title: Spectrum of Bacterial Infections in Rheumatology and the Role of Urinary Tract Infection

acronym: SIBERIE

summary:
Retrospective study of patients with a proved non-tuberculous osteoarticular infection (OAI) diagnosed in a rheumatology department during the years 2010-2020. The objectives are :

To describe sites, type of micro-organism, clinical data, origin of infection, therapeutic modalities et outcome
To compare OAI of urinary origin with those with another origin

ReferenceCitation: Ross JJ. Septic Arthritis of Native Joints. Infect Dis Clin North Am. 2017 Jun;31(2):203-218. doi: 10.1016/j.idc.2017.01.001. Epub 2017 Mar 30. Review.

ReferenceCitation: Berbari EF, Kanj SS, Kowalski TJ, Darouiche RO, Widmer AF, Schmitt SK, Hendershot EF, Holtom PD, Huddleston PM 3rd, Petermann GW, Osmon DR, Infectious Diseases Society of America. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015 Sep 15;61(6):e26-46. doi: 10.1093/cid/civ482. Epub 2015 Jul 29. Review.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Department of Rheumatology, Hospital René Dubos, Pontoise


title: Interaction Between Air Pollution, Pollens and Allergic Rhinitis in the Aix-Marseille-Provence Metropolis

acronym: MISTRAL

summary:
Seasonal allergic rhinitis has multiple consequences: sleep disturbances, fatigue, depressed mood, impaired quality of life and productivity, and co-morbid conditions such as asthma, which affects one third of AR patients.

In Europe, more than 150 million people suffer from allergic rhinitis and more than 25 million suffer from asthma. About 30% have uncontrolled rhinitis during exposure to allergens. The impact of allergic diseases on work productivity is estimated to be between 30 and 50 billion € per year in the EU.

Studies show that pollution can play a role in the amplification of the response to inhaled pollen allergens by inducing morphological and functional modifications of nasal and bronchial epithelia, but also by inducing structural modifications of allergenic molecules. However, although data show that the symptoms of AR are aggravated by exposure to air pollution, this effect is not observed for all pollens.

The study area is very exposed to pollens (with a significant presence of cypress pollen) and air pollution, and presents a prevalence of asthma of 17% while the national average is about 7%.

The aim of this study is to establish, if they exist, links between pollens of various species, air pollution and symptoms of allergic rhinitis. The knowledge of these links will allow public authorities to set up prevention actions, and patients to better manage their allergic rhinitis on a daily basis.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: MASK-air SAS

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.

acronym: CHALAXIE

summary:
The main objective of this study is to determine the benefit of the Chalaxie pedagogical evaluation tool in the management of overweight or obese children with intellectual disability.

Chalaxie is a software developped as a pedagogical evaluation tool. It is used in the therapeutic education of overweight and obese children and allow the clinican to explore several skills of the child, such as self-esteem.

study_type: Interventional

primary_purpose: Supportive Care

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

intervention_type: Procedure

lead_sponsor_type: academique


design_allocation: Randomized

intervention_type: Drug

status: Not yet recruiting

study_start_date_type: Anticipated

lead_sponsor: University Hospital, Tours

primary_purpose: Treatment

acronym: PROTO-BRAIN

type: EudraCT Number

source: euctr

title: Nitrous Oxide for Late-Life Depression : a Randomized Controlled Trial With Comparator - PROTO-BRAIN

summary:
Resistant Depression is a common condition in older adults and there is an urgent need for novel antidepressant in this population. Nitrous Oxide (N2O) has recently shown rapid antidepressant effect in midlife depression but no study has currently investigated the efficacy and safety of N2O in Late-Life Depression (LLD), while N2O may prove to be an ideal treatment for LLD because of glutamatergic antagonism and cerebrovascular effects and also a relatively good safety profile.

The goal of our study is to compare changes in depressive symptoms after 2 hours, 24 hours, 1 week and 2 week of a 1-hour exposure to EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) versus Medical Air.

Secondary Objectives include comparing differences in neuroimaging measures between 3 groups (responders and non-responders in the EMONO group, and patients in the control group).


title: Impact of the Lockdown Due to the COVID Pandemic in French Wilson's Disease Patients

acronym: WILL-Ecco

summary:
Wilson's disease is a rare genetic disorder that causes copper to build up in the body. This overload is initially localized in the liver and the brain, but can spread throughout the body and cause systemic damage if copper chelation or zinc salt therapy is not implemented quickly. Treatment should be taken daily and continued all the lifelong.

Patients usually have a follow-up (clinical examination, ultrasound of the liver, blood and urine samples) every six months in the maintenance phase of the disease and more frequently in the event of destabilization of the disease which requires adaptation of the doses of treatment or when initiating treatment. Some patients also benefit from regular psychological follow-up and patients with a disabling neurological form may have physiotherapy, and speech therapy. The Covid 19 pandemic has imposed the lockdown of the entire population, including patients with Wilson's disease. The non-urgent care of these patients was therefore suspended. Medical consultations and paramedical care (physiotherapy, speech therapy, psychologist, etc.) have been postponed. Only very urgent hospitalizations in the event of imbalance of their illness with life-threatening risk were maintained.

Wilson's disease patients could in this situation be particularly anxious and present disturbances of their quality of life. The psychiatric consequences could not be limited to the current period but also concern long-term patients, in particular if there is a worsening of the disease. The consequences of inactivity and the end of specific treatments (physiotherapy and speech therapy) could also be sources of aggravation. The behavioral and cognitive characteristics of the disease and the major difficulties in adherence to treatment already observed in this chronic disease, may suggest a repercussion of the pandemic in this population.

The consequences of the COVID pandemic in these fragile patients with a rare disease must be assessed. It will be important to look at the consequences of the lockdown on the adherence to treatment and on the course of the disease.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


type: Other Identifier

title: Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent

acronym: ELECTROSTROKE

summary: The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke ; and to assess recurrence of Ischemic Cerebral Accident (ICA) at 6 months in patients hospitalized for Ischemic stroke.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de St-Etienne

intervention_type: Biological


title: Facteurs Pronostiques Des Troubles Fonctionnels Neurologiques : étude rétrospective et évaluation d'un Score

acronym: POSiF

summary:
Monocentric retrospective observational cohort study, using a consecutive series of patients hospitalized for FND from 2012 to 2015 in the neurology department A of the Grenoble Alpes University Hospital. During the discharge staff, an estimation of different prognostic factors had been performed in a consensual way by the medical team for all subjects. It is possible to calculate a score (POS) retrospectively from the data collected during the staff. The following items were evaluated on a Likert scale from 1 to 5: quality of adherence to the diagnosis, presence of a current medical treatment, presence of a similar history, duration of evolution of the disorders presented, ability to verbalize, presence of a social adaptation to the disorders, access to psychiatric care.

The aim of the study will be to study the properties of the calculated score according to the evolution of the patients. The investigators will retrospectively collect information from the medical records. In addition, the evolution of the disorder since the initial hospitalization will be analyzed via a self-evaluation by the subjects and the study of the current medical records.

The investigators will also collect information on the quality of life of the patients in the cohort and their perception of the disease at present.

Using a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations). The prognostic properties of the POS score will be then studied in order to establish an ROC curve that will allow to classify patients in the two groups.

time_perspective: Retrospective

lead_sponsor: University Hospital, Grenoble


title: Effect of Implementation of Enhanced Recovery After Surgery (ERAS) Protocol on 3-year Survival After Colorectal Surgery for Cancer - a Retrospective Cohort of 1001 Patients

acronym: RACCOR

summary: Several recent studies have shown that the Enhanced Recovery After Surgery (ERAS) protocol reduces morbidity and mortality and shortens the length of stay compared to conventional recovery strategy (pre-ERAS). The aim of this study was to evaluate the effect of the implementation of this protocol on 3-year overall survival and postoperative outcome in patients undergoing colorectal resection for cancer.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Alfonsi P, Slim K, Chauvin M, Mariani P, Faucheron JL, Fletcher D; le groupe de travail de la Société française d'anesthésie et réanimation (Sfar) et de la Société française de chirurgie digestive (SFCD). [Guidelines for enhanced recovery after elective colorectal surgery]. Ann Fr Anesth Reanim. 2014 May;33(5):370-84. doi: 10.1016/j.annfar.2014.03.007. Epub 2014 May 20. French.

family: Alfonsi

full_name: P. Alfonsi

given: P.

sequence: first

family: Slim

full_name: K. Slim

given: K.

sequence: additional

family: Chauvin

full_name: M. Chauvin

given: M.

family: Mariani

full_name: P. Mariani

family: Faucheron

full_name: J.-L. Faucheron

family: Fletcher

full_name: D. Fletcher

given: D.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annales Françaises d'Anesthésie et de Réanimation

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Réhabilitation rapide après une chirurgie colorectale programmée

ReferenceCitation: Gignoux B, Gosgnach M, Lanz T, Vulliez A, Blanchet MC, Frering V, Faucheron JL, Chasserant P. Short-term Outcomes of Ambulatory Colectomy for 157 Consecutive Patients. Ann Surg. 2019 Aug;270(2):317-321. doi: 10.1097/SLA.0000000000002800.

family: Gignoux

full_name: Benoit Gignoux

given: Benoit

family: Gosgnach

full_name: Marilyn Gosgnach

given: Marilyn

family: Lanz

full_name: Thomas Lanz

given: Thomas

family: Vulliez

full_name: Alexandre Vulliez

given: Alexandre

family: Blanchet

full_name: Marie-Cecile Blanchet

given: Marie-Cecile

family: Frering

full_name: Vincent Frering

given: Vincent

full_name: Jean-Luc Faucheron

given: Jean-Luc

family: Chasserant

full_name: Philippe Chasserant

given: Philippe

journal_name: Annals of Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Faucheron JL, Trilling B, Sage PY. Ambulatory colectomy: fast-track management pushed to its limits? Tech Coloproctol. 2018 Oct;22(10):741-742. doi: 10.1007/s10151-018-1871-5. Epub 2018 Nov 9. Review.

family: Trilling

full_name: B. Trilling

given: B.

family: Sage

full_name: P.-Y. Sage

journal_name: Techniques in Coloproctology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

ReferenceCitation: Trilling B, Sage PY, Faucheron JL. What is fast track multimodal management of colorectal cancer surgery in real life? Tech Coloproctol. 2018 May;22(5):401-402. doi: 10.1007/s10151-018-1799-9. Epub 2018 Jun 1.

ReferenceCitation: Carrier G, Cotte E, Beyer-Berjot L, Faucheron JL, Joris J, Slim K; Groupe Francophone de Réhabilitation Améliorée après Chirurgie (GRACE). Post-discharge follow-up using text messaging within an enhanced recovery program after colorectal surgery. J Visc Surg. 2016 Aug;153(4):249-52. doi: 10.1016/j.jviscsurg.2016.05.016. Epub 2016 Aug 8.

