. doi: 10.1159/000350215. Epub 2013 Mar 23. No abstract available.

ReferenceCitation: Witko-Sarsat V, Allen RC, Paulais M, Nguyen AT, Bessou G, Lenoir G, Descamps-Latscha B. Disturbed myeloperoxidase-dependent activity of neutrophils in cystic fibrosis homozygotes and heterozygotes, and its correction by amiloride. J Immunol. 1996 Sep 15;157(6):2728-35.

ReferenceCitation: Witko-Sarsat V, Cramer EM, Hieblot C, Guichard J, Nusbaum P, Lopez S, Lesavre P, Halbwachs-Mecarelli L. Presence of proteinase 3 in secretory vesicles: evidence of a novel, highly mobilizable intracellular pool distinct from azurophil granules. Blood. 1999 Oct 1;94(7):2487-96.

ReferenceCitation: Witko-Sarsat V, Halbwachs-Mecarelli L, Sermet-Gaudelus I, Bessou G, Lenoir G, Allen RC, Descamps-Latscha B. Priming of blood neutrophils in children with cystic fibrosis: correlation between functional and phenotypic expression of opsonin receptors before and after platelet-activating factor priming. J Infect Dis. 1999 Jan;179(1):151-62. doi: 10.1086/314532.

ReferenceCitation: Witko-Sarsat V, Mocek J, Bouayad D, Tamassia N, Ribeil JA, Candalh C, Davezac N, Reuter N, Mouthon L, Hermine O, Pederzoli-Ribeil M, Cassatella MA. Proliferating cell nuclear antigen acts as a cytoplasmic platform controlling human neutrophil survival. J Exp Med. 2010 Nov 22;207(12):2631-45. doi: 10.1084/jem.20092241. Epub 2010 Oct 25.

ReferenceCitation: Witko-Sarsat V, Ohayon D. Proliferating cell nuclear antigen in neutrophil fate. Immunol Rev. 2016 Sep;273(1):344-56. doi: 10.1111/imr.12449.

ReferenceCitation: Witko-Sarsat V, Pederzoli-Ribeil M, Hirsch E, Sozzani S, Cassatella MA. Regulating neutrophil apoptosis: new players enter the game. Trends Immunol. 2011 Mar;32(3):117-24. doi: 10.1016/j.it.2011.01.001. Epub 2011 Feb 12. Erratum In: Trends Immunol. 2011 May;32(5):187. Hirsh, Emilio [corrected to Hirsch, Emilio].

ReferenceCitation: Witko-Sarsat V, Rieu P, Descamps-Latscha B, Lesavre P, Halbwachs-Mecarelli L. Neutrophils: molecules, functions and pathophysiological aspects. Lab Invest. 2000 May;80(5):617-53. doi: 10.1038/labinvest.3780067. No abstract available.

ReferenceCitation: Witko-Sarsat V, Sermet-Gaudelus I, Lenoir G, Descamps-Latscha B. Inflammation and CFTR: might neutrophils be the key in cystic fibrosis? Mediators Inflamm. 1999;8(1):7-11. doi: 10.1080/09629359990658.

ReferenceCitation: Worlitzsch D, Tarran R, Ulrich M, Schwab U, Cekici A, Meyer KC, Birrer P, Bellon G, Berger J, Weiss T, Botzenhart K, Yankaskas JR, Randell S, Boucher RC, Doring G. Effects of reduced mucus oxygen concentration in airway Pseudomonas infections of cystic fibrosis patients. J Clin Invest. 2002 Feb;109(3):317-25. doi: 10.1172/JCI13870.

ReferenceCitation: Wright HL, Makki FA, Moots RJ, Edwards SW. Low-density granulocytes: functionally distinct, immature neutrophils in rheumatoid arthritis with altered properties and defective TNF signalling. J Leukoc Biol. 2017 Feb;101(2):599-611. doi: 10.1189/jlb.5A0116-022R. Epub 2016 Sep 6.

ReferenceCitation: Heijerman HGM, McKone EF, Downey DG, Van Braeckel E, Rowe SM, Tullis E, Mall MA, Welter JJ, Ramsey BW, McKee CM, Marigowda G, Moskowitz SM, Waltz D, Sosnay PR, Simard C, Ahluwalia N, Xuan F, Zhang Y, Taylor-Cousar JL, McCoy KS; VX17-445-103 Trial Group. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1940-1948. doi: 10.1016/S0140-6736(19)32597-8. Epub 2019 Oct 31. Erratum In: Lancet. 2020 May 30;395(10238):1694.


title: Prognostic Impact of the Inflammatory Microenvironment in Atypical Meningiomas

summary:
Atypical meningiomas represent 15% of meningiomas. They present a high rate of recurrence, and therapeutic strategies are limited. There is a need for novel treatment strategies, such as immuotherapy.

This is a retrospective study including 84 patients with primary diagnosis of atypical meningiomas. The presence of T cells (CD4, CD8, Treg and memory T cells) and mature dendritic cells will be quantified on whole tissue sections stained by immunohistochemistry (CD4, CD8, FOXP3, CD45RO and CD208).

This could allow us to identify novel biomarkers for survival, and facilitate the selection of patients who may benefit from immunotherapeutic modalities.

lead_sponsor: Central Hospital, Nancy, France


title: Rôle du Cervelet et de l'Aire Motrice supplémentaire Dans le contrôle Postural au Cours de la Marche Chez l'Homme

acronym: CERESMARCHE

summary: In human, the physiology of gait and balance is not clearly established. By using functional imaging and electrophysiological techniques, various brain regions from the cortex to the midbrain area, including the cerebellum, have been identified as involved in such control. The specific role of these structures in both the capacity to go forward (locomotion) and stand upright (balance), but also in the different phases of the gait initiation process, are not known, however. In this study,the investigators aimed to assess the specific role of both the supplementary motor area (SMA) and the cerebellum in postural control during the initiation of gait. For this purpose, the investigators plan to study the gait initiation in 20 healthy subjects before and after functional inactivation (using inhibitory repetitive transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic and electromyographic parameters of the gait initiation will be recorded using a force platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG electrodes.


title: Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : the Circadian Rhythms of Urinary Excretion of Modified Nucleosides.

summary: Observational, non randomized study aimed at measuring the circadian rhythms in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer and in 30 age and sex-matched healthy subjects.


title: Prospective Randomized Study Comparing 3 Post-operative Rehabilitation Programs After Arthroscopic Supra-spinatus Tendon Repair

summary:
Through a prospective randomized study the aims of this study is to analyze the impact of 3 types of rehabilitation protocols on the Optimization of the post-operative clinical and anatomic healing of the rotator cuff. After an arthroscopic repair of a stage 1 or 2 supra-spinatus tendon rupture, patients will be included in 3 groups (98 patients per group):

strict immobilization for 6 weeks then active rehabilitation,
or 3 weeks of immobilization then 3 weeks of passive motion before active rehabilitation,
or immediate passive motion for 6 weeks and then active rehabilitation.

Patients will be evaluated clinically at 6 weeks, 3 months, 6 months and 1 year and an arthro-CT will be performed at 1 year.

The investigators will evaluate: constant score and rate of tendon healing.

location_facility: CCOM, Service de Chirurgie du membre supérieur, Hôpitaux Universitaires de Strasbourg

location_facility: Service de radiologie, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service d'Imagerie Guilloz, Hôpital Central, CHU de Nancy


title: Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria: Pilot Study

acronym: POP-UP

summary:
In 2013 in France, 29,000 people are reported to be unaware of their HIV status. HIV testing is a priority in France where one third of all diagnoses remain late despite 5 million annual tests. It is recommended to offer at least one HIV test to the general population, over the life course, when seeking care and more frequently to populations at risk. Several international and national articles have shown that emergency screening is feasible and well accepted. But also that during systematic screening few infections were discovered, and the majority of newly diagnosed people belonged to the most exposed groups.

Our hypothesis is that an electronic alert would identify people who are unaware of their HIV status. This alert would be based on two data: social data (French health coverage) and the country of birth. This alert is only relevant in high-prevalence regions, as is the case in the Ile de France region.

primary_purpose: Screening

lead_sponsor: Hopital Foch


title: Evaluation of a Therapeutic Immunization Strategy Associating a DNA Vaccine (GTU-MultiHIV B) Followed by a Lipopeptide Vaccine (LIPO-5) in the Control of Viral Replication Following Antiretroviral Treatment Interruption in HIV-1 Infected Patients With a CD4 Cell Count ≥ 600/mm3

summary:
The combination of GTU-MultiHIV B DNA and LIPO-5 vaccines in a prime-boost strategy is expected to induce strong and diverse HIV-specific immune responses in HIV-infected patients. The investigators will carry out the clinical therapeutic immunization "proof of concept" trial in HIV infected patients. The investigators propose a multi-center double blind randomized versus placebo phase II clinical trial in patients who are chronic asymptomatic HIV-infected patients, with undetectable viral load while treated with a potent combination of antiviral drugs. Patients will continue antiviral therapy combined with either therapeutic vaccination or placebo vaccination. Patients will undergo the procedure which includes a prime with the GTU-MultiHIV B DNA vaccine or placebo administered by IM injections via Biojector (a needle-free injection system) followed by a boost of LIPO-5 vaccine or placebo also given IM.

In total, 105 HIV-1 patients will be enrolled: 35 in the placebo arm and 70 in the vaccine arm. Patients will receive antiretroviral treatments and 3 administrations of DNA vaccine or its placebo at weeks 0, 4 and 12 (corresponding to prime vaccinations). They also receive 2 doses of LIPO-5 vaccines or its placebo at week 20 and 24 (corresponding to boost vaccinations). At week 36 antiretroviral treatments will be interrupted until week 48. Patients will be intensely monitored during the treatment interruption period. After start of cART treatment (at the latest in W48), a data collection from clinical car will be carried out. A blood sample with W74 will allow to study the persistence ot the immunizing responses, 1 year after the injection of the last vaccine/placebo.

The primary efficacy endpoint is a plasma HIV-1 RNA level at week 48 (e.g. 12 weeks after stopping all antiviral treatment).

The main hypothesis for conducting a phase II randomized trial is that immune responses in vaccinated patients may be associated with a better control of viral replication following c-ART interruption as compared to placebo-vaccinated patients.

ReferenceCitation: Levy Y, Lacabaratz C, Lhomme E, Wiedemann A, Bauduin C, Fenwick C, Foucat E, Surenaud M, Guillaumat L, Boilet V, Rieux V, Bouchaud O, Girard PM, Molina JM, Morlat P, Hocqueloux L, Richert L, Pantaleo G, Lelievre JD, Thiebaut R. A Randomized Placebo-Controlled Efficacy Study of a Prime Boost Therapeutic Vaccination Strategy in HIV-1-Infected Individuals: VRI02 ANRS 149 LIGHT Phase II Trial. J Virol. 2021 Apr 12;95(9):e02165-20. doi: 10.1128/JVI.02165-20. Print 2021 Apr 12.

oa_colors: green hybrid

evidence: open (via crossref license)

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

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

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

version: acceptedVersion

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

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

unpaywall_oa_status: hybrid

publisher_dissemination: American Society for Microbiology

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service d'Immunologie clinique, Centre de vaccination anti-VIH ANRS Mondor Ile-de-France, Hôpital Henri Mondor