title: Influence of Patient Characteristics on the Tracheobronchial Anatomy Evaluated by a CT Examination

acronym: Scan-Bronchi

summary:
The clinical use of double lumen tubes and bronchial blockers requires a thorough knowledge of the tracheobronchial anatomy in order to establish the best choice for the patient. The literature is limited regarding major bronchi dimensions. In addition, the measurement method is not always adequate or properly described and some publications have evaluated only the left bronchial diameter. Computed tomography with 3D reconstruction, technical reference, has been little used.

The project is to conduct a prospective study to compare patient characteristics (age, height, weight, gender, smoking, sign of chronic obstructive pulmonary disease (if available), and dimensions of the trachea and of the main bronchi from CT scans with 3D reconstruction.

ReferenceCitation: Jit H, Jit I. Dimensions & shape of the trachea in the neonates, children & adults in northwest India. Indian J Med Res. 2000 Jul;112:27-33.

ReferenceCitation: Chunder R, Nandi S, Guha R, Satyanarayana N. A morphometric study of human trachea and principal bronchi in different age groups in both sexes and its clinical implications. Nepal Med Coll J. 2010 Dec;12(4):207-14.

ReferenceCitation: Zahedi-Nejad N, Bakhshayesh-Karam M, Kahkoei S, Abbasi-Dezfoully A, Masjedi MR. Normal dimensions of trachea and two main bronchi in the Iranian population. Pol J Radiol. 2011 Oct;76(4):28-31.

ReferenceCitation: Benumof JL, Partridge BL, Salvatierra C, Keating J. Margin of safety in positioning modern double-lumen endotracheal tubes. Anesthesiology. 1987 Nov;67(5):729-38. doi: 10.1097/00000542-198711000-00018.

ReferenceCitation: Robinson CL, Muller NL, Essery C. Clinical significance and measurement of the length of the right main bronchus. Can J Surg. 1989 Jan;32(1):27-8.

ReferenceCitation: Eberle B, Weiler N, Vogel N, Kauczor HU, Heinrichs W. Computed tomography-based tracheobronchial image reconstruction allows selection of the individually appropriate double-lumen tube size. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):532-7. doi: 10.1016/s1053-0770(99)90003-4.

ReferenceCitation: Olivier P, Hayon-Sonsino D, Convard JP, Laloe PA, Fischler M. Measurement of left mainstem bronchus using multiplane CT reconstructions and relationship between patient characteristics or tracheal diameters and left bronchial diameters. Chest. 2006 Jul;130(1):101-7. doi: 10.1378/chest.130.1.101.

ReferenceCitation: Breatnach E, Abbott GC, Fraser RG. Dimensions of the normal human trachea. AJR Am J Roentgenol. 1984 May;142(5):903-6. doi: 10.2214/ajr.142.5.903.

ReferenceCitation: Kamel KS, Lau G, Stringer MD. In vivo and in vitro morphometry of the human trachea. Clin Anat. 2009 Jul;22(5):571-9. doi: 10.1002/ca.20815.

ReferenceCitation: Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.

ReferenceCitation: Mrudula C, Krishnaiah M. The study of bronchial tree. International Journal of Pharma and Bio Sciences 2011;2:B166-B172

ReferenceCitation: Otoch JP, Minamoto H, Perini M, Carneiro FO, de Almeida Artifon EL. Is there a correlation between right bronchus length and diameter with age? J Thorac Dis. 2013 Jun;5(3):306-9. doi: 10.3978/j.issn.2072-1439.2013.03.12.

ReferenceCitation: Kim JH, Park SH, Han SH, Nahm FS, Jung CK, Kim KM. The distance between the carina and the distal margin of the right upper lobe orifice measured by computerised tomography as a guide to right-sided double-lumen endobronchial tube use. Anaesthesia. 2013 Jul;68(7):700-5. doi: 10.1111/anae.12208. Epub 2013 May 8.

lead_sponsor: Hopital Foch


title: Biological Phosphocalcic Metabolism and Coronary Artery Calcifications

acronym: BIOCAC

summary: Study a sample of patients in primary prevention, moderate cardiovascular risk (n = 83 patients), with normal, non-diabetic renal function. The investigators quantify the phophocalcic intake and excretion, realizing a food examination and a urine collection of 24 particular. The investigators will measure plasma levels of FGF23 serum calcium, phosphatemia, the investigators will calculate the tubular reabsorption of phosphate. The investigators will conduct a quantitative assessment of coronary calcification by a non-injected CT scan, measuring semi automated way Agatston calcium score. There will be an analysis of collinearity. An adjustment will be made for confounding variables in a generalized linear regression model.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: French Cardiology Society

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Effect of Hypnosis on Dyspnea

acronym: Hypnopnee

summary: The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.

study_start_date_type: Actual

study_type: Interventional

primary_purpose: Basic Science

ipd_sharing: No

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

intervention_type: Behavioral


title: Impact of Chyme Reinfusion Compared to Parenteral Nutrition on the Incidence of Complications in Patients With a Temporary High-output Double Enterostomy: a Multicentre Randomized Controlled Trial - FRY: efFiciency of Reinfusion of chYme - (FRY)

acronym: FRY

summary: In the case of intestinal failure with a high-output double enterostomy, the parenteral nutrition (PN) is the gold standard treatment until the surgical reestablishment of digestive continuity. PN has its own morbidity, and in the absence of expertise, the risks of infectious, mechanical, and metabolic complications are increased. Chyme reinfusion (CR) is an enteral nutritional technique which reestablishes the functional continuity of the anatomically present small bowel through an extracorporeal circulation of the chyme. In patients with intestinal failure with a temporary high-output double enterostomy, we hypothesize that CR, compared to PN will reduce post-operative complications after surgical reestablishment of digestive continuity, maintain the intestinal function including absorption, and reduce the complications during the transitional period pending the surgical reestablishment of digestive continuity.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

type_etablissement: CHUR

acronyme: FRY

titre: Impact de la réinjection de chyme par rapport à la nutrition parentérale sur l'incidence des complications chez les patients avec une entérostomie temporaire à haut débit : un essai contrôlé randomisé multicentrique

discipline_principale: gastro-entérologie

nom_porteur: CHAMBRIER

prenom_porteur: Cécile


title: Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis

acronym: ACEU

summary:
For the new-born, diagnosis and prognosis of congenital urine flow impairment (UFI) are difficult to confirm only with morphological examination (ultrasonography, intravenous pyelography) and functional examination (dynamic renal scan MAG3). Only the test of time allows the post confirmation of a significant UFI requiring a surgery. This meant that the actual therapeutic indications are imperfect by the absence of an "absolute" endpoint for UFI.

The objective of the study is to characterize the urinary metabolomics profile of new born with renal pelvis and/or ureters tract dilatation (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux), detected by prenatal ultrasonography, by Nuclear Magnetic Resonance (NMR) and metabolomics analysis. This characterization will allow the identification of statistically significant metabolomics markers for the diagnosis and prognosis of a favourable evolution of the anomaly. The evolution with time of these metabolomics profiles will also considered.

location_facility: Hospices Civils de LYon - Hôpital Femme Mère Enfant


title: Evaluation of the Bleeding Risk in Patient Undergoing Hemodialysis by the Analysis of Platelet Function by PFA-100®

summary:
The objective is to evaluate the function of the platelet in patients undergoing hemodialysis. The investigators will use the assay called PFA-100, an in vitro whole blood assay with three pathways of platelet activation to describe a platelet response profile.

The hypothesis is that patients undergoing hemodialysis present a platelet dysfunction, that may be reversed by hemodialysis. The effect of heparin, used during hemodialysis session to anticoagulate the hemodialyzer, on platelet function will be assessed.

primary_purpose: Screening

lead_sponsor: CHU de Reims

intervention_type: Biological


title: Feasibility and Reproducibility of T1 Rho MRI in the Evaluation of Hip Cartilage

summary: Hip osteoarthritis is a frequent and invalidating disease. Early detection of cartilage modifications could provide better patient treatment. The T1rho MRI sequence allows the quantification of the cartilage signal that is correlated to modifications of the cartilage matrix, notably of the proteoglycans. The primary objective is to evaluate normal values of hip cartilage in vivo using T1rho MRI in healthy subjects and the reproducibility of the measurements. T1rho and T2 mapping sequences were acquired twice during the same session with 30 minutes interval to see if values were modified after a 30 minutes delay in a supine position. The secondary objective was to assess the correlation between T1rho and T2 values.

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot Pavillon B Radiologie


title: Respiratory Variability in Aortic Blood Velocity Measured by Suprasternal View as an Indicator of Fluid Responsiveness

acronym: SUPRA-PAM

summary: Respiratory changes in aortic blood velocity have been described as an indicator of fluid responsiveness when measured in the left ventricular outflow tract by trans esophageal echography. A threshold value of 12% allowed discrimination between responders and nonresponders with a sensitivity of 100% and a specificity of 89%. The suprasternal window is already used to measure cardiac output. The primary endpoint of this study is to determine the predictive value of the respiratory variability in aortic blood velocity measured by suprasternal view (∆VpicSS) as an indicator of fluid responsiveness. The secondary endpoint is to compare maximum velocity and velocity time integral measured by suprasternal and transthoracic view.

primary_purpose: Diagnostic

location_facility: Hopital de la Croix-Rousse, Hospices Civils de Lyon


title: Creation and Validation of an Instrument for Measuring the Quality of Experience of a Hemodialysis of Chronic Renal Insufficiency Subject

acronym: VecuHD

summary: Chronic Hemodialysis is a treatment for kidney failure. It involves the construction of three treatment sessions per week extrarenal lasting 4 hours each. This treatment is necessary but it has an impact on the quality of life of patients.The investigators believe that to improve the overall quality of life in hemodialysis patients, the quality of each hemodialysis session must be improved. The quality criterion is not only medical, it must also take into account the patient's perception about the course of its meeting : that's what we call quality of experience of the dialysis session. Our daily healthcare practice shows that each hemodialysis session is experienced differently by the patient according to different factors : physical, psychological, relational, technical, temporal. The quality of the experience of a hemodialysis session could be positively influenced by the use of supplements occupational assets or liabilities, for improving patient satisfaction or by enhancing its relationship with the staff. Indeed, a preliminary study ( in the nephrology unit of our establishment in January 2012) of 8 patients undergoing active occupational educational activity during hemodialysis, showed that the experience of the hemodialysis session was potentially improvable (experienced patients improved, reduced cramps ... ). However, to assess the impact of such measures on the lives of the dialysis session and the quality of life in general, the investigators need to measure the quality of living of a dialysis session. There is not, at present, specific tool to measure the quality of the experience of a hemodialysis session. This tool would measure the impact of a caregiver support occupational during dialysis sessions. The main objective of this study is to create and validate an instrument to measure the quality of living of a hemodialysis of chronic renal insufficiency subject.

appel_a_projets: PHRIP

region: Grand Est

nom_etablissement: CHU REIMS

type_etablissement: CH

acronyme: VecuHD

titre: Création et validation d'un instrument de mesure de la qualité de vécu d'une séance d'hémodialyse d'un sujet insuffisant rénal chronique

discipline_principale: néphrologie

nom_porteur: KHAZNADJI

prenom_porteur: Sylvette


type: EudraCT Number

title: A Single-center, Open-label, Randomized, Two-treatment Crossover Study to Investigate the Effect of Selexipag on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam in Healthy Male Subjects

summary: The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood)

lead_sponsor: Actelion

intervention_type: Drug


title: Multicenter Pilot Study: Measuring the Evolution of Learning Words and Phrases in Children With Autism Spectrum Disorder Using an Innovative Edutainment Software (SEMATIC)

acronym: sematic

summary:
Use of the software could allow learning of reading code in subjects with ASD through the design of serious games for educational and therapeutic purposes.

This SEMATIC software could improve communication and could be integrated into medical management (speech therapy and neuropsychological).

The benefit of an action research will enable training professionals to autism, cognitive characteristics of autism and the use of IT support for this population.

lead_sponsor: Fondation Lenval

location_facility: Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL


title: 5 Years Follow-up in the Lorraine Institute of Oncology With Adjuvant Therapy for Women With Breast Invasive Carcinoma

acronym: HACAMI

summary: Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor

acronym: TCSEQ

summary: Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.

primary_purpose: Other

lead_sponsor: Centre Francois Baclesse


title: Fragility Assessment in Adults With ADHD and Mental Retardation, Advancing Age

acronym: EFAAR

summary:
Frailty is a age dependent physiological state of vulnerability. Frailty is screened by the phenotypic model (5 clinical criteria) or the cumulative model (various clinical and biological criteria). Currently, aging with autism spectrum disorder and mental retardation (ADS-MR) is poor described. Nevertheless many data indicate that people with ADS-MR may present an early aging.

Principal aim of this study is to determine if frailty in people with ADS-MR aged over 20 years depend on age. Secondary aims are to evaluate frailty prevalence, to describe with details health according to age, and to verify the frailty index validity for predicting falls, hospitalisation and death, in this population of ADS-MR patients aged over 20 years.

This monocentric and prospective study will include 60 ADS-MR patients aged over 20 years and living in Languedoc-Roussillon's medico-social care homes. Patients are evaluated at the time of inclusion. Frailty index is calculated from 104 clinical and biological criteria. Furthermore the investigator staff collect data about ADS severity (CARS), adaptative and intellectual functionning (Vineland), and psychiatric and somatic comorbidities (Reiss scale, DSQIID and CIRS). Falls, hospitalisations or death occurrence is then collected every year during 5 years.

The connection between frailty index and age will be studied using linear regression. The frailty index validity will be analysed using ROC curves. Modelisation of the falls, hospitalisations or death risk in the 5 years after the initial evaluation will help in identification of the more frailty predictive criteria.

lead_sponsor: University Hospital, Montpellier


title: Clinical Impact of the Transition From Pediatric to Adult Cystic Fibrosis Care Center

acronym: SAFETIM RNM

summary:
The main objective of register-SAFETIM is to assess the impact of the transition from pediatric to adult cystic fibrosis care center on changes in lung function and nutritional status of patients.

This is a multicenter, observational, longitudinal, with analysis of the French national registry data of patients with cystic fibrosis.

Our study will assess the clinical features of adolescent patients with cystic fibrosis during the transition from pediatric care to adult care. It will explore factors associated with the impact of the transition on the clinical course of adolescent patients (respiratory and nutritional functions).

location_facility: Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne - Bâtiment A


title: Evaluation of Automated Immunoassay, Particle Gel Immunoassay and Pretest Scoring Systems (4Ts and HEP Scores) in the Diagnosis of Heparin-induced Thrombocytopenia in Surgical Critically Ill Patients

acronym: TIH

summary: The early diagnosis of heparin-induced thrombocytopenia is particularly difficult in surgical critically ill patients. If the use of rapid immunological diagnostic methods and pretest scoring systems has been proposed in the medical intensive care unit (ICU), none of these methods have been specifically evaluated in the diagnosis of HIT in surgical patients.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Adjustment Exploratory Protocols (MagnetoEncephaloGraphy Study : MEG, ElectroEncephaloGram : EEG, Magnetic Resonance Imaging : MRI, Functional MRI : MRIf, Motor Platform) and Functional Evaluation of New Non Invasive Devices (REX BIONICS Exoskeleton) in Patient Volunteers

acronym: MAP-EFNI PV

summary: Parameters, sequences or paradigms optimisation in view of data quality and relevancy improvement.

lead_sponsor: University Hospital, Grenoble


title: Adjustment Exploratory Protocols (MagnetoEncephaloGraphy Study : MEG, ElectroEncephaloGram : EEG, Magnetic Resonance Imaging : MRI, Functional MRI : MRIf, Motor Platform) and Functional Evaluation of New Non Invasive Devices (REX BIONICS Exoskeleton) in Healthy Volunteers

acronym: MAP-EFNI


title: Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study

acronym: talobot

summary: This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.

status: Active, not recruiting

intervention_type: Procedure

status_simplified: Ongoing


title: Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome: A Prospective, National and Multicentric Study

acronym: ACROSAS

summary:
Prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. It seems that comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with acromegaly and sleep apnea syndrome. Besides sleep apnea syndrome associated to acromegaly gives rise to few symptoms, that explains it is under diagnosed. The mechanisms of the association are based on maxillofacial modifications linked to acromegaly, a thickening of soft tissues with deposits of glyco-aminoglycanes but probably also because of the associated obesity, of the potential existence of a goiter and a muscular dystrophy of the dilatative muscles of the pharynx.

At present, no study clearly documented prevalence of acromegaly in a diagnostic consultation for sleep apnea syndrome.

sponsor_collaborators:
University Hospital, Grenoble
Ipsen


type: Other Identifier

title: Analysis of the Distribution of Regulatory B Cells in Blood of Multiple Sclerosis Patients

acronym: B-MS

summary: New therapeutic approaches of MS are emerging, targeting different actors of the immune system. Some of them target a specific population of white blood cells: B lymphocytes composed of different subpopulations. The subsets of B cells express different functional properties that control the immune response, but these regulation mechanisms have yet to be clearly described. Some subpopulations could amplify inflammation through IL-6 production for example, whereas some ones contribute to its regulation through the production of IL-10. Using samples collected in a large cohort of individuals with risk of MS and treatment-naive patients in the early onset of the disease, the investigators aim to develop a 2 year follow-up study of the different blood B cells subset distribution and their functional properties in terms of pro- and anti-inflammatory cytokine production in MS. This approach can identify new biomarkers for monitoring of MS patients and lead to better define the indication use of depletive B cell drugs and not to counteract the regulatory action of these cells.

lead_sponsor: University Hospital, Lille


title: Treatment of Idiopathic and Recurrent Aphthous Stomatitis by a Probiotic, the Lactobacillus Rhamnosus Lcr35® : a Randomized, Double Blind and Placebo-controlled Trial

acronym: Aphtose

summary: Recurrent aphthous stomatitis (RAS) is a frequent condition characterized by recurrent and painful oral ulcers with unknown pathophysiology. Recent studies suggest that a dysregulation of the oral microbiota may be implicated. Currently, therapies for RAS are limited by severe side effects or inconstant effectiveness. The aim of this study is to assess the effectiveness and safety of a probiotic, the Lactobacillus rhamnosus Lcr35® , in the treatment of RAS. A placebo-controlled, parallel study will be conducted in 40 subjects with RAS. Treatment consisted on the administration of the daily probiotics or placebo during 3 months.All patients will be then followed up for additional 3months without treatment. The main outcome measure will be the number of occurring aphtae.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Starches Digestion After Obesity Surgery. A Comparative Study.

acronym: GLUBYPASS

summary:
Despite an impressive capacity to induce diabetes remissions, the gastric bypass surgery has been associated with the onset of hyperglycemic peaks, which are very intensive and transient, in formally non diabetic patients. The aim of this study is to study the digestion of starch as compared to that of glucose (same glucose load) before and after gastric bypass surgery in obese patients.

Volunteers will be recruited among the candidates to a gastric bypass, and will be studied before and 3 months after surgery. They will have on each occasion 2 random meals, corresponding to 30g glucose, one made of starch the other made of glucose, both naturally labeled with 13C. The digestion of starch will be assessed with the increase in the plasma 13C-glucose tracer. Plasma samples will be collected for 3 hours.

Some studies have already investigated time of absorption of glucose, but any study has examined the time of digestion of glucose. Other study always used glucose syrup, so they cannot have results about digestion. It is the reason why, in this study, glucose syrup and a starch meal will be taken by the same patient and glycaemia will be compared. In this way, results will be obtained about the kinetic of digestion of starch.

lead_sponsor: University Hospital, Toulouse

location_facility: Department of Endocrinology, metabolic diseases and nutrition


title: Nutrition and Quality of Life of Patients With Head and Neck Carcinoma After Radiotherapy

summary:
Undernutrition in cancerology is frequent because it's present for thirty to fifty percent of the patients at the time of the diagnosis. According to the recommendations of the French Speaking Society of Clinical Nutrition and Metabolism (SFNEP) of November 2012, a five percent loss of weight compared to the previous weight increases the risk of toxicity of the chemotherapy and worsens the patient's quality of life.

The treatment of the tumors of the head and the neck comes along very often with a loss of weight (17.4 % after one year of radiotherapy according to the study of Larsson et al.) which varies with the chosen treatment, and shows a major risk at the patients whose therapeutic sequence involves a radiotherapy. The irradiation of the upper aerodigestive tract is source of aftereffects and late complications: xerostomia, oedemas of mucous membranes.

The xerostomia, connected to the damage of the salivary glands, is a frequent complaint of the patients. It reveals or even increases, a dysphagia. According to Woisard, six months after the end of treatments, forty percent of the patients suffer from a dysphagia.

All these complications limit quantitatively and qualitatively the food intake. The adaptation of the texture of the food is necessary by fifty four percent at three months of the end of treatments according to Logemann et al., and a few patients remain dependent on an long term enteral nutrition.

Beyond a change of the nutritional state, the feeding difficulties or even the absence of resumption of an oral feeding are responsible for a social isolation. The meal which lost its dimension of pleasure becomes a source of fear and obsession for the patient as well as for his relations, and this fact generates family tensions. The quality of life of the patient is heavily affected.

Ravasco showed in his study that the impact on the nutritional state of a nutritional care by dietary advices was more important as the prescription of oral nutritional supplements but based on a short period (the dietary intervention covered only the duration of the radiotherapy). But what would happen after the end of treatments? The investigators emit the hypothesis that a post-therapeutic systematic and regular dietary support has a positive impact on the prevention of the undernutrition among the patients affected by a first cancer of the upper aerodigestive tract whom therapeutic sequence involves a radiotherapy.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Caen

sponsor_collaborators:
University Hospital, Caen
University Hospital, Rouen
Centre Francois Baclesse


title: Assessment of Coronary Endothelial Function and Myocardial Fibrosis in Positron Emission Tomography With the Waning of Acute Coronary Syndrome With Elevated ST Segment : Relationship With Left Ventricular Remodeling

acronym: REMOD-TEP

summary: Left ventricular remodeling is a common complication in patients with ST-elevation myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory mechanisms are involved in this pathophysiological process. Recent data demonstrated that remote, noninfarct-related region of the myocardium is also implicated. There is no data about the assessment of coronary endothelial function or myocardial fibrosis in the remote zone in patients with STEMI . The correlation between these parameters and left ventricular remodeling is not known.

status: Suspended

sponsor_collaborators:
University Hospital, Caen
Société Française de Cardiologie


title: Effects of Microgravity on Central Aortic Pressure During Parabolic Flights

acronym: CapFlight

summary:
Cardiovascular events remain the main cause of death of the industrialized world (Global status report on noncommunicable diseases 2010. Geneva, World Health Organization, 2011). Arterial hypertension, hyperlipoproteinemia, smoking, diabetes and family history represent the main cardiovascular risk factors. Arteriosclerosis leads to coronary heart disease, cerebrovascular insufficiency and peripheral vascular diseases that reflect in myocardial infarction and stroke.

The main objective of this experiment is to investigate the differential effect of microgravity on central aortic blood pressure.

The main criterion is the central aortic pressure (measured in mmHg). The hypothesis is that microgravity leads to an increased central aortic pressure.

sponsor_collaborators:
University Hospital, Caen
Novespace


title: Effects of Parabolic Flight on Spatial Cognition and Hippocampal Plasticity

acronym: HypoCampus

summary:
The main objective of this experiment is to assess the impact of parabolic flight on (1) spatial memory and orientation, (2) the changes in brain structure and function, and particularly the hippocampal formation, and (3) biochemical markers of stress and neuroplasticity.

A preliminary study will be performed with the aims (1) to test during weightlessness hardware used to administer visuo-spatial testing and (2) to determine the optimal body posture for testing under microgravity conditions (i.e. body posture for which change in visuo-spatial testing induced by weightlessness is maximal).

The main criteria are:

Structural and functional changes of brain evaluated by fMRI;
Cognitive performance, and specifically spatial cognition using a series computer-based tasks.
Key neurotrophins determined in venous blood samples The criteria used in the preliminary experiment is visuo-spatial performance evaluated with a computer-based test assessing spatial cognition.

The investigators hypothesize that hippocampal structure and function, and particularly the dentate gyrus, will be altered after parabolic flight compared to ground based controls. Specifically, the 3 tested hypotheses are:

Parabolic flight induces changes in hippocampal structure;
Weightlessness induces changes in cognitive performance, and specifically spatial cognition;
There is a correlation between changes in hippocampal structure and changes in visuo-spatial memory performance.
There is a correlation between changes in hippocampal structure and changes in key neurotrophins.

The hypothesis tested during the preliminary experiment is that body posture affects the changes in spatial cognition performance.


title: Conflict Detection Development During the Reasoning

acronym: DéCoR

summary: The study to explore the development of these abilities with age, and called "Development of the conflict detection during the reasoning - Decor" will take place at CYCERON center and will include two groups of 22 participants: adolescents and young adults (N = 44). More specifically, this study aims to compare the changes in the brain of adolescents and young adults when conducting reasoning tasks for which there may be a cognitive conflict. Both groups of participants then spend an MRI (Magnetic Resonance Imaging) focused on the brain and in which they will carry out two classic tasks covering the main areas of reasoning (probabilistic and economic). Each of these tasks will be manipulated to include, or not, of making information call intuition to create or not a conflict between the correct answer (logic, normative) and biased response (intuitive, heuristic). Because of the major implication of this brain region in cognitive inhibition processes [of intuitive answer], measured brain activity in the anterior cingulate cortex (ACC) during both tasks version "with" or "no" conflict will be compared between groups. To better understand the links between the development of the CCA from adolescence to adulthood and conflict detection, activity measurements will be correlated with a part in morphometric measurements taken from the same area (volume Substance Grise - SG; characteristics of cortical sulci) and secondly to cognitive measures (executive functions - inhibitory control). This cross-sectional study focused on two age groups: 11-15 years and 19-25 years. For each age group, the participation of men / boys and women / girls will be balanced up.

design_allocation: Non-Randomized

sponsor_collaborators:
University Hospital, Caen
Cyceron


title: Study of Collagen IV and XIX in Bronchoalveolar Lavage, Pulmonary Aspiration and Bronchial Biopsies

acronym: BRONCOLL

summary:
Collagens are proteins present in all tissues. Besides their structural role, recent data showed that they were able to regulate many cellular functions. Many interactions occur between extracellular matrix macromolecules, especially collagen, and various cell types. These interactions can be controlled by peptides derived extracellular matrix macromolecules, called matrikines. Previous work from the investigators laboratory and others have shown that several C-terminal domain (NC1 domains) from basement membrane-associated collagens could regulate many cellular activities.

Lung is an organ particularly abundant in basement membranes. It is likely that various lung diseases may affect metabolism of basement membrane associated collagens. To the investigators knowledge, no study has focused on the expression of collagen XIX α1 chain and collagen IV chains α3 and α4 chains in lung and studied possible variations of expression in various pathophysiological situations.

The aim of this study are to:

Study the presence of collagen IV and XIX (or fragments) in different types of sampling such as bronchoalveolar lavage, pulmonary aspiration and bronchial biopsies
Evaluate quantitative variations of expression of these collagen in different pulmonary diseases, especially chronic obstructive bronchopneumopathy, infectious pneumonia, pneumonitis or lung cancer.

ReferenceType: background

ReferenceCitation: Dupont-Deshorgue A, Oudart JB, Brassart B, Deslee G, Perotin JM, Diebold MD, Monboisse JC, Ramont L, Brassart-Pasco S. A competitive enzyme-linked immunosorbent assay for quantification of tetrastatin in body fluids and tumor extracts. Anal Biochem. 2015 Aug 1;482:16-21. doi: 10.1016/j.ab.2015.04.023. Epub 2015 Apr 29.


title: Revisiting the Volume-outcome Relationship in Surgery: Trends Analysis in French Hospitals

acronym: TREVORS

summary: The explanatory mechanism of the relationship between the volume of surgical procedures performed by individual hospitals and the occurrence of serious adverse events is not clear. Based on the " practice makes perfect " dogma, we will explore whether a learning effect can explain the volume-outcome relationship for complex surgical procedures using a nationwide dataset. Especially, we assume that increasing volume of procedures over time may be associated with improved outcomes.

time_perspective: Retrospective

ReferenceType: derived

ReferenceCitation: Payet C, Polazzi S, Lifante JC, Cotte E, Grinberg D, Carty MJ, Sanchez S, Rabilloud M, Duclos A. Influence of trends in hospital volume over time on patient outcomes for high-risk surgery. BMC Health Serv Res. 2020 Apr 1;20(1):274. doi: 10.1186/s12913-020-05126-4.

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: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

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

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

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

appel_a_projets: PREPS

acronyme: TREVORS

titre: Reconsidérer le Lien « Volume-Résultat » : Analyse des Tendances Observées dans les Hôpitaux Français en Chirurgie Digestive

discipline_principale: organisation des soins

nom_porteur: DUCLOS

prenom_porteur: Antoine


title: Serotoninergic Pathways in Sudden and Unexpted Death in Epilepsy (SUDEP)

acronym: SUDEP

summary: The mortality rate is increased in patients with epilepsy, and especially among patients with drug-resistant epilepsy. This increased mortality is mainly related to the risk of SUDEP whose incidence is between 3.5 and 9 per 1,000 for patients with drug-resistant epilepsy. The term SUDEP refers to a sudden death occurring in a patient with epilepsy in whom anamnestic and post-mortem evidence does not identify a particular cause. Experimental and clinical data strongly suggest that most of SUDEP result from a postictal respiratory dysfunction progressing to terminal apnea. Due to the major role of serotonin in regulating breathing rhythms and data in animal models of epilepsy, it is envisaged that an alteration of serotonergic systems of the brainstem and limbic regions may play a central role in the occurrence of SUDEP. The objective of this work is to look for abnormalities of the serotonergic transmission within regulatory regions of respiratory and autonomic functions in brain samples prospectively collected in patients died from SUDEP.

location_facility: Hospices Civils de Lyon - Institut Médico-Légal


title: Comparison of the Mallampati Classification and Best Visible Mallampati for Prediction of Difficult Tracheal Intubation

summary:
Mallampati score (classification of the visibility of oropharyngeal structures) should be performed in the sitting position, head in the neutral position, mouth widely open, and tongue protrudes, without phonation. However, phonation, and position modify the visibility of oropharyngeal structures and thus the Mallampati score.

We aimed at evaluating the predictive value of the best observable Mallampati score as compare to the recommended Mallampati score.


title: Dosage of Serum Tryptase Levels in a Population of Premature Newborns to Evaluate Mast Cell Activity

summary:
Compare serum tryptase levels of premature babies (<37 weeks of amenorrhea) to children born at full term.

Study the evolution of serum tryptase levels in premature babies(<37 weeks of amenorrhea). Study the relationship between the onset of infectious complications, mainly the type of necrotizing enterocolitis seen in premature babies (<37 weeks of amenorrhea) and the evolution profile of serum tryptase levels.


summary: The hyperactivation of the sympathetic nervous system is a feature of the heart failure and the determinants of disease progression and risk of sudden cardiac death. This research project aims to study, in the drug use conditions provided in the summary of product characteristics based on European marketing authorization (indications and dosage), the effect of the Entresto® on the activity of sympathic nervous system using the reference method, the microneurographic recording of sympathetic activity in muscle destiny (MSNA). This study will try to determine if the double inhibition of AT1 receptor and neprilysin activity result in lower sympathic nervous system burst rate versus single AT1 receptor inhibition using angiotensin-converting-enzyme inhibitor or AT1 receptor of angiotensin II inhibitor.

title: Evaluation of the Effect of Double Inhibition of Angiotensin II AT1 Receptor and Neprilysin Activity on Sympathic Nervous System Activity in Patient With Heart Failure

source: euctr

ipd_sharing: Undecided


title: Dynamic Knee Laxity Measurement Coupled to MRI in Cases of Suspected Partial Anterior Cruciate Ligament Tear

acronym: LaxIRM

summary: Anterior cruciate ligament (ACL) tear is frequent, but the diagnosis of partial tears is difficult. Standard MRI may be used but is of limited diagnostic value. The present study aimed to evaluate the diagnostic interest of dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear.


title: Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.

acronym: Honeymoon

summary:
Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease.

Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.


title: Feasibility of Regional Lung Ventilation Imaging Using 3T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences (PULMOREM Study)

acronym: PULMOREM

summary: Structural lung and airway alterations in CF lead to focal or heterogeneous abnormalities in regional lung ventilation. The quantitative assessment of structural and functional alterations in the lung is of great importance for the phenotyping and follow-up of CF patients. The goal of this study is to assess the feasibility of measuring the changes in proton density in the lung parenchyma with inflation and deflation during the respiratory cycle, using ultrashort echo time (UTE) pulse sequence MRI, in healthy adult volunteers.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Impact of Antenatal Exposure to Pesticides on Neurophysiological Functions (Sleep, Respiration) of Preterm Neonates

acronym: PHYSIOMECO

summary:
During pregnancy, the foetus is therefore chronically exposed to a large number of substances. A number of studies have started to emphasize the effects of this antenatal exposure on the newborn infant's morphological parameters (weight, crown-rump length, etc.). However, in addition to these morphological effects, pesticides may also induce various effects on physiological functions, as some pesticides act as inhibitors of neurotransmitters involved in many nervous system regulation pathways in man. This is particularly the case for organophosphates, which act as acetylcholinesterase inhibitors. A previous study conducted by the coordinator of the project presented here demonstrated the presence of high levels of this type of pesticide in meconium (1st stool) in neonates born in Picardy. This inhibition of the enzyme metabolizing ACh could have an impact on neurophysiological functions mediated by this neurotransmitter. Sleep or respiratory control, vital functions of the neonate particularly in preterm neonates, could therefore be affected.

The PhysioMéco project is therefore designed to study the possible links between antenatal exposure to pesticides and modifications of respiratory control allowed by peripheral chemoreceptor in preterm neonates. Antenatal exposure will be determined by pesticide assays in the meconium of neonates in combination with an exposure questionnaire to determine the sources of these pesticides. Sleep and respiratory control will be studied in these neonates nursed in incubators. Hypoxic test will be used in order to assess respiratory control involving the peripheral chemoreceptors.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Evaluating the Effectiveness of Supervised Practice or Distance Supervised Physical Activity (Walking) in the Overall Management of Fatigue in Breast Cancer Patients During Hormonal Therapy: Pilot Study

acronym: SBSAC

summary: After treatment, women want to regain a 'normal' lifestyle while some factors interfere as chronic fatigue. In the absence of anemia, fatigue is often a consequence of physical deconditioning . The following protocol will focus at this problem.It will consist of a brisk walking program twice a week over a period of 6 weeks, at an intensity of 60% of HR pic during 20 minutes.

status: Recruiting


title: The Challenge of Cancer-related Thromboembolic Disease: Can we Better Predict the Risk?

acronym: PROSPECT

summary:
Patients with cancer are at particularly high risk of venous thromboembolism (VTE). The guidelines therefore strongly recommend thromboprophylaxis but recent surveys clearly show that oncologists are reluctant to use it because of concern over bleeding, absence of validated risk stratification tools and uncertainties concerning the optimal thromboprophylaxis. Hence, it is a real challenge to identify the individual VTE risk of each cancer patient and individually tailor their thromboprophylaxis.

The study aims to identify thrombin generation test (TGT) as a reliable, standardized overall haemostasis assay that can be used to evaluate individual thrombosis risk

The secondary objectives are:

To define the limits of TGT parameters that indicate thrombosis risk in cancer patients
To evaluate values of other clotting activation markers in patients with cancer

Patients recently diagnosed with locally advanced or metastatic adenocarcinoma of any origin, who are scheduled for systemic chemotherapy, will be enrolled in the trial at baseline (Visit 1). Thrombin generating capacity will be measured within the first month following diagnosis and before the start of the chemotherapy (between Visit 1 and Visit 2) and subsequently at the end of the first cure line of chemotherapy (Visit 3). Patients will be followed up for a period of 1 year, or until the occurrence of a thromboembolic event. Two follow up visits are foreseen - 6-month (Visit 4) and 12-month (or at the end of trial - Visit 5) visits.

Patients eventually undergoing second-line chemotherapy during the course of the follow-up will remain on study.

The study will document all cases of symptomatic thromboembolic events together with the relevant diagnostic work-up.

location_facility: Unité d'Hémostase Clinique Hôpital Louis Pradel


title: The Influence of the Proteins of the Contact Activation System on Thrombus Formation in Human Blood

acronym: CONTACT

summary:
Cardiovascular diseases are important causes of morbidity and mortality in the industrialized world. Abnormalities in the coagulation system, causing a hypercoagulable state, are a known risk factor for arterial and venous thrombosis. The contact activation system is part of the coagulation system and consists of four proteins: coagulation factor XII (FXII), FXI, prekallikrein and high molecular weight kininogen (HMWK). Clinical studies indicate an important role for the contact activation system on the risk of arterial thrombosis. Furthermore, there is substantial evidence from mouse studies that FXII and FXI participate in the formation and stability of thrombi. In vitro studies show that collagen, present in the vascular wall, is able to activate FXII and hereby stimulate thrombin formation and potentiate the formation of platelet-fibrin thrombi and FXIIa is able to change the structure of fibrin clots by binding to fibrin(ogen) and by generation of additional thrombin. However, the contact system also participates in the process of fibrinolysis, which degrades thrombi.

The investigators would like to investigate the contribution of the contact activation system to the formation of thrombi. The formation of a thrombus within the vascular bed is the main cause for occlusion of an artery or vein, which can lead to an infarct such as a heart attack. Due to the other functions of the contact system it is important to fully understand how the contact system contributes to thrombus formation, before it can be used as a target in the treatment of arterial thrombosis. The aim of this study is to determine the contribution of the proteins of the contact system, mainly FXII and FXI, in the platelet mediated formation and degradation of thrombi. This will be studied in flow models (perfusion-flow model and Chandler loop), in a static model (ROTEM®) and using thrombin generation assay.


title: Sleep-dependent Memory Consolidation in Children With Sleep Diseases

acronym: EnSOM

summary: Sleep exerts a dual effect on learning: on the one hand, good sleep quality allows good daytime aptitudes leading to knowledge acquisition. On the other hand, sleep after learning is necessary for knowledge consolidation. A key role of sleep has clearly been demonstrated in memory consolidation in adults. Sleep leads to strengthen memory by promoting brain plasticity. Surprisingly, sleep influence on learning stabilization has scarcely been studied during childhood and in children affected by sleep disorders. Yet, sleep disorders concern almost 30% of children and are frequently related to a worsening in academic performances. Classical neuropsychological evaluations of these children, based on daytime learning, often fail to determine cognitive profiles explaining their academic difficulties. The investigators hypothesize that a lack of sleep-dependent consolidation could take an active part in these children's cognitive and academic difficulties. This proposal aims at characterizing interactions between sleep, learning and memory processes that have not been studied in children of elementary school age (6-12 years). The investigators will evaluate sleep-dependent memory consolidation processes in children with sleep disorders before and after treatment and healthy controls. Neuropsychological testing and academic performances will be also evaluated.. The comparison of performances obtained before and after medical treatment, will allow to understand whether normalisation of sleep quality permits the restoration of sleep-dependent memory consolidation.

location_facility: Service d'exploration et pathologie du sommeil, Hôpital Femme Mère Enfant, 59 Bd Pinel


title: Role of Molecular Aging of Matrix Proteins of the Vessel Wall in the Aneurysm Pathology

acronym: VIMANE

summary: During their biological life, proteins undergo molecular aging due to many non-enzymatic post-translational modifications that alter their structural and functional properties. These reactions concern all proteins but especially tissue proteins (whose half-life in the organism can be several decades) and lead to the formation of complex products called PTMDPs ("post-translational modification derived products"). Molecular aging is responsible for the alteration of protein properties which may cause changes in mechanical properties of tissues during aging and pathologies. However, the involvement of these processes in vivo remains unclear, particularly in the aneurysmal pathology. So, the aim of this study is to determine whether the molecular aging of matrix proteins within the vessel wall may participate in the development of aortic aneurysm.


summary: The aim of the study is to evaluate the antalgic efficacity of Feeligreen® patch on osteoarthritic knee pain acute. This patch work by diffusion controlled by iontophoresis allowing an improvement of transdermal diffusion of active (Diclofenac).

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Diagnostic Value of 18F-Choline PET/CT in Patients With a Thyroid Nodule With an Indeterminate Cytology: Pilot Study

acronym: CHOCOLATE

summary: The purpose of the study is to investigate the contribution of PET-CT with F18-choline in the diagnosis of thyroid nodule with indeterminate cytology in order to guide the best indication of surgical resection.

ReferenceCitation: Ciappuccini R, Licaj I, Lasne-Cardon A, Babin E, de Raucourt D, Blanchard D, Bastit V, Saguet-Rysanek V, Lequesne J, Peyronnet D, Grellard JM, Clarisse B, Bardet S. 18F-Fluorocholine Positron Emission Tomography/Computed Tomography is a Highly Sensitive but Poorly Specific Tool for Identifying Malignancy in Thyroid Nodules with Indeterminate Cytology: The Chocolate Study. Thyroid. 2021 May;31(5):800-809. doi: 10.1089/thy.2020.0555. Epub 2020 Dec 23.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Mary Ann Liebert Inc

sponsor_collaborators:
Centre Francois Baclesse
Canceropôle Nord Ouest


title: Phase I Study Assessing Safety of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Detection of Neoplastic Lesions in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer

summary:
The digestive cancer is the second cause of death worldwide. The presence of peritoneal carcinomatosis is common in the evolution of this type of cancer, as well as increased levels of ACE. This peritoneal carcinomatosis is often underestimated, this being due to low sensitivity detection means.

In recent years, it has been shown that peritoneal carcinomatosis surgery as complete as possible associated with an intraperitoneal chemotherapy gave better results but still failures associated with the presence of microscopic residual tumors.

The use of SGM -101 (developped by SURGIMAB SAS) allows surgeons to detect tumor nodules of small size very easily, in real-time, during surgery (shown in animals).

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut régional du Cancer de Montpellier


acronym: BRAINSPEAK

summary: New method for speech area cartography in patient individual cortical anatomy in view of improving functional area limit preservation during surgery.


title: Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient

acronym: VITRECAT

summary: This study evaluates the association between surgery of the cataract and posterior vitreous detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in the same group of patients

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: URC Fondation Ophtalmologique A de Rothschild


title: Evaluation of Efficacy and Safety of the 2-layer Compression System Kit Biflex® Versus the 4-layer Compression System PROFORE® in the Management of Venous Leg Ulcers (Stage C6).

acronym: COMPULCE

summary: The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.

lead_sponsor: Thuasne


acronym: DBS V3

summary: Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.


title: Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery

acronym: SUCCESS

summary:
This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.

Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.

Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg).

Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.

ReferenceCitation: Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1016/s0967-2109(99)00089-7.

ReferenceCitation: Gavazzi A, Berzuini C, Campana C, Inserra C, Ponzetta M, Sebastiani R, Ghio S, Recusani F. Value of right ventricular ejection fraction in predicting short-term prognosis of patients with severe chronic heart failure. J Heart Lung Transplant. 1997 Jul;16(7):774-85.

ReferenceCitation: Christakis GT, Fremes SE, Weisel RD, Ivanov J, Madonik MM, Seawright SJ, McLaughlin PR. Right ventricular dysfunction following cold potassium cardioplegia. J Thorac Cardiovasc Surg. 1985 Aug;90(2):243-50.

ReferenceCitation: Durand M, Chavanon O, Tessier Y, Casez M, Gardellin M, Blin D, Girardet P. Right ventricular function after coronary surgery with or without bypass. J Card Surg. 2006 Jan-Feb;21(1):11-6. doi: 10.1111/j.1540-8191.2006.00161.x.

ReferenceCitation: Mouren S, Delayance S, Mion G, Souktani R, Fellahi JL, Arthaud M, Baron JF, Viars P. Mechanisms of increased myocardial contractility with hypertonic saline solutions in isolated blood-perfused rabbit hearts. Anesth Analg. 1995 Oct;81(4):777-82. doi: 10.1097/00000539-199510000-00021.

ReferenceCitation: Ueti OM, Camargo EE, Ueti Ade A, de Lima-Filho EC, Nogueira EA. Assessment of right ventricular function with Doppler echocardiographic indices derived from tricuspid annular motion: comparison with radionuclide angiography. Heart. 2002 Sep;88(3):244-8. doi: 10.1136/heart.88.3.244.

ReferenceCitation: Hammarstrom E, Wranne B, Pinto FJ, Puryear J, Popp RL. Tricuspid annular motion. J Am Soc Echocardiogr. 1991 Mar-Apr;4(2):131-9. doi: 10.1016/s0894-7317(14)80524-5.

ReferenceCitation: Romano SM. Cardiac cycle efficiency: a new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J Cardiol. 2012 Mar 8;155(2):326-7. doi: 10.1016/j.ijcard.2011.12.008. Epub 2011 Dec 22. No abstract available.

ReferenceCitation: Scolletta S, Bodson L, Donadello K, Taccone FS, Devigili A, Vincent JL, De Backer D. Assessment of left ventricular function by pulse wave analysis in critically ill patients. Intensive Care Med. 2013 Jun;39(6):1025-33. doi: 10.1007/s00134-013-2861-8. Epub 2013 Mar 9.

location_facility: Reanimation Cardiovasculaire Et Thoracique


title: Validation of an Ecological Assessment of Executive Function (Multiple Errands Test) in Patients With Schizophrenia : Study of Discriminant Validity

acronym: VALITEM

summary:
Schizophrenia (SZ) is a chronic, severe disease resulting in a misperception of reality, major social withdrawal and cognitive disturbances. Executive dysfunctions are widely considered as primary determinants of functional outcome. However, classic neuropsychological executive function measures poorly represent patients' functional outcome and seem inappropriate to evaluate the real-world functional impact of the disease.

In this perspective, Shallice and Burgess have developed for brain-damaged patients, the Multiple Errands Test (MET) allowing to assess planning, adaptation, problem solving and mental flexibility in real life settings, thus better capturing day-to-day abilities and including contextual (social, perceptive) influences. Setting the assessment outside the laboratory can help to identify subtle executive impairment not systematically expressed in standard care conditions and consequently improve the future care solutions. MET is based on the Supervisory Attentional System model of executive functioning and attention control that specifies how thought and action schema become activated or suppressed for routine and non-routine circumstances.

MET has been designed to measure real-world executive performance confronting the participants to unpredictable affordances and interpersonal interactions while planning and problem solving. Patients are asked to accomplish several tasks of variable complexity in an unknown commercial district. Severals rules must be respected and thus an action plan, strategy formulation, time and space management with very little assistance of the examiner are required.

Most of the studies involving MET were conceived for patients with acquired brain damage. LeThiec offered an extensive protocol with the initial scoring system (in terms of inefficiencies, rule breaks, interpretation failures and task execution failures). Simplified versions of MET were also suggested to be more suitable in hospital settings. Only one study was done in SZ including a single patient, it is therefore difficult to draw conclusions about clinical utility in SZ. To date, no other studies investigated the suitability of MET in patients with psychosis, while executive impairment is well documented in this population The investigators hypothesized that the Multiple Errands Test (MET), an ecological assessment of executive function has a better ability to measure everyday adaptative functioning SZ, compared to conventional EF assessment methods.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: VALITEM

titre: Validation d'un test d'évaluation écologique des fonctions exécutives (Test des Errances Multiples) chez des patients souffrant de schizophrénie : Etude de validité discriminative.

discipline_principale: psychiatrie / addictologie

nom_porteur: SCHURHOFF

prenom_porteur: Franck


title: Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections

acronym: DALARI

summary: Clindamycin and rifampicin are authorized in osteoarticular infection treatment (IDSA guidelines) but some interaction is observed. The objective of this study is to evaluate and quantify rifampicin interaction on clindamycin

location_facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard

appel_a_projets: PHRCI

acronyme: DALARI

titre: Evaluation de l'interaction pharmacologique de la rifampicine sur la clindamycine dans le traitement per os des infections ostéo-articulaires à staphylocoque

discipline_principale: autre

nom_porteur: GOULENOK

prenom_porteur: Tiphaine


title: Exhaled Breath Olfactory Signature of Pulmonary Arterial Hypertension Detected by an Artificial Nose: A Clinical Validation Study

summary:
In this prospective case-control study, the investigators will evaluate the diagnostic performance of a novel electronic nose (E-nose) for the detection of Pulmonary Arterial Hypertension (PAH). This study is designed to:

Assess the performance of the E-nose to discriminate controls from patients with PAH
Assess the performance of the E-nose to discriminate between different subtypes of pulmonary hypertension (PH), namely idiopathic PAH, heritable PAH with BMPR2 mutation and chronic thromboembolic PH
Assess the performance of the E-nose to discriminate controls from asymptomatic patients with PH who carry BMPR2 mutations.

collaborators: Technion, Israel Institute of Technology


type: Registry Identifier

title: Effect of Prehabilitation in Gastroesophageal Adenocarcinoma: Study Protocol of a Multicentric, Randomised Control Trial

acronym: PREHAB

summary:
Perioperative chemotherapy is the gold standard treatment in the resectable and advanced gastroesophageal adenocarcinoma. The efficacy of this strategy has been demonstrated in two randomized studies (1,2). It reduces tumour size before surgery, treats micrometastases and evaluates chemosensitivity. Disease free and overall survival rates were significantly improved with perioperative chemotherapy compared to surgery alone. However, the limitation of these studies is that among all patients requiring chemotherapy, almost 70% of patients will not have the complete sequence. This sequence is defined by the administration of 2 to 4 cycles before and 2 to 4 cycles after the surgery, according to the protocol. The major cause of absence or impossibility of realization of postoperative chemotherapy was the presence of postoperative complication, postoperative serious asthenia and impaired nutritional and physical status (1,2). Poor physical condition assessed by cardiopulmonary exercise testing, reflecting a reduced physiological reserve, is predictive of postoperative complications (3,4). A physical training, even during a short period and on a various population, is beneficial in improving physical condition, cardiopulmonary function and muscular mass of the patient (5-8). A prehabilitation over a 6 week period between surgical consultation and surgery decreases postoperative morbidity and the hospital stay in cardiovascular surgery but no study has ever been performed in the gastric or oesophageal cancer (7,9).

Prehabilitation revolves around three axes: 1) a physical training based on initial cardiopulmonary exercise testing (VO2peak, anaerobic threshold (AT) and 6-min walk test (6MWT)), 3 times by week, supervised by a physical therapist 2) a nutritional care to ensure the compliance of the nutrition program and adapt the nutritional management based on protein and energy needs and on the level of spontaneous oral intake and 2) a psychological treatment by a psychologist to reduce preoperative anxiety. To our knowledge, no study ever focused on the gastroesophageal cancer. The benefit of prehabilitation in this cancer may be particularly important because 1) this surgery is associated with a high postoperative morbidity (40%, especially respiratory) and mortality (5%) 2) the physical and nutritional status of these patients is often precarious (cancer cachexia, gastroesophageal obstruction), and 3) the need to preoperative chemotherapy declines physical reserves and is associated with a lengthening of the time between consultation and surgery of more than 3 months (10). Also, the investigators hypothesize that with a physical training, a personalized nutritional support and a psychologist management may decrease postoperative complications, increase postoperative nutritional status and so, would allow for more patients to receive their full cancer treatment. The aim of this study was to evaluate, in gastroesophageal adenocarcinoma, the effect of prehabilitation compared to conventional care, the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board.

ReferenceCitation: Le Roy B, Pereira B, Bouteloup C, Costes F, Richard R, Selvy M, Petorin C, Gagniere J, Futier E, Slim K, Meunier B, Mabrut JY, Mariette C, Pezet D. Effect of prehabilitation in gastro-oesophageal adenocarcinoma: study protocol of a multicentric, randomised, control trial-the PREHAB study. BMJ Open. 2016 Dec 7;6(12):e012876. doi: 10.1136/bmjopen-2016-012876.

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Direction Générale de l'Offre de Soins


title: Prophylactic Non-invasive Ventilation During Surgical Procedure in Rhythmology

acronym: VNI-RYTHMO

summary: Acute respiratory failure is frequent during rhythmology procedure under light sedation in high risks selected patients. Non invasive ventilation (NIV) is recommended for acute cardiogenic pulmonary oedema and sleep apnea. The investigators will perform a monocentric, prospective, randomized controlled trial to compare the efficacy of NIV which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in prevention of peroperative respiratory event. Our hypothesis is that peroperative use of NIV should reduce the incidence of apnea and hypoxia during procedure in rhythmology under light sedation.

primary_purpose: Prevention


title: Feasibility of Endoscopic Pylorotomy in the Treatment of Refractory Gastroparesis, Pilot Study.

acronym: GASTROPOP

summary:
Gastroparesis is a common chronic condition, disabling the limited therapeutic resources justifying the exploration of new therapeutic possibilities.

By analogy to the technique of Per Oral Endoscopic Myotomy (POEM), we believe that myotomy pyloric muscle (POP = Per Oral Pyloromyotomy) endoscopically could become a treatment of choice in the refractory gastroparesis with drug treatments by attacking the pyloric obstacle often spastic that counteracts an effective gastric emptying.

ReferenceType: result

ReferenceCitation: Jacques J, Pagnon L, Hure F, Legros R, Crepin S, Fauchais AL, Palat S, Ducrotte P, Marin B, Fontaine S, Boubaddi NE, Clement MP, Sautereau D, Loustaud-Ratti V, Gourcerol G, Monteil J. Peroral endoscopic pyloromyotomy is efficacious and safe for refractory gastroparesis: prospective trial with assessment of pyloric function. Endoscopy. 2019 Jan;51(1):40-49. doi: 10.1055/a-0628-6639. Epub 2018 Jun 12.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Georg Thieme

lead_sponsor: University Hospital, Limoges

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: Gastro-POP

titre: Faisabilité de la pylorotomie endoscopique dans le traitement de la gastroparésie réfractaire, étude pilote

discipline_principale: endoscopie interventionnelle

nom_porteur: JACQUES

prenom_porteur: Jérémie


title: Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)

summary: The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).

location_facility: Clinical research center of Grenoble university hospital


title: Evaluation of Tissue Regeneration Potential (in the Skin) of Child's Adipose Cells During the Development.

acronym: cicASChild

summary: The beneficial effect related to the administration of adipose tissue-derived stromal cells (ADSC) is demonstrated in various situations of physiological and pathological wound healing, thus opening a new field for cell therapy. Despite the use of new technologies, management of burns in children as well as congenital malformation such as hypospadias and cleft lip and/ or cleft palate can lead to aesthetic and functional sequelae requiring multiple surgical procedures. Cell therapy based on the administration of the ADSC seems a promising issue in such indications, however, to date no study has been conducted with ADSC from a pediatric population. An initial study (Protocol 0808203) allowed investigors to obtain the first samples of adipose tissue from children and to conduct an in vitro comparative study on the characterization and properties of the ADSC from children compared to adults. In the continuity, this second study aims to complete knowledge on the efficacy and safety of children ADSC cell therapy assessed in an animal model of skin wound healing developed in the lab.

ReferenceCitation: Abbo O, Taurand M, Monsarrat P, Raymond I, Arnaud E, De Barros S, Auriol F, Galinier P, Casteilla L, Planat-Benard V. Comparison between pediatric and adult adipose mesenchymal stromal cells. Cytotherapy. 2017 Mar;19(3):395-407. doi: 10.1016/j.jcyt.2016.11.012. Epub 2016 Dec 28.

publisher_dissemination: Elsevier


title: Facial Mask Tightness: A Comparative Study

acronym: EMAF

summary: A correct preoxygenation can be obtained after a 3min delay of calm ventilation through a tight mask thereafter mask is used to make the patient breathing before intubation. Most tight masks are actually sold but they have never been compared in studies. The aim of this study is to compare air leaks with standard facial mask and QuadraLite masks during preoxygenation and induction of anesthesia.


title: The Effect of Acute Hypnotic Intake Before a Night at High Altitude on Cognitive and Motor Performances

acronym: CHAM

summary: This study aims to determine the effect of acute hypnotic intake (Zolpidem) on sleep, cognitive and motor performances and on acute mountain sickness symptoms at high altitude. Healthy subjects will be evaluated on 4 occasions (twice at sea level and twice at high altitude), after hypnotic or placebo intake. Following an early wake-up (01:00), symptoms, cognitive and motor performances will be assessed to determine potential residual effects of Zolpidem within such conditions.

lead_sponsor: Centre d'Expertise sur l'Altitude EXALT


title: Development and Validation of a Comprehensive Standardised Clinical Assessment Tool for Patient Needs

acronym: ACTI-PALLI

summary: The purpose of this study is to develop and validate a comprehensive and standardised tool for assessment of patient needs in palliative care.

lead_sponsor: Maison Médicale Jeanne Garnier

sponsor_collaborators:
Maison Médicale Jeanne Garnier
Ministère de la Santé
Unité de Recherche Clinique Paris-Ouest


acronym: STERPROSER

summary:
Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy.

Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer).
Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30mL) will be performed preoperatively in Patients followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of prostate tissue or metastasis will be analyze.

Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.

lead_sponsor: Hopital Foch


title: Analgesic Efficacy of Transversus Abdominis Plane (TAP) Block After Lumbar Spine Surgery Through Anterior Approach (Anterior Lumbar or Direct Lateral Interbody Fusion): a Prospective, Randomized, Double-blind Placebo-controlled Study

acronym: TAP-LIF

summary: Anterior Lumbar Interbody Fusion (ALIF) as well as Direct Lateral Interbody Fusion (DLIF) are established techniques for lumbar interbody fusion. In contrast with posterior approaches, they allow free approach to the anterior disc space without opening of the spinal canal or the neural foramina. However, the additional anterior approach conveys specific concerns, including abdominal pain that may delay recovery after surgery. The transversus abdominis plane (TAP) block is a validated approach for postoperative pain relief following abdominal surgeries. There is currently no evidence of the possible benefits of TAP block as part of multimodal pain management after ALIF/DLIF surgery. The investigator hypothesize that a single-injection TAP block reduces opioid consumption after anterior lumbar fusion surgery. The main goal of this prospective, randomized, double-blind, placebo-controlled study is to demonstrate a >35% reduction in opioid consumption during the 24h following ALIF/DLIF surgery.

ReferenceCitation: Comite douleur-anesthesie locoregionale et le comite des referentiels de la Sfar. [Formalized recommendations of experts 2008. Management of postoperative pain in adults and children]. Ann Fr Anesth Reanim. 2008 Dec;27(12):1035-41. doi: 10.1016/j.annfar.2008.10.002. Epub 2008 Nov 21. No abstract available. French.

ReferenceCitation: Tran TM, Ivanusic JJ, Hebbard P, Barrington MJ. Determination of spread of injectate after ultrasound-guided transversus abdominis plane block: a cadaveric study. Br J Anaesth. 2009 Jan;102(1):123-7. doi: 10.1093/bja/aen344.

ReferenceCitation: Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.

ReferenceCitation: Raoul S. Etude anatomique du nerf sinus vertébral. Thèse pour le Doctorat en Médecine. Faculté de Médecine de Lille (1996)

ReferenceCitation: Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.

ReferenceCitation: McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.

ReferenceCitation: McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.

ReferenceCitation: Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery. Br J Anaesth. 2009 Nov;103(5):726-30. doi: 10.1093/bja/aep235. Epub 2009 Aug 22.

ReferenceCitation: Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.

ReferenceCitation: El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17. Erratum In: Br J Anaesth. 2009 Oct;103(4):622.

ReferenceCitation: Farooq M, Carey M. A case of liver trauma with a blunt regional anesthesia needle while performing transversus abdominis plane block. Reg Anesth Pain Med. 2008 May-Jun;33(3):274-5. doi: 10.1016/j.rapm.2007.11.009. No abstract available.

ReferenceCitation: Transversus Abdominal Plane Block. 52ème congrès national d'anesthésie et de réanimation. SFAR 2010


title: Cancer Chronic Pain Predicted by Emotional and Cognitive Status

acronym: CanoPEe

summary: The aim of this study is to investigate the predictive dimension of cognitive-emotional status of cancer patients on the chronic pain development 6 months after different cancer treatment protocol (surgery, chemotherapy, radiotherapy, hormone therapy, targeted therapy ...).


title: Motivators and Barriers to Physical Activity in Knee Osteoarthritis Patients: a Qualitative Study

summary: This study sought to better identify the motivators and barriers to osteoarthritic patients practising regular physical activity. This is a crucial step towards enabling each health professional to adapt their therapy recommendations, while taking into account the patient's overall lifestyle.

time_perspective: Cross-Sectional

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Innovatherm


title: Comparison of Serological Tests for the Varicella-zoster Virus and Correlation With the Memory of the Infection or Vaccination

acronym: VARI-IMM

summary:
Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women.

Secondary goals :

Correlation memory / Immunity;
Prevalence of VZV immunity in pregnant women;
Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory;
Evaluation of acceptability of vaccination in the post partum period in non immune patients.

Methods Not randomized prospective study,

Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients

ReferenceCitation: LAFORET EG, LYNCH CL Jr. Multiple congenital defects following maternal varicella; report of a case. N Engl J Med. 1947 Apr 10;236(15):534-7. doi: 10.1056/NEJM194704102361504. No abstract available.

ReferenceCitation: Alkalay AL, Pomerance JJ, Rimoin DL. Fetal varicella syndrome. J Pediatr. 1987 Sep;111(3):320-3. doi: 10.1016/s0022-3476(87)80447-x. No abstract available.

ReferenceCitation: SAUERBREI A. Fetales varizellen syndrom. Monatsschr kinderheiledkd 2003;151:209-213.

ReferenceCitation: Miller E, Cradock-Watson JE, Ridehalgh MK. Outcome in newborn babies given anti-varicella-zoster immunoglobulin after perinatal maternal infection with varicella-zoster virus. Lancet. 1989 Aug 12;2(8659):371-3. doi: 10.1016/s0140-6736(89)90547-3.

ReferenceCitation: ENDERS G. Varicella and herpes zoster in pregnancy and the newborn. . Varicella-zoster virus and clinical management. Arvin AM and Gershon AA, eds; UK: Cambridge University Press 2000:317-347.

ReferenceCitation: MIRLESSE V. Varicelle et grossesse. Les virus transmissibles de la mère à l'enfant. Denis F. Ed John Libey Eurotext, In Montrouge 1999:252-269.

ReferenceCitation: Khoshnood B, Debruyne M, Lancon F, Emery C, Fagnani F, Durand I, Floret D. Seroprevalence of varicella in the French population. Pediatr Infect Dis J. 2006 Jan;25(1):41-4. doi: 10.1097/01.inf.0000195636.43584.bb.

ReferenceCitation: Wu MF, Yang YW, Lin WY, Chang CY, Soon MS, Liu CE. Varicella zoster virus infection among healthcare workers in Taiwan: seroprevalence and predictive value of history of varicella infection. J Hosp Infect. 2012 Feb;80(2):162-7. doi: 10.1016/j.jhin.2011.11.011. Epub 2011 Dec 19.

ReferenceCitation: Vandersmissen G, Moens G, Vranckx R, de Schryver A, Jacques P. Occupational risk of infection by varicella zoster virus in Belgian healthcare workers: a seroprevalence study. Occup Environ Med. 2000 Sep;57(9):621-6. doi: 10.1136/oem.57.9.621.

ReferenceCitation: Alp E, Cevahir F, Gokahmetoglu S, Demiraslan H, Doganay M. Prevaccination screening of health-care workers for immunity to measles, rubella, mumps, and varicella in a developing country: What do we save? J Infect Public Health. 2012 Apr;5(2):127-32. doi: 10.1016/j.jiph.2011.11.003. Epub 2012 Jan 18.

ReferenceCitation: Almuneef M, Memish ZA, Abbas ME, Balkhy HH. Screening healthcare workers for varicella-zoster virus: can we trust the history? Infect Control Hosp Epidemiol. 2004 Jul;25(7):595-8. doi: 10.1086/502445.

ReferenceCitation: Saadatian-Elahi M, Mekki Y, Del Signore C, Lina B, Derrough T, Caulin E, Thierry J, Vanhems P. Seroprevalence of varicella antibodies among pregnant women in Lyon-France. Eur J Epidemiol. 2007;22(6):405-9. doi: 10.1007/s10654-007-9136-z. Epub 2007 May 30.

ReferenceCitation: Reignier F, Romano L, Thiry N, Beutels P, Van Damme P, Fau C, Gaspard C, Mamoux V, Zanetti A, Floret D. [Varicella-zoster virus seroprevalence in nursery and day-care workers in Lyon (France)]. Med Mal Infect. 2005 Apr;35(4):192-6. doi: 10.1016/j.medmal.2005.01.007. French.

ReferenceCitation: Dashraath P, Ong ES, Lee VJ. Seroepidemiology of varicella and the reliability of a self-reported history of varicella infection in Singapore military recruits. Ann Acad Med Singap. 2007 Aug;36(8):636-41.

ReferenceCitation: Fung LW, Lao TT, Suen SS, Chan OK, Lau TK, Ngai KL, Chan PK, Leung TY. Seroprevalence of varicella zoster virus among pregnant women in Hong Kong: comparison with self-reported history. Vaccine. 2011 Oct 26;29(46):8186-8. doi: 10.1016/j.vaccine.2011.08.090. Epub 2011 Sep 10.

ReferenceCitation: Pourahmad M, Davami MH, Jahromi AR. Evaluation of anti-varicella antibody in young women before their marriage: A sero-epidemiologic study in Iran. J Clin Virol. 2010 Aug;48(4):260-3. doi: 10.1016/j.jcv.2010.04.015. Epub 2010 Jun 9.

ReferenceCitation: Perella D, Fiks AG, Jumaan A, Robinson D, Gargiullo P, Pletcher J, Forke CM, Schmid DS, Renwick M, Mankodi F, Watson B, Spain CV. Validity of reported varicella history as a marker for varicella zoster virus immunity among unvaccinated children, adolescents, and young adults in the post-vaccine licensure era. Pediatrics. 2009 May;123(5):e820-8. doi: 10.1542/peds.2008-3310. Erratum In: Pediatrics. 2009 Aug;124(2):846.

ReferenceCitation: Koturoglu G, Kurugol Z, Turkoglu E. Seroepidemiology of varicella-zoster virus and reliability of varicella history in Turkish children, adolescents and adults. Paediatr Perinat Epidemiol. 2011 Jul;25(4):388-93. doi: 10.1111/j.1365-3016.2010.01180.x. Epub 2011 Apr 3.

ReferenceCitation: Enders G, Miller E, Cradock-Watson J, Bolley I, Ridehalgh M. Consequences of varicella and herpes zoster in pregnancy: prospective study of 1739 cases. Lancet. 1994 Jun 18;343(8912):1548-51. doi: 10.1016/s0140-6736(94)92943-2.

ReferenceCitation: Breuer J, Schmid DS, Gershon AA. Use and limitations of varicella-zoster virus-specific serological testing to evaluate breakthrough disease in vaccinees and to screen for susceptibility to varicella. J Infect Dis. 2008 Mar 1;197 Suppl 2:S147-51. doi: 10.1086/529448.

ReferenceCitation: Maple PA, Rathod P, Smit E, Gray J, Brown D, Boxall EH. Comparison of the performance of the LIAISON VZV-IgG and VIDAS automated enzyme linked fluorescent immunoassays with reference to a VZV-IgG time-resolved fluorescence immunoassay and implications of choice of cut-off for LIAISON assay. J Clin Virol. 2009 Jan;44(1):9-14. doi: 10.1016/j.jcv.2008.08.012. Epub 2008 Sep 27.

ReferenceCitation: Sauerbrei A, Schafler A, Hofmann J, Schacke M, Gruhn B, Wutzler P. Evaluation of three commercial varicella-zoster virus IgG enzyme-linked immunosorbent assays in comparison to the fluorescent-antibody-to-membrane-antigen test. Clin Vaccine Immunol. 2012 Aug;19(8):1261-8. doi: 10.1128/CVI.00183-12. Epub 2012 Jun 20.

ReferenceCitation: Tischer A, Gassner M, Richard JL, Suter-Riniker F, Mankertz A, Heininger U. Vaccinated students with negative enzyme immunoassay results show positive measles virus-specific antibody levels by immunofluorescence and plaque neutralisation tests. J Clin Virol. 2007 Mar;38(3):204-9. doi: 10.1016/j.jcv.2006.12.017. Epub 2007 Feb 7.

ReferenceCitation: Mancuso JD, Krauss MR, Audet S, Beeler JA. ELISA underestimates measles antibody seroprevalence in US military recruits. Vaccine. 2008 Sep 8;26(38):4877-8. doi: 10.1016/j.vaccine.2008.06.028. Epub 2008 Jun 27.

ReferenceCitation: Seward JF, Watson BM, Peterson CL, Mascola L, Pelosi JW, Zhang JX, Maupin TJ, Goldman GS, Tabony LJ, Brodovicz KG, Jumaan AO, Wharton M. Varicella disease after introduction of varicella vaccine in the United States, 1995-2000. JAMA. 2002 Feb 6;287(5):606-11. doi: 10.1001/jama.287.5.606.


title: Cognitive Markers of Response to Treatment in Resistant Depression

acronym: DEP-ICOR

summary:
Patients with depression are frequently treatment resistant. Clinical manifestations of depression are various, but cognitive dysfunctions are commonly present. Many factors are involved in treatment resistance. As no biological marker is available, clinical markers could be considered in predicting response to antidepressive treatment.

The aim of this study is to investigate the relation between the cognitive changes and the remission of depressive symptoms in patients with recurrent depression (Stage 2 of Thase and Rush classification).

To explore the dynamics of cognitive dimension associated to clinical and functional remission, the investigators will observe neurocognitive functioning before and after introducing a new antidepressive therapy.


title: Phase 0 Study Aiming at Identifying Predictive Biomarkers of Biological Activity and Efficacy of Nilotinib on ZAK Target in Non-metastatic Colon Cancer

summary: This is a monocentric prospective non randomized phase 0 clinical trial targeting patients with colon cancer for whom an upfront surgery has been advised by the pluridisciplinary team.

status: Withdrawn

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Novartis Pharmaceuticals


acronym: EVARESERVE

summary: The proposed study is to validate a non-invasive imaging technique to evaluate the myocardial perfusion reserve in comparison with a validated invasive technique, the measure of coronary flow reserve (CRF) with thermodilution.


title: Randomised Study of Propofol Versus Placebo for Sedation During Cataract Surgery Under Topical Anesthesia

acronym: CATARSIS

summary: Controversies exist about the use of propofol in sedation of patients for cataract surgery. This prospective randomised double-blind study evaluates the efficacy of patient-controlled sedation compared with placebo using the same device.

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmique Adolphe de Rothschild


title: Impact of Comorbidities Among Adolescents Infected Pain Associated With Disorders of the Masticatory System

summary:
The pain associated with disorders of the masticatory system (DAM) include pain in the masticatory muscles, temporomandibular joints, or deux.1-5 In terms of frequency, the DAM is the second musculoskeletal disorder most common behind chronic pain in the dos.

Pain associated with DAM not interested adults; they were also observed in adolescents (2-6%) 7 with significant changes in their quality of life.8 The annual incidence of pain associated with DAM is 2.6% among adolescents and 3.9% for adults. 9 half to two-thirds of patients affected by DAM resorted to professional care, and one-third continued to be subjected to moderate pain and incapacity to severe, regardless of treatment given.

Co-morbidities were identified in adults 12-14, children and adolescents with pain related to DAM, the United States and Suède. The most common painful co-morbidities among children and adolescents were headaches, neck, back, limbs or abdomen.

The reasons for the co-existence of DAM with other painful conditions are not well understood. Nevertheless, it has been demonstrated in adults that they contributed to apparition and persistence DAM beyond healing time conventionally predicted; they increased deterioration state health and could complicate significantly the diagnosis and efficacy of treatment.

Co-morbidity is defined as "the simultaneous existence and the occur two or more diseases, medically diagnosed in the same person.

The prevalence of several chronic painful conditions appears to be greater among people of low socioeconomic status compared with those of higher and higher socioeconomic status among women than hommes.

head pain is commonly reported in the general population (46%) The headache prevalence ranges from 9% to 97% among adults and 30% to 94% among Adolescents with DAM.

Women have a higher probability have pain related to DAM (odds ratio (OR) = 2.2, 95% confidence interval (CI): 2.1-2.4) or headache (OR = 2.5, 95% CI: 2.4-2.5) than men. Cross-sectional studies and case-control demonstrated that subjects with DAM-related pain were 1.5 to 8.8 times more likely to have headaches compared to those without pain associated with DAM.

The relationship between headaches and DAM n'est unclear. Both conditions seem to share similar pathophysiological mechanisms that would promote the development of both diseases in a individual. Patients affected by headaches are more likely to develop a DAM? A cohort study showed that adolescents affected by headaches, the chance of developing pain related to DAM was 2.7 times (95% CI: 1.6-4.4) than adolescents without headaches. Conversely, the probability of having headache increases with the number of symptoms according to a relationship of DAM.

Following the results of these studies cited before, it is now necessary to confirm the relationship between headaches and DAM among adolescents.

Neck pain and back are symptoms commonly reported in adults with DAM (35% to 44%). 23 The adults affected by DAM have smaller mobility angles in the cervical and more sensitive points to trapezoids when compared to those without DAM.

Cross-sectional studies and case-control have demonstrated that adult patients with DAM-related pain had 2.6 to 5 times more likely have back pain than individuals without pain related to DAM. Chances pain joint (OR = 4.0, 95% CI: 3.7-4.3) are larger among adults affected by DAM related pain compared to those indemnes. adults affected by DAM-related pain were also more likely to experience neck pain (OR = 4.0 to 7.9).

Adult women affected by DAM-related pain are more likely to have pain in the neck (OR = 1.5; 95% CI: 1.4-1.8) and back (OR = 1.2; 95% CI: 1.2-1.3) compared to hommes a prospective cohort study demonstrated that there was a greater likelihood of pain related to DAM among adolescents affected by back pain compared to those not affected (OR = 3.0, 95% CI: 2.2-6.8) Our study aims to seek more evidence on the supposed relationship between pain related to DAM and sore neck or back in the adolescent population.

The irritable bowel syndrome (CIS; 9% to 16%), interstitial cystitis (17%), and stomach pain (34%) are rated among adults affected by DAM. Adults affected by DAM were 2.7 times (95% CI: 1.4-5.1) more likely to have irritable bowel syndrome than subjects of the same age not affected. teenagers affected by DAM were 1.5 times (95% CI: 1.0- 2.1) over have luck stomach upset that the subjects of the same age unaffected.


title: Impact on Adverse Events (AE) Occurrence of Two Types of Experience Feedback on AE Analysed During Local Morbidity Mortality Reviews (MMR), (by Multi Professional Simulation Education Versus Simple Diffusion of MMR Decisions)

acronym: RMM Simulation

summary:
After implementing a French version of a trigger tool validated for computerized detection of adverse events in patient's medical record, the study will be performed in three parallel randomized arms of three identical departments (each steaming from 6 types of medical, surgical or obstetrical departments with a total of 18 departments involved). This three arms will be: no intervention, education of department's staff by multi professional in situ simulation (adapted to the discovered adverse events), or simple but large diffusion of results and decisions of Morbidity Mortality Reviews.

The interventions will be performed during a two-years period.

ReferenceCitation: Michel N, Bui-Xuan B, Bapteste L, Rimmele T, Lilot M, Chollet F, Favre H, Duclos A, Michel P. Implementation of an in situ simulation-based training adapted from Morbidity and Mortality conference cases: effect on the occurrence of adverse events-study protocol of a cluster randomised controlled trial. Trials. 2022 Feb 2;23(1):106. doi: 10.1186/s13063-022-06040-2.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Direction DOQRU

acronyme: RMM SIMULATION

titre: Impact de revues de morbi-mortalité suivies de formations multi-professionnelles par simulation (fondées sur les cas analysés en revues) sur l'incidence des événements indésirables dans des services hospitaliers.

nom_porteur: BUI XUAN

prenom_porteur: Bernard


title: Dynamics of Regulatory and Effector T Lymphocyte Subsets in Patients With Crohn's Disease During Postoperative Recurrence : Implications for Identifying Patients at High Risk of Relapse.

acronym: PREDICT

summary:
It is assumed that gut inflammation and lesions characterizing flares of Crohn's disease (CD) result from an aberrant T-cell mediated immune responses characterized by a complex balance between peripheral and lamina propria regulatory and effector T cell subsets. Because most of CD patients who undergo a surgery experienced a postoperative endoscopic recurrence of the disease (70 % at one year) leading to a clinical recurrence (10 % per year), the "model" of postoperative recurrence in CD represents a privileged situation that mimicks what happens in the gut of CD patients in clinical remission before the occurrence of further flares. It is likely that the same factors which underlie the immunopathogenesis of CD at its early stages also contribute to disease recurrence in the postoperative setting. Indeed, the postoperative state is performed for intent of disease remission and this situation represents probably an ideal setting to investigate the dynamics of most of T cell subsets in the peripheral and mucosal compartments because one may argue that removal of the diseased segment of bowel resets the disease to its earliest phases, providing an interesting window to better understand which T cell subsets predispose to disease recurrence.

That is the reason why this model will be used in the present project i) to understand better the immunopathogenesis of CD relapse; ii) to identify novel and promising immune cell-associated biomarkers capable to predict relapse of the disease and finally iii) to identify potential specific therapeutic target associated with T cell subsets involved in the initiation of disease.

location_facility: Service d'Hépato-Gastroentérologie Centre hospitalier Lyon Sud Hospices Civils de Lyon


title: Utility of Amyloid Beta-peptide 1-40 Measurement in the Diagnosis of Alzheimer's Disease

summary: The combined measurement of Ab42 and tau protein (total and phosphorylated) in the spinal fluid has been shown to be promising in the diagnosis of Alzheimer's disease (AD), and has justified its inclusion new diagnostic criteria. However, it can sometimes yield discordant results that are not discriminant (isolated variation in Ab42 or P-181 Tau). To answer this challenge, a new marker has been developed in recent years, namely amyloid beta-peptide 1-40 (Aβ40). This marker reflects the patient's total amyloid deposits and is used to calculate the Aβ42/Aβ40 ratio. This ratio measures the relative variation of Aβ42 as compared to the total amyloid burden. Literature data on this topic are sparse and to date, no report has been published evaluating the utility of this marker in the diagnostic strategy for AD.

lead_sponsor: CHU de Reims