ReferenceCitation: Slim K, Delaunay L, Joris J, Léonard D, Raspado O, Chambrier C, Ostermann S; Le Groupe francophone de réhabilitation améliorée après chirurgie (GRACE). How to implement an enhanced recovery program? Proposals from the Francophone Group for enhanced recovery after surgery (GRACE). J Visc Surg. 2016 Dec;153(6S):S45-S49. doi: 10.1016/j.jviscsurg.2016.05.008. Epub 2016 Jun 14. Review.

ReferenceCitation: Faujour V, Slim K, Corond P. [The future, in France, of enhanced recovery after surgery seen from the economical perspective]. Presse Med. 2015 Jan;44(1):e23-31. doi: 10.1016/j.lpm.2014.07.021. Epub 2014 Dec 22. French.

title: L’avenir en France de la réhabilitation améliorée après chirurgie, vu sous l’angle médico-économique

ReferenceCitation: Launay-Savary MV, Mathonnet M, Theissen A, Ostermann S, Raynaud-Simon A, Slim K; GRACE (Groupe francophone de Réhabilitation Améliorée après Chirurgie). Are enhanced recovery programs in colorectal surgery feasible and useful in the elderly? A systematic review of the literature. J Visc Surg. 2017 Feb;154(1):29-35. doi: 10.1016/j.jviscsurg.2016.09.016. Epub 2016 Nov 11. Review.


title: Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia

acronym: MusicAnx-SSPI

summary: Our hypothesis is that listening to music has a beneficial effect on the French population receiving spinal anesthesia for a scheduled procedure. We think we can reduce anxiety when switching to SSPI, using creative music therapy software (Music Care) French validated by clinical research.

lead_sponsor: CHU de Reims


lead_sponsor: Rennes University Hospital

acronym: FLUDROSEPSIS

location_facility: Rennes University Hospital - Intensive Care unit

title: Evaluation of the Hemodynamics Effects of Fludrocortisone on the Pressor Response to Noradrenaline in Septic Shock Patients

summary: The benefit of low-dose steroids in septic shock is still debated today, especially with mineralocorticoids. Fludrocortisone is a synthetic mineralocorticoid, an analogue of aldosterone, which has shown, in combination with hydrocortisone, a favorable effect on the mortality of septic shock patients with relative adrenal insufficiency. In a previous study in healthy volunteers, we showed for the first time that fludrocortisone at a dose of 400 μg per day significantly improved the pressor response to phenylephrine. These results confirm the observations reported in rats with endotoxin shock, where fludrocortisone was shown to significantly increase blood pressure and contractile response to phenylephrine. These encouraging results argue for a potential vascular beneficial effect of fludrocortisone and need to be confirmed in a population of septic shock patients. In this context, we aimed to evaluate the effect of oral administration of 100 μg every 6 hours of fludrocortisone on vascular responsiveness to noradrenaline in septic shock patients.


title: Efficacy of Soluble Dexamethasone by Echo-guided Infiltration Through the Sacrococcygeal Hiatus in Refractory Sciatica: a Prospective Randomised Double-blind Study Versus Placebo

acronym: Dexhia

summary: This is a phase 3 prospective randomised double-blind study versus placebo, measuring the efficacy of soluble Dexamethasone by echo-guided infiltrations through the sacro-coccygeal hiatus in intractable sciatica

lead_sponsor: Nantes University Hospital


title: Etude Pilote d'évaluation de l'efficacité de l'ETP Sur l'Insomnie Chronique

acronym: ETP-INSOMNIE

summary:
20 to 30% of the general population suffers from chronic insomnia. Cognitive behavioral therapy (CBT) is the first-line treatment, but unfortunately its implementation is complex. Long waiting times for a consultation / exploration, too short a consultation period, non-reimbursement of specialists and a lack of trained staff make the current care of insomniac patients difficult. Patients are thus treated late, often with heavy drug treatment, dependence on sleeping pills, difficult withdrawal and / or reactive mood disorders. The treatment is therefore limited to advice on sleep hygiene and a restriction of time spent in bed without ultimately intervening in the cognitive domain. Therapeutic education consists of empowering the patient in the management of chronic insomnia through group education workshops. The patient learns the principles of normal sleep, the way in which sleep evolves with aging, the dangers of treatments as well as the rules of sleep hygiene and the behaviors to modify to sleep well. In addition to benefiting from sharing of experience with other patients, therapeutic education makes the care pathway smoother and considerably reduces the long waiting times of the traditional care pathway in consultation.

The study investigators hypothesize that therapeutic education is more effective as a treatment for chronic insomnia than traditional management in individualized consultation (IC). Thus, therapeutic education could constitute an effective alternative to CBT.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Nurses-driven, Capnography-guided Protocol Weaning From the Mechanical Ventilation at Bedside: A Feasibility Study

acronym: NURSES-WEAN

summary:
Background: Prolonged mechanical ventilation (MV) exposes patients to increased risk of infection and mortality. A weaning protocol (WP) reduces the duration of MV. However, these protocols remain complicated to implement in clinical practice. These considerations led to the development of automated weaning systems (AWS) which are expensive and limited to expert centers.

Scope of the problem: AWS are not yet the standard care because evidence of AWS benefit is weak and several unanswered questions remain regarding their roles in weaning. There is a need for building new ways to improve WP. Indeed, medical staff's compliance with a daily screening of patients to wean is low. Moreover, modifications in ventilator settings require the availability of physicians at bedside and are rarely modified on a daily basis. This leads to impaired weaning process and prolonged MV for patients.

Acknowledge gap: Capnography (CAP) has been validated for intubation procedures and integrated into AWS. Some studies encouraging use of CAP have shown an optimization of MV, a decrease of unnecessary arterial blood gas without impacting patients' prognosis. However, the role of CAP in WP in intensive care units (ICU) has not been assessed so far.

Hypothesis: A nurse driven WP based on CAP may improve accuracy of weaning procedures at bedside. Such protocol might be easy to apply in daily practice and could reduce both the duration of MV and its related complications.

Methods: This is a prospective, bi-center, pilot study to assess the feasibility of a new nurses managed WP based on capnography among patients requiring more of 48 hours of MV. Enrollment of 100 consecutive patients in two ICU of the universitary hospital in Reims. The primary endpoint is the protocol compliance. Secondary endpoints are: capacity to performed a weaning (time to first extubation, total duration of MV...) caregivers' acceptance and feelings regarding the protocol, a safety evaluation with report of hospital mortality, ventilator associated-pneumonia, autoextubation, length of stay and the number of ABG/patient/day during the study period. Inclusion critera: all patients on MV for more than 48 hours and stabilization of the ICU entry pathology. Exclusion critera: Patients with severe neuropathy, cardiopathy or pulmonary disease. Weaning protocol begins when the following criteria are present: PEEP ≤ 8 cmH2O, PaO2/FiO2 ratio ≥150 (mmHg) or SaO2 ≥ 90% with FiO2 ≤ 0.5. The final criterion for study entry is successful completion of a 30-min spontaneous breathing test (SBT) using pressure support (PS) (max 30 cmH2O). After a successful test, nurse reduces PS by 2 mmHg every 3 hours and the FIO2 as long as the patient remains in his comfort zone defined as: FR 12-30/min, VT ≥ 6ml/kg and ETCO2 ≤ 55 mmHg (≤65 mmHg for chronic obstructive pulmonary disease (COPD) patients). A scale allows FIO2 and PEEP to be titrated with an oxygen saturation between 90% and 98% (92% for COPD). Nurses recorded every 3 hours ventilatory, hemodynamic, sedation parameters and modifications. At any time physicians can return to the previous settings if the patient is leaving the comfort zone. SBT are conducted when a minimum level of PS and PEEP is reached, 7cmH20 and 5cmH20 respectively. SBT performed using a T piece with or no oxygen for 30-120 min. If a patient passes a successful SBT and meets extubation criteria, he is extubed. Extubation and SBT protocols are performed according to French guidelines SFAR/SRLF. Nevertheless, extubation always remains the decision of the attending physician. Protocols continue until successful extubation (at least 48 hours of unassisted spontaneous breathing), ICU death, ICU discharge or until day 90 after randomization.

Interests and Scientific impacts: For patients, a potential reduction of VM duration and its associated-complications. For caregivers, a more efficient WP and a better optimization of workload. This pilot study will be a step before to investigate larger studies to compare our WP to standard care.


title: Osteopathic Consultation in the Emergency Department for Fresh Lateral Ligament Sprain : a Randomized Controlled Trial

acronym: OASED

summary:
The study consists in recruiting patients with ankle sprains who visit the emergency department (ED).

Each patient will be tested by an osteopath who we will measure pain, swelling and/or edema, and mobility of the ankle. Patients will be asked to reproduce exercises such as to hold on one foot, to stand on tiptoes...

Then, patients will be divided into two groups. The first group will undergo medical treatment during the ED visit, while the second group will undergo osteopathic treatment.

Three time points will be planned. The first one will be the patient's consultation in the ED where treatment will be carried out according to its assignment, as well as the clinical measures previously described. The second time point will be seven days later (plus or minus three days), where only clinical measurements will be performed. The third time point will be three weeks later (plus or minus three days), when the ankle sprain has consolidated, in order to carry out the clinical measurements again.

These clinical measurements will allow to evaluate the effectiveness of a single osteopathic consultation in the ED. The investigators expect a reduction in immediate pain, and thereafter, a reduction in swelling, and an improved mobility and stability of the ankle.

ipd_sharing: Undecided


title: Impact of Obesity, Chronic Kidney Disease and Type 2 Diabetes on Human Urinary Stem Cells

acronym: URISTEM

summary:
Obesity is at risk for the development of chronic kidney disease but the involved mechanisms are not known (Navarro et al. 2015). Establishing the link between obesity and kidney damage is difficult. Indeed, kidney function measurement lacks precision in obese people (Lemoine et al. 2014) and requires expensive methods such as measurement of 99mTc-DTPA clearance. Biopsies are too invasive for the detection of emerging kidney damage or for the following of the kidney function. Therefore new tools are required for the early identification of at risk individuals for the kidney damage complication.

Mesenchymal stem cells may represent such a relevant tool. These cells are present in a large number of organs, including kidney (Costa et al. 2020).

In addition to be differentiated cells progenitors (Dominici et al. 2006), they also support immunosuppressive, anti-fibrotic and pro-angiogenic functions that have been used for the treatment of kidney fibrosis (Usunier et al. 2014). Therefore, mesenchymal stem cells contribute to tissue homeostasis and their alterations may reflect organ dysfunctions. Indeed, mesenchymal stem cells from obese adipose tissue lose their immunosuppressive (Serena et al. 2016) and differentiation (Gustafson et al. 2009) functions and contribute to fibrosis (Keophiphath et al. 2009) and inflammation (Lee et al. 2010; Gustafson, Nerstedt, et Smith 2019). It is thus probable that kidney dysfunctions are associated with functional alterations of kidney mesenchymal stem cells.

The collection of mesenchymal stem cells from kidney can easily be performed from urine and next cultivated for amplification. They are called urine stem cells (USC).

From our experience with obese mouse adipose stem cells, we observed that functional changes of stem cells preceded adipose tissue dysfunctions. Functional signatures of mesenchymal stem cells are thus representative of changes occuring in the function of the tissue notably in answer to obesity. These features could be used to identify obese people presenting ongoing alterations of kidney function, before clinical manifestations of kidney dysfunction. Because kidney mesenchymal stem cells are easy to isolate from urine, their collection is compatible with the follow up of patients and can be applied to a large number of individuals, including the younger. USC could represent a valuable tool to detect progression towards kidney damage.

In this project we plan to analyse USC alterations induced by obesity and to identify signatures associated with the progression towards kidney damage and type 2 diabetes. The goal is to evaluate USC as potential marker for the non invasive monitoring of patients in answer to a need that is not achieved by the present available approaches.

lead_sponsor: Hospices Civils de Lyon


title: Prospective Phase II Pilot Study, Assessing Imaging Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT (Positron Emission Tomography/Computerized Tomography) in Metastatic Triple Negative Breast Cancer Patients

acronym: OPALESCENCE

summary: The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT tracer for the imaging of metastatic triple negative breast cancer (TNBC) patients.

primary_purpose: Diagnostic

lead_sponsor: Institut Cancerologie de l'Ouest


title: The Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Young Healthy Adults

acronym: AttNIRS

summary: Attention may influence the motor performance and frontal activity. This study will examine the effect of different attentional focus : internal, external and divided attention (dual task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty young healthy voluntary adults will participate in this study.

primary_purpose: Basic Science

ReferenceType: background

ReferenceCitation: Wulf G, Höß M, Prinz W. Instructions for motor learning: differential effects of internal versus external focus of attention. J Mot Behav. 1998 Jun;30(2):169-79. doi: 10.1080/00222899809601334.

ReferenceCitation: Kim SA, Ryu YU, Shin HK. The effects of different attentional focus on poststroke gait. J Exerc Rehabil. 2019 Aug 28;15(4):592-596. doi: 10.12965/jer.1938360.180. eCollection 2019 Aug.

ReferenceCitation: Lu CF, Liu YC, Yang YR, Wu YT, Wang RY. Maintaining Gait Performance by Cortical Activation during Dual-Task Interference: A Functional Near-Infrared Spectroscopy Study. PLoS One. 2015 Jun 16;10(6):e0129390. doi: 10.1371/journal.pone.0129390. eCollection 2015.

ReferenceCitation: Herold F, Wiegel P, Scholkmann F, Thiers A, Hamacher D, Schega L. Functional near-infrared spectroscopy in movement science: a systematic review on cortical activity in postural and walking tasks. Neurophotonics. 2017 Oct;4(4):041403. doi: 10.1117/1.NPh.4.4.041403. Epub 2017 Aug 1. Review.

ReferenceCitation: Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E. FeetMe® Monitor-connected insoles are a valid and reliable alternative for the evaluation of gait speed after stroke. Top Stroke Rehabil. 2021 Mar;28(2):127-134. doi: 10.1080/10749357.2020.1792717. Epub 2020 Jul 13.

ReferenceCitation: Kal EC, van der Kamp J, Houdijk H. External attentional focus enhances movement automatization: a comprehensive test of the constrained action hypothesis. Hum Mov Sci. 2013 Aug;32(4):527-39. doi: 10.1016/j.humov.2013.04.001. Epub 2013 Jun 30.

ReferenceCitation: Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. Review.

ReferenceCitation: Wood JN, Grafman J. Human prefrontal cortex: processing and representational perspectives. Nat Rev Neurosci. 2003 Feb;4(2):139-47. Review.

ReferenceCitation: Pelicioni PHS, Tijsma M, Lord SR, Menant J. Prefrontal cortical activation measured by fNIRS during walking: effects of age, disease and secondary task. PeerJ. 2019 May 3;7:e6833. doi: 10.7717/peerj.6833. eCollection 2019.

ReferenceCitation: Shafizadeh M, Platt GK, Mohammadi B. Effects of different focus of attention rehabilitative training on gait performance in Multiple Sclerosis patients. J Bodyw Mov Ther. 2013 Jan;17(1):28-34. doi: 10.1016/j.jbmt.2012.04.005. Epub 2012 May 10.

ReferenceCitation: Yogev-Seligmann G, Rotem-Galili Y, Mirelman A, Dickstein R, Giladi N, Hausdorff JM. How does explicit prioritization alter walking during dual-task performance? Effects of age and sex on gait speed and variability. Phys Ther. 2010 Feb;90(2):177-86. doi: 10.2522/ptj.20090043. Epub 2009 Dec 18.

ReferenceCitation: Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17.

ReferenceCitation: Udina C, Avtzi S, Durduran T, Holtzer R, Rosso AL, Castellano-Tejedor C, Perez LM, Soto-Bagaria L, Inzitari M. Functional Near-Infrared Spectroscopy to Study Cerebral Hemodynamics in Older Adults During Cognitive and Motor Tasks: A Review. Front Aging Neurosci. 2020 Jan 21;11:367. doi: 10.3389/fnagi.2019.00367. eCollection 2019. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans

intervention_type: Device

status_simplified: Completed


title: Effect of a Mixture of Probiotics (Lactibiane Reference) in Patients With Irritable Bowel Syndrome Predominantly Constipation and Assessment of a Potential Biomarker (Resolvin D1): an Exploratory Study

acronym: EPORE

summary: Probiotics efficacy is mainly assessed by subjective endpoints such as the FDA responder rate or global relief, which partly explain contradictory results obtained in clinical trials with probiotic bacteria. Objective biomarkers of IBS will allow to measure the efficacy of probiotics. In the case of IBS-C, serum resolvin-D1 appears to be an interesting candidate due to its non-invasive and discriminating character compared to a healthy population. It is, inversely correlated with the severity of symptoms. Resolvin-D1 modulates the duration and intensity of inflammation by regulating the transcription of cytokines, chemokines and their receptors as well as other proteins involved in inflammation. Resolvin D1 could serve as a predictor of probiotic response based on its baseline value.

lead_sponsor: CEN Biotech

intervention_type: Dietary Supplement


title: Prospective National Cohort Study on Swedish Adjustable Gastric Band (SAGB) for Gastroplasty (Étude de Cohorte Nationale Prospective de l'Implant Annulaire Ajustable Pour Gastroplastie SAGB)

summary:
Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.

Verification by means of a screening log (exhaustive list of all bariatric procedures performed by participating surgeons between the beginning and end of the cohort inclusion period) requested from all centers.

No comparator group. No randomization or blinding techniques

ReferenceType: derived

ReferenceCitation: Ribaric G, Buchwald J. Gastric band is safe and effective at three years in a national study subgroup of non-morbidly obese patients. Croat Med J. 2014 Aug 28;55(4):405-15.

lead_sponsor: Ethicon Endo-Surgery (Europe) GmbH


title: Efficacy and Tolerance Study on the Use of the In-exsufflator in the Hospitalized Elderly

acronym: INEXPA

summary: The mechanical in-exsufflator (MI-E) is a medical device used to facilitate coughing when the patients' cough is not efficient. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular disorders however there is lack of evidence in older populations. This study's aim is to evaluate the feasibility of the MI-E in older adults. The hypothesis is that the use of MI-E in older adults is feasible.

lead_sponsor: University Hospital, Clermont-Ferrand


ReferenceCitation: Ceccaldi M, Jonveaux T, Verger A, Krolak-Salmon P, Houzard C, Godefroy O, Shields T, Perrotin A, Gismondi R, Bullich S, Jovalekic A, Raffa N, Pasquier F, Semah F, Dubois B, Habert MO, Wallon D, Chastan M, Payoux P; NEUUS in AD study group, Stephens A, Guedj E. Added value of (18)F-florbetaben amyloid PET in the diagnostic workup of most complex patients with dementia in France: A naturalistic study. Alzheimers Dement. 2018 Mar;14(3):293-305. doi: 10.1016/j.jalz.2017.09.009. Epub 2017 Nov 4.

name: AP-HM-Hôpital de la Timone, Neurology and Neuropsychology Department; Aix Marseille University, Inserm, INS, Institut de Neurosciences des Systèmes; Marseille France

family: Ceccaldi

full_name: Mathieu Ceccaldi

given: Mathieu

name: Geriatric Department; CHRU de Nancy-Hôpital Brabois; Vandoeuvre-les-Nancy France

family: Jonveaux

full_name: Thérèse Jonveaux

given: Thérèse

name: INSERM U947; Unité d'Imagerie Adaptative Diagnostique et Interventionnelle; Nancy France

family: Verger

full_name: Antoine Verger

given: Antoine

name: Clinical and Research Memory Center of Lyon; Hospices civils de Lyon, Université Claude Bernard Lyon 1; Inserm 1028 Lyon France

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

given: Pierre

name: Nuclear Medicine Department; CHU Lyon; Lyon France

family: Houzard

full_name: Claire Houzard

given: Claire

name: Neurology Department; CHU Amiens Picardie-Hôpital Sud; Amiens France

family: Godefroy

full_name: Olivier Godefroy

given: Olivier

name: Nuclear Medicine Department; CHU Amiens Picardie-Hôpital Sud; Amiens France

family: Shields

full_name: Trevor Shields

given: Trevor

name: Piramal Imaging; Clinical Research and Development; Berlin Germany

family: Perrotin

full_name: Audrey Perrotin

given: Audrey

name: Piramal Imaging; Market Access and HEOR; Berlin Germany

family: Gismondi

full_name: Rossella Gismondi

given: Rossella

name: AP-HP-Hôpital Pitié Salpétrière; Memory and Alzheimer Disease Institute IM2A; Paris France

family: Bullich

full_name: Santiago Bullich

given: Santiago

name: Laboratoire d'Imagerie Biomédicale; Sorbonne Universités, UPMC Univ Paris 06, Inserm U 1146, CNRS UMR 7371; Paris France

family: Jovalekic

full_name: Aleksandar Jovalekic

given: Aleksandar

family: Raffa

full_name: Nicola Raffa

given: Nicola

family: Pasquier

full_name: Florence Pasquier

given: Florence

family: Semah

full_name: Franck Semah

given: Franck

family: Dubois

full_name: Bruno Dubois

given: Bruno

family: Habert

full_name: Marie-Odile Habert

given: Marie-Odile

family: Wallon

full_name: David Wallon

given: David

family: Chastan

full_name: Mathieu Chastan

family: Payoux

full_name: Pierre Payoux

family: Guedj

full_name: Eric Guedj

given: Eric

family: Felician

full_name: Olivier Felician

family: Didic

full_name: Mira Didic

given: Mira

family: Gueriot

full_name: Claude Gueriot

given: Claude

name: Nuclear Medicine Department; Univ. Lille, U1171, CHU Lille; Lille France

name: Piramal Imaging; Medical Affairs; Berlin Germany

name: Nuclear Medicine Department; Centre Henri Becquerel; Rouen France

name: Inserm 1171; Université de Lille, CHU, DistAlz; Lille France

name: ToNIC, Toulouse NeuroImaging Center; Université de Toulouse, Inserm, UPS; Toulouse France

name: Neurology Department; CHU de Rouen-Hôpital Charles Nicolle; Rouen France

name: AP-HM-Hôpital de la Timone, Nuclear Medicine Department; Aix-Marseille University, CERIMED, CNRS, INT, Institut de Neurosciences de la Timone; Marseille France

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

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

title: Added value of18F-florbetaben amyloid PET in the diagnostic workup of most complex patients with dementia in France: A naturalistic study

location_facility: Coordinating center (Hôpital de La Timone) and 18 associated centers in France

title: Multicenter Study to Explore the Impact of Florbetaben (FBB) in Change of Diagnosis in Patients Who Are Evaluated for AD and in Whom Lumbar Puncture is Contraindicated or CSF Results Are Ambiguous

summary:
This phase 4 study will explore, in the context of the present French clinical practice, the impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for etiologic determination of the cognitive and functional impairment, but in whom:

lumbar puncture was not feasible for medical conditions
results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating physicians
lumbar puncture (LP) was refused by the patient


title: Detection of Plasma DNA by Allelotyping in Non Small Cell and Small Cell Lung Cancer Patients. Evolution During Treatment and Follow-up.

summary: The majority of lung cancer patients have a tumor-derived genetic alteration in circulating plasma DNA that could be exploited as a diagnostic tool. The aim of this study is to evaluate if plasma DNA can be used as a valuable non invasive test to monitor disease progression without assessing the tumor.

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Chirurgie Thoracique, Hôpital Civil

location_facility: Service de Pneumologie, Hôpital de Hautepierre


title: Use of Smartphone Health Applications Among Patients Aged 18 to 69 Years Recruited in Primary Care in Grenoble Area

acronym: Smartcheck

summary:
This study evaluates the frequency of use of smartphone health applications among people consulting in primary care in the Grenoble region, France.

This is a descriptive study using a questionnaire completed by the patient and distributed by general practitioners. The study also collects the type of used application as well as the rhythm of usage, and compares the use of mobile health applications according to the sociodemographic, geographical and medical characteristics of the studied population.

time_perspective: Cross-Sectional

lead_sponsor: University Grenoble Alps

location_facility:
Dr Fuentes
Dr Moulis
Dr Chatellard
Dr Grasset
Dr Riehl
Centre de santé de l'abbaye
Dr CROS
Dr Bichon
Dr PARADIS
Maison Médicale de Tullins
Maison médicale Moirans
Maison médicale Saint Martin d'Hères
Dr Ronflet


title: Interest of Routine Screening for Hepatitis B and C in Patients Receiving Chemotherapy for Solid Tumors

acronym: HepScreen

summary:
Immunosuppression induced by cancer treatment increases the risk of hepatitis B virus (HBV) and hepatitis C virus (HCV) reactivations. These viral reactivations may be asymptomatic but can cause fulminant hepatitis and death. More, they impact the treatment of cancer by chemotherapy delays or stops. They can occur during cancer treatment but also after stopping, at the immunological rebound. This risk persists for at least 6 months after cessation.

The key to the prevention, and the first step, is serological testing. It is also the main problem because international recommendations diverge. Hepatologists and infectious disease specialists recommend routine screening HBV of all candidates for immunosuppressive therapy. These recommendations are more implemented by hematologists, given the frequency of HBV reactivation associated to haematological malignancies. Clinical oncology societies guidelines suggest a selective screening in case of risk factors of hepatitis B or in patients with a strong immunosuppression (such as anti-CD20 based treatment, stem cell transplantation or lymphoma treatment).

The consequence of these differences is a sub-screening by oncologists and the persistence of fatal cases. Screening before cytotoxic chemotherapy for solid tumors in countries with low prevalence of HBV and HCV virus is questionable. Selective screening of patients at risk HBV and HCV can be assessed.

ReferenceCitation: Brasseur M, Heurgué-Berlot A, Barbe C, Brami C, Rey JB, Vella-Boucaud J, Dabouz F, Deslée G, Grange F, Volet J, Bouché O. Prevalence of hepatitis B and C and sensibility of a selective screening questionnaire in patients receiving chemotherapy for solid tumors. BMC Cancer. 2015 Dec 23;15:999. doi: 10.1186/s12885-015-2033-z.


type: Registry Identifier

title: Rôle de la Microarchitecture Osseuse Dans le déterminisme héréditaire de la fragilité Osseuse

acronym: MODAM

summary: The aim of this study is to analyze the hereditary determinism of bone microarchitecture measured at the distal radius and distal tibia from a case control-study of mother-daughter pairs.

status: Unknown status

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

location_facility: Unité Inserm 831, Pavillon F, Hôpital Edouard Herriot

intervention_type: Radiation

status_simplified: Unknown


title: Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment, a French Cohort

acronym: PsyCovART

summary:
In France, one couple in eight encounters difficulties to conceive. The diagnosis of infertility frequently leads to symptoms of anxiety and depression. These symptoms appear to be higher than in the general population.

Some recent studies have looked at the relationship between anxiety and depression in ART cares.

Results are controversial, but it appears that patients with lower levels of anxiety and depression have higher pregnancy rates. Moreover, in couple, women seem to have more symptoms of anxiety and depression than men.

First epidemiological studies related to the COVID 19 pandemic have shown strong psychological impact on the general population with an anxiety rate estimated at more than 30%.

With COVID 19 pandemic and cessation of ART, it is highly likely that psychic symptoms of anxiety or even depression may have appeared or worsened in women undergoing infertility treatment.


title: Seroprevalence of Chikungunya at the End of the First Chikungunya Outbreak in the French Antilles Within a Sample of Patients Treated for a HIV Infection

acronym: ChikVIH

summary:
Late 2013, the first indigenous cases of chikungunya have been observed in the French Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected by the outbreak.

During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack rate was 38%. The most active period was three months.

In this context, knowledge of the attack rate and the epidemic in the Caribbean is an important issue for outbreak management and modeling work.

As the chikungunya virus had never circulated in the Caribbean, determining the seroconversion rate can be achieved by realizing a seroprevalence survey among the general population at the end of the outbreak. Another simple method is to estimate the rate in a cohort of patients followed regularly and whose habitat is distributed throughout the territory studied.

The follow up of patients infected by the human immunodeficiency virus (HIV) in the French West Indies is almost exclusively performed in hospitals in department of Infectious and Tropical Diseases.The high prevalence of HIV and homogeneous distribution of infected patients on all of our territories, allow to hypothesize that the risk of transmission of arboviruses by exposure to mosquito bites is comparable to the general population. This patient cohort is well suited to study the emergence of Chikungunya in the French West Indie .

Primary objective :

To estimate the cumulative incidence at the end of the first Chikungunya outbreak in the French West Indies by estimating the prevalence of specific antibodies of chikungunya virus in a sample (randomly constituted) from patients infected by HIV and representative of the general population of Martinique and Guadeloupe

Secondary objective :

To estimate the frequency of asymptomatic infections by the chikungunya virus in the studied population To estimate the frequency of chronic forms of chikungunya in the studied population

ReferenceCitation: Pialoux G, Gaüzère BA, Jauréguiberry S, Strobel M. Chikungunya, an epidemic arbovirosis. Lancet Infect Dis. 2007 May;7(5):319-27. Review.

ReferenceCitation: Farnon EC, Sejvar JJ, Staples JE. Severe disease manifestations associated with acute chikungunya virus infection. Crit Care Med. 2008 Sep;36(9):2682-3. doi: 10.1097/CCM.0b013e3181843d94.

ReferenceCitation: Brouard C, Bernillon P, Quatresous I, Pillonel J, Assal A, De Valk H, Desenclos JC; workgroup "Quantitative Estimation of the Risk of Blood Donation Contamination by Infectious Agents". Estimated risk of Chikungunya viremic blood donation during an epidemic on Reunion Island in the Indian Ocean, 2005 to 2007. Transfusion. 2008 Jul;48(7):1333-41. doi: 10.1111/j.1537-2995.2008.01646.x. Epub 2008 Feb 22.

ReferenceCitation: Liumbruno GM, Calteri D, Petropulacos K, Mattivi A, Po C, Macini P, Tomasini I, Zucchelli P, Silvestri AR, Sambri V, Pupella S, Catalano L, Piccinini V, Calizzani G, Grazzini G. The Chikungunya epidemic in Italy and its repercussion on the blood system. Blood Transfus. 2008 Oct;6(4):199-210.

ReferenceCitation: Sissoko D, Moendandze A, Malvy D, Giry C, Ezzedine K, Solet JL, Pierre V. Seroprevalence and risk factors of chikungunya virus infection in Mayotte, Indian Ocean, 2005-2006: a population-based survey. PLoS One. 2008 Aug 26;3(8):e3066. doi: 10.1371/journal.pone.0003066.

ReferenceCitation: Appassakij H, Khuntikij P, Kemapunmanus M, Wutthanarungsan R, Silpapojakul K. Viremic profiles in asymptomatic and symptomatic chikungunya fever: a blood transfusion threat? Transfusion. 2013 Oct;53(10 Pt 2):2567-74. doi: 10.1111/j.1537-2995.2012.03960.x. Epub 2012 Nov 26.

ReferenceCitation: Bianco C. Dengue and Chikungunya viruses in blood donations: risks to the blood supply? Transfusion. 2008 Jul;48(7):1279-81. doi: 10.1111/j.1537-2995.2008.01806.x.

ReferenceCitation: Ramful D, Carbonnier M, Pasquet M, Bouhmani B, Ghazouani J, Noormahomed T, Beullier G, Attali T, Samperiz S, Fourmaintraux A, Alessandri JL. Mother-to-child transmission of Chikungunya virus infection. Pediatr Infect Dis J. 2007 Sep;26(9):811-5.

ReferenceCitation: Gérardin P, Barau G, Michault A, Bintner M, Randrianaivo H, Choker G, Lenglet Y, Touret Y, Bouveret A, Grivard P, Le Roux K, Blanc S, Schuffenecker I, Couderc T, Arenzana-Seisdedos F, Lecuit M, Robillard PY. Multidisciplinary prospective study of mother-to-child chikungunya virus infections on the island of La Réunion. PLoS Med. 2008 Mar 18;5(3):e60. doi: 10.1371/journal.pmed.0050060.

ReferenceCitation: Gérardin P, Guernier V, Perrau J, Fianu A, Le Roux K, Grivard P, Michault A, de Lamballerie X, Flahault A, Favier F. Estimating Chikungunya prevalence in La Réunion Island outbreak by serosurveys: two methods for two critical times of the epidemic. BMC Infect Dis. 2008 Jul 28;8:99. doi: 10.1186/1471-2334-8-99.

ReferenceCitation: Van Bortel W, Dorleans F, Rosine J, Blateau A, Rousset D, Matheus S, Leparc-Goffart I, Flusin O, Prat C, Cesaire R, Najioullah F, Ardillon V, Balleydier E, Carvalho L, Lemaître A, Noel H, Servas V, Six C, Zurbaran M, Leon L, Guinard A, van den Kerkhof J, Henry M, Fanoy E, Braks M, Reimerink J, Swaan C, Georges R, Brooks L, Freedman J, Sudre B, Zeller H. Chikungunya outbreak in the Caribbean region, December 2013 to March 2014, and the significance for Europe. Euro Surveill. 2014 Apr 3;19(13). pii: 20759. Erratum in: Euro Surveill. 2014;19(14):pii/20764. Rousset, D [added].

ReferenceCitation: Curlier E, Fagour L, Herrmann-Storck C, Staelen A, Vingadassalom I, Breurec S, Abel S, Pierre-François S, Jean-Marie J, Laouénan C, Césaire R, Hoen B, Cabié A. Seroprevalence of chikungunya virus infection among HIV-infected adults in French Caribbean Islands of Martinique and Guadeloupe in 2015: A cross-sectional study. PLoS Negl Trop Dis. 2021 Apr 9;15(4):e0009267. doi: 10.1371/journal.pntd.0009267. eCollection 2021 Apr.

family: Curlier

full_name: Elodie Curlier

given: Elodie

family: Fagour

full_name: Laurence Fagour

given: Laurence

family: Herrmann-Storck

full_name: Cécile Herrmann-Storck

given: Cécile

family: Staelen

full_name: Adrien Staelen

given: Adrien

family: Vingadassalom

full_name: Ingrid Vingadassalom

given: Ingrid

family: Breurec

full_name: Sébastien Breurec

given: Sébastien

family: Abel

full_name: Sylvie Abel

given: Sylvie

family: Pierre-François

full_name: Sandrine Pierre-François

given: Sandrine

family: Jean-Marie

full_name: Janick Jean-Marie

given: Janick

family: Laouénan

full_name: Cédric Laouénan

given: Cédric

family: Césaire

full_name: Raymond Césaire

given: Raymond

family: Hoen

full_name: Bruno Hoen

family: Cabié

full_name: André Cabié

given: André

currency_apc_doaj: USD

journal_name: PLOS Neglected Tropical Diseases

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: University Hospital Center of Martinique

location_facility: Centre Hospitalier Universitaire de Fort-de-France


title: Transcranial Magnetic Stimulation-based Assessment of Mental Training Effects on Motor Learning in Healthy Participants

acronym: IMAP-TMS

summary: The general purpose of this research project is to analyze the specific role of motor imagery on motor learning, assessed through corticospinal excitability measurements and behavioral data collection. This project is based on four sequences. For Sequence 1, the main objective is to examine the effect of mental training on movement speed and accuracy in a manual motor sequence task, as well as the influence of sensory feedback in immediate post-test (i.e., execution of a similar, but not identical, manual motor sequence, other manual tasks) on performance in delayed post-test. The secondary objective will be to examine corticospinal changes (i.e., amplitude of motor evoked potentials) induced by mental training, by measuring the amplitude of motor evoked potentials before and after mental training. For Sequence 2, the main objective is to examine the impact of a motor disturbance induced by a robotic arm at different intervals during the motor imagery process. The secondary objective will be to examine the corticospinal changes (i.e. amplitude of evoked motor potentials) induced by mental training as a function of the applied perturbations, before and after perturbation. For Sequence 3, the main objective will be to examine the influence of neuroplasticity on the quality of mental training. More specifically, the investigators will study the links between brain plasticity and motor learning through mental training. The secondary objective will be to examine the corticospinal changes (i.e. amplitude of evoked motor potentials) induced by mental training at different levels of the neuromuscular system (cortical, cervicomedullar, peripheral) after a training period. For Sequence 4, the main objective will be to examine the effect of short-term arm-immobilization of on the retention of motor learning induced by mental training. The secondary objective will be to examine the corticospinal changes (i.e., amplitude of motor evoked potentials) induced by of short-term arm-immobilization, or by transcranial direct current stimulation (tDCS), on motor learning. The results of this fundamental research project will allow a better understanding of neurophysiological and behavioral mechanisms that underlie motor learning through motor imagery. The results will allow to efficiently consider inter-individual specificities and will thus open up to clinical research perspectives, towards the establishment of adapted motor rehabilitation protocols.

ReferenceCitation: Abraham WC. Metaplasticity: tuning synapses and networks for plasticity. Nat Rev Neurosci. 2008 May;9(5):387. doi: 10.1038/nrn2356. Review.

ReferenceCitation: Anwar MN, Khan SH. Trial-by-trial adaptation of movements during mental practice under force field. Comput Math Methods Med. 2013;2013:109497. doi: 10.1155/2013/109497. Epub 2013 May 7.

ReferenceCitation: Allami N, Paulignan Y, Brovelli A, Boussaoud D. Visuo-motor learning with combination of different rates of motor imagery and physical practice. Exp Brain Res. 2008 Jan;184(1):105-13. Epub 2007 Sep 12.

ReferenceCitation: Arora S, Aggarwal R, Sevdalis N, Moran A, Sirimanna P, Kneebone R, Darzi A. Development and validation of mental practice as a training strategy for laparoscopic surgery. Surg Endosc. 2010 Jan;24(1):179-87. doi: 10.1007/s00464-009-0624-y. Epub 2009 Jul 25.

ReferenceCitation: Avanzino L, Giannini A, Tacchino A, Pelosin E, Ruggeri P, Bove M. Motor imagery influences the execution of repetitive finger opposition movements. Neurosci Lett. 2009 Nov 27;466(1):11-5. doi: 10.1016/j.neulet.2009.09.036. Epub 2009 Sep 20.

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ReferenceCitation: Burianová H, Marstaller L, Sowman P, Tesan G, Rich AN, Williams M, Savage G, Johnson BW. Multimodal functional imaging of motor imagery using a novel paradigm. Neuroimage. 2013 May 1;71:50-8. doi: 10.1016/j.neuroimage.2013.01.001. Epub 2013 Jan 12.

ReferenceCitation: Cantarero G, Tang B, O'Malley R, Salas R, Celnik P. Motor learning interference is proportional to occlusion of LTP-like plasticity. J Neurosci. 2013 Mar 13;33(11):4634-41. doi: 10.1523/JNEUROSCI.4706-12.2013.

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ReferenceCitation: Doyon J, Bellec P, Amsel R, Penhune V, Monchi O, Carrier J, Lehéricy S, Benali H. Contributions of the basal ganglia and functionally related brain structures to motor learning. Behav Brain Res. 2009 Apr 12;199(1):61-75. doi: 10.1016/j.bbr.2008.11.012. Epub 2008 Nov 17. Review.

ReferenceCitation: Doyon J, Benali H. Reorganization and plasticity in the adult brain during learning of motor skills. Curr Opin Neurobiol. 2005 Apr;15(2):161-7. Review.

ReferenceCitation: Gentili R, Han CE, Schweighofer N, Papaxanthis C. Motor learning without doing: trial-by-trial improvement in motor performance during mental training. J Neurophysiol. 2010 Aug;104(2):774-83. doi: 10.1152/jn.00257.2010. Epub 2010 Jun 10.

ReferenceCitation: Gentili R, Papaxanthis C, Pozzo T. Improvement and generalization of arm motor performance through motor imagery practice. Neuroscience. 2006 Feb;137(3):761-72. Epub 2005 Dec 9.

ReferenceCitation: Grush R. The emulation theory of representation: motor control, imagery, and perception. Behav Brain Sci. 2004 Jun;27(3):377-96; discussion 396-442.

ReferenceCitation: Guillot A, Moschberger K, Collet C. Coupling movement with imagery as a new perspective for motor imagery practice. Behav Brain Funct. 2013 Feb 20;9:8. doi: 10.1186/1744-9081-9-8.

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ReferenceCitation: Keller PE. Mental imagery in music performance: underlying mechanisms and potential benefits. Ann N Y Acad Sci. 2012 Apr;1252:206-13. doi: 10.1111/j.1749-6632.2011.06439.x. Review.

ReferenceCitation: Lebon F, Lotze M, Stinear CM, Byblow WD. Task-dependent interaction between parietal and contralateral primary motor cortex during explicit versus implicit motor imagery. PLoS One. 2012;7(5):e37850. doi: 10.1371/journal.pone.0037850. Epub 2012 May 31.

ReferenceCitation: Lehéricy S, Benali H, Van de Moortele PF, Pélégrini-Issac M, Waechter T, Ugurbil K, Doyon J. Distinct basal ganglia territories are engaged in early and advanced motor sequence learning. Proc Natl Acad Sci U S A. 2005 Aug 30;102(35):12566-71. Epub 2005 Aug 17.

ReferenceCitation: Malouin F, Jackson PL, Richards CL. Towards the integration of mental practice in rehabilitation programs. A critical review. Front Hum Neurosci. 2013 Sep 19;7:576. doi: 10.3389/fnhum.2013.00576. Review.

ReferenceCitation: Minkova L, Peter J, Abdulkadir A, Schumacher LV, Kaller CP, Nissen C, Klöppel S, Lahr J. Determinants of Inter-Individual Variability in Corticomotor Excitability Induced by Paired Associative Stimulation. Front Neurosci. 2019 Aug 14;13:841. doi: 10.3389/fnins.2019.00841. eCollection 2019.

ReferenceCitation: Mulder T. Motor imagery and action observation: cognitive tools for rehabilitation. J Neural Transm (Vienna). 2007;114(10):1265-78. Epub 2007 Jun 20. Review.

ReferenceCitation: Opie GM, Evans A, Ridding MC, Semmler JG. Short-term immobilization influences use-dependent cortical plasticity and fine motor performance. Neuroscience. 2016 Aug 25;330:247-56. doi: 10.1016/j.neuroscience.2016.06.002. Epub 2016 Jun 6.

ReferenceCitation: Palmiero M, Belardinelli MO, Nardo D, Sestieri C, Di Matteo R, D'Ausilio A, Romani GL. Mental imagery generation in different modalities activates sensory-motor areas. Cogn Process. 2009 Sep;10 Suppl 2:S268-71. doi: 10.1007/s10339-009-0324-5.

