title: Induced Membrane Properties in Children and Adults

acronym: EMIH

summary: Bone reconstruction in critical sized defect (CSD) remains a real challenge in orthopedic surgery in children and adults. The Masquelet technique is an innovative therapeutic technique, which offers a bone reconstruction in two steps, by the formation of an induced membrane (IM) around a polymethylmethacrylate (PMMA) spacer placed into the bone defect. After, PMMA removal, the cavity is filled with corticocancellous graft allowing bone healing. Up to date, all angiogenesis and osteogenic properties of IM remain unknown. The purpose of this study is to characterize angiogenesis and osteogenic properties of IM in children and adults.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Treatment of Common Bile Duct Stones in a Laparoscopic Center : What Are the Limits and When Should we Call the Endoscopist ? Observationnal Study Between 2007-2019

summary: The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year.

acronym: cardiac shock

summary: Cardiogenic shock (CC) is one of the major challenges of current cardiology. Despite the difficulty of establishing a strict and consensual definition, it is accepted that the CC clinically corresponds to persistent hypotension (systolic blood pressure 90 mmHg for at least 30 minutes or need for vasopressor support) associated with signs of visceral hypoperfusion (confusion, mottling, oliguria, hyperlactatemia), and hemodynamic with a lowered heart index ( 1.8 L/min/m2) despite appropriate or high filling pressures. This definition of the European Society of Cardiology (ESC) masks however the great variability of hemodynamic tables grouped under the term of CC and severity levels, also variable.However, it was suggested that the etiology of CC influenced both its hemodynamic profile and therefore its therapeutic management but also its prognosis in the medium and long term.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

status_simplified: Ongoing


title: Interaction Between Right Heart Dysfunction and Emphysema: Impact of Endoscopic Lung Volume Reduction (RVDD)

acronym: RVDD

summary:
Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are very commonly associated.

Emphysema by increasing intrathoracic pressure appears to affect cardiac function.

Interestingly, previous studies have shown a link between the telediastolic volume of the right ventricle (measured by RMI) and the intensity of emphysema.

Our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload.

To verify this hypothesis the investigators will perform KT loop procedures in order to acquire intracardiac pressure/volume curves before and after lung volume reduction.

The pressure/volume curves allow the analysis of systolic and diastolic function, cardiac contractility and loading conditions.


title: Early Detection of Mental Disorders in Adolescents With Chronic Pain: Creation of a Screening Tool for Use by the General Practitioner

acronym: REPERADO

summary: This research aims to create a tool for detection of mental health disorders in adolescents with chronic pain. The first part is testing a screening questionnaire and comparing in with existing questionnaires. The second part involves two focus group with the adolescents aimed at recording their perception of the questionnaire.

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre de la douleur et de la migraine-Hôpital Trousseau

intervention_type: Behavioral


title: Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop

acronym: COVID-TEST

summary: This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

lead_sponsor: CMC Ambroise Paré


title: Evaluation of the Reproducibility of the Measurement of the QSM Signal (Quantitative Susceptibility Mapping)

acronym: ERESI

summary: Those included will perform an MRI without injection to obtain the QSM then they will exit the machine and reinstall themselves there to perform the second measurement. They will then change the MRI machine to perform a third measurement

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hhopital fondation adolphe de rothschild

intervention_type: Other

lead_sponsor_type: industriel


title: Adaptation and Validation of the Exercise Adherence Rating Scale of Knee Osteoarthritis Patients

acronym: GONEARS

summary:
The origin of knee osteoarthritis is multifactorial but the disease is strongly related to age. The pain and functional disability are the main reasons for consultation. Non-pharmaceutical treatment is always indicated.

The rehabilitation will reduce the pain, maintain or partially recover the amplitude of the movements as well as fight against vicious analgesic attitudes and strengthen the muscles to stabilize the joints. A program of self-rehabilitation exercises performed at home may be prescribed to people with knee osteoarthritis. It must include exercises adapted to the patient's functional abilities and painful level and requires education to improve the patient's motivation to practice a regular exercise program. However, adherence to such exercises is low, and until 2016 there was no objective way to find out the reasons for patients' lack of adherence to self-workout programs. The EARS ("Exercise Adherence Rating Scale" or Adhesion to Physical Exercise Programs) is validated in 2016 and reliable to evaluate the physical activity of patients with low back pain.

As far as we know, this questionnaire is the only one validated in the international literature, a validation for French patients is currently underway. We believe this tool can be used for patients with knee osteoarthritis after minor changes.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Scleral Buckling for Retinal Detachment Prevention in Genetically Confirmed Stickler Syndrome : a Randomized Controlled Trial

acronym: STL-DR-PREV

summary: The purpose of this study is to determine whether a scleral buckling surgical procedure performed on fellow eyes of patients with genetically confirmed Stickler syndrome can prevent the occurrence retinal detachment and/or severe vision loss of the study eye.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Monin C, Van Effenterre G, Andre-Sereys P, Haut J. [Prevention of retinal detachment in Wagner-Stickler disease. Comparative study of different methods. Apropos of 22 cases]. J Fr Ophtalmol. 1994;17(3):167-74. French.

ReferenceCitation: Abeysiri P, Bunce C, da Cruz L. Outcomes of surgery for retinal detachment in patients with Stickler syndrome: a comparison of two sequential 20-year cohorts. Graefes Arch Clin Exp Ophthalmol. 2007 Nov;245(11):1633-8. Epub 2007 Jun 20.

ReferenceCitation: Carroll C, Papaioannou D, Rees A, Kaltenthaler E. The clinical effectiveness and safety of prophylactic retinal interventions to reduce the risk of retinal detachment and subsequent vision loss in adults and children with Stickler syndrome: a systematic review. Health Technol Assess. 2011 Apr;15(16):iii-xiv, 1-62. doi: 10.3310/hta15160. Review.

ReferenceCitation: Ang A, Poulson AV, Goodburn SF, Richards AJ, Scott JD, Snead MP. Retinal detachment and prophylaxis in type 1 Stickler syndrome. Ophthalmology. 2008 Jan;115(1):164-8. Epub 2007 Aug 2.

ReferenceCitation: Fincham GS, Pasea L, Carroll C, McNinch AM, Poulson AV, Richards AJ, Scott JD, Snead MP. Prevention of retinal detachment in Stickler syndrome: the Cambridge prophylactic cryotherapy protocol. Ophthalmology. 2014 Aug;121(8):1588-97. doi: 10.1016/j.ophtha.2014.02.022. Epub 2014 May 1.


title: Assessment of Language Disorders in Multiple Sclerosis Patients

acronym: LANSEP

summary:
Multiple sclerosis (MS) is an autoimmune disease of the central nervous systems that results in focal inflammatory lesions and then diffuse and degenerative inflammatory phenomena. It is considered to be the leading cause of non-traumatic disability in young adults.

Cognitive impairment is a common and disabling part of MS. Studies carried out in the years 1990-2000 estimated their frequency to be between 40 and 60% of MS patients: they reflect the natural history of the disease. Effective treatments for the inflammatory component of the disease that are now available may have led to a reduction in their frequency.

Cognitive disorders were identified at an early stage of the disease and affect certain areas preferentially:

The most common achievement is the reduction in the speed of information processing. It is present from the early stage of the disease. Progressive deterioration over time is observed, which is a prognostic factor for long-term cognitive decline.

Long-term memory was impaired in 40-65% of patients in historical cohorts. More specifically, encoding and retrieval were affected, with storage and consolidation being preserved.

The attainment of executive functions is also common.
Phonemic and semantic fluency are also disturbed in MS patients. Among cognitive impairments, language impairment has been little studied in MS: in 2016 only 22 controlled studies were identified. The assessments carried out were most often partial, making it impossible to define the characteristics or to conclude that specific linguistic impairments are independent of other cognitive impairments. Finally, recent studies suggest that the frequency of language impairment in MS may be underestimated.

Therefore, it seems important to assess the prevalence of language disorders in a large cohort of patients with RRMS or MS, and to characterize these disorders by identifying the linguistic processes involved and the brain substrates involved. This will make it possible to envisage the implementation of more systematic screening for language disorders in MS and to improve patient management, in particular by developing targeted rehabilitation protocols.

design_allocation: Non-Randomized

primary_purpose: Supportive Care


title: Unexplained Infertility Treated by Hysteroscopy-laparoscopy : Predictive Factors of Pregnancy

summary: Retrospective study, including patients from january 2013 to december 2018, who were diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI normal. Semen analyses were normal according to the World Health Organization criteria. Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed for spontaneous fertility or ART to conceive. The investigators would like to see how many surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy rate. The investigators would like to assess how many diagnosis was done after surgery and how many pregnancy were obtained. The investigators search other prognostic factors than age or parity.


title: Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns

acronym: Coropreg

summary: The purpose of this study is to characterize the incidence and clinical features of the maternal COVID 19 infection, as well as the associated morbidity of the mother and the child, in the French context


title: Factors Associated With the Evolution of Presenteeism Under Biotherapy in Severe Asthma

acronym: PRESATHMA

summary:
Severe asthma is a condition characterized by a lower sensitivity to high doses of inhaled corticosteroids combined with a second controller, most often a long-acting bronchodilator. It concerns approximately 5% of asthmatics. Treatment failure and co-morbidities induced by systemic corticosteroid therapy can cause debilitating dyspnea, limited physical activity, and impaired quality of life. Severe asthma could therefore be associated with major presenteeism, defined as the presence of an employee at work despite his health issues and which implies a limitation of the employee's productive capacity. Uncontrolled asthma and co-morbidities of asthma have been shown to be associated with a decrease in work productivity that includes absenteeism and presenteeism. Although there is little data, a recent study found a decline in work productivity in severe asthma. Various factors associated with presenteeism could be involved, such as asthma control, frequency and severity of exacerbations, comorbidities, or treatments.

Biotherapies targeting the signaling pathways involved in airway inflammation improve asthma control, decrease the frequency of asthma exacerbations which are major determinants of quality of life, improve lung function, and allow oral steroid sparing. Biotherapies could therefore be associated with a decrease in presenteeism.

