title: Mitochondrial Activity and Myosteatosis in the Cachexia of Cancers of the Upper Aerodigestive Tract

acronym: MYOMEC

summary:
Loss of muscle mass (scientific term: cachexia) affects about 80% of patients with advanced cancer and impacts their prognosis by decreasing tolerance and response to treatment, decreasing quality of life and survival. The prognosis in these patients depends directly on the importance of the loss of muscle mass. Preserving it is therefore an essential therapeutic objective. It is therefore important to understand perfectly the mechanism of this muscular loss. The accumulation of fat in the muscle (scientific term: myosteatosis) could be a mechanism responsible for this loss of muscle mass. It is indeed a hypothesis proved on animal models. Moreover, it has recently been shown that more the cancer patient loses weight, more his muscle contains fat. This lets think that this deposit of fat in the muscle would be directly related to the loss of muscle mass. All of these observations could not be clearly established in humans and investigators are seeking by this study to illuminate these mechanisms at the human level. A better understanding of these mechanisms would allow investigator to set up targeted treatments against the accumulation of fat in the muscle, which would significantly improve the quality of life of patients with cancer of the aerodigestive pathways and their chances of recovery.

The MYOMEC study includes the inclusion of healthy patients (to form a control group) but also patients with cancer of the upper aero-digestive tract. The study will be divided into two parts: clinical examination and nutritional evaluation the day before surgery at the time of the participants' admission to hospital and then the biological samples during surgery. The nutritional examination consists in collecting the morphological data of the patient, namely:

Its weight, size, calculation of the body mass index Tests of muscular strength (wearing weight of 1, 2 and 3 kilos) Measurement of the percentage of fat mass and lean mass (Impedancemetry)

In this study, participants benefit from the following investigations:

Clinical examination complete with elaboration of the clinical nutritional status, realized the day before the surgical intervention in hospitalization.
Elaboration of the radiological nutritional status by a complementary analysis of the scanner envisaged in the balance of extension of the disease
Performing surgical site sampling during surgery without additional invasive procedure and under general anesthesia. It will be realized:

A muscle biopsy of the sterno-cleido-mastoid muscle (neck muscle) (maximum volume 5 mm3), A tumor biopsy (maximum volume 5mm3). A blood sample (maximum volume 5ml)

No invasive procedure, supplemental examination or additional consultation is required for the whole off-set study for the extensive muscular percutaneous biopsy regarding which additional patient agreement will be required. No additional follow-up is required when participating in this study. Participation in this study does not entail any particular constraint or additional treatment. The duration of the patient's participation is defined as follows: from the date of the preoperative consultation or from the consultation of announcement until his / her discharge from hospital. The exclusion period defined in this study extends from the date of inclusion of the patient to the date of the surgical procedure, during which time the patient can not participate in another clinical research protocol.

intervention_type: Procedure


type: Other Identifier

title: CT Evaluation of Cardiovascular Risk Markers in Obese Patients

acronym: RisqOScan

summary:
Obesity is a chronic metabolic disorder : it leads to coronary heart disease and early atherosclerosis.

Coronary artery calcium measured by CT is known as a robust predictor to predict risk for cardiac events in symptomatic and asymptomatic individuals. Furthermore, recent studies show that other CT risk factor exists, independent of calcium scoring, such as epicardial fat, intrathoracic fat and visceral fat.

The aim of this prospective study is to evaluate these new cardiovascular risk markers in obese patients, using standard dose CT and low dose CT with adaptative statistical iterative reconstruction.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle

acronym: RIVAFAG

summary: Atrial fibrillation (AF) is a frequent heart rhythm disorder, responsible for the formation of cardiac thrombi, which can embolize in the systemic circulation, responsible for strokes (Cerebrovascular accidents). AF increases the risk of stroke and stroke-related disability. Preventing the thromboembolic risk associated with FMD is therefore a public health issue. The reference treatment is oral anticoagulation but this treatment is contraindicated in patients with a history of intracranial hemorrhage. The percutaneous closure of the auricle is a recent technique which makes it possible to exclude this appendix from the left atrium where the majority of thrombi are formed in the framework of the AF. Comparative studies have shown the effectiveness of this technique, appearing to be similar to that of anticoagulation. However, in view of the per-procedural risk, the indication of closure was retained by the health authorities only in the event of a contraindication to oral anticoagulants in patients with non-valvular AF with a high thromboembolic risk. Patients with a history of intracranial hemorrhage are therefore candidates for this technique, but there are few studies where these patients were included. The risk-benefit must be demonstrated over the long term, in terms of ischemic, hemorrhagic recurrence and becoming functional and cognitive.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Screening

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Diagnostic Test

status_simplified: Completed


title: Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis, With Analysis of CD4 + Follicular Helper T Subpopulations

acronym: PROMETHEE

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

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Rennes University Hospital


title: Connectome Characterization With Aging Using Functional and Structural MRI

acronym: AGE-CONNECT

summary: The main aim of this project is to develop a new model to characterize brain connectivity and its changes with aging. This characterization will be based on new sensitive and specific markers, allowing a better understanding of structural and functional brain networks. To this end, two complementary MRI methods will be developed: 1) Resting-state functional MRI (rs-fMRI) which allows the measurement of cerebral activity in different cortical gray matter regions, and 2) high angular resolution diffusion imaging (HARDI) MRI, which allows to characterize brain tissue microarchitecture. HARDI sequences will be developed to acquire and reconstruct fiber tractography of patient's brains. In combination with conventional MRI, both HARDI and rs-fMRI will be used to estimate the connection degree between each pair of cortical regions, so- called "Connectome". Once generated, brain networks will be quantified through numerous graph metrics, such as graph density, global efficiency and assortativity (etc.), reflecting the organization and topology of subjects' connectivity with aging.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon


type: EudraCT Number

title: A Phase I of Olaparib With Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (Triple Negative Breast Cancer) or Patient With Operated TNBC With Residual Disease

acronym: RadioPARP

summary: A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC with Residual Disease.

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Loap P, Loirat D, Berger F, Rodrigues M, Bazire L, Pierga JY, Vincent-Salomon A, Laki F, Boudali L, Raizonville L, Mosseri V, Jochem A, Eeckhoutte A, Diallo M, Stern MH, Fourquet A, Kirova Y. Concurrent Olaparib and Radiotherapy in Patients With Triple-Negative Breast Cancer: The Phase 1 Olaparib and Radiation Therapy for Triple-Negative Breast Cancer Trial. JAMA Oncol. 2022 Oct 27. doi: 10.1001/jamaoncol.2022.5074. Online ahead of print.

ReferenceCitation: Loap P, Loirat D, Berger F, Ricci F, Vincent-Salomon A, Ezzili C, Mosseri V, Fourquet A, Ezzalfani M, Kirova Y. Combination of Olaparib and Radiation Therapy for Triple Negative Breast Cancer: Preliminary Results of the RADIOPARP Phase 1 Trial. Int J Radiat Oncol Biol Phys. 2021 Feb 1;109(2):436-440. doi: 10.1016/j.ijrobp.2020.09.032. Epub 2020 Sep 21.

lead_sponsor: Institut Curie

intervention_type: Radiation


title: Build-up of Action Representation During Neurodevelopment: Dysfunctions in Autism Spectrum Disorders?

acronym: ASD-BARN

summary:
Autistic spectrum disorders (ASD) are highly debilitating developmental syndromes which core feature is social and communications disorders. Motor skill impairments are frequently described in autism, but few studies have addressed the question of their origin and their specificity. Furthermore, it is not clear whether motor problems encountered in autism are related to dyspraxia, or if they present with specific features. This project aims at deciphering the origin of motor problems encountered by children who grow-up with autism in order to propose early interventions that could influence the other developmental trajectories, such as the social one.

Brain dynamics during sensori-motor learning is explored by applying magnetoencephalography (MEG) during the Bimanual Load-Lifting paradigm. Different motor processes namely: proprioceptive monitoring, use and update of a sensori-motor representation, anticipatory executive control will be correlated to brain oscillation modulation, both topographically and temporally. Two groups of children (aged between 7 and 12) are compared: a group of children with ASD and a control group of typically developing children.


title: Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation

acronym: PrevAsPI-Obs

summary: Inhalation pneumonia (PI) is common in clinical practice but is rarely studied. For example, there are no data on the incidence of pneumonia after inhalation and risk factors or protective factors to develop one since it is known that anyone who inhaled does not necessarily develop an IP. There is no data on the benefit of treating inhalation by antibiotic therapy pre-emptively although this practice is common. In this context, this observational study wishes to take stock of the situation on the subject in order to determine what actions to implement to prevent IP.

time_perspective: Prospective


title: Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation

acronym: PPROM

summary:
Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal membranes prior to 37 weeks' gestation. PPROM complicates 2-4% of all pregnancies and accounts for approximately 30 % of preterm births.

The etiology of PPROM remains elusive. PPROM is one of the main causes of prematurity and its complications, such as newborn respiratory distress syndrome, neonatal sepsis, necrotizing enterocolitis, intraventricular hemorrhage, perventricular leucomalacia, varying degrees of lung hypoplasia and bronchopulmonary dysplasia. All these factors contribute greatly to an increase in neonatal morbidity and mortality Management of PPROM followed actual guidelines. Conservative management to prolong a pregnancy is a classical approach to treat PPROM before 34 weeks' gestation in association with antibiotic therapy and corticosteroids.

Maternal and neonatal data were collected from maternal and newborns medical records.

time_perspective: Retrospective


title: Evaluation of the Interest and Tolerance of a Photoprotection Strategy in Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment Associated or Not With Cobimetinib

summary:
Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.

Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.

These treatments are associated with a lot of adverse reactions, which may lead to dose reduction, temporary interruption or discontinuation of treatment, which often leads to treatment failure or a decrease in treatment compliance.

The most commonly reported adverse reactions (> 30%) with Vemurafenib are arthralgia, rash, photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse events (> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia, photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate aminotransferase, blood creatine phosphokinase elevation and vomiting.

