title: Evaluation de la gêne Oculaire après Injections intravitréennes

acronym: EVAGO

summary: In this study, ocular discomfort following intravitreal injection in naïve patients will be studied, as well as the efficacy of wetting agent (Optive eyewash) to prevent ocular discomfort.

ReferenceCitation: Ba J, Peng RS, Xu D, Li YH, Shi H, Wang Q, Yu J. Intravitreal anti-VEGF injections for treating wet age-related macular degeneration: a systematic review and meta-analysis. Drug Des Devel Ther. 2015 Sep 28;9:5397-405. doi: 10.2147/DDDT.S86269. eCollection 2015.

ReferenceCitation: Pe'er J, Folberg R, Itin A, Gnessin H, Hemo I, Keshet E. Vascular endothelial growth factor upregulation in human central retinal vein occlusion. Ophthalmology. 1998 Mar;105(3):412-6. doi: 10.1016/S0161-6420(98)93020-2.

ReferenceCitation: Nghiem-Buffet S, Cohen SY. [Retinal vein occlusion: anti-VEGF treatments]. J Fr Ophtalmol. 2009 Nov;32(9):679-86. doi: 10.1016/j.jfo.2009.10.002. Epub 2009 Oct 29. French.

ReferenceCitation: Salam A, DaCosta J, Sivaprasad S. Anti-vascular endothelial growth factor agents for diabetic maculopathy. Br J Ophthalmol. 2010 Jul;94(7):821-6. doi: 10.1136/bjo.2009.163576. Epub 2009 Jun 24.

ReferenceCitation: Massin P, Bandello F, Garweg JG, Hansen LL, Harding SP, Larsen M, Mitchell P, Sharp D, Wolf-Schnurrbusch UE, Gekkieva M, Weichselberger A, Wolf S. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care. 2010 Nov;33(11):2399-405. doi: 10.2337/dc10-0493.

ReferenceCitation: Stewart MW. The clinical utility of aflibercept for diabetic macular edema. Diabetes Metab Syndr Obes. 2015 Sep 18;8:473-82. doi: 10.2147/DMSO.S72792. eCollection 2015.

ReferenceCitation: Massamba N, Elluard M, Agoune W, Guyader V, Ingram A, Pasquier B, Knoeri J. Assessment of ocular pain following ranibizumab intravitreal injection. Acta Ophthalmol. 2015 May;93(3):e231-2. doi: 10.1111/aos.12531. Epub 2014 Aug 13. No abstract available.

ReferenceCitation: Meyer CH, Krohne TU, Charbel Issa P, Liu Z, Holz FG. Routes for Drug Delivery to the Eye and Retina: Intravitreal Injections. Dev Ophthalmol. 2016;55:63-70. doi: 10.1159/000431143. Epub 2015 Oct 26.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly Trabectedin Combined With Metronomic Cyclophosphamide (CP) in Patients With Advanced Pretreated Soft-tissue Sarcomas. A Phase I/II Study From the French Sarcoma Group.

acronym: TARMIC

summary: Assessment of the efficacy and safety of trabectedin and metronomic cyclophosphamide (CP) in patients with advanced pretreated soft-tissue sarcomas, once the Maximum Tolerated Dose (MTD) have been determined (phase I trial).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
PharmaMar

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Osteopathic Support Evaluation of Fibromyalgia Patients

acronym: FMostéo

summary:
At present, the literature does not account for much of scientific data on the assessment of osteopathic intervention for patients with (Fibromyalgia) FM. The investigators propose a pilot study evaluating the efficacy of osteopathic care, consists of several osteopathic interventions in the treatment of FM, in order to improve the painful experiences of FM patients. This study must include 44 patients with FM according to (American College of Rheumatology) ACR criteria and followed the University Hospital of Caen.

The osteopathic care will last eight months and will be followed by a report three months after the end of osteopathic interventions. This in order to evaluate the effect in the short term and long term, of osteopathic care in patients with FM.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

lead_sponsor: University Hospital, Caen

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Simultaneous Determination of Blood Pressure by Oscillometry and Photoplethysmography Compared to the Standard Inert Gas Rebreathing Technique

acronym: CeCi

summary:
Main objective of the experiment is threefold: 1) to technically test a device for central blood pressure estimation for its applicability in a spaceflight-related environment and on the International Space Station. 2) Furthermore the objective is to compare central blood pressure estimates based on arterial pressure readings of different peripheral arteries. For central blood pressure estimation mathematical transfer functions as described by Karamanoglu and colleagues (11) will be used. 3) Finally the experiments' objective is to simultaneously apply phonocardiography together with ECG and carotid plethysmography to determine cardiac systolic time intervals in parabolic flight during gravity transitions.

Secondary objective of the experiment is to simultaneously measure key variables of the central circulation during gravity transitions to expand the understanding of cardiovascular regulation in weightlessness. Furthermore spirometric measurements shall be performed during a parabolic flight day to observe changes in end-expiratory CO2. Arterial CO2 content is central for cardiovascular regulation.

Our main hypothesis is that there is no difference between different methods of central arteria pressure determination.

Concerning our secondary objective, this experiment is designed as an observational study. Thus no clear hypothesis was generated but the measured cardiovascular and respiratory variables will be analysed regarding differences correlated to gravity.

enrollment_type: Anticipated

ipd_sharing: No

sponsor_collaborators:
University Hospital, Caen
Novespace

intervention_type: Other


title: Neurocognitive Performance During Space Flight. Validation of a Test Battery

acronym: NeuroCog

summary:
The main objective of this experiment is to evaluate the alterations in brain cortical activity induced by micro- and hypergravity conditions.

A secondary objective is to correlate changes in brain cortical activity and brain oxygenation level with neurocognitive performance.

Another secondary objective is to differentiate between the influences of hemodynamic and electro cortical changes and the influence of stress on cognitive performance alterations


title: Comparison Between Actually Sutureless Devices for PICC to a New Device KT FIX PLUS

acronym: KTFIXPICC

summary:
PICC (Peripherally Inserted Central Catheter) are commun used. Just one paper report morbidity with suture as fixation system for PICC (dislodgement, infection) In the guidelines it's recommended to use sutureless device. The devices actually used are unsatisfactory because of the high risk of migration, accidental removal.

A new device, called KTFIX PLUS, seem to be more secure for PICC fixation and offer the possibility to simplify the after care. This device may stay on patient for 4 weeks. Others devices may be changed 1/week.

The investigators aimed to compare morbidity between this new device and the old one. The investigators also want to perform an economic evaluation of this device and compare patient quality of life.

primary_purpose: Supportive Care

ipd_sharing: Yes

intervention_type: Device


title: Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit: a Randomized Study

summary:
Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation.

In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from one centre to another and from one study to another.

The investigators intend to compare two currently used AR techniques with regard to their ventilatory efficacy and hemodynamic safety:

An end-tidal plateau at 30 cmH20 for 30 seconds.
An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds, without exceeding 30 cmH20.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of the Alveolar Recruitment Obtained During Non-invasive Ventilation After Cardiac Surgery

acronym: ARCTICS

summary: The great majority of cardiac surgery patients develop a degree of post-operatory respiratory failure. This is due to several factors. The predominant element in the onset of this respiratory impairment is the constitution of foci of pulmonary atelectasis, caused by peroperative hypoventilation (in the presence or absence of ECC). The incidence has been evaluated at between 54% and 92%, depending on the study. The use of NIV (non-invasive ventilation) might (through the application of continuous positive expiratory pressure) help to counter the development of these atelectasic foci.

status: Terminated

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Identification of Molecular Defects in Idiopathic Cytopenia of Undetermined Significance

acronym: AMICUS

summary: The project's objective is to identify and characterize somatic mutations in cases of idiopathic cytopenia of undetermined significance (ICUS) on the basis of molecular defects found in myelodysplastic syndrome (MDS), in order to validate the hypothesis whereby ICUS may be a precursor of MDS

intervention_type: Genetic


title: Cardiovascular Comorbidities, Inflammation, Aging and Bronchiectasis

acronym: BRONCOCA

summary:
Bronchiectasis have multiple etiologies but share a similar bronchial injury associated with inflammation, which leads to a progressive lung deterioration. This disease is responsible for a frequent access to care with an exacerbation rate of 1.8 per year with a high risk of hospitalization. Natural history is marked by recurrent infectious diseases which are the main prognosis factor. This disease is associated with an inflammation rate in the lung as well as in the blood. Up to now, no study has been described comorbidities associated with this chronic disease but our hypothesis is that cardiovascular diseases will be more frequent in these patients. In fact systemic inflammation driven by bronchial infections may increase frequency of cardiovascular diseases.

The investigators decide to conduct a monocentric observational study to define the prevalence and characterization of cardiovascular comorbidities as well as markers of accelerated aging. We would like to test the hypothesis that cardiovascular comorbidities are frequent in bronchiectasis and may be associated with markers of inflammation and aging.

Phenotype of the lung disease will include: spirometry, plethysmography, DLCO measurement according to the ATS/ERS guideline. 6M walking test and echocardiography will be also performed.

Frequency of comorbidities will be calculated with data from questionnaire as well as standardized explorations.

Aging related manifestations will be measured: arterial stiffness using aortic pulse wave velocity, bone mineral density using dual energy X-ray absorptiometry. Appendicular skeletal muscle mass and grip test were also performed.

Blood test were also performed to measure inflammatory markers, cytokines and length of telomere in circulating leucocytes.

status: Active, not recruiting

sponsor_collaborators: Centre Hospitalier Intercommunal Creteil

status_simplified: Ongoing


title: Impact of DietarY and LIfestyle Risk Factors on Colorectal Cancer Screening (IDYLIC Study). Is it Possible to Target Risk Subjects by Using a Predictive Score?

acronym: IDYLIC

summary: The main purpose of our project is to construct a lifestyle score based on a short questionnaire easy to complete and to validate it among participants in mass screening for colorectal cancer in Maine and Loire department over the next 2 years (2012 and 2013). We will evaluate the ability of our score to identify subjects with colorectal cancer diagnosed by the screening procedure (Hemoccult II ®, and colonoscopy if the test result is positive). Colorectal cancer will be the primary outcome for the assessment of the score's performance. The secondary endpoint will focus on colorectal adenomas diagnosed by the same procedure. Our secondary objectives are to test a second weighting system, evaluate the benefit in terms of predictive performance to add to the lifestyle score other dietary factors among that have a probable link with the risk of colorectal cancer, determine the acceptability of the questionnaire and to estimate by a cost-utility analysis the impact of applying a strategy of targeted screening using the developed score.

lead_sponsor: University Hospital, Angers


title: Physiopathological and Therapeutic Value of microRNA in the Progression of Carotid Artery Plaques: Carotid Protocol and microRNA

summary: Molecular analysis of the atheroma plaque. Screening for a novel biomarker of carotid status.


title: Children Severe Traumatic Skin Lesions and Functional Outcome

summary: Traumatic skin lesions require an adapted and early patient care management

time_perspective: Retrospective


title: Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome

acronym: PRADOTIM

summary: The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.

lead_sponsor: University Hospital, Toulouse

location_facility: Centre de référence Prader-Willi - Hôpital Purpan


title: Plasma Aldosterone Levels and Atrial Fibrillation Reduction (ALDO-AF Study)

acronym: ALDO-AF

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing prevalence. Two main techniques are used today to restore sinus rhythm: electrical cardioversion and radiofrequency ablation.

Radiofrequency ablation has become a recognized and effective treatment of AF. Despite a relatively high success rate (about 80%), a substantial number of patients require a second procedure to obtain sinus rhythm. Many publications have led to the study of predictors of failure of this ablation factors (BMI, uncontrolled hypertension, size of the OG...) but to date no parameter is reliable and usable in daily practice.

It is the same for electrical cardioversion. Despite a relatively high immediate success rate of approximately 80%, a significant number of patient relapse arrhythmia in short and long term. Many publications have led to the study of predictive factors of failure (seniority and type of AF, uncontrolled hypertension, size of the OG, mitral valve disease...) but so far the results are disappointing.

In AF patients with heart disease underlying, it has been well demonstrated that the renin-angiotensin system (RAAS) was strongly activated. In addition, it is now well established that elevated plasma aldosterone as in primary hyperaldosteronism is associated with a significantly increased risk of occurrence of cardiovascular events. The high plasma concentrations were also highlighted in the acute phase of myocardial infarction, or heart failure and are associated with an increase in major cardiovascular event rate, especially arrhythmias. In some experimental models of heart failure, it has been demonstrated a suppression of the occurrence of spontaneous FA by an anti-aldosterone treatment. The arrhythmogenic effect of aldosterone has also been shown in animal models. All these results indicate a potential role of aldosterone in the genesis of an arrhythmogenic substrate and the FA.

The hypothesis of this study is that aldosterone plasma levels in pre-reduced patients is predictive of recurrence risk of atrial fibrillation or other supraventricular tachycardias (flutter or atrial tachycardia) after FA reduction, either in using a radiofrequency ablation or via electrical cardioversion.


title: Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database

acronym: AZITHRO

summary:
Azithromycin is an antibiotic currently prescribed continuously in cystic fibrosis patients. It was shown that this treatment taken every day or every week for 12 months, can improve the respiratory state of patients. From the second year of treatment, it would appear there is more profit to continue such treatment.

The main objective is to study the association between continuous use of azithromycin and lung function measured by Forced expiratory volume in one second (FEV1), after two years of treatment.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet


title: Diagnostic Ability of Diffusion MRI and Diffusion Tensor in Renal Graft Biopsies: Pilot Study

summary:
While renal graft outcomes were really improved for the last decade, long time outcomes remains stable. Indeed, at 10 years after transplantation, the renal graft survival rate reaches 50%. The chronic allograft nephropathy is the main cause of renal graft loss. Other features such as acute allograft rejection, delayed renal recovery and anti-human leukocyte antigen (anti-HLA) antibodies are associated with poor renal graft survival prognosis. Renal graft protocol biopsies at 3 and 12 months after transplantation are valuable to detect precociously renal injuries at a reversible stage before clinical manifestation. However, renal biopsy is an invasive examination with hemorrhagic risk. Diffusion MRI could be a non-invasive diagnostic tool allowing the early detection of renal injuries, especially allograft rejection without hemorrhagic risk. This tool could be applied routinely to the renal allograft recipient in replacement of protocol biopsies.

Here, aim of this study is to correlate the results from diffusion MRI of renal graft with pathologic findings from protocol renal graft biopsies.

In this view, the investigators include prospectively all recipients of renal transplantation who beneficiate of a protocol renal graft biopsy without barrier to peform MRI examination. Thus, the investigators exclude patients who are not be able to beneficiate of a MRI examination and patient obstacle to renal graft biopsy.

Expected results are the Banff classification from the histopathologic analysis of biopsies. The expected results for MRI examination are signal intensity, diffusive coefficient, anisotropy fraction and change of the diffusion way. Next, the investigators search an association between these features by statistical analysis (Wilcoxon test, Chi², Fisher, Pearson or Spearman).

The investigators performed this study since 01/06/2014 and projected end-time to 01/06/2017.

primary_purpose: Diagnostic

lead_sponsor: CHU de Reims


title: Analysis of the Impact of Patent Ductus Arteriosus on Brain Function in Preterm Neonates: Multimodal Approach Integrating EEG-NIRS, Ultrasound and Clinical Data

acronym: NNP-MULTIMODAL

summary:
This project corresponds to the main field of research of the investigators's laboratory concerning analysis of cerebral electrometabolic and haemodynamic activity in neonates. In this context, the investigators have developed know-how and specific acquisition and analysis tools (2 patents and several publications), allowing them to apply this know-how in children with patent ductus arteriosus.

Patent ductus arteriosus after birth is characterized by shunting of a variable proportion of cardiac output towards the pulmonary circulation. The direct consequences of this shunting are: (i) overload of the pulmonary vasculature and left heart chambers, increasing the risk of left heart failure, haemorrhagic pulmonary oedema and late respiratory complications such as bronchopulmonary dysplasia; (ii) in contrast with the pulmonary circulation, other systemic organs are deprived of part of their normal perfusion and are subject to ischaemic hypoxia; the resulting neuronal hypoxia rapidly leads to metabolic and electrical dysfunction, the analysis of which constitutes one of the objectives of this project.

primary_purpose: Basic Science


title: Clinical Significance of Antiphospholipid Antibodies in Healthy Subjects: Study of Their Association With Cardiovascular Risk Factors, Markers of Arterial Inflammation and Markers of Oxidative Stress

acronym: SAPL

summary:
Antiphospholipid (APL) antibodies are a heterogeneous family of auto-antibodies, predominantly represented by anticardiolipin (ACL) antibodies and lupus anticoagulant (LA). Antiphospholipid syndrome (APS) is defined as the presence of APL associated with venous and/or arterial thrombosis or repeated foetal loss. APS may be either primary or secondary to an autoimmune disease, mainly systemic lupus erythematosus (SLE). However, other than in the context of APS, APL can also be observed in various clinical situations and in healthy subjects. Published studies have reported a variable prevalence of APL in healthy subjects, essentially ACL and/or LA, and their clinical significance currently remains unclear.

Several studies have highlighted the link between APL and atherosclerosis. It therefore appears interesting to more specifically study the association between the presence of APL and the presence of cardiovascular risk factors in a population of healthy subjects. Atherosclerosis is currently considered to be a chronic inflammatory disease arising from a complex interaction between atherogenic plasma factors and cells of the arterial wall. Several inflammatory markers are now known to be associated with cardiovascular risk. Lipid peroxidation also plays a major role during the atherogenesis process. It will therefore also be important to correlate APL with markers of vascular inflammation and markers of oxidative stress.

A prospective case-control study will therefore be conducted on 1,500 healthy blood donors. Subjects screened APL-positive will be compared to APL-negative subjects in terms of cardiovascular risk factors (cardiovascular risk per se, the presence of cardiovascular disease will not be studied). In the context of a blood donation, all subjects wishing to participate in this study will attend a medical interview and a clinical examination during which various data will be collected, mainly the presence of cardiovascular risk factors. A blood sample will also be taken to assay the various laboratory markers studied.

This study should provide a better understanding of the role of APL in healthy subjects and more clearly specify their possible link with atherosclerosis in this population.

intervention_type: Biological


title: Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life

acronym: PREMARISQ

summary: Preterm neonates less than 32 weeks of gestational age admitted at birth to the Neonatal Medicine unit will be included after informing the parents. Abdominal skin and peripheral (arm or leg) and incubator air temperatures and relative humidity will be obtained from data recorded by the incubator without using any additional transducer compared to standard care. Pulse and respiratory rate, blood pressure, the incidence of apnoeas and sleep organization will also be recorded from routine monitoring. A case report form and a wide-angle video recording of the infant's room will allow description of the type of care, determine the duration of care and the impact on incubator function. Data will be recorded for the first 7 days of life of the preterm neonate.


title: HSP90 as a Predictive Marker of the Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Carcinomatosis From Ovarian Origin.

summary: Peritoneal carcinomatosis (PC) is the stage III of the FIGO ovarian cancer staging. It corresponds to an advanced stage with a relative 5 year survival rate of 52%. The multimodal treatment approach combines neoadjuvant chemotherapy, cytoreductive surgery of macroscopic lesions, and hyperthermic intraperitoneal chemotherapy (HIPEC). It has significantly improved survival rate in patients with ovarian PC and decreased recurrence and mortality rate by 21%. The efficacy of HIPEC is based on chemotherapy potentiated by the hyperthermia (43°). However, the cellular mechanisms involved are not fully understood, but they include cell death pathways and heat shock proteins (Hsp70 and Hsp90). RICCI et al. showed, based on pre-clinical models, that the efficacy of HIPEC was partly due to the overexpression and exposure of HSP90 on the cell surface leaded to an anti-cancer immune response. The aims of this study are to validate these findings in tissue samples of patients with ovarian PC. We will constitute a bank of isolated tumor samples before and after HIPEC and measure postoperative HSP90 serum levels in order to establish if they are predictive of a response. HSPs expression on the cancer cell surface will be determined by flow cytometry. Forty-four patients will be included. Elucidating the underlying mechanisms of HIPEC will broaden therapeutic possibilities including the use of new immunotherapy. The multimodal approach could improve the efficacy of HIPEC with a minimal systemic toxicity.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration (IMMUNOSEPSIS)

acronym: IMMUNOSEPSIS

summary:
Septic syndromes (systemic inflammatory response associated with infection) remain a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units. While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immunologic response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (CMV or HSV) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. Both arms of immunity (innate and adaptive) are indeed markedly suppressed (including enhanced leukocyte apoptosis, lymphocyte anergy and deactivated monocyte functions). New promising therapeutic avenues are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (IFNg, GM-CSF, IL-7) however relies on the investigators capacity in identifying the patients who could benefit from it, as there is no clinical sign of immune dysfunctions. The main objectives are:

to identify the best biomarkers for sepsis-induced immunosuppression and
to evaluate ex vivo whether drugs could rejuvenate immune functions.

ReferenceType: derived

ReferenceCitation: Bodinier M, Peronnet E, Brengel-Pesce K, Conti F, Rimmele T, Textoris J, Vedrine C, Quemeneur L, Griffiths AD, Tan LK, Venet F, Maucort-Boulch D, Monneret G; REALISM study group. Monocyte Trajectories Endotypes Are Associated With Worsening in Septic Patients. Front Immunol. 2021 Nov 29;12:795052. doi: 10.3389/fimmu.2021.795052. eCollection 2021.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

location_facility: Hospices Civils de Lyon - Hopital Edouard Herriot


title: Impact of Proportional Assisted Ventilation on Dyspnea and Asynchrony in Mechanically Ventilated Patients

acronym: DYS-PAV

summary:
Rational. The mismatch between the activity of the respiratory muscles and the assistance delivered by the ventilator results in patient-ventilator disharmony, which is commonly observed in ICU patients and is associated with dyspnea and patient-ventilator asynchrony. Both dyspnea and asynchrony are in turn associated with a worse prognosis. Unlike conventional modes of mechanical ventilation, such as pressure support ventilation (PSV) that deliver a constant level of assistance regardless of the patient effort, Proportional Assisted Ventilation (PAV) adjusts the level of ventilator assistance to the activity of respiratory muscles. To date, data on the impact of PAV on dyspnea and patient ventilator asynchrony are scarce and most studies have been conducted in healthy subjects or in ICU patients who had no severe dyspnea nor severe asynchrony. To our knowledge, there are no data in patients with severe patient-ventilator dysharmony.

Study Aim. To evaluate the impact of PAV on dyspnea and patient-ventilator asynchrony in ICU mechanically ventilated patients in intensive care with severe patient-ventilator disharmony defined as either severe dyspnea or severe patient-ventilator asynchrony.

Patients and Methods. Will be included 24 ICU mechanically ventilated patient exhibiting severe patient-ventilator dysharmony with PSV. The intensity of dyspnea will be assessed by the VAS, the ICRDOSS and by the electromyogram of extradiaphragmatic inspiratory muscles and pre inspiratory potential collected from the electroencephalogram. The prevalence of patient-ventilator asynchrony will be quantified.

Expected results. It is anticipated that the switch from PSV to PAV will decrease the prevalence and severity of dyspnea and the prevalence of patient-ventilator asynchrony.

ReferenceType: result

ReferenceCitation: Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.

ReferenceCitation: Campbell ML. Psychometric testing of a respiratory distress observation scale. J Palliat Med. 2008 Jan-Feb;11(1):44-50. doi: 10.1089/jpm.2007.0090.

ReferenceCitation: Campbell ML, Templin T, Walch J. A Respiratory Distress Observation Scale for patients unable to self-report dyspnea. J Palliat Med. 2010 Mar;13(3):285-90. doi: 10.1089/jpm.2009.0229.

ReferenceCitation: Raux M, Ray P, Prella M, Duguet A, Demoule A, Similowski T. Cerebral cortex activation during experimentally induced ventilator fighting in normal humans receiving noninvasive mechanical ventilation. Anesthesiology. 2007 Nov;107(5):746-55. doi: 10.1097/01.anes.0000287005.58761.e8.

ReferenceCitation: Raux M, Straus C, Redolfi S, Morelot-Panzini C, Couturier A, Hug F, Similowski T. Electroencephalographic evidence for pre-motor cortex activation during inspiratory loading in humans. J Physiol. 2007 Jan 15;578(Pt 2):569-78. doi: 10.1113/jphysiol.2006.120246. Epub 2006 Nov 16.

ReferenceCitation: Carteaux G, Mancebo J, Mercat A, Dellamonica J, Richard JC, Aguirre-Bermeo H, Kouatchet A, Beduneau G, Thille AW, Brochard L. Bedside adjustment of proportional assist ventilation to target a predefined range of respiratory effort. Crit Care Med. 2013 Sep;41(9):2125-32. doi: 10.1097/CCM.0b013e31828a42e5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1.

ReferenceCitation: Dres M, Schmidt M, Ferre A, Mayaux J, Similowski T, Demoule A. Diaphragm electromyographic activity as a predictor of weaning failure. Intensive Care Med. 2012 Dec;38(12):2017-25. doi: 10.1007/s00134-012-2700-3. Epub 2012 Sep 26.

ReferenceCitation: Hug F, Raux M, Morelot-Panzini C, Similowski T. Surface EMG to assess and quantify upper airway dilators activity during non-invasive ventilation. Respir Physiol Neurobiol. 2011 Sep 15;178(2):341-5. doi: 10.1016/j.resp.2011.06.007. Epub 2011 Jun 15.

ReferenceCitation: Schmidt M, Chiti L, Hug F, Demoule A, Similowski T. Surface electromyogram of inspiratory muscles: a possible routine monitoring tool in the intensive care unit. Br J Anaesth. 2011 Jun;106(6):913-4. doi: 10.1093/bja/aer141. No abstract available.

ReferenceCitation: Schmidt M, Kindler F, Gottfried SB, Raux M, Hug F, Similowski T, Demoule A. Dyspnea and surface inspiratory electromyograms in mechanically ventilated patients. Intensive Care Med. 2013 Aug;39(8):1368-76. doi: 10.1007/s00134-013-2910-3. Epub 2013 Apr 11.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Springer

ReferenceCitation: Gayan-Ramirez G, Testelmans D, Maes K, Racz GZ, Cadot P, Zador E, Wuytack F, Decramer M. Intermittent spontaneous breathing protects the rat diaphragm from mechanical ventilation effects. Crit Care Med. 2005 Dec;33(12):2804-9. doi: 10.1097/01.ccm.0000191250.32988.a3.

ReferenceCitation: Sassoon CS, Zhu E, Caiozzo VJ. Assist-control mechanical ventilation attenuates ventilator-induced diaphragmatic dysfunction. Am J Respir Crit Care Med. 2004 Sep 15;170(6):626-32. doi: 10.1164/rccm.200401-042OC. Epub 2004 Jun 16.

ReferenceCitation: Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

ReferenceCitation: Putensen C, Zech S, Wrigge H, Zinserling J, Stuber F, Von Spiegel T, Mutz N. Long-term effects of spontaneous breathing during ventilatory support in patients with acute lung injury. Am J Respir Crit Care Med. 2001 Jul 1;164(1):43-9. doi: 10.1164/ajrccm.164.1.2001078.

ReferenceCitation: Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.

ReferenceCitation: Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, Gonzalez M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montanez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. doi: 10.1164/rccm.200706-893OC. Epub 2007 Oct 25.

ReferenceCitation: Schmidt M, Banzett RB, Raux M, Morelot-Panzini C, Dangers L, Similowski T, Demoule A. Unrecognized suffering in the ICU: addressing dyspnea in mechanically ventilated patients. Intensive Care Med. 2014 Jan;40(1):1-10. doi: 10.1007/s00134-013-3117-3. Epub 2013 Oct 17.

oa_colors: green other

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

repositories_concat: PubMed Central

ReferenceCitation: Schmidt M, Demoule A, Polito A, Porchet R, Aboab J, Siami S, Morelot-Panzini C, Similowski T, Sharshar T. Dyspnea in mechanically ventilated critically ill patients. Crit Care Med. 2011 Sep;39(9):2059-65. doi: 10.1097/CCM.0b013e31821e8779.

ReferenceCitation: de Miranda S, Pochard F, Chaize M, Megarbane B, Cuvelier A, Bele N, Gonzalez-Bermejo J, Aboab J, Lautrette A, Lemiale V, Roche N, Thirion M, Chevret S, Schlemmer B, Similowski T, Azoulay E. Postintensive care unit psychological burden in patients with chronic obstructive pulmonary disease and informal caregivers: A multicenter study. Crit Care Med. 2011 Jan;39(1):112-8. doi: 10.1097/CCM.0b013e3181feb824.

ReferenceCitation: Rotondi AJ, Chelluri L, Sirio C, Mendelsohn A, Schulz R, Belle S, Im K, Donahoe M, Pinsky MR. Patients' recollections of stressful experiences while receiving prolonged mechanical ventilation in an intensive care unit. Crit Care Med. 2002 Apr;30(4):746-52. doi: 10.1097/00003246-200204000-00004.

ReferenceCitation: Pochard F, Lanore JJ, Bellivier F, Ferrand I, Mira JP, Belghith M, Brunet F, Dhainaut JF. Subjective psychological status of severely ill patients discharged from mechanical ventilation. Clin Intensive Care. 1995;6(2):57-61.

ReferenceCitation: Cuthbertson BH, Hull A, Strachan M, Scott J. Post-traumatic stress disorder after critical illness requiring general intensive care. Intensive Care Med. 2004 Mar;30(3):450-5. doi: 10.1007/s00134-003-2004-8. Epub 2003 Sep 5.

ReferenceCitation: Dreyfuss D, Soler P, Basset G, Saumon G. High inflation pressure pulmonary edema. Respective effects of high airway pressure, high tidal volume, and positive end-expiratory pressure. Am Rev Respir Dis. 1988 May;137(5):1159-64. doi: 10.1164/ajrccm/137.5.1159.

ReferenceCitation: Alexopoulou C, Kondili E, Plataki M, Georgopoulos D. Patient-ventilator synchrony and sleep quality with proportional assist and pressure support ventilation. Intensive Care Med. 2013 Jun;39(6):1040-7. doi: 10.1007/s00134-013-2850-y. Epub 2013 Feb 16.

ReferenceCitation: Younes M, Webster K, Kun J, Roberts D, Masiowski B. A method for measuring passive elastance during proportional assist ventilation. Am J Respir Crit Care Med. 2001 Jul 1;164(1):50-60. doi: 10.1164/ajrccm.164.1.2010068.

ReferenceCitation: Younes M, Kun J, Masiowski B, Webster K, Roberts D. A method for noninvasive determination of inspiratory resistance during proportional assist ventilation. Am J Respir Crit Care Med. 2001 Mar;163(4):829-39. doi: 10.1164/ajrccm.163.4.2005063.

ReferenceCitation: Younes M, Puddy A, Roberts D, Light RB, Quesada A, Taylor K, Oppenheimer L, Cramp H. Proportional assist ventilation. Results of an initial clinical trial. Am Rev Respir Dis. 1992 Jan;145(1):121-9. doi: 10.1164/ajrccm/145.1.121.

ReferenceCitation: Younes M. Proportional assist ventilation, a new approach to ventilatory support. Theory. Am Rev Respir Dis. 1992 Jan;145(1):114-20. doi: 10.1164/ajrccm/145.1.114.

ReferenceCitation: Wysocki M, Meshaka P, Richard JC, Similowski T. Proportional-assist ventilation compared with pressure-support ventilation during exercise in volunteers with external thoracic restriction. Crit Care Med. 2004 Feb;32(2):409-14. doi: 10.1097/01.CCM.0000108869.12426.51.

ReferenceCitation: Ranieri VM, Giuliani R, Mascia L, Grasso S, Petruzzelli V, Puntillo N, Perchiazzi G, Fiore T, Brienza A. Patient-ventilator interaction during acute hypercapnia: pressure-support vs. proportional-assist ventilation. J Appl Physiol (1985). 1996 Jul;81(1):426-36. doi: 10.1152/jappl.1996.81.1.426.

ReferenceCitation: Grasso S, Puntillo F, Mascia L, Ancona G, Fiore T, Bruno F, Slutsky AS, Ranieri VM. Compensation for increase in respiratory workload during mechanical ventilation. Pressure-support versus proportional-assist ventilation. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):819-26. doi: 10.1164/ajrccm.161.3.9902065.

ReferenceCitation: Kondili E, Prinianakis G, Alexopoulou C, Vakouti E, Klimathianaki M, Georgopoulos D. Respiratory load compensation during mechanical ventilation--proportional assist ventilation with load-adjustable gain factors versus pressure support. Intensive Care Med. 2006 May;32(5):692-9. doi: 10.1007/s00134-006-0110-0. Epub 2006 Mar 8.

ReferenceCitation: Giannouli E, Webster K, Roberts D, Younes M. Response of ventilator-dependent patients to different levels of pressure support and proportional assist. Am J Respir Crit Care Med. 1999 Jun;159(6):1716-25. doi: 10.1164/ajrccm.159.6.9704025.

ReferenceCitation: Appendini L, Purro A, Gudjonsdottir M, Baderna P, Patessio A, Zanaboni S, Donner CF, Rossi A. Physiologic response of ventilator-dependent patients with chronic obstructive pulmonary disease to proportional assist ventilation and continuous positive airway pressure. Am J Respir Crit Care Med. 1999 May;159(5 Pt 1):1510-7. doi: 10.1164/ajrccm.159.5.9804130.

ReferenceCitation: Passam F, Hoing S, Prinianakis G, Siafakas N, Milic-Emili J, Georgopoulos D. Effect of different levels of pressure support and proportional assist ventilation on breathing pattern, work of breathing and gas exchange in mechanically ventilated hypercapnic COPD patients with acute respiratory failure. Respiration. 2003 Jul-Aug;70(4):355-61. doi: 10.1159/000072897.

ReferenceCitation: Xirouchaki N, Kondili E, Vaporidi K, Xirouchakis G, Klimathianaki M, Gavriilidis G, Alexandopoulou E, Plataki M, Alexopoulou C, Georgopoulos D. Proportional assist ventilation with load-adjustable gain factors in critically ill patients: comparison with pressure support. Intensive Care Med. 2008 Nov;34(11):2026-34. doi: 10.1007/s00134-008-1209-2. Epub 2008 Jul 8.

ReferenceCitation: Bosma K, Ferreyra G, Ambrogio C, Pasero D, Mirabella L, Braghiroli A, Appendini L, Mascia L, Ranieri VM. Patient-ventilator interaction and sleep in mechanically ventilated patients: pressure support versus proportional assist ventilation. Crit Care Med. 2007 Apr;35(4):1048-54. doi: 10.1097/01.CCM.0000260055.64235.7C.

ReferenceCitation: Fernandez-Vivas M, Caturla-Such J, Gonzalez de la Rosa J, Acosta-Escribano J, Alvarez-Sanchez B, Canovas-Robles J. Noninvasive pressure support versus proportional assist ventilation in acute respiratory failure. Intensive Care Med. 2003 Jul;29(7):1126-33. doi: 10.1007/s00134-003-1768-1. Epub 2003 Jun 12.

ReferenceCitation: Gay PC, Hess DR, Hill NS. Noninvasive proportional assist ventilation for acute respiratory insufficiency. Comparison with pressure support ventilation. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1606-11. doi: 10.1164/ajrccm.164.9.2011119.

ReferenceCitation: Hernandez P, Maltais F, Gursahaney A, Leblanc P, Gottfried SB. Proportional assist ventilation may improve exercise performance in severe chronic obstructive pulmonary disease. J Cardiopulm Rehabil. 2001 May-Jun;21(3):135-42. doi: 10.1097/00008483-200105000-00003.

ReferenceCitation: Wysocki M, Richard JC, Meshaka P. Noninvasive proportional assist ventilation compared with noninvasive pressure support ventilation in hypercapnic acute respiratory failure. Crit Care Med. 2002 Feb;30(2):323-9. doi: 10.1097/00003246-200202000-00010.

ReferenceCitation: Mols G, von Ungern-Sternberg B, Rohr E, Haberthur C, Geiger K, Guttmann J. Respiratory comfort and breathing pattern during volume proportional assist ventilation and pressure support ventilation: a study on volunteers with artificially reduced compliance. Crit Care Med. 2000 Jun;28(6):1940-6. doi: 10.1097/00003246-200006000-00042.

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

location_facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière


title: Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study

acronym: RaVem

summary: At the time of birth, nearly 5% of children are in breech presentation. This type of presentation requires a medical environment and leads to more frequent use of Caesarean sections. This is why the external version can be proposed, usually from the 36th week. Its success rate is 40%, and is usually performed under simple sedation. One of the causes of failure is the lack of relaxation of the uterus, which could be higher in case of deeper anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary and secondary objectives.


title: Evaluation of an Innovative Medical Device Made of a Bimodal Endoscopic Imager and of a Software for Panoramic Images Building of the Bladder Inner Wall (French National Research Agency, CyPaM2 Project, ANR-11-TECS-001) (CyPaM2)

summary:
This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of the inner bladder using white light and blue light excitations and (ii) high resolution panoramic images of the bladder inner wall.

All participants will undergo fluorescence cystoscopy: the first half using first a reference medical device for fluorescence cystoscopy already on the market then using the innovative device specifically developped for the CyPaM2 project.

The other half will undergo fluorescence cystoscopy using first the innovative then the reference medical device.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Amouroux M, Salleron J, Huin-Schohn C, Ali S, Berthaud S, Rizo P, Schneider S, Vever-Bizet C, Bourg-Heckly G, Guillemin F, Le Coupanec P, Galbrun E, Daouk J, Daul C, Blondel W, Eschwege P. Clinical evaluation of a device providing simultaneous white-light and fluorescence video streams as well as panoramic imaging during fluorescence assisted-transurethral resection of bladder cancer. J Opt Soc Am A Opt Image Sci Vis. 2019 Nov 1;36(11):C62-C68. doi: 10.1364/JOSAA.36.000C62.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases

summary:
The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.

The management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensation, the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.

The objective of this pilot study was designed to evaluate the cerebral plasticity of patients who undergo bilateral hand allograph

location_facility: Service d'Urologie et Chirurgie de la Transplantion


title: Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease

acronym: GERIOX

summary:
According to several reports, the oxidative stress and the nutrition could have an impact in the Alzheimer disease.

The association of these two parameters measurements and the cognitive impairment decline could help in a predictive diagnosis of cognitive decline evolution in patients presenting cognitive disorders.

This is a monocentric prospective "routine care" clinical trial on patients showing cognitive troubles especially memory complaints.

The objective is to demonstrate a correlation between oxydative stress and nutrition biomarkers and the clinical evolution of patients complaining of cognitive impairments.

The neuropsychologic data collection (the mini mental Status Examination (MMSE), the clock test, the Grober-Buschke test (FCSR-IR), the executive function evaluated by the Trail making test, and the medical imaging (by magnetic resonance imaging (MRI) or tomography in case of MRI contraindication) will be realized during the study inclusion phase in the usual intake of patients. Whole blood samples for the oxydative and nutrition biomarkers measurements will be taken at the study inclusion day during the stay at the Day hospital dedicated to the routine intake of patients issued from the memory consultation.

In this study, the principal evaluation criteria will be the MMSE score evolution during the 60 months of the patients follow-up, measured during the routine visits scheduled approximately every 6 months, according to the french national authority for health recommendations. It will allow evaluating the correlation between the cognitive decline evolution measured by MMSE during the Alzheimer disease or related diseases method during the 2 years follow-up, and the oxydative stress blood markers.

status: Recruiting

location_facility: Service de Médecine Gériatrique. Groupement Hospitalier Sud. Hospices Civils de Lyon.


title: Characteristics and Outcomes of Odontoid Fragility Fractures in Elderly

acronym: FOOP

summary:
Usually, cervical spine fractures are not considered as osteoporotic fractures. However, recent studies show that odontoid fractures are the most common fractures of the cervical spine in elderly and may occur in a context of low trauma energy. Thus, the goal of this observationnal study is :

to describe the different type of odontoid fracture and to characterize bone status in elderly patient (>65 y) who underwent odontoid fracture in a context of low trauma energy.
To describe short and long term outcomes

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: 3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

summary:
Pulmonary hypertension is a rare and severe disease, affecting a young population. Survival is very poor and has been closely related to right ventricular dysfunction. Current prognostic equations rely mostly on right heart catheterization data. The identification of simple echocardiographic prognostic factor is urgently needed. It could help identifying with a non invasive method, high risk patients who could benefit from an intensive specific therapy. 3D right ventricular imaging is a new echocardiographic tool which provides RV volumic analysis, RV ejection fraction, overcoming the classical limits of 2D ultrasound.

The aim of this study is to validate a new software for 3D analysis of the right ventricle and assess its prognostic role in pulmonary hypertension.

To do so, the investigators will realize a prospective monocentric longitudinal cohort study, including 100 pulmonary hypertension patients. Echocardiographic data will be collected at baseline and after 6 months.

ReferenceCitation: Moceri P, Duchateau N, Baudouy D, Squara F, Bun SS, Ferrari E, Sermesant M. Additional prognostic value of echocardiographic follow-up in pulmonary hypertension-role of 3D right ventricular area strain. Eur Heart J Cardiovasc Imaging. 2022 Oct 20;23(11):1562-1572. doi: 10.1093/ehjci/jeab240.

oa_host_type: repository

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

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press


title: Is There a Change in the Total Metabolism Over 24 Hours for Narcoleptic Children That Could Explain Their Tendency to Obesity?

acronym: Narcolepsy

summary:
A significant weight gain and obesity are observed for most patients with narcolepsy, mainly at the beginning of the disease and narcolepsy in young children. There is no specific study on the population and the consequences of overweight in the lives of these long-term patients. Narcoleptic patients gain weight significantly at the onset of their illness. It is also known that weight gain is not related to the treatment of narcolepsy. The etiology of obesity in narcoleptic patients is not established. Several assumptions were made (physical activity, leptin diet, metabolism). The reason and the pathophysiology of overweight and obesity in this population therefore remain unclear.

In this study, potential change in the total metabolism (24h) for narcoleptic children that could explain their tendency to obesity will be assessed ?

location_facility: Service d'Exploration et pathologie du sommeil, Hôpital Femme Mère Enfant


title: Observational Study of Incident Patients With Pre Capillary Pulmonary Hypertension and Interstitial Lung Disease

summary:
HYPID-2 study is an extension of HYPID study (NCT01443598) :

HYPID-2 is also an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization.

It concerns only incident patients (i.e patients included within 6 months after PH diagnosis) whereas HYPID concerned prevalent and incident cases.

The primary aim is the same than HYPID : identify prognostic factors

lead_sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires


type: Other Identifier

title: Comparison of Mood Disorders Screening Scales in Geriatric Oncology

acronym: Thymog

summary:
The objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the GDS15 (15 issues closed binary response seeking signs of depression ) the HADS (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ).

The prospective observational study will be conducted in parallel on two sites ( University Hospital Centre and François Baclesse ) after informed patient information.

It will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .

sponsor_collaborators:
University Hospital, Caen
Centre Francois Baclesse


title: Biomarkers for the Diagnosis of Transient Ischemic Attack

acronym: MAESTRO

summary:
A transient ischemic attack (TIA) should be considered an emergency prevention opportunity in order to avoid recurrence as cerebral infarction (CI) serious (fatal or disabling). Indeed, about 20% of patients who have IC had in previous days or weeks, a TIA, which can be defined as a brief episode of cerebral dysfunction (or eye) do not result in permanent brain damage and thus no sequelae. Moreover, about 20% of ischemic events observed in practice are AIT. Despite the progress achieved in the treatment in the acute phase of an IC, prevention remains the most effective way to fight against this disease. This prevention can be put in place before the occurrence of a first IC, or after a first IC, especially when minor as a TIA.

However, the diagnosis of TIA remains particularly difficult and it is necessary now to identify new tools for the diagnosis of transient ischemic attack. Our study focused on the identification of one or more molecules (called biological markers or biomarkers) present in the bloodstream of patients, which will serve to facilitate the differential diagnosis of patients with TIA.


title: Evaluation of Medical and Economic Incidence of Hypnosis in Conization

acronym: HYPNONISAT°

summary:
Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in Anesthesia's field.

This study wants to prove that the Hypnosis in conization are cheaper.

ReferenceCitation: Defechereux T, Faymonville ME, Joris J, Hamoir E, Moscato A, Meurisse M. [Surgery under hypnosedation. A new therapeutic approach to hyperparathyroidism]. Ann Chir. 1998;52(5):439-43. French.

ReferenceCitation: Sefiani T, Uscain M, Sany JL, Grousseau D, Marchand P, Villate D, Vincent JL. [Laparoscopy under local anaesthesia and hypnoanaesthesia about 35 cholecystectomies and 15 inguinal hernia repair]. Ann Fr Anesth Reanim. 2004 Nov;23(11):1093-101. doi: 10.1016/j.annfar.2004.08.014. French.

ReferenceCitation: Defechereux T, Degauque C, Fumal I, Faymonville ME, Joris J, Hamoir E, Meurisse M. [[Hypnosedation, a new method of anesthesia for cervical endocrine surgery. Prospective randomized study]. Ann Chir. 2000 Jul;125(6):539-46. doi: 10.1016/s0003-3944(00)00238-8. French.

ReferenceCitation: Faymonville EM, Mambourg HP, Joris J, Vrijens B, Fissette J, Albert A, Lamy M. Psychological approaches during conscious sedation. Hypnosis versus stress reducing strategies: a prospective randomized study. Pain. 1997 Dec;73(3):361-367. doi: 10.1016/S0304-3959(97)00122-X.

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble


title: Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)

acronym: LANGLAT

summary: Recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. The reference test used up until very recently was the Wada test, which consisted of injecting an anaesthetic (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in order to determine the predominant cerebral hemisphere for language. This invasive test has been progressively replaced by fMRI, which is nevertheless difficult to perform in children under the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast with fMRI, can be easily repeated and allows simple investigation of the various facets of language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development of language structures.


title: Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study

acronym: GPCBasedow

summary: Lymphocytic thyroiditis is the most common autoimmune disease, usually affecting young women. Although the aetiology and pathogenesis remain obscure, the most widely accepted hypothesis is an interaction between a genetic predisposition and an environmental trigger factor such as viral infection. Parvovirus infections have been proposed as trigger factors for Hashimoto's thyroiditis and Graves' disease.


title: Evaluation of Lactoferrin, Procalcitonin and Aution® Urine Dipsticks for the Diagnosis of Spontaneous Bacterial Peritonitis in Cirrhotic Patients

summary: Bacterial infections are a major cause of mortality in cirrhotic patients in the context of gastrointestinal bleeding or spontaneous bacterial peritonitis (SBP). Rapid diagnosis of SBP is therefore an important research goal because the gold standard neutrophil count in ascitic fluid cannot be performed 24 hours a day in all healthcare structures. The use of urine dipsticks in ascites cannot be recommended at the present time due to their insufficient sensitivity with an unacceptable risk of false-negatives in the context of a fatal disease for which effective antibiotic therapy is available. Ascitic fluid lactoferrin assay has recently been demonstrated to be a very good diagnostic test for SBP. The investigators plan to conduct a prospective study on lactoferrin as well as procalcitonin (PCT) to determine the best laboratory test(s) for the rapid, automated diagnosis of SBP. These tests will be compared with the Aution® urine dipstick, which has been shown to present better diagnostic sensitivity than the Multistix® dipstick . This single-centre study (Amiens University Hospital) will be performed in the context of routine clinical practice on ascitic fluid that is usually incinerated.


title: Polyethylene Bag: a Way of Preventing Hypothermia During Central Venous Catheter Placement in Preterm Neonates?

acronym: PSac

summary:
Particular attention is paid to thermal management of preterm neonates in neonatal intensive care units because of the major risk of morbidity associated with hypothermia. Percutaneous central venous catheter placement is essential to ensure adequate caloric intake and intravenous administration of treatments, but this procedure can cause major body temperature variations, responsible for complications in these neonates, as convection incubator function is impaired during opening of the incubator, which can be prolonged (30 minutes to 2 hours) depending on the technical difficulties encountered during catheter placement.

In parallel, the use of a polyethylene bag or sheet in the delivery room and for neonatal transport is now clearly defined and ensures stability or even a considerable temperature gain during transfer immediately after birth. In the light of several clinical cases, the use of a polyethylene bag during central venous catheter placement appears to be effective to prevent body temperature loss in preterm neonates. No data are currently available concerning the value of this method of prevention of hypothermia during this type of procedure.

Preliminary studies conducted by our team on a dummy suggest that a polyethylene bag or sheet could be useful during this procedure by significantly reducing heat loss caused by convection and evaporation. However, compensation phenomena such as generalized vasoconstriction to cold in preterm infants are very poorly described, but can induce a functional conflict between mechanisms ensuring maintenance of homeostasis and those involved in maintenance of blood pressure.


title: Improving Awakening Prognostication After Non Anoxic Coma Using PET-MRI in Intensive Care Unit

acronym: ETIC

summary:
In last decades, several advances in the neuro-intensive management have lead to decrease mortality in Intensive Care Units. A significant morbidity remains as patients survive after a traumatic coma with uncertain quality of awakening and a high risk of functional disability. Predicting awareness recovery and functional disability of those who will awake constitutes a major challenge to inform patients' relatives, to give the best chances in terms of rehabilitation resources or to adapt intensive cares to a reasonable level. Tools currently available are not sufficient neither to predict bad awakening outcome nor to predict good functional outcome. In many countries, life's support cessation is a constant call for robust evaluation as soon as possible in ICU but it is mandatory to reach a positive predictive value of non-awaking close to 100%. Many clinical, electro-physiological, biological, radiological and functional parameters have been conducted with comatose patients assuming the purpose to predict outcome. Regarding unfavourable outcome, the gold standard is the abolition of the N20 component of somatosensory evoked potentials but the specificity is high enough only for patients with anoxic coma. Several neurophysiological markers such as MMN, P300 are correlated to a favourable outcome but the sensitivity and specificity remains low for patients who suffered a severe traumatic brain injury. New Diffusion Tensor imaging sequences provide complementary information to detect small structural lesions (diffuse axonal lesions). Recently, functional MRI analyzing Resting State has also been proposed as a prognostic marker during coma. PET using Fluoro-Desoxy-Glucose is able to assess the metabolism in key regions of the awakening network in either anaesthesia or sleep. Recent studies have reported interesting results at the chronic stage but to knowledge, these tools have only been used to address pathophysiology's issues and never to improve coma prognosis at the initial stage. The investigators hypothesize that the heterogeneity of the population requires a global and accurate assessment of the central nervous system, combining structural, metabolic and functional information in order to refine the prognosis.

The protocol integrates in one-sequence most radiological markers of brain injury within a unique PET-MRI in Lyon. The most relevant originality of the study consists in confronting FDG-PET and MRI sequences to a large clinical, electrophysiological and biological battery. The added clinical value would be to question the synergistic effect of each parameter and to find out which ones are the most useful for awakening prediction, as they have not been compared in a multi-parametric database.

PET-MRI, as a new device combining physiological and prognostic questioning, allows us:

to implement a more integrative physio-pathological analysis
to avoid the cofounding effect of awareness' fluctuations in recording simultaneously multiple functional imaging techniques.

The RS will be analyzed at 2 epochs in order to assess the stability of brain connectivity, related to neuronal activity (glucose metabolism) and brain perfusion.

location_facility: Réanimation polyvalente neurologique Hôpital Neurologique HCL

intervention_type: Radiation


title: Hepatitis B Virus Particles-bound Human Proteins : Identification in Clinical Samples and Implication in the Viral Life Cycle

summary:
The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough understanding of the biology of one of its major causative agents, the hepatitis B virus (HBV). HBV particles acquire via budding and encapsidation cellular proteins. There is mounting evidence on several viral species that virion-bound proteins are prone to be involved either at the replication, budding/egress or entry/release steps of the viral cycle.

Identifying such targets may yield ideal candidates for gaining insight on the dependence of HBV upon a restricted subset of host proteins, therefore providing refined sets of genetically stable targets for therapy. This project's goals are to set up adequate conditions for robust and reproducible purification of HBV virions in clinical samples, followed by the identification of their HBV-bound host proteins and the characterization of their functions. Proteomics profiling of HBV particles purified from clinical samples will be overlaid with proteins identified and characterized in cell culture grown HBV particles, using clinical biomarker discovery grade criteria. Targets identified in both samples sets will be subjected to in vitro investigations using HBV-replicating cells. Conventional biochemical and imaging methods will be used in order to: (i) ascertain their physical association with HBV virions; (ii) define the modalities of their interaction with HBV proteins; (iii) decipher the topology and subcellular localization of their association with HBV proteins and virions; (iv) quantitatively assess their functional involvement in particle budding, egress or secretion and infectivity. A candidate that yielded satisfactory results in these experiments will be disclosed and further investigated at the level of structural biology, in collaborative research programs.

location_facility: Service d'Hépato-Gastroentérologie, Hopital de la Croix-Rousse, Hospices Civils de Lyon


title: Panton Valentine Leucocidin : Independent Severity Factor of Staphylococcus Aureus Pneumonias

acronym: PVL

summary:
Staphylococcus aureus expresses a variety of virulence factors, including Panton Valentine leukocidin (PVL), a cytotoxin. PVL is specifically associated with primary skin and soft-tissue infections and severe necrotizing pneumonia (Gillet et al. Lancet, 2002;359:753-9). PVL-positive S. aureus pneumonia is often preceded by influenza-like symptoms, and is mainly characterized by hemoptysis, pleural effusion, rapid onset of acute respiratory distress, leukopenia and a high fatality rate (65%) (Gillet et al. Lancet, 2002;359:753-9). Ten year after the first description of this disease and a number of controversies in the scientific literature, the question arise as to whether PVL remains an independent factor of severity in S.aureus pneumonia. In addition, numerous questions remain unanswered yet; these are:

(i) which factors, including treatment regimen, are associated with favourable outcome?,
(ii) what is the susceptibility toward antibiotics of strains associated with this disease ?
(iii) is there any genetic susceptibility of the host to explain both the rarity, and the explosive presentation of the disease ? To address the above questions a prospective observational study at the nationwide level will be set up. All French hospitals will be invited to describe the clinical features of all new cases of S. aureus community-acquired pneumonia with severity criteria, regardless PVL production. The study will include an investigation of a possible innate immune dysfunction in collaboration with the INSERM-U550 (Génétique Humaine des Maladies Infectieuses, Faculté Necker, Paris). Hence, in addition to collecting clinical and biological data from all pneumonia cases as well as all strains of S. aureus isolated, the patients with PVL-positive pneumonia will be sampled for immune genetic studies (ORFeome sequencing and functional studied)

primary_purpose: Prevention

location_facility: Centre National de Références des Staphylocoques Centre de Biologie et Pathologie Est 59 bd Pinel


title: Comparison of Two Rehabilitation Programs in Patients With Mild to Moderate Parkinson's Disease. A Randomized, Controlled Study.

acronym: ASYMOT

summary:
Parkinson's disease is a major source of handicap, for which physical treatments are often underutilized with respect to chemical or surgical treatments. Yet, dopaminergic treatments alone prove unable to stop or control the gradual worsening of motor disability after a few years.

The training program that this study sets out to evaluate aims to restore balance between agonist extensors and antagonist flexors in Parkinson's disease.

There is indeed in Parkinson's disease an imbalance between weak flexors and weaker extensors, with excessive predominance of the flexors. The hypothesis of the study is that a motor strengthening program targeting extensor muscles specifically will improve body posture and restore motor function better than a conventional physical therapy program, in mild to moderate Parkinson's disease.

This is a parallel-group, single blind, randomized trial (investigators will be kept unaware of the physical treatment followed by study subjects).

The duration of patient participation is 5 months: 2-month intervention and 3-month follow-up following the intervention.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: "Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders

acronym: COGNITUS

summary: Holders children with intellectual disabilities have great difficulty in adapting to social situations and relationships.Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved.Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are children with intellectual disabilities manner in their daily functioning.

ReferenceCitation: Favre E, Peyroux E, Babinet MN, Poisson A, Demily C. Computer-based cognitive remediation program for the treatment of behavioral problems in children with intellectual disability: the <<COGNITUS & MOI>> study protocol for a randomized controlled trial. BMC Psychiatry. 2018 Jul 20;18(1):235. doi: 10.1186/s12888-018-1810-z.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

publisher_dissemination: Springer-Nature

lead_sponsor: Hôpital le Vinatier

intervention_type: Behavioral


acronym: REVASC-TAVI

summary: Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.

lead_sponsor: University Hospital, Montpellier


title: Prevalence of S. Aureus Among Patients Presenting With Skin and Soft Tissue Infections: a Multi-centre Pilot Study in Europe

acronym: SSTIs

summary:
Methicillin-resistant Staphylococcus aureus (MRSA) is reported as one of the main causative pathogen of community acquired SSTIs. In the USA, high prevalence of MRSA among Skin and soft tissue infections (SSTIs) is known to be due to the spread of the USA300 clone [Moran et al. 2006]. Among S. aureus SSTIs infections in Europe, data regarding the prevalence of MRSA in SSTIs and the causative genotypes remain scarce. The paucity of literature on the prevalence of MSSA, MRSA and PVL-producing S. aureus strains in SSTI in Europe is probably due to the fact that culture and antimicrobial susceptibility testing is not a routine component of SSTI management.

Setting-up a prospective multi-centre study involving patients presenting to emergency departments with SSTIs in several European countries would allow drawing a picture on the role and the respective contribution of MSSA, MRSA and PVL-producing S. aureus strains as a cause of SSTIs. However, the roles of emergency rooms and local policies with regard to performing microbiological analysis after surgical drainage of SSTIs vary between countries.

In order to evaluate the feasibility of such multicenter European study, we aim at performing a pilot study based on few European clinical laboratories (five to seven) which will: i) evaluate the prevalence of MSSA, MRSA and S. aureus PVL-positive strains in community-acquired SSTIs; and ii) determine molecular characteristics of the isolated strains. The main objectives of this pilot study are to collect some preliminary information on the role of S. aureus in SSTIs and to determine factors that need to be harmonized or taken into consideration for the set-up a larger prospective cross-sectional study involving more European countries with several centers per country to cover different geographical areas per country.

ReferenceCitation: Moran GJ, Krishnadasan A, Gorwitz RJ, Fosheim GE, McDougal LK, Carey RB, Talan DA; EMERGEncy ID Net Study Group. Methicillin-resistant S. aureus infections among patients in the emergency department. N Engl J Med. 2006 Aug 17;355(7):666-74. doi: 10.1056/NEJMoa055356.

location_facility: National Reference Center for Staphylococci, 59 boulevard Pinel


title: Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)

summary: Patients with type 1 diabetes have poorer glycemic control that could lead to macrovascular or neuropathic complications; in addition to an optimal treatment, prevention of diabetes complications requires to control associated risk factors, such as hypertension or dyslipidemia. Sleep apnea syndrome is a public health problem due to its high prevalence and marked morbidity and mortality, one increasingly interesting aspect is its relationship with metabolic disorders, specifically diabetes.Obstructive sleep apnea syndrome seems to be underestimated in this population. In this context, it appears to be important to estimate the prevalence of sleep respiratory diseases in patients with type 1 diabetes.

ReferenceCitation: Borel AL, Benhamou PY, Baguet JP, Debaty I, Levy P, Pepin JL, Mallion JM. Short sleep duration is associated with a blood pressure nondipping pattern in type 1 diabetes: the DIAPASOM study. Diabetes Care. 2009 Sep;32(9):1713-5. doi: 10.2337/dc09-0422. Epub 2009 Jun 19.

ReferenceCitation: Borel AL, Benhamou PY, Baguet JP, Halimi S, Levy P, Mallion JM, Pepin JL. High prevalence of obstructive sleep apnoea syndrome in a Type 1 diabetic adult population: a pilot study. Diabet Med. 2010 Nov;27(11):1328-9. doi: 10.1111/j.1464-5491.2010.03096.x. No abstract available.

ReferenceCitation: Borel AL, Pepin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: American Diabetes Association

ReferenceCitation: Pallayova M, Banerjee D, Taheri S. Novel insights into metabolic sequelae of obstructive sleep apnoea: a link between hypoxic stress and chronic diabetes complications. Diabetes Res Clin Pract. 2014 May;104(2):197-205. doi: 10.1016/j.diabres.2014.01.007. Epub 2014 Jan 14.

ReferenceCitation: Seidell JC. Waist circumference and waist/hip ratio in relation to all-cause mortality, cancer and sleep apnea. Eur J Clin Nutr. 2010 Jan;64(1):35-41. doi: 10.1038/ejcn.2009.71. Epub 2009 Jul 29.

ReferenceCitation: van Dijk M, Donga E, van Dijk JG, Lammers GJ, van Kralingen KW, Dekkers OM, Corssmit EP, Romijn JA. Disturbed subjective sleep characteristics in adult patients with long-standing type 1 diabetes mellitus. Diabetologia. 2011 Aug;54(8):1967-76. doi: 10.1007/s00125-011-2184-7. Epub 2011 May 15.

ReferenceCitation: Vgontzas AN, Papanicolaou DA, Bixler EO, Hopper K, Lotsikas A, Lin HM, Kales A, Chrousos GP. Sleep apnea and daytime sleepiness and fatigue: relation to visceral obesity, insulin resistance, and hypercytokinemia. J Clin Endocrinol Metab. 2000 Mar;85(3):1151-8. doi: 10.1210/jcem.85.3.6484.

ReferenceCitation: Young T, Peppard PE, Taheri S. Excess weight and sleep-disordered breathing. J Appl Physiol (1985). 2005 Oct;99(4):1592-9. doi: 10.1152/japplphysiol.00587.2005.

lead_sponsor: University Hospital, Grenoble

collaborators: VitalAire ResMed

sponsor_collaborators:
University Hospital, Grenoble
VitalAire
ResMed


title: Evaluation of the Effectiveness of Nutritional Practical Counseling for Elderly Patients at Risk of Malnutrition (and Their Caregivers) on Nutritional Status at Home

acronym: NutriPratiC

summary: At hospital, short term actions are used (adaptation of meals, oral supplementation…) to fight malnutrition. Oral supplementation can have a positive impact on weight gain. But actions should continue at home, particularly to maintain autonomy for elderly. The hypothesis is that practical workshop about enrichment and interest of foods can help malnourished patients to change their eating habits. The main goal of this study is to evaluate the effects of this workshop on improving nutritional status, measured by Mini Nutritional Assessment

ReferenceCitation: Arnaud-Battandier F, Malvy D, Jeandel C, Schmitt C, Aussage P, Beaufrere B, Cynober L. Use of oral supplements in malnourished elderly patients living in the community: a pharmaco-economic study. Clin Nutr. 2004 Oct;23(5):1096-103. doi: 10.1016/j.clnu.2004.02.007.

ReferenceCitation: Boumendjel N, Herrmann F, Girod V, Sieber C, Rapin CH. Refrigerator content and hospital admission in old people. Lancet. 2000 Aug 12;356(9229):563. doi: 10.1016/S0140-6736(00)02583-6.

ReferenceCitation: Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003 Jun;22(3):235-9. doi: 10.1016/s0261-5614(02)00215-7.

ReferenceCitation: McMurdo ME, Price RJ, Shields M, Potter J, Stott DJ. Should oral nutritional supplementation be given to undernourished older people upon hospital discharge? A controlled trial. J Am Geriatr Soc. 2009 Dec;57(12):2239-45. doi: 10.1111/j.1532-5415.2009.02568.x. Epub 2009 Nov 17.

ReferenceCitation: Persson M, Hytter-Landahl A, Brismar K, Cederholm T. Nutritional supplementation and dietary advice in geriatric patients at risk of malnutrition. Clin Nutr. 2007 Apr;26(2):216-24. doi: 10.1016/j.clnu.2006.12.002. Epub 2007 Feb 1.

ReferenceCitation: Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. J Clin Oncol. 2005 Mar 1;23(7):1431-8. doi: 10.1200/JCO.2005.02.054. Epub 2005 Jan 31.


title: Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

acronym: OB-APE

summary:
Background :

Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation.

Objective :

The main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).

Strategy and method:

A prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).

A third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes).

Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.

Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta.

Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.

Two days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. Investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.

lead_sponsor: University Hospital, Lille

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille


title: Prospective and Monocentric Study of the Incidence of Venous Thromboembolic Disease (VTE) in Spinal Cord Injury (SCI) Patient Between 3 and 12 Months After SCI

acronym: IMATEM

summary:
Venous Thromboembolic Disease (VTE) in SCI patients is very common, its prevalence is 60 to 80% against 10-20% in the general population.

The risk of VTE is very important in the first weeks after spinal cord injury, and then declines with a prevalence of VTE slightly higher than the general population after 12 weeks. However there is no prospective study of incidence of VTE in SCI patients after 3 months. The investigators wish to conduct such a study during the year following spinal cord injury with performing venous Doppler ultrasound of the lower limbs 6, 9 and 12 months of the initial injuryassociated with a standardized clinical assessment, to know the incidence of VTE and determine prognostic factors for VTE.

lead_sponsor: Nantes University Hospital


title: Exploration of Mesocorticolimbic Pathway in Impulse Control Disorders in Parkinson's Disease: Study Using Tensor Diffusion Imaging and Tractography.

acronym: TCI-IRMdiff

summary:
Impulse control disorders (ICD) are frequent in Parkinson's Disease. Neurobiological substrates of these symptoms are largely unknown.

The investigators aim to explore mesocorticolimbic pathway in Parkinson's disease patients with impulse control disorders (ICD) using an MRI technique called tensor diffusion imaging (DTI).

More precisely, the main purpose is to demonstrate that fractional anisotropy (FA) (data obtained with DTI) in the ventral tegmental area (VTA) is different between patients with ICD and patients without ICD. Secondary objectives are to demonstrate a difference in volume of VTA, in FA in others structures included in reward system (prefrontal cortex, nucleus accumbens, amygdala), and in number of fibers between VTA and the other structures of reward system between this two groups. Other objective is to measure and compare these same variables between Parkinson's patients and healthy controls.

We hypothesized that a denervation of mesocorticolimbic pathway predisposes Parkinson's patients to ICD.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Multicentric Evaluation of in Utero Dexamethasone (DEX) on the Cognitive Development of Children at Risk of Congenital Adrenal Hyperplasia

acronym: Prenatal Dex

summary: The classic form of 21-hydroxylase deficiency (prevalence 1/15,000) is the most common cause of congenital adrenal hyperplasia (CAH). This autosomic recessive disease is responsible for virilization of the external genitalia in girls through androgen hypersecretion during fetal life. Since 1984, the Lyon Pediatric Endocrinology group has proposed prenatal dexamethasone (DEX) for all fetuses at risk of CAH With the aim of preventing fetal androgen hypersecretion in affected girls and avoiding poor long-term results from reconstructive surgery. Prenatal DEX was used in Europe and the USA but its use was recently suspended: in 2007, a Swedish study conducted on 26 children treated with DEX in utero for a short period of time reported cognitive impairments. These data were not confirmed by an American study on the short-term DEX use, which showed potential cognitive impairments in CAH children exposed to DEX for long periods of time. These confusing and controversial results have caused the scientific community to question its position and have resulted in the suspension of the use of prenatal DEX with drastic consequences for CAH girls (virilization; genital surgery etc.). In this context, an evaluation of neuropsychological development under in utero DEX is essential to validate its indication for use during the prenatal period. This study will evaluate outcomes using prospective cognitive and emotional assessments. It will first focus on the unaffected children previously treated in utero in order to assess the adverse effects of the drug. The study will then assess the children with CAH for whom DEX could have beneficial effects.

location_facility: Groupement Hospitalier Est - Laboratoire d'endocrinologie moléculaire et maladies rares - Centre de biologie et de pathologie Est. 59 boulevard Pinel

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: prenatalDEX

titre: Evaluation multicentrique du traitement in utero par dexaméthasone (DEX) sur le développement cognitif des enfants à risque d'Hyperplasie Congénitale des Surrénales

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: TARDY GUIDOLLET

prenom_porteur: Véronique


title: Deep Brain Stimulation and Parkinson's Disease: Analysis of the Modifications of the Cortical Activation During Driving Tasks and During Tasks Involving the Control of the Impulses by Means of the Optical Imaging and of the Technique of Delay Discounting Task

acronym: SCP TCI NIRS

summary:
Background : Deep brain stimulation of SubThalamic Nucleus (STN-DBS) is an effective treatment for a large variety of movement disorders. However, the efficacy of STN-DBS relies on unclear mechanisms.
Purpose: In this study, using optical imaging, the investigators will evaluate the cortical hemodynamic changes induced by STN-DBS of parkinsonian patients during motor task and delay discounting task. the investigators will perform an optical imaging study using Near-InfraRed Spectroscopy (NIRS) in a parkinsonian patient after STN-DBS. The investigators will measure bilateral local cortical hemodynamic changes under "On" and "Off" stimulation conditions and during a motor task (left hand movement) and delay discounting task Relative concentration changes of oxy-Hb, deoxy-Hb, and total Hb will be continuously analyze.
Primary outcome: Study of local cortical hemodynamic change (oxy-Hb, deoxy-Hb, and total Hb) under " on " and " off " stimulation during a motor task.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Hepatitis C Virus Particles-bound Human Proteins : Identification in Clinical Samples and Implication in the Viral Life Cycle

summary:
The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough understanding of the biology of one of its major causative agents, the hepatitis C virus (HCV). HCV particles acquire via budding and encapsidation cellular proteins. There is mounting evidence on several viral species that virion-bound proteins are prone to be involved either at the replication, budding/egress or entry/release steps of the viral cycle.

Identifying such targets may yield ideal candidates for gaining insight on the dependence of HCV upon a restricted subset of host proteins, therefore providing refined sets of genetically stable targets for therapy. This project's goals are to set up adequate conditions for robust and reproducible purification of HCV virions in clinical samples, followed by the identification of their HCV-bound host proteins and the characterization of their functions. Proteomics profiling of HCV particles purified from clinical samples will be overlaid with proteins identified and characterized in cell culture grown HCV particles during my post-doctoral training, using clinical biomarker discovery grade criteria. Targets identified in both samples sets will be subjected to in vitro investigations using HCV-replicating cells. Conventional biochemical and imaging methods will be used in order to: (i) ascertain their physical association with HCV virions; (ii) define the modalities of their interaction with HCV proteins; (iii) decipher the topology and subcellular localization of their association with HCV proteins and virions; (iv) quantitatively assess their functional involvement in particle budding, egress or secretion and infectivity. A candidate that yielded satisfactory results in these experiments will be disclosed and further investigated at the level of structural biology, in collaborative research programs.

location_facility: Service d'Hépato-Gastroentérologie Lyon Croix-Rousse Hospices Civils de Lyon


title: AlcoholPredict: Neuropsychology, Brain Imaging and Genetic Polymorphisms in Binge Drinking

acronym: AlcoolPredict

summary: The purpose of this study is to specify the psychological, cognitive, neuro-functional and genetic profile associated with binge drinker behaviors among young adults. Results will help identifying more precisely vulnerability factors associated with this pattern of alcohol consumption and guiding prevention efforts.

primary_purpose: Health Services Research


title: Impact of the Oxidative Stress on the Skeletal Muscle Dysfunction in Hemodialysis Patient

acronym: POPEYE

summary:
In hemodialysis patient (HD) a reduction of the skeletal muscle mass and strength has previously been reported. This muscle impairment constitutes an independent prognosis factor in HD patients. Oxidative stress and inflammation have been linked to the muscle impairment. The mitochondria is a classical producer and target of reactive oxygen species (ROS), and may thus constitute a central actor of the skeletal muscle impairment in HD patients. Therefore, the aim of the present study is to investigate the role of the muscle mitochondrial density on the muscle impairment in HD patients, in comparing the muscle mitochondrial density and oxidative stress in HD patients vs. healthy matched controls.

In order to assess the effect of the oxidative stress and inflammation on the muscle impairment in HD patients, muscle function assessements will be performed after renal transplantation (which lowers the oxidative stress and inflammation levels) in the HD patient group.

No therapeutic intervention will be tested in the present study.

ReferenceCitation: Souweine JS, Gouzi F, Badia E, Pomies P, Garrigue V, Morena M, Hayot M, Mercier J, Ayoub B, Quintrec ML, Raynaud F, Cristol JP. Skeletal Muscle Phenotype in Patients Undergoing Long-Term Hemodialysis Awaiting Kidney Transplantation. Clin J Am Soc Nephrol. 2021 Nov;16(11):1676-1685. doi: 10.2215/CJN.02390221.

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

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


title: Functional Magnetic Resonance Imaging of Formal Thought Disorders in Bipolar Disorder

acronym: i-TCP

summary: Bipolar disorder is a mental disease characterized by mood dysregulation and arises from manic, depressive or mixed episodes. The observations of the patient's speech and language behaviour due to flight of ideas or loss of goal probably result from an underlying disturbance in semantic networks dealing with semantic associations. The aim of our study will be to have a better comprehension of thought disorders in bipolar disorder by cognitive exploration of semantic processing.


title: Self-defining Memories and Future Projections in Bipolar Disorder Patients

summary: Self-defining memories (SDMs) are memories that are still important today to understand who the investigators are and participate to the maintain of personal identity. SDMs are also linked to our capacity to project ourselves into the future. In bipolar disorder, life events play an important role in the course and outcome of the disease. the study is the first to investigate SDMs and self-defining future projections in a population of remitted patients with bipolar disorder.


title: Antimicrobial Peptides in Periodontitis : a Pilot Study

acronym: PAROPAM

summary: Periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide. Etiopathological process involved in initiation and progression of these multifactorial diseases are not well understood, explaining the huge clinical forms variability and the complexity of the currently used classification of periodontal diseases. Recently, the implication of antimicrobial peptides (AMPs) have been suggested as potential track of explanation for periodontal diseases pathogeny. The here presented study explore the level of expression of genes coding those peptides by studying periodontal smears obtained from healthy and periodontitis patients.


title: Clinical Results After Medical Therapy Alone or Medical Therapy Associated With Lumbar Traction in the Treatment of Nerve Root Pain of Lumbar Disc Herniation With Disco-radicular Conflict

summary: The purpose of this study is to compare the clinical outcome of medical treatment associated with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.


title: Evaluation of Advanced Glycation End Products of Proteins as a Long-term Retrospective Markers of Glycemic Control in a Population of Non-complicated Type 1 Diabetic Children.

acronym: AGEDIA

summary: The objective of the study is to quantify the products of non-enzymatic glycation of proteins (called AGEs for advanced glycation end-products) in serum of type 1 diabetic patients without clinical complications in order to define the contribution of this markers in the long-term monitoring of glycemic control in these patients. The results will define the criteria for using these new markers in daily clinical practice for the monitoring of these patients


title: Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression

acronym: EmoStim

summary: Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. In this randomized double-blind study, the investigators aim to assess the effect of tDCS on emotional processing in major depression.