title: Is it Possible to Improve Static and Dynamic Postural Stability in Cerebral Palsy Children by Modulating Attention?

acronym: Dual-Task

summary:
Cerebral palsy (CP) concerns 2 children out of 1000 in the general population (SCPE 2002). It is the main cause of postural and motor deficits in children.

During the past 20 years, the postural deficits exhibited by these children have been attributed to various factors :

neuromuscular functions
sensory integration
muscular-squeletic functions.

The common point of all these studies is the existence of immature motor patterns, probably related to an inability to implement more elaborated and adapted motor patterns with respect the task to perform.

CP children do not develop the characteristics of the plant grad locomotion. They exhibit a uniform muscular activation with a high level of co-activation. Locomotion is generally characterized by an increase of stretching reflexes at short latencies and by a low level of activation associated to a low modulation of gastrocnemius muscles..

These data also suggest that it is the control of the temporal rather than the spatial parameters of the head which are mainly altered in CP children.

Even though static postural control and locomotion are considered as automatic processes, this control requires, however, a significant amount of attentional resources.

Within this context, the amount of attentional resources which need to be solicited can provide information on two complementary dimensions. On one hand, on the level of automaticity of postural control and/or locomotion when subjects' attention is oriented toward another task. On the other hand, on the cognitive cost of postural control and/or locomotion, depending on children age, that is, as a function of their level of maturation and of the nature and importance of their sensory-motor deficits. When the amount of required attentional resources is reduced, postural control and/or locomotion is considered as automatic processes with a low cognitive cost.

The dual task paradigm in which subjects have to simultaneously process a cognitive (e.g. Stroop task) and a postural or motor task (e.g., standing upright on a force platform) is generally used to investigate these questions.

How an appropriate allocation of attention is performed as a function of the cognitive and postural/motor tasks is important in the developmental process of posture and locomotion. It seems to be even more crucial in CP children and more generally in pathology.

The main goal of the present project is to investigate the contribution of attentional processes in postural control and locomotion of CP children as compared to control healthy children.

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ReferenceCitation: Cherng RJ, Su FC, Chen JJ, Kuan TS. Performance of static standing balance in children with spastic diplegic cerebral palsy under altered sensory environments. Am J Phys Med Rehabil. 1999 Jul-Aug;78(4):336-43.

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ReferenceCitation: Crenna P, Inverno M, Frigo C, Palmieri R, Fedrizzi E. Pathophysiological profile of gait in children with cerebral palsy. In: Forssberg H, hirschfeld H, editors. Movement disorders in children. Karger: Medicine and Sport Sciences. Basel; 1992. p. 186-98.

ReferenceCitation: Crenna P, Inverno M. Objective detection of pathophysiological factors contributing to gait disturbance. In motor development in children, E. Fedrizzi, G. Avanzini and P. Crenna. John Libbey (Eds) London;1994. p. 103-18.

ReferenceCitation: Crenna P. Spasticity and 'spastic' gait in children with cerebral palsy. Neurosci Biobehav Rev. 1998 Jul;22(4):571-8. Review.

ReferenceCitation: Heinen F, Desloovere K, Schroeder AS, Berweck S, Borggraefe I, van Campenhout A, Andersen GL, Aydin R, Becher JG, Bernert G, Caballero IM, Carr L, Valayer EC, Desiato MT, Fairhurst C, Filipetti P, Hassink RI, Hustedt U, Jozwiak M, Kocer SI, Kolanowski E, Krägeloh-Mann I, Kutlay S, Mäenpää H, Mall V, McArthur P, Morel E, Papavassiliou A, Pascual-Pascual I, Pedersen SA, Plasschaert FS, van der Ploeg I, Remy-Neris O, Renders A, Di Rosa G, Steinlin M, Tedroff K, Valls JV, Viehweger E, Molenaers G. The updated European Consensus 2009 on the use of Botulinum toxin for children with cerebral palsy. Eur J Paediatr Neurol. 2010 Jan;14(1):45-66. doi: 10.1016/j.ejpn.2009.09.005. Epub 2009 Nov 14. Review.

ReferenceCitation: Holt KG, Ratcliffe R, Jeng SF. Head stability in walking in children with cerebral palsy and in children and adults without neurological impairment. Phys Ther. 1999 Dec;79(12):1153-62.

ReferenceCitation: Lajoie Y, Teasdale N, Bard C, Fleury M. Attentional demands for static and dynamic equilibrium. Exp Brain Res. 1993;97(1):139-44.

ReferenceCitation: Laufer Y, Ashkenazi T, Josman N. The effects of a concurrent cognitive task on the postural control of young children with and without developmental coordination disorder. Gait Posture. 2008 Feb;27(2):347-51. Epub 2007 May 29.

ReferenceCitation: Leonard C. Neural and behavioral changes associated with perinatal damage. In: H.Forssberg and H. Hirschfeld Eds. Movement Disorders in Children. Karger: Medicine and Sport Science Basel; 1992. p. 50-6.

ReferenceCitation: Lowes LP, Westcott SL, Palisano RJ, Effgen SK, Orlin MN. Muscle force and range of motion as predictors of standing balance in children with cerebral palsy. Phys Occup Ther Pediatr. 2004;24(1-2):57-77.

ReferenceCitation: Mainly T., Robertson IH, Anderson V., & Mimmo-Smith I. 2004. Test d'évaluation de l'attention chez l'enfant. Éditions ECPA

ReferenceCitation: Molin I, Alricsson M. Physical activity and health among adolescents with cerebral palsy in Sweden. Int J Adolesc Med Health. 2009 Oct-Dec;21(4):623-33.

ReferenceCitation: Nashner LM, Shumway-Cook A, Marin O. Stance posture control in select groups of children with cerebral palsy: deficits in sensory organization and muscular coordination. Exp Brain Res. 1983;49(3):393-409.

ReferenceCitation: Okoshi Y, Itoh M, Takashima S. Characteristic neuropathology and plasticity in periventricular leukomalacia. Pediatr Neurol. 2001 Sep;25(3):221-6.

ReferenceCitation: Olivier I, Cuisinier R, Vaugoyeau M, Nougier V, Assaiante C. Dual-task study of cognitive and postural interference in 7-year-olds and adults. Neuroreport. 2007 May 28;18(8):817-21.

ReferenceCitation: Olivier I, Cuisinier R, Vaugoyeau M, Nougier V, Assaiante C. Age-related differences in cognitive and postural dual-task performance. Gait Posture. 2010 Oct;32(4):494-9. doi: 10.1016/j.gaitpost.2010.07.008. Epub 2010 Aug 9.

ReferenceCitation: Olivier I, Palluel E, Nougier V. Effects of attentional focus on postural sway in children and adults. Exp Brain Res. 2008 Feb;185(2):341-5. doi: 10.1007/s00221-008-1271-6. Epub 2008 Jan 24.

ReferenceCitation: Palluel E, Nougier V, Olivier I. Postural control and attentional demand during adolescence. Brain Res. 2010 Oct 28;1358:151-9. doi: 10.1016/j.brainres.2010.08.051. Epub 2010 Aug 22.

ReferenceCitation: Platt MJ, Cans C, Johnson A, Surman G, Topp M, Torrioli MG, Krageloh-Mann I. Trends in cerebral palsy among infants of very low birthweight (<1500 g) or born prematurely (<32 weeks) in 16 European centres: a database study. Lancet. 2007 Jan 6;369(9555):43-50.

ReferenceCitation: Reilly DS, van Donkelaar P, Saavedra S, Woollacott MH. Interaction between the development of postural control and the executive function of attention. J Mot Behav. 2008 Mar;40(2):90-102. doi: 10.3200/JMBR.40.2.90-102.

ReferenceCitation: Reilly DS, Woollacott MH, van Donkelaar P, Saavedra S. The interaction between executive attention and postural control in dual-task conditions: children with cerebral palsy. Arch Phys Med Rehabil. 2008 May;89(5):834-42. doi: 10.1016/j.apmr.2007.10.023.

ReferenceCitation: Seidman LJ, Valera EM, Makris N, Monuteaux MC, Boriel DL, Kelkar K, Kennedy DN, Caviness VS, Bush G, Aleardi M, Faraone SV, Biederman J. Dorsolateral prefrontal and anterior cingulate cortex volumetric abnormalities in adults with attention-deficit/hyperactivity disorder identified by magnetic resonance imaging. Biol Psychiatry. 2006 Nov 15;60(10):1071-80. Epub 2006 Jul 28.

ReferenceCitation: Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.

ReferenceCitation: Woollacott MH, Burtner P. Neural and musculoskeletal contributions to the development of stance balance control in typical children and in children with cerebral palsy. Acta Paediatr Suppl. 1996 Oct;416:58-62. Review.

ReferenceCitation: Woollacott MH, Burtner P, Jensen J, Jasiewicz J, Roncesvalles N, Sveistrup H. Development of postural responses during standing in healthy children and children with spastic diplegia. Neurosci Biobehav Rev. 1998 Jul;22(4):583-9. Review.

ReferenceCitation: Woollacott MH, Crenna P. Postural control in standing and walking in children with cerebral palsy. Chapter. In: Hadders-Algra M, Brogren Carlberg E, editors. Posture: a key issue in developmental disorders. London: Mac Keith Press; 2008.


type: Other Identifier

title: Effect of Selective Laser Trabeculoplasty on the Intraocular Pressure Nycthemeral Rhythm.

acronym: PIO laser SPNP

summary: The main objective of this study is to characterize the changes in IOP over 24 hours after selective trabeculoplasty SLT (before and 1 and 6 months after treatment, decreased IOP, type of rhythm, mesor, acrophase, amplitude). The secondary objective is to evaluate changes in ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after selective laser trabeculoplasty.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Khayi H, Pepin JL, Geiser MH, Tonini M, Tamisier R, Renard E, Baguet JP, Levy P, Romanet JP, Chiquet C. Choroidal blood flow regulation after posture change or isometric exercise in men with obstructive sleep apnea syndrome. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9489-96. doi: 10.1167/iovs.11-7936.

name: From the Departments of Ophthalmology, the 2Laboratory of Hypoxia and Physiopathology, University Hospital, Université Joseph Fourier, Grenoble, France; and

family: Khayi

full_name: Hafid Khayi

given: Hafid

sequence: first

name: Rehabilitation and Physiology and the 2Laboratory of Hypoxia and Physiopathology, University Hospital, Université Joseph Fourier, Grenoble, France; and

family: Pepin

full_name: Jean-Louis Pepin

given: Jean-Louis

sequence: additional

name: Haute Ecole Spécialisée de Suisse Occidentale, University of Applied Sciences, Western Switzerland, Switzerland.

family: Geiser

full_name: Martial H. Geiser

given: Martial H.

family: Tonini

full_name: Matthieu Tonini

given: Matthieu

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Renard

full_name: Elisabeth Renard

given: Elisabeth

name: Cardiology, and the 2Laboratory of Hypoxia and Physiopathology, University Hospital, Université Joseph Fourier, Grenoble, France; and

family: Baguet

full_name: Jean-Philippe Baguet

given: Jean-Philippe

family: Levy

full_name: Patrick Levy

given: Patrick

family: Romanet

full_name: Jean-Paul Romanet

given: Jean-Paul

family: Chiquet

full_name: Christophe Chiquet

given: Christophe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Investigative Opthalmology & Visual Science

publisher: Association for Research in Vision and Ophthalmology (ARVO)

title: Choroidal Blood Flow Regulation after Posture Change or Isometric Exercise in Men with Obstructive Sleep Apnea Syndrome

lead_sponsor: University Hospital, Grenoble

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Impact of an Educational Program 'Narrative Medicine (Workshop Reading Diaries) ' Dedicated to Medical Students. A Randomized Controlled Trial.

acronym: INAMEDI

summary:
Objective: The aim of this study is to assess the impact of an educational program of Narrative Medicine "workshop reading diaries" dedicated to medical students on their empathy.

Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of the University Paris Descartes. Methods: participants will be randomized in 2 groups. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician. Participants will be blinded of the study hypothesis. Allocation concealment will be provided because only the statistician will have access to the randomization list.

A program of Narrative Medicine with lesson in small group of "workshop reading patients' diaries " vs "workshop reading literature".

Outcome: The primary endpoint will be a first measure of the empathy of the medical students. The secondary endpoints will be a second measure of the empathy of the medical student; satisfaction of the student relative to the educational program .

Potential interests: We believe that the workshop "reading patients' diaries" can develop the thinking of the student with respect to his behavior with the patient, and so the relation between student and patient.

Sample size expected: 200 participants.

design_allocation: Randomized

primary_purpose: Health Services Research

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'épidémiologie clinique, Hôtel Dieu

intervention_type: Behavioral


title: Impact of an Educational Program 'Narrative Medicine (Workshop Reflexive Writing) ' Dedicated to Medical Students. A Randomized Controlled Trial.

acronym: INAMERE

summary:
Objective: The aim of this study is to assess the impact of an educational program of Narrative Medicine "workshop reflexive writing "dedicated to medical students on the satisfaction of standardized patients.

Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of the University Paris Descartes. Methods: Participants will be randomized in two groups. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician. Participants will be blinded of the study hypothesis. Allocation concealment will be provided because only the statistician will have access to the randomization list.

A program of Narrative Medicine in Class-led instruction "workshop reflexive writing "vs "workshop reading medical publication".

Outcome: The primary endpoint will be the satisfaction of standardized patient relative to the empathy of the medical students. The secondary endpoints will be the empathy of the medical students; recommendation of the student by the standardized patients to friends or relatives; students' satisfaction.

Potential interests: The investigators believe that the workshop "reflexive writing" can develop the thinking of the student with respect to his behavior with the patient, and so the relation between student and patient.

location_facility: Centre d'Epidémiologie Clinique, Assistance Publique, Hôtel Dieu


title: Performance Evaluation of Pupillary Reactivity in Monitoring of Brain-damaged Patients in Intensive Care

summary:
The pupillary examination is a major component of the clinical examination and monitoring of brain-damaged patients in intensive care. The occurrence of abnormal size or pupillary reactivity is a prognostic factor of poor neurological outcome or an indicator of the neurological status degradation. To date, the monitoring of the pupils is clinical. The subjectivity of this measure and, the lack of reproducibility and definition of the abnormality remain as many obstacles to the development of a monitoring of early neurological deterioration. The recent development in pupillometer electronics allows the assessment of responsiveness to a calibrated light stimulus. It offers a reliable and reproducible measure of the pupil diameter. The pupillometers were funded by the association of " Gueules Cassées ".

This study aims to establish a relationship between an abnormal pupillary reactivity detection by the electronic pupillometer and a deterioration in neurological status of the patient brain-damaged in the intensive-care unit (ICU). This is considered clinically relevant and has been defined by a lower Glasgow Coma Score of at least 2 points for 2 hours or involving a therapeutic action. If this relationship is demonstrated, the temporal relationship between data pupillometry and the patient's neurological status remain to be established more precisely. This is particularly relevant in neurosurgical context and aim to define the status of the electronic pupillometer in intensive care but also in emergency rooms services, the neurovascular units or in the pre-hospital care.

Therefore the investigators will compare the pupillometry data in two patients groups, defined accordingly to the appearance or absence of neurological aggravation in the first 5 days of treatment in intensive care, time-frame defined as the maximum risk period in patients with brain damage. The primary endpoint is represented by the estimated area under the ROC curve corresponding to the last measure of the change in pupil size before the onset of neurological deterioration and worse for the fifth day for non-aggravated.

Thus the investigators propose to conduct a prospective trial, aiming to record the diagnostic value of pupillary reactivity by the electronic pupillometer in the monitoring of the neurological aggravation of brain damaged patient in ICU. The duration of the follow-up for a subject does not exceed 5 days. The statistical analysis requires the recruitment of 90 patients, which sets the length of the inclusions to 14 months.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Other

status_simplified: Unknown


title: Assessment of Distal Limbs Fractures With Cone-Beam CT Newtom 5G

acronym: FRADICOBE

summary: ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging. Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for an analysis of the distal appendicular skeleton. The investigators' hypothesis is that the cone-beam scanner could detect and characterize fractures of the extremities similarly to a multidetector CT (MDCT). 150 patients over 18 years requiring a CT scan for a suspected distal limb fracture or a preoperative assessment will be enrolled. The primary endpointis based on the ability of cone-beam scanner to properly characterize the type of fracture using a classification derived from Maurice E. Müller (AO) classification. Secondary endpoints will concern the depiction of the fracture, the assessment of the soft tissues near the fracture, quality of images, inter and intra-operator reproducibility and tolerance of the patient for the examination. Patients will have a MDCT considered as the reference exam, then a CBCT. Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis of fracture type between the two techniques will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be achieved by studying the sensitivity, specificity, negative predictive value and positive predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the consistency of the characterization of the fracture and the evaluation of soft tissue near the fracture. A Student t test will be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not painful) will be calculated for each technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not apply).

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Dubreuil T, Mouly J, Ltaief-Boudrigua A, Martinon A, Tilhet-Coartet S, Tazarourte K, Pialat JB. Comparison of Cone-Beam Computed Tomography and Multislice Computed Tomography in the Assessment of Extremity Fractures. J Comput Assist Tomogr. 2019 May/Jun;43(3):372-378. doi: 10.1097/RCT.0000000000000843.

family: Dubreuil

full_name: Thibaut Dubreuil

given: Thibaut

family: Mouly

full_name: Jérôme Mouly

given: Jérôme

family: Ltaief-Boudrigua

full_name: Aïcha Ltaief-Boudrigua

given: Aïcha

family: Martinon

full_name: Amanda Martinon

given: Amanda

family: Tilhet-Coartet

full_name: Stéphane Tilhet-Coartet

given: Stéphane

family: Tazarourte

full_name: Karim Tazarourte

given: Karim

family: Pialat

full_name: Jean-Baptiste Pialat

given: Jean-Baptiste

journal_name: Journal of Computer Assisted Tomography

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon- hôpital Edouard Herriot

intervention_type: Device


title: Exploration électroencéphalographie et Pharmacologique Des Dysfonctionnements exécutifs Induits Par la Stimulation cérébrale Profonde du Noyau Sous-thalamique Dans la Maladie de Parkinson

acronym: EEGDBSNAd

summary:
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) remarkably improves motor functions in patients with Parkinson disease (PD). However, growing evidence suggests that STN-DBS also causes executive inhibitory deficits and impulsive behaviour (Jahanshahi et al 2000; Schroeder et al 2002; Hershey et al 2004; Thobois et al 2007; Frank et al 2007; Ballanger et al., 2009). Despite a widespread use, the mechanisms of action of STN-DBS are still unclear. Two reasons might explain this. 1) From a theoretical point of view, cognitive models of executive control mechanisms are incomplete. 2) From a methodological point of view, investigating cerebral activity during STN-DBS is very limited because most techniques are incompatible with locally implanted electrodes.

This project relies on a double opportunity to answer these questions offered by recent theoretical and methodological advances. First, investigations in healthy subjects (Jaffard et al 2007, 2008, Boulinguez et al 2009) revealed an essential function of inhibitory control, so far ignored, consisting in locking in advance movement triggering processes to prevent undesired automatic or anticipated responses to unattended stimuli. In other words, key processes of executive control may act tonically before stimulation occurs, calling brain imaging studies to look at proactive and not only reactive activations. Second, recent advances in EEG signal processing now allow suppressing from the electroencephalogram DBS-related artifacts (Allen et al. 2010), providing a tremendous opportunity to use a non-invasive technique with the high temporal resolution necessary to disentangle proactive from reactive brain activity. To our knowledge, up to date no study has been published using EEG with STN-DBS patients since Allen et al.'s paper. The first operational purpose of this project is to identify the anatomo-functional origin of STN-DBS-induced executive dysfunction using EEG recordings in classical stimulus-response tasks. Results expected from this first part of the project may help resolving other long-lasting issues. Indeed, reactivity as assessed by simple reaction time in non-implanted patients as well as impulsivity in STN-DBS patients are known to remain insensitive to dopaminergic medication. Since the proactive activity related to executive, inhibitory, control may be supported by the noradrenergic (NA) system, the second purpose of this project is to test the original hypothesis according to which NA plays a central role in both akinesia and STN-DBS side effects.

primary_purpose: Basic Science

ReferenceCitation: Spay C, Albares M, Lio G, Thobois S, Broussolle E, Lau B, Ballanger B, Boulinguez P. Clonidine modulates the activity of the subthalamic-supplementary motor loop: evidence from a pharmacological study combining deep brain stimulation and electroencephalography recordings in Parkinsonian patients. J Neurochem. 2018 Aug;146(3):333-347. doi: 10.1111/jnc.14447.

name: INSERM, U 1028; Lyon Neuroscience Research Center; Lyon France

name: CNRS, UMR 5292; Lyon Neuroscience Research Center; Lyon France

family: Spay

full_name: Charlotte Spay

given: Charlotte

name: CNRS, UMR 5229; Institut des Sciences Cognitives Marc Jeannerod; Bron France

name: Sorbonne Universités; UPMC Université Pierre et Marie Curie Paris 06; UMR 7225; Paris France

name: INSERM UMR 1127; Institut du cerveau et de la moelle épinière; ICM; Paris France. CNRS, UMR 7225; Institut du cerveau et de la moelle épinière; ICM; Paris France

family: Albares

full_name: Marion Albares

given: Marion

family: Lio

full_name: Guillaume Lio

given: Guillaume

name: Hospices civils de Lyon, hôpital neurologique Pierre Wertheimer; Bron France

family: Thobois

full_name: Stephane Thobois

given: Stephane

family: Broussolle

full_name: Emmanuel Broussolle

given: Emmanuel

family: Lau

full_name: Brian Lau

given: Brian

family: Ballanger

full_name: Benedicte Ballanger

given: Benedicte

family: Boulinguez

full_name: Philippe Boulinguez

given: Philippe

journal_name: Journal of Neurochemistry

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Hospices Civils de Lyon Hôpital Pierre Wertheimer


title: Prediction of Immediate Postoperative Pain Using Analgesia/Nociception Index (ANI): an Observational Study

summary: The aim of this study is to evaluate the performance of Analgesia/Nociception Index (ANI) measured at the end of surgery for the prediction of immediate postoperative pain in postoperative care unit in adult patients undergoing general anesthesia.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Boselli E, Daniela-Ionescu M, Bégou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16.

ReferenceType: derived

ReferenceCitation: Boselli E, Bouvet L, Bégou G, Dabouz R, Davidson J, Deloste JY, Rahali N, Zadam A, Allaouchiche B. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014 Apr;112(4):715-21. doi: 10.1093/bja/aet407. Epub 2013 Dec 8.

family: Boselli

full_name: E. Boselli

given: E.

family: Bouvet

full_name: L. Bouvet

given: L.

family: Bégou

full_name: G. Bégou

given: G.

family: Dabouz

full_name: R. Dabouz

given: R.

family: Davidson

full_name: J. Davidson

given: J.

family: Deloste

full_name: J.-Y. Deloste

family: Rahali

full_name: N. Rahali

given: N.

family: Zadam

full_name: A. Zadam

given: A.

family: Allaouchiche

full_name: B. Allaouchiche

given: B.

journal_name: British Journal of Anaesthesia

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Emmanuel Boselli

lead_sponsor_type: industriel


title: Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI): an Observational Study

summary: The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.


type: Registry Identifier

title: A Multicentric, Randomized, Phase II Study Evaluating the Combination of METFORMIN With TAXOTERE®+Metformine Placebo Versus TAXOTERE®+Metformin for the Treatment of Metastatic Hormone-refractory Prostate Cancer.

acronym: TAXOMET

summary:
Prostate cancer is the second leading cause of mortality in men, representing 10 deaths about of 100 cancers (INVS 2009). Treatment for metastatic prostate cancer, when becoming resistant to hormone-treatment, is mostly resumed to a relatively ineffective chemotherapy (Docetaxel/TAXOTERE®) (1). Recently, numerous clinical and preclinical works showed that Metformin could represent an excellent candidate for treatment of advanced prostate cancer. This is a widely prescribed drug, for type 2 diabetes, with clinical advantage of exhibiting very rare serious side effects. On the other hand, the use of this molecule in patients was associated with a decrease of tumors incidence, in particular prostate cancer (2). Numerous in vitro and in vivo studies support its role as an anti-cancer drug, in several cell lines (3). These experimental results are consistent with a clinical trial pilot study, performed in colorectal cancer, showing anti proliferative effect of Metformin (4). In the field of prostate, F. Bost in J.F. Tanti's team (INSERM U895, Nice) demonstrated that Metformin inhibits cell viability of human prostate cancer cells, via mTOR downregulation and decrease tumor growth in a xenograft model (5). Furthermore, preclinical data performed by this team showed that Metformin increased significantly apoptosis induced by TAXOTERE®. Therefore, by targeting specifically cancer cell metabolism, Metformin offers new promising therapeutic strategy.

The primary objective of this randomized study is to evaluate the biological efficacy of Metformin combination with TAXOTERE® in patients with metastatic hormone-refractory prostate cancer. To achieve this purpose, PSA response rate will be evaluated according to ASTRO definitions (Bubley, Carducci et al. 1999). Concurrently, secondary endpoints will be under investigation in order to evaluate the clinical response according to RECIST criteria, the overall and free-progression survival and the quality of life. Toxicity assessment will also be performed regarding to this drug combination.

Considering the well tolerability of Metformin and the first clinical and pre-clinical data reports of it use in cancer treatment, combining Docetaxel (TAXOTERE®) with Metformin may represent a promising strategy for treatment of hormone-refractory prostate cancer.

lead_sponsor: Centre Antoine Lacassagne

intervention_type: Drug


title: Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL

acronym: ARCHER

summary: The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.

status: Terminated

location_facility: Pitié Salpetriere university Hospital - Cardiology


title: JAK2 Inhibitors RUXOLITINIB in Patients With High or Intermediate Risk Primary or Secondary Myelofibrosis Eligible for Allogeneic Stem Cell Transplantation: a Prospective Multicentric Phase II Study

summary: JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis : a prospective phase II

ipd_sharing: No

lead_sponsor: French Innovative Leukemia Organisation


title: Identification of Take Home Message in Lecture Based Learning: a Randomize Controlled Trial

acronym: T-REX 2

summary:
Medical education involves the acquisition of a large quantity of information. Lecture-based learning (LBL) is the best known of conventional teaching methods. Two thirds of critical care junior doctors identified at best only one of the three main take-home messages of a lecture, suggesting that knowledge transfer is poor during passive format learning.

The investigators assess the impact of an intervention including the identification of take-home message of lecture with slides calling "Learning Objectives", "Message", "Conclusion", in the identification of take-home message in critical care junior doctors.

ReferenceCitation: Lautrette A, Boyer A, Gruson D, Argaud L, Schwebel C, Tardy B, Vignon P, Megarbane B, Schoeffler P, Chabrot P, Schmidt J, Boirie Y, Guerin C, Darmon M, Klouche K, Souweine B, Dellamonica J, Pereira B; TREX group. Impact of take-home messages written into slide presentations delivered during lectures on the retention of messages and the residents' knowledge: a randomized controlled study. BMC Med Educ. 2020 Jun 3;20(1):180. doi: 10.1186/s12909-020-02092-7.

family: Lautrette

full_name: Alexandre Lautrette

given: Alexandre

family: Boyer

full_name: Alexandre Boyer

family: Gruson

full_name: Didier Gruson

given: Didier

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Tardy

full_name: Bernard Tardy

given: Bernard

family: Vignon

full_name: Philippe Vignon

family: Megarbane

full_name: Bruno Megarbane

given: Bruno

family: Schoeffler

full_name: Pierre Schoeffler

given: Pierre

family: Chabrot

full_name: Pascal Chabrot

given: Pascal

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

family: Boirie

full_name: Yves Boirie

given: Yves

family: Guerin

full_name: Claude Guerin

given: Claude

family: Darmon

full_name: Michaël Darmon

given: Michaël

family: Klouche

full_name: Kada Klouche

given: Kada

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

family: Dellamonica

full_name: Jean Dellamonica

given: Jean

family: Pereira

full_name: Bruno Pereira

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

family: Terzi

full_name: Nicolas Terzi

given: Nicolas

family: Papazian

full_name: Laurent Papazian

family: Gainnier

full_name: Marc Gainnier

given: Marc

family: Roch

full_name: Antoine Roch

given: Antoine

family: Forel

full_name: Jean-Marie Forel

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

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

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

title: Impact of take-home messages written into slide presentations delivered during lectures on the retention of messages and the residents’ knowledge: a randomized controlled study


title: Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase

acronym: APAC

summary: Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. Cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant or néoadjuvant chemotherapy.

study_start_date_type: Actual

primary_purpose: Other

ReferenceCitation: Vincent F, Deluche E, Bonis J, Leobon S, Antonini MT, Laval C, Favard F, Dobbels E, Lavau-Denes S, Labrunie A, Thuillier F, Venat L, Tubiana-Mathieu N. Home-Based Physical Activity in Patients With Breast Cancer: During and/or After Chemotherapy? Impact on Cardiorespiratory Fitness. A 3-Arm Randomized Controlled Trial (APAC). Integr Cancer Ther. 2020 Jan-Dec;19:1534735420969818. doi: 10.1177/1534735420969818.

name: Department of Physiology, University Hospital, Limoges, France

name: Faculty of Medicine, University of Limoges, Limoges, France

family: Vincent

full_name: François Vincent

given: François

name: Department of Medical Oncology, University Hospital, Limoges, France

family: Deluche

full_name: Elise Deluche

given: Elise

family: Bonis

full_name: Joëlle Bonis

given: Joëlle

name: Department of Biostatistics and Clinical Research, University Hospital, Limoges, France

family: Leobon

full_name: Sophie Leobon

given: Sophie

family: Antonini

full_name: Marie-Thérèse Antonini

given: Marie-Thérèse

family: Laval

full_name: Caroline Laval

given: Caroline

family: Favard

full_name: Florent Favard

given: Florent

family: Dobbels

full_name: Eloïse Dobbels

given: Eloïse

family: Lavau-Denes

full_name: Sandrine Lavau-Denes

given: Sandrine

family: Labrunie

full_name: Anaïs Labrunie

given: Anaïs

family: Thuillier

full_name: Frédéric Thuillier

given: Frédéric

family: Venat

full_name: Laurence Venat

given: Laurence

family: Tubiana-Mathieu

full_name: Nicole Tubiana-Mathieu

given: Nicole

currency_apc_doaj: USD

journal_name: Integrative Cancer Therapies

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: University Hospital, Limoges


title: Lumbar Proprioception in Lower Back Pain Patients Versus Healthy Subjects : a Comparative Study on the Effects of Low- and High-frequency Muscle Vibrations

acronym: Vibrioception

summary:
The primary objective of this study is to compare the lumbar proprioception of patients with chronic back pain to that of healthy volunteers during low- and high-frequency muscle vibration.

The order of measures (low frequency of vibration, high frequency vibration and no vibration) is randomized in a cross-over design.

Patients and volunteers are matched by age and body mass index.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Comparison Between Two New Generation Dressings in the Prevention of Intravascular Catheter Related Complications in Intensive Care Units

acronym: Advanced

summary: Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications associated with intravascular catheters in intensive care.

location_facility: University Hospital of Grenoble, Medical Intensive Care Unit


title: Influence of Muscle Strength on the Energy Cost of Walking in Obese Subjects

acronym: OBELIX

summary: The purpose of this study is to evaluate the efficacy of 2 physical exercise training programs, with a supplementation in fruits and vegetables, on energy cost of walking. 60 subjects will be randomized into 2 groups. The first program will be consist of an interval strength training for 30 min on bicycle ergometer (which include strengthening exercises in an high intensity interval training). The second program will be conducted at a relatively low intensity of effort, corresponding to 50% of oxygen uptake (VO2) peak measured by indirect calorimetry. All subjects will receive a free supplement of 5 fruits and vegetables per day during all the intervention. The intervention will last 9 months in total : 5 month at the hospital fallow by 4 month at home.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer

summary: The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.

lead_sponsor: Laboratoires Thea


title: Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery. Prospective Randomised Controlled and Single Centre Trial

acronym: VP-hTA-XCar

summary: The effects on brain perfusion of the two currently vasopressors used to treat accidental hypotension occurring during carotid surgery (i.e. ephedrine and phenylephrine) is not known, but a disadvantage to use phenylephrine is suspected, due to its mechanism of action and according to published reports

ReferenceCitation: Aliane J, Dualé C, Guesmi N, Baud C, Rosset E, Pereira B, Bouvier D, Schoeffler P. Compared effects on cerebral oxygenation of ephedrine vs phenylephrine to treat hypotension during carotid endarterectomy. Clin Exp Pharmacol Physiol. 2017 Jul;44(7):739-748. doi: 10.1111/1440-1681.12759.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Role of Mesocorticolimbic Pathway in Apathy of Patients With Parkinson's Disease. - Study Using Diffusion Tensor Imaging and Fibres Tracking

summary:
Use lay language.

Apathy is one of the most under recognised, underdiagnosed and poorly managed aspects of Parkinson's disease. Depending on methodological approach of the study, its prevalence is estimated to be between 16 and 51%.

Apathy derives from a dysfunction of the dopaminergic meso cortico limbic systems, which seems to play a central role in the control of mood and motivation. The subcortical components of this system are the ventral tegmental area (VTA), the nucleus accumbens, and the constituents of the limbic system (particularly the hippocampus and amygdala), all of which are located deep inside the brain (18). The hypothesis is that depletion of striatal dopamine from regulators located in the midbrain (VTA and SNpc) in striato-thalamo-cortical circuits results in hypofunction of these circuits and the loss of frontal cortical activity, particularly within in the frontal orbital cortex, the anterior cingulate cortex and the prefrontal cortex

The objective of this study is to explore, using diffusion weighted MRI, the regions of the brain which are proposed to play a role in motivation in apathetic Parkinson's disease patients and to define more precisely the relation between dopaminergic fibres and the meso-cortico-limbic system with the help of tractography methods


title: Evaluation on Seropositive Patients of a Synthetic Vaccine Targeting the HIV Tat Protein

acronym: EVATAT

summary: Tat Oyi vaccination on seropositive patients could help their immune system to recognize and neutralize Tat. The neutralization of extra cellular Tat should help the cellular immune response to eliminate HIV-1 infected cells.

ReferenceCitation: Loret E. HIV extracellular Tat: myth or reality? Curr HIV Res. 2015;13(2):90-7. Review.

ipd_sharing: Yes

ipd_sharing_description: Data base (HIV RNA, CD4, CD8, HIV DNA, Tat immune response) and statistical analysis

lead_sponsor: BIOSANTECH

location_facility: Centre d'Investigation Clinique - Universitary Hospital Centre Conception

intervention_type: Biological


title: Presurgical Language Mapping With fMRI: Comparison of BOLD and fASL Techniques

acronym: MALTA

summary: One of the aim of the neurosurgical treatment of brain tumor is to offer the maximal resection with the minimal neurological risk. The presurgical mapping of eloquent areas with functional magnetic resonance imaging (fMRI) is helpful to plan the surgery. BOLD fMRI is now the gold standard to map language areas. However, BOLD signal is diminished near the brain tumor. It is now possible to detect cortical activation with arterial spin labeling (ASL) techniques, detecting variations of perfusion during an activation paradigm (fASL), fASL could be interesting to detect eloquent areas near a brain tumor.

lead_sponsor: Rennes University Hospital


title: Predictive Abilities for Transfusion Needs of Capillary Lactate Measure in Emergency for Injured Normotensive Patients

summary:
13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion of six or more units of packed Red Blood Cells. It is currently difficult to predict the need for such a mass blood-transfusion. Indeed hemoglobin point of care testing (hemocue) and blood pressure can be normal during the first hours despite intensive bleeding.

It's well known that blood or arterial lactate measures correlate with trauma severity but these measures are not available in a pre-hospital setting. The investigators want to test whether capillary lactate measures also correlate with trauma severity and can therefore predicts earlier transfusion needs.

ReferenceCitation: Bouzat P, Schilte C, Vinclair M, Manhes P, Brun J, Bosson JL, Payen JF. Capillary lactate concentration on admission of normotensive trauma patients: a prospective study. Scand J Trauma Resusc Emerg Med. 2016 Jun 7;24:82. doi: 10.1186/s13049-016-0272-x.

family: Bouzat

full_name: Pierre Bouzat

given: Pierre

family: Schilte

full_name: Clotilde Schilte

given: Clotilde

family: Vinclair

full_name: Marc Vinclair

family: Manhes

full_name: Pauline Manhes

given: Pauline

family: Brun

full_name: Julien Brun

given: Julien

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: Payen

full_name: Jean-François Payen

given: Jean-François

currency_apc_doaj: GBP

journal_name: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Tracheostomy and Weaning From Mechanical Ventilation : Evaluation of the Lung Ultrasound Score

acronym: TRAWELUS

summary: Prospective, interventional multicentric study in ICU during weaning from mechanical ventilation in tracheotomized patients


type: EudraCT Number

title: Randomized and Multicenter Study Assessing the Efficacy of Intravenous Sodium Valproate in Addition to First Line Anti Epileptic Treatment of Generalized Convulsive Status Epilepticus.

acronym: VALSE

summary:
Study Hypothesis Generalized Convulsive Status Epilepticus (GCSE) is a medical emergency associated with an increased morbidity and a prolonged length of hospital stay. Only 50% of patients are discharged from the hospital within the first month after GCSE. Recent Guidelines from Experts highlight the necessity to improve the efficiency of the first line anti-epileptic (AE) therapy.

Intravenous Sodium Valproate (SV) might be an adjuvant AE drug to the recommended first line AEs. Intravenous SV is available, well tolerated and easily injectible but also has pharmacologic properties for reducing the risk of seizures relapses and for being neuroprotective. However, efficacy of intravenous as an adjuvant therapy in GCSE has never been properly assessed.

Primary Purpose The primary purpose is to assess if the association of intravenous Sodium Valproate with the recommended treatment for Generalized Convulsive Status Epilepticus increases to 20 % the number of living patients, discharged from the hospital at day 15.

ReferenceCitation: Sharshar T, Ben Hadj Salem O, Porcher R, Grimaldi-Bensouda L, Heming N, Clair B, Azabou E, Mazeraud A, Rohaut B, Outin H. Valproic Acid as an Adjuvant Treatment for Generalized Convulsive Status Epilepticus in Adults Admitted to Intensive Care Units: Protocol for a Double-Blind, Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 24;10(2):e22511. doi: 10.2196/22511.

family: Sharshar

full_name: Tarek Sharshar

given: Tarek

family: Ben Hadj Salem

full_name: Omar Ben Hadj Salem

given: Omar

family: Porcher

full_name: Raphaël Porcher

given: Raphaël

family: Grimaldi-Bensouda

full_name: Lamiae Grimaldi-Bensouda

given: Lamiae

family: Heming

full_name: Nicholas Heming

given: Nicholas

family: Clair

full_name: Bernard Clair

given: Bernard

family: Azabou

full_name: Eric Azabou

given: Eric

family: Mazeraud

full_name: Aurélien Mazeraud

given: Aurélien

family: Rohaut

full_name: Benjamin Rohaut

given: Benjamin

family: Outin

full_name: Hervé Outin

given: Hervé

journal_name: JMIR Research Protocols

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

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications


title: Comparison of the Effect of Repeated Exposure, Flavor-Flavor Learning and Flavor-Nutrient Learning on Vegetable Acceptance in Weaning Age Infants

summary: This study aims at comparing learning mechanisms to increase vegetable acceptance in infants at complementary feeding, namely repeated exposure (RE), flavor-flavor learning (FFL) and flavor-nutrient learning (FNL); measuring the stability of the learning effect; and examining the impact of infants' feeding history on vegetable acceptance.

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation


title: A Randomized Study Evaluating the Role of Ultra-sound Guidance When Drawing Radial Arterial Blood Samples

acronym: ECHO-PARDIF

summary:
Previous studies have demonstrated that an experienced ultrasound operator is able to efficiently perform radial arterial puncture on patients where an initial operator failed to puncture arteries via simple palpation.

The objective of this study is to compare "difficult-to-puncture" patients randomized into two groups: one group where ultrasound is used to aid artery localisation, and one group where only palpation is used.

ReferenceCitation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10:CD013585. doi: 10.1002/14651858.CD013585.pub2. Review.

name: Department of Surgery, Division of Vascular and Endovascular Surgery; Universidade Federal de São Paulo; São Paulo Brazil

family: Flumignan

full_name: Ronald LG Flumignan

given: Ronald LG

name: Emergency Medicine; Universidade Federal de São Paulo; São Paulo Brazil

name: Rheumatology; Universidade de Santo Amaro; São Paulo Brazil

family: Trevisani

full_name: Virginia FM Trevisani

given: Virginia FM

name: Division of Cardiology; Duke University Medical Center; Durham USA

family: Lopes

full_name: Renato D Lopes

given: Renato D

name: Evidence-based Medicine; Cochrane Brazil; São Paulo Brazil

family: Baptista-Silva

full_name: Jose CC Baptista-Silva

given: Jose CC

full_name: Carolina DQ Flumignan

given: Carolina DQ

family: Nakano

full_name: Luis CU Nakano

given: Luis CU

journal_name: Cochrane Database of Systematic Reviews


title: Contribution of 3D Sonohysterography and Virtual Hysteroscopy in Exploration of the Uterine Cavity in Comparison to the Diagnostic Hysteroscopy.

summary: To prove that the 3 dimensional sonohysterography is, at least, as effective as the diagnostic hysteroscopy in examining the uterine cavity.

lead_sponsor: Hopital Foch


title: Physiotherapy Versus Self Rehabilitation After Shoulder Dilatation for Primary Idiopathic Capsulitis

summary: Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.


title: Interest of Transient Elastography in the Determination of Advanced Fibrosis in Alcoholic Liver Didease in Alcoholic Patients in Weaning.

acronym: FIBR-OH

summary: Alcoholic liver disease is the most frequent complication of excessive alcohol consumption. Early diagnosis of alcoholic liver disease is essential to avoid its complications that could be fatal. To date, the reference diagnostic tool is an invasive procedure: the liver biopsy. The transient elastography is a useful tool for early diagnosis of liver fibrosis. This tool is validated in the diagnosis of liver fibrosis due to C chronic hepatitis. Because it is non-invasive, fast, given immediate results; transient elastography could be repeated in alcoholic patients for liver fibrosis follow-up. In the present study, the investigators propose to realize liver biopsy and transient elastography in 300 alcoholic patients in weaning to evaluate the transient elastography accuracy in the exclusion of sever liver fibrosis (Metavir 3 and 4). The reference liver fibrosis diagnosis tool will be the liver biopsy.

ReferenceCitation: Legros L, Bardou-Jacquet E, Turlin B, Michalak S, Hamonic S, Le Gruyer A, Aziz K, Lemoine C, Bouvard N, Chavagnat JJ, Silvain C, Kerjean J, Le Dréau G, Lacave-Oberti N, Oberti F, Le Lan C, Guyader D, Moirand R. Transient Elastography Accurately Screens for Compensated Advanced Chronic Liver Disease in Patients With Ongoing or Recent Alcohol Withdrawal. Clin Gastroenterol Hepatol. 2021 Feb 12. pii: S1542-3565(21)00155-5. doi: 10.1016/j.cgh.2021.02.021. [Epub ahead of print]

family: Legros

full_name: Ludivine Legros

given: Ludivine

family: Bardou-Jacquet

full_name: Edouard Bardou-Jacquet

given: Edouard

family: Turlin

full_name: Bruno Turlin

given: Bruno

family: Michalak

full_name: Sophie Michalak

given: Sophie

family: Hamonic

full_name: Stéphanie Hamonic

given: Stéphanie

family: Le Gruyer

full_name: Antonia Le Gruyer

given: Antonia

family: Aziz

full_name: Karim Aziz

given: Karim

family: Lemoine

full_name: Cynthia Lemoine

given: Cynthia

family: Bouvard

full_name: Nicole Bouvard

given: Nicole

family: Chavagnat

full_name: Jean-Jacques Chavagnat

given: Jean-Jacques

family: Silvain

full_name: Christine Silvain

given: Christine

family: Kerjean

full_name: Jacqueline Kerjean

given: Jacqueline

family: Le Dréau

full_name: Gérard Le Dréau

given: Gérard

family: Lacave-Oberti

full_name: Natacha Lacave-Oberti

given: Natacha

family: Oberti

full_name: Frederic Oberti

given: Frederic

family: Le Lan

full_name: Caroline Le Lan

given: Caroline

family: Guyader

full_name: Dominique Guyader

given: Dominique

family: Moirand

full_name: Romain Moirand

given: Romain

journal_name: Clinical Gastroenterology and Hepatology

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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


title: Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients

acronym: AREAS

summary:
Type-2 Diabetes and Sleep Apnea Syndrome (SAS) are both related to an increase in platelet activation. Type 2 diabetes is often associated with sleep apnea syndrome with a prevalence up to 60%.

The main objective of our study is to analyze the influence of sleep apnea on the response to antiplatelet therapy in stable aspirin-treated type-2 diabetes patients.

Consecutive stable aspirin-treated type-2 diabetes patients referred for suspicion of sleep apnea will be recruited after providing informed consent. Response to aspirin will be assessed with the Verify Now Aspirin(TM)rapid analyser in the morning after nocturnal polysomnography, and compared with a group of type-2 diabetes free of sleep apnea. Other endocrine, metabolic, hematologic and cardiovascular confounders will also be assessed at baseline to determine their influence on the response to aspirin.

Then, Patients with severe SAS (Apnea-Hypopnea Index> 30 events/h) and response with Aspirin (ARU > 454) will be randomized to 3 months of active or sham continuous positive airway pressure treatment in a pilot study. After the 3-months of intervention, response to aspirin will be compared between the sham and effective CPAP groups.


title: Evaluation of the Bone Microarchitecture in a Young Cystic Fibrosis Patients Using High-Resolution Peripheral Quantitative Computed Tomography

summary:
Patients with cystic fibrosis are at risk of developing low bone mineral density (BMD) potentially leading to pathological fractures at adult age. Recent data from our center and others have suggested that low BMD could be observed very early in life. However, quantitative bone abnormalities found out by Dual X-ray absorptiometry (DXA) need to be confronted to qualitative evaluation of bone microarchitecture (surrogate of bone strength).

High-Resolution peripheral quantitative computed tomography (HR-pQCT) is a recent technology with very high spatial resolution. Images obtained with this technic are considered as virtual bone biopsies. It enables an accurate bones' cortical and trabecular surfaces exploration in a three-dimensional manner, and therefore provides informations on bone microarchitecture as well as bone density.

The aim of this study is to evaluate bone microarchitecture of paediatric patients matched to sex-age-pubertal status-healthy volunteers. In the meantime, biological markers will be collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore potential correlations HR-pQCT parameters.

ReferenceCitation: Braun C, Bacchetta J, Braillon P, Chapurlat R, Drai J, Reix P. Children and adolescents with cystic fibrosis display moderate bone microarchitecture abnormalities: data from high-resolution peripheral quantitative computed tomography. Osteoporos Int. 2017 Nov;28(11):3179-3188. doi: 10.1007/s00198-017-4179-9. Epub 2017 Aug 9.

family: Braun

full_name: C. Braun

given: C.

family: Bacchetta

full_name: J. Bacchetta

given: J.

family: Braillon

full_name: P. Braillon

given: P.

family: Chapurlat

full_name: R. Chapurlat

given: R.

family: Drai

full_name: J. Drai

family: Reix

full_name: P. Reix

journal_name: Osteoporosis International


title: Cemented Versus Uncemented Hemiarthroplasty for Displaced Femoral Neck Fracture in Elderly Patient : a Randomized Prospective Trial

acronym: PIH

summary:
The purpose of this study was to identify the clinical relevance of cementless hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the relevance of cementless hemiarthroplasties in displaced femoral neck fractures.

150 patients will be included, 75 with cemented hemiarthroplasty and 75 with uncemented hemiarthroplasty. They will be followed during one year after the surgery, with a functionality assessment at 3 month and 12 month.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: orthopedics department, University Hospital


title: Feasibility of Microdialysis by Laparoscopy

acronym: MTM-COLON-I

summary: The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.

ReferenceCitation: Högberg N, Carlsson PO, Hillered L, Meurling S, Stenbäck A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. Epub 2011 Nov 21.

ReferenceCitation: Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Epub 2008 May 24. Erratum in: Dis Colon Rectum. 2008 Nov;51(11):1741. Hanna, B G [corrected to Hanna, G B].

ReferenceCitation: Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Measure of Ano-rectal Motility in Fecal Incontinence

summary: Traditionnal measurment of anorectal function is perfomed with manometric device using 2 to 3 pressure sensors. The investigators aim to evaluate the usefulness of high resolution manometry to measure anorectal motility

lead_sponsor: University Hospital, Rouen


title: Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program

acronym: PETRUS

summary: Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells.

ReferenceCitation: Lindsay CR, Le Moulec S, Billiot F, Loriot Y, Ngo-Camus M, Vielh P, Fizazi K, Massard C, Farace F. Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer. BMC Cancer. 2016 Feb 29;16:168. doi: 10.1186/s12885-016-2192-6.

family: Lindsay

full_name: C. R. Lindsay

given: C. R.

family: Le Moulec

full_name: S. Le Moulec

given: S.

family: Billiot

full_name: F. Billiot

given: F.

family: Loriot

full_name: Y. Loriot

given: Y.

family: Ngo-Camus

full_name: M. Ngo-Camus

given: M.

family: Vielh

full_name: P. Vielh

family: Fizazi

full_name: K. Fizazi

given: K.

family: Massard

full_name: C. Massard

family: Farace

full_name: F. Farace

journal_name: BMC Cancer

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Interest of a Bi-truncal Nerve Block (Femoral + Sciatic) Extended, Systematically Associated With General Anesthesia, in the Femoropopliteal Bypass: Study of Post-operative Analgesia and Peripheral Circulation Downstream.

acronym: BLOC-FEMPOP

summary:
The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and clonidine in a single dose, performed before induction of general anaesthesia, on analgesia postoperatively assessed by morphine consumption.

Applied to the patient at the beginning of general anesthesia, this technique could allow one hand, to reduce the need for opiates, on the other hand - due to anesthetized limb vasodilation - to improve tissue perfusion downstream.

ReferenceCitation: Charvin M, Longeras F, Jouve P, Cherprenet AL, Futier E, Pereira B, Dualé C. Effects of adding a combined femoral and sciatic nerve block with levobupivacaine and clonidine to general anaesthesia in femoropopliteal bypass surgery: A randomised, double-blind, controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):787-795. doi: 10.1097/EJA.0000000000001263.

family: Charvin

full_name: Martin Charvin

given: Martin

family: Longeras

full_name: François Longeras

given: François

family: Jouve

full_name: Philippe Jouve

given: Philippe

family: Cherprenet

full_name: Anne-Laure Cherprenet

given: Anne-Laure

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Dualé

full_name: Christian Dualé

given: Christian

journal_name: European Journal of Anaesthesiology


title: Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU

acronym: REVECOL

summary: Prospective, observational clinical multicentric study in ICU; during the period surrounding the orotracheal intubation.


title: Implementing Referral Guidelines for Imaging Exams Requested Via the Emergency Department: Impact on Exam Relevance and Associated Delays

acronym: RIU

summary: The main objective of this study is to evaluate the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on exam relevance. The latter is assessed via the rate of suspected diagnoses that are confirmed by the requested exam.


title: Renal Prognosis of Former Preterm Infants 3 to 10 Years After Neonatal Acute Renal Failure

acronym: IRENEO

summary: The aim of this study is to evaluate the signs of nephronic reduction in preterm infants who have presented neonatal acute renal failure. The investigators hypothesize that signs of nephronic reduction would appear earlier in former preterm with neonatal acute renal failure than in control preterm infants.

ReferenceCitation: Bruel A, Rozé JC, Quere MP, Flamant C, Boivin M, Roussey-Kesler G, Allain-Launay E. Renal outcome in children born preterm with neonatal acute renal failure: IRENEO-a prospective controlled study. Pediatr Nephrol. 2016 Dec;31(12):2365-2373. Epub 2016 Jun 22.

lead_sponsor: Nantes University Hospital


title: HEPFER-Evaluation of a New Phenotypic Biological Marker in Genetic Type 1 Hemochromatosis

acronym: HEPFER

summary:
HFE(High iron FE)-related hereditary hemochromatosis has a highly variable penetrance. No phenotypic or genetic markers can predict the disease. The Iron Reabsorption Index (IRI), recently described by our group, correspond to the daily reabsorbed iron for a subject whose iron stock is stable and less than 50 µg / L.

The IRI is constant over time, reflecting the importance of the underlying functional deficit.

Hepcidin / ferritin (H / F) ratio may be an independent and constant over time marker of disease stage.No data are available on the validated values of this ratio.

The goal of this project is to determine the intra-individual variations of the H / F ratio over time during maintenance therapy and to assess the correlation with the IRI.


title: Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab. A Randomized Phase II Trial.

acronym: IIPOP

summary: Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis


title: Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study

summary:
Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities).

Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.

lead_sponsor: Baxter Healthcare Corporation


title: Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area.

summary:
Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area.

The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).


title: PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

acronym: PREONIV

summary: Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.


title: DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

acronym: DAILY

summary: This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.

lead_sponsor: Bayer


title: Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients.

summary:
Use lay language.

Many decisions involve the possibility of gaining or losing relative to the status quo. The loss aversion behaviour is a cognitive concept explaining that people are more sensitive to the possibility of losing objects or money than they are to the possibility of gaining the same objects or amounts of money.

We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money.

The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.

2 groups :

20 parkinsonian patients (tested two times : with and without treatment by L dopa)
20 healthy paired control

Description of the protocol for patients :

J0 : Inclusion visit (duration : 4h):

motor assessment (UPDRS)
neuropsychological and psychiatric assessment (MMS, MATTIS, BREF, Stroop, Ardouin scale, UPPS, MADRS, Hamilton, LARS).

J0+1 day and J0 +2 days : 2 visits of MRI (magnetic resonance imaging) acquisition (with or without treatment) :

Each acquisition was composed by an orientation sequence+ an anatomic sequence + a functional sequence.

For healthy subjects, they have only one visit of 2 hours including a MMS, a MADRS and the MRI acquisitions.


title: Secondary Prevention of Osteoporosis in Women Over 50 Years Old After Low Intensity Fracture of the Upper Limb: Evaluation of an Intervention Focused on the Patient.

acronym: PREVOST

summary:
Osteoporosis is a disease characterized by reduced bone mass and increased skeletal fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture is a powerful predictor of future fractures and about 50% of patients with a fragility fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007). Osteoporotic fractures are associated with an increased morbidity and mortality but also high financial costs. However, less than 20% of patients presenting a low trauma fracture receive an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The hypothesis of a lack of information and an under assessment of consequences by both patients and physicians has been raised to explain this gap between recommended care and usual practices.

The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old.

This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.

ReferenceCitation: Merle B, Chapurlat R, Vignot E, Thomas T, Haesebaert J, Schott AM. Post-fracture care: do we need to educate patients rather than doctors? The PREVOST randomized controlled trial. Osteoporos Int. 2017 May;28(5):1549-1558. doi: 10.1007/s00198-017-3953-z. Epub 2017 Feb 28.

family: Merle

full_name: B. Merle

given: B.

family: Chapurlat

full_name: R. Chapurlat

family: Vignot

full_name: E. Vignot

given: E.

family: Thomas

full_name: T. Thomas

given: T.

family: Haesebaert

full_name: J. Haesebaert

family: Schott

full_name: A.-M. Schott

lead_sponsor: Hospices Civils de Lyon


title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Crossover Study of Single Doses of LY2624803 in a 5-hour Phase Advance Model of Transient Insomnia in Healthy Subjects

summary: The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy people. The study has four treatment periods. Participants will receive a single dose of LY2624803, another sleeping pill, or placebo in each treatment period. The study will last approximately 1 month for each participant.

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Conducting Airways in Lung Fibrosis

acronym: VACFI

summary: The purpose of this study is to determine whether extension of the conducting airways into the distal lung, or bronchiolization, occurs early in the course of Idiopathic Pulmonary Fibrosis, a disease wherein normal lung structures are destroyed and replaced by non-functional scar tissue.

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma

acronym: ASMATHERM

summary: To determine, from patients presenting severe asthma and an increase in bronchial smooth muscle mass, those who would be the best candidates for bronchial THERMOPLASTY. THERMOPLASTY should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations, and improve respiratory function

ReferenceCitation: Debray MP, Dombret MC, Pretolani M, Thabut G, Alavoine L, Brillet PY, Taillé C, Khalil A, Chanez P, Aubier M. Early computed tomography modifications following bronchial thermoplasty in patients with severe asthma. Eur Respir J. 2017 Mar 15;49(3). pii: 1601565. doi: 10.1183/13993003.01565-2016. Print 2017 Mar.

family: Debray

full_name: Marie-Pierre Debray

given: Marie-Pierre

family: Dombret

full_name: Marie-Christine Dombret

given: Marie-Christine

family: Pretolani

full_name: Marina Pretolani

given: Marina

family: Thabut

full_name: Gabriel Thabut

given: Gabriel

family: Alavoine

full_name: Loubna Alavoine

given: Loubna

family: Brillet

full_name: Pierre-Yves Brillet

given: Pierre-Yves

family: Taillé

full_name: Camille Taillé

given: Camille

family: Khalil

full_name: Antoine Khalil

given: Antoine

family: Chanez

full_name: Pascal Chanez

given: Pascal

family: Aubier

full_name: Michel Aubier

given: Michel

journal_name: European Respiratory Journal

evidence: open (via free pdf)

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ipd_sharing: Undecided


title: Detection and Characterization of Circulating Tumor Cells in Patients With Malignant Pleural Mesothelioma: Towards a New Phase in the Understanding of the Natural History of This Cancer?

summary:
Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare distant metastases. There is now a sizable body of evidence that metastases could develop from circulating tumor cells (CTC) spread in blood before or during surgery. Thus, sensitive and specific detection of CTC in blood is considered as a potentially relevant predictive biomarker for patients with carcinomas. In exchange, the prognostic value of CTC in MPM has not yet been evaluated.

Indeed, the main goal for preoperative detection of CTC is to identify patients with high risk of recurrence after surgery, in order to perform more adapted therapeutic strategy. Despite several studies reported about CTC detection, methodological aspects concerning sensitivity, specificity and reproducibility have prevented a clear appraisal of their clinical impact. Thus, the aim of our study is to evaluate the presence and the prognostic value of CTC in MPM by a double approach. In our setting, cytopathological analysis of circulating non hematological cells (CNHC), of epithelial origin, isolated according to their size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic selection, identification and enumeration of circulating epithelial cells in peripheral blood (CellSearch method) is considered a promising approach.

location_facility: CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine


title: The Role of Central and Systemic Inflammation and Aβ-specific Immune Responses in Early AD

summary: The main objective of this study is to investigate the central and peripheral inflammatory, as well as the spontaneous Aβ-specific, immune responses at the asymptomatic stage and early stages of AD by combining molecular imaging techniques with blood biomarker analyses. The early and preclinical stages of AD will be studied in the relatives of patients with PSEN1, PSEN2 or APP mutations that are at-risk (50%) to be mutation carriers. This study will evaluate the contribution of Inflammatory and immune anti-Aβ responses (I2ARs) in AD progression. Inclusion of sporadic and familial forms of AD will aid in studying the chronology of pathological events. Clinical follow-ups will be conducted annually for two years and will include an MRI and a blood draw on the last visit. We expect I2ARs to appear in the early stages of the disease and to constitute new prognostic factors. I2ARs could also become therapeutic markers for the assessment of novel anti-amyloid treatments and may offer new insights to the development of Aβ-specific immunotherapy strategies.

ReferenceCitation: Corlier F, Rivals I, Lagarde J, Hamelin L, Corne H, Dauphinot L, Ando K, Cossec JC, Fontaine G, Dorothée G, Malaplate-Armand C, Olivier JL, Dubois B, Bottlaender M, Duyckaerts C, Sarazin M, Potier MC; Clinical ImaBio3 Team. Modifications of the endosomal compartment in peripheral blood mononuclear cells and fibroblasts from Alzheimer's disease patients. Transl Psychiatry. 2015 Jul 7;5:e595. doi: 10.1038/tp.2015.87.

family: Corlier

full_name: F Corlier

given: F

family: Rivals

full_name: I Rivals

given: I

family: Lagarde

full_name: J Lagarde

given: J

family: Hamelin

full_name: L Hamelin

given: L

family: Corne

full_name: H Corne

given: H

family: Dauphinot

full_name: L Dauphinot

family: Ando

full_name: K Ando

given: K

family: Cossec

full_name: J-C Cossec

given: J-C

family: Fontaine

full_name: G Fontaine

given: G

family: Dorothée

full_name: G Dorothée

family: Malaplate-Armand

full_name: C Malaplate-Armand

given: C

family: Olivier

full_name: J-L Olivier

given: J-L

family: Dubois

full_name: B Dubois

given: B

family: Bottlaender

full_name: M Bottlaender

given: M

family: Duyckaerts

full_name: C Duyckaerts

family: Sarazin

full_name: M Sarazin

family: Potier

full_name: M-C Potier

given: M-C

journal_name: Translational Psychiatry

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

title: Modifications of the endosomal compartment in peripheral blood mononuclear cells and fibroblasts from Alzheimer’s disease patients

ReferenceCitation: Hamelin L, Bertoux M, Bottlaender M, Corne H, Lagarde J, Hahn V, Mangin JF, Dubois B, Chupin M, de Souza LC, Colliot O, Sarazin M. Sulcal morphology as a new imaging marker for the diagnosis of early onset Alzheimer's disease. Neurobiol Aging. 2015 Nov;36(11):2932-2939. doi: 10.1016/j.neurobiolaging.2015.04.019. Epub 2015 Jul 15.

ReferenceCitation: Hamelin L, Lagarde J, Dorothée G, Leroy C, Labit M, Comley RA, de Souza LC, Corne H, Dauphinot L, Bertoux M, Dubois B, Gervais P, Colliot O, Potier MC, Bottlaender M, Sarazin M; Clinical IMABio3 team. Early and protective microglial activation in Alzheimer's disease: a prospective study using 18F-DPA-714 PET imaging. Brain. 2016 Apr;139(Pt 4):1252-64. doi: 10.1093/brain/aww017. Epub 2016 Mar 15.

repository_institution: CERN European Organization for Nuclear Research - Zenodo

title: Early and protective microglial activation in Alzheimer’s disease: a prospective study using18F-DPA-714 PET imaging


title: IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

acronym: NIDOCIGA

summary:
IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it represents an important cause of end-stage kidney failure. This disease was described as a distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis remain still obscure. Clinical observations and immunisation studies indicate that IgAN represents a dysregulation of the immune system, rather than an intrinsic renal abnormality. Twenty years ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the disease. Mucosal IgA plasmocytes are displaced and take up residence in systemic sites. The unusual characteristics featured by the IgA produced by these cells (charge, size, glycosylation) drive their accumulation, deposition and mesangial activation characteristic of IgAN.

Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant localization.

lead_sponsor: University Hospital, Limoges


title: Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet

acronym: NEUROXAPOL

summary:
Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy appearing with the repetition of chemotherapy cycles.

To this date there is no effective therapy able to prevent and/or to treat these adverse drug reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute oxaliplatin-induced hypersensitivity in animals.

So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may prevent acute oxaliplatin-induced hypersensitivity in patients.

ReferenceCitation: Balayssac D, Ferrier J, Pereira B, Gillet B, Pétorin C, Vein J, Libert F, Eschalier A, Pezet D. Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet-NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial. BMJ Open. 2015 Apr 1;5(4):e007479. doi: 10.1136/bmjopen-2014-007479.

family: Balayssac

full_name: D. Balayssac

given: D.

family: Ferrier

full_name: J. Ferrier

given: J.

family: Pereira

full_name: B. Pereira

given: B.

family: Gillet

full_name: B. Gillet

family: Petorin

full_name: C. Petorin

given: C.

family: Vein

full_name: J. Vein

family: Libert

full_name: F. Libert

given: F.

family: Eschalier

full_name: A. Eschalier

given: A.

family: Pezet

full_name: D. Pezet

journal_name: BMJ Open

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet--NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial


title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

summary: This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.

lead_sponsor: AbbVie

location_country:
United States
France
Spain

location_facility: Mary Crowley Cancer Research /ID# 148580

location_facility: South Texas Accelerated Research Therapeutics /ID# 141715

location_facility: Carolina BioOncology Institute /ID# 148583

location_facility: Hosp Univ Madrid Sanchinarro /ID# 146039

location_facility: Washington University-School of Medicine /ID# 151348

location_facility: Dana-Farber Cancer Institute /ID# 143782

location_facility: Univ of Colorado Cancer Center /ID# 148581

location_facility: University of California, Los Angeles /ID# 148586


title: A Multicenter, Prospective, Randomized, Open-label, Intra-subject Controlled Study of the Efficacy and Safety of ABH001 for the Treatment of Stalled Chronic Cutaneous Wounds Associated With Generalized Epidermolysis Bullosa

summary:
The purpose of this study is to evaluate the efficacy and safety of ABH001 in the treatment of patients with epidermolysis bullosa who have wounds that are not healing.

It is hypothesized that ABH001 may initiate and continue wound healing in patients with epidermolysis bullosa.

lead_sponsor: Shire Regenerative Medicine, Inc.

location_country:
Austria
Spain
Germany
France
Poland
Portugal
United States
Canada

location_facility: University of Freiburg (Studiensekretariat Hautklinik Universitätsklinikum Freiburg - Hautklinik)

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der Paracelsus Medizinischen Privatuniversität

location_facility: Warszawki Uniwersytet Medyczny Katedra I Klinika Dermatologiczna

location_facility: Lucile Packard Children's Hospital at Stanford University

location_facility: Rady Children's Hospital - San Diego/UCSD, Pediatric and Adolescent Dermatology

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago


status: Recruiting

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Hong Kong
Spain
France
Japan
Singapore
China
Germany
Canada

location_facility: University of Texas MD Anderson Cancer Center Dept of Onc

source: euctr

title: A Phase I/II, Multicenter, Open-label Study of MAK683 in Adult Patients With Advanced Malignancies

summary: The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.

status_simplified: Ongoing


ReferenceCitation: Blume-Peytavi U, Shapiro J, Messenger AG, Hordinsky MK, Zhang P, Quiza C, Doshi U, Olsen EA. Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study. J Drugs Dermatol. 2016 Jul 1;15(7):883-9.

lead_sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

location_country:
United States
France
Germany
United Kingdom
Canada

location_facility: Klinik für Dermatologie, Venerologie und Allergologie, Clinical Research Center for Hair and Skin Science

title: A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5 % Minoxidil Foam vs. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)

summary:
This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day.

This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks).

This trial will determine if the benefit of using either study product outweighs the risks.


title: A Six-month Double-blind, Randomized, Placebo-controlled Study Investigating the Safety and Tolerability of Deferiprone in Patients With Friedreich's Ataxia

summary:
The primary objective of this study is to demonstrate the safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA).

The secondary objective is to evaluate the efficacy of deferiprone for the treatment of FRDA, as assessed by a 9-Hole Peg Test (9HPT), Timed 25-Foot Walk (T25FW), Low-Contrast Letter Acuity test (LCLA), International Cooperative Ataxia Rating Scale (ICARS), and Friedreich's Ataxia Rating Scale (FARS).

The tertiary objectives are to evaluate the effect of deferiprone on:

cardiac function as measured by changes in Left Ventricular Shortening Fraction (LVSF), Left Ventricular Ejection Fraction (LVEF) and Left Ventricular (LV) mass using echocardiogram (ECHO),
quality of life using quality-of-life surveys, and
functional status using Activities of Daily Living (ADL).

lead_sponsor: ApoPharma

location_country: Italy France Belgium Australia Spain Canada

location_facility: La Fundacion Para la Investigacion Biomedica

location_facility: Fondazione IRCCS Istituto Neurologico "C. Besta"