ReferenceCitation: Rozand V, Lebon F, Stapley PJ, Papaxanthis C, Lepers R. A prolonged motor imagery session alter imagined and actual movement durations: Potential implications for neurorehabilitation. Behav Brain Res. 2016 Jan 15;297:67-75. doi: 10.1016/j.bbr.2015.09.036. Epub 2015 Sep 30.

ReferenceCitation: Rosenkranz K, Seibel J, Kacar A, Rothwell J. Sensorimotor deprivation induces interdependent changes in excitability and plasticity of the human hand motor cortex. J Neurosci. 2014 May 21;34(21):7375-82. doi: 10.1523/JNEUROSCI.5139-13.2014.

ReferenceCitation: Ruffino C, Papaxanthis C, Lebon F. The influence of imagery capacity in motor performance improvement. Exp Brain Res. 2017 Oct;235(10):3049-3057. doi: 10.1007/s00221-017-5039-8. Epub 2017 Jul 21.

ReferenceCitation: Saimpont A, Mercier C, Malouin F, Guillot A, Collet C, Doyon J, Jackson PL. Anodal transcranial direct current stimulation enhances the effects of motor imagery training in a finger tapping task. Eur J Neurosci. 2016 Jan;43(1):113-9. doi: 10.1111/ejn.13122. Epub 2015 Dec 15.

ReferenceCitation: Rulleau T, Robin N, Abou-Dest A, Chesnet D, Toussaint L. Does the Improvement of Position Sense Following Motor Imagery Practice Vary as a Function of Age and Time of Day? Exp Aging Res. 2018 Oct-Dec;44(5):443-454. doi: 10.1080/0361073X.2018.1521496. Epub 2018 Oct 9.

ReferenceCitation: Schuster C, Hilfiker R, Amft O, Scheidhauer A, Andrews B, Butler J, Kischka U, Ettlin T. Best practice for motor imagery: a systematic literature review on motor imagery training elements in five different disciplines. BMC Med. 2011 Jun 17;9:75. doi: 10.1186/1741-7015-9-75. Review.

location_facility: INSERM - U1093 Cognition, Action, and Sensorimotor Plasticity


title: Impact of Weight Loss on the Human Sperm Epitranscriptome

acronym: EPI-SPERM

summary:
Increasing evidence suggests that non-communicable diseases such as in particular obesity and its associated metabolic diseases are inherited from parents to children throughout several generations by epigenetic mechanisms. Thus, this environmental stress would induce epigenetic modification in the germ line that once transmitted and maintained in the progeny would induce the development of the parental pathologies. Considering the increasing prevalence of these pathologies worldwide, we urgently need to understand this process in human. Based on published and unpublished data demonstrating that sperm RNAs are vectors of epigenetic inheritance of obesity mouse model, the investigative team hypothesizes that epitranscriptome of obese men play a central role in the paternal epigenetic inheritance of obesity and its associated metabolic diseases as epigenetic vectors in this process.

To validate this hypothesis, the investigative team will use sperm from non-obese and obese men taken before and after surgery weight loss. Thanks to these cohorts, they propose to: (i) compare the epitranscriptome profiles of non-obese and obese men to identify the RNAs molecules which will be either qualitatively or quantitatively epigenetically modulated by obesity; (ii) compare the epitranscriptome profiles of obese men before and after surgery-weight loss to assess the reversibility of the newly acquired RNA modifications.

Giving some answers to this central question will provide not only some clues about the molecular mechanisms involved in this process, elements which might be crucial to stop the spread of this disorder, but will also allow the identification of obese-susceptibility loci which expression may be modulate by environmental factors and consequently able to transmit the disease.


title: Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral Disease

acronym: ECOCAPTURE

summary:
Apathy can be defined as a quantitative reduction of voluntary or goal-directed behavior.

So, the investigators propose a behavioral approach for assessing apathy, to obtain a quantifiable and objective signature of reduced goal-directed behavior by directly observing a patient in a real-life situation.

ECOCAPTURE consists of a multi-step scenario in a functional exploration platform equipped with data acquisition system based on video and sensors that track a participant's behavior.

The primary objective of this trial is to create a diagnostic tool for apathy, based on the video and sensors metrics.

A secondary objective of this trial is to validate a new experimental task (ICM_APATHY_TASKS) to test independently three main presumed mechanisms of apathy (motivation, cognitive inertia and coupling between motivation and action).

Another secondary objective aims to specify the pathophysiological mechanisms of apathy, corresponding to cognitive and behavioral processes, neural bases and neurohormonal mechanisms. The definition of pathophysiological mechanisms will allow the classification of apathetic patients (or several forms of apathy) and indicate which mechanism (s) best explains the apathy in a given patient.

location_facility: ICM / Pitié-Salpêtrière Hospital AP-HP / CIC


title: Decoding Presymptomatic White Matter Changes in Huntington Disease

acronym: Win-HD

summary:
WIN-HD is a monocentric longitudinal study comparing premanifest Huntingtin (HTT) mutation carriers and non HTT mutation carriers to determine that white-matter atrophy occurs far earlier than clinical onset in HD using Diffusion-weighted Nuclear Magnetic Resonance (N spectroscopy (DWS) and Diffusion Tensor Imaging (DTI).

The investigators will recruit up to 20 premanifest HTT mutation carriers (15 completed) and up to 20 non HTT mutation carriers (15 completed). It is important to have those 2 populations in order to compare our results and determine if there are significant white-matter changes far from the onset of HD. Therefore, non HTT mutation carriers will be age and gender matched to premanifest HTT mutation carriers.

In order to test the hypothesis, the study has 2 visits with a year interval.

This study is based on 4 principal criteria:

Imaging criteria
Clinical and neurological criteria
Psychological criteria
Behavioral criteria

primary_purpose: Other


title: Influence of TaqIB (rs708272) Polymorphism in Cholesteryl Ester Transfer Protein (CETP) Gene on Functionality of HDL Particles, in the Pathway of Reverse Transport of Fasting and Post-prandial Cholesterol.

acronym: HDL-PP

summary: Reverse cholesterol transport (RCT) pathway explains the anti-atherosclerosis role of HDL. Post prandial hypertriglyceridemia is highly predictive of atherosclerosis. TaqIB polymorphism in CETP gene plays a role on HDL particles, and might give a link between TaqIB polymorphism and the cardioprotective efficiency of HDL particles. Our main objective was to compare post-prandial HDL particles between patients having B2 allele carriers (genotype AA) to B1 allele carriers (genotype GG), and their ability to mediate cellular cholesterol efflux, via SR-BI Scavenger Receptor class B type I (SR-BI) , ABCG1 and ABCA1 pathways.

location_facility: Centre d'Investigation Clinique Paris Est


title: Analysis of Blood Cells Innate Immune Response in Patients With Lobar Pneumonia

acronym: ASTRAL

summary:
Pulmonary bacterial infections such as exacerbations of chronic bronchitis, nosocomial and community-acquired pneumonia represent a major public health issue. Antibiotics have shown their efficacy by direct antimicrobial activity and their limit particularly in case of multidrug-resistant microorganisms or in treating patients with aggravating pathologies. Innate immunity could be an alternative or complementary therapeutic pathway. Innate immunity receptors bind universal and invariant microbial molecular patterns present in bacteria, virus, fungus or parasite. Toll-like Receptors (TLR) activation by microbial agonist stimulates the innate immunity response which results in the production of chemokines, cytokines, antimicrobial molecules and the recruitment of innate cells.

The " Pulmonary Infection and Innate Immunity " team of the Immunity and Infection Center in Lille (Group of Dr. Sirard and Carnoy) has a long expertise in the study of TLR5 and its agonist, the flagellin, a structural protein of bacterial flagella. TLR5 is expressed on the cell surface of macrophages, monocytes, dendritic and epithelial cells. Several studies in mice have shown the flagellin prophylactic potential during bacterial infections through a TLR5 dependent stimulation of innate immunity. Recently, the group of Dr. Sirard and Carnoy has shown that flagellin can be used in association with antibiotics to treat Streptococcus pneumoniae respiratory infections in mice. The results demonstrate that an agonist of TLR can increase the therapeutic index of an antibiotic and improve the pulmonary anti-infectious reaction. This innovative approach allows us to consider new antibacterial strategies where antibiotics have reached their limit (nosocomial infection, multidrug-resistant bacteria…). TLR agonists can activate multiple human cell type. Indeed, blood cells activation by TLR agonists have been recently characterized in healthy volunteers.

However, there is no available data on the ability of TLR agonists to activate cells from patients with infectious pneumopathies. A study in these patients is inevitable if one is to consider the therapeutic use of agonists in respiratory pathologies.

lead_sponsor: Lille Catholic University


title: Effets du Tabagisme in Utero Sur la fonctionnalité de l'épithelium Respiratoire et Sur la Fonction Ventilatoire du Nouveau-né.

summary: Despite public campaigns to prevent cigarette smoking, it's about 20% of women who keep on smoking during pregnancy, exposing their fetus to prenatal tobacco adverse effects. Although environnemental tobacco smoke exposure effects are well known, consequences of prenatal tobacco smoke exposure (PTSE) need better caracterization. Previous animal study from our group have shown, in prenatal nicotine exposed mouse pups, alterations in tracheal epithelial structure similar to those observed in KO α7-nAChR mouse pups. These findings support the hypothesis that α7-nAChR are involved in the process of deleterious effects of tobacco smoking on respiratory epithelium development. The purpose of the present clinical study is to compare PTSE neonates with controls according to lung function and respiratory epithelial functionality. At the age of 3 days, small respiratory epithelium fragments will be obtained from gentle nasal brushing performed under antalgic premedication according to the method we previously published. Epithelium samples will be used for in vitro studies of α7-nAChR and CFTR functionality. Between the ages of 2 and 6 weeks, lung function testing will be performed, by means of baby-body plethysmography.

intervention_type: Diagnostic Test


title: Emotional and Change-related Attention in Autism

acronym: AUTATTEN

summary: Several studies seem to indicate that emotional attention and change-related attention are impaired in ASD. The goal of this study is to identify the relationships between those two types of automatic attention in visual and auditory modalities in subjects with ASD compared to healthy controls and also, over the course of development (children, adults). In order to achieve this goal, the investigators will use complementary techniques (EEG and MRI-based techniques (fMRI, DTI)).


title: Relationship Between Endogenous CETP Activity and Atherosclerosis Distribution in Patients With High Cardiovascular Risk

acronym: CETP-ATHERO

summary:
The reverse cholesterol transport (RCT) pathway, which involves the centripetal movement of free cholesterol from peripheral tissues, including the vessel wall, to the liver represent the primary mechanism by which HDL protects against atherosclerosis and by which it may induce plaque regression. Recent data reveal that the capacity of HDL to efflux cholesterol from macrophages, a metric of HDL function reflecting the initial step of the RCT, is clinically relevant, displaying a strong inverse association with both carotid intima-media thickness and the severity of angiographic CAD; such observations were independent of HDL-C levels.

In human, the Cholesteryl Ester Transfer Protein (CETP), represents a key protein of the RCT pathway and mediates redistribution of neutral lipids between lipoproteins, has been identified as a potential therapeutic target against atherosclerosis. It is known that CETP activity correlates with HDL-C levels and represents a key modulator of the ability of whole plasma to mediate free cholesterol efflux from human macrophages.

Recent studies showed that 23% of endogenous plasma CETP activity variability is explained by plasma LDL-C (12.0%), HDL-C (6.4%) and TG (4.4%) whereas sex and BMI accounted together for only 0.7% of its variability. Scoring patients for cardiovascular risk on the basis of their plasma lipid levels (TC, TG, LDL-C and HDL-C), revealed that patients with high cardiovascular risk (score ≥3) displayed a mean endogenous plasma CETP activity above 34%. Therefore plasma CETP activity represents a potent indicator of cardiovascular risk in patients with metabolic disorders since it integrates major independent risk factors.

The objective of this study is to decipher the relationship between CETP, HDL efflux capacity and the development of atherosclerosis in humans in order to identify CETP as a potent biomarker of atherosclerosis distribution.


title: Remote Evaluation of Quality of Life and Functional Capacities in Patients Hospitalised for COVID-19: a Prospective Observational Study

acronym: TELECOVID

summary:
Around 90.000 patients have been hospitalised due to COVID-19 infection in France between March 1st and June 15th; 19% of those requiring intensive care. Approximately 80% of these patients have been discharged home by September 30th. Nonetheless, COVID-19 infection along with intensive care consequences are very likely to impede those patients quality of life and functional capacities.

This study aims to describe the quality of life outcomes and functional capacities of COVID-19 survivors, at least 6 months after primary care hospital discharge.

lead_sponsor: Groupe Hospitalier du Havre


title: Factors Associated With Post-Traumatic Stress Disorder in Patients With After Preterm Delivery

acronym: PTSD-preterm

summary: Each year in France, between 50,000 and 60,000 children are born prematurely (< 37 weeks of amenorrhea). Literature has shown that preterm deliveries can be associated with the development of PTSD (Post-Traumatic Stress Disorder) in mothers. Around ¼ of women suffer from a PTSD after giving birth prematurely. Moreover, studies highlighted the consequences of a PTSD on the child-mother relationship. Beyond the importance of early detection, it could be important to predict factors that make women more likely to develop a PTSD. This study will focus on personal factors (5 dimensions of personality). Our hypothesis is that personality traits are associated with the likeliness of developing a PTSD after a preterm delivery.


title: Role of PET/CT With Fluorine-18 Tracers and of Diffusion Weighted Whole-body MRI in the Early Detection of Bone Metastases in Prostate Cancer

acronym: FLUPROSTIC

summary: Compare PET/CT and MRI for the early detection of bone metastases of prostate cancer: diagnostic performance and impact on the patient management.Determine the lowest cost strategy according to the precise clinical circumstances.

ReferenceCitation: Gauthé M, Zarca K, Aveline C, Lecouvet F, Balogova S, Cussenot O, Talbot JN, Durand-Zaleski I. Comparison of (18)F-sodium fluoride PET/CT, (18)F-fluorocholine PET/CT and diffusion-weighted MRI for the detection of bone metastases in recurrent prostate cancer: a cost-effectiveness analysis in France. BMC Med Imaging. 2020 Mar 2;20(1):25. doi: 10.1186/s12880-020-00425-y.

family: Gauthé

full_name: Mathieu Gauthé

given: Mathieu

family: Zarca

full_name: Kevin Zarca

given: Kevin

family: Aveline

full_name: Cyrielle Aveline

given: Cyrielle

family: Lecouvet

full_name: Frédéric Lecouvet

given: Frédéric

family: Balogova

full_name: Sona Balogova

given: Sona

family: Cussenot

full_name: Olivier Cussenot

given: Olivier

family: Talbot

full_name: Jean-Noël Talbot

given: Jean-Noël

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

currency_apc_doaj: GBP

journal_name: BMC Medical Imaging

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Comparison of 18F-sodium fluoride PET/CT, 18F-fluorocholine PET/CT and diffusion-weighted MRI for the detection of bone metastases in recurrent prostate cancer: a cost-effectiveness analysis in France

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service Médecine Nucléaire - Hôpital TENON


title: Obtention d'un modèle Cellulaire de la Maladie CADASIL à Partir de Fibroblastes cutanés de Patients

summary:
Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leucoencephalopathy (CADASIL) is an archetypal small vessel disease of the brain caused by dominant mutations in the NOTCH3 receptor. Cardinal vascular lesions include deposition of granular osmiophilic material (GOM) within the basal lamina of smooth muscle cells, progressive smooth muscle cell loss, and fibrosis of the media. Pathogenic mutations alter the number of cysteine residues in the extracellular domain of NOTCH3 (Notch3 ECD), leading to its abnormal accumulation in the GOM deposits. Vascular smooth muscle cell has been identified as the primary target cell in this disease. Pathophysiological processes leading from NOTCH3 mutations to smooth muscle cell loss remain poorly understood.

The investigators propose to study these mechanisms by reprogramming skin cells to become stem cells and then differentiating them to vascular smooth muscle cells.

The hypothesis of this study is that the differentiated smooth muscle cells will display the characteristic features of CADASIL, ie, Notch3 ECD accumulation and GOM deposits.


title: Etude génétique Des Arméniens

summary: This study aims at better understanding the genetic structure of the Armenians, an old population whose genetics has not been the subject of many studies. We will study 500 individuals whom grandparents originate from different regions of Armenia. Each individual will be genotyped using a large panel of genetic markers. Principal component analysis will be used to analyze the genetic structure of this population.


title: Phase II Open Label Study Using Triheptanoin in Patients With Glucose Type 1 Transporter Deficiency GLUT1-DS

acronym: GLUT-HEP

summary: The purpose of this project is to study the efficacy of triheptanoin oil in patients with GLUT1 deficiency syndrome.

ReferenceCitation: Mochel F, Hainque E, Gras D, Adanyeguh IM, Caillet S, Héron B, Roubertie A, Kaphan E, Valabregue R, Rinaldi D, Vuillaumier S, Schiffmann R, Ottolenghi C, Hogrel JY, Servais L, Roze E. Triheptanoin dramatically reduces paroxysmal motor disorder in patients with GLUT1 deficiency. J Neurol Neurosurg Psychiatry. 2016 May;87(5):550-3. doi: 10.1136/jnnp-2015-311475. Epub 2015 Nov 3.

family: Mochel

full_name: Fanny Mochel

given: Fanny

family: Hainque

full_name: Elodie Hainque

given: Elodie

family: Gras

full_name: Domitille Gras

given: Domitille

family: Adanyeguh

full_name: Isaac M Adanyeguh

given: Isaac M

family: Caillet

full_name: Samantha Caillet

given: Samantha

family: Héron

full_name: Bénédicte Héron

given: Bénédicte

family: Roubertie

full_name: Agathe Roubertie

given: Agathe

family: Kaphan

full_name: Elsa Kaphan

given: Elsa

family: Valabregue

full_name: Romain Valabregue

given: Romain

family: Rinaldi

full_name: Daisy Rinaldi

given: Daisy

family: Vuillaumier

full_name: Sandrine Vuillaumier

family: Schiffmann

full_name: Raphael Schiffmann

given: Raphael

family: Ottolenghi

full_name: Chris Ottolenghi

given: Chris

family: Hogrel

full_name: Jean-Yves Hogrel

given: Jean-Yves

family: Servais

full_name: Laurent Servais

given: Laurent

family: Roze

full_name: Emmanuel Roze

given: Emmanuel

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


title: Recherche et caractérisation de Nouveaux gènes impliqués Dans la déficience Intellectuelle.

acronym: GeneDefi

summary:
Intellectual disability (ID) occurs in 2 to 3 % of the general population but the cause is identified only in 30 to 60% of cases.

The purpose of this study is to indentify genes involved in ID with new genetics tools (SNP-arrays, next generation sequencing...) and establish genotype-phenotype correlations.

ReferenceCitation: Nava C, Lamari F, Héron D, Mignot C, Rastetter A, Keren B, Cohen D, Faudet A, Bouteiller D, Gilleron M, Jacquette A, Whalen S, Afenjar A, Périsse D, Laurent C, Dupuits C, Gautier C, Gérard M, Huguet G, Caillet S, Leheup B, Leboyer M, Gillberg C, Delorme R, Bourgeron T, Brice A, Depienne C. Analysis of the chromosome X exome in patients with autism spectrum disorders identified novel candidate genes, including TMLHE. Transl Psychiatry. 2012 Oct 23;2:e179. doi: 10.1038/tp.2012.102.

family: Nava

full_name: C Nava

given: C

family: Lamari

full_name: F Lamari

given: F

full_name: D Héron

given: D

family: Mignot

full_name: C Mignot

family: Rastetter

full_name: A Rastetter

given: A

family: Keren

full_name: B Keren

given: B

family: Cohen

full_name: D Cohen

family: Faudet

full_name: A Faudet

family: Bouteiller

full_name: D Bouteiller

family: Gilleron

full_name: M Gilleron

given: M

family: Jacquette

full_name: A Jacquette

family: Whalen

full_name: S Whalen

given: S

family: Afenjar

full_name: A Afenjar

family: Périsse

full_name: D Périsse

family: Laurent

full_name: C Laurent

family: Dupuits

full_name: C Dupuits

family: Gautier

full_name: C Gautier

family: Gérard

full_name: M Gérard

family: Huguet

full_name: G Huguet

given: G

full_name: S Caillet

family: Leheup

full_name: B Leheup

family: Leboyer

full_name: M Leboyer

family: Gillberg

full_name: C Gillberg

location_facility: CRICM - UPMC/Inserm UMR_S975/CNRS UMR7225, Groupe Hospitalier de la Pitié-Salpêtrière,


title: Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study

acronym: CUP-DIU

summary:
In France, 26% of women of childbearing age use an intrauterine device (IUD) containing copper or levonorgestrel as a method of contraception. Failures of IUD contraception are mainly due to shifting or expulsion of the IUD. The risk factors for expulsion of IUDs most often found in the literature are young age (<25 years), the existence of menorrhagia, dysmenorrhea, being a carrier of a copper IUD rather than a levonorgestrel IUD , a history of IUD expulsion, nulliparity, and an anomaly of the uterine cavity unrecognized (fibroma, adenomyosis).

More and more women are turning to menstrual cups (MCs) as a means of periodic protection. But the use of MC has also been mentioned as a risk factor for IUD expulsion (via a suction effect). In May 2013, reports of displacement, rupture, or even expulsion of copper IUDs in CM users were reported to ANSM.

However, few studies have examined the risks associated with the concomitant use of an MC and an IUD. The data are contradictory and insufficient to provide a clear answer to women. Hence the interest in carrying out a larger prospective study to explore the relationship between IUD expulsion and the use of MC.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation de l'efficacité thérapeutique de la Stimulation magnétique transcrânienne répétée Sur le Traitement du Craving à l'Alcool et la prévention de la Rechute Alcoolique à 6 Mois Chez Les Sujets dépendants et Des Facteurs génétiques déterminant la réponse thérapeutique

summary: Prior research in substance dependence has suggested potential anti-craving effects of repetitive transcranial magnetic stimulation (rTMS) when applied to the dorsolateral prefrontal cortex (DLPFC). The aim of the investigators study was to investigate the effect of high frequency rTMS of the left dorsolateral prefrontal cortex compared to sham stimulation on craving and alcohol consumption.


title: Identification of HCV Specific T Cells Using Tetramer Technology - TETRA Study

acronym: TETRA

summary:
Nearly 175 million people worldwide are infected by Hepatitis C Virus (HCV), close to 3% of the global population. Contrary to other chronic infections such as HIV, clearance of HCV is possible. While much is now known about the response to treatment in chronic HCV patients, the fact that acute HCV infection is typically asymptomatic (~80% of patients show no clinical signs) has made it challenging to define the mechanisms involved in spontaneous clearance.

Immune protection against HCV is thought to be largely dependent upon the CD8 T cell response. Therefore using the latest T cell detection technology the investigators will develop a panel of tetramers specific for all potential HCV epitopes. To produce the tetramers the investigators will utilize HLA ligand exchange technology which allows the production of very large collections of peptide-HLA multimers for T cell staining. The investigators have already performed a large scale identification of HCVg1 and HCVg4 CD8 T cell epitopes using published viral sequences and algorithm prediction databases. Using this information the investigators are currently in the process of developing collections of peptide-HLA multimers for T cell staining. Therefore the investigators require large lymphocyte pools from HCV+ patients to test both the sensitivity and accuracy of each tetramer on the CD3+CD8+ T cells.

The investigators wish to examine cells from patients infected with HCV g1 and HCV g4 to be able to test and compare the frequency of possible conserved epitopes present in both HCVg1 and HCVg4 infections. Once developed this technique will allow us to examine all virus-specific CD8 T cells present in patients with acute or chronic disease, and on smaller quantities of blood. The development of these technologies will also allow us to tailor such future diagnostic tests to local populations where a viral subspecies is prevalent; for example using North-African HLA alleles for HCVg4 epitopes.

The work carried out using such assays will provide important immunological correlates of viral clearance that will impact vaccine design for HCV infections. Finally, the identification of protective CD8 T cells specific for HCV may allow new diagnostic tools with predictive powers of disease progression that can be used on any flow cytometer machine.


title: Adaptation Sensorimotrice, Cervelet et Mouvements Anormaux: Projet d'étude Oculomotrice

acronym: MOUVADOC

summary:
Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Essential tremor is a slowly progressive neurologic disorder characterized by the appearance of a tremor during the voluntary movement. The pathophysiology of dystonia or essential tremor is not fully elucidated. Dystonia and essential tremor are associated with dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the cerebellum and cerebellar pathways has also been recently suggested.

The investigators propose to study 30 patients having a primary dystonia (15 DYT11 genetically documented), 15 patients having an essential tremor without deep brain stimulation and 15 patients having an essential tremor with deep brain stimulation.A group of 30 healthy volunteers will be recruited and tested according to the same modalities. They will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.

Eye position will be sampled with a video-based monocular eye tracker (SMI, Germany) before and immediately after an adaptation task. Saccade adaptation is evaluated as the percentage change in the mean saccade amplitude between pre-test and post-test.

Expected results:

no or fewer alteration of the performance to the adaptation task in the Parkinson group than in the Essential Tremor group/ dystonia group.
abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor group, providing further neurophysiological evidence of cerebellar dysfunction.

location_facility: : Fédération des Maladies du Système Nerveux


title: Dopaminergic Reactivity In Idiopathic Generalized Epilepsy: A "Proof Of Concept" Clinical, Pharmacological And Neurophysiological Study

acronym: BYE BYE DOPA

summary:
The objective of the present study is to assess dopaminergic reactivity with behavioural markers (i.e. yawning and blinking) in patients with idiopathic generalized epilepsy compared to matched healthy controls, after injection of either low dose of apomorphine or placebo.

Other parameters will be recorded: biochemical (prolactin, GH) and neurophysiological (Spike-Waves Discharge: SWD rating). Safety parameters will be recorded to assess tolerance.

ReferenceCitation: Ahmad S, Fowler LJ, Whitton PS. Effect of acute and chronic lamotrigine on basal and stimulated extracellular 5-hydroxytryptamine and dopamine in the hippocampus of the freely moving rat. Br J Pharmacol. 2004 May;142(1):136-42. Epub 2004 Mar 22.

ReferenceCitation: Ahmad S, Fowler LJ, Whitton PS. Lamotrigine, carbamazepine and phenytoin differentially alter extracellular levels of 5-hydroxytryptamine, dopamine and amino acids. Epilepsy Res. 2005 Feb;63(2-3):141-9.

ReferenceCitation: Aymard G, Berlin I, de Brettes B, Diquet B. Pharmacokinetic-pharmacodynamic study of apomorphine's effect on growth hormone secretion in healthy subjects. Fundam Clin Pharmacol. 2003 Aug;17(4):473-81.

ReferenceCitation: Biraben A, Semah F, Ribeiro MJ, Douaud G, Remy P, Depaulis A. PET evidence for a role of the basal ganglia in patients with ring chromosome 20 epilepsy. Neurology. 2004 Jul 13;63(1):73-7.

ReferenceCitation: Blin O, Masson G, Azulay JP, Fondarai J, Serratrice G. Apomorphine-induced blinking and yawning in healthy volunteers. Br J Clin Pharmacol. 1990 Nov;30(5):769-73.

location_facility: CIC Department - University Hospital of Grenoble


title: A Phase II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation of Oral mTOR-inhibitor Everolimus (RAD001) 10 mg Daily in Patients Suffering From Classic or Endemic Kaposi's Sarcoma

summary: Classic Kaposi's sarcoma (CKS) is an angioproliferation associated with human herpes virus 8 (HHV8), which sometimes requires systemic treatment. Rapamycin and everolimus are mTOR inhibitors. The PI3K-AKT-mTOR pathway is activated in CKS.The aim of this study is to evaluate the rate of clinical response and tolerance to everolimus 10mg/d in CKS. Patients suffering from CKS will be enrolled in a multicenter two-stage phase II trial. At inclusion, all patients will have at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral CKS. The primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria). The trial is planned using Simon's minimax two-stage design to demonstrate a response rate of 50% as compared to 20% with type I error rate 2.5% and power of 90%. Accordingly, 11 patients will to be enrolled in the first stage and provided at least 3 patients responded, 15 patients will be accrued in a second stage.

status: Terminated


title: Neuropsychological and Anatomical Study of Concept Formation in Frontal Patients

summary:
The capacity of concept formation is not well understood, even if a link is supposed with the functioning of the frontal lobes.

Our aim is to better understand the cognitive mechanisms underlying this function and to try to correlate the performance with atrophy of the frontal lobe in neurodegenerative diseases involving this region (frontotemporal lobar degeneration and progressive supranuclear palsy).


title: Study of Abnormal Structure and Bone Density at the Feet of Diabetic Patients

summary:
Assumptions and Objectives: The working hypotheses are: 1 - subjects with type 1 diabetes and / or type 2, compared to subjects without diabetes are at risk for osteopenia and / or abnormal bone structure the foot (calcaneus and ankle) can lead to bone deformities, fractures and final stage of Charcot foot. These anomalies are favored by the presence of peripheral neuropathy and plasma levels of advanced glycation end products higher than in diabetic subjects without bone abnormalities.

The objectives of this research are to evaluate these anomalies quantitative and qualitative bone in the foot (calcaneus and ankle) through the use of MicroScanner. In parallel a whole body bone mineral density (BMD) and calcaneal ultrasound will be performed to measure bone mineral density as realized in clinical practice in a defined population of patients with type 1 or type 2. These bone abnormalities will be correlated with the presence of peripheral neuropathy and the rate of advanced glycation end products of proteins and reference to parameters of chronic inflammation and oxidative stress to better understand the pathophysiology and target a population at risk.

The importance of this study is paramount in the management of diabetic foot. Indeed for the moment we are dealing primarily the consequences of diabetes impact bone when bone deformities have appeared with their attendant disability and the risk of recurrent infections in areas of friction in this fragile environment. The ultimate goal is to target people with diabetes have abnormal bone subclinical and take care to avoid changes to bone deformities and find ways to treat them.


title: Study of a Large Family With Congenital Mirror Movements : From Underlying Pathophysiology to Culprit Gene Identification : MOMIC

acronym: MOMIC

summary: Mirror movements are involuntary, symmetrical and simultaneous movements occurring on one side of the body that accompany controlateral voluntary movements. Congenital mirror movements (CMM) are characterized by childhood onset and the absence of additional manifestations. The aim of this study is to unravel the pathophysiology of the CMM that remains poorly elucidated. The combination of imaging studies and neurophysiological studies using transcranial magnetic stimulation in a homogeneous and relatively large group of patient is likely to allow us to better understand the underlying pathophysiology of the disorder. Using a linkage analysis approach we will try to identify a locus associated with CMM and related candidate genes.

location_facility: Fédération des Maladies du Système Nerveux, Hôpital Pitié Salpétrière


title: Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome

acronym: rTMSPPCGT

summary: Repetitive transcranial stimulation (rTMS) of the posterior parietal cortex will be applied daily over five days in adult Gilles de la Tourette patients. This approach aims at reducing premonitory sensations believed to induce tics. Patients will be randomized to an active or placebo (sham) group in a crossover design.


title: Etude Multicentrique en Population de la susceptibilité génétique à Faire Une Mort Subite

acronym: CARTAGENE

summary: Sudden death is a major problem in industrially developed countries. Despite a decline in ischemic heart disease mortality and the progress has been made in resuscitation, treatment of sudden death victims is frequently unsuccessful. the ideal solution would be to prevent the disease process that causes the initial episode of cardiac arrest. Parental sudden death is an independent risk factor for sudden death. So, detect a gene predisposing to sudden death may help provide better identification of subjects at high risk of cardiac arrest. This research is a genetic study of sudden cardiac death, recruited 2000 subjects in out-of-hospital cardiac arrest.