The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in combination with Cobimetinib is very common (≥ 1/10) according to MedDRA.

The use of optimal photoprotection including the repeated daily use of external photoprotection products is currently recommended for all patients receiving treatment with vemurafenib or with the combination of vemurafenib and cobimetinib.

primary_purpose: Prevention

lead_sponsor: Michele Sayag

lead_sponsor_type: industriel


title: Multicenter Pilot Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy

summary: The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

primary_purpose: Supportive Care

lead_sponsor: BBraun Medical SAS

intervention_type: Device


title: Therapeutic Implications of Early Transesophageal Echocardiography in Embolic Stroke of Undetermined Source (ESUS)

acronym: ETO

summary:
The ESUS concept was introduced recently to describe a non-lacunar stroke of undetermined etiology. The following etiological workup is required in this setting: head CT or MRI, 12-lead ECG, transthoracic echocardiography, continuous cardiac monitoring for at least 24 hours after stroke, vascular imaging (ultrasound, magnetic resonance angiography, CT angiography, catheter angiography). Transesophageal echocardiography (TEE) is considered not to be required.

However, aortic arch atheroma as diagnosed by TEE in the setting of recent ischemic stroke is a major aortic source of embolism, as supported by numerous well conducted studies. The European Association of Echocardiography considers that TEE is the gold standard for the diagnosis and the characterization of aortic atheroma. It is also the method of choice for the diagnosis of infectious endocarditis.

The aim of this work was to evaluate the rate of patients with a therapeutic modification induced by TEE (mainly anticoagulation and surgery), in consecutive patients admitted with ESUS at our institution stroke unit.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A de Rothschild


title: Comparison of the Predictive and Prognostic Value of Cellular Dysoxia Markers in the Postoperative Period of Cardiac Surgery With Extracorporeal Circulation

summary: The study consist of evaluation in cardiac surgery with cardiopulmonary bypass (CPB) setting the ability of PCO2 derived variables (ΔPCO2, ΔPCO2/C(a-v)O2 ratio), compared to lactate and ScVO2 to predict major postoperative adverse events.

ReferenceType: result

ReferenceCitation: Shahbazi S, Khademi S, Shafa M, Joybar R, Hadibarhaghtalab M, Sahmeddini MA. Serum Lactate Is not Correlated with Mixed or Central Venous Oxygen Saturation for Detecting Tissue Hypo Perfusion During Coronary Artery Bypass Graft Surgery: A Prospective Observational Study. Int Cardiovasc Res J. 2013 Dec;7(4):130-4. Epub 2013 Dec 1.

ReferenceCitation: Laine GA, Hu BY, Wang S, Thomas Solis R, Reul GJ Jr. Isolated high lactate or low central venous oxygen saturation after cardiac surgery and association with outcome. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1271-6. doi: 10.1053/j.jvca.2013.02.031. Epub 2013 Sep 5.

ReferenceCitation: Balzer F, Sander M, Simon M, Spies C, Habicher M, Treskatsch S, Mezger V, Schirmer U, Heringlake M, Wernecke KD, Grubitzsch H, von Heymann C. High central venous saturation after cardiac surgery is associated with increased organ failure and long-term mortality: an observational cross-sectional study. Crit Care. 2015 Apr 16;19:168. doi: 10.1186/s13054-015-0889-6.

ReferenceCitation: Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O₂ saturation and venous-to-arterial CO₂ difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. Epub 2010 Oct 29.

ReferenceCitation: Gasparovic H, Gabelica R, Ostojic Z, Kopjar T, Petricevic M, Ivancan V, Biocina B. Diagnostic accuracy of central venous saturation in estimating mixed venous saturation is proportional to cardiac performance among cardiac surgical patients. J Crit Care. 2014 Oct;29(5):828-34. doi: 10.1016/j.jcrc.2014.04.012. Epub 2014 Apr 26.

ReferenceCitation: Robin E, Futier E, Pires O, Fleyfel M, Tavernier B, Lebuffe G, Vallet B. Central venous-to-arterial carbon dioxide difference as a prognostic tool in high-risk surgical patients. Crit Care. 2015 May 13;19:227. doi: 10.1186/s13054-015-0917-6.

ReferenceCitation: Ospina-Tascón GA, Umaña M, Bermúdez W, Bautista-Rincón DF, Hernandez G, Bruhn A, Granados M, Salazar B, Arango-Dávila C, De Backer D. Combination of arterial lactate levels and venous-arterial CO2 to arterial-venous O 2 content difference ratio as markers of resuscitation in patients with septic shock. Intensive Care Med. 2015 May;41(5):796-805. doi: 10.1007/s00134-015-3720-6. Epub 2015 Mar 20.

ReferenceCitation: Mallat J, Lemyze M, Meddour M, Pepy F, Gasan G, Barrailler S, Durville E, Temime J, Vangrunderbeeck N, Tronchon L, Vallet B, Thevenin D. Ratios of central venous-to-arterial carbon dioxide content or tension to arteriovenous oxygen content are better markers of global anaerobic metabolism than lactate in septic shock patients. Ann Intensive Care. 2016 Dec;6(1):10. doi: 10.1186/s13613-016-0110-3. Epub 2016 Feb 3.

ReferenceCitation: Moussa MD, Durand A, Leroy G, Vincent L, Lamer A, Gantois G, Joulin O, Ait-Ouarab S, Deblauwe D, Caroline B, Decoene C, Vincentelli A, Vallet B, Labreuche J, Kipnis E, Robin E. Central venous-to-arterial PCO2 difference, arteriovenous oxygen content and outcome after adult cardiac surgery with cardiopulmonary bypass: A prospective observational study. Eur J Anaesthesiol. 2019 Apr;36(4):279-289. doi: 10.1097/EJA.0000000000000949.

lead_sponsor: University Hospital, Lille

location_facility: Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille


title: Investigation of the Links Between Waking-life and Dream Content in the Case of the Death of a Close Relative

acronym: DreamDeath

summary: The aim of the study is to investigate a possible role of dreaming in emotion regulation testing whether dreaming of a close relative recently deceased is correlated with a positive evolution of the bereavement process

status: Recruiting

location_facility: Hospices Civils de Lyon Hôpital le Vinatier/Inserm

intervention_type: Behavioral

status_simplified: Ongoing


title: Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease

acronym: NT-pro-MICI

summary:
NT-proBNP is a major diagnostic and prognostic marker in cardiology, but it is also a new marker for biological inflammation, especially in rheumatology.

Its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study, the OPERA study where in a population of 12 patients showed an increase in NT-proBNP correlated with the biological and endoscopic activity of the disease. This larger study is therefore a pilot study that could see NTproBNP as a new biomarker of inflammation in MICI.

status: Terminated


title: Association Between Trend in Length of Stay and Risk of Readmission at Hospital After Surgery

acronym: ELIPSE

summary: Medical and surgical innovations have allowed to shorter length of hospital stay (LOS). We assume that hospitals with uncontrolled reduction in LOS may expose patients to unsafe care. At the institutional level, a dynamic analysis of LOS evolution over time could clarify the existence of a link with the risk of readmission.

location_facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon


title: Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis

acronym: METHO-PR

summary:
Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence of this treatment decreases the control of the disease and the effectiveness of the associated treatments.

The aim would be to study the observance of patients with RA and to be able to propose adequate solutions favoring patient compliance and thus the stability of the pathology.

For this purpose, 3 methods of communication have been put in place to encourage adherence: usual care by the rheumatologist, sms sending or pharmaceutical maintenance.

design_allocation: Randomized

ReferenceCitation: Mary A, Boursier A, Desailly Henry I, Grados F, Séjourné A, Salomon S, Fardellone P, Brazier M, Goëb V. Mobile Phone Text Messages and Effect on Treatment Adherence in Patients Taking Methotrexate for Rheumatoid Arthritis: A Randomized Pilot Study. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1344-1352. doi: 10.1002/acr.23750.


title: Development of an in Vitro Hematopoietic Culture System and Application to Myelodysplastic Syndromes.

acronym: HEMASTEM

summary: Myelodysplastic syndromes (MDS) are myeloid hemopathies characterized by ineffective clonal haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid leukemias. Their diagnosis involves a cytological evaluation of the medulla, while their prognosis, in addition to extrinsic factors depending on the patient himself (age, comorbidities), intrinsic factors. The cytological evaluation is subject to a certain subjectivity since qualitative and the diagnosis is sometimes difficult in the absence of marker of clonality. More and more studies emphasize the interest of flow cytometry (CMF) in the diagnosis of SMD: by looking for qualitative and / or quantitative aberrations of the expression of membrane markers, CMF allows to establish scores Diagnosis that we have put in place within the laboratory. However, these studies are based on a static model that studies the phenotypic characteristics of patients at a given time but does not really reflect ineffective hematopoiesis. A dynamic model for in vitro reproduction of hematopoiesis would be an innovative tool for the study of SMD. This project aims to develop and standardize a system of differentiation in liquid medium of hematopoietic stem cells (CSH) in mature cells by studying each stage of the differentiation in terms of proliferation, apoptosis and phenotypic expression. HSCs will be obtained by CD34 + sorting from the medullary sample at diagnosis: the investigator will study cell proliferation, apoptosis and the acquisition of surface markers, in order to identify the quantitative and qualitative abnormalities associated with the differentiation of haematopoietic progenitors Smart. This should make it possible to identify diagnostic and prognostic factors in terms of response to treatment, acutism and survival.


title: The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.

summary:
There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25% according to the studies.

Age is the main risk of OCDD. The management of this pathology should be early to avoid loss of autonomy of the patient. Finding a relationship, if it exists, would therefore significantly improve the mortality and morbidity of the said patient.


title: PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "

acronym: PREOPTI-POOP

summary: Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients

ReferenceCitation: Vourc'h M, Baud G, Feuillet F, Blanchard C, Mirallie E, Guitton C, Jaber S, Asehnoune K. High-flow Nasal Cannulae Versus Non-invasive Ventilation for Preoxygenation of Obese Patients: The PREOPTIPOP Randomized Trial. EClinicalMedicine. 2019 Jun 5;13:112-119. doi: 10.1016/j.eclinm.2019.05.014. eCollection 2019 Aug.

lead_sponsor: Nantes University Hospital

location_facility: Nantes University Hospital, Hôtel Dieu, Medical intensive care unit


title: Intérêt de l'électroporation irréversible Dans le Traitement de l'adénocarcinome du pancréas

summary: The aim of the study is to evaluate the use of irreversible electroporation in the treatment of locally advanced cancers of the head of pancreas with vascular spread. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.

lead_sponsor: Poitiers University Hospital


title: Etude INCIPAVE: INCidence Des Pneumopathies Acquises Sous Ventilation Chez l'Enfant

acronym: INCIPAVE

summary:
Rationale : ventilator associated pneumonia (VAP) has been extensively studied in adults, however, few data exist regarding VAP in the paediatric intensive care population. The Centers for Disease Control (CDC) definition for VAP is regularly updated trying to homogenised practice, and the last version for paediatrics has been published in 2015. According to the latest CDC definition, the investigators aim to study incidence of VAP in different paediatric intensive care units (PICUs), diagnostic methods of identifying VAP, microbiology of VAP, and utilisation of empirical antimicrobial therapy.

Methods and population : a prospective multicentre observational study will be conducted in European PICUs for one year. All patients admitted to PICU aged more than 28 days and < 18 years, mechanically ventilated either by endotracheal or tracheostomy tube are included. Clinical data, ventilation settings, and risk factors for VAP are inserted daily in an electronic database on the internet. The investigators are going to identify patients, who presented one or more episodes of VAP during PICUs stay, analysing onset circumstances, diagnostic methods, bacteria pathogens identified, and antibiotic treatment. VAP incidence will be reported as number of events per 1,000 ventilator-days. Risk factors associated to VAP will be identified by univariate and multivariate analysis.

Results and perspective : the investigators aim to define for the first time the incidence of VAP among European PICUs with a prospective and multicentre study. The identification of risk factors, diagnostic methods, epidemiology, treatment strategies will define the basis to start prevention manoeuvres and improve the clinical strategies for VAP in paediatric intensive care population.

ipd_sharing: Undecided

lead_sponsor: Sylvie Chevret


title: Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease

acronym: HALLUPARK

summary:
This study aims to describe hallucinations prevalence in a sample of patients affected by Parkinson's disease and consulting in an outpatient facility.

An unique one hour interview will be offered to volunteers patients. Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics.

The study hypothesis is that hallucinations prevalence in Parkinson's disease is underestimated and is higher than usually described in the scientific literature when all hallucinations modalities and minor hallucinatory phenomenons are searched for.

location_facility: Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité


title: Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.

acronym: IPoTAIG

summary: Autoimmune thyroiditis and goitres are frequent pathologies.


title: The Interest of the ANI in the Monitoring of Peroperative Analgesia in Bariatric Surgery: a Randomized Single Blind Study.

acronym: ANI

summary: The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice.


title: Relationship Between the Pupillary Pain Index Measured One Minute Before Incision and the Motor, Hemodynamic and Electroencephalographic Reaction to Skin Incision in Patients Under General Anesthesia

summary: During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Then, variations in heart rate, blood pressure and bispectral index during the three minutes following skin incision were recorded, as well as the occurrence of movements.

lead_sponsor: Pr Isabelle CONSTANT

location_facility: Departement d'anesthesie Hopital Armand Trousseau


title: Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression

acronym: NEUROPHONE

summary: The aim of our study is to show by fMRI the involvement of the motor system in the perception of speech, and more particularly how this implication is modulated by the degree of prototypicity of the stimuli.

lead_sponsor: University Hospital, Grenoble


title: Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?

acronym: REPLIPO

summary: To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies presenting an exanthema. This will make it possible to evaluate the prevalence of the positivity of this PCR in the skin. Then the investigator can investigate whether there is an association between the positivity of HHV6 PCR in the blood and / or skin and the viral etiology of the exanthema. If this association exists, it will make it possible to improve the diagnosis in the context of the exanthema and thus to improve the therapeutic management of these patients.


title: Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma

acronym: SCANN'AIR

summary: New insights of small airway contribution to asthma have been gained. Poor levels of control and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with predominant small airway involvement. Very few pathological specificities were identified at this site: mast cells infiltration was suggested as the specific inflammatory change when compared to the proximal airways.Biomarkers in asthma are still complex to validate, especially in the blood, since compartmentalisation is intense in the lung and the airways, a property attributed to the filtering role of the lung to maintain homeostasis. Over the last few years, Fraction exhaled Nitric Oxide (FENO) was developed as a non-invasive and indirect reflection of airway eosinophilic inflammation]. In the blood, peripheral eosinophil counts were shown as a correct T helper 2 (TH2)-phenotype identifier but not perfectly related to airway eosinophilic infiltration. Club cell secretory protein (SCGB1A1) levels have been shown to have some relevance in asthma, chronic obstructive pulmonary disease (COPD), BOS, sarcoidosis, and lung cancer.A biomarker for small airway disease in asthma may improve the management of the disease, identify areas of therapeutic resistance and constitute a therapeutic guidance tool. In this study, investigators aimed to assess small airway involvement in asthmatic women as far as they could. For this purpose, investigators analysed trends in air trapping by acquiring expiratory CT slices at each dose during a bronchoprovocation test with metacholine. Biomarkers were subsequently tested and confronted to clinical and demographical characteristics in their ability to predict the small airway involvement index obtained at CT.

lead_sponsor: University Hospital, Montpellier


title: Gluten Sensibility in Elite Athletes

acronym: GLUTHEALTH

summary: This clinical project aims to study the relationship between gluten consumption and its impact on digestive comfort, quality of life and performance of non-celiac athletes practicing an intensive physical activity..


title: (18)F-FDG PET Database of Adult Healthy Individuals for Clinical Studies in Epileptic Patients

acronym: BDD-FDG

summary:
Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide.

Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Focal Hypometabolism on interictal [18F]-FDG PET is a hallmark of the Seizure Onset Zone as well as surrounding areas. Using [18F]-FDG PET is thus particularly useful to determine the seizure onset zone of epileptic patients and thus to guide surgical treatment when antiepileptic drugs fail.

Interpretation of PET images primarily relies on standard visual analysis, but statistical analysis, with the widely used Statistical Parametric Mapping (SPM) software improves the diagnostic yield of PET. Over the past years, some authors have thus reported that the use of SPM can result in greater sensitivity and specificity of PET imaging in patients with partial epilepsy.

In order to perform statistical analysis of PET images to compare brain metabolism of epileptic patients and healthy controls, it is necessary to collect a normative database of [18F]-FDG PET images in healthy controls.

The purpose of this study is (i) collect a normative database of [18F]-FDG PET images in healthy adults controls to evaluate rigorously the diagnostic value of multimodal imaging for non-invasive localization of the EZ and (ii) to evaluate the test-retest reliability of [18F]-FDG PET scanning.


title: A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Dose Regimens of Etamicastat (BIA 5-453) in Hypertensive Subjects

summary: The purpose of this study was to characterise the plasma and urine pharmacokinetic profile of Etamicastat (BIA 5-453) and its metabolites after three multiple rising dose regimens of Etamicastat (BIA 5-453).

lead_sponsor: Bial - Portela C S.A.

intervention_type: Drug


title: Study of Prognostic Factors in Interventional Rhythmology

acronym: PRINT

summary: Develop a prospective register assessing the short- and long-term complications of patients undergoing interventional rhythm

lead_sponsor: University Hospital, Brest


title: Prediction of Thromboembolic Recurrences in Cancer Patients With Venous Thromboembolic Disease (TED)

acronym: PREDICARE

summary: The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)

lead_sponsor: LEO Pharma


title: Spectral Analysis of Heart Rate Variability at BIS 25 and BIS 55 Under Propofol or Sevoflurane

summary: Patients were randomized into 2 groups according to the anesthetic, propofol or sevoflurane. Induction and maintenance were standardized, and after the end of surgery, two steady-state recordings were performed at BIS 25 and BIS 55. Bispectral Index and ECG were continuously recorded and cardiac autonomic nervous activity was investigated using spectral analysis of RR Interval variability

lead_sponsor: Hôpital Armand Trousseau


title: Endothelial Microparticules as Biomarker of Antibody-mediated Rejection in Kidney Transplantation

acronym: MICROMARK RJ

summary:
Context and rationale:

Antibody-mediated rejection is the leading cause of long-term renal graft loss. It's due to the production by the recipient of antibodies directed against antigens (belonging or not to the HLA system) present on the surface of the donor specific endothelial cells (DSA), leading to graft failure.

The main difficulty to manage the humoral rejection is the delay of the diagnosis and the treatment to slow the evolution towards fibrosis.

Positivity of anti-HLA antibodies is the main risk factor for the rejection but the only way to make the diagnosis of humoral rejection is to perform a graft biopsy, an invasive process.

Endothelial microparticles (MPE) are small membrane vesicles generated by endothelial cell activation and / or apoptosis processes.

We test the hypothesis that endothelial microparticles are an early diagnostic biomarker of humoral rejection in renal transplantation allowing to detect it at the "subclinical" stage.

Primary and secondary objectives:

The main objective of this study is to estimate the performance of MPE plasma concentration for the diagnosis of humoral rejection in renal transplant patients with DSA. The secondary objective is to investigate by mass spectrometry the MPEs specific to the endothelium of the graft and to evaluate their diagnostic performance in relation to non-specific MEPs

Methodology :

We will conduct a cross-sectional evaluation of a diagnostic method from a collection of biological samples. The gold standard for the diagnosis of humoral rejection is the histological diagnosis on graft biopsy. The new test under study will be the flow cytometric assay of the MPE concentration carried out on plasma taken on the day of the graft biopsy.

Feasibility:

Among the active list of renal transplant patients attending the Montpellier University Hospital, we estimate that we can include the number of subjects required (N = 250) over 18 months. This work will be carried out in a laboratory with all the tools and techniques used, in particular flow cytometry and mass spectrometry, perfectly mastered and realized on dedicated technical platforms

Benefits / Outlook:

find a non-invasive early diagnostic biomarker to detect humoral rejection from the "subclinical" stage in order to set up an adapted treatment as quickly as possible.

primary_purpose: Diagnostic

ipd_sharing_description: NC

intervention_type: Biological


title: Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer: Pilot Study

acronym: GESPACE

summary:
Anastomotic fistula is the most feared complication after surgical resection of colorectal cancer (CCR). It occurs in 6 to 15% of patients. Beyond the risk of death in the immediate postoperative period, the pain that it induces, the resources required for its management, the need for stomata with a negative impact on patients' quality of life and the prolongation of hospitalization, it also has a now-recognized adverse effect on long-term survival.

The early detection of this complication may limit its impact. C-reactive protein (CRP) has proved to be an early, reliable marker of the onset of infectious complications of colorectal surgery.

However, the diagnostic procedure to implement in these patients is not at all codified, since this population concerned by systematic CRP assay in the postoperative period is very recent.

The procedures to implement in these patients so that they can obtain the maximal benefit of an early diagnosis have not yet been established. An algorithm for the proactive clinical management must be drawn up to be able to confirm or rule out the presence of a fistula as soon as a high level of CRP is detected, and to propose a quick treatment to ensure that patients benefit from this early diagnosis.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Is the Walking Velocity an Efficient Outcome of Rehabilitation Program in Non- Specific Low Back Pain Patient

acronym: MARLO

summary: Despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance). However, there are some experimental elements that involve objective assessment of locomotor capabilities - at forefront objectives which the walking velocity in the evaluation of this pathology in terms of severity of functional impairment. Recent evidence suggest the effectiveness of physical rehabilitation program for improving patients functional capacities and their reintegration in socio-professional life. This retrospective study aims to quantify the evolution of the parameters collected during standardized walking tests performed before and after rehabilitation program. These patients have systematically carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the beginning and end of their program. Furthermore, a maximal stress test on a treadmill was performed before the program in order to detect any cardiovascular events and to allow the personalization of the effort level required (target heart rate) during rehabilitation. In this study the evolution of the comfortable and fast speed will be collected and compared with the stress test data, and other measured parameters (functional score of Quebec, muscle Tests Shirado and Sorensen).


title: Food Decisions and Reward System: Modulation by Olfaction and Taste

summary: Functional Magnetic resonance study on the effect of cognitive context variables on the perception and valuation of food odorants and flavor. The study is composed of two experiments; in a first experiment we address the question of how valuation of food odors are modulated by 3 cognitive conditions (indulgence, healthy, and neutral). Food odors are delivered using a custom-made olfactometer. Here we hypothesize that cognitive regulation can modulate the primary sensory processing of food odors. We expect that cortical regions related with valuation and cognitive regulation such as the ventromedial prefrontal cortex and the dorsolateral prefrontal cortex operate the modulation of primary olfactory cortex and amygdala. In a second experiment, we aim to reveal the brain areas involved in integrating food color cues with odor and taste stimuli. Here we hypothesize that color cues are capable of biasing flavor attributes of food (flavor intensity), and that this bias occurs at different cortical areas commonly associate with multisensory integration such as the orbitofrontal cortex, insula, amygdala and hippocampus.

lead_sponsor: Hospices Civils de Lyon


title: Brain Mechanism of Social Decision-making

summary: The purpose of this study is to investigate neural mechanism of healthy humans underlying group decision making and compare it with that of individual decision-making. Using functional neuroimaging technology combining with computational modeling, we examine how the human brain process social information to make a decision within a group, which often guides humans to make a better decision using collective wisdom.


title: Cognitive Consequences of an Activation of the Cortical Drive to Breath

acronym: VENTIPSY

summary: The purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière


title: Impact of Intraperitoneal Pressure and Warmed, Humidified CO2 Gas on Clinical Outcomes After Laparoscopic Surgery for Uterine Prolapse in Patients Aged ˃75 Years: A Observational Study

summary: The primary purpose is to evaluate the quality of post-operative recovery and post-operative pain in elderly patients (more than 75 years) who undergo laparoscopic surgery for uterine prolapse.

ReferenceCitation: Matsuzaki S, Bonnin M, Fournet-Fayard A, Bazin JE, Botchorishvili R. Effects of Low Intraperitoneal Pressure on Quality of Postoperative Recovery after Laparoscopic Surgery for Genital Prolapse in Elderly Patients Aged 75 Years or Older. J Minim Invasive Gynecol. 2021 May;28(5):1072-1078.e3. doi: 10.1016/j.jmig.2020.09.017. Epub 2020 Sep 24.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Determinants of Volumetric Bone Mineral Density at the Tibia and Radius and it's Relationship With Osteoporotic Fractures in Idiopathic Parkinson's Disease

acronym: DOPPA

summary: Idiopathic Parkinson's disease (IPD) is the second most frequent neurodegenerative disease. Its association with osteroporosis and fragility fracture is now clearly demonstrated, but the determinants of this osteoporosis are yet to be explained. Our aim was to study factors associated with volumetric bone mineral density (vBMD) and bone microstructure at the tibia and radius in IPD.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Acute and Chronic Effects of Dynamic Apnea in Healthy Untrained Subjects

acronym: APNEX

summary:
The inclusion of short periods of apnea (several seconds) during exercise (i.e. dynamic apnea) induces a significant decrease in blood oxygenation and muscle tissue. To date, the immediate effects ("acute apnea") of this decrease in the quantity of oxygen available at the muscle and brain level are poorly understood. Moreover, a physical training during which these short periods of apnea ("chronic apnea") would be included could lead to physiological adaptations and to improvement in physical performance similar to those obtained during altitude training.

The purpose of this study is to evaluate the effects of acute dynamic apnea on metabolism.

ReferenceType: background

ReferenceCitation: Andersson JP, Linér MH, Rünow E, Schagatay EK. Diving response and arterial oxygen saturation during apnea and exercise in breath-hold divers. J Appl Physiol (1985). 2002 Sep;93(3):882-6.

ReferenceCitation: Caquelard F, Burnet H, Tagliarini F, Cauchy E, Richalet JP, Jammes Y. Effects of prolonged hypobaric hypoxia on human skeletal muscle function and electromyographic events. Clin Sci (Lond). 2000 Mar;98(3):329-37.

ReferenceCitation: de Bruijn R, Richardson M, Schagatay E. Increased erythropoietin concentration after repeated apneas in humans. Eur J Appl Physiol. 2008 Mar;102(5):609-13. Epub 2007 Dec 19.

ReferenceCitation: Dufour SP, Ponsot E, Zoll J, Doutreleau S, Lonsdorfer-Wolf E, Geny B, Lampert E, Flück M, Hoppeler H, Billat V, Mettauer B, Richard R, Lonsdorfer J. Exercise training in normobaric hypoxia in endurance runners. I. Improvement in aerobic performance capacity. J Appl Physiol (1985). 2006 Apr;100(4):1238-48.


title: Auditory Perceptual and Memory Deficits in Congenital Amusia: Studies of Cerebral Correlates With MEG, Anatomical MRI and Functional MRI

summary:
The project studies auditory deficits in congenital amusia at the behavioral and neurophysiological levels.

The auditory processes investigated are pitch discrimination, short-term memory, sound-induced emotions. To characterize auditory deficits in the amusic population, neuropsychological assessments are combined with neurophysiological markers (Electro-encephalography: EEG, Magneto-encephalography: MEG, Magnetic Resonance Imaging: MRI).

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot


title: Evaluation of the Visual Motor Task's Impact on the Behavior of a Neuronal and Spinal Network in Hemiplegic Patients

summary:
The general objective being to determine the modifications nature induced by upper extremity kinematic rhythmic task realization on cervical HSCC.

The obtained knowledge could open up new prospects for rehabilitation in cerebro-injured subjects in addition to existing therapeutics.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Evaluation of the Risk of Cognitive Deficit After Surgery of Epilepsy by Dynamic Spectral Imaging (ISD) of the Cognitive Functions in Patients Explored in StereoElectroEncephaloGraphy (SEEG)

acronym: ISD SEEG

summary:
Epilepsy affects between 0.5 and 0.7% of the European population. Despite the availability of numerous drug treatments, one third of patients still have seizures, which are associated with significant cognitive and social complications and excess mortality. In these patients, surgical treatment to remove the epileptogenic zone (EZ), the region of the brain responsible for seizures, is the only approach that can allow control of the disease. However, before investigating this surgery, investigations have to answer two questions: (i) what is the location and extension of the EZ and (ii) what functional risks, both motor and cognitive, would represent the resection of this Cortical region? As it is a functional surgery, it is in fact inconceivable that the surgery will result in an over-handicap. For these reasons, all candidates for surgery benefit from a complete assessment including imaging examinations, a neuropsychological assessment and a long-term video-EEG recording to record seizures. Nevertheless, in some patients, this assessment does not give us a formal answer. In these subjects, it is then necessary to carry out a second step, consisting of an invasive exploration by implantation of intracerebral electrodes during a stereoencephalography (SEEG). Due to its temporal and spatial resolution, the SEEG allows, besides the precise determination of the EZ, to carry out a functional mapping of the cortical regions likely to be included in cortectomy. Conventionally, this mapping is carried out on the basis of the cortical electrical stimulations applied to the implanted electrodes. If this approach is very robust for exploring primary functions such as motor skills or language, it cannot be used to evaluate more complex cognitive tasks such as face recognition or attention Effective cognitive treatment on a daily basis. This has led to the development in recent years, in Lyon and Grenoble, of a complementary approach to cerebral stimulation: dynamic spectral imaging (ISD). Numerous experimental paradigms have demonstrated that the realization of a cognitive task associates with the generation within the cortical regions involved in its treatment of a particular cortical activity. This activity is characterized by oscillations of the cortical rhythm in high frequencies (> 30 Hz), called gamma activities. The ISD thus consists in mapping this gamma activity during various cognitive tasks, thus making it possible to study more widely the complexity of the cognitive functions. Correlations between gamma activity and cognitive tasks have so far been exclusively performed in the non-epileptic cortex explored at the periphery of the EA during SEEG. Nevertheless, the cortical oscillatory pattern study associated with a specific cognitive task within the EZ could better anticipate complex cognitive deficits that could be generated by the resection of a cortical region.

The main objective of this project is to establish the predictive character of the gamma cortical oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after surgery of epilepsy.


title: Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial

summary: Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. Its pathophysiology remains poorly understood and the investigators have few therapeutic options. Following a review of the literature, the investigators hypothesize that luminotherapy could be an innovative treatment of BED by its favorable effect on triggers of hyperphagic access, circadian disturbances, attention and impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (<500 lux). Treatment will be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main objective is to compare the evolution of the number of hyperphagic access before and after treatment between the two groups. Secondary objectives are to compare characteristics of hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety, cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time Estimation Task, Switching Task), liking / wanted for different food categories and carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid abnormalities, 25-OH vitamin D3).

location_facility: HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)


title: Effects of Pulmonary Rehabilitation on Dyspnoea Affective Dimension and Emotional Cognition in Patients With Chronic Obstructive Pulmonary Disease

acronym: READ-COG BPCO

summary: To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).To evaluate whether pulmonary rehabilitation improves emotional cognition, using facial emotions recognition and smile production, by improving the emotional dimension of dyspnoea in patients with chronic obstructive pulmonary disease (COPD).

location_facility: Centre d'Investigation Clinique Paris Est, Groupe Hospitalier Pitié-Salpêtrière


title: Analysis of DNA Methylation in Spondyloarthritis

acronym: METYLAS

summary: The aim of this project is to quantify global DNA methylation in patients with Ankylosing Spondylitis or Axial Spondyloarthritis as compared with control subjects.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of the Effectiveness of a Probiotic Treatment on Clinical Activity, Relapse Rates and Modification of the Intestinal Microbiota in Patients With Juvenile Idiopathic Arthritis (JIA)

acronym: PERMAJI

summary: This study investigates the efficacy of probiotic VSL#3 as an add on standard care on the activity of the disease in patients with Juvenile Idiopathic Arthritis.

status: Active, not recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Dietary Supplement


title: Participation of Relative or Surrogate in the Patient's Care in Reanimation

acronym: PARTICIPATE

summary:
ICUs have always perceived by the public has a very technical unit with a restricted and/or forbidden access. Physical alteration of the patient, seeing the patient sedated, the large numbers of devices, the alarms and an uncertain prognosis. All this factors can be perceived by people close to the patient as a source of stress. In the literature, numerous studies have shown that families develop anxiety and depression symptoms while their loved one is hospitalized in the ICU. French intensive care societies thought of ways to prevent or diminish these symptoms. The 6th consensus conference on " Live better in the ICU " recommends: effective and adapted information, large visiting hours to reach an unrestricted access and family participation in care.

The unit has taken this path to improve patient and family centered care by: creating a welcome leaflet, a room dedicated to meetings with families and an ICU open 24/7bto families, with the possibility for children to visit their parents. Hence, spontaneously, relatives have expressed the wish to participate to certain care and when participating, expressed their satisfaction. This observation and testimonies from family members and patients led us to think about the impact of participation of care. Two major French studies have shown contradictory outcomes: 16% of families would have been willing to participate in the first study against 97% in the second one. These studies were survey done after the ICU discharge.

No study today has assessed the actual impact of family participation in care. The aim of this clinical trial is to diminish anxiety and depression symptoms. By participating in care, relatives can develop or strengthen a relationship of trust with caregivers. It could contribute also to a better understanding of the plan of care and an easier context to announce negative outcomes.

ReferenceCitation: Azoulay E, Pochard F, Chevret S, Arich C, Brivet F, Brun F, Charles PE, Desmettre T, Dubois D, Galliot R, Garrouste-Orgeas M, Goldgran-Toledano D, Herbecq P, Joly LM, Jourdain M, Kaidomar M, Lepape A, Letellier N, Marie O, Page B, Parrot A, Rodie-Talbere PA, Sermet A, Tenaillon A, Thuong M, Tulasne P, Le Gall JR, Schlemmer B; French Famirea Group. Family participation in care to the critically ill: opinions of families and staff. Intensive Care Med. 2003 Sep;29(9):1498-504. Epub 2003 Jul 10.

ReferenceCitation: Garrouste-Orgeas M, Willems V, Timsit JF, Diaw F, Brochon S, Vesin A, Philippart F, Tabah A, Coquet I, Bruel C, Moulard ML, Carlet J, Misset B. Opinions of families, staff, and patients about family participation in care in intensive care units. J Crit Care. 2010 Dec;25(4):634-40. doi: 10.1016/j.jcrc.2010.03.001.


title: Cholinergic Markers as Predictive Tools of Therapeutic Response in Alzheimer's Disease (CHOLINE)

acronym: CHOLINE

summary:
Several previous studies have assessed acetylcholine (Ach) and acetylcholinesterase activity (AchE-a) levels in Alzheimer's disease (AD) pathophysiology. The cerebrospinal fluid (CSF) Ach level was significantly decreased in AD patients, and correlated positively with dementia score and MMSE (1, 2). Two studies have demonstrated positive correlations between CSF AchE-a and CSF Tau, phosphorylated-Tau (P-Tau) and AB 1-42 peptide (3,4). ChEIs (cholinesterase inhibitors) have been approved for the treatment of AD but only 20 to 30 % of patients are responders (5). Any consistent data allow the clinician to predict the response to the treatment. The link between basal cholinergic status and ChEIs efficiency has never been done. Even if, there is a wild research in AD treatment, ChEIs or treatment acting on the Ach pathways will remain a long time valuable treatment particularly in moderate AD in which disease modifying therapies did not show any efficiency.

The investigators's objective is to prospectively explore the predicting value of CSF Ach and AchE-a levels on ChEIs response in AD patients.

location_facility: Centre Mémoire de Ressources et de Recherche Paris Nord


title: Biomarkers of Fetal Infection and Disease Following Maternal HCMV Infection

acronym: BIO-CCMV

summary: The purposes of this study are to determine 1) if the diagnosis of CMV fetal infection could be done directly in the maternal blood instead of requesting an amniocentesis and 2) if innovative technologies such as proteomic, transcriptomic, methylomic and lipidomic applied in fetal samples could allow the discovery of new biomarkers of fetal infection.

ReferenceCitation: Benoist G, Salomon LJ, Jacquemard F, Daffos F, Ville Y. The prognostic value of ultrasound abnormalities and biological parameters in blood of fetuses infected with cytomegalovirus. BJOG. 2008 Jun;115(7):823-9. doi: 10.1111/j.1471-0528.2008.01714.x.

ReferenceCitation: Fabbri E, Revello MG, Furione M, Zavattoni M, Lilleri D, Tassis B, Quarenghi A, Rustico M, Nicolini U, Ferrazzi E, Gerna G. Prognostic markers of symptomatic congenital human cytomegalovirus infection in fetal blood. BJOG. 2011 Mar;118(4):448-56. doi: 10.1111/j.1471-0528.2010.02822.x. Epub 2010 Dec 24.

ReferenceCitation: Desveaux C, Klein J, Leruez-Ville M, Ramirez-Torres A, Lacroix C, Breuil B, Froment C, Bascands JL, Schanstra JP, Ville Y. Identification of Symptomatic Fetuses Infected with Cytomegalovirus Using Amniotic Fluid Peptide Biomarkers. PLoS Pathog. 2016 Jan 25;12(1):e1005395. doi: 10.1371/journal.ppat.1005395. eCollection 2016 Jan.

ReferenceCitation: Bourgon N, Fitzgerald W, Aschard H, Magny JF, Guilleminot T, Stirnemann J, Romero R, Ville Y, Margolis L, Leruez-Ville M. Cytokine Profiling of Amniotic Fluid from Congenital Cytomegalovirus Infection. Viruses. 2022 Sep 28;14(10). pii: 2145. doi: 10.3390/v14102145.


title: Single-dose and Steady-state Pharmacokinetics of BIA 5-453 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young Subjects

summary: The purpose of this study was to assess the effects of age on the pharmacokinetic (PK) profile of BIA 5-453 and its metabolites.


title: Comparative Bioavailability Study of BIA 5-453 Under Fasted and Fed Conditions

summary: The purpose of this study was to compare the bioavailability and tolerability of BIA 5-453 under fasted and fed conditions.


title: Sleep & Quality of Life Evaluation of Patients With Atopic Dermatitis Based on Real-world Data Collection With a Smartphone Application and a Validated Actigraphy Wristband

acronym: ACTISLEEP

summary: Atopic dermatitis is a chronic disease with a high impact on patient's quality of life. Nocturnal pruritus is one of the main symptoms affecting quality of life. Treatment efficacy is generally measured by healthcare professionals during consultations with both questioning and visual examination of the lesions. Quality of Life (QoL) can also be evaluated retrospectively with the Dermatology Life Quality Index (DLQI) scale. Collecting data retrospectively introduces a significant recall bias that can be addressed by collecting data in Real World (RW). Real World data collection is prospective and take place within the patient's own environment. While data collection is generally done with diaries, it has been demonstrated that smartphone and connected devices were able to produce more precise and granular data than traditional methods.

lead_sponsor: Ad scientiam


title: Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory

acronym: QoVNI

summary: The purpose of the study is to assess the therapeutic education of patients with chronic respiratory failure who start to be treated with non invasive ventilation and during the first six months of ventilation.

status: Withdrawn

location_facility: INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière


title: A Phase 1, Open Label, Non-randomized, Single Center Study to Evaluate the Safety and Immunogenicity of 1 Booster Vaccination With (GVGH Shigella Sonnei 1790GAHB) Vaccine Administered Intramuscularly in Healthy Adults Previously Primed With Three Doses of the Same Vaccine in Study H03_01TP Compared to 1 Vaccination With (1790GAHB) Administered Intramuscularly Either to Subjects Who Received Placebo in the H03_01TP Study or naïve Subjects Who Were Not Part of H03_01TP Study

summary:
GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei.

A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with detectable versus undetectable antibody titres at baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic in completely naïve adults.

This study was then designed to further characterize the immunogenicity profile of the vaccine and to evaluate whether it was able to induce an immunological memory response.

ReferenceCitation: Launay O, Ndiaye AGW, Conti V, Loulergue P, Sciré AS, Landre AM, Ferruzzi P, Nedjaai N, Schütte LD, Auerbach J, Marchetti E, Saul A, Martin LB, Podda A. Booster Vaccination With GVGH Shigella sonnei 1790GAHB GMMA Vaccine Compared to Single Vaccination in Unvaccinated Healthy European Adults: Results From a Phase 1 Clinical Trial. Front Immunol. 2019 Mar 8;10:335. doi: 10.3389/fimmu.2019.00335. eCollection 2019.

ReferenceCitation: Micoli F, Rossi O, Conti V, Launay O, Sciré AS, Aruta MG, Nakakana UN, Marchetti E, Rappuoli R, Saul A, Martin LB, Necchi F, Podda A. Antibodies Elicited by the Shigella sonnei GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalation Trial Followed by a Booster Extension. Front Immunol. 2021 May 4;12:671325. doi: 10.3389/fimmu.2021.671325. eCollection 2021.

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline


title: Temporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC)

summary: Expanded access to Avelumab solution for infusion will be made available for adult patients with mMCC whose disease has progressed after receiving at least one prior chemotherapy.

status: Approved for marketing

study_type: Expanded Access

lead_sponsor: Merck KGaA, Darmstadt, Germany


title: Assessment of Bronchial Thickness Using MRI in Asthma

acronym: ASTHMAGRI

summary: Bronchial remodeling is a major pathological feature of asthma. Non-invasive assessment of this bronchial remodeling is a crucial issue for asthma patients' follow-up. Currently, computed tomography (CT) is the method of reference to evaluate and quantify bronchial thickness but it remains unable to differentiate bronchial inflammation from remodelling and is a radiation-based technique. Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective is to evaluate bronchial thickness in asthma patients using CT and MRI-UTE, and to test the agreement between both techniques.

lead_sponsor: University Hospital, Bordeaux


title: Prospective Study to Assess the Foreseeable Impact of TIP Score on Thromboprophylaxis in Patients With Isolated Non-surgical Lower Limb Trauma Compared to the Physicians' Judgment in Standard Practice.

acronym: EvaTIP

summary:
Traumatic lesions are the leading causes of admission to the emergency center (39%), isolated non-surgical lower limbs trauma are in the foreground. Two recent meta-analyzes suggest the value of Low Molecular Weight Heparins (LMWH) which would reduce symptomatic Thromboembolism Events (TE) in patients with lower limb trauma. However, many recent studies conclude to the need of stratifying the TE risk according to the patient and the nature of his trauma to obtain an individualized therapeutic decision.

The retrospectively established L-TRIP (cast) score allows stratification of the risk without taking into account the type of trauma. The TIP score (Trauma, Immobilization and Patient) was established by consensus of international experts via the Delphi method.

We suggest that the application of the TIP score to rationalize indications of thromboprophylaxis in patients with isolated non-surgical trauma of a lower limb should reduce the rate of anticoagulation prescription without increasing the risk of symptomatic thromboembolic complications with a direct benefit for patients and medico-economic for the society.

lead_sponsor: University Hospital, Angers


title: Pre-operative Screening for HIV and Viral Hepatitis B and C: Pilot Study in Stomatology

acronym: OPDEP

summary:
The purpose of the OPDEP pilot study is to assess the feasibility of implementing a pre-operative HIV / HCV / HBV screening proposal for all persons over 18 years of age and refer for surgical intervention under general anesthesia in the Department of Stomatology of the Pitié-salpêtrière hospital.

Patients undergoing treatment in Stomatology have particular areas at risk for the infections we are looking for: young patients, precarious situation, drug use, migrants ...

The aim is to evaluate the conditions for a generalization of screening in the framework of the preoperative assessment.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida


title: Validation of the French Version of the Questionnaires of Self-efficacy Received From the People With a Chronic Low Back Pain After Return to the Work (10 and 19 Items)

acronym: RTWSE

summary:
The back pain connected to the work stay a major problem in industrialized countries, in particular because of the repercussions of this affection on the work (sick leave, absenteeism, handicap and inaptitude). It is difficult to consider among all the patients with a Chronic Low Back Pain in the work: how much they are going to stop. However, Investigator can consider that approximately 20 % of the patients have a sick leave. Several studies showed well that more the sick leave work stoppage goes on more the risk of not resumption of work increases. Several risk factors were associated to the evolutionary forecast of the pathology and thus to the extension extra time of the sick leave: individual, environmental, psychosocial and organizational.

The evaluation of the self-efficiency perceived of return in the work of the patients by a validated auto-questionnaire is thus an additional objective parameter determining the risk factors of unfavorable evolution of the patients with Low Back Pain. This parameter also allows highlight other levers of actions in the therapeutic education.

time_perspective: Other

ReferenceCitation: Rossignol M, Rozenberg S, Leclerc A. Epidemiology of low back pain: what's new? Joint Bone Spine. 2009 Dec;76(6):608-13. doi: 10.1016/j.jbspin.2009.07.003.

ReferenceCitation: Gourmelen J, Chastang JF, Ozguler A, Lanoë JL, Ravaud JF, Leclerc A. Frequency of low back pain among men and women aged 30 to 64 years in France. Results of two national surveys. Ann Readapt Med Phys. 2007 Nov;50(8):640-4, 633-9. Epub 2007 Jun 27. English, French.

ReferenceCitation: Ozguler A, Leclerc A, Landre MF, Pietri-Taleb F, Niedhammer I. Individual and occupational determinants of low back pain according to various definitions of low back pain. J Epidemiol Community Health. 2000 Mar;54(3):215-20.

ReferenceCitation: Brouwer S, Franche RL, Hogg-Johnson S, Lee H, Krause N, Shaw WS. Return-to-work self-efficacy: development and validation of a scale in claimants with musculoskeletal disorders. J Occup Rehabil. 2011 Jun;21(2):244-58. doi: 10.1007/s10926-010-9262-4.

ReferenceCitation: Shaw WS, Reme SE, Linton SJ, Huang YH, Pransky G. 3rd place, PREMUS best paper competition: development of the return-to-work self-efficacy (RTWSE-19) questionnaire--psychometric properties and predictive validity. Scand J Work Environ Health. 2011 Mar;37(2):109-19. doi: 10.5271/sjweh.3139. Epub 2011 Jan 4.

ReferenceCitation: Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95.

ReferenceCitation: Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. Epub 2006 Aug 24.


title: Etude Observationnelle Comparant l'efficacité du GANciclovir en Fonction de l'EXposition Sanguine au médicament

acronym: GANEX

summary: This study aims to better define the target range of ganciclovir trough concentrations by investigating the relationship between ganciclovir concentration and the time to undetectable CMV-DNA load, in preemptive and curative treatments by (val)ganciclovir.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes


title: Chronic Stress Protection for Post-natal Depression Prevention: An Exploratory Study

acronym: serene

summary:
The risk of emergence of a post natal depression is based on an interaction between a maternal psychic vulnerability and a chronic environmental context of stress. The PND appears as a relevant model for studying the mechanisms of chronic stress and vulnerability to psychological pathologies.

This study aim to follow a cohort of pregnant women to determine the predictive psychobiological factors of the emergence of postnatal depression

ReferenceCitation: Tharwat D, Trousselard M, Balès M, Sutter-Dallay AL, Fromage D, Spitz E, Dallay D, Harvey T, Welter E, Coatleven F, Cherier L, Teissèdre F, Pouly JL, Dutheil F, Duffaud AM. Chronic Stress protection for postnatal dEpREssioN prEvention (SERENE): a protocol for an exploratory study. BMJ Open. 2018 May 3;8(5):e018317. doi: 10.1136/bmjopen-2017-018317.

lead_sponsor: Institut de Recherche Biomedicale des Armees


title: Effect of Preoxygenation With Spontaneous Breathing or Noninvasive Positive Pressure Ventilation With or Without a Calibrated Leak. An Experimental Study in Healthy Volunteers

summary:
During preoxygenation, imperfect seal between the face mask and patient's face can induce an inward air leak decreasing its effectiveness. We assume that noninvasive ventilation could cancel the effect of the leak.

This is a prospective study. Healthy volunteers are randomised in cross-over between spontaneous breathing or noninvasive ventilation pressure support preoxygenation in the presence or absence of a calibrated leak on the inspiratory circuit.

ReferenceCitation: Hanouz JL, Le Gall F, Gérard JL, Terzi N, Normand H. Non-invasive positive-pressure ventilation with positive end-expiratory pressure counteracts inward air leaks during preoxygenation: a randomised crossover controlled study in healthy volunteers. Br J Anaesth. 2018 Apr;120(4):868-873. doi: 10.1016/j.bja.2017.12.002. Epub 2018 Jan 17.

lead_sponsor: University Hospital, Caen


title: Clustering Among the Clinical Profiles of Patients With Pectus Excavatum

acronym: PECTUS-cluster

summary: The primary objective of this study is to describe the relative distances between patient clinical profiles (i.e. patient clustering) in multivariate space.

lead_sponsor: University Hospital, Montpellier

location_facility: Centre Hospitalier Universitaire de Montpellier


title: Corticomotor Plasticity as a Biomarker for Functional Improvement After Botulinium Treatment in Writer's Cramp

acronym: IWCToxin

summary: Writer's cramp (WC) is a form of focal dystonia, a movement disorder characterized by sustained or intermittent muscle contractions causing abnormal, often repetitive movements, postures, or both. It typically manifests while writing, making handwriting impossible in the most severe cases. Treatment can be difficult, but one effective and well-tolerated treatment consists in local muscle injections with botulinum toxin. Although clinical improvement seems to be related to focal muscle chemodenervation, central plasticity changes may occur. The main aim of the study is to characterize and quantify the changes in intrinsic hand muscle cortical representations at rest and during isometric contractions of the finger muscles before and after treatment with botulinum toxin and the changes in sensorimotor integration in patients with writer's cramp.

lead_sponsor: University Hospital, Grenoble


title: Effect of the Maternal Obesity and/or the By-pass on the Growth and the Nutritional Balance of the Child

acronym: SMOOTHIE

summary: This study evaluates effect of the Maternal Obesity and/or the By-pass on the Growth and the Nutritional Balance of the Child.The data stemming from mothers presenting obesity or an overweight during their pregnancy and the data stemming from mothers having had a by-pass will be compared with the data stemming from mothers with a normal BMI (Body Mass Index), considered as a reference group. It's the same for the data stemming from newborn children. The newborn children stemming from groups of obese mothers or in overweight will be compared with the data stemming from mothers belonging to the reference group.


title: Long Term Evaluation of Infants Aged From 3 to 4 Years Old Included in the Ancient Study (Repeated Administrations of Oxytocin in Infants With Prader Willi Syndrome Aged From 0 to 6 Months) and Comparison With Not Treated and Age-matched Prader Willi Syndrome Infants (OT2SUITE)

summary: The objective of this study is to collect data on tolerance and effects of early treatment with oxytocin in children with Prader Willi Syndrome aged from 3 to 4 years and to compare these infants with not treated age-matched infants with Prader Willi Syndrome.

ReferenceCitation: Amico JA, Vollmer RR, Cai HM, Miedlar JA, Rinaman L. Enhanced initial and sustained intake of sucrose solution in mice with an oxytocin gene deletion. Am J Physiol Regul Integr Comp Physiol. 2005 Dec;289(6):R1798-806. Epub 2005 Sep 8.

ReferenceCitation: Arletti R, Benelli A, Bertolini A. Oxytocin inhibits food and fluid intake in rats. Physiol Behav. 1990 Dec;48(6):825-30.

ReferenceCitation: Billings LB, Spero JA, Vollmer RR, Amico JA. Oxytocin null mice ingest enhanced amounts of sweet solutions during light and dark cycles and during repeated shaker stress. Behav Brain Res. 2006 Jul 15;171(1):134-41. Epub 2006 May 4.

ReferenceCitation: Bittel DC, Kibiryeva N, Sell SM, Strong TV, Butler MG. Whole genome microarray analysis of gene expression in Prader-Willi syndrome. Am J Med Genet A. 2007 Mar 1;143A(5):430-42.

ReferenceCitation: Dykens EM, Lee E, Roof E. Prader-Willi syndrome and autism spectrum disorders: an evolving story. J Neurodev Disord. 2011 Sep;3(3):225-37. doi: 10.1007/s11689-011-9092-5. Epub 2011 Aug 20.

ReferenceCitation: Dykens EM, Maxwell MA, Pantino E, Kossler R, Roof E. Assessment of hyperphagia in Prader-Willi syndrome. Obesity (Silver Spring). 2007 Jul;15(7):1816-26.

ReferenceCitation: Dykens EM, Roof E, Hunt-Hawkins H. Cognitive and adaptive advantages of growth hormone treatment in children with Prader-Willi syndrome. J Child Psychol Psychiatry. 2017 Jan;58(1):64-74. doi: 10.1111/jcpp.12601. Epub 2016 Aug 2.

ReferenceCitation: Goldstone AP, Holland AJ, Butler JV, Whittington JE. Appetite hormones and the transition to hyperphagia in children with Prader-Willi syndrome. Int J Obes (Lond). 2012 Dec;36(12):1564-70. doi: 10.1038/ijo.2011.274. Epub 2012 Jan 24.

ReferenceCitation: Guastella AJ, Einfeld SL, Gray KM, Rinehart NJ, Tonge BJ, Lambert TJ, Hickie IB. Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders. Biol Psychiatry. 2010 Apr 1;67(7):692-4. doi: 10.1016/j.biopsych.2009.09.020. Epub 2009 Nov 7.

ReferenceCitation: Hall SS, Lightbody AA, McCarthy BE, Parker KJ, Reiss AL. Effects of intranasal oxytocin on social anxiety in males with fragile X syndrome. Psychoneuroendocrinology. 2012 Apr;37(4):509-18. doi: 10.1016/j.psyneuen.2011.07.020. Epub 2011 Aug 20.

ReferenceCitation: Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6.

ReferenceCitation: Lischke A, Gamer M, Berger C, Grossmann A, Hauenstein K, Heinrichs M, Herpertz SC, Domes G. Oxytocin increases amygdala reactivity to threatening scenes in females. Psychoneuroendocrinology. 2012 Sep;37(9):1431-8. doi: 10.1016/j.psyneuen.2012.01.011. Epub 2012 Feb 23.

ReferenceCitation: McDonald NA, Kuzmiski JB, Naderi N, Schwab Y, Pittman QJ. Endogenous modulators of synaptic transmission: cannabinoid regulation in the supraoptic nucleus. Prog Brain Res. 2008;170:129-36. doi: 10.1016/S0079-6123(08)00412-3. Review.

ReferenceCitation: Meziane H, Schaller F, Bauer S, Villard C, Matarazzo V, Riet F, Guillon G, Lafitte D, Desarmenien MG, Tauber M, Muscatelli F. An Early Postnatal Oxytocin Treatment Prevents Social and Learning Deficits in Adult Mice Deficient for Magel2, a Gene Involved in Prader-Willi Syndrome and Autism. Biol Psychiatry. 2015 Jul 15;78(2):85-94. doi: 10.1016/j.biopsych.2014.11.010. Epub 2014 Nov 20.

ReferenceCitation: Miller JL, Lynn CH, Driscoll DC, Goldstone AP, Gold JA, Kimonis V, Dykens E, Butler MG, Shuster JJ, Driscoll DJ. Nutritional phases in Prader-Willi syndrome. Am J Med Genet A. 2011 May;155A(5):1040-9. doi: 10.1002/ajmg.a.33951. Epub 2011 Apr 4.

ReferenceCitation: Salles J, Strelnikov K, Carine M, Denise T, Laurier V, Molinas C, Tauber M, Barone P. Deficits in voice and multisensory processing in patients with Prader-Willi syndrome. Neuropsychologia. 2016 May;85:137-47. doi: 10.1016/j.neuropsychologia.2016.03.015. Epub 2016 Mar 16.

ReferenceCitation: Schaller F, Watrin F, Sturny R, Massacrier A, Szepetowski P, Muscatelli F. A single postnatal injection of oxytocin rescues the lethal feeding behaviour in mouse newborns deficient for the imprinted Magel2 gene. Hum Mol Genet. 2010 Dec 15;19(24):4895-905. doi: 10.1093/hmg/ddq424. Epub 2010 Sep 28.

ReferenceCitation: Skokauskas N, Sweeny E, Meehan J, Gallagher L. Mental health problems in children with prader-willi syndrome. J Can Acad Child Adolesc Psychiatry. 2012 Aug;21(3):194-203.

ReferenceCitation: Swaab DF, Purba JS, Hofman MA. Alterations in the hypothalamic paraventricular nucleus and its oxytocin neurons (putative satiety cells) in Prader-Willi syndrome: a study of five cases. J Clin Endocrinol Metab. 1995 Feb;80(2):573-9.

ReferenceCitation: van Lieshout CF, de Meyer RE, Curfs LM, Koot HM, Fryns JP. Problem behaviors and personality of children and adolescents with Prader-Willi syndrome. J Pediatr Psychol. 1998 Apr;23(2):111-20.

lead_sponsor: University Hospital, Toulouse

location_facility: Centre de référence du syndrome de Prader-Willi Hôpital des Enfants


title: Quantitative Sensory Testing in Subjects With Sensitive Skin or Not

acronym: SENSISKIN

summary:
Sensitive skin is a common problem, with 50% of women and 30% of men in Europe feel they have sensitive skin.

The Quantitative sensory testing (QST) is a physico-psychic method that uses gradients stimuli of different modalities to measure a subjective somatosensory response. This allows to characterize sensory dysfunction by assessing the participation of small and large nerve fibers.

The aim of this project is to characterize the presence or absence of a neurological disorder in patients with sensitive skin. This discovery would be a decisive argument to reinforce the suspicion that sensitive skins is linked to a small fiber neuropathy.

lead_sponsor: University Hospital, Brest


title: Corynebacterium Spp Bone and Joint Infection: Retrospective Study of Microbiological, Diagnostic and Therapeutic Features

summary:
Corynebacterium spp have been considered as innocuous commensals of human skin, but are now accepted as important opportunistic pathogens responsible for various nosocomial infections, especially implicating foreign materials. In particular, they accounted for up to 10% of prosthetic joint infection (PJI), and are mostly identified in chronic forms of bone and joint infections (BJI). However, little is known about the pathophysiological pathway implicated in Corynebacterium BJI, species distribution and antimicrobial susceptibility, and the management of these difficult-to-treat clinical entities.

This study aims to report a retrospective cohort of patients with Corynebacterium spp BJI, aiming to : i) describe microbiological characteristics of the implicated clinical isolates, including species identification and antimicrobial susceptibility (and especially according to previous antimicrobial exposure); ii) assess pathophysiological mechanisms associated with BJI chronicity, including biofilm formation and bone cell invasion, to better understand mechanisms of Corynebacterium spp and to evaluate their ability to distinguished colonizing and infective isolates; iii) describe the medical (nature and duration of antimicrobial therapy) and surgical management of these patients; and iv) evaluate the patient outcome according to this management strategy, and highlight risk factor for treatment failure in order to improve patient's management.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de reference des infections ostéo-articulaires- Hôpital de la Croix Rousse


type: Registry Identifier

title: Trial of a Nutritional Blend to Prevent Cognitive Decline in Older Adults

summary: To demonstrate the beneficial effects of 1-year intervention with a nutritional blend of ingredients on blood levels of nutritional biomarkers known to be linked with cognitive decline in non-demented adults with subjective memory concerns aged 70+ years

lead_sponsor: Nestlé


title: Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study

acronym: INDIE

summary:
Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of tissue perfusion.

After intravenous injection of indocyanine green, using a near infrared light, the vascularisation becomes fluorescent.

In endometriosis disease, the treatment of recto vaginal node can be complicated by rectovaginal fistula.

An abnormal vascularisation related to the surgery would be a risk factor of post operative fistulas.

The aim of this study is to evaluate the rectal and vaginal vascularisation during the treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine green fluorescence.

ReferenceCitation: Bourdel N, Jaillet L, Bar-Shavit Y, Comptour A, Pereira B, Canis M, Chauvet P. Indocyanine green in deep infiltrating endometriosis: a preliminary feasibility study to examine vascularization after rectal shaving. Fertil Steril. 2020 Aug;114(2):367-373. doi: 10.1016/j.fertnstert.2020.03.042. Epub 2020 Jul 7.

ReferenceCitation: Bar-Shavit Y, Jaillet L, Chauvet P, Canis M, Bourdel N. Use of indocyanine green in endometriosis surgery. Fertil Steril. 2018 Jun;109(6):1136-1137. doi: 10.1016/j.fertnstert.2018.02.113. Epub 2018 Jun 6.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Impact of Air Quality on Exacerbations of COPD in the Somme

acronym: PolluBPCO

summary: All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie between 01/01/2017 and 31/12/2017. The investigator will collect for each patient the home address and the work address. The duration of 1 year was chosen to take into account seasonal variations. In parallel, a daily report of the rate of ozone, particles (PM2.5 and PM10), dioxide nitrogen but also odours and pollens will be done by ATMO Picardie.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Effect of Different Strength Training Intensities on Achilles and Patellar Tendon Adaptations With Aging

acronym: TAGE

summary: Tendons are essential structures for transmitting muscle forces to skeletal structures. A stiffer tendon will transmit muscle force faster, and then allow faster movement. Moreover, tendons are a living tissue and respond to mechanical forces by changing their metabolism as well as their structural and mechanical properties. The aim of the present study is to answer essential questions remaining unanswered that are necessary in order to optimize physical activity with ageing in humans, and thus improve quality of life in elderly. The main questions are: What is the minimal training intensity leading to tendon adaptations? What is the time-course of tendon adaptations? Does the same loading protocol lead to similar tendon adaptations for different tendons (Achilles vs Patellar) and does the same training program lead to identical tendon adaptations with age (25yrs vs 75yrs)? To answer these questions, tendon architecture and mechanical properties will be investigated in humans of different age and applying different training intensities. The kinematic of the tendon adaptations due to these different training characteristics will also be investigated. The training protocol will be applied on plantar flexors and knee extensors. MRI and ultrasound techniques as well as the use of ankle and knee ergometers will allow the quantification of possible modifications in tendon architecture and mechanical properties (tendon stiffness and Young's Modulus). This will be assessed in vivo, using ultrasound images to assess tendon displacement during an incremental maximal contraction.

ReferenceCitation: Létocart AJ, Mabesoone F, Charleux F, Couppé C, Svensson RB, Marin F, Magnusson SP, Grosset JF. Muscles adaptation to aging and training: architectural changes - a randomised trial. BMC Geriatr. 2021 Jan 13;21(1):48. doi: 10.1186/s12877-020-02000-0.

lead_sponsor: Université de Technologie de Compiegne


title: Sequential Chemotherapy Prior Conditioning Reduced Intensity: Study Routine Care in Haploidentical Allogeneic Hematopoietic Stem Cells in Patients With Relapsed or Refractory Lymphoid Hematological Disorders

acronym: LY-SET-HAPLO

summary:
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option with a significant chance of healing in lymphoid hematological refractory or multiple relapses after chemotherapy. However, all patients with an indication of allo-HSC can not benefit because of two limitations: the toxicity of the treatment and graft shortage available.

For patients refractory or in relapses with an indication of allo-HSC, used the combinaison of an SET followed by the reduced-intensity allo-HSC (RIC) has shown some interesting results.

A post-transplant immune modulation with prophylactic injections of donor lymphocytes (PDLI) showed its effectiveness to decrease the risk of relapse while having a lower toxicity than chemotherapy

lead_sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation

location_facility: Service d'hématologie clinique Hôpital Saint Antoine


title: Subjective and Objective Benefits of a Contralateral Routing of Signals (CROS) System in Unilateral Cochlear Implant Recipients

summary:
The objective is to investigate the new Naida CROS device in adult recipients including chronic phases and to generate some preliminary pre-launch data.

The formal study objectives are to compare the speech intelligibility in quiet and noise when using the CROS device with the Naida CI Q70 processor versus the Naida CI processor alone in quiet and noise conditions. Subjects will be tested with and without CROS at the baseline visit and then at follow-up visits taking place one month and three months after baseline. Subjects will use the new device at home between the first two visits appointments and then will only use the Naida CI processor for two additional weeks to better evaluate the handicap of not having access to contralateral signal input. There will be four visits to the centre in total.

Subjective feedback will be collected through questionnaire like the APHAB and Speech, Spatial and Qualities of Hearing Scale (SSQ). A customised questionnaire focusing usability and benefit of the CROS will also be administered.

Additional interest of the study will be to evaluate any acclimatisation effect with the CROS device both objectively and subjectively.

primary_purpose: Device Feasibility

lead_sponsor: Advanced Bionics AG

location_facility: Groupe Hospitalier de la PITIE-SALPETRIERE


title: LUNG MRI in the Management of Idiopathic Pulmonary Fibrosis : PIC'IRM

acronym: PIC'IRM

summary: High resolution computed tomography (HRCT) plays a major role in the management of idiopathic pulmonary fibrosis (IPF) by identifying characteristic lesions of usual interstitial pneumonia (UIP). Though HRCT is the standard reference to describe pulmonary structural alterations using a non invasive technique, it is nonetheless a radiating exam which provides limited functional information regarding inflammation. In this trial, the investigators aimed to evaluate whether MRI (Magnetic Resonance Imaging) using ultra-short echotime could be an alternative to HRCT in the assessment of the four morphological criteria required to define an UIP pattern. The investigators also planned to study the clinical value of the additional informations derived from MRI such as contrasts and lung perfusion using functional MRI.

lead_sponsor: University Hospital, Bordeaux


title: Clinical Validation of SCALA, a New Rating Scale for Assessing Lateropulsion After Stroke

acronym: SCALA

summary:
Development and clinical validation of SCALA, a new rating scale for lateropulsion after stroke. A monocentric clinical study including 78 post-stroke individuals and 30 patients without stroke and/or healthy volunteers.

In order to analyze the SCALA's content validity, a Delphi-type consensus process was applied prior to clinical validation. The Delphi process, including 20 international experts, has given rise to the version of the scale to be tested clinically (SCALA-V1; Paper in preparation).


title: Suivi Prospectif Des Patients Presentant un Rhumatisme Inflammatoire Chronique

acronym: PPCRNice

summary: It is a prospective follow-up. The aim is to study the maintenance of therapeutic at 10 years and 20 years of inflammatory rheumatism (rheumatoid arthritis and spondyloarthritis)

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Medication Assessment Through Real Time Information eXchange - Distributed Pharmaceutical Record System

acronym: MATRIX-DPRS

summary: The aim of MATRIX-DPRS is to assess the clinical and organizational impacts of the use of the medication record, opened, filled and managed by pharmacists (from private office and hospital units) by hospital physicians in private and public healthcare establishments (volunteers), for three clinical contexts: anaesthesiology visit before surgery, medications abuse and emergency hospitalization, medications and elderly hospitalisations.


title: Intracardiac Flow Remodeling in Athletes

acronym: INFINITE

summary: The uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. A better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are physiological or pathological. This prospective study proposes to assess in a trained-athlete population the cardiac remodeling in response to intensive exercise training. This study is observational, we do not interfere with athlete's training.


title: Nurses Ability to Assess Visual Acuity in Geriatric Consultation

acronym: AVIGE

summary:
Nurses participate to geriatric evaluations for falling patients. For these patients, it is recommended to evaluate,especially, visual acuity but this is not currently done because it is difficult to systematically combine with an ophthalmologic consultation.

The HAS french recommendations propose to detect visual acuity deficiency using Monoyer and Parinaud scales, without specifying the professional qualification. According to the nurse competence decree of State Graduates, "sensory disorders" screening is a "non-vulnerable" examination, and can be performed by nurses. Therefore, they can use these scales, after training.

We propose to evaluate the correlation between visual acuity scores obtained by nurses in geriatric consultations and an ophthalmologist.

This study should include 204 patients over 65 years, who have fallen at least twice in the last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after the geriatric consultation.


title: Cardiovascular Variability, Heart Rate Response, and Electromyogram Power Associated With Periodic Leg Movements.

acronym: PLMS

summary: Periodic leg movements during sleep is associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between periodic leg movements severity, age, gender, electromyographic power and heart rate response associated with periodic leg movements. Drug-free patients diagnosed with periodic leg movements were included. Clinical data and 24-h polysomnography recordings were analyzed.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Hed-O-Shift: Hedonic and Neurocognitive Processes in Relation to Dietary Habits and Weight Status

acronym: Hed-O-Shift

summary:
This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the filling of two on-line questionnaires.

The first visit to the University-Hospital of Rennes, during which a blood sample will be taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry will be carried out in the Clinical Investigation Unit.

During this visit, the volunteers will also have to bring a sample of urine and faeces previously collected at home.

The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital.

Finally, the volunteers will go to the University-Hospital of Rennes for the second visit, on the Neurinfo platform, during which they will be subjected to a cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire Rennes Pontchaillou