The objective of the study is to describe the evolution of presenteeism at work, evaluated by the WPAI: Asthma, after 6 months of treatment by biotherapy and to identify factors associated with this evolution

lead_sponsor: University Hospital, Lille


title: Systemic Endothelial Dysfunction in Reversible Cerebral Vasoconstriction Syndrome : a Case Control Study

acronym: DESS

summary: Reversible Cerebral Vasoconstriction Syndrome (RCVS) is a syndrome described at the end of the 20th century. Generally, it has a benign course. It is revealed by acute headaches, in different circumstances such as sexual activity, physical exertion or emotional disturbances. But, in few cases, it might be complicated by seizure, stroke and subarachnoid haemorrhage. The diagnosis is confirmed on radiological examination, which shows diffuse cerebral vasoconstriction of brain vessel. It calls reversible because at three month, vasoconstriction disappears. Most cases occur during post partum or after serotoninergic/adrenergic drug use. The pathophysiology is unknown but a transient disturbance in the control of cerebrovascular tone by sympathic hyperactivity and/or endothelial dysfunction are suspected. The assessment of endothelial dysfunction in brain is possible with transcranial doppler. Chen et al. showed an impairment of vasodilatation post apnea induced called BHI on RCVS subjects compared with healthy control. BHI is a reflect of endothelial function in brain. Currently, investigators do not know if endothelial dysfunction occurred only in brain or if it may occur in systemic vessel. Some case reports talk about systemic complication such as kidney infarct or hepatic arterial vasospasm so a systemic vascular dysfunction may be suspected. In this study, researchers will study systemic endothelial function by measure of the pulse wave velocity during RCVS and after its recovering at 3 months, and compare it at healthy controls.

lead_sponsor: Nantes University Hospital


title: Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children With Autism Spectrum Disorder Aged 8-12 Years Old

acronym: TIPI

summary: This study aims to evaluate the relevance of a new computerized test for pragmatic inferences (TIPi) in children aged 8 to 12 YO, presenting a typical development, autism spectrum disorders or another neurodevelopmental condition.

lead_sponsor: Hôpital le Vinatier


title: Abdominal Massage to Prevent Postoperative Ileus as Part of an Enhanced Recovery Program After Colorectal Surgery

acronym: MATRAC

summary:
Post operative ileus refers to an disrupt in normal gastrointestinal motility responsible of nausea and vomiting. It occurs in about 15-20% of colorectal surgeries. Some preventive measures have been included in the Enhanced Recovery After Surgery Program such as early mobilisation and enteral feeding or minimal invasive approach.

Abdominal massage is not widely applied amongst general surgery team and is not part of the recommendation. This technique refers to profound manœuvrers of visceras through abdominal palpation and breathing, and has been used as part of the local protocol of Grenoble Alps University Hospital for many years with satisfactory results. No complications have been reported.

Various studies have evaluated the value of physiotherapy and massage for resumption of normal bowel function. A study from Rouen University Hospital demonstrated that a mechanical stress to the cuteaneous tissue by LPG Cellu M50® machine would reduce pain and lower the time to first flatus. Similar results were obtained after Cardiac surgery. In a preclinical study on operated rats, abdominal massage also improved normal bowel function recovery.

Physiotherapist plays a key role in RAC. Their action on respiratory function (movement of diaphragm) and musculoskeletal system (early walking) allows a faster recovery and a reduction of time of hospitalization. Even though the results on time to first flatus and anxiety seem interesting, Deep abdominal massage has never been evaluated.

primary_purpose: Other

ReferenceCitation: Le Blanc-Louvry I, Costaglioli B, Boulon C, Leroi AM, Ducrotte P. Does mechanical massage of the abdominal wall after colectomy reduce postoperative pain and shorten the duration of ileus? Results of a randomized study. J Gastrointest Surg. 2002 Jan-Feb;6(1):43-9.

ReferenceCitation: Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.

ReferenceCitation: Dreyer NE, Cutshall SM, Huebner M, Foss DM, Lovely JK, Bauer BA, Cima RR. Effect of massage therapy on pain, anxiety, relaxation, and tension after colorectal surgery: A randomized study. Complement Ther Clin Pract. 2015 Aug;21(3):154-9. doi: 10.1016/j.ctcp.2015.06.004. Epub 2015 Jun 12.

ReferenceCitation: Chapelle SL, Bove GM. Visceral massage reduces postoperative ileus in a rat model. J Bodyw Mov Ther. 2013 Jan;17(1):83-8. doi: 10.1016/j.jbmt.2012.05.004. Epub 2012 Aug 12.

ReferenceCitation: Navalgund A, Axelrod S, Axelrod L, Singhal S, Tran K, Legha P, Triadafilopoulos G. Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus. J Gastrointest Surg. 2019 May;23(5):982-989. doi: 10.1007/s11605-018-4030-4. Epub 2018 Nov 2.

lead_sponsor: University Hospital, Grenoble


title: Management of Infant Digestive Disorders and Quality of Life

summary: The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.

lead_sponsor: Nestlé


title: Feasibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA

acronym: REMARK

summary:
Use HeprAN ™ membrane (coated with heparin) should be allow the success of dialysis sessions, with adequate dialysis parameters, in patients treated by long-term anticoagulation with VKA, without addition of heparin perdialytic.

Less use of heparin (UFH or LMWH) during hemodialysis session should be allow a decrease of bleedings (moderate or major) and blood transfusions for hemodialysed patients with HeprAN ™ membrane and treated by long-term anticoagulation with VKA

primary_purpose: Treatment

lead_sponsor: CHU de Reims

intervention_type: Drug


title: Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity

acronym: IMISS

summary: Gougerot-Sjögren syndrome or Sjögren syndrome is a chronic autoimmune disease belonging to connectivitis, the classic triad of symptoms being the association of a sicca syndrome (generally predominant in the mouth and / or ocular, but also present at the cutaneous, vaginal or tracheal level), diffuse arthromyalgia and marked fatigue. The study investigators hypothesize that changes in the gut microbiota, by modulating gut permeability and thereby promoting microbial translocation, would have immunomodulatory effects that could be correlated to changes in the activity of Gougerot-Sjögren disease.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: AiCR : Artificial Intelligence in Cardiac aRrest Application of an Algorithm in the Prognosis of Recovered Cardiorespiratory Arrests

acronym: AiCR

summary:
The overall incidence of cardiorespiratory arrest in Europe is estimated at 350,000 to 700,000 cases per year. Survival rate is estimated at 10.7% for all rhythm disorders combined.

Several examples of AI application in the medical field exist. Ting et al have developed a computer tool capable of diagnosing the presence of diabetic retinopathy with excellent power. In resuscitation, Celi et al proposed a tool capable of predicting the need for crystalloid vascular filling during a systemic inflammatory state. In Nature in 2018, Komorowski demonstrated the efficacy of AI in the hemodynamic management of sepsis. In a study of the renal response to fluid challenge, Zhang et al. demonstrate the effectiveness of the learning machine.

Objectives: Determination of an algorithm capable of predicting the mortality of patients admitted to intensive care units (ICU) for ACR from hospitalization reports (CRH). Also use of the algorithm to predict the risk of recurrence of the arrest, the duration of mechanical ventilation, the appearance of sepsis, the development of organ failure, prediction of the CPC (Cerebral Performance Category), time to obtain catecholamine withdrawal, the appearance of acute renal failure with or without the need for extra-renal purification (EER) and duration under EER, the average length of stay.

This project is part of a larger, nationwide project with greater power, and includes all the data generated during hospitalization in intensive care.

Method: an estimated total number of patients included in this study to be between 300 and 500. The population will come from the intensive care units of Nice, Antibes, Cannes, Grasse.

Inclusion will be retrospective, on CRH, CR of CT imaging (cerebral and thoraco-abdomino-pelvic), MRI, EEG, and daily follow-up words, from 2014 to the end of 2020.

After anonymisation, application of semantisation using natural language processing (NLP) methods. The data to be extracted are entered in a document written by intensive care physicians. These data will then be stored in a database. In order to meet the main objective, we will develop a computer algorithm capable of predicting mortality in the study population. This algorithm, based on a large database, can be designed using machine learning or even deep learning techniques depending on the amount of data to be processed.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Assessment of Pain of Pelvic Congestion Syndrome Treated by Coils Embolization (SCVPC)

acronym: SCVPC

summary:
Summary:

Main Objective: to evaluate the efficacy of pelvic gonadal vein embolization with coils in treatment of pelvic congestion syndrome Methods: retrospective study included 25 patients in the University hospital of Brest.

The Primary Outcome Measure: To evaluate (to measure) pain relief using visual analogous scale (VAS) before and after gonadal vein embolization for pelvic congestion syndrome The Secondary Outcome Measures were to assess the impact of the treatment on specific and general symptoms through a survey.

time_perspective: Other

ipd_sharing: Yes

lead_sponsor: University Hospital, Brest


title: Ultrasonographic Evaluation of the Evolution of the Gastric Volume After Colorectal

acronym: EVOL

summary:
Postoperative ileus (POI) is a serious complication after colorectal surgery. One of its most frequent consequences is the replacement of nasogastric tube because of the vomiting. Vomiting is due to the distension of the stomach and information on the evolution of gastric filling after surgery could help to better understand the physiopathology of POI. It could also give indication to help the physician in the management of POI.

The ultrasonography has been shown to be a reliable technic to assess the gastric emptying.

To date, there is no indication in the literature about the evolution of the gastric filling after colorectal surgery while these information could help to identify patients at risk for POI and to predict the need for POI replacement.

lead_sponsor: University Hospital, Angers

intervention_type: Diagnostic Test


title: Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of WHO II and III Grade Incident Gliomas.

summary: From the medical records of a series of patients operated on for incident grade II and III glioma, the primary objective is to evaluate the correlation between the molecular profile of tumours and preoperative imaging data (by FDG and FDOPA PET-scan and multimodal MRI).

status: Enrolling by invitation

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

status_simplified: Unknown


title: Reward and Punishment Sensitivity in Bipolar Disorders

acronym: Recodec-BP

summary:
Bipolar disorder (BD) represents a chronic mood disorder and one of the leading causes of disability worldwide. Complexity of its clinical presentations leads to delayed diagnosis and difficult management in routine clinical settings. Whereas distinguishing BD-I and BD-II main subtypes has a significant relevance for treatment strategy and for outcome, there are currently no clinical determinants of the BD subtype which could be used as early diagnostic predictors.

While neurobiological specificity of each BD subtype is still controversial, available evidence suggest different dopaminergic abnormalities in each subtype. Dopaminergic function is involved in decision making and reward processing which may represent useful BD subtype markers.
This study aims at assessing decision making during appetitive and punitive reinforcement learning in patients with BD I and BD II subtypes compared to healthy controls

time_perspective: Cross-Sectional


title: Demonstration of the Presence of a Carbonyl Stress in the Hair Follicles of Postpartum Women

summary: In this study, the investigator will try to highlight the presence of carbonyl compounds in the hair follicles of postpartum women by comparing these compounds before and after delivery.

primary_purpose: Basic Science

ipd_sharing_description: Proof of concept study, with confidential data

lead_sponsor: Pierre Fabre Dermo Cosmetique


title: Description of neurolOgical Involvement Observed During SARS COV2 Infection

acronym: NeuroSARS

summary: Description of the neurological impairment: clinico-radiological and electrophysilogical correlations

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Detection of SARS-CoV-2 in the Semen of COVID+ Patients (Positive RT-PCR on a Nasopharyngeal Swab)

acronym: COVISPERM

summary: The objective of this study is to look for the presence of SARS-CoV-2 in the semen of patients diagnosed with COVID+ based on RT-PCR analysis of nasopharyngeal swabs.


title: Observatoire du Portage rhinopharyngé de Streptococcus Pneumoniae (Sp) Chez Des Nourrissons Ayant Une Otite Moyenne aiguë (OMA) et Sains - Etude Ancillaire Sur la détection Des Porteurs de E Coli BLSE

summary: This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a shift in the distribution of Streptococcus pneumoniae serotypes in children with acute otitis media and modified the resistance of this bacterial species to antibiotics.

ReferenceType: result

ReferenceCitation: Ouldali N, Cohen R, Levy C, Gelbert-Baudino N, Seror E, Corrard F, Vie Le Sage F, Michot AS, Romain O, Bechet S, Bonacorsi S, Angoulvant F, Varon E. Pneumococcal susceptibility to antibiotics in carriage: a 17 year time series analysis of the adaptive evolution of non-vaccine emerging serotypes to a new selective pressure environment. J Antimicrob Chemother. 2019 Oct 1;74(10):3077-3086. doi: 10.1093/jac/dkz281.

name: ACTIV, Association Clinique et Thérapeutique Infantile du Val-de-Marne, Saint Maur-des-Fossés, France

name: GPIP, Groupe de Pathologie Infectieuse Pédiatrique, Paris, France

name: Unité d’épidémiologie clinique, Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré, ECEVE INSERM UMR 1123, Paris, France

name: Urgences pédiatriques, hôpital Necker Enfants Malades, Université Paris Descartes, Paris, France

family: Ouldali

full_name: Naim Ouldali

given: Naim

sequence: first

name: AFPA, Association Française de Pédiatrie Ambulatoire, Saint-Germain-en-Laye, France

name: Université Paris Est, IMRB-GRC GEMINI, Créteil, France

name: Clinical Research Center (CRC), Centre Hospitalier Intercommunal de Créteil, Créteil, Créteil, France

family: Cohen

full_name: Robert Cohen

given: Robert

sequence: additional

family: Levy

full_name: Corinne Levy

given: Corinne

family: Gelbert-Baudino

full_name: Nathalie Gelbert-Baudino

given: Nathalie

name: Hématologie pédiatrique, Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré, Paris, France

family: Seror

full_name: Elisa Seror

given: Elisa

family: Corrard

full_name: François Corrard

given: François

family: Vie Le Sage

full_name: François Vie Le Sage

family: Michot

full_name: Anne-Sylvestre Michot

given: Anne-Sylvestre

name: Réanimation et pédiatrie néonatales, Hôpitaux Universitaires Paris-Sud, Hôpital Antoine Béclère, Clamart, France

family: Romain

full_name: Olivier Romain

given: Olivier

family: Bechet

full_name: Stéphane Bechet

given: Stéphane

name: Université Paris Diderot, Sorbonne Paris Cité, Paris, France

name: Service de Microbiologie, Assistance Publique-Hôpitaux de Paris, Hôpital Robert-Debré, Paris, France

family: Bonacorsi

full_name: Stéphane Bonacorsi

name: Centre de recherche des Cordeliers, INSERM UMR 1138, Paris, France

family: Angoulvant

full_name: François Angoulvant

name: National Reference Center for Pneumococci, Centre Hospitalier Intercommunal de Créteil, Créteil, France

family: Varon

full_name: Emmanuelle Varon

given: Emmanuelle

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Rybak A, Levy C, Bonacorsi S, Béchet S, Vié le Sage F, Elbez A, Varon E, Cohen R. Antibiotic Resistance of Potential Otopathogens Isolated From Nasopharyngeal Flora of Children With Acute Otitis Media Before, During and After Pneumococcal Conjugate Vaccines Implementation. Pediatr Infect Dis J. 2018 Mar;37(3):e72-e78. doi: 10.1097/INF.0000000000001862.

family: Rybak

full_name: Alexis Rybak

given: Alexis

family: Béchet

full_name: Stéphane Béchet

family: Vié le Sage

full_name: François Vié le Sage

family: Elbez

full_name: Annie Elbez

given: Annie

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Birgy A, Bidet P, Levy C, Sobral E, Cohen R, Bonacorsi S. CTX-M-27-Producing Escherichia coli of Sequence Type 131 and Clade C1-M27, France. Emerg Infect Dis. 2017 May;23(5):885. doi: 10.3201/eid2305.161865.

publisher: Centers for Disease Control and Prevention (CDC)

title: CTX-M-27–Producing Escherichia coli of Sequence Type 131 and Clade C1-M27, France

ReferenceCitation: Cohen R, Varon E, Doit C, Schlemmer C, Romain O, Thollot F, Béchet S, Bonacorsi S, Levy C. A 13-year survey of pneumococcal nasopharyngeal carriage in children with acute otitis media following PCV7 and PCV13 implementation. Vaccine. 2015 Sep 22;33(39):5118-26. doi: 10.1016/j.vaccine.2015.08.010. Epub 2015 Aug 11.

ReferenceCitation: Cohen R, Levy C, Bonnet E, Thollot F, Boucherat M, Fritzell B, Derkx V, Bingen E, Varon E. Risk factors for serotype 19A carriage after introduction of 7-valent pneumococcal vaccination. BMC Infect Dis. 2011 Apr 18;11:95. doi: 10.1186/1471-2334-11-95.

ReferenceCitation: Cohen R, Bingen E, Levy C, Thollot F, Boucherat M, Derkx V, Varon E. Nasopharyngeal flora in children with acute otitis media before and after implementation of 7 valent pneumococcal conjugate vaccine in France. BMC Infect Dis. 2012 Mar 7;12:52. doi: 10.1186/1471-2334-12-52.

ReferenceCitation: Levy C, Vie le Sage F, Varon E, Chalumeau M, Grimprel E, Cohen R. Pediatric Ambulatory and Hospital Networks for Surveillance and Clinical Epidemiology of Community-Acquired Infections. J Pediatr. 2018 Mar;194:269-270.e2. doi: 10.1016/j.jpeds.2017.11.050. Epub 2018 Feb 22.

ReferenceCitation: Vermee Q, Cohen R, Hays C, Varon E, Bonacorsi S, Bechet S, Thollot F, Corrard F, Poyart C, Levy C, Raymond J. Biofilm production by Haemophilus influenzae and Streptococcus pneumoniae isolated from the nasopharynx of children with acute otitis media. BMC Infect Dis. 2019 Jan 11;19(1):44. doi: 10.1186/s12879-018-3657-9.

ReferenceCitation: Birgy A, Madhi F, Jung C, Levy C, Cointe A, Bidet P, Hobson CA, Bechet S, Sobral E, Vuthien H, Ferroni A, Aberrane S, Cuzon G, Beraud L, Gajdos V, Launay E, Pinquier D, Haas H, Desmarest M, Dommergues MA, Cohen R, Bonacorsi S; Group of the National Observatory of Urinary tract Infection due to ESBL-producing Enterobacteriaceae in children. Diversity and trends in population structure of ESBL-producing Enterobacteriaceae in febrile urinary tract infections in children in France from 2014 to 2017. J Antimicrob Chemother. 2020 Jan 1;75(1):96-105. doi: 10.1093/jac/dkz423.

name: Université de Paris, IAME, INSERM, F-75018, Paris, France

name: AP-HP, Hôpital Robert Debré, Service de Microbiologie, F-75019, Paris, France

name: Service de Pédiatrie Générale, Centre Hospitalier Intercommunal de Créteil, France

name: Groupe de Pathologie Infectieuse Pédiatrique (GPIP), Paris, France

name: Centre de Recherche Clinique, Centre Hospitalier Intercommunal de Créteil, France

name: Association Clinique Thérapeutique Infantile du Val de Marne (ACTIV), Saint Maur des Fossés, France

name: Université Paris Est, IMRB-GRC GEMINI, ACTIV, 94000, Créteil, France

name: AP-HP, HU-Est Parisien site Trousseau, Service de Bactériologie, F-75012, Paris, France

name: AP-HP, Hopital Necker, Service de Microbiologie, University Paris Descartes, Paris, France

name: Microbiology Laboratory, Créteil Hospital, Créteil, France

name: Bacteriology-Hygiene Unit, Assistance Publique/Hôpitaux de Paris, Bicêtre Hospital, Le Kremlin-Bicêtre, France

name: Université Paris Sud, LabEx LERMIT, Faculty of Medicine, Le Kremlin-Bicêtre, France

name: Associated French National Reference Center for Antibiotic Resistance: Carbapenemase-producing Enterobacteriaceae, Le Kremlin-Bicêtre, France

name: Evolution and Ecology of Resistance to Antibiotics Unit, Institut Pasteur, APHP-Université Paris Sud, Paris, France

name: Centre National de Référence des Légionelles, Institut des Agents Infectieux, Hospices Civils de Lyon, Lyon, France

name: Service de Pédiatrie, Antoine Béclère University Hospital, Assistance Publique-Hôpitaux de Paris, Clamart, France

name: Centre for Research in Epidemiology and Population Health, Villejuif, France

name: Service de Pédiatrie Générale et Infectiologie Pédiatrique, Hôpital Femme-Enfant-Adolescent, Centre Hospitalier Universitaire de Nantes, Nantes, France

name: Unité de Pneumologie et Allergologie pédiatriques & CRCM mixte, Pédiatrie Médicale, CHU Charles Nicolle, Rouen, France

name: Hôpitaux pédiatriques CHU Lenval, Nice, France

name: Service d'Accueil des Urgences Pédiatriques, AP-HP, Hôpital Robert Debré, Paris, France

name: Service de pédiatrie, centre hospitalier de Versailles, Le Chesnay, France

name: Unité Court Séjour, Petits Nourrisson, Service de Néonatologie, Centre Hospitalier Intercommunal de Créteil, France

ReferenceCitation: Mizrahi A, Cohen R, Varon E, Bonacorsi S, Bechet S, Poyart C, Levy C, Raymond J. Non typable-Haemophilus influenzae biofilm formation and acute otitis media. BMC Infect Dis. 2014 Jul 19;14:400. doi: 10.1186/1471-2334-14-400.

ReferenceCitation: Birgy A, Levy C, Bidet P, Thollot F, Derkx V, Béchet S, Mariani-Kurkdjian P, Cohen R, Bonacorsi S. ESBL-producing Escherichia coli ST131 versus non-ST131: evolution and risk factors of carriage among French children in the community between 2010 and 2015. J Antimicrob Chemother. 2016 Oct;71(10):2949-56. doi: 10.1093/jac/dkw219. Epub 2016 Jun 20.

title: ESBL-producingEscherichia coliST131 versus non-ST131: evolution and risk factors of carriage among French children in the community between 2010 and 2015

ReferenceCitation: Hau I, Levy C, Caeymaex L, Cohen R. Impact of pneumococcal conjugate vaccines on microbial epidemiology and clinical outcomes of acute otitis media. Paediatr Drugs. 2014 Feb;16(1):1-12. doi: 10.1007/s40272-013-0044-2.

title: Impact of Pneumococcal Conjugate Vaccines on Microbial Epidemiology and Clinical Outcomes of Acute Otitis Media

ReferenceCitation: Birgy A, Cohen R, Levy C, Bidet P, Courroux C, Benani M, Thollot F, Bingen E. Community faecal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceae in French children. BMC Infect Dis. 2012 Nov 21;12:315. doi: 10.1186/1471-2334-12-315.

title: Community faecal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceaein french children

ReferenceCitation: Caeymaex L, Varon E, Levy C, Béchet S, Derkx V, Desvignes V, Doit C, Cohen R. Characteristics and outcomes of acute otitis media in children carrying streptococcus pneumoniae or haemophilus influenzae in their nasopharynx as a single otopathogen after introduction of the heptavalent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 May;33(5):533-6. doi: 10.1097/INF.0000000000000213.

title: Characteristics and Outcomes OF Acute Otitis Media in Children Carrying Streptococcus Pneumoniae or Haemophilus Influenzae in Their Nasopharynx as a Single Otopathogen After Introduction of the Heptavalent Pneumococcal Conjugate Vaccine

ReferenceCitation: Cohen R, Levy C, Bingen E, Koskas M, Nave I, Varon E. Impact of 13-valent pneumococcal conjugate vaccine on pneumococcal nasopharyngeal carriage in children with acute otitis media. Pediatr Infect Dis J. 2012 Mar;31(3):297-301. doi: 10.1097/INF.0b013e318247ef84.

title: Impact of 13-valent Pneumococcal Conjugate Vaccine on Pneumococcal Nasopharyngeal Carriage in Children With Acute Otitis Media

ReferenceCitation: Cohen R, Levy C, Bingen E, Bechet S, Derkx V, Werner A, Koskas M, Varon E. [Nasopharyngeal carriage of children 6 to 60 months during the implementation of the 13-valent pneumococcal conjugate vaccine]. Arch Pediatr. 2012 Oct;19(10):1132-9. doi: 10.1016/j.arcped.2012.07.013. Epub 2012 Aug 24. French.

title: Portage rhinopharyngé d’enfants âgés de six à 60 mois durant l’implémentation du vaccin pneumococcique conjugué 13-valent

ReferenceCitation: Cohen R, Levy C, Thollot F, de La Rocque F, Koskas M, Bonnet E, Fritzell B, Varon E. Pneumococcal conjugate vaccine does not influence Staphylococcus aureus carriage in young children with acute otitis media. Clin Infect Dis. 2007 Dec 15;45(12):1583-7. doi: 10.1086/523734. Erratum in: Clin Infect Dis. 2008 Feb 1;46(3):489.

title: Pneumococcal Conjugate Vaccine Does Not Influence Staphylococcus aureus Carriage in Young Children with Acute Otitis Media

ReferenceCitation: Cohen R, Levy C, de La Rocque F, Gelbert N, Wollner A, Fritzell B, Bonnet E, Tetelboum R, Varon E. Impact of pneumococcal conjugate vaccine and of reduction of antibiotic use on nasopharyngeal carriage of nonsusceptible pneumococci in children with acute otitis media. Pediatr Infect Dis J. 2006 Nov;25(11):1001-7.

lead_sponsor: Association Clinique Thérapeutique Infantile du val de Marne


title: Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

summary: The overall goal of this study is to identify risk and prognosis factors of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment

acronym: KneeKG Sphere

summary:
Total knee arthroplasty (TKA) is a treatment for advanced femoro-tibial osteoarthritis. This surgery is justified in case of significant discomfort and failure of medical treatment.

The functional results of TKA are good with a recovery of 6 months - 1 year. Nevertheless, very few patients forget their prostheses. A United Kingdom study assessed patient satisfaction in a cohort of 10,000 patients more than one year after TKA: nearly 20% were not satisfied with their TKA.

The knee is indeed a complex articulation that works differently in the three space plans. Current knee prostheses are trying to replicate this biomechanics and get as close as possible to the anatomy of a native knee.

Bellemans et al. found in 250 asymptomatic patients 32% of men with a constitutional varus greater than 3 ° and 17% of women. Restoration of normal knee function can also be achieved by restoring a moderate constitutional deformity present preoperatively. The objective of the femorotibial alignment was dogmatically fixed at 180° (mechanical femorotibial alignment). In recent years, some surgical teams have attempted to reproduce the preoperative constitutional deformity in varus or valgus with the prosthesis. This femorotibial alignment is called kinematic alignment. This kinematic alignment has already been studied in several randomized studies and has demonstrated improved functional scores. However, these studies focused on specific TKA, which are posterior cruciate TKA, and the assessment was subjective through functional scores. In addition, these TKA were often made with patient specific instrumentation (PSI). Some studies have evaluated walking kinematics after TKA with kinematic alignment. But it was again TKA retaining the posterior cruciate ligament.

The investigators would like to prospectively evaluate the restoration of the medially stabilized TKA walking kinematics (medial-stable TKA or ball in socket stability) implanted with a kinematic alignment compared to a mechanical alignment.

lead_sponsor: Hospices Civils de Lyon


title: Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey

summary:
With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to understand the impact of infection on immunodeficient individuals. Whilst co-morbidities (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in people infected with SARS-CoV-2, there is currently no information on the consequences and outcomes for individuals with primary immunodeficiencies (PID).

Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui (CEREDIH & IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on obtaining this top level of information), we are launching the 2nd phase: "COPID19".

COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics Committee. However, this retrospective survey is designed for global distribution. Data can be entered by a health care professional (mostly clinicians) through a personal login and password.

Each documenting person will have access to his/her own patients' data. COPID19 require a greater level of information than the 1st phase. The eCRF will be open to evolutions depending on progresses in our knowledge of this pandemic.

lead_sponsor: Imagine Institute


title: Evaluation of Cerebral, Hemodynamic and Neuronal Activities in Neonates in the Immediate Postpartum

acronym: POSTPARTUM

summary:
Neonatal anoxia-ischemia causes significant neurodevelopmental disorders. In this study the investigators want to better understand the interactions between the nervous and the hemodynamic cerebral systems during the adaptation of the neonate to ectopic life just after birth. Birth is an at risk situation of neonatal anoxic ischemia and the lack of objective criteria for cerebral tissue oxygenation has consequences on neuronal activity. Ph cord analysis is inadequate and only indirectly reflects the state of cerebral oxygenation. Both neuronal and vascular systems are part of the same functional entity and the analysis of their interactions is likely to reveal some early malfunctions of these networks.

In this study, the investigators want to develop a multi-scale, multimodal approach that allows simultaneous interrogation of both neuronal and vascular compartments during the 15 minutes after delivery. The investigators will record, with the aid of a single sensor placed on the scalp of the child, the electroencephalogram and the cerebral tissue oxygenation. The investigators will measure interactions by means of correlation analysis between both signals.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Intimacy of Women With Cystic Fibrosis

acronym: IFAM

summary:
The intimate life of patients with cystic fibrosis has not been the subject of specific research, it is even left behind in favor of respiratory, digestive or endocrinological dysfunctions endangering these patients. After 16 years of practice, it is significant that this subject is problematic, painful but difficult to tackle; No doubt just as much on the side of caregivers: this question has never found its way into team exchanges, it seems to be evaded doubtless difficult or too intimate to welcome. These disorders arise from the effects of the disease on the health of the mucous epithelial tissues also located in the genital area. These difficulties are more closely approached by the difficulties of procreation; PMA allows them to get around them, nevertheless making it possible to be a parent, with the residual frustration of a satisfactory sex life: a deaf "addition", adding to many care constraints.

It is therefore in terms of sexual health and quality of sexual life that it is desirable to shed light on this aspect of cystic fibrosis in women.

Bibliographic research confirms this approach: this subject is not explored, the rare publications concern the vulnerability of the cervix or the difficulty on both sides of tackling this subject.


title: Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy

acronym: EVAMYLOSE

summary:
The aging of the population is a reality in our society, with a strong increase in the number of elderly patients hospitalized for heart failure in our institutions. Heart failure in these patients is more present than to younger patients, with preserved ejection fraction form (HFpEF). Aging is responsible for the onset of senile amyloid cardiomyopathy. This pathology is still imperfectly understood and its link with the increase in the frequency of HFpEF is important. In addition, specific treatments have just shown their effectiveness. It is therefore urgent to better identify the prognostic predictive parameters of this cardiomyopathy.

The pathophysiological involvement of the coronary microcirculation responsible for a true microvascular coronary disease (CMVD) has been described as predictive factor in all cardiomyopathies. However the implementation of preventive strategies and / or therapeutic of the coronary microcirculation dysfunction are limited because we lack of diagnostic tests available and applicable to large cohorts of patients.

Our team INSERM U1039 Radiopharmaceutiques Biocliniques in collaboration with the laboratory GIPSA-lab (Grenoble Images Speech Signal Automatique), laboratory specialized in the signal analysis, has developed a new method of analysis allowing to measure the coronary microcirculation dysfunction usable in SPECT thanks to the measurement of a myocardial perfusion heterogeneity index (IHPM) (patented technique). The 3C registry (NCT03479580) is a registry studying the prevalence and cardiovascular prognosis of macro and microcirculatory coronary artery disease using the latest coronary evaluation techniques in patient with cardiomyopathy. This registry deployed on interventional cardiology centers on the Alpine Arc is therefore also addressed to patients with senile cardiomyopathy. The data collected will provide a better understanding of the factors influencing the prognosis of senile cardiomyopathy and the prognostic contribution of the measurement of the IHPM will be evaluated.


title: Evaluation of the Effectiveness of a Muscular Strengthening Protocol With an Instrumented Orthosis for Gonarthrosis Patients

summary: The management of knee osteoarthritis via a physical activity protocol for rehabilitation has convincing results. However, the effectiveness of these protocols could be improved with a connected instrumented knee brace with an exercise protocol adapted for the patient which is supervise by an online physiotherapist to check the progression during home-based rehabilitation.

intervention_type: Device


title: Efficacité Clinique comparée de la Stimulation transcutanée du Nerf Tibial postérieur unilatérale vs bilatérale Pour Traiter Une hyperactivité vésicale Neurologique Non sévère : Essai Clinique randomisé

acronym: UROSTIM

summary: This study evaluates the effectiveness of bilateral stimulation of the tibial nerve compared to unilateral stimulation in neurological bladder disorders.

status: Unknown status

lead_sponsor: University Hospital, Caen


title: Liquid Biopsies and IMAging for Improved Cancer Care - Non Metastatic Rectal Cancer

acronym: LIMA

summary: The recently developed liquid biopsy technology (to obtain and characterize tumour cells and tumour components like Deoxyribonucleic acid (DNA) or Ribonucleic Acid (RNA) from a simple blood draw), in combination with advanced Magnetic Resonance Imaging techniques (MRI), can tackle the following problems in rectal cancer: 1. Assessment of tumour heterogeneity from liquid biopsies. 2. Assessment from advanced MRI feature extraction to indicate poor outcome 3. Faster assessment of therapy response in Neoadjuvant chemotherapy (NAT) for rectal cancer; 4. Detection of emerging drug/therapy resistance. This project's overall objective is to develop and validate technologies and tools to include liquid biopsies in the clinical workflow, aiming at introducing a more precise and dynamic genetic characterization of tumour at the diagnosis and during treatment phases.

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

location_facility: Insitut Régional du Cancer de Montpellier

intervention_type: Biological


title: Influenza, Pneumococcal and Diphtheria-tetanus-poliomyelitis Vaccine Coverage in Patients With Primary Sjögren's Syndrome: a Cross-sectional Study

acronym: VACGREN

summary: Evaluation of vaccination coverage for influenza, pneumococcus and DTP in patients with pSS and investigated the reasons for non-vaccination.

ReferenceCitation: Gluthmann J FL, Bonmarin I, Levy-Bruhl D. Enquête nationale de couverture vaccinale, France, janvier 2011. http://www.invs.sante.fr. . 2001.

lead_sponsor: University Hospital, Montpellier


title: Prospective Non-randomized Comparative Study Between IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas of Early Local Stage of Oropharynx

acronym: TORPHYNX

summary: Compare patients' feelings in terms of swallowing ability assessed by the overall score of MD Anderson Dysphagia Inventory (MDADI) 2 years after starting treatment between patients who have been treated with IMRT and those who were treated by transoral surgery for a squamous cell carcinoma of the early stage oropharynx.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Radiation


title: Impact of Gamma-OH on Sleep in ICU Patients Difficult to Wean From Mechanical Ventilation

acronym: GO-SLEEP

summary: The Main objective of the trial is to assess sleep quality with Gamma-OH® in patients difficult to wean from mechanical ventilation in the ICU.

lead_sponsor: Poitiers University Hospital


title: Optimisation of Diffusion Tensor Sequences (DTI) for Study of Lumbar Roots by Magnetic Resonance Imaging (MRI) : a Feasibility Study

acronym: OPTI-DTI

summary: Diffusion tensor imaging (DTI) is a non-invasive MRI technique offering a functional approach that provides morphological information about the microstructures of the nerve roots. DTI is a widely used neuroimaging technique and is a current topic of research in the field of peripheral nerve imaging. The aim of this work is therefore to improve DTI sequences by specifically evaluating the contribution of the multiband technique in healthy volunteers.

lead_sponsor: Lille Catholic University


title: Identification of a New Blood Biomarker for the Diagnosis and Prognosis of Liposarcomas

acronym: ESPACE

summary: The main objective of this project is to identify a new non-invasive biological test for the diagnosis of LPS by measuring circulating serine levels. The current gold standard is the detection of Mdm2 amplification by the FISH.

ReferenceCitation: Burningham Z, Hashibe M, Spector L, Schiffman JD. The epidemiology of sarcoma. Clin Sarcoma Res. 2012 Oct 4;2(1):14. doi: 10.1186/2045-3329-2-14.

ReferenceCitation: Smolle MA, Tunn PU, Goldenitsch E, Posch F, Szkandera J, Bergovec M, Liegl-Atzwanger B, Leithner A. The Prognostic Impact of Unplanned Excisions in a Cohort of 728 Soft Tissue Sarcoma Patients: A Multicentre Study. Ann Surg Oncol. 2017 Jun;24(6):1596-1605. doi: 10.1245/s10434-017-5776-8. Epub 2017 Jan 20.

ReferenceCitation: Chandrasekar CR, Wafa H, Grimer RJ, Carter SR, Tillman RM, Abudu A. The effect of an unplanned excision of a soft-tissue sarcoma on prognosis. J Bone Joint Surg Br. 2008 Feb;90(2):203-8. doi: 10.1302/0301-620X.90B2.19760.

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


title: The Inspire Bio-resource Research Platform for Healthy Aging

acronym: INSPIRE

summary: Since aging is a systemic (not organ-specific) phenomenon, the main objective of Inspire Bio-resource Research Platform for Healthy Aging is to build a comprehensive research platform gathering biological, clinical (including imaging) and digital resources that will be explored to identify robust (set of) markers of aging, age-related diseases and IC evolution. The Inspire Platform will gather data and biospecimens from subjects of different ages (from 30 years or over - no upper limit for age) and functional capacity levels (from robust to frail to disabled) over 10 years.

lead_sponsor: University Hospital, Toulouse


title: The Life and Care of Colorectal Cancer Patients After 65 Years and Their Family

summary: Given a context where patients autonomy respect is important, it is necessary to pay a sustained attention to the patients care and life experiences, as well as the families and relatives of patients with colorectal cancer or patients in remission of colorectal cancer. Thanks to families and relatives data, it will allow to improve the analyses carried out by the "Societal Cancer Observatory" in 2016.


title: Evaluation of Tidal Volume Challenge to Detect Preload-responsiveness in Patients With Acute Respiratory Distress Syndrome (ARDS) During Prone Position

acronym: PR-ARDS-PP

summary: Evaluation of preload responsiveness in ARDS patients during prone position is difficult and only one study showed Trendelenburg manoeuvre can be used in this group of patients. This study aims to investigate whether end-expiratory occlusion test, tidal volume challenge (using the changes in PPV) can be used to evaluate preload responsiveness in patients with ARDS ventilated with a low tidal volume and who underwent a PP session.

status: Active, not recruiting

ReferenceCitation: Ware LB, Matthay MA. The acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1334-49. Review.

ReferenceCitation: Vieillard-Baron A, Matthay M, Teboul JL, Bein T, Schultz M, Magder S, Marini JJ. Experts' opinion on management of hemodynamics in ARDS patients: focus on the effects of mechanical ventilation. Intensive Care Med. 2016 May;42(5):739-749. doi: 10.1007/s00134-016-4326-3. Epub 2016 Apr 1. Review.

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: Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

family: Guérin

full_name: Claude Guérin

given: Claude

family: Reignier

full_name: Jean Reignier

given: Jean

family: Richard

full_name: Jean-Christophe Richard

given: Jean-Christophe

family: Beuret

full_name: Pascal Beuret

given: Pascal

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Mercier

full_name: Emmanuelle Mercier

family: Badet

full_name: Michel Badet

given: Michel

family: Mercat

full_name: Alain Mercat

given: Alain

family: Baudin

full_name: Olivier Baudin

family: Clavel

full_name: Marc Clavel

given: Marc

family: Chatellier

full_name: Delphine Chatellier

given: Delphine

family: Jaber

full_name: Samir Jaber

given: Samir

family: Rosselli

full_name: Sylvène Rosselli

given: Sylvène

family: Mancebo

full_name: Jordi Mancebo

given: Jordi

family: Sirodot

full_name: Michel Sirodot

family: Hilbert

full_name: Gilles Hilbert

given: Gilles

family: Bengler

full_name: Christian Bengler

given: Christian

family: Richecoeur

full_name: Jack Richecoeur

given: Jack

family: Gainnier

full_name: Marc Gainnier

family: Bayle

full_name: Frédérique Bayle

given: Frédérique

family: Bourdin

full_name: Gael Bourdin

given: Gael

family: Leray

title: Prone Positioning in Severe Acute Respiratory Distress Syndrome

ReferenceCitation: Jozwiak M, Monnet X, Teboul JL. Optimizing the circulation in the prone patient. Curr Opin Crit Care. 2016 Jun;22(3):239-45. doi: 10.1097/MCC.0000000000000308. Review.

ReferenceCitation: Jozwiak M, Teboul JL, Anguel N, Persichini R, Silva S, Chemla D, Richard C, Monnet X. Beneficial hemodynamic effects of prone positioning in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2013 Dec 15;188(12):1428-33. doi: 10.1164/rccm.201303-0593OC.

ReferenceCitation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

name: School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy2Department of Emergency and Intensive Care, San Gerardo Hospital, Monza, Italy

name: Departments of Anesthesia and Critical Care Medicine, Keenan Research Centre for Biomedical Science, St Michael’s Hospital4Departments of Anesthesia, Physiology and Interdepartmental division of Critical Care Medicine, University of Toronto, Canada

name: AP-HP, Hôpital Tenon, Unité de Réanimation médico-chirurgicale, Pôle Thorax Voies aériennes, Groupe hospitalier des Hôpitaux Universitaires de l’Est Parisien, Paris, France6UMR 1153, Inserm, Sorbonne Paris Cité, ECSTRA Team, Université Paris Diderot, Pari

name: Department of Medicine, University Health Network and Mount Sinai Hospital9Interdepartmental Division of Critical Care Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada

name: Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Canada11Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada

name: Hospital Universitario de Getafe, CIBER de Enfermedades Respiratorias, Madrid, Spain

name: Istituto di Anestesia e Rianimazione, Università degli Studi di Milano, Ospedale Maggiore, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy

name: Intensive Care Unit, Canberra Hospital, and Australian National University, Canberra, Australia

name: Section of Anesthesiology and Intensive Care, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden

name: Centre for Experimental Medicine, Queen's University of Belfast, Belfast, Northern Ireland17Wellcome-Wolfson Institute for Experimental Medicine, Belfast, Northern Ireland18Regional Intensive Care Unit, Royal Victoria Hospital, Grosvenor Road, Belfast, No

name: SAPIENZA Università di ROMA, Dipartimento di Anestesia e Rianimazione, Policlinico Umberto I, Viale del Policlinico 155, 00161 Roma, Italy

name: Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada21Program in Trauma, Emergency and Critical Care, Sunnybrook Health Sciences Center, Toronto, Canada

name: Division of Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston

name: Department of Anesthesiology and Intensive Care Medicine, University of Leipzig, Liebigstr. 20, D-04103 Leipzig, Germany

name: Keenan Research Center at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, the Interdepartmental Division of Critical Care Medicine, and the Department of Medicine, University of Toronto, Toronto, Canada

name: for the LUNG SAFE Investigators and the ESICM Trials Group

repository_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Guérin C, Beuret P, Constantin JM, Bellani G, Garcia-Olivares P, Roca O, Meertens JH, Maia PA, Becher T, Peterson J, Larsson A, Gurjar M, Hajjej Z, Kovari F, Assiri AH, Mainas E, Hasan MS, Morocho-Tutillo DR, Baboi L, Chrétien JM, François G, Ayzac L, Chen L, Brochard L, Mercat A; investigators of the APRONET Study Group, the REVA Network, the Réseau recherche de la Société Française d'Anesthésie-Réanimation (SFAR-recherche) and the ESICM Trials Group. A prospective international observational prevalence study on prone positioning of ARDS patients: the APRONET (ARDS Prone Position Network) study. Intensive Care Med. 2018 Jan;44(1):22-37. doi: 10.1007/s00134-017-4996-5. Epub 2017 Dec 7.

ReferenceCitation: Wheeler AP, Bernard GR. Acute lung injury and the acute respiratory distress syndrome: a clinical review. Lancet. 2007 May 5;369(9572):1553-1564. doi: 10.1016/S0140-6736(07)60604-7. Review.

ReferenceCitation: Chiumello D, Brochard L, Marini JJ, Slutsky AS, Mancebo J, Ranieri VM, Thompson BT, Papazian L, Schultz MJ, Amato M, Gattinoni L, Mercat A, Pesenti A, Talmor D, Vincent JL. Respiratory support in patients with acute respiratory distress syndrome: an expert opinion. Crit Care. 2017 Sep 12;21(1):240. doi: 10.1186/s13054-017-1820-0. Review.

ReferenceCitation: Roch A, Guervilly C, Papazian L. Fluid management in acute lung injury and ards. Ann Intensive Care. 2011 May 30;1(1):16. doi: 10.1186/2110-5820-1-16.

ReferenceCitation: Teboul JL, Monnet X, Chemla D, Michard F. Arterial Pulse Pressure Variation with Mechanical Ventilation. Am J Respir Crit Care Med. 2019 Jan 1;199(1):22-31. doi: 10.1164/rccm.201801-0088CI.

ReferenceCitation: Yonis H, Bitker L, Aublanc M, Perinel Ragey S, Riad Z, Lissonde F, Louf-Durier A, Debord S, Gobert F, Tapponnier R, Guérin C, Richard JC. Change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in the prone position under protective ventilation. Crit Care. 2017 Dec 5;21(1):295. doi: 10.1186/s13054-017-1881-0.

ReferenceCitation: Sibbald WJ, Paterson NA, Holliday RL, Baskerville J. The Trendelenburg position: hemodynamic effects in hypotensive and normotensive patients. Crit Care Med. 1979 May;7(5):218-24.

ReferenceCitation: Geerts BF, van den Bergh L, Stijnen T, Aarts LP, Jansen JR. Comprehensive review: is it better to use the Trendelenburg position or passive leg raising for the initial treatment of hypovolemia? J Clin Anesth. 2012 Dec;24(8):668-74. doi: 10.1016/j.jclinane.2012.06.003. Review.

ReferenceCitation: Myatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.

ReferenceCitation: Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.


title: Language and Brain Rhythms

acronym: LaBRhythms

summary:
For humans and other animals, predicting the timing of sensory events is essential for their daily behavior. Importantly, natural sensory stimulation (such as movements, music, or speech) can present temporal regularities allowing for temporal prediction of incoming sensory information. For instance, individuals can easily predict in time the next step of a walker, or the next beat of a song based on the rhythm. The phenomenon of temporal prediction has for now only been investigated experimentally in deterministic scenarios, i.e. when the duration between two sensory events is fixed, or when stimuli present a regular beat. The objective of this project is to understand how we process more natural, hence more complex forms of temporal regularities, and how individuals make inferences on the timing of sensory events based on past temporal statistics of sensory information. This is particularly important for speech processing, considering that speech is an acoustic signal that is known to possess some form of temporal regularity, and yet is not purely rhythmic nor does have a deterministic temporal structure. Temporal regularities are specific to each spoken language, and both native and non-native language listeners are known to use temporal acoustic cues during speech listening. This affects speech comprehension and has a strong impact during language learning. Hence, understanding the processing of temporal regularities in speech can help improve language abilities in first and second language learners.

The project is composed of three experiments. The first behavioral experiment will investigate how auditory perception is affected by the temporal statistics of past sensory information using artificial stimuli. The second axis will investigate the neural mechanisms underlying auditory timing processing with electroencephalography (EEG). The last Magnetoencephalography (MEG) experiment will test the role of temporal statistics in an ecological setting, namely speech listening. The project will thus provide strong theoretical advances as it will give new insights on brain mechanisms for the processing of complex temporal information in audition and speech, and their role in language comprehension. It will also provide methodological advances. Specifically, the project will contribute to the development and validation of cutting-edge methods in MEG. Namely, it will aim at creating new tools to investigate the neural correlates of auditory and speech processing with an unprecedented temporal and spatial resolution.

location_facility: Centre de Recherche en Neuroscience de Lyon


title: Evaluation of the Impact of Lesions of the Motor and Proprioceptive Brain and Pan-medullary Pathways on Their Clinically and Electrophysiologically Assessed Function in Multiple Sclerosis

acronym: MS-TRACTS

summary:
Multiple Sclerosis (MS) is the most common acquired neurological disease leading to disability, especially ambulatory, in young adults. To date, the correlation between the number or volume of white matter lesions seen on conventional MRI and the degree of disability of patients remains low to moderate. This phenomenon is known as the "clinical-radiological paradox".

In this new project, we hypothesize that an evaluation of the corticospinal pathways including their thoracic medullary portion, as well as taking into account the severity of the lesions using quantitative MRI, will allow the investigators to refine the correlation with ambulatory disability in MS patients. We will complete the evaluation of motor pathways with those of the proprioceptive pathways also strongly involved in ambulation.

lead_sponsor: Rennes University Hospital


title: Pilot Study on the Contribution of Molecular Analysis of Endometrial Cancers: Reliability, and Interest of Circulating Tumor DNA

summary:
The recent histo-prognostic molecular discoveries of the TCGA (The Cancer Genome Atlas) have shed new light on the classification of endometrial carcinomas.

After carrying out different types of high-throughput molecular analyzes on 373 endometrial carcinomas of different histological types, 4 major tumor subtypes could be identified, each with a different survival profile (the "ultra-mutated" group with POLE mutations, the "hypermuted" group with microsatellite instability (MSI), the "low number of copies" group, and the "high number of copies" group).

This histomolecular classification is not yet directly transposable to clinical practice and tumor genetic characteristics have not had any direct therapeutic impact to date.

The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.

ipd_sharing_description:
Analyzes will be only realised on biology molecular plateform at CHU Poitiers on a first time.

If we failed to obtain results we perhaps send plasma in other laboratory


title: Autoantibodies Prevalence and Their Related-diseases During Checkpoint Inhibitor Treatment

summary:
The use of Checkpoint inhibitors (ICIs) is rapidly expanding to the treatment of many cancer types. Autoimmunity and clinical autoimmune diseases represent adverse events of ICIs with variable severity and consequences. Clinical trials using ICIs have largely excluded patients with preexisting autoimmune diseases but the rate of autoimmune flares has been reported to be high in patients with preexisting autoimmune diseases in retrospective cohort studies. Moreover numerous retrospective cases and series reported ICI-related autoimmune diseases in patients without any previous autoimmune event.

To date, no study has prospectively evaluated the rate of biological and clinical autoimmunity in patients. Moreover, guidelines concerning autoantibodies monitoring in patients are subject of debate.

lead_sponsor: CHU de Reims


title: Interest of Rocamed Urethral Device for Treatment of Acute or Chronic Urinary Retention in Males

acronym: RUD

summary: Prospective non randomized study of the feasibility of the insertion of Rocamed urethral device by hand manipulation, i.e., without use of cystoscopy, sonography or fluoroscopy. Patients with an acute urinary retention treated by Foley catheterization in the Emergency department have a few days later a trial of Foley removal in the ambulatory unit of the Urology department. In case of failure of the Foley removal trial, i.e., recurrence of urinary retention, patients will be proposed either the insertion of a new Foley or insertion of the urethral device. After signature of an informed consent, insertion of the urethral device will be performed after instillation in the urethra of a local anesthetic gel. Device insertion success rate and complications will be studied. The device will be left in place for one month. Tolerance and complications during the month with the device in place will be studied. At one month the device will be removed: the ease of retrieval of the device and complications will be studied. Patient and doctor satisfaction with the urethral device will be compared to patient and doctor satisfaction with the Foley.

location_facility: Service d'Urologie Hôpital Lyon Sud, Hospices Civils de Lyon


title: Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials

acronym: HYPOT

summary:
Somatosensory evoked potentials corresponds to a neurophysiological exam that studies the functioning of the sensitivity pathways. It is often complementary to the imaging examination (MRI or scanner) and the electroneuromyogram which studies only the peripheral part of the sensory and motor pathways while the somatosensory evoked potentials are interested in their central and peripheral component.

The studied information are the potentials generated in the nervous system by the presentation of sensory stimulation. The examination makes it possible to study conduction times which will be defined as normal or pathological according to standards established on control subjects. Their indication is multiple: study of the repercussions of cervical osteoarthritis, specify the diagnosis of certain neuropathies, study of the conduction pathways at the medullary level in the event of trauma or inflammatory or other lesion.

In our study, the investigators will only be interested in the somatosensory evoked Potentials.

A study has shown that hypnotic suggestions to reduce the unpleasantness of pain triggered by thermal stimulation lead to a selective reduction of activity in the anterior cingulate cortex without modifying the activation of the somesthetic cortex.

Pain is, like all sensory stimulation, subject to the influences of attention, anticipation, mental imagery, previous conditioning. The fronto-cingular areas, activated by analgesics such as morphine, or by cortical stimulation are the same as those used by non-drug techniques such as hypnosis.

Therapeutic hypnosis is "a relational experience bringing into play physiological and psychological mechanisms allowing the individual to live better, reduce or eliminate an acute or chronic painful pathology" (Definition of Doctor Jean Marc Benhaiem).

The study of somatosensory evoked Potentials is a long examination (90 to 120 minutes), which can be uncomfortable for the patient (patient lying down, immobile and relaxed), not having to contract his muscles, especially if he is already painful due to his pathology or if it is difficult for him to remain motionless in the supine position. It is indeed necessary to average around 600 to 1000 responses (number of averages) to a small electrical simulation on each member studied.

The muscular contractions of an anxious and/or painful patient prolong the duration of the examination or even disturb the results, to the point of making it impossible to interpret the examination.

To our knowledge, hypnosis has already been used to improve muscle relaxation and reduce anxiety and pain during electromyograms, but hypnosis has never been used to improve the outcome of somatosensory evoked Potentials. Furthermore, if hypnosis modifies certain late cortical waves, it does not cause modification of the early waves and therefore does not disturb the results expected in our clinical practice.

ReferenceCitation: Del Percio C, Triggiani AI, Marzano N, De Rosas M, Valenzano A, Petito A, Bellomo A, Soricelli A, Cibelli G, Babiloni C. Subjects' hypnotizability level affects somatosensory evoked potentials to non-painful and painful stimuli. Clin Neurophysiol. 2013 Jul;124(7):1448-55. doi: 10.1016/j.clinph.2013.02.008. Epub 2013 Apr 25.

ReferenceCitation: Fiorio M, Recchia S, Corrà F, Tinazzi M. Behavioral and neurophysiological investigation of the influence of verbal suggestion on tactile perception. Neuroscience. 2014 Jan 31;258:332-9. doi: 10.1016/j.neuroscience.2013.11.033. Epub 2013 Nov 27.

family: Fiorio

full_name: M. Fiorio

given: M.

family: Recchia

full_name: S. Recchia

given: S.

family: Corrà

full_name: F. Corrà

given: F.

family: Tinazzi

full_name: M. Tinazzi

bso_classification: Biology (fond.)

journal_name: Neuroscience

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Rainville P, Duncan GH, Price DD, Carrier B, Bushnell MC. Pain affect encoded in human anterior cingulate but not somatosensory cortex. Science. 1997 Aug 15;277(5328):968-71.

ReferenceCitation: Faymonville ME, Laureys S, Degueldre C, DelFiore G, Luxen A, Franck G, Lamy M, Maquet P. Neural mechanisms of antinociceptive effects of hypnosis. Anesthesiology. 2000 May;92(5):1257-67.

ReferenceCitation: Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90.

ReferenceCitation: Stoelb BL, Molton IR, Jensen MP, Patterson DR. THE EFFICACY OF HYPNOTIC ANALGESIA IN ADULTS: A REVIEW OF THE LITERATURE. Contemp Hypn. 2009 Mar 1;26(1):24-39.

ReferenceCitation: Vanhaudenhuyse A, Boveroux P, Boly M, Schnakers C, Bruno MA, Kirsch M, Demertzi A, Lamy M, Maquet P, Laureys S, Faymonville ME. [Hypnosis and pain perception]. Rev Med Liege. 2008 May-Jun;63(5-6):424-8. French.

ReferenceCitation: Slack D, Nelson L, Patterson D, Burns S, Hakimi K, Robinson L. The feasibility of hypnotic analgesia in ameliorating pain and anxiety among adults undergoing needle electromyography. Am J Phys Med Rehabil. 2009 Jan;88(1):21-9. doi: 10.1097/PHM.0b013e31818e00bd.

family: Slack

full_name: David Slack

given: David

family: Nelson

full_name: Lonnie Nelson

given: Lonnie

family: Patterson

full_name: David Patterson

family: Burns

full_name: Stephen Burns

given: Stephen

family: Hakimi

full_name: Kevin Hakimi

given: Kevin

family: Robinson

full_name: Lawrence Robinson

given: Lawrence

journal_name: American Journal of Physical Medicine & Rehabilitation

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: The Feasibility of Hypnotic Analgesia in Ameliorating Pain and Anxiety Among Adults Undergoing Needle Electromyography

ReferenceCitation: De Pascalis V, Magurano MR, Bellusci A. Pain perception, somatosensory event-related potentials and skin conductance responses to painful stimuli in high, mid, and low hypnotizable subjects: effects of differential pain reduction strategies. Pain. 1999 Dec;83(3):499-508. doi: 10.1016/S0304-3959(99)00157-8.

family: De Pascalis

full_name: Vilfredo De Pascalis

given: Vilfredo

family: Magurano

full_name: Maria R Magurano

given: Maria R

family: Bellusci

full_name: Anna Bellusci

given: Anna

title: Pain perception, somatosensory event-related potentials and skin conductance responses to painful stimuli in high, mid, and low hypnotizable subjects: effects of differential pain reduction strategies ☆


title: Cetuximab Therapeutic Drug Monitoring in Squamous Cell Carcinoma Head and Neck Cancer Patients: Determination of the Predictive Value Exposure Levels Through a Single Arm Multicentric Study

acronym: CETUXIMAX

summary:
Only about 30 percent of cancer patients have a clinical benefit upon cetuximab administration. Pilot studies in colorectal and head and neck cancer patients have suggested that cetuximab pharmacokinetics (PK), i.e. clearance values, could impact on clinical outcomes such as survival.

Determining cetuximab plasma clearance requires sophisticated PK modeling using population approaches, thus making it difficult to implement in routine clinical practice. In addition, all the preliminary studies with cetuximab were based upon Elisa determination of cetuximab plasma levels, an analytical method that fails to meet the requirements of daily practice in laboratories performing therapeutic drug monitoring. This pilot study aimed at evaluating the mass spec method analytical performance as part of a " real life " study, evaluating the inter-patient variability of exposure levels in head and neck cancer patients, and establishing a putative link between those exposure levels and clinical outcome. Results from 25 patients fully confirmed the analytical performance of the mass spec method (e.g., lack of matrix effect, acceptable sensitivity to monitor trough levels, lack of impact of sampling processing or freezing/thawing cycles). In addition, a large inter-individual variability (Superior at 50 percent) was observed, both in the peak concentrations (Cmax) and in trough levels (Cmin). Most interestingly, despite the limited number of patients enrolled, a statistically significant association was shown between exposure levels (i.e. calculated AUC) and clinical outcome (DCR). This difference was even more significant on Cmin, thus suggesting that simple trough levels monitoring could help to predict efficacy. Further analysis on survival showed that although not statistically significant, a trend towards longer both progression-free survival and overall survival was observed in the subgroup of patients with higher trough levels. In particular, 3-year survival was 29 percent and 0 percent in the subgroups with high and low trough concentrations, respectively (unpublished data).

Beyond tumoral factors, these preliminary data suggest that cetuximab Cmin levels could be a predictive marker of therapeutic efficacy and that simple therapeutic drug monitoring could help to forecast clinical outcome or enable dosage adaptation.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Impact of Follow-up in Subjects With Obesity and Food Addiction

acronym: ADDICTAL

summary: Obesity is a chronic disease. Its prevalence, which is constantly increasing, as well as the morbidity and mortality caused, require the development of new treatments, particularly for associated eating disorders. Indeed, it has been shown that a participation of abnormalities of food addiction type behaviour was frequently found in patients hospitalized for obesity (25% of patients). These disorders require specific management if you want to achieve a good weight result. The aim of the study is to compare the weight evolution of patients with addiction-type disorder (addict) versus those without addiction (non-addict) as well as the management modalities.

location_facility: Service Endocrinologie, Hôpital Lyon Sud,


title: The CardioPostCovid Study: Cardiovascular Consequences After COVID-19

summary:
The occurrence of cardiovascular complications in SARS-CoV-2 infections appears to be more frequent than in other viral respiratory infections, probably due to a singular pathophysiology of this coronavirus.

The lack of characterization of cardiovascular damages linked to Covid-19 could have medium and long-term consequences on the prognosis of patients. This problematic could lead to a second major public health problem linked to Covid-19 and it is therefore crucial to keep monitoring and screening patients at risk.

In this context of emerging infectious diseases, of poorly characterized cardiovascular damages during infection and of absence of data on the long-term evolution of the infection, the investigators propose to carry out a prospective and observational cohort study focused on the evaluation and the systematic cardiovascular follow up of patients who survived an episode of Covid-19, regardless of their cardiovascular profiles.


title: Pelvic Ring Fractures: New Analysis Method and Treatment Decision Algorithm

acronym: BASSINJO

summary:
Pelvic ring fractures are common and often the result of high energy trauma but also sometimes of lower energy trauma in older patients. A good classification and description of the fracture is essential to the choice of treatment.

The classifications used to describe these fractures are numerous (Tile modified AO, Young and Burgess, Letournel, Rommens) and of a descriptive order more or less depending on the lesion mechanism allowing some to orient the surgical reduction technique. However, none of them helps with the choice of surgical or functional treatment, which is currently based on obvious notions of instability and / or displacement of lesions and, by habit, all different services.

In addition, the complexity of these classifications leads to poor reproducibility of these.

A new method for analyzing unitary lesions has been developed in the Orthopedic Surgery department of the Paris Saint-Joseph Hospital Group with a rating system which determines the indication according to the score.

Teaching this new method of analyzing pelvic ring fractures would simplify decision making between surgical and functional treatment.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia

acronym: HYPOTHALNET

summary:
Food intake is a motivated behaviour that consists of seeking, selecting and ingesting nutritional resources from the environment. Its main function is therefore, depending on these conditions, to ensure the supply, in adequate quantities, of the energy and biochemical substrates necessary for the proper functioning and need of the body. Thus, in addition to maintaining the body's fat mass level stable, dietary behaviour is part of the energy homeostasis system and is thus regulated and maintained by the central nervous system.

Although diet regulation involves several brain regions, the way in which these different regions communicate with each other and influence each other to orchestrate appropriate eating behaviour is not yet fully characterized. Among the structures of this network, the hypothalamus, a small structure (less than 1 cm3 in humans) composed of several nuclei such as the lateral hypothalamus, the arched nucleus or the lateral tuberal nucleus plays a crucial role.

The investigators propose to use ultra high field (7T) magnetic resonance imaging equiping the CEMEREM (CHU Timone, APHM, Marseille) to better characterize the role of this crucial small structure in food intake networks in order to better understand the impact of these structural and functional disorders observed in patients with anorexia nervosa and obesity compared to a control population without eating behaviour disorders.


lead_sponsor: University Hospital, Tours

acronym: EVAPOR

type: EudraCT Number

source: euctr

title: Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab (EVAPOR Study)

summary: Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax® at least two months later than Prevenar®. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%).


title: Changes in Physical and Sports Activity, Anxiety and Sleep Patterns Following the Containment Period Imposed by the COVID-19 Pandemic in Patients With Chronic Medical Conditions and in Healthy Athletes.

acronym: PhysiCOVID

summary: In the context of the containment imposed by the COVID-19 pandemic and taking into account the numerous restrictions imposed, the practice of physical and sports activities (PSA) could be reduced by general population and sports population. While the practice of regular physical activity (PA) is prescribed and widely recognized as effective for the management of many chronic conditions and that regular participation in sports (SA) reduces the risk of injury and cardiac accidents- vascular disease in sports subjects, the reduction in regular physical activity levels in the wake of the period of confinement is likely to induce a medical risk in connection with the resumption of PSA.


title: Analysis of the Glycemic Profile of People Suffering From Compulsive Eating Disorders Aiming to Offer an Innovative Nutritional Approach

acronym: GLUCOPULSE

summary: Eating Disorders (ED) are a major public health problem. Current care remains only partially effective and the pathophysiology of the disorders remains to be deepened. With regard to compulsive ED (bulimia and binge eating disorder), our clinical experience suggests that one of the major triggers for crisis may be related to glycemia. In fact, bulimia could be considered as a vicious circle where the binge eating disorder is going to be followed by a food restriction in order to control weight , putting the subject in a situation of "energy deficiency" which will favor the emergence of new crises . Technological advances have resulted in the emergence of new measuring devices, such as "tracking", which records continuous glycemia, which would allow us to explore these clinical hypotheses.


title: Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients

acronym: SYSTOE-HAIDI

summary:
Evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients

Hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (FAV) of hemodialysis in the upper limb. The diagnostic and therapeutic stakes are major as it concerns the functional prognosis of the hand and, to a lesser extent, vascular access for hemodialysis.

In some cases, the diagnosis of ischemic hemo-hijacking is evident, in other cases, the ischemic condition appears to be rather the result of uncompensated arteriatory of the upper limb or limbs. Echo-doppler exploration is usual for assessing vascular access but without validated formal criteria for arterial disease in the upper limbs, with fistula flow calculation and analysis of FAV hemodynamics. Compression manoeuvres on or under the FAV can also be performed. The pressures of the digital arteries are also indicated with non-consensual values found in the literature for the diagnosis of digital ischemia but with varying tools in terms of collection of measurements.

The main objective of this study is to collate the characteristics of arterial condition of the upper limbs of medium or severe renal patients, medium- or short-term candidates for kidney dialysis. The data collected will match the data of the arterial echodoppler as well as measures of pressures doppler laser and plethysmography. Candidates for dialysis tend to be older and polyvascular. A better assessment of the vascular condition of their upper limbs, including the diagnosis of advanced arterial disease, could eventually guide the choice of type of dialysis (compared to an indication of FAV).

lead_sponsor: University Hospital, Grenoble


title: Study Pilot - Hybrid EEG/fMRI Neurofeedback in Depressed Patients

acronym: NEUROFEEDEP

summary:
Cognitive impairment is a common residual symptom after a depressive episode and expose patients to a risk of relapsing or therapeutic resistance.

Neurofeedback (using ElectroEncephaloGraphy - EEG or functional Magnetic Resonance Imaging - fMRI) allows patients to self-regulate their cerebral activity, which is supposedly provided through an intelligible and motivating feedback.

Recent results exhibited clinical improvement in depressed patients who underwent a fMRI neurofeedback protocol targeting the amygdala. Furthermore, prefrontal alpha activity was temporally correlated to variations of the BOLD signal in the amygdala. Simultaneous fMRI/EEG neurofeedback is hypothesized to potentialize its antidepressant effect.

Our objective will be to test this assumption by conducting a double-blind randomized trial, and to prove the superiority of bimodal fMRI/EEG neurofeedback over fMRI neurofeedback alone in depressed patients.

An original visual feedback will be provided and validated beforehand by a pilot study.


title: Study of the Longitudinal Changes in Perception and Cognition Occurring During a Meditation Retreat

acronym: LONGIMED

summary: This study aims at assessing neuro-behavioral changes occuring during an intensive ten days meditation retreat. The investigator will study changes in tactile, auditory and pain perceptions as well as changes in cognitive and affective mental contents and their neural markers, as measured by self-reports, EEG event-related potentials, and functional connectivity of resting state fMRI. He will recruit healthy participants with a prior meditation experience. They will be randomly assigned to two groups, one active group who will undergo measurements just before, during and 3 weeks after the retreat. The other group will serve of control for task habituation, control participants will undergo the same measurements, equally spaced in time, but before the retreat. The main hypothesis is that meditation training strengthens meta-awareness, attention capacities resulting in enhanced bodily- and self-awareness during sensory perception and emotion regulation during pain.


title: Scapular Positioning in Standing Position Using Sonography

summary: The objective of this study is to analyse the positioning of the scapula in standing position and compared to the supine position (CT scan) in 3 dimensions (3 rotations of the scapula) using a non-radiant, portable system, combining an ultrasound probe with marker and a camera integrated into a Tablet for the three-dimensional location of the marker (probe).

lead_sponsor: University Hospital, Brest


title: Socio-demographic Factors and Emergence of the COVID 19 Epidemic in the City of Nice in 2020

summary: Descriptive analysis of the appearance of the first cases of COVID 19 diagnosed in the city of Nice. Analysis of the association of socio-demographic factors with the viremia attack rate according to the district of residence.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: RESting-state Functional MRI in Patients With Optic Neuritis for ANticipation of reCovEry

acronym: RESONANCE

summary:
When patients arrive in the waiting room of the MRI department, patients will be given the briefing note explaining the purpose of the study and how it is going. During the consultation, the radiologist will check the inclusion and non-inclusion criteria, and will take the time to answer all of the patient's questions about the study. If the patient agrees to participate in the research, the investigating doctor will obtain his consent.

The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional sequence of f-mRI, called resting state, and performed before injection of gadolinium contrast agent.

A consultation with an ophthalmologist will also be carried out the same day, at the Adolphe de Rothschild Foundation. During this visit, an OCT examination (optical coherence tomography), a visual field as well as the measurement of visual acuity will be carried out, in accordance with the treatment usually practiced at the Adolphe de Rothschild Foundation.

The subjects of the control group who agreed to participate will benefit from an MRI examination which will include, in addition to the sequences planned for these patients according to their indications, the two non-injected sequences which will be performed on patients with suspected NO.

The possible existence of visual problems in the subjects of the control group will also be asked to them by interrogation. No eye exams or follow-up visits are planned, and control group participation will end after the MRI scan.

Patients with NO will be seen in consultation by an ophthalmologist during a follow-up visit approximately 6 months after diagnosis. During this consultation, an OCT, a visual field and the measurement of visual acuity will be performed. This visit and the examinations carried out correspond to the usual care of patients suffering from NO and followed at the Adolphe de Rothschild Foundation Hospital.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild