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


type: Other Identifier

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

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Lille

lead_sponsor_type: academique

status_simplified: Ongoing


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.

ipd_sharing: No

lead_sponsor: Nantes University Hospital


title: Does the Needle-pilot Device Improve the Success of Vascular Catheterization Compared to the Classical Ultrasound-guided Technique

acronym: NEEDLE-VISIO

summary: Real-time ultrasound guidance for central venous catheter catheterism is recommended in order to reduce complication, in particular for internal jugular site1. Nevertheless, the usefulness of ultrasound guidance for subclavian approach remains controversial, in particular because needle visualisation is more complex as compared to jugular site2,3. New magnetic devices (Needle-pilotTM device, Samsung Healthcare) could theoretically allow a better needle visualisation and a better success rate. The investigators hypothesize that such device could improve the feasibility of subclavian catheterism. As this device has not been evaluated in patients, the investigators decided to perform a simulation study on a human torso mannequin. This methodology has been already used by Vogel et al in 20154. The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilot™ device.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for subclavian or femoral vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1:CD011447. doi: 10.1002/14651858.CD011447. Review.

ReferenceCitation: Jiang L, Zhang M, Ma Y. Ultrasound-Guided Subclavian Vein Catheterization: A Systematic Review and Meta-Analysis: Several Facts Need To Be Noticed. Crit Care Med. 2015 Oct;43(10):e474-5. doi: 10.1097/CCM.0000000000001071.

ReferenceCitation: Vogel JA, Haukoos JS, Erickson CL, Liao MM, Theoret J, Sanz GE, Kendall J. Is long-axis view superior to short-axis view in ultrasound-guided central venous catheterization? Crit Care Med. 2015 Apr;43(4):832-9. doi: 10.1097/CCM.0000000000000823.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes, Hôpital Universitaire Carémeau

intervention_type: Device

status_simplified: Completed


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.

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

intervention_type: Procedure


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.

ipd_sharing: Undecided

lead_sponsor: Nestlé

intervention_type: Other

lead_sponsor_type: industriel


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

study_start_date_type: Anticipated

status: Unknown status

primary_purpose: Treatment

lead_sponsor: CHU de Reims

intervention_type: Drug

status_simplified: Unknown


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.


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.

time_perspective: Retrospective

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.

primary_purpose: Diagnostic

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


title: Evaluation of the Impact of Customization of Total Knee Prostheses on Patient Satisfaction and Functional Outcome of Arthroplasty.

acronym: ESPACE

summary: The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty.

status: Not yet recruiting


title: SARS-CoV2 (COVID-19) Diagnosis in Human Saliva by MALDI-TOF MS Profiling

acronym: CoviDiagMS

summary:
Since March 2020, SARS-CoV2 virus (nCoV19; COVID-19) is considered pandemic. Its high rate of spread and infection in the human population and the lack of effective and validated treatment have led the authorities of several countries to confine their populations to slow the spread of COVID-19. As part of the management of this health crisis, the screening of individuals is essential in order to isolate "infected cases". These screening tests are currently performed on nasopharyngeal swabs using RT-PCR for the detection of viral RNA. Although sensitive and specific, these tests remain relatively long (2-5 hours), expensive and the strong international demand for nucleic extraction kits and enzymes are factors limiting the implementation of widespread screening (problem of supply of swabs, molecular biology consumables).

In order to prevent the risks of a shortage of screening means, we propose to develop an innovative alternative strategy, PCR-free, based on the detection of specific protein signatures in human saliva by MALDI-TOF MS profiling. MALDI-TOF MS profiling is a method used in routine diagnostics by microbiology laboratories for the identification of microorganisms. MALDI-TOF MS profiling has been successfully used to classify individuals according to their infectious status (oral pathologies) based on the analysis of their saliva, but also as a tool for the identification of respiratory viruses from cell culture supernatants. In addition, we have expertise and skills in the field of MALDI-TOF MS profiling and have implemented new strategies to improve the quality of profiles and their analysis, particularly in the context of entomological and vector identification projects. Finally, recent Chinese studies have reported that COVID-19 was detectable in saliva by RT-PCR.

The main objective of this study is to develop a test based on the MALDI-TOF profiling method to detect individuals infected with SARS-CoV2 from saliva sample.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Laveran

intervention_type: Biological


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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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: Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age.

acronym: TDR-Arthrite

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

summary:
The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm".

The aims of this study are:

To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU
To identify specific risk factors for AKI
To explore pathophysiologic mechanism of AKI during COVID-19 infection

lead_sponsor: Hospices Civils de Lyon

location_facility: Intensive care units attached to the Hospices Civils de Lyon (HCL)


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: The Use of Neuromuscular Blockade Monitor as a Strategy for Neuromuscular Blockade Agents Saving in ICU COVID-19 Patients

acronym: TOF-COVID

summary:
This is a retrospective case-controlled study of the effect of the use of a neuromuscular blockade (NMB) monitor on the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.

The use of NMB agents during mechanical ventilation in patients with acute respiratory distress syndrome (ARDS) improves respiratory support conditions and reduces mortality. In the context of COVID-19 pandemic, patients with severe forms of the disease hospitalized in intensive care units (ICU) benefit from prolonged mechanical ventilation with frequent use of NMB agents. Large amount of such patient admitted in a short time has led to a shortage of NMB agents, particularly cisatracurium.

The use of NMB monitors (for example - Train of Four (TOF)) is a well-established practice in general anesthesia. There is no recommendation for the use of NMB monitor in ICU patients available up to date. However, in the attempt to reduce the consumption of NMB agents a NMB monitoring was used in ICU patients during the COVID-19 pandemic at university hospitals of Hospices Civil de Lyon, with the endorsement of the local College of Anesthetists.

The aim of our study is to evaluate if the use of a NMB monitor decreases the consumption of NMB agents in patients under mechanical ventilation in the context of COVID-19.

location_facility: Department of Anesthesiology and Intensive Care Medicine, Hôpital de la Croix Rousse, Hospices Civils de Lyon


title: Chronic Obstructive Pulmonary Disease (COPD) and Advance Directives

acronym: DIABPCO

summary: The aim of this study is to evaluate if the participation of COPD patients to a workshop on advance directives increases the number of patients who write them.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Les Cèdres SSR Pneumologie / