title: BANCO Study: Behavioral Addictions and Related NeuroCOgnitive Aspects: A Monocentric, Prospective, Controlled, Open-label Study of a Sample of Patients With Gambling Disorder

acronym: BANCO

summary: The prevalence of people suffering from gambling disorder is relatively high, and the impact on this disorder the individual and those around him is considerable. The etiopathogenic model of gambling disorder is multifactorial, involving various risk and vulnerability factors, involved in the initiation and maintenance of the disorder. Among these factors, neurocognitive alterations associated with the disorder has recently aroused interest among researchers. In this study, the investigators propose to explore the neurocognitive impairments of patients suffering from gambling disorder compared to a control group, in order to identify alterations that could be the target of cognitive remediation programs. Gambling disorder provides a unique opportunity to study the specific neurocognitive impairments of the addictive process because it is not biased by the neurotoxic effect of substances as it is the case in substance use disorders.

ReferenceCitation: Hurel E, Grall-Bronnec M, Thiabaud E, Saillard A, Hardouin JB, Challet-Bouju G. A Case-Control Study on Behavioral Addictions and Neurocognition: Description of the BANCO and BANCO2 Protocols. Neuropsychiatr Dis Treat. 2021 Jul 20;17:2369-2386. doi: 10.2147/NDT.S292490. eCollection 2021.

family: Hurel

full_name: Elodie Hurel

given: Elodie

family: Grall-Bronnec

full_name: Marie Grall-Bronnec

given: Marie

family: Thiabaud

full_name: Elsa Thiabaud

given: Elsa

family: Saillard

full_name: Anaïs Saillard

given: Anaïs

family: Hardouin

full_name: Jean-Benoît Hardouin

given: Jean-Benoît

family: Challet-Bouju

full_name: Gaëlle Challet-Bouju

given: Gaëlle

journal_name: Neuropsychiatric Disease and Treatment

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: A Case–Control Study on Behavioral Addictions and Neurocognition: Description of the BANCO and BANCO2 Protocols


title: Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. PACMI (Pancreatic AdenoCarcinoma Multimodality Imaging)

acronym: PACMI

summary: The aim of this study was to assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Cerebral Bases of Multisensory Perception of the Body and Its Action Space

summary: To accurately control body movements to interact with objects, our brain needs representations of the body and the nearby space. The broader aim of this research project is to study the behavioural and physiological mechanisms involved in the constitution of these representations, to identify their neural bases, in order to better understand the dysfunctions in the context of neurological or developmental disorders.

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other

status_simplified: Ongoing


title: Prospective, Single Centre Cohort Study on the Impact of Binaural Audition on Postural Performance and Orientation in Healthy Subjects and Patients With Cochlear Implants.

acronym: AUDIPIC

summary:
This is a prospective research study talking place at University hospital of Dijon and requiring the inclusion of 20 healthy subjects, 10 patients with unilateral cochlear implants and 10 patients with bilateral cochlear implants to carry out:

an audio-vestibular examination,
a videonystagmoscopic study,
a posturography study and
a movement study. The aim of the study is to evaluate the impact of binaural audition on postural performance and orientation.

status: Completed

study_completion_date_type: Actual

primary_purpose: Other

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire Dijon

status_simplified: Completed


type: Other Identifier

acronym: SASER

summary: Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Lille

location_facility: CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique


title: Motor Unit Recruitment Study With Fatigue Testing: 9 Months Following up After Anterior Cruciate Ligament Surgery.

acronym: WEAKNESS

summary:
An assessment of the effect of surgical anterior cruciate ligament (ACL) on thigh muscles is critical to the improvement of knee rehabilitation and preservation. However, if a large number of studies had rated surgical technics, giving high results level for ACL reconstruction (ACLR), muscle recovery is still conditioning functional success. Furthermore there is no consensus about criteria in return to sport.

The aim of this exploratory study is to quantify the mechanisms of neuromuscular adaptation of muscle thigh after ACL surgery.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Clermont-Tonnerre


title: Analytic and Functional Evaluation After Surgical Treatment Using an Original Arthroscopic Trillat Technique in Patients With Chronic Anterior Shoulder Instability

acronym: TRILLARTHRO

summary:
The shoulder is the most mobile joint in the body, and the most exposed to the risk of dislocation notably anterior. Chronic instability of the shoulder is frequent after dislocation, and principally affects people who are young and active. It can have major functional repercussions, leading to restricted participation in professional or sports activities, even in everyday life activities.

Surgical stabilisation is the reference treatment for chronic anterior shoulder instability, and has given good results. There are numerous surgical techniques available; the orthopaedists at Dijon CHU now practice the Bristow-Trillat technique under arthroscopy, following many years of reflexion and adaptation.

Rehabilitation following the surgery is essential, notably to recover muscle strength in the shoulder rotator cuff after surgery, which correlates directly with dynamic stability of the joint. At the moment, we do not know the objective evolution of muscle strength after the Trillat arthroscopic technique.

The isokinetic evaluation of muscle strength in the rotator cuff has been validated and is reproducible. It gives objective and reliable values for muscle strength, thus making it possible to guide and to optimise rehabilitation protocols done by patients under the supervision of a physiotherapist, and to estimate time to the return to physical, professional or sports activities, without risk.

study_type: Observational

time_perspective: Other


title: The Right Ventricle in Chronic Pressure Overload: Identifying Novel Molecular Targets for Functional Imaging

acronym: MVD

summary: Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage.

lead_sponsor: Centre Chirurgical Marie Lannelongue

intervention_type: Procedure

lead_sponsor_type: industriel


summary:
The main objectives of the prolonged resuscitation paralysis are usually adaptation to mechanical ventilation, lower insufflation pressures and cough suppression.

The use of monitoring during the prolonged neuromuscular blockade is the subject of recommendations. Its interest is subject to a recommendation grade B and its use in prevention of overdose is associated with a recommendation of Grade C.

However, many practitioners continue to objectify the depth of neuromuscular blockade and reversal by simple clinical evaluation. This is a subjective estimate of the depth of neuromuscular block.

Resuscitation in several pharmacokinetic parameters are taken into account. First, the drug distribution volume is usually increased in the Intensive Care patient and requires an increase in initial doses to obtain the same pharmacological effect.

Then, unlike a short-term administration, the administration of neuromuscular blocking agents on days causes diffusion in peripheral compartments. Their diffusion coefficients are slower which contributes to the increase of the elimination period after interruption of the administration of curare. There is therefore a risk of residual paralysis.

Secondarily, the curare needs can be influenced by thermoregulation, water and electrolyte disorders and acid-base, administration of certain drugs, the inter- and intra-individual variability and tachyphylaxis (form tolerance of particularly rapid installation during a few close administration, linked to the proliferation of cholinergic receptors).

The value of monitoring neuromuscular blockade in intensive care is the prevention of overdose and in finding the lowest effective dose.

lead_sponsor: Poitiers University Hospital

intervention_type: Drug


title: Involvement of Plasmatic Factors in the Peripheral Muscle Dysfunction of COPD Patients - In Vitro Study

summary: Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. It is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Determination of Factors Influencing the Physical Condition of Obese Patients Following Bariatric Surgery. Randomized Controlled Trial

acronym: CaPaCITy

summary: The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.

primary_purpose: Prevention

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Perioperative Transesophageal Portal Vein Pulsatility as a Predictor of Persistent Organ Dysfunction Plus Death 7 Days After Pulmonary Endarterectomy

acronym: PVP-ETO-CPC

summary: The investigators aim to evaluate the utility of portal vein pulsatility as a predictor of the composite outcome of persistent organ dysfunction plus death in patients undergoing elective or urgent pulmonary endarterectomy for thromboembolic pulmonary hypertension. The investigators' hypothesis is that the portal vein pulsatility fraction, measured using transesophageal echocardiography immediately after weaning of cardiopulmonary bypass, is proportional to the risk of developing subsequent end-organ dysfunction in the postoperative setting.

primary_purpose: Screening

ReferenceType: background

ReferenceCitation: Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH; American Society of Echocardiography; Society of Cardiovascular Anesthesiologists. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. Anesth Analg. 2014 Jan;118(1):21-68. doi: 10.1213/ANE.0000000000000016.

ReferenceCitation: Jenkins D. Pulmonary endarterectomy: the potentially curative treatment for patients with chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2015 Jun;24(136):263-71. doi: 10.1183/16000617.00000815. Review.

ReferenceCitation: Dittrich HC, Chow LC, Nicod PH. Early improvement in left ventricular diastolic function after relief of chronic right ventricular pressure overload. Circulation. 1989 Oct;80(4):823-30.

ReferenceCitation: Olson N, Brown JP, Kahn AM, Auger WR, Madani MM, Waltman TJ, Blanchard DG. Left ventricular strain and strain rate by 2D speckle tracking in chronic thromboembolic pulmonary hypertension before and after pulmonary thromboendarterectomy. Cardiovasc Ultrasound. 2010 Sep 27;8:43. doi: 10.1186/1476-7120-8-43.

ReferenceCitation: Marston N, Brown JP, Olson N, Auger WR, Madani MM, Wong D, Raisinghani AB, DeMaria AN, Blanchard DG. Right ventricular strain before and after pulmonary thromboendarterectomy in patients with chronic thromboembolic pulmonary hypertension. Echocardiography. 2015 Jul;32(7):1115-21. doi: 10.1111/echo.12812. Epub 2014 Oct 18.


title: Validation of a Screening Test of Sarcopenia in the Elderly People at Hospital and in Retirement Houses

acronym: SARCSA

summary:
Identify the threshold which the handgrip strenght can be used as a screening test of sarcopenia.

Handgrip strenght can be used in daily clinical practice to screen patients having sarcopenia to improve treatment and quality of life.


title: Population Pharmacokinetics of Antiepileptic in Pediatrics

acronym: EPIPOP

summary:
The purpose of this study is to develop population pharmacokinetic models for antiepileptic drugs in a pediatric population.

The interest of these models is multiple:

describe the pharmacokinetics of these molecules in children and explain the inter-individual variability of concentrations through covariates such as weight, age, co-treatments, genetic polymorphisms and renal function;
estimate maximum, minimum and exposure concentrations from the individual pharmacokinetic parameters for each patient;
propose adaptations of doses for certain classes of children (according to age, weight etc.) and individualize the doses.


title: Observational Study to Assess Adherence of Oral Anticancer Therapies

acronym: ObservAG

summary:
Oral anticancer treatments are increasingly numerous. They represent an additional alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who prefer this route of administration over intravenous treatment. The objective of oral therapies is twofold: to remove the constraints and risks associated with infusions and to allow the patient to follow his treatment at home.

However, they have significant adverse effects that may affect patients, who are sometimes at a disadvantage compared to how they are treated, and potentially lead to non-compliance with the consequences.

This study will identify the factors associated with non-adherence and determine the impact of this non-adherence in terms of treatment efficacy and tolerance.

The aim of this routine care study is to evaluate the adherence to oral anticancer therapies during 3 months.

time_perspective: Prospective

lead_sponsor: Centre Georges Francois Leclerc


title: Is There a Real Diaphragm-Sparing Nerve Block for Arthroscopic Shoulder Surgery?

summary: This study aims at assessing the effectiveness of combined suprascapular nerve block (SSNB), infraclavicular brachial plexus block (ICB) and supraclavicular nerve block (SCNB) as surgical anesthesia for patients scheduled for arthroscopic shoulder surgery. The secondary objective is to test the hypothesis that SSNB-ICB-SCNB combination could spare the phrenic nerve.

lead_sponsor: Clinique Medipole Garonne


title: Observational Study for Feasibility and Performance of Sub-millisievert Coronary Computed Tomography Angiography (CCTA) for Coronary Artery Anomalies (CAA) in Paediatric Patients

acronym: COROPEDIA

summary:
Congenital heart defects are the most frequent manifestation of congenital diseases (8 per 1000 live births). Imaging modalities play an increasing role in their diagnosis, follow-up, and pre/post-surgery check-up. Echocardiography usually provides a first line diagnosis, but Coronary CT Angiography (CCTA) also demonstrated its usefulness whenever accurate modelling of anatomic structures is required.

CCTA is well defined for adult patients. This is not the case for paediatric population, which rises two main difficulties:

The use of ionising radiation in young subjects involves a very radio-sensitive population, potentially subject to multiple exams during their follow up.
Technical issues related to young patients: No breath-holding, uncontrolled movements during acquisition, very high heart rates (making ECG gating more complex) and very small structures.

These conditions usually result in a deteriorated image quality or in radiation dose increase (retrospective gating). These two outcomes are not acceptable for both, clinician and patient.

In this study, investigators make the hypothesis that despite difficult conditions stated above, ultra-low dose acquisitions may results in diagnostic quality acquisition, thanks to state of art CT technologies combined with acquisition parameters specially designed for that purpose.

Investigators aim to demonstrate feasibility and performances of such exams.

ReferenceCitation: Le Roy J, Vernhet Kovacsik H, Zarqane H, Vincenti M, Abassi H, Lavastre K, Mura T, Lacampagne A, Amedro P. Submillisievert Multiphasic Coronary Computed Tomography Angiography for Pediatric Patients With Congenital Heart Diseases. Circ Cardiovasc Imaging. 2019 Feb;12(2):e008348. doi: 10.1161/CIRCIMAGING.118.008348.

ReferenceCitation: Ultra-low dose multiphasic coronary computed tomography angiography for pediatric patients with congenital heart diseases: A prospective cross-sectional study - 14/08/18 Doi : 10.1016/j.acvdsp.2018.06.036 Julien Le Roy, MSc a, b, c, Hélène Vernhet Kovacsik, MD, Ph.D. d, Hamid Zarqane, MD d, Marie Vincenti, MD a, b, Hamouda Abassi, MSc a, Kathleen Lavastre, MSc a, Thibault Mura, MD, Ph.D. e, Alain Lacampagne, Ph.D. b, Pascal Amedro, MD, Ph.D. a, b, ⁎

location_facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

intervention_type: Diagnostic Test


title: Interest of Cervical Dilators in the Induction of Labor in Second Trimester Medical Termination of Pregnancy.

acronym: DILATOP

summary: The purpose of this study is to evaluate whether the use of cervical dilators for cervical ripening in case of second trimester medical termination of pregnancy (TOP) is effective to reduce duration of labor.

primary_purpose: Supportive Care

ReferenceCitation: Vincienne M, Anselem O, Cordier AG, Le Ray C, Tsatsaris V, Benachi A, Goffinet F. Comparison of the Induction-to-Delivery Interval in Terminations of Pregnancy with or without Dilapan-S®. Fetal Diagn Ther. 2018;43(1):61-67. doi: 10.1159/000458410. Epub 2017 Mar 29.

ReferenceCitation: Jain JK, Mishell DR Jr. A comparison of misoprostol with and without laminaria tents for induction of second-trimester abortion. Am J Obstet Gynecol. 1996 Jul;175(1):173-7.

ReferenceCitation: Mazouni C, Vejux N, Menard JP, Bruno A, Boubli L, d'Ercole C, Bretelle F. Cervical preparation with laminaria tents improves induction-to-delivery interval in second- and third-trimester medical termination of pregnancy. Contraception. 2009 Jul;80(1):101-4. doi: 10.1016/j.contraception.2009.01.013. Epub 2009 Mar 4.

ReferenceCitation: Pluchon M, Winer N. [Misoprostol in case of termination of pregnancy in the second and third trimesters. Trials]. J Gynecol Obstet Biol Reprod (Paris). 2014 Feb;43(2):162-8. doi: 10.1016/j.jgyn.2013.11.009. Epub 2014 Jan 16. Review. French.

ReferenceCitation: Gitz L, Morel O, Thiebaugeorges O, Sibiude J, Desfeux P, Barranger E. [Termination of pregnancy and intra-uterine fetal death after 14 weeks of pregnancy: Which protocol for induction of labour in 2010?]. J Gynecol Obstet Biol Reprod (Paris). 2011 Feb;40(1):1-9. doi: 10.1016/j.jgyn.2010.11.007. Epub 2010 Dec 23. Review. French.

ReferenceCitation: Thong KJ, Baird DT. A study of gemeprost alone, dilapan or mifepristone in combination with gemeprost for the termination of second trimester pregnancy. Contraception. 1992 Jul;46(1):11-7.


title: Impact of Phonatory and Facial Morphology Disorders, on the Quality of Life of Adolescents With Pierre Robin Sequence

acronym: ADOROBIN

summary:
The study team has made the hypothesis that the intensity of the phonatory disorders (rhinolalia), and of the maxillo-mandibular growth anomalies (facial morphology), may have negative effects on the quality of life of adolescents with Pierre Robin sequence.

The investigators also want to assess the impact of 2 different surgical protocols of closure of the cleft palate (1 or 2 step(s)), on the current phonatory and morphology aspects. These 2 protocols were performed, by 2 parisian clinical teams, that have now been merged at Necker hospital.

lead_sponsor: Imagine Institute


title: Population Pharmacokinetics of Antiretroviral in Children

acronym: POPARV

summary:
The purpose of this study is to develop population pharmacokinetic models for antiretroviral drugs in a pediatric population.

The interest of these models is multiple :

describe the pharmacokinetics of these drugs in children and explain the inter-individual variability of concentrations through covariates such as weight, age, sex, smoking status, co-treatments and bilirubin;
estimate maximum, minimum and exposure concentrations from the individual pharmacokinetic parameters for each patient;
propose adaptations of doses for certain classes of children (according to age, weight etc.) and individualize the doses.

intervention_type: Biological


title: Observational Prospective Study Describing the Global Patient Care and Follow-up of Prostate Cancer Patients Treated With Degarelix (DUO)

acronym: DUO

summary:
The DUO study's main objective is to evaluate, in the real life, the prevalence of cardiovascular risk in patients with prostate cancer that hormone treatment of androgen suppression by Degarelix was introduced.

This study will also assess, at the initiation of therapy, the prevalence of osteoporosis, metabolic comorbidities, depression, sexual and geriatric patients suffering from prostate cancer.

lead_sponsor: Ferring Pharmaceuticals

location_facility: Hopital de la Source (there may be multiple sites in this country)


title: Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery: Consequences and Causes

summary: This study aims to assess consequences and causes of hemidiaphragmatic paralysis for ambulatory arthroscopic shoulder surgery in patients with BMI ≥ 30 kg/m².


title: Development of a Decision-making Aid for Referring Severe Kidney Injury Patients for Nephrology Consultations

acronym: IRA Cible

summary: Acute kidney injury is a frequent and growing complication associated with a risk of progressing into a chronic kidney disease. Recent guidelines have recommended systematic consultations with a nephrologist 3-6 months following hospitalization. Risk factors of developing chronic kidney disease between hospital visits are understudied.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection

summary:
The purpose of this study is to establish a bacterial epidemiology in patients who present a prosthetic joint infection and for which a surgery is necessary. At the time of the first surgery, as the bacteria responsible for the infection are not known, a probabilistic antibiotherapy is initiated at once after the surgical treatment. The antibiotherapy is then adapted to the bacteria from samples collected during the surgery when they are identified (the delay is 14-21 days).

The study will focus on bacteria identified on samples collected during the surgery; the delay between the implantation of the prosthesis and the presentation of symptoms will be considered : more than one year vs. less than one year.

Investigators assume that there is not the same type of bacteria involved in those two cases of delays and that the probabilistic antibiotherapy may be not optimal when the symptoms are presented more than one year after implantation of the prosthesis. A probabilistic antibiotherapy not adapted lead to develop resistance for the bacteria and decrease the chance to cure the patient (increasing of relapse).

The result of this study will allow medical doctors to have an optimal probabilistic antibiotherapy, depending on the delay between implantation of the prosthesis and the presentation of the symptoms.


title: Perception of Baby's Painful Cry: Investigation in fMRI to Neuronal Activity Related to Empathy in Adults

summary: Crying is the primary signaling strategy available to the human newborn for eliciting parental care. Yet, the investigators only have superficial understanding of the information carried by cries, and how this information is perceived by parents. Using modern tools of sound processing and functional Magnetic Resonance Imaging (fMRI) experiment, this study aims to investigate cry-induced brain activation in adult depending on the cry's acoustic properties expressing various degrees of stress and distress levels. For that, Adults will be tested inside a fMRI magnet to determine their brain activations elicited by different babies cries according to whether the cry was evoked in a pain situation or not. The cerebral activity will be investigated in relation to acoustic features of cries (e.g. with pitch and/or roughness variations). To test if the gender or parentally of adult listeners influence their perceptions and brain responses, the task will be applied to 2 different groups (men and women not-parents). The hypothesis is that the brain of adult listeners will be able to discriminate adequately the intensity of the pain mediated by the cries. This process should involve brain areas such as the insular and the orbito frontal cortex that are known to participate in the integration of pain intensity and pain controls. The experiment should also determine which one of the acoustic features is able to transmit pain and to recruit brain areas involved in pain processes.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de Neurologie - CHU de Saint-Etienne


title: Respiratory Muscle Training in Patients With Cystic Fibrosis

acronym: MUCOMUREE

summary: The present study aims at evaluating the effect of respiratory muscle training in adult patients with cystic fibrosis on lung function, exercise performance and quality of life.

ReferenceType: derived

ReferenceCitation: Stanford G, Ryan H, Solis-Moya A. Respiratory muscle training for cystic fibrosis. Cochrane Database Syst Rev. 2020 Dec 17;12:CD006112. doi: 10.1002/14651858.CD006112.pub5.

name: Department of Cystic Fibrosis; Royal Brompton & Harefield NHS Foundation Trust; London UK

name: National Heart and Lung Insititute; Imperial College London; London UK

family: Stanford

full_name: Gemma Stanford

given: Gemma

sequence: additional

family: Ryan

full_name: Harrigan Ryan

given: Harrigan

name: Servicio de Neumología; Hospital Nacional de Niños; San José Costa Rica

family: Solis-Moya

full_name: Arturo Solis-Moya

given: Arturo

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Grenoble


title: Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock

summary:
With a prevalence of more than 15% in ICU, septic shock today represents a real public health problem and remains the leading cause of mortality in ICU. Undernutrition is characterized by an alteration of the body composition and in particular by a loss of muscle mass. In intensive care, there are indirect elements suggesting a link between loss of muscle mass and prognosis.

Muscle mass results from a balance between the pathway of proteolysis and that of protein synthesis, depending on many factors, not one of the most important are insulin. The protein PTP1B (Protein Tyrosine Phosphatase 1B), by the dephosphorylation of its numerous substrates, constitutes an endogenous regulator of numerous intracellular signaling pathways, including that of insulin. PTP1B could play a role in the protein synthesis abnormalities observed during sepsis leading clinically to impaired body composition including muscle body mass. Therefore, we propose to study the association between PTP1B and loss of muscle mass in patients in sepsis in resuscitation.

The intestinal barrier plays an essential role in protecting against microbial luminal flora and the phenomenon of bacterial translocation. Zonulin is one of the major regulators of tight junctions, important actors in the intestinal barrier function. The increase in plasma zonulin levels, greater than 0.6 ng / mg, is directly correlated with increased intestinal permeability (16). However, elevation of plasma zonulin has never been evaluated in septic resuscitation patients. This is why we propose the evaluation of the association between plasma zonulin and the loss of muscle mass in these resuscitation patients.

lead_sponsor: University Hospital, Rouen


title: Study of the QUadratus Lumborum Bloc in Total Hip ARthroplasty: Efficacy and Safety

acronym: SQUARE

summary: The purpose of this prospective research study is to determine the best way to manage post-operative pain after a total hip arthroplasty. Currently, there is no standard of care for managing post-operative pain in these patients. The quadratus lumborum block (QLB) first described by Blanco in 2007, is a promising technique in this indication: recently, there is a growing evidence for the use of the QLB as an alternative technique for pain management after hip surgery.

location_facility: Lapeyronie Teaching Hospital Montpellier


title: New Therapeutic Strategy Against Preeclampsia: Angiogenic Switch to Physiological State by Extracorporeal Removal of sFlt-1

acronym: APHERESE

summary: The aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sFlt-1

ReferenceCitation: Tsatsaris V, Goffin F, Munaut C, Brichant JF, Pignon MR, Noel A, Schaaps JP, Cabrol D, Frankenne F, Foidart JM. Overexpression of the soluble vascular endothelial growth factor receptor in preeclamptic patients: pathophysiological consequences. J Clin Endocrinol Metab. 2003 Nov;88(11):5555-63.

ReferenceCitation: Thadhani R, Hagmann H, Schaarschmidt W, Roth B, Cingoez T, Karumanchi SA, Wenger J, Lucchesi KJ, Tamez H, Lindner T, Fridman A, Thome U, Kribs A, Danner M, Hamacher S, Mallmann P, Stepan H, Benzing T. Removal of Soluble Fms-Like Tyrosine Kinase-1 by Dextran Sulfate Apheresis in Preeclampsia. J Am Soc Nephrol. 2016 Mar;27(3):903-13. doi: 10.1681/ASN.2015020157. Epub 2015 Sep 24.

ReferenceCitation: Levine RJ, Maynard SE, Qian C, Lim KH, England LJ, Yu KF, Schisterman EF, Thadhani R, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83. Epub 2004 Feb 5.

ReferenceType: result

ReferenceCitation: Trapiella-Alfonso L, Alexandre L, Fraichard C, Pons K, Dumas S, Huart L, Gaucher JF, Hebert-Schuster M, Guibourdenche J, Fournier T, Vidal M, Broutin I, Lecomte-Raclet L, Malaquin L, Descroix S, Tsatsaris V, Gagey-Eilstein N, Lecarpentier E. VEGF (Vascular Endothelial Growth Factor) Functionalized Magnetic Beads in a Microfluidic Device to Improve the Angiogenic Balance in Preeclampsia. Hypertension. 2019 Jul;74(1):145-153. doi: 10.1161/HYPERTENSIONAHA.118.12380. Epub 2019 May 13.

name: From the UMR 8638 (L.T.-A., K.P., L.H., M.V., N.G.-E.), CNRS, Université Paris Descartes, Faculté des Sciences Pharmaceutiques et Biologiques, Sorbonne Paris Cité, Paris, France

family: Trapiella-Alfonso

full_name: Laura Trapiella-Alfonso

given: Laura

sequence: first

name: UMR 168 CNRS Institut Curie, PSL Research University, Institut Pierre Gilles de Gennes, Paris, France (L.A., S.Dumas, S. Descroix.)

family: Alexandre

full_name: Lucile Alexandre

given: Lucile

name: Cochin Hospital, Assistance Publique-Hôpital de Paris, DHU Risques et grossesse, Paris Descartes University, INSERM UMR 1139, Fondation PremUp, Paris, France (C.F., M.H.-S., J.G., T.F., V.T.)

family: Fraichard

full_name: Camille Fraichard

given: Camille

name: Centre Hospitalier Intercommunal de Créteil, Service de Gynécologie Obstétrique, France (K.P., E.L.)

family: Pons

full_name: Kelly Pons

given: Kelly

family: Dumas

full_name: Simon Dumas

given: Simon

name: UMR 8038 (L.H., J.-F.G., I.B.), CNRS, Université Paris Descartes, Faculté des Sciences Pharmaceutiques et Biologiques, Sorbonne Paris Cité, Paris, France

family: Huart

full_name: Lucie Huart

given: Lucie

family: Gaucher

full_name: Jean-François Gaucher

given: Jean-François

name: Cochin Hospital, UF d’Hormonologie, Service de Biologie Automatisée, Paris, France (M.H.-S., J.G.)

family: Hebert-Schuster

full_name: Marylise Hebert-Schuster

given: Marylise

family: Guibourdenche

full_name: Jean Guibourdenche

given: Jean

family: Fournier

full_name: Thierry Fournier

given: Thierry

family: Vidal

full_name: Michel Vidal

given: Michel

family: Broutin

full_name: Isabelle Broutin

given: Isabelle

name: URC - CIC P1419, Cochin Hôtel-Dieu Hospital, Assistance Publique–Hôpitaux de Paris, France (L.L.-R.)

family: Lecomte-Raclet

full_name: Laurence Lecomte-Raclet

given: Laurence

family: Malaquin

full_name: Laurent Malaquin

given: Laurent

family: Descroix

full_name: Stéphanie Descroix

given: Stéphanie

family: Tsatsaris

full_name: Vassilis Tsatsaris

given: Vassilis

family: Gagey-Eilstein

full_name: Nathalie Gagey-Eilstein

given: Nathalie

name: Université Paris Est Créteil, France (E.L.)

name: INSERM, U955, Institut Mondor de Recherche Biomédicale, Créteil, France (E.L.)

family: Lecarpentier

full_name: Edouard Lecarpentier

given: Edouard

journal_name: Hypertension

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_normalized: HAL

publisher: Ovid Technologies (Wolters Kluwer Health)


lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: TIGER

type: EudraCT Number

source: euctr

title: Treatment of IgA Nephropathy According to Renal Lesions

summary:
TIGER study (Treatment of IgA nEphropathy according to Renal lesions) is a prospective openly randomized controlled study.

The main objective is to evaluate the efficacy of early corticotherapy + RAS blockade (versus RAS blockade alone) after two years of evolution in IgAN patients with severe histological lesions The study will include 122 IgAN patients, it is scheduled to start in september 2017.


title: Demonstration of the Diagnostic Character of the Rheology of Mucus

acronym: RhéMuc

summary:
This is a prospective study comparing 4 groups: (1) non-smoking controls, (2) smokers without chronic obstructive pulmonary disease (COPD), (3) smokers with COPD, (4) severe asthma.

Bronchial biopsy specimens from each subject will be obtained to produce air-liquid-interface cell cultures. These will then be used to make observations concerning cilia and mucus rheology.

This is a first pilot study. The working hypothesis is that the largest group differences will be found for cilia densities; the latter metric was thus chosen as a primary criterion.

location_facility: Centre Hospitalier Universitaire de Montpellier


ReferenceCitation: Czock D, Keller F, Rasche FM, Häussler U. Pharmacokinetics and pharmacodynamics of systemically administered glucocorticoids. Clin Pharmacokinet. 2005;44(1):61-98. Review.

ReferenceCitation: Sagcal-Gironella AC, Sherwin CM, Tirona RG, Rieder MJ, Brunner HI, Vinks AA. Pharmacokinetics of prednisolone at steady state in young patients with systemic lupus erythematosus on prednisone therapy: an open-label, single-dose study. Clin Ther. 2011 Oct;33(10):1524-36. doi: 10.1016/j.clinthera.2011.09.015. Epub 2011 Oct 7.

ReferenceCitation: Piotrowski P, Burzynski M, Lianeri M, Mostowska M, Wudarski M, Chwalinska-Sadowska H, Jagodzinski PP. Glucocorticoid receptor beta splice variant expression in patients with high and low activity of systemic lupus erythematosus. Folia Histochem Cytobiol. 2007;45(4):339-42.

ReferenceCitation: Du J, Li M, Zhang D, Zhu X, Zhang W, Gu W, Feng Y, Zhai X, Ling C. Flow cytometry analysis of glucocorticoid receptor expression and binding in steroid-sensitive and steroid-resistant patients with systemic lupus erythematosus. Arthritis Res Ther. 2009;11(4):R108. doi: 10.1186/ar2763. Epub 2009 Jul 14.

ReferenceCitation: Stahn C, Löwenberg M, Hommes DW, Buttgereit F. Molecular mechanisms of glucocorticoid action and selective glucocorticoid receptor agonists. Mol Cell Endocrinol. 2007 Sep 15;275(1-2):71-8. Epub 2007 Jun 2. Review.

ReferenceCitation: Derijk RH, de Kloet ER. Corticosteroid receptor polymorphisms: determinants of vulnerability and resilience. Eur J Pharmacol. 2008 Apr 7;583(2-3):303-11. doi: 10.1016/j.ejphar.2007.11.072. Epub 2008 Jan 30. Review.

ReferenceCitation: Mwinyi J, Wenger C, Eloranta JJ, Kullak-Ublick GA. Glucocorticoid receptor gene haplotype structure and steroid therapy outcome in IBD patients. World J Gastroenterol. 2010 Aug 21;16(31):3888-96.

ReferenceCitation: Nicolaides NC, Galata Z, Kino T, Chrousos GP, Charmandari E. The human glucocorticoid receptor: molecular basis of biologic function. Steroids. 2010 Jan;75(1):1-12. doi: 10.1016/j.steroids.2009.09.002. Epub 2009 Oct 7. Review.

ReferenceCitation: van Rossum EFC, van den Akker ELT. Glucocorticoid resistance. Endocr Dev. 2011;20:127-136. doi: 10.1159/000321234. Epub 2010 Dec 16. Review.

ReferenceCitation: Duru N, van der Goes MC, Jacobs JW, Andrews T, Boers M, Buttgereit F, Caeyers N, Cutolo M, Halliday S, Da Silva JA, Kirwan JR, Ray D, Rovensky J, Severijns G, Westhovens R, Bijlsma JW. EULAR evidence-based and consensus-based recommendations on the management of medium to high-dose glucocorticoid therapy in rheumatic diseases. Ann Rheum Dis. 2013 Dec;72(12):1905-13. doi: 10.1136/annrheumdis-2013-203249. Epub 2013 Jul 19.

ReferenceCitation: Luijten RK, Fritsch-Stork RD, Bijlsma JW, Derksen RH. The use of glucocorticoids in systemic lupus erythematosus. After 60 years still more an art than science. Autoimmun Rev. 2013 Mar;12(5):617-28. doi: 10.1016/j.autrev.2012.12.001. Epub 2012 Dec 8. Review.

ReferenceCitation: Fangtham M, Petri M. 2013 update: Hopkins lupus cohort. Curr Rheumatol Rep. 2013 Sep;15(9):360. doi: 10.1007/s11926-013-0360-0. Review.

ReferenceCitation: Zonana-Nacach A, Barr SG, Magder LS, Petri M. Damage in systemic lupus erythematosus and its association with corticosteroids. Arthritis Rheum. 2000 Aug;43(8):1801-8.

ReferenceCitation: Al Sawah S, Zhang X, Zhu B, Magder LS, Foster SA, Iikuni N, Petri M. Effect of corticosteroid use by dose on the risk of developing organ damage over time in systemic lupus erythematosus-the Hopkins Lupus Cohort. Lupus Sci Med. 2015 Mar 11;2(1):e000066. doi: 10.1136/lupus-2014-000066. eCollection 2015.

acronym: DECOR

title: Personalised Pharmacological Approach to the Tapering of Corticosteroid Doses in Systemic Lupus Patients Treated With Prednisone

summary: This research study is a multicentre prospective pharmacokinetic study. The clinical and biological data will be collected in the framework of a prospective study. The drug to be evaluated is a glucocorticoid routinely used to treat Systemic lupus erythematosus (SLE) patient. Initial dose of prednisone must be oral and at least 0.5mg/Kg/day, but the precise dosage and the tapering regimen will be determined according to the clinical judgment of the investigator. The duration of the research period for each patient will be 3 months. Three visits (which are all usual care visits) will be needed within the 3 months of the study for collecting data and/or blood sampling


title: Short-term Efficacy of a Single Ultrasound-guided Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis: a Randomized Controlled Double-blind Pilot Study

acronym: RHIBOT

summary: The primary purpose of this study is to determine whether a single ultrasound-guided intra-articular injection of botulinum toxin A associated to splinting is effective in reducing pain at 3 months in base-of-thumb osteoarthritis.

ReferenceCitation: Gil C, Abdoul H, Campagna R, Guerini H, Ieong E, Chagny F, Bedin C, Roren A, Lefèvre-Colau MM, Poiraudeau S, Feydy A, Rannou F, Nguyen C. Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT). BMJ Open. 2018 Jun 30;8(6):e022337. doi: 10.1136/bmjopen-2018-022337.

family: Gil

full_name: Charlotte Gil

given: Charlotte

family: Abdoul

full_name: Hendy Abdoul

given: Hendy

family: Campagna

full_name: Raphaël Campagna

given: Raphaël

family: Guerini

full_name: Henri Guerini

given: Henri

family: Ieong

full_name: Estelle Ieong

given: Estelle

family: Chagny

full_name: Franck Chagny

given: Franck

family: Bedin

full_name: Catherine Bedin

given: Catherine

family: Roren

full_name: Alexandra Roren

given: Alexandra

family: Lefèvre-Colau

full_name: Marie-Martine Lefèvre-Colau

given: Marie-Martine

family: Poiraudeau

full_name: Serge Poiraudeau

given: Serge

family: Feydy

full_name: Antoine Feydy

given: Antoine

family: Rannou

full_name: François Rannou

given: François

family: Nguyen

full_name: Christelle Nguyen

given: Christelle

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility: Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin


title: Cardiovascular Risk and Chronic Inflammatory Rheumatism

acronym: RCVRIC

summary: Chronic inflammatory rheumatism and inflammation can increase the risk of cardiovascular problems. Indeed, these diseases can increase the risk of myocardial infarction. The objective of this project is a better understanding and preventing the risk of cardiovascular problems in chronic inflammatory rheumatism through the study on the long-term flexibility of the arteries, blood markers of cardiovascular risk and muscle mass.


title: Intraventricular Fibrinolysis Versus External Ventricular Drainage Alone in Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial.

acronym: FIVHeMA

summary: Aneurysmal subarachnoid hemorrhage (SAH) is a devastating form of stroke, with delayed cerebral ischemia (DCI) as a major complication. There are several evidences, both in preclinical and in clinical studies that intraventricular fibrinolysis (IVF) controls the phenomenon that are leading to DCI. Here, the investigators propose to conduct a phase III trial to provide a clear evaluation of the impact of IVF after aneurysmal SAH.

ReferenceCitation: Etminan N, Beseoglu K, Eicker SO, Turowski B, Steiger HJ, Hänggi D. Prospective, randomized, open-label phase II trial on concomitant intraventricular fibrinolysis and low-frequency rotation after severe subarachnoid hemorrhage. Stroke. 2013 Aug;44(8):2162-8. doi: 10.1161/STROKEAHA.113.001790. Epub 2013 Jun 4.

ReferenceCitation: Goulay R, Flament J, Gauberti M, Naveau M, Pasquet N, Gakuba C, Emery E, Hantraye P, Vivien D, Aron-Badin R, Gaberel T. Subarachnoid Hemorrhage Severely Impairs Brain Parenchymal Cerebrospinal Fluid Circulation in Nonhuman Primate. Stroke. 2017 Aug;48(8):2301-2305. doi: 10.1161/STROKEAHA.117.017014. Epub 2017 May 19.

ReferenceCitation: Hanley DF, Lane K, McBee N, Ziai W, Tuhrim S, Lees KR, Dawson J, Gandhi D, Ullman N, Mould WA, Mayo SW, Mendelow AD, Gregson B, Butcher K, Vespa P, Wright DW, Kase CS, Carhuapoma JR, Keyl PM, Diener-West M, Muschelli J, Betz JF, Thompson CB, Sugar EA, Yenokyan G, Janis S, John S, Harnof S, Lopez GA, Aldrich EF, Harrigan MR, Ansari S, Jallo J, Caron JL, LeDoux D, Adeoye O, Zuccarello M, Adams HP Jr, Rosenblum M, Thompson RE, Awad IA; CLEAR III Investigators. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017 Feb 11;389(10069):603-611. doi: 10.1016/S0140-6736(16)32410-2. Epub 2017 Jan 10.

lead_sponsor: University Hospital, Caen


title: Feasibility of Opportunistic Salpingectomy at the Time of Vaginal Hysterectomy for Benign Pathology and Evaluation of Occult Tubal Lesions Prevalence: Preliminary Study

acronym: FPS

summary: In this prospective study, patients who underwent vaginal hysterectomy with salpingectomy or salpingo-oophorectomy were included. The objective of this study is to assess the feasibility of prophylactic salpingectomy during vaginal hysterectomy for benign pathology and the prevalence of occult tubal lesions. The hypothesis is that prophylactic salpingectomy during vaginal hysterectomy for benign pathology present a low failure rate and it makes it possible to avoid the appearance of a certain number of ovarian cancers. The prevalence of bilateral salpingectomy with or without ovariectomy and the prevalence of histopathological and immunohistochemical (p53 expression) abnormalities were evaluated.

lead_sponsor: Hospices Civils de Lyon


title: Exploratory Study of the Interest of MRI Susceptibility Weighted Imaging for the Pre-operative Assessment of Pelvic Endometriosis Extent

acronym: EndoSWI

summary: Knowledge of the precise location of endometriosis is essential for a successful surgical treatment. MRI Susceptibility-Weighted Imaging (SWI-MRI) yields high sensitivity for blood by-products detection. Since endometriosis lesions are haemorrhagic, and therefore rich in blood by-products such as hemosiderin, SWI-MRI could be useful in the pre-operative assessment of endometriosis, especially in superficial peritoneal lesion detection. The purpose of our study is to evaluate the performance of SWI-MRI for the preoperative work-up of endometriosis

ReferenceCitation: Saha R, Kuja-Halkola R, Tornvall P, Marions L. Reproductive and Lifestyle Factors Associated with Endometriosis in a Large Cross-Sectional Population Sample. J Womens Health (Larchmt). 2017 Feb;26(2):152-158. doi: 10.1089/jwh.2016.5795. Epub 2016 Sep 15.

ReferenceCitation: Olive DL, Schwartz LB. Endometriosis. N Engl J Med. 1993 Jun 17;328(24):1759-69. Review.

ReferenceCitation: Siegelman ES, Oliver ER. MR imaging of endometriosis: ten imaging pearls. Radiographics. 2012 Oct;32(6):1675-91. doi: 10.1148/rg.326125518.

ReferenceCitation: Fritzer N, Haas D, Oppelt P, Renner S, Hornung D, Wölfler M, Ulrich U, Fischerlehner G, Sillem M, Hudelist G. More than just bad sex: sexual dysfunction and distress in patients with endometriosis. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):392-6. doi: 10.1016/j.ejogrb.2013.04.001. Epub 2013 May 1.

ReferenceCitation: Chapron C, Dubuisson JB. Management of deep endometriosis. Ann N Y Acad Sci. 2001 Sep;943:276-80. Review.

ReferenceCitation: Benacerraf BR, Groszmann Y. Sonography should be the first imaging examination done to evaluate patients with suspected endometriosis. J Ultrasound Med. 2012 Apr;31(4):651-3.

ReferenceCitation: Holland TK, Cutner A, Saridogan E, Mavrelos D, Pateman K, Jurkovic D. Ultrasound mapping of pelvic endometriosis: does the location and number of lesions affect the diagnostic accuracy? A multicentre diagnostic accuracy study. BMC Womens Health. 2013 Oct 29;13:43. doi: 10.1186/1472-6874-13-43.

ReferenceCitation: Abrao et al. "Comparison between Clinical Examination, Transvaginal Sonography and Magnetic Resonance Imaging for the Diagnosis of Deep Endometriosis." Human Reproduction (Oxford, England) 22, no. 12 (December 2007). Bazot et al. "Diagnostic Accuracy of Physical Examination, Transvaginal Sonography, Rectal Endoscopic Sonography, and Magnetic Resonance Imaging to Diagnose Deep Infiltrating Endometriosis." Fertility and Sterility 92, no. 6 (December 2009). Bazot, M., N. Bharwani, C. Huchon, K. Kinkel, T. M. Cunha, A. Guerra, L. Manganaro, et al. "European Society of Urogenital Radiology (ESUR) Guidelines: MR Imaging of Pelvic Endometriosis." European Radiology, December 5, 2016

ReferenceCitation: Jarlot C, Anglade E, Paillocher N, Moreau D, Catala L, Aubé C. [MR imaging features of deep pelvic endometriosis: correlation with laparoscopy]. J Radiol. 2008 Nov;89(11 Pt 1):1745-54. French.

ReferenceCitation: Bazot M, Gasner A, Lafont C, Ballester M, Daraï E. Deep pelvic endometriosis: limited additional diagnostic value of postcontrast in comparison with conventional MR images. Eur J Radiol. 2011 Dec;80(3):e331-9. doi: 10.1016/j.ejrad.2010.12.006. Epub 2011 Jan 7.

ReferenceCitation: Siegelman ES, Outwater E, Wang T, Mitchell DG. Solid pelvic masses caused by endometriosis: MR imaging features. AJR Am J Roentgenol. 1994 Aug;163(2):357-61.

ReferenceCitation: Haacke EM, Mittal S, Wu Z, Neelavalli J, Cheng YC. Susceptibility-weighted imaging: technical aspects and clinical applications, part 1. AJNR Am J Neuroradiol. 2009 Jan;30(1):19-30. doi: 10.3174/ajnr.A1400. Epub 2008 Nov 27. Review.

ReferenceCitation: Nair JR, Van Hecke W, De Belder F, Venstermans C, van den Hauwe L, Van Goethem J, Parizel PM. High-resolution susceptibility-weighted imaging at 3 T with a 32-channel head coil: technique and clinical applications. AJR Am J Roentgenol. 2010 Oct;195(4):1007-14. doi: 10.2214/AJR.10.4218.

ReferenceCitation: Bai Y, Wang MY, Han YH, Dou SW, Lin Q, Guo Y, Li W, Ding DG, Dai JP, Qin W, Shi DP, Tian J, Dai YM. Susceptibility weighted imaging: a new tool in the diagnosis of prostate cancer and detection of prostatic calcification. PLoS One. 2013;8(1):e53237. doi: 10.1371/journal.pone.0053237. Epub 2013 Jan 7.

ReferenceCitation: Cimsit C, Yoldemir T, Guclu M, Akpinar IN. Susceptibility-weighted magnetic resonance imaging for the evaluation of deep infiltrating endometriosis: preliminary results. Acta Radiol. 2016 Jul;57(7):878-85. doi: 10.1177/0284185115602147. Epub 2015 Aug 27.

ReferenceCitation: Takeuchi M, Matsuzaki K, Harada M. Susceptibility-weighted MRI of extra-ovarian endometriosis: preliminary results. Abdom Imaging. 2015 Oct;40(7):2512-6. doi: 10.1007/s00261-015-0378-z.

ReferenceCitation: Takeuchi M, Matsuzaki K, Nishitani H. Susceptibility-weighted MRI of endometrioma: preliminary results. AJR Am J Roentgenol. 2008 Nov;191(5):1366-70. doi: 10.2214/AJR.07.3974.

ReferenceCitation: Solak A, Sahin N, Genç B, Sever AR, Genç M, Sivrikoz ON. Diagnostic value of susceptibility-weighted imaging of abdominal wall endometriomas during the cyclic menstrual changes: a preliminary study. Eur J Radiol. 2013 Sep;82(9):e411-6. doi: 10.1016/j.ejrad.2013.04.030. Epub 2013 Jun 10.

lead_sponsor: University Hospital, Bordeaux


title: Impact of a Nurse Implemented Sedation and Analgesia Algorithm on Complications of Critical Illness and Outcome of Surgical Intensive Care Patients

acronym: ALGOSEDA

summary: To show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of the environment. This, compared to the less frequent assessments by doctors and thus regular adjustments during the day as opposed to a fixed drug dose.


title: Sensitivity and Specificity of the AHA Post-exercise ABI Criteria

acronym: ExercisePAD

summary: The aim of this study was to evaluate exercise testing in case of patients suspected of Peripheral Artery Disease (PAD).

lead_sponsor: Rennes University Hospital


acronym: CHARGE

summary:
Clinical description of a French cohort of patients with CHARGE syndrome.
Search any phenotype-genotype correlation in typical, atypical or incomplete form of the syndrome
Using Next generation Sequencing, try to identify other genes involved in this syndrome, as the CHD7 gene is involved in only 40-60% of cases

location_facility: French Referent centers for developement abnomalies

intervention_type: Genetic


title: Evaluation of the Ambulatory Feasibility of Appendicectomy for Acute Appendicitis in Children 6 to 17 Years

summary: The investigators will conduct a monocentric prospective preliminary study evaluating the feasibility of appendectomy for simple acute appendicitis in a cohort of 6-17 year-old children presenting to the emergency department of the Hôpital Pédiatrique de Nice CHU-Lenval (Lenval Childre Hospital, Nice) on a Period of 1 year.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-LENVAL


title: Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur

acronym: ALGOFRACT

summary:
The fracture of the proximal femur is a common traumatic pathology in patients aged over 70 years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing antiescarres slippers. Mobilization, source of pain, is also problematic.

759/5000

lead_sponsor: University Hospital, Limoges


title: Comparison of the Hemodynamic Effect Between the Paravertebral Block and Thoracic Epidural in Esophageal Surgery With Thoracotomy .

acronym: HEMOBLOC

summary: Continuous Paravertebral block (PVB) was reported to provide less episodes of hypotension than continuous thoracic epidural block (TEB). The maintenance of optimal tissue perfusion is essential for esophageal anastomosis in patients undergoing oesophagectomy. the aim of this study is to compare Hemodynamic effect of continous PVB compared to TEB , in patient undergoing oesophagectomy with laparoscopy and thoracotomy.

ReferenceCitation: Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. Epub 2006 Feb 13. Review. Erratum in: Br J Anaesth. 2007 Nov;99(5):768.

lead_sponsor: University Hospital, Lille


title: Qualification of Ultrasound Imaging Technique in the Quantitative Evaluation of Cartilaginous Tissue of Femoral Condyle Articulation and Osteoarthritis

acronym: CARTILAGE

summary: This study investigates the potential of the ultrasound imaging technique to diagnose the severity of knee osteoarthritis (OA). In parallel, measurements will also be conducted using Magnetic Resonance Imaging (MRI) and histology analysis as reference tools.

location_facility: Orthopedic Surgery Department, University Hospital, Grenoble


title: Neurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults

acronym: PROSCEA

summary:
It is now widely accepted that autism is linked to a developmental disorder and cerebral function.

Our research team (UMR U930 INSERM, François-Rabelais University of Tours, whom Pr F Bonnet-Brilhault is responsible for team "Autism") hypothesizes that atypical sensory information processing, especially auditory and / or visual information, could underly the symptoms observed in autism. A better knowledge of the typical development of the sensory and cognitive processes must therefore make it possible in the long term to identify the abnormalities linked to the autism spectrum disorders (ASD).

Studies in healthy subjects are therefore necessary in order to identify neurophysiological indices of cerebral functioning and to study their evolution during normal development, making it possible in the future to compare with populations of subjects with ASD.

The investigators intend to study the development of all the cognitive processes involved in the processing of sensory and, in particular, auditory and visual information in humans: from low-level perception processes to higher-level cognitive processes (attention, emotion, language, prediction, ...). For this the investigators will use non-invasive neurophysiological explorations (EEG, eye tracking) as well as neuropsychological explorations (Questionnaires or spontaneous language recording).

A better understanding of the pathophysiological mechanisms underlying the symptoms observed in autism could ultimately lead to the development of new specific therapeutic strategies, particularly in the field of exchange and development therapy or cognitive remediation .

lead_sponsor: University Hospital, Tours


title: Evaluation du Dosage de l'Amylase Dans le Liquide Broncho Alveolaire Dans le Diagnostic précoce de la Pneumopathie d'Inhalation Infectieuse du Sujet Comateux intubé-ventilé.

acronym: KIDNAP

summary: To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.


title: Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain?

acronym: BoNT-A

summary: Studying the therapeutic effect of paravertebral injections of BoNT-A (botulinum toxin A) requires further studies to confirm the reported short-term therapeutic effect and to determine potential predictive factors of efficacy.

ReferenceCitation: Foster et al., 2001 and Machado et al., 2016

ReferenceCitation: Cogné M, Petit H, Creuzé A, Liguoro D, de Seze M. Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial. BMC Musculoskelet Disord. 2017 Nov 15;18(1):454. doi: 10.1186/s12891-017-1816-6.

family: Cogné

full_name: Mélanie Cogné

given: Mélanie

family: Petit

full_name: Hervé Petit

given: Hervé

family: Creuzé

full_name: Alexandre Creuzé

given: Alexandre

family: Liguoro

full_name: Dominique Liguoro

given: Dominique

family: de Seze

full_name: Mathieu de Seze

given: Mathieu

journal_name: BMC Musculoskeletal Disorders

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Evaluation of Magnetic Resonance Imaging Diffusion Tensor and Knee Cartilage Tractography Reconstructions for the Study of Early Osteoarthritis

acronym: TRACTILAGE

summary: The aim of this study is the evaluation of new MRI tractography maps for early knee osteoarthritis assessment.

location_facility: Orthopedic Surgery Department, University Hopital Grenoble Alpes


title: Evaluation of the Performances of the Cincinnati Prehospital Stroke Severity Scale Realized During Telephone Call With Emergency Department Physicians to Predict Large-vessel Occlusion

acronym: SCENE

summary: The effectiveness of acute ischemic stroke (AIS) management has improved considerably in recent years with thrombolysis and more recently with mechanical thrombectomy (MT). Currently, mechanical thrombectomy can only be performed in stroke unit with an interventional neuroradiology center by experienced/qualified interventional neuroradiologists. In the Rhone area, only one hospital has the authorization to perform mechanical thrombectomy. Therefore, transferring directly eligible acute ischemic stroke patients for mechanical thrombectomy to this center constitutes an important stake of the triage of suspected acute ischemic stroke patients. Some validated scores for the identification of severe strokes and large vessel occlusion, including the Cincinnati prehospital stroke severity scale (CPSSS), appear to be relevant for pre-hospital use in order to identify patients potentially eligible for mechanical thrombectomy and address them to a stoke unit with interventional radiology center.


title: Longitudinal Descriptive Study of the Correlation Between Cognitive Functions, White Matter Anatomical Pathways and Functional Magnetic Resonance Imaging Activations in Patients With Moderate to Severe Head Trauma.

summary: Longitudinal descriptive study of a cohort of twenty brain-damaged patients for a two years period.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Modeling Bronchial Epithelia Modifications Associated With Chronic Obstructive Pulmonary Disease (COPD) Using Induced Pluripotent Stemcells (iPS)

acronym: INVECCO

summary:
The primary objective of this study is to to verify the feasibility of obtaining and comparing two epithelia in two populations based on the following experiments:

Differentiation of an Induced Pluripotent Stem cell (iPS) clone derived from cutaneous biopsy in a population of heavy smokers (plus patients with chronic obstructive pulmonary disease) in order to obtain differentiated bronchial epithelia in vitro.
For each of these same patients, generation of bronchial epithelium in vitro from bronchial biopsy using human bronchial epithelial cells (HBECs) in air-liquid interface (ALI) cultures.

time_perspective: Cross-Sectional

ReferenceCitation: Ahmed E, Fieldes M, Mianné J, Bourguignon C, Nasri A, Vachier I, Assou S, Bourdin A, De Vos J. Generation of four severe early-onset chronic obstructive pulmonary disease (COPD) patient-derived induced pluripotent stem cell lines from peripheral blood mononuclear cells. Stem Cell Res. 2021 Oct;56:102550. doi: 10.1016/j.scr.2021.102550. Epub 2021 Sep 27.

family: Ahmed

full_name: Engi Ahmed

given: Engi

family: Fieldes

full_name: Mathieu Fieldes

family: Mianné

full_name: Joffrey Mianné

given: Joffrey

family: Bourguignon

full_name: Chloé Bourguignon

given: Chloé

family: Nasri

full_name: Amel Nasri

given: Amel

family: Vachier

full_name: Isabelle Vachier

given: Isabelle

family: Assou

full_name: Said Assou

given: Said

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: De Vos

full_name: John De Vos

given: John

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Stem Cell Research

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Fieldès M, Ahmed E, Bourguignon C, Mianné J, Vernisse C, Fort A, Vachier I, Bourdin A, Assou S, De Vos J. [Modelling the bronchial epithelium in chronic obstructive pulmonary disease using human induced pluripotential stem cells]. Rev Mal Respir. 2020 Mar;37(3):197-200. doi: 10.1016/j.rmr.2020.02.003. Epub 2020 Mar 4. Review. French.

family: Fieldès

full_name: M. Fieldès

given: M.

full_name: E. Ahmed

given: E.

full_name: C. Bourguignon

given: C.

full_name: J. Mianné

given: J.

family: Vernisse

full_name: C. Vernisse

family: Fort

full_name: A. Fort

given: A.

full_name: I. Vachier

given: I.

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

title: Modélisation de l’épithélium bronchique dans la bronchopneumopathie chronique obstructive par les cellules souches pluripotentes induites humaines


title: Vaccines Immunogenicity in Children Transplanted or Candidate for a Renal, Hepatic, Cardiac or Pulmonary Transplantation, Followed in the Rhône-Alpes Region. A Descriptive and Prospective Monocentric Cohort Study

acronym: COVAGREF

summary:
Thanks to improved surgical techniques, postoperative management and immunosuppressive therapies, an increasing number of children benefit from renal, hepatic, cardiac and pulmonary transplantation. Infection is a significant cause of mortality and morbidity in these patients, particularly due to vaccine-preventable diseases. Vaccination is one of the effective means of reducing infection-related mortality in these particularly vulnerable children. It is mostly well-tolerated, but all the more effective as it is performed early before transplantation, at best during a dedicated consultation, according to a vaccine scheme adapted to the immunocompromised child. In the almost constant absence of clinical efficacy data in populations of immunocompromised individuals, vaccine efficacy is most often indirectly estimated by immunogenicity, using protective correlates obtained by extrapolation in immunocompetent individuals.

Primary objective: To estimate the immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation, using serological titers measurements before and after a vaccine injection for: influenza, pneumococcus, chicken pox, measles, tetanus, hepatitis A and hepatitis B.

These serological titers will be compared to correlates of protection existing for each valency.

The evolution of serological titers will be described during the first year. The vaccination will be carried out within the routine care, according to the recommendations.

Secondary objectives:

describe and quantify the vaccination status of patients
describe the vaccination coverage of their entourage
evaluate the tolerance and efficacy of vaccines


title: Interest of a Systematic Assessment of the Treatment of Lower Urinary Tract Symptoms (LUTS) in the Management of Benign Prostatic Hyperplasia (BPH) in Urology

acronym: UROEVAL

summary: The high level of unsatisfactory outcome observed in patients treated for LUTS associated with BPH with respect to the different existing therapeutic options strongly emphasizes the need for treatment optimisation in daily practice by a careful LUTS monitoring and treatment adjustment when needed. The poorer outcome observed in patients for whom treatment has been initiated recently suggests that the duration of the disease itself may influence the patient satisfaction.To achieve this goal, we propose to systematically assess LUTS associated with BPH in patients treated for at least 6 months and to assess whether an alpha-blocker therapy initiation/modification may improve the outcome in case of persisting symptoms. We also investigate the influence of the symptom duration on the frequency of unsatisfactory outcome.

lead_sponsor: Laboratoires Bouchara-Recordati


title: Evaluation of the Interest of Ultra-high Frequency Doppler Ultrasound (UFDU) in the Surgical Management of Patients Operated in an Awake Condition for a Cerebral Tumor

summary:
In brain tumor surgery we are confronted mainly with two types of difficulties: (i) the identification of the tumor and its limitations in relation to the healthy brain; (ii) the identification of functional cerebral regions, ie implicated in neurological function (motor skills, sensitivity, language, vision, cognition, etc.). The reference method currently used to improve the quality of resection of brain tumors while minimizing neurological risk for patients is so called "wakeful" surgery with direct electrical stimulation (DES) of the brain. The investigators routinely use ultrasound to localize the tumor within the brain, but to date there is no pre- or intra-operative imaging tool to reliably identify tumors and functional brain regions. There is therefore a need for innovative imaging in this field.

For this reason, the investigators propose to evaluate the interest of a new High Frequence Ultrasound Doppler (HFUD) (VEVO ®, Visualsonics, Toronto, Canada) in the surgical management of patients operated in an awake condition for a brain tumor. The ultra high frequency allows to reach a spatial resolution of 30 μm, 5 to 10 times better than MRI and conventional ultrasound. The Doppler mode allows the detection of microvascular flows of speeds less than 1 mm / second. The safety of this device is demonstrated and validated by CE marking (December 2015).

ReferenceCitation: Almairac F, Fontaine D, Demarcy T, Delingette H, Beuil S, Raffaelli C. Motor cortex neurovascular coupling: inputs from ultra-high-frequency ultrasound imaging in humans. J Neurosurg. 2018 Nov 9:1-7. doi: 10.3171/2018.5.JNS18754. [Epub ahead of print]

family: Almairac

full_name: Fabien Almairac

given: Fabien

name: 2FHU INOVPAIN, CHU de Nice, Université Cote d’Azur, Nice; and

family: Fontaine

full_name: Denys Fontaine

given: Denys

name: 3Asclepios Research Team, INRIA Sophia Antipolis-Mediterranée, France

family: Demarcy

full_name: Thomas Demarcy

given: Thomas

family: Delingette

full_name: Hervé Delingette

given: Hervé

name: 4Ultra-Sound Imaging, CHU de Nice, Université Cote d’Azur, Nice;

family: Beuil

full_name: Stéphanie Beuil

given: Stéphanie

family: Raffaelli

full_name: Charles Raffaelli

given: Charles

journal_name: Journal of Neurosurgery

oa_host_type: publisher

publisher: Journal of Neurosurgery Publishing Group (JNSPG)

publisher_dissemination: American Association of Neurological Surgeons

title: Motor cortex neurovascular coupling: inputs from ultra–high-frequency ultrasound imaging in humans

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery

summary:
This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery.

To obtain a correct prospective clinical trial completion we have to begin a new series of inclusion.

lead_sponsor: Maison de Santé Prostestante de Bordeaux Bagatelle

location_facility: Maison de Santé Protestante de Bordeaux-Bagatelle


title: Teicoplanin-based Antimicrobial Therapy in Staphylococcus Aureus Bone and Joint Infection: Tolerance, Efficacy and Experience With Subcutaneous Administration

summary:
Staphylococci represent the first etiologic agents of bone and joint infection (BJI), leading glycopeptides use, especially in case of methicillin-resistance or betalactam intolerance. Teicoplanin may represent an alternative to vancomycin because of its acceptable bone penetration and possible subcutaneous administration. Various studies have shown that teicoplanin pharmacodynamic profile was superior compared to vancomycin regarding bone diffusion. Few studies have investigated the use of teicoplanin in BJI, particularly through subcutaneous administration.

The aim of this study assesses the efficacy and tolerance of teicoplanin in S. aureus BJI, especially focusing on subcutaneous use. This study is a retrospective single-center observational cohort study (2001 to 2011) including all consecutive patients managed at our institution receiving teicoplanin as part of S. aureus BJI treatment.

location_facility: Hospices Civils de Lyon - Hopital de la Croix Rousse - Centre de reference des infection ostéo-articulaires de Lyon


title: Pristinamycin in the Treatment of MSSA Bone and Joint Infection

summary:
Staphylococcus aureus represents the leading pathogen implicated in bone and joint infection (BJI), usually requiring prolonged combination antimicrobial therapy, which may be particularly challenging in the case of MDR bacteria and/or for patients with multiple drug intolerance. In the absence of new well-tolerated oral antistaphylococcal drugs, older antibiotics must be considered, such as the pristinamycin.

However, pristinamycin is not currently licensed for treatment of staphylococcal BJI and lack of clinical data prevents it from being considered as a reliable alternative therapeutic option in current guidelines.

The aim of this study is to evaluate pristinamycin (efficacy and tolerance) in the treatment of MSSA bone and joint infection (BJI).


title: Impact of the Continuous Measurement of Blood Glucose on Insulin Pump on Child Quality of Life With Type 1 Diabetes. A French Monocentric Prospective Study (IM-CAPT)

acronym: IM-CAPT

summary: The implementation of a sensor of glycemia Enlite coupled with an insulin pump (Medtronic Minimed 640G) is a therapeutic option that Hospital of Mulhouse can propose to the children affected by type 1 diabetes. The glycemic rate detected by the sensor of continuous measure of the glycemia is visible in real time on the pump and then the rate can be normalized. The study will evaluate the impact of the continuous measurement of blood glucose on insulin pump on child quality of life with type 1 diabetes aged 2 to 13 years old.

ReferenceCitation: Rewers MJ, Pillay K, de Beaufort C, Craig ME, Hanas R, Acerini CL, Maahs DM; International Society for Pediatric and Adolescent Diabetes. ISPAD Clinical Practice Consensus Guidelines 2014. Assessment and monitoring of glycemic control in children and adolescents with diabetes. Pediatr Diabetes. 2014 Sep;15 Suppl 20:102-14. doi: 10.1111/pedi.12190.

ReferenceCitation: Danne T, Tsioli C, Kordonouri O, Blaesig S, Remus K, Roy A, Keenan B, Lee SW, Kaufman FR. The PILGRIM study: in silico modeling of a predictive low glucose management system and feasibility in youth with type 1 diabetes during exercise. Diabetes Technol Ther. 2014 Jun;16(6):338-47. doi: 10.1089/dia.2013.0327. Epub 2014 Jan 21.

ReferenceCitation: Conget I, Choudhary P, Olsen BS et al. Prevention of hypoglycaemia by the predictive low glucose management feature in a user evaluation study. abstract #865

ReferenceCitation: Choudhary P, Olsen BS, Conget I, Welsh JB, Vorrink L, Shin JJ. Hypoglycemia Prevention and User Acceptance of an Insulin Pump System with Predictive Low Glucose Management. Diabetes Technol Ther. 2016 May;18(5):288-91. doi: 10.1089/dia.2015.0324. Epub 2016 Feb 23.

ReferenceCitation: Besbes H, Hammami S et al. SFP P-024 - Etude de la qualité de vie des enfants atteints de diabète de type 1 ; Archives de Pédiatrie Volume 21, Issue 5, Supplement 1, May 2014, Pages 734

ReferenceCitation: Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003 Mar;26(3):631-7.

ReferenceCitation: Institut de Veille Sanitaire. Prévalence et incidence du diabète / Données épidémiologiques / Diabète / Maladies chroniques et traumatismes / Dossiers thématiques / Accueil

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


title: Clinical and Biological Predictive Factors of Iron Deficiency Anemia in the Third Trimester of Pregnancy

acronym: IMAGE

summary:
Iron deficiency anemia is the leading cause of anemia during pregnancy, which can still reach 10 to 20% of pregnant women in developed countries, with potentially serious consequences for the child. Systematic iron supplementation remains controversial.

This study aims to identify in the first trimester of pregnancy clinical and biological predictive factors for the occurrence of iron deficiency anemia in the third trimester of pregnancy.


title: Evaluation of a Parent/Child Cognitive-Behaviorial Therapy Program in ADHD Children With Emotional Dysregulation Profile : a Study Prospective, Controlled and Randomized

acronym: DP-KID

summary:
Attention Deficit Disorder (ADD) with or without Hyperactivity/Impulsivity (ADHD) is a neurodevelopmental syndrome that has a lasting impact on the child's daily lifestyle and leads to functional impairment. ADHD is recognized as the most common psychiatry disorder in children and it's considered as a public health problem.

ADHD is frequently associated with a new diagnostic entity " Disruptive Disorder with Emotional dysregulation ". This disorder is characterized by crisis of anger with verbal or physical aggression, intensity disproportionate to the context and developmental age.

Few studies have examined the elements of emotional dysregulation in ADHD in children. Many studies have shown the interest of CBT in multimodal management of ADHD symptoms and associated disorders.

The main objective is to evaluate the effectiveness of a Cognitive-Behavioral Therapy Parent/Child program versus a body mediation focused on emotional and behaviorial aspects in ADD children aged 7-13 years with dimensional emotional dysregulation at 6 months after intervention. Secondary objectives are to evaluate the impact of this program, at short-term (at the end of CBT) and at 6 months after intervention, on socio-communicative capacities, quality of life, children's functioning and parental stress.

It's a biomedical research, prospective, controlled, randomized, monocentric, two parallels, with an evaluation of the criteria of blind judgment.

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier


title: Description of the Ability to Learn How to Handle Inhaler Devices in Asthma - AUDIT

acronym: AUDIT

summary: Asthma is a major public health problem. The main treatments against asthma are delivered to the lung through several dry-powder inhaler such as Turbuhaler ®, Diskus® and the new Ellipta® device. In real life, patient's ability to handle a device is not routinely assessed by their practitioner. We hypothesized that many asthmatics cannot properly prepare and prime their device, which may alter the positive effects observed in clinical trials.

study_start_date_type: Anticipated

status: Withdrawn


title: AVP Study: Autophagy and Pathological Aging Human Study in Osteoporosis With or Without Dementia of Alzheimer's Type

acronym: AVP

summary:
Autophagy is recognized as a central mechanism for the regulation of aging. . Osteoporosis (OA) and Alzheimer's disease (AD) are two forms of pathological aging, sometimes entangled, including an over-risk of OP in AD and degradation of cognitive functions after OP fracture, but the link between These two pathologies remain poorly understood.

The aim of this prospective pilot study is to evaluate the level of autophagy of osteocytes (OST) in postmenopausal women with OP and to explore the hypothesis that the defect of autophagy is one of the physiopathological links of the OP During the MA


title: Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients (SUPERSONIC)

acronym: SUPERSONIC

summary: Interventional study with minimal risks and constraints, prospective, mono-centric.


title: Evaluation of Academic and Professional Trajectories of Narcoleptic Patients

acronym: NARCOWORK

summary:
Narcolepsy is a chronic, disabling condition characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an important handicap in everyday life, and are often misunderstood by the family and professional environment. In addition, many comorbidities are associated with narcolepsy, such as depression, anxiety, or obesity.

Few studies have examined the impact of narcolepsy on patients' educational background, socio-professional integration, and quality of life. In particular, the factors of professional handicap related to the characteristics of the disease and the determinants of the insertion of the patients remain poorly known.

As a better understanding of these determinants could help to inform patients and guide them in their choices, NARCOWORK study aims at evaluating the academic and professional trajectories of a wide population of narcoleptic patients.

ReferenceCitation: White M, Charbotel B, Fort E, Bastuji H, Franco P, Putois B, Mazza S, Peter-Derex L. Academic and professional paths of narcoleptic patients: the Narcowork study. Sleep Med. 2020 Jan;65:96-104. doi: 10.1016/j.sleep.2019.07.020. Epub 2019 Aug 2.

family: White

full_name: M. White

family: Charbotel

full_name: B. Charbotel

given: B.

full_name: E. Fort

family: Bastuji

full_name: H. Bastuji

given: H.

family: Franco

full_name: P. Franco

given: P.

family: Putois

full_name: B. Putois

family: Mazza

full_name: S. Mazza

given: S.

family: Peter-Derex

full_name: L. Peter-Derex

given: L.

journal_name: Sleep Medicine

evidence: open (author manuscript)

version: acceptedVersion

location_facility: Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon


title: Quantification of Hepatic Fibrosis by IVIM Sequences in 1.5T MRI.

acronym: IVIM-MRI

summary: Quantification of hepatic fibrosis by IVIM sequences in 1.5T MRI.


title: Clinical, Biological and Genetic Determinants of Oral Anticoagulants' Activity

acronym: ANTIGOAG

summary:
The primary objective of the present study is to determine the clinical, biological and genetic determinants of the anticoagulant activity in patients treated with either anti-IIa or anti Xa oral anticoagulants.

The secondary objective is to determine the clinical, biological or genetic determinants of hemorrhagic or thrombotic complications during a one year follow-up.

Results will lead to a better prediction of both drug response and risk of complications.

status: Terminated


title: Skeletal Muscle Expression of Myostatin and Cancer of Digestive System Associated Cachexia(MYOCAC Study)

acronym: MYOCAC

summary: Cancer cachexia is responsible for the death of approximately 20% of patients. Myostatin is a master negative regulator of skeletal muscle mass. If the role of myostatin in cancer cachexia is now well established in murine models, no study has focused on muscle expression of Myostatin in relation to the degree of cachexia. the hypothesize is that muscle Myostatin a biological marker of cachexia in patients with cancer of digestive system. The main objective is to compare skeletal muscle Myostatin messenger RiboNucleic Acid (mRNA) level as a function of cachexia in cancer of digestive system patients. Myostatin messenger RiboNucleic Acid (mRNA) level will be determined in a muscle sample taken during the resection under general anaesthesia. Skeletal muscle index will be determined before surgery, 3 and 6 months after surgery. Muscle strength of the lower and upper limbs will be determined before resection, at 1 month, 3 months and 6 months postoperatively. Blood sampling will also be performed on these 4 occasions.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: In Vivo Evaluation of Growth and Risk of Rupture of Dilated Ascending Aorta Using 4D Cardiac Magnetic Resonance

summary: Ascending aorta aneurysmal disease is common and can be complicated by dissection or rupture. There is substantial variation in individual aneurysm progression: established risk factors for an accelerated aneurysm growth rate include initial size or localization, the presence of aortic valve disease, congenital bicuspid aortic valve or connective tissue disorders.


title: Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-Vascular Endothelial Growth Factor in Patients Treated With Proton Therapy for a Large Choroidal Melanoma

acronym: PROTECT

summary: The reference treatment of ocular melanoma is a conservative treatment by proton therapy. Its goal is to treat the tumor while preserving the eyeball and visual acuity. However, ablation of the eyeball is sometimes necessary after proton therapy in the case of neovascular glaucoma. This complication occurs in 7 to 47% of cases (depending on the size of the tumor) and is associated with hypersecretion of Vascular Endothelial Growth Factor (VEGF) related to necrotic and inflammatory tumor tissue after proton therapy or ischemic retina. The intravitreal injections of anti-VEGF are used in the treatment of neovascular radicular glaucoma without avoiding enucleation in all cases. The investigators propose to study the prevention of neovascular glaucoma by intravitreal prophylactic administration of anti-VEGF.

status: Not yet recruiting


title: Radiofrequency Technic's Impact on Perineal Postpartum Pain

summary:
A study in the postpartum period reveals that among women who delivered vaginally and having perineal lesions, between 95 and 100% of them suffer from perineal pain (episiotomy, tears from 1st to 4th degree) to 24 hours of vaginal delivery; and between 60 and 91% 7 days after delivery.

Severe pain that is not taken into account can become chronic pain. It has physical and psychological consequences. It is therefore essential to prevent these risks in young mothers.

The main objective of this study is to assess the efficacy of radiofrequency treatment on perineal pain postpartum, after a vaginal delivery, instrumented or not, in patients with perineal lesions.

A double-blind randomized prospective single-center study will be conducted on patients delivering at Marseille's north hospital.

Women who gave birth to the North hospital site, with perineal lesions (tears, episiotomy) will be invited to enroll in the study.

Patients will be then randomized into two groups, one with radiofrequency treatment, the other without treatment with radiofrequency.

The duration of inclusion is provided over 6 months. Each topic will be followed over a period of 1 month. The total study duration is 7 months.

The expected results are a significant reduction in pain scores during the first days postpartum in women with perineal alteration caused by a vaginal delivery instrumented or not. Also an improvement in the quality of life of patients during the first days.

ReferenceCitation: Bretelle F, Fabre C, Golka M, Pauly V, Roth B, Bechadergue V, Blanc J. Capacitive-resistive radiofrequency therapy to treat postpartum perineal pain: A randomized study. PLoS One. 2020 Apr 27;15(4):e0231869. doi: 10.1371/journal.pone.0231869. eCollection 2020.

family: Bretelle

full_name: Florence Bretelle

given: Florence

family: Fabre

full_name: Chantal Fabre

given: Chantal

family: Golka

full_name: Marine Golka

given: Marine

family: Pauly

full_name: Vanessa Pauly

given: Vanessa

family: Roth

full_name: Brimbelle Roth

given: Brimbelle

family: Bechadergue

full_name: Valérie Bechadergue

given: Valérie

family: Blanc

full_name: Julie Blanc

given: Julie

bso_classification: Chemistry

journal_name: PLOS ONE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories:
HAL
PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

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: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Masreille


title: Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up

acronym: VIRCH

summary: Flare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that requires the use of immunosuppressive therapies. In previous studies, the active role of cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex) together with that of CMV in colonic mucosa depending of the local inflammation (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to severe UC flare-up (Mayo score >6 with endoscopic score higher or equal than 2). The viral load will also be correlated to the Mayo endoscopic score and the response to immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).


title: Analysis of Volatile Organic Compounds in the Exhaled Air Breath of in Bilateral Lung Transplant Recipients Bi-pulmonary Transplant Patients: Search for Acute Rejection Markers

acronym: VOC-TP

summary: The aim of research is to identify markers of acute rejection by VOC analysis in exhaled breath of bilateral-lung transplanted patients. 120 bi-lung transplanted patients will be divided into two groups : patients with acute rejection diagnosed on transbronchial biopsies and patients with no acute rejection. Exhaled breath will be collected for VOC analysis woth electronic nose and mass spectrometry. VOC profiles will be compared between the two groups of patients.

lead_sponsor: Hopital Foch


title: Early Skin to Skin in Neonatal reanimation_Risk Assessment in the Newborn With an Umbilical Venous Catheter

summary:
In the reanimation neonatal department of the Nice's hospital, 34% of newborns admitted have an umbilical vein catheter (KTVO). Their parents are admitted 24h/24h by their side, where everything is done to set up the Attachment (participation in care, skin to skin, support of breastfeeding, ...).

The benefits of skin to skin described in developmental care of the newborn in the neonatal health services are well established. Nevertheless, for supposed risks (infectious and displacement of the catheter), registered in the memory of the teams, this care is not currently carried out when the newborns are carrying an umbilical venous catheter.

Sometimes, because of the presence of an umbilical venous catheter, parents and their newborns could not enjoy this moment of well-being in the first days of life. We therefore propose a study evaluating the current risks of skin to skin with an umbilical venous catheter by reflecting on a new protocol for laying and fixing this medical device.


title: Personal Lifestyle Assistant for Better Health Through Nutrition : Cook to Health Study

summary: Unhealthy lifestyles are major factors contributing to chronic conditions that impose a huge financial burden in EU healthcare systems. Unfortunately, the communication of Public Health failed to influence consumer to change their habits. In this study, the aim is to evaluate the impact of a regular monitoring during 1 year on wellbeing and dietary habits in healthy volunteers.

lead_sponsor: University Hospital, Grenoble


title: "Cook to Health 2" : Monitoring Wellbeing and Health in the Community

summary:
Unhealthy lifestyles are major factors contributing to chronic conditions that impose a huge financial burden in EU healthcare systems. Unfortunately, the communication of Public Health failed to influence consumer to change their habits.

In this study, the aim is to evaluate the impact of a regular monitoring during 1 year on wellbeing and dietary habits in healthy volunteers.

This study follows the pilot study "cook to health" and is intended to confirm the results obtained by the tools used in C2H, in a larger population (25-50 years)

ReferenceCitation: Hood L, Auffray C. Participatory medicine: a driving force for revolutionizing healthcare. Genome Med. 2013 Dec 23;5(12):110. doi: 10.1186/gm514. eCollection 2013.

ReferenceCitation: Hood L, Flores M. A personal view on systems medicine and the emergence of proactive P4 medicine: predictive, preventive, personalized and participatory. N Biotechnol. 2012 Sep 15;29(6):613-24. doi: 10.1016/j.nbt.2012.03.004. Epub 2012 Mar 18.

ReferenceCitation: Hood L, Price ND. Demystifying disease, democratizing health care. Sci Transl Med. 2014 Feb 26;6(225):225ed5. doi: 10.1126/scitranslmed.3008665.

ReferenceCitation: Dzau VJ, Ginsburg GS, Van Nuys K, Agus D, Goldman D. Aligning incentives to fulfil the promise of personalised medicine. Lancet. 2015 May 23;385(9982):2118-9. doi: 10.1016/S0140-6736(15)60722-X. Epub 2015 May 6. Erratum in: Lancet. 2015 Jun 27;385(9987):2576.

ReferenceCitation: Kramer CK. Weight loss is a useful therapeutic objective. Can J Cardiol. 2015 Feb;31(2):211-5. doi: 10.1016/j.cjca.2014.08.003. Epub 2014 Aug 14. Review.

ReferenceCitation: Scalbert A, Brennan L, Manach C, Andres-Lacueva C, Dragsted LO, Draper J, Rappaport SM, van der Hooft JJ, Wishart DS. The food metabolome: a window over dietary exposure. Am J Clin Nutr. 2014 Jun;99(6):1286-308. doi: 10.3945/ajcn.113.076133. Epub 2014 Apr 23. Review.

ReferenceCitation: Chiuve SE, Fung TT, Rimm EB, Hu FB, McCullough ML, Wang M, Stampfer MJ, Willett WC. Alternative dietary indices both strongly predict risk of chronic disease. J Nutr. 2012 Jun;142(6):1009-18. doi: 10.3945/jn.111.157222. Epub 2012 Apr 18.

ReferenceCitation: Gooding HC, Shay CM, Ning H, Gillman MW, Chiuve SE, Reis JP, Allen NB, Lloyd-Jones DM. Optimal Lifestyle Components in Young Adulthood Are Associated With Maintaining the Ideal Cardiovascular Health Profile Into Middle Age. J Am Heart Assoc. 2015 Oct 29;4(11). pii: e002048. doi: 10.1161/JAHA.115.002048.


title: Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)

acronym: NEUROMOD

summary:
The main objective of this study is to estimate the effect of the neuromodulation on the behavioral performances during the access in semantics according to the age of the individuals.

Neuromodulation by non-invasive stimulation allows to explore the functioning of the brain by exciting or by inhibiting localized cortical zones. The modulation of the performances in cognitive tasks, further to the neuromodulation of these zones, allows to deduce on their functional roles.

ReferenceCitation: Monti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. Transcranial direct current stimulation (tDCS) and language. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):832-42. doi: 10.1136/jnnp-2012-302825. Epub 2012 Nov 8. Review.

ReferenceCitation: Liuzzi G, Freundlieb N, Ridder V, Hoppe J, Heise K, Zimerman M, Dobel C, Enriquez-Geppert S, Gerloff C, Zwitserlood P, Hummel FC. The involvement of the left motor cortex in learning of a novel action word lexicon. Curr Biol. 2010 Oct 12;20(19):1745-51. doi: 10.1016/j.cub.2010.08.034. Epub 2010 Sep 30.

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