title: Evaluation of Mirus™ for Sedation in Resuscitation

acronym: MIRUS

summary:
Current recommendations for the conduct of sédationanalgésie ICU encourage the use of the lightest possible sedation strategies, avoiding the administration of benzodiazepines source of longer durations of ventilation and ICU stay of syndrome cessation, mental confusion. Among the proposed alternatives, administration of halogenated volatile agents (sevoflurane) in resuscitation is interesting because their favorable pharmacokinetic even after prolonged administration: no tachyphylaxis, rapid clearance, no withdrawal syndrome.

There are two suitable delivery devices sevoflurane in intensive care, both with CE marking. The device Mirus ™ (Pall Medical, Fribourg, Switzerland) is the newest and it is easy to use and reliable. The objective of this study was to evaluate the use of Mirus ™ device in trauma resuscitation and cardiovascular resuscitation.

Specifically, it will use this modality in case of failure with conventional sedation products (propofol, midazolam): maximum permissible doses, sedation weaning failure due to severe agitation.

ReferenceCitation: Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72. Review.

ReferenceCitation: Kong KL, Willatts SM, Prys-Roberts C. Isoflurane compared with midazolam for sedation in the intensive care unit. BMJ. 1989 May 13;298(6683):1277-80.

ReferenceCitation: Sackey PV, Martling CR, Carlswärd C, Sundin O, Radell PJ. Short- and long-term follow-up of intensive care unit patients after sedation with isoflurane and midazolam--a pilot study. Crit Care Med. 2008 Mar;36(3):801-6. doi: 10.1097/CCM.0B013E3181652FEE.

ReferenceCitation: Sackey PV, Martling CR, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med. 2004 Nov;32(11):2241-6.

ReferenceCitation: Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S. Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med. 2011 Jun;37(6):933-41. doi: 10.1007/s00134-011-2187-3. Epub 2011 Mar 29.

ReferenceCitation: Röhm KD, Wolf MW, Schöllhorn T, Schellhaass A, Boldt J, Piper SN. Short-term sevoflurane sedation using the Anaesthetic Conserving Device after cardiothoracic surgery. Intensive Care Med. 2008 Sep;34(9):1683-9. doi: 10.1007/s00134-008-1157-x. Epub 2008 May 24.

ReferenceCitation: Hellström J, Öwall A, Bergström J, Sackey PV. Cardiac outcome after sevoflurane versus propofol sedation following coronary bypass surgery: a pilot study. Acta Anaesthesiol Scand. 2011 Apr;55(4):460-7. doi: 10.1111/j.1399-6576.2011.02405.x. Epub 2011 Feb 22.

ReferenceCitation: Soukup J, Schärff K, Kubosch K, Pohl C, Bomplitz M, Kompardt J. State of the art: sedation concepts with volatile anesthetics in critically Ill patients. J Crit Care. 2009 Dec;24(4):535-44. doi: 10.1016/j.jcrc.2009.01.003. Epub 2009 Mar 27. Review.

ReferenceCitation: Perbet S, Bourdeaux D, Sautou V, Pereira B, Chabanne R, Constantin JM, Chopineau J, Bazin JE. A pharmacokinetic study of 48-hour sevoflurane inhalation using a disposable delivery system (AnaConDa®) in ICU patients. Minerva Anestesiol. 2014 Jun;80(6):655-65. Epub 2013 Nov 13.

ReferenceCitation: Chabanne R, Perbet S, Futier E, Ben Said NA, Jaber S, Bazin JE, Pereira B, Constantin JM. Impact of the anesthetic conserving device on respiratory parameters and work of breathing in critically ill patients under light sedation with sevoflurane. Anesthesiology. 2014 Oct;121(4):808-16. doi: 10.1097/ALN.0000000000000394.

ReferenceCitation: Sackey PV, Martling CR, Nise G, Radell PJ. Ambient isoflurane pollution and isoflurane consumption during intensive care unit sedation with the Anesthetic Conserving Device. Crit Care Med. 2005 Mar;33(3):585-90.

ReferenceCitation: Berton J, Sargentini C, Nguyen JL, Belii A, Beydon L. AnaConDa reflection filter: bench and patient evaluation of safety and volatile anesthetic conservation. Anesth Analg. 2007 Jan;104(1):130-4.

ReferenceCitation: Bomberg H, Glas M, Groesdonk VH, Bellgardt M, Schwarz J, Volk T, Meiser A. A novel device for target controlled administration and reflection of desflurane--the Mirus™. Anaesthesia. 2014 Nov;69(11):1241-50. doi: 10.1111/anae.12798. Epub 2014 Jul 9.

lead_sponsor: University Hospital, Grenoble


title: Concordance Study of Molecular Biology Analysis for Para-aortic Nodes in the Ultra-staging of Advanced Cervical Cancers (GYNOSNA)

acronym: GYNOSNA

summary:
The para-aortic lymph node involvement in the advanced stage of cervical cancer is a poor prognostic factor for overall survival. Concomitant chemo-radiotherapy has become the standard treatment for advanced cervical cancer. In case of para-aortic lymph node involvement, an extension of radiotherapy fields is recommended.

A prospective multicentre study shown that the survival rate of patients with node ≤ 5 mm and which benefited from the expansion of radiotherapy fields was identical to the survival of pN0 patients.

However, due to a specific disease, this technique should not be performed in all patients. It is necessary to reliably select patients with retroperitoneal lymph node involvement. For this, it is recommended that prior to the concurrent chemo-radiotherapy, nodal staging surgery with a definitive histological analysis.

So we propose to use molecular diagnostic test OSNA (One Step Nucleic Acid Amplification) to improve lymph node metastasis detection sensitivity to achieve ultra-staging compared to conventional histology.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Completed


title: Randomised, Evaluation-blinded, Crossover, Controlled Study Assessing the Antispastic Efficacy and Safety of Dynamic Night Hand Splinting in Adults With Post-stroke Hemiplegia Treated by Botulimum Toxin (Dysport®) - (a Pilot Study)

acronym: ORTHOX

summary:
Upper limb spasticity is currently mainly managed with local toxin treatments. Recent studies suggested combining botulinum toxin injections with splinting to optimise rehabilitation in spastic patients. However, one study focused exclusively on lower limb spasticity, the second on elbow flexor hypertonia, and the last on wrist and finger spasticity in children.

A study was performed in adult patients with upper limb spasticity treated with botulinum toxin injections used as primary objective the tolerance for dynamic splinting. The authors noted that the need for botulinum toxin was reduced in 2 patients out of 6. No study has been conducted to date on the splinting + toxin combination in adults.

Another study showed that stretching sessions over 2 weeks of a muscle just given botulinum toxin helped improve the toxin's efficacy 2, 6 and 12 weeks after the injection. For this reason, rehabilitation teams routinely prescribe 10 sessions of physiotherapy for 15 days after botulinum treatment.

Based on this principle, we hypothesise that dynamic night splinting applied just after botulinum toxin treatment may also increase the toxin's efficacy. We chose a dynamic splint providing continuous stretching of the wrist and fingers in extension whilst allowing active flexion. Night splinting is thought to promote optimal functional use of the paretic upper limb during the day and thus prevent learned non-use, which could worsen the spasticity.

Each patient will receive treatment cycles, whose results will be compared, so that each patient will act as his/her own control. The evaluation will be based on the Tardieu scale chosen for its greater inter-individual reproducibility and greater reliability to measure spasticity.

The degree of extension of wrist and fingers provided by the splint will be adjusted to the patient's clinical condition with the elastic tensioners. The purpose of the splint is to maintain the stretch beyond the Tardieu spasticity angle at fast speed (V3) without reaching maximum extension, which could be harmful.

This protocol is designed to determine whether dynamic night hand splinting combined with botulinum toxin injections will improve botulinum antispastic efficacy in adults with brain damage.

status: Terminated

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: CHU de Reims

lead_sponsor_type: academique

status_simplified: Unknown


title: Intensive Care Unit and Secondary and Primary Immune Deficiency

acronym: ICUSPID

summary: Primary immune deficiencies (PID) are characterized by a failure of the immune system that is not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300 different inherited rare disorders were described. The occurrence of PID in adult is rare and diagnosis may be supported by the 6 ESID signs for adult. However these warnings signs are based only on expert recommendations and do not include comprehensive symptoms of PIDs. Recurrent infections, more aggressive, are the most common mode of revelation of the PID. Less frequently, autoimmune manifestation, solid tumor, lymphoproliferation tumor, chronic granulomatosis or hemophagocytic lymphohistiocytosis syndrome (HLS) may also revealed a PID. The objective of this study was to evaluate the occurrence of unknown PID in adult admitted in critical care unit and to determinate if the investigation of PID in patients with severe infections or HLS should be routinely performed in MCIU.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Caen

intervention_type: Other


title: Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

acronym: IMODLAM

summary:
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. The occurrence of relapses is important during the first three months post-allogeneic transplant, then gradually decreases during the first year post-allograft and then becomes weaker. After relapse, therapeutic options include the reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy or a new transplant. The performance is influenced by the early introduction of treatment whose effectiveness is related to the importance of tumor burden. Immunomodulation of preemptive strategies have recently been established by decreasing immunosuppression and achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.

The aim of this study is to evaluate the incidence of relapse following the recommendations of post-allogeneic transplant immunomodulation of the French society of bone marrow transplantation.

intervention_type: Biological


title: Caractérisation Des Anomalies Immunologiques au Cours de la Pseudopolyarthrite rhizomélique et Effets du Traitement Par Tocilizumab

acronym: TENOR-IMMUNO

summary: Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at characterizing immunological abnormalities in PMR patients, and to assess the effects of tocilizumab therapy on this abnormalities.

ReferenceType: background

ReferenceCitation: Devauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10. doi: 10.1136/annrheumdis-2015-208742. Epub 2016 Feb 29.

family: Devauchelle-Pensec

full_name: Valérie Devauchelle-Pensec

given: Valérie

sequence: first

family: Berthelot

full_name: Jean Marie Berthelot

given: Jean Marie

sequence: additional

family: Cornec

full_name: Divi Cornec

given: Divi

family: Renaudineau

full_name: Yves Renaudineau

given: Yves

family: Marhadour

full_name: Thierry Marhadour

given: Thierry

family: Jousse-Joulin

full_name: Sandrine Jousse-Joulin

given: Sandrine

family: Querellou

full_name: Solène Querellou

given: Solène

family: Garrigues

full_name: Florent Garrigues

given: Florent

family: De Bandt

full_name: Michel De Bandt

given: Michel

family: Gouillou

full_name: Maelenn Gouillou

given: Maelenn

family: Saraux

full_name: Alain Saraux

given: Alain

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of Oxford - Oxford Academic Notes & Queries

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Brest

intervention_type: Drug


title: CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation

acronym: CYRUS II

summary:
Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors.

The objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre, randomized, placebo-controlled study. They will receive one single injection of cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave or absent motor response or extension to the nociceptive stimulation…) will be assessed 7 days after CA.

status: Withdrawn

lead_sponsor: Hospices Civils de Lyon


title: Basic Auditory Processing and Acoustico-verbal Hallucinations: a Pathophysiological Study

acronym: AUDISCHIZ

summary: Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the population worldwide. Although pathophysiology of this disease remains unclear, a growing interest is emerging for low-level sensory function, acknowledging that deficits in early stages of sensory processing are related to higher-order cognitive disturbances in schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were found correlated with disabilities to discriminate psychoacoustic parameters of sounds.

status: Recruiting

primary_purpose: Basic Science

lead_sponsor: Hôpital le Vinatier

status_simplified: Ongoing


title: Mapping the Lumbar Spine Marrow Adiposity

acronym: FATFRAC

summary: The objective of this study is to describe the change in the percentage of fat in the lumbar spine.

time_perspective: Retrospective


title: An Open-label Study to Assess the Potential for Pre-systemic Inhibition of Cytochrome P450 3A4 (CYP3A) by Idebenone in Healthy Male Subjects Using Midazolam as a Substrate

summary: This phase I open label study is conducted to assess the potential pharmacokinetic interaction of Raxone® with midazolam in healthy male volunteers

lead_sponsor: Santhera Pharmaceuticals


title: French Adaptation of the CCST (California Card Sorting Task). Comparison of 3 Packages to CCST With Multiple Sclerosis (MS) Patients

summary: Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially executive functions. The California Card Sorting Task (CCST) assesses specific components of problem-solving ability. There is currently no French version of this test. Reims neurological department in collaboration with Rothschild Foundation has developed a French adaptation of CCST. This version includes three cards packages with two alternate forms to control practice effects (test-retest). In order to assess "test-retest reliability" we have to verify the comparability of the three cards packages within one session in MS patients.

time_perspective: Cross-Sectional

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: tDCS as Continuation Treatment to Sustain Remission After Electroconvulsive Therapy in Depression

summary:
While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive side effects limit its long-term use. There is no consensus about optimal continuation pharmacological treatments after a ECT course.

Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse rates.

primary_purpose: Prevention

intervention_type: Device


title: Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

acronym: REVOIR

summary: This study will assess the effectiveness of a stimulus, in the blind field of hemianopsic patients, to restore the vision of patients with homonymous hemianopsia consecutive to stroke (unilateral occipital lesion). Hemianopsia occurs in 30% of strokes regardless of the cerebral localization and in 60% of stroke interesting the territory of the posterior cerebral artery.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


acronym: COAG

summary: When focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.


acronym: SILOG

summary: The study aims at searching for a genotype-phenotype correlation in patients with a genetic pathology of the ocular surface, in order to identify genetic abnormalities associated with the most severe clinical situations.


acronym: KEOPS

summary:
This study aims to:

describe the monitoring of patients treated for spinal disorders.
create a comprehensive database of reliable and readily exploitable quickly to produce a library of cross publications between orthopedic surgery and neurosurgical services. This database will include clinical, functional , radiographic , educational, social and professional data.
obtain a cohort of patients in the comprehensive range of spinal pathologies.
standardize data collection in this cohort with similar national projects.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Creation and Evaluation of a Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative

acronym: HEMOSTASE

summary: The main objective of this study is to determine the capacity of a questionnaire to predict a normal balance sheet of haemostasis.


acronym: KELOIDS SCARS

summary: Treatment of keloids scars is difficult and controversial. These keloids have a functional and aesthetic impact. A lot of treatment are described with a lot of relapses and aggravation. Authors report outcomes of the treatment with shaving and cryosurgery


title: Cluster-randomized Controlled Study Evaluating the Impact of a Call Center Providing Standardized Pediatric Advices Based on the Number of Unscheduled and Medically Unjustified Consultations

acronym: PLATEL-EVAL

summary:
In order to show that tailored pediatric counselling by telephone can reduce the number of unscheduled and medically unjustified physicians visits in emergency structures, a randomized controlled study is conducted. It compares the proportion of cases which used the emergency services or unscheduled consultation according to whether they received (or not) nurses' telephone advices from the platform. Indeed, our hypothesis is that the presence of nurses responding at the Reception and Control Calls Center inside the Emergency Medical Services (in french : Service d'Aide Médicale d'Urgence SAMU) - whose role is to deliver appropriate advice to people calling for benign pathologies they see as urgent and to answer questions following specific recommendations - will reduce the number of unplanned and medically unjustified consultations in medical emergency structures.

This platform was set-up in order to show it may be a solution in response to the growing demand for pediatric care from the population, helping to reduce overcrowding in emergency care facilities. Indeed, promoting home care or only if necessary scheduled consultation reinforces the conduct to have when facing a pathology from their child. It will also help by reducing unjustified use of emergency structures, improving not only the users' reception conditions who actually require support in these structures with less waiting time, but also the working conditions for employees who perform there.

study_start_date_type: Anticipated

status: Not yet recruiting


type: Other Identifier

title: Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation

acronym: QUAFI

summary: Three groups of patients will be considered: a control group (n = 10); a group of patients with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI will replace CT-scan usually performed in routine before the procedure (n = 15); a group of patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution 2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA relaxation times. Argus software will be used for post-treatment imaging. Quantitative data will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed between the three groups. Statistics will be performed with SPSS software in bilateral analysis and a value of p < 0.05 will be considered as significant.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Combination of Multiparametric MRI and Electrophysiology for the Development of New Biomarkers in Spinal Cord Diseases

summary:
The spinal cord is a common site for the development of several neurodegenerative neurological disorders (spinal muscular atrophy or SMA, amyotrophic lateral sclerosis or ALS, X-linked spinal bulbar muscular atrophy or SBMA). In different proportions, these diseases involve axonal loss in large funiculi of the spinal white matter, their demyelination, and loss of ventral horn motor neurons or motoneurones of the spinal gray matter. The lack of specific biomarkers of these macro and microscopic spinal damages, makes it difficult the differential diagnosis and monitoring of these diseases.

Techniques to explore non-invasively the human central nervous system, such as magnetic resonance imaging (MRI) and electrophysiology, are potential tools to extract specific biomarkers of spinal damages. However, imaging techniques are still poorly developed at spinal level for technical (specific antennas), anatomical (size of the spinal cord, vertebrae) and physiological reasons (cardio-respiratory movements). However, recent advances in the field of spinal cord imaging allowed to extract quantitative data on neuron loss, axonal degeneration and demyelination in different spinal pathologies whether degenerative (ALS or SMA) or traumatic (SCI). Correlations were found with clinical data, and in ALS patients, the changes in MRI metrics over time paralleled the functional deterioration. The electrophysiological techniques are used since a long time, leading to a good knowledge of the neurophysiology of human spinal cord. In addition, electrophysiology indirectly provides data at a microscopic scale, providing information on the excitability of spinal neural networks and giving an estimate of the amount of functional neurons.

By combining these techniques for the investigation of human spinal cord in vivo, the goal is to extract new biomarkers using as study models, diseases of the spinal cord affecting differentially the white and the gray matter (SMA, SBMA and ALS).

At first, new methods of diffusion MRI and modelling will be performed in healthy subjects to assess the axonal density and diameter of the fibers in the white matter. The anatomical imaging T2 will measure the geometrical parameters of the spinal cord such as its surface and/or volume at a given vertebral level. Thanks to imaging, we will construct via methods of segmentation and image processing, an atlas of the spinal cord that will allow to locate spatially spinal atrophy in patients. After this phase of validation, A study of patients will be conducted using these new MRI techniques, in addition to those already developed in the laboratory. The contribution of electrophysiology will be to assess more accurately the microscopic damage. Quantitative data from imaging and electrophysiology will be correlated with clinical data in order to extract the most relevant biomarkers.

This project has thus a methodological interest by proposing the development of new methods to assess the human spinal cord, at both macro and microscopic levels. These methods are based on the development of the techniques developed at spinal level and which are already applicable to human pathologies. The original combination of imaging and electrophysiology will also enable us to further analyze the human spinal cord, both anatomically and functionally. This project has an important clinical value for the extraction of biomarkers in diseases where there is an unmet need for diagnosis, monitoring, prognosis and evaluation of new therapies.

ipd_sharing: Undecided

lead_sponsor: Institut de Recherche sur la Moelle épinière et l'Encéphale


title: Effects of Inverted Vision on Pointing and Grasping in Parabolic Flight

acronym: SpaceInVision

summary:
Parabolic flight is the only ground-based condition in which weightlessness (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.

Spatial orientation perception is a critical subsystem that is used by the central nervous system in the control of vehicles and other complex systems in a high-level integrative function. Evidence from space flight research demonstrates that spatial orientation is altered by the transitions in gravito-inertial force levels (Clément 2011; Clément & Reschke 2008), transitions corresponding to mission phases particularly critical for crew safety and mission success. Accurate perception of self-in-space motion and self-motion relative to other objects is critical for successful operations that involve motor control e.g. doing an extra-vehicule activity or piloting the spacecraft. To date, there is only limited operational evidence that these alterations cause functional impacts on mission-critical operations and control capabilities. Immediately after space flight, most crewmembers have reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or other symptoms of motion sickness), and frequently manifested by lack of coordination, particularly during locomotion The hypothesis is that alteration in sensorimotor performance induced by inverted vision is gravity depend: maximum alteration during hypergravity, intermediary alteration during normal gravity, minimal alteration during weightlessness.


title: Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip : Improvement or Overtreatment ?

acronym: BBH

summary: The aim of this study is to prove the improvement of pubo-femoral distance by early abduction splintage in one-month-old infants with developmental dysplasia of the hip (with a clinical stable hip but an abnormal hip ultrasonography).


title: Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis

summary: Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential effects on B cells are not well described. This study will assess the effects of abatacept therapy on the phenotype and function of peripheral blood B cells in patients with RA.


title: Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.

acronym: ANTATROC

summary:
The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.

There is however no forward-looking or retrospective study comparing the microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section) in gynecological surgery.

The objective of this preliminary study is to compare both surgical care in terms of morbidity died operating, in adnexa surgeries.

lead_sponsor: Institut Paoli-Calmettes


summary: High frequency percussive ventilation (HFPV) is a high frequency ventilation mode in which high frequency pulses accumulate to generate a low frequency tidal volume at a controlled airway pressure. Previous studies have suggested a protective effect of HFPV on lung injury. The goal of our study is to compare, in early ARDS patients, the effects of conventional mechanical ventilation and of high frequency percussive ventilation on alveolar recruitment and distension evaluated by CT-scan

primary_purpose: Supportive Care

location_facility: Assistance Publique-Hôpitaux de Marseille


summary:
Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an infection or an inflammatory process that affects millions of people. The first symptoms usually appear from 40-50 years and at this point, conventional radiological tests provide diagnostic elements relatively late, poorly correlated with pain relief and providing no functional information. In this context, there is a real need for imaging techniques for early detection of osteoarthritic changes in a still reversible stage for faster support and MRI appears to be the tool of choice.

Conventional proton MRI sequences already allow improved detection possibilities compared to conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to recent technological advances, exploration MRI other nuclei such as sodium is now possible. Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss and ultimately a gradation osteoarthritic reached.

This project's main objective is to quantify the biochemical changes (sodium content) occurring at different stages of osteoarthritis defined by clinical algofunctional scores (Lequesne) and conventional radiographic scores (Kellgren and Lawrence).

location_facility: Assistance Publique Hopitaux de Marseille


acronym: NCVG

summary: The main objective of this study is to clarify prospectively prognosis of patients newly diagnosed as carriers of a LVNC (incident cases) (i.e. without the occurrence of a survival of the following events: death, heart transplantation or hospitalization for cardiovascular complications). In a second time, prognosis factors will be identify in these patients with LVNC.

location_facility: Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone


title: Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease : Clinical and Neurophysiological Study

summary:
Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS) could make a profit on the pain in PD.

The investigator would drive a study with a follow up of PD patients before and after STN-DBS. The pain will be clinically explored by targeted questionnaires and electrophysiological through laser evoked potentials.

The questionnaires are designed to quantify and characterize the pain in these patients. Laser evoked potentials will, through repetitive stimulation, study both the functional status of the afferent nociceptive pathways, their habituation to repetitive nociceptive stimuli, and so better understand any abnormalities of the central processing of nociceptive information.

location_facility: Service de Neurologie C, Hôpital Neurologique, HCL


acronym: MUCEM

summary: Local excision for early rectal cancer has proven its feasibility and oncological safety. Indeed, lymph node invasion does not exceed 1% and 10% in pT1sm1 and pT1sm2 rectal carcinomas respectively. Two procedures are currently performed in these early cancers as well as in preneoplastic lesions. Transanal endoscopic microsurgery (TEM), which has proven its superiority over traditional transanal excision, is a surgical approach associated with a 92% R0 excision rate, a survival comparable to radical anterior resection and a low morbidity. It consists of a full-thickness excision. The second procedure is a recently introduced technique: the endoscopic submucosal dissection (ESD), which encompasses only the mucosa and submucosa. ESD enables endoscopists to achieve higher en bloc resection rates than standard mucosectomy and is associated with a 88% R0 resection rate, which decreases to 65% in the subgroup of European series. Though very promising, the role of ESD remains controversial in malignant lesions with few published reports. There are therefore 2 different techniques with 2 different dissections (full-thickness vs. submucosal) to achieve the same oncological treatment. So far, only one retrospective single-center study including 63 patients has compared TEM and ESD in early rectal cancer without finding any difference between the 2 procedures, and there are no other available studies comparing TEM and ESD for any type of colorectal tumor. The aim of the present research is to compare ESD with TEM for early rectal cancer and rectal adenomas for short- and long-term outcomes.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn

acronym: TRIPAIN

summary: The purpose of this study is to correlate the composite PIPP-R (Premature Infant Pain Profile-Revised) scale and the parasympathetic nervous system (heart rate variability).

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication


title: Management of Bleeding and Coagulopathy in Trauma and Compliance to European Trauma Guidelines

acronym: APP

summary: This cohort study describes the epidemiology of trauma patients and their management in a French academic trauma center. It also aims to determine what recommendations from the European trauma guidelines is applied in routine.


title: Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia: Neuropsychological and Neurophysiological Study of Changes in Emotional Experiences

acronym: KALISS

summary: Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments.

location_facility: Centre Hospitalier Régional Universitaire de Brest


title: Study of Biological Determinants of Bleeding Postpartum : Predictive Role in the Number of Immature Platelets

acronym: HPP-IPF

summary:
At the entry of the delivery room, a standard blood analysis will be performed (Blood count, PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the center's practices.

The percentage of the immature platelets is a an additional parameter on the hemogram.

The clinical assessments (recorded in medical records) and biological values will be used to determine if there is a correlation between these data and the occurrence of postpartum hemorrhage.


title: Assessment of the Usual Choice for a First-line Treatment in Case of Atrial Fibrillation : Comparison Between Cardiology Department and Geriatric Unit.

acronym: ACFA

summary: In order to evaluate the implementation for the recommendations about the patient care for atrial fibrillation in aged patients, a non-interventional study is performed retrospectively by comparing two approach of the focus in Cardiology Department and in Geriatric unit.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Association Between Asthma and Food Allergy in Children and Adults

acronym: AAAli

summary:
Prevalences of food allergies and asthma increased in the population during the last decades. These two pathologies, responsible for a real burden, are often associated and are to be considered as comorbidities; this aspect is more and more studied in the literature and many authors tried to find a link between diets and asthma. The narrow link between these two atopic pathologies and the fact that food allergy can come along with respiratory symptoms also in patients without history of asthma must be better understood, considered into the management of food allergy. The main objective of this study is to study the prevalence of signs and/or symptoms suggestive of bronchial hyperreactivity, during an oral food challenge (OFC) in patients older than 5 years. The secondary objective is to study the risk factors to develop asthma during a food allergy reaction.

This historical-prospective single center study , was realized in the Allergy Unit of the University Hospital of Montpellier. All the patients having been hospitalized for a positive OFC between January, 2001 and January, 2016 were included. The diagnosis of asthma was established according to the recommended international clinical and physiological criteria. Prevalence of bronchial hyperreactivity during OFC among those with positive OFC, was calculated. The search for risk factors was made by a logistic regression univariate then multivariate, completed by a decision tree.

lead_sponsor: University Hospital, Montpellier


title: Post-hospital Evaluation of Anxiety / Depression in Parents of Children Who Required Tracheostomy Before the Age of 1 Year

acronym: TRACH

summary: To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.


title: Evaluation of the Expression of Natural Killer T Cells (NKT) Marker in the Gut of Patients With Primary Sclerosing Cholangitis (PSC) Complicated by an Inflammatory Bowel Disease (IBD)

acronym: NKT-CSP/MICI

summary:
Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000). IBDs are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. Their exact cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is a liver inflammatory disease of unknown origin that is known to be strongly associated with IBD. An important clinical observation highlights the mild symptoms of IBD when associated to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation.

Based, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer T cell (NKT) as essential in control of experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell markers are increased in the colon of patients with PSC+IBD compared to patients with IBD alone or PSC alone.

lead_sponsor: University Hospital, Lille


title: Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study

acronym: TAP ALIF

summary: Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption

lead_sponsor: Rennes University Hospital


title: Creation of a Prospective and Retrospective Breast Cancer Database

summary:
In order to accelerate border crossing between basic research and clinical research in breast cancer, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic beast cancer database, mainly prospective but also retrospective. All data are from patients treated in Toulouse Centre.

The scientific community will easily have access to clinical and biological informations through a centralized, structured database , leading to optimize patients with breast cancer treatment.

lead_sponsor: Institut Claudius Regaud


title: In Vitro Fertilization (IVF) Outcome After Bariatric Surgery: a Multicentric Case-control Study.

summary: This case-control study compares IVF results and live birth rates in women undergoing IVF with a history of bariatric surgery as compared to 2 age-matched control groups composed of (A) non-operated women matched on cases' post-operative BMI (controls 1) and (B) non-operated severely obese women (controls 2).

time_perspective: Other

ReferenceType: derived

ReferenceCitation: Grzegorczyk-Martin V, Fréour T, De Bantel Finet A, Bonnet E, Merzouk M, Roset J, Roger V, Cédrin-Durnerin I, Wainer R, Avril C, Landais P. IVF outcomes in patients with a history of bariatric surgery: a multicenter retrospective cohort study. Hum Reprod. 2020 Dec 1;35(12):2755-2762. doi: 10.1093/humrep/deaa208.

name: Department of Assisted Reproductive Technology and Fertility Preservation, Clinique Mathilde, ROUEN

family: Grzegorczyk-Martin

full_name: V Grzegorczyk-Martin

given: V

name: CHU Nantes, Nantes Université, Service de Biologie et Médecine de la reproduction, Nantes, France

family: Fréour

full_name: T Fréour

given: T

family: De Bantel Finet

full_name: A De Bantel Finet

given: A

name: Montpellier University, UPRES EA2415, Decision Support for a Personalized Medicine, Clinical Research University Institute, Montpellier, France

family: Bonnet

full_name: E Bonnet

given: E

name: Department of Reproductive Medicine, CHI POISSY-ST GERMAIN

family: Merzouk

full_name: M Merzouk

given: M

family: Roset

full_name: J Roset

given: J

name: Department of Digestive Surgery, Clinique Mathilde, ROUEN

family: Roger

full_name: V Roger

name: Department of Assisted Reproductive Technology, Hôpital Jean Verdier, BONDY

family: Cédrin-Durnerin

full_name: I Cédrin-Durnerin

given: I

family: Wainer

full_name: R Wainer

given: R

family: Avril

full_name: C Avril

given: C

family: Landais

full_name: P Landais

given: P

journal_name: Human Reproduction

evidence: open (via crossref license)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Clinique Mathilde


title: Study of the Efficacy and Safety of Perampanel in Combination in Glioma-refractory Epilepsy

summary:
Gliomas are primitive brain tumors frequently associated with epilepsy. In a significant number of these patients epilepsy is resistant to antiepileptic drugs. There are currently no recommendations for the management of these drug-resistant epilepsies associated with glioma. In addition, few studies have addressed the subject and no treatment appears to be superior to others in the literature for this indication. In addition, many antiepileptic drugs pose problems of tolerance or interaction with chemotherapy in these patients.

Fundamental studies on glioma-associated epilepsies have shown that there is a major dysregulation of glutamatergic systems involved in epileptogenesis and tumor growth. Targeting this glutamatergic system seems particularly interesting from a physiopathological point of view. Perampanel is a recent antiepileptic treatment with a novel mode of action targeting AMPA glutamate receptors. It has been shown to be effective in patients with drug-resistant epilepsies. He has demonstrated his tolerance in these patients. He has obtained a marketing authorization and is therefore used in routine epileptology without serious problems of tolerance being reported. It is neither an inducer nor an enzyme inhibitor, avoiding the problems of interaction with chemotherapy and is used in a daily dose facilitating compliance.

Therefore, there may be specific antiepileptic efficacy of perampanel in patients with glioma. Nevertheless, the only current data is limited to a retrospective study of 12 patients.

The objective of this protocol is to evaluate the efficacy and safety of perampanel in patients with glioma with drug-resistant epilepsy.

a prospective randomized study with two parallel arms: antiepileptic combination therapy with perampanel and antiepileptic combination therapy without perampanel (free choice of the practitioner). The main criterion of judgment will be the decrease of the monthly frequency of crisis. Secondary endpoints will assess tolerance, efficacy on responder rate (at least 50% decrease in seizure frequency), seizure severity (secondary generalization, loss of consciousness), and quality. patients' lives (quality of life questionnaires, side effects and anxiety / depression). The duration of participation per patient will be 23 weeks (6 weeks of baseline, 5 weeks of titration and 12 weeks of maintenance). The recruitment period will be 3 years. Investigators plan to recruit 120 patients.

In the context of no recommendation in the management of these patients, superior efficacy of perampanel compared with other antiepileptic drugs is expected. This would allow targeted treatment in this population and confirm the tolerance of this treatment in these patients.

location_facility: Assistance Publique Des Hopitaux de Marseille

location_facility: Department of Epileptology and Cerebral Rhythmology, Hôpital La Timone, APHM


title: Prospective Study to Assess Quality of Life and Psychological Vulnerability in Patients With Metastatic Breast Cancer RH+

acronym: EPOCA

summary:
Metastatic breast cancer (MBC) is a dark prognostic disease with survival at 5 years of less than 20% and a median survival of 24 to 30 months after diagnosis of metastasis. Thus, metastatic diagnosis can be expected to have a different impact on the quality of life of patients in early and advanced stages.

However, MBC benefits from therapeutics that improve patients' quality of life and even improve overall survival. The main objectives of this prospective study are :

to evaluate the evolution over time of the quality of life of patients treated for positive hormonal receptors (RH+) metastatic breast cancer, according to the therapeutic class ;
to evaluate the psychological vulnerability of these patients since the announcement of their metastatic diagnosis and during their treatments. Finally, when interviewing oncologists, to know the factors involved in a treatment change decision process for the same patient.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Ico Nantes
Ico Angers


title: Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy.

acronym: MARTA

summary:
Prospective, multicentric, non-randomized phase II study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by TomoTherapy +/-Chemotherapy.

Patients with non-inflammatory and non-metastatic invasive mammary carcinoma will be included in this study.

The study procedure will be a surgical treatment by mastectomy with immediate prosthetic breast reconstruction followed by an adjuvant therapy: TomoTherapy +/-Chemotherapy (radiation therapy alone or preceded by chemotherapy).

The nature of the chemotherapy treatment will be decided according to the standards of each center.

The patients will be followed for the study up to 36 months after the surgical procedure.

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients

acronym: IMMUSPHINX

summary:
This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma.

The study will be conducted on a population of patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) or in combination (nivolumab + ipilimumab) in the context of routine care.

For each included patient, blood samples will be collected at different time points.

If feasible, an optional tumor biopsy specimen will be collected during baseline visit.

All included patients will be followed-up for tumor response and toxicity until Week 12.

After Week 12, survival data (tumor status and/or survival status) will be collected every 3 months until a maximum duration of 1 year from the first study dose.


title: Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization

summary: The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing ovarian tumors can select patients who can benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. The results obtained are very promising. This study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHU Tenon
CHI Creteil


title: Development and Validation of a Language Screening Test in Acute Right Hemispheric Strokes

acronym: R-LAST

summary:
This is a bi-centric study whose main objective is the validation of a rapid screening test for language disorders in the acute phase of right hemisphere stroke.

Primary objective

The main objective is the validation of a rapid language disorder screening tool that will be used in the acute phase of right hemispheric stroke.

Secondary objectives

Secondary objectives are:

Characterize the "atypical crossed aphasia" since the acute phase of stroke with a large cohort of patients , which, to our knowledge, has never been done.
Re-evaluate the number of patients with acute language disorder in right hemisphere stroke.
Validate the use of R-LAST by different categories of carers

lead_sponsor: Versailles Hospital

location_facility:
CH de Versailles
CH Sud Francilien

intervention_type: Diagnostic Test


title: MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?

acronym: MYMO

summary: The investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal MRI alone is sufficient or whether it is necessary to perform a total skeletal MRI.

location_facility:
CHU Nimes
CHU Montpellier


title: Comparison of the Radiological Pattern Between the Cerebral Stroke of Arterial and Venous Origin

acronym: PATTERN

summary: There are few published data on the patterns of parenchymal imaging abnormalities in a context of cerebral venous thrombosis (CVT). The objectives of the present study were to describe the patterns of parenchymal lesions associated with CVT and to determine the lesion sites.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Rouen
CHU Amiens


title: Multicenter Large-scale Validation Study of the Interest of Broadband Spectroscopy Analysis (Femto/Attosecond by Infrared Laser) on Liquid Biopsies in Breast Cancer Screening

summary: The purpose of this study is to validate the interest of broadband spectroscopy analysis (femto/attosecond by infrared laser) on liquid biopsies in breast cancer screening.

lead_sponsor: Centre Jean Perrin

location_facility:
Pôle Santé République
Hôpital Tenon
La Chataigneraie (Selimed 63)
Centre Jean PERRIN
Hôpital La Pitié Salpêtrière


title: A Randomized, Double-blind, Placebo-controlled, Multicentre Proof-of-concept Trial of IVA337 in the Treatment of Diffuse Cutaneous Systemic Sclerosis

acronym: FASST

summary: Systemic sclerosis (SSc), or scleroderma is a connective tissue disease of autoimmune origin. It is a life-threatening orphan disease with severe physical and psychosocial consequences. IVA337 has a novel mechanism of action and this study is designed to compare IVA337 at two dose levels with a placebo control treatment. Patients will be unaware of the treatment they are receiving and will be randomized to one of three treatment arms , either IVA337 400mg bid, IVA337 600mg bid or placebo bid. They will receive drug for 48 weeks and during that time assessments will be made to monitor both the efficacy and safety of the treatment.

lead_sponsor: Inventiva Pharma

location_country:
Italy
Switzerland
Netherlands
United Kingdom
France
Bulgaria
Poland
Spain
Germany
Slovenia

location_facility: University Multiprofile Hospital for Active Treatment -Kaspela

location_facility: Klinik fur Dermatologie und Venerologie der Universitat zu Köln

location_facility: Azienda Ospedalaria Spedali Civili di Brescia

location_facility: University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: CIRI GmbH Centrum für Innovative Diagnostik und Therapie

location_facility: Multiprofile Hospital for Active Treatment Plovdiv

location_facility: Erasmus MC Universitair Medisch Centrum Rotterdam

location_facility: University Multiprofile Hospital for Active Treatment - "Sveti Ivan Rilski"

location_facility: Istituto di Clinica Medica Generale Polo Didattico

location_facility: Leeds Institut of Rheumatic and Musculoskeletal Medicine

location_facility: Ospedale di Alta Specializzazione "San Camillo"


type: EudraCT Number

title: A Phase Ib/II Trial Evaluating the Efficacy of MK-3475 and Trastuzumab in Patients With Trastuzumab-resistant, HER2-positive Metastatic Breast Cancers

acronym: PANACEA

summary: Panacea is a phase Ib/II trial evaluating the efficacy of MK-3475 and trastuzumab in patients with trastuzumab-resistant, HER2- positive metastatic breast cancers

ReferenceCitation: Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92.

ReferenceCitation: Hurvitz SA, Betting DJ, Stern HM, Quinaux E, Stinson J, Seshagiri S, Zhao Y, Buyse M, Mackey J, Driga A, Damaraju S, Sliwkowski MX, Robert NJ, Valero V, Crown J, Falkson C, Brufsky A, Pienkowski T, Eiermann W, Martin M, Bee V, Marathe O, Slamon DJ, Timmerman JM. Analysis of Fcγ receptor IIIa and IIa polymorphisms: lack of correlation with outcome in trastuzumab-treated breast cancer patients. Clin Cancer Res. 2012 Jun 15;18(12):3478-86. doi: 10.1158/1078-0432.CCR-11-2294. Epub 2012 Apr 13.

ReferenceCitation: Denkert C, Loibl S, Noske A, Roller M, Müller BM, Komor M, Budczies J, Darb-Esfahani S, Kronenwett R, Hanusch C, von Törne C, Weichert W, Engels K, Solbach C, Schrader I, Dietel M, von Minckwitz G. Tumor-associated lymphocytes as an independent predictor of response to neoadjuvant chemotherapy in breast cancer. J Clin Oncol. 2010 Jan 1;28(1):105-13. doi: 10.1200/JCO.2009.23.7370. Epub 2009 Nov 16. Erratum in: J Clin Oncol. 2010 Feb 1;28(4):708.

ReferenceCitation: Loi S, Sirtaine N, Piette F, Salgado R, Viale G, Van Eenoo F, Rouas G, Francis P, Crown JP, Hitre E, de Azambuja E, Quinaux E, Di Leo A, Michiels S, Piccart MJ, Sotiriou C. Prognostic and predictive value of tumor-infiltrating lymphocytes in a phase III randomized adjuvant breast cancer trial in node-positive breast cancer comparing the addition of docetaxel to doxorubicin with doxorubicin-based chemotherapy: BIG 02-98. J Clin Oncol. 2013 Mar 1;31(7):860-7. doi: 10.1200/JCO.2011.41.0902. Epub 2013 Jan 22.

ReferenceCitation: Loi S, Giobbie-Hurder A, Gombos A, Bachelot T, Hui R, Curigliano G, Campone M, Biganzoli L, Bonnefoi H, Jerusalem G, Bartsch R, Rabaglio-Poretti M, Kammler R, Maibach R, Smyth MJ, Di Leo A, Colleoni M, Viale G, Regan MM, André F; International Breast Cancer Study Group and the Breast International Group. Pembrolizumab plus trastuzumab in trastuzumab-resistant, advanced, HER2-positive breast cancer (PANACEA): a single-arm, multicentre, phase 1b-2 trial. Lancet Oncol. 2019 Mar;20(3):371-382. doi: 10.1016/S1470-2045(18)30812-X. Epub 2019 Feb 11.

family: Loi

full_name: Sherene Loi

given: Sherene

family: Giobbie-Hurder

full_name: Anita Giobbie-Hurder

given: Anita

family: Gombos

full_name: Andrea Gombos

given: Andrea

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Hui

full_name: Rina Hui

given: Rina

family: Curigliano

full_name: Giuseppe Curigliano

given: Giuseppe

family: Campone

full_name: Mario Campone

given: Mario

family: Biganzoli

full_name: Laura Biganzoli

given: Laura

family: Bonnefoi

full_name: Hervé Bonnefoi

given: Hervé

family: Jerusalem

full_name: Guy Jerusalem

given: Guy

family: Bartsch

full_name: Rupert Bartsch

given: Rupert

family: Rabaglio-Poretti

full_name: Manuela Rabaglio-Poretti

given: Manuela

family: Kammler

full_name: Roswitha Kammler

given: Roswitha

family: Maibach

full_name: Rudolf Maibach

given: Rudolf

family: Smyth

full_name: Mark J Smyth

given: Mark J

family: Di Leo

full_name: Angelo Di Leo

given: Angelo

family: Colleoni

full_name: Marco Colleoni

given: Marco

family: Viale

full_name: Giuseppe Viale

family: Regan

full_name: Meredith M Regan

given: Meredith M

family: André

full_name: Fabrice André

given: Fabrice

family: Fumagalli

full_name: Debora Fumagalli

given: Debora

family: Gelber

full_name: Richard D Gelber

given: Richard D

title: Pembrolizumab plus trastuzumab in trastuzumab-resistant, advanced, HER2-positive breast cancer (PANACEA): a single-arm, multicentre, phase 1b–2 trial

location_facility:
Istituto Europeo di Oncologia
Peter MacCallum Cancer Centre
Westmead Hospital
Institut de Cacérologie de l'OUEST
Azienda USL4 Prato
Medical University of Vienna
CHU Sart Tilman
Centre Leon Berard
Jules Bordet Institute
Institut Gustave Roussy
Institut Bergonie


title: European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

acronym: ESMART

summary:
The first molecular profiling protocols have been launched in Europe (MOSCATO-01 (Geoerger 2014), MAPPYACTS, INFORM, iTHER, SM-PAEDS, etc.) determining multiple actionable alterations in pediatric recurrent cancers. Increasingly, stratified approaches are being implemented to enrich clinical trials of molecularly targeted agents and possibly improve outcomes in specific populations i.e. a molecularly enriched/predictive biomarker-driven approach. The diversity and heterogeneity of the detected molecular alterations and the low number of pediatric patients mandate an adapted, innovative trial design for the attributed treatment options in order to satisfy the current unmet medical need.

This basket trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe.

ReferenceCitation: Morscher RJ, Brard C, Berlanga P, Marshall LV, André N, Rubino J, Aerts I, De Carli E, Corradini N, Nebchi S, Paoletti X, Mortimer P, Lacroix L, Pierron G, Schleiermacher G, Vassal G, Geoerger B. First-in-child phase I/II study of the dual mTORC1/2 inhibitor vistusertib (AZD2014) as monotherapy and in combination with topotecan-temozolomide in children with advanced malignancies: arms E and F of the AcSé-ESMART trial. Eur J Cancer. 2021 Nov;157:268-277. doi: 10.1016/j.ejca.2021.08.010. Epub 2021 Sep 17.

family: Morscher

full_name: Raphael J. Morscher

given: Raphael J.

family: Brard

full_name: Caroline Brard

given: Caroline

family: Berlanga

full_name: Pablo Berlanga

given: Pablo

family: Marshall

full_name: Lynley V. Marshall

given: Lynley V.

full_name: Nicolas André

given: Nicolas

family: Rubino

full_name: Jonathan Rubino

given: Jonathan

family: Aerts

full_name: Isabelle Aerts

given: Isabelle

family: De Carli

full_name: Emilie De Carli

given: Emilie

family: Corradini

full_name: Nadège Corradini

given: Nadège

family: Nebchi

full_name: Souad Nebchi

given: Souad

family: Paoletti

full_name: Xavier Paoletti

given: Xavier

family: Mortimer

full_name: Peter Mortimer

given: Peter

family: Lacroix

full_name: Ludovic Lacroix

given: Ludovic

family: Pierron

full_name: Gaelle Pierron

given: Gaelle

family: Schleiermacher

full_name: Gudrun Schleiermacher

given: Gudrun

family: Vassal

full_name: Gilles Vassal

given: Gilles

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Pasqualini C, Rubino J, Brard C, Cassard L, André N, Rondof W, Scoazec JY, Marchais A, Nebchi S, Boselli L, Grivel J, Aerts I, Thebaud E, Paoletti X, Minard-Colin V, Vassal G, Geoerger B. Phase II and biomarker study of programmed cell death protein 1 inhibitor nivolumab and metronomic cyclophosphamide in paediatric relapsed/refractory solid tumours: Arm G of AcSé-ESMART, a trial of the European Innovative Therapies for Children With Cancer Consortium. Eur J Cancer. 2021 Jun;150:53-62. doi: 10.1016/j.ejca.2021.03.032. Epub 2021 Apr 20.

family: Pasqualini

full_name: Claudia Pasqualini

given: Claudia

ReferenceCitation: Rossoni C, Bardet A, Geoerger B, Paoletti X. Sequential or combined designs for Phase I/II clinical trials? A simulation study. Clin Trials. 2019 Dec;16(6):635-644. doi: 10.1177/1740774519872702. Epub 2019 Sep 20.

name: Biostatistics and Epidemiology Department, Gustave Roussy, Villejuif, France

name: INSERM U1018, CESP OncoStat, Université Paris-Saclay, UVSQ, Villejuif, France

name: Department of Pediatric and Adolescent Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Italy
Netherlands
France
Spain
Denmark
Germany
United Kingdom

location_facility: Pediatric and Adolescent Oncology The Royal Marsden Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Unidad de Oncología Pediátrica Hospital Niño Jesús


title: Neurophysiological Validation of the Clinical Criteria of Sensitization in Chronic Pelvic and Perineal Pain Population : a Prospective Controlled Interventional Study

acronym: DOPEC

summary: The purpose of this study is to assess and validate the clinical criteria of sensitization ("Convergences PP criteria") selected by the expert consensus with neurophysiological sensory testing.

lead_sponsor: Nantes University Hospital

location_facility:
Groupe Confluent
Nantes university Hospital


title: A Prospective Phase II Study Of Nivolumab Alone, Or In Combination With Vinblastin In Patients Aged 61 Years And Older, With Classical Hodgkin Lymphoma And Coexisting Medical Conditions.

summary:
This study is a multicentric phase II open-label trial consisting of 6 cycles Nivolumab (2 weeks interval) followed by a PET-CT scan. The treatment will be allocated according to PET and CT scan responses. :

In case of CMR according to Lugano Classification (Cheson et al.2014, PET-CT based response), patients will receive 18 additional cycles of Nivolumab, according to CT-based response at Cycle 12.
In case of Partial Metabolic Response (PMR) or No Metabolic Response(NMR), according to Lugano Classification (Cheson et al.2014, PET-CT based response) patients will receive 12 to 18 cycles of Nivolumab combined with Vinblastin according to CT-based response at Cycle 12.
In case of progressive disease, according to Lugano Classification (Cheson et al.2014, PET-CT scan based response) patients will be considered in treatment failure.

status: Active, not recruiting

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre

location_facility: CHU de Poitiers - Hôpital de La Milétrie

location_facility: Centre Hospitalier Annecy-Genevois - Site d'Annecy

location_facility: Centre François Magendie - Hôpital du Haut Lévêque


title: Evaluation of the Quality of Life in Patients With Multimetastatic Melanoma Currently in Remission

acronym: QUALM

summary:
Few studies have been conducted on the quality of life of patients with stage IV melanoma. Particularly, there is no data regarding the quality of life of patients with a multimetastatic melanoma currently in remission.

Then, the main objective of this study is to evaluate the quality of life from a point of view medico-psycho-social in patients with multimetastatic melanoma in remission for more than 6 months.

lead_sponsor: Lille Catholic University

location_facility:
Lille Catholic Hospitals
CHRU Lille


title: Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy

acronym: MINER

summary:
This trial is a translational, open-label, multi-site, prospective cohort study of 440 patients aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers.

The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.

Patients with any of the following tumor types may be enrolled in the trial:

Non-Small Cell Lung Cancer (NSCLC),
Head and neck cancer,
Melanoma,
Bladder cancer,
Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option.

For each included patient, tumor biopsy specimens and blood samples will be collected at different time points.

All included patients will be followed-up until progression. After this date, survival data will be collected.

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT

acronym: HYPHYCA

summary: Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal

ReferenceCitation: Aide N, Tainturier LE, Nganoa C, Houdu B, Kammerer J, Galais MP, Ciappuccini R, Lasnon C. HYPHYCA: a prospective study in 613 patients conducting a comprehensive analysis for predictive factors of physiological (18)F-FDG anal uptake. EJNMMI Res. 2020 Mar 20;10(1):28. doi: 10.1186/s13550-020-0615-5.

family: Aide

full_name: Nicolas Aide

family: Tainturier

full_name: Laure-Eugénie Tainturier

given: Laure-Eugénie

family: Nganoa

full_name: Cathy Nganoa

given: Cathy

family: Houdu

full_name: Benjamin Houdu

given: Benjamin

family: Kammerer

full_name: Jennifer Kammerer

given: Jennifer

family: Galais

full_name: Marie-Pierre Galais

given: Marie-Pierre

family: Ciappuccini

full_name: Renaud Ciappuccini

given: Renaud

family: Lasnon

full_name: Charline Lasnon

given: Charline

currency_apc_doaj: GBP

journal_name: EJNMMI Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: HYPHYCA: a prospective study in 613 patients conducting a comprehensive analysis for predictive factors of physiological 18F-FDG anal uptake

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU
Centre François Baclesse


title: Etude rétrospective et Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la sécurité de l'Implant AMIStem

summary:
The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up.

All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice

lead_sponsor: Medacta International SA

location_facility:
Clinique Paris V
Clinique du Cèdre


title: Effectiveness and Safety of Antibiotherapy in Diabetic Patients Treated for a Diabetic Foot Infection.

acronym: DIABASE

summary:
Diabetes is a frequent and serious disease, with many complications. Diabetic foot ulcers are a frequent complication. Infection of diabetic foot ulcers is common, and requires heavy medical and/or surgical treatments. Antibiotherapy is one of the main options for the treatment of the diabetic foot ulcers, but it has many side effects.

The aim of this study is to evaluate effectiveness and safety of medical treatments, in this population of patients.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Groupement Hospitalier Est
Centre Hospitalier Lyon Sud


title: Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease

acronym: MiDCR

summary: The objective of the study is to highlight a modification of the composition of the intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most unfavorable form, Rapid Cognitive Decline (DCR). This identification could lead to diagnostic strategies based on the analysis of the intestinal microbiome, and preventive and curative treatments, based on the modulation of intestinal microbiota

location_facility:
CHU de Angers
CHU de Nantes


title: Predictive Platform for PEople aGed and Requiring ASsistancE

summary: The study aim is to assess the capacity of a technological solution for analyzing older person's functional and cognitive autonomy at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to detect early infra-clinical disability.

ReferenceCitation: Piau A, Lepage B, Bernon C, Gleizes MP, Nourhashemi F. Real-Time Detection of Behavioral Anomalies of Older People Using Artificial Intelligence (The 3-PEGASE Study): Protocol for a Real-Life Prospective Trial. JMIR Res Protoc. 2019 Nov 18;8(11):e14245. doi: 10.2196/14245.

family: Piau

full_name: Antoine Piau

given: Antoine

family: Lepage

full_name: Benoit Lepage

given: Benoit

family: Bernon

full_name: Carole Bernon

given: Carole

family: Gleizes

full_name: Marie-Pierre Gleizes

family: Nourhashemi

full_name: Fati Nourhashemi

given: Fati

currency_apc_doaj: USD

journal_name: JMIR Research Protocols

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital, Toulouse
CHU Toulouse


title: The Inclined Position in Case of Respiratory Discomfort in the One Year Less Infant : Study on the Profits and the Risks in the Home

acronym: PROCLIVE

summary:
The inclined position at 30 ° in case of transient respiratory discomfort is recommended since the consensus conference of September 2000. This recommendation is based on a low level of evidence (grade C). This advice is found in the health book, and in many tips for parents. However, it does not comply with the recommendations of the American Academy of Pediatrics for sleeping on the back, on a firm mattress and without other objects in the bed.

70% of pediatricians advise this position in a specific medical context according to a study of Bellaïche conducted in 2013. 40% of parents use it for no particular reason.

Anatomically, the upper airways of infants are of reduced caliber, and therefore at risk of obstruction.

A study by Bergougnioux on the cases of MIN in infants wearing a wrap-around sling shows that the flexion of the neck causes the chin to be positioned against the chest and contributes to the suffocation of the infant. This is especially important in infants under 3 months whose neck muscles do not yet support the weight of the head.

The 2009 InVS national survey of unexpected infant deaths shows that bed crashes accounted for 11.1% of all deaths reported. Among unexplained deaths, maladaptive bedding was a contributing factor, including the use of a pillow in the bed in 24.3% of cases.

It was observed in the study by Kornhauser Cerar et al in 2009 that half-sitting in a car seat for an extended duration was at the origin of a significant desaturations rate, which was also found in the car bed group. The control group "hospital bed" was not subject to these desaturations. These results support the fact that only an adapted bedding that complies with the recommendations protects against asphyxiation.

Since 2016, INPES recommends in its advice sheet on bronchiolitis for parents, a flat bed on the back.

Hypothesis :

The inclined position in infants under one year of age is at risk of unexpected death of the infant by obstruction of the upper airways, because of the changes of position that it entails, including a risk of slipping at the bottom of the bed and of asphyxiation under the covers.

location_facility: Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône


title: Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer

acronym: APPAHOCA

summary: The investigator propose to evaluate the interest of the provision of a suitable treadmill offering fall protection and verticalization assistance.


title: MILAR, is a Controlled, Randomised, Comparative, Prospective, Multi-center, Superiority French Clinical Trial Comparing the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation by Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.

acronym: MILAR

summary: The MILAR trial is a multicenter randomised , prospective, controlled, single-blind, superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh laryngoscope for patients with less than 2 criteria of difficult intubation in elective surgery.

ReferenceCitation: Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.

ReferenceCitation: Hasegawa K, Shigemitsu K, Hagiwara Y, Chiba T, Watase H, Brown CA 3rd, Brown DF; Japanese Emergency Medicine Research Alliance Investigators. Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study. Ann Emerg Med. 2012 Dec;60(6):749-754.e2. doi: 10.1016/j.annemergmed.2012.04.005. Epub 2012 Apr 28.

ReferenceCitation: Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents.

ReferenceCitation: Sakles JC, Javedani PP, Chase E, Garst-Orozco J, Guillen-Rodriguez JM, Stolz U. The use of a video laryngoscope by emergency medicine residents is associated with a reduction in esophageal intubations in the emergency department. Acad Emerg Med. 2015 Jun;22(6):700-7. doi: 10.1111/acem.12674. Epub 2015 May 20.

ReferenceCitation: Kaplan A, Göksu E, Yıldız G, Kılıç T. Comparison of the C-MAC Videolaryngoscope and Rigid Fiberscope with Direct Laryngoscopy in Easy and Difficult Airway Scenarios: A Manikin Study. J Emerg Med. 2016 Mar;50(3):e107-14. doi: 10.1016/j.jemermed.2015.06.070. Epub 2015 Dec 22.

ReferenceCitation: Ruetzler K, Imach S, Weiss M, Haas T, Schmidt AR. [Comparison of five video laryngoscopes and conventional direct laryngoscopy : Investigations on simple and simulated difficult airways on the intubation trainer]. Anaesthesist. 2015 Jul;64(7):513-9. doi: 10.1007/s00101-015-0051-5. Epub 2015 Jul 15. German.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Orleans Hospital Center
Chartres Hospital Center


title: Effects on an Experimental Dyspnea by Thoraco-abdominal Elastic Strapping of the High Flow Nasal Cannula

acronym: EDEN

summary: To develop an experimental model of dyspnea by external thoraco-abdominal elastic strapping at rest in order to study the mechanisms involved in the relief of dyspnea by the administration of high flow by nasal cannula (HFNC).

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

location_facility: Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation


title: Expiratory Fow Assessment in ARDS Patients

acronym: FLAIR

summary: This study intended to assess the expiratory flow limitation (EFL) during tidal breath in patients intubated in intensive care unit (ICU) for moderate or severe acute respiratory distress syndrome (ARDS). EFL is defined as the lack of increase in expiratory flow in response to an increase in alveolar-to-atmospheric pressure gradient. It reflects airway closure. Early studies have been done using the Negative expiratory pressure (NEP) technique, which is no longer available. We proposed in present study a new method, which consists of diverting manually the expiratory flow to the atmosphere by-passing the expiratory valve. We aimed at assessing EFL at positive expiratory pressure (PEP) 5 cmH2O in semi-recumbent then in supine position together with measurement of trans-pulmonary pressure and regional lung ventilation. Higher PEP levels will be tested, namely 10, 15 and a trans-pulmonary PEP of 3 cmH2O, in semi-recumbent position.

location_facility:
Hôpital de la Croix Rousse
CHU Grenoble Alpes


title: Medico-economic Evaluation of a "IsereADOM" Package of Services Versus Conventional Health and Social Monitoring, in the Care of a Population of People With Heart Failure in Isère.

acronym: CardIC

summary:
The goal of this study is to evaluate the health and social benefit of innovative management - IsereADOM - versus conventional follow-up in patients with heart failure.

There is a medico-economic goal too, is to perform a cost-utility analysis of the service bundle (IsereADOM) versus conventional 6-month community-based follow-up in a population with heart failure.

primary_purpose: Health Services Research

ReferenceCitation: Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442.

ReferenceCitation: Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435.

ReferenceCitation: McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012 Aug;14(8):803-69. doi: 10.1093/eurjhf/hfs105. Erratum in: Eur J Heart Fail. 2013 Mar;15(3):361-2.

ReferenceCitation: Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735.

name: From the Advanced Heart Disease Section, Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA.

family: Desai

full_name: Akshay S. Desai

given: Akshay S.

journal_name: Circulation: Heart Failure

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: The Three-Phase Terrain of Heart Failure Readmissions

ReferenceCitation: Takeda A, Taylor SJ, Taylor RS, Khan F, Krum H, Underwood M. Clinical service organisation for heart failure. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD002752. doi: 10.1002/14651858.CD002752.pub3. Review. Update in: Cochrane Database Syst Rev. 2019 Jan 08;1:CD002752.

ReferenceCitation: Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9.

ReferenceCitation: Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.

ReferenceCitation: Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96.

lead_sponsor: University Hospital, Grenoble

location_facility:
CHU Grenoble-Alpes
Groupe Hospitalier Mutualiste


ReferenceCitation: Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21. Erratum in: Intensive Care Med. 2018 Feb 23;:.

ReferenceCitation: Lamontagne F, Rochwerg B, Lytvyn L, Guyatt GH, Møller MH, Annane D, Kho ME, Adhikari NKJ, Machado F, Vandvik PO, Dodek P, Leboeuf R, Briel M, Hashmi M, Camsooksai J, Shankar-Hari M, Baraki MK, Fugate K, Chua S, Marti C, Cohen D, Botton E, Agoritsas T, Siemieniuk RAC. Corticosteroid therapy for sepsis: a clinical practice guideline. BMJ. 2018 Aug 10;362:k3284. doi: 10.1136/bmj.k3284.

ReferenceCitation: Rochwerg B, Oczkowski SJ, Siemieniuk RAC, Agoritsas T, Belley-Cote E, D'Aragon F, Duan E, English S, Gossack-Keenan K, Alghuroba M, Szczeklik W, Menon K, Alhazzani W, Sevransky J, Vandvik PO, Annane D, Guyatt G. Corticosteroids in Sepsis: An Updated Systematic Review and Meta-Analysis. Crit Care Med. 2018 Sep;46(9):1411-1420. doi: 10.1097/CCM.0000000000003262.

ReferenceCitation: Nishida O, Ogura H, Egi M, Fujishima S, Hayashi Y, Iba T, Imaizumi H, Inoue S, Kakihana Y, Kotani J, Kushimoto S, Masuda Y, Matsuda N, Matsushima A, Nakada TA, Nakagawa S, Nunomiya S, Sadahiro T, Shime N, Yatabe T, Hara Y, Hayashida K, Kondo Y, Sumi Y, Yasuda H, Aoyama K, Azuhata T, Doi K, Doi M, Fujimura N, Fuke R, Fukuda T, Goto K, Hasegawa R, Hashimoto S, Hatakeyama J, Hayakawa M, Hifumi T, Higashibeppu N, Hirai K, Hirose T, Ide K, Kaizuka Y, Kan'o T, Kawasaki T, Kuroda H, Matsuda A, Matsumoto S, Nagae M, Onodera M, Ohnuma T, Oshima K, Saito N, Sakamoto S, Sakuraya M, Sasano M, Sato N, Sawamura A, Shimizu K, Shirai K, Takei T, Takeuchi M, Takimoto K, Taniguchi T, Tatsumi H, Tsuruta R, Yama N, Yamakawa K, Yamashita C, Yamashita K, Yoshida T, Tanaka H, Oda S. The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016). Acute Med Surg. 2018 Feb 5;5(1):3-89. doi: 10.1002/ams2.322. eCollection 2018 Jan.

ReferenceCitation: Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

ReferenceCitation: Tavaré A, O'Flynn N. Recognition, diagnosis, and early management of sepsis: NICE guideline. Br J Gen Pract. 2017 Apr;67(657):185-186. doi: 10.3399/bjgp17X690401.

ReferenceCitation: van der Poll T, van de Veerdonk FL, Scicluna BP, Netea MG. The immunopathology of sepsis and potential therapeutic targets. Nat Rev Immunol. 2017 Jul;17(7):407-420. doi: 10.1038/nri.2017.36. Epub 2017 Apr 24. Review.

ReferenceCitation: Wong HR, Cvijanovich NZ, Anas N, Allen GL, Thomas NJ, Bigham MT, Weiss SL, Fitzgerald J, Checchia PA, Meyer K, Shanley TP, Quasney M, Hall M, Gedeit R, Freishtat RJ, Nowak J, Shekhar RS, Gertz S, Dawson E, Howard K, Harmon K, Beckman E, Frank E, Lindsell CJ. Developing a clinically feasible personalized medicine approach to pediatric septic shock. Am J Respir Crit Care Med. 2015 Feb 1;191(3):309-15. doi: 10.1164/rccm.201410-1864OC.

ReferenceCitation: Antcliffe DB, Burnham KL, Al-Beidh F, Santhakumaran S, Brett SJ, Hinds CJ, Ashby D, Knight JC, Gordon AC. Transcriptomic Signatures in Sepsis and a Differential Response to Steroids. From the VANISH Randomized Trial. Am J Respir Crit Care Med. 2019 Apr 15;199(8):980-986. doi: 10.1164/rccm.201807-1419OC.

ReferenceCitation: Annane D, Pastores SM, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Meduri GU, Olsen KM, Rochwerg B, Rodgers SC, Russell JA, Van den Berghe G. Critical illness-related corticosteroid insufficiency (CIRCI): a narrative review from a Multispecialty Task Force of the Society of Critical Care Medicine (SCCM) and the European Society of Intensive Care Medicine (ESICM). Intensive Care Med. 2017 Dec;43(12):1781-1792. doi: 10.1007/s00134-017-4914-x. Epub 2017 Sep 21. Review.

ReferenceCitation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

name: Bloomsbury Institute of Intensive Care Medicine, University College London, London, United Kingdom

family: Singer

full_name: Mervyn Singer

given: Mervyn

name: Hofstra–Northwell School of Medicine, Feinstein Institute for Medical Research, New Hyde Park, New York

family: Deutschman

full_name: Clifford S. Deutschman

given: Clifford S.

name: Department of Critical Care and Emergency Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania

family: Seymour

full_name: Christopher Warren Seymour

given: Christopher Warren

name: Department of Critical Care Medicine, Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom

family: Shankar-Hari

full_name: Manu Shankar-Hari

given: Manu

name: Department of Critical Care Medicine, University of Versailles, France

family: Annane

full_name: Djillali Annane

given: Djillali

name: Center for Sepsis Control and Care, University Hospital, Jena, Germany

family: Bauer

full_name: Michael Bauer

given: Michael

name: Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, and Austin Hospital, Melbourne, Victoria, Australia

family: Bellomo

full_name: Rinaldo Bellomo

given: Rinaldo

name: Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University, Nashville, Tennessee

family: Bernard

full_name: Gordon R. Bernard

given: Gordon R.

name: Réanimation Médicale-Hôpital Cochin, Descartes University, Cochin Institute, Paris, France

family: Chiche

full_name: Jean-Daniel Chiche

given: Jean-Daniel

name: Critical Care Center, Emory University School of Medicine, Atlanta, Georgia

family: Coopersmith

full_name: Craig M. Coopersmith

given: Craig M.

name: Washington University School of Medicine, St Louis, Missouri

family: Hotchkiss

full_name: Richard S. Hotchkiss

given: Richard S.

name: Infectious Disease Section, Division of Pulmonary and Critical Care Medicine, Brown University School of Medicine, Providence, Rhode Island

family: Levy

full_name: Mitchell M. Levy

given: Mitchell M.

name: Department of Surgery, University of Toronto, Toronto, Ontario, Canada

family: Marshall

full_name: John C. Marshall

given: John C.

name: Emory University School of Medicine and Grady Memorial Hospital, Atlanta, Georgia

family: Martin

full_name: Greg S. Martin

given: Greg S.

family: Opal

full_name: Steven M. Opal

given: Steven M.

name: Trauma, Emergency & Critical Care Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada16Interdepartmental Division of Critical Care, University of Toronto

family: Rubenfeld

full_name: Gordon D. Rubenfeld

given: Gordon D.

name: Department of Infectious Diseases, Academisch Medisch Centrum, Amsterdam, the Netherlands

family: van der Poll

full_name: Tom van der Poll

given: Tom

name: Department of Intensive Care, Erasme University Hospital, Brussels, Belgium

family: Vincent

full_name: Jean-Louis Vincent

given: Jean-Louis

name: Department of Critical Care Medicine, University of Pittsburgh and UPMC Health System, Pittsburgh, Pennsylvania20Associate Editor, JAMA

family: Angus

full_name: Derek C. Angus

given: Derek C.

journal_name: JAMA

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

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

ReferenceCitation: ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

title: Acute Respiratory Distress Syndrome

location_facility: Department of medical and surgical Intensive Care Unit, Raymond Poincaré Hospital - APHP

title: A Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy

summary:
Main objective and primary endpoint: To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 90 days on intensive care unit (ICU) adults and having different biological profiles for immune responses and corticosteroids bioactivity.

Secondary objectives and endpoints:

Mortality and health-related quality of life at 6 months;
Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, 28, and 90);
Daily secondary infections (up to 90 days)
Daily blood and urinary levels of glucose, sodium and potassium (up to 28 day)
Daily gastroduodenal bleeding (up to 28 day)
Daily cognitive function and muscles' strength (days 1 to 28, 90 and 180 days).


title: Multi-center Prospective European Cohort Study in Patients With Rheumatoid Arthritis or Juvenile Idiopathic Arthritis Planned to be Treated Independently of the Present Study, With the First Line of Adalimumab, Etanercept, Infliximab Therapy or With Rituximab or Tocilizumab (After Anti-Tumor Necrosis Factor Therapy or Another Biotherapy or in First Line)

acronym: ABI-RA

summary: One of the main potential causes of these failures of BP therapy response is the development of Anti-drug Anti-body (ADAb) in some patients. ADAb may decrease the efficacy of BPs by neutralizing them or modifying their clearance and they may be associated with BP-specific hypersensitivity reactions. The prediction, prevention and cure of anti-drug (AD) immunization are thus major goals in BP development. This prospective study (ABI-RA) will assess the occurrence of ADAb using standardized and validated assay(s) and also cellular, genetic and molecular parameters in RA/JIA patients treated with adalimumab, etanercept, infliximab and rituximab or tocilizumab, to address the mechanism of immunogenicity. Patient-related factors that might predispose an individual to an immune response will be taken into account: underlying disease, genetic background, immune status, including immunomodulating therapy and dosing schedule.

ReferenceCitation: Duhazé J, Caubet M, Hässler S, Bachelet D, Allez M, Deisenhammer F, Fogdell-Hahn A, Gleizes A, Hacein-Bey-Abina S, Mariette X, Pallardy M, Broët P; ABIRISK Consortium. Assessing the effect of genetic markers on drug immunogenicity from a mechanistic model-based approach. BMC Med Res Methodol. 2020 Mar 20;20(1):69. doi: 10.1186/s12874-020-00941-z.

family: Duhazé

full_name: Julianne Duhazé

given: Julianne

family: Caubet

full_name: Miguel Caubet

given: Miguel

family: Hässler

full_name: Signe Hässler

given: Signe

family: Bachelet

full_name: Delphine Bachelet

given: Delphine

family: Allez

full_name: Matthieu Allez

given: Matthieu

family: Deisenhammer

full_name: Florian Deisenhammer

given: Florian

family: Fogdell-Hahn

full_name: Anna Fogdell-Hahn

given: Anna

family: Gleizes

full_name: Aude Gleizes

given: Aude

family: Hacein-Bey-Abina

full_name: Salima Hacein-Bey-Abina

given: Salima

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Pallardy

full_name: Marc Pallardy

given: Marc

family: Broët

full_name: Philippe Broët

given: Philippe

journal_name: BMC Medical Research Methodology

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

ReferenceCitation: Bitoun S, Nocturne G, Ly B, Krzysiek R, Roques P, Pruvost A, Paoletti A, Pascaud J, Dönnes P, Florence K, Gleizes A, Hincelin-Mery A, Allez M, Hacein-Bey-Abina S, Mackay F, Pallardy M, Le Grand R, Mariette X. Methotrexate and BAFF interaction prevents immunization against TNF inhibitors. Ann Rheum Dis. 2018 Oct;77(10):1463-1470. doi: 10.1136/annrheumdis-2018-213403. Epub 2018 Jun 23. Erratum in: Ann Rheum Dis. 2021 May;80(5):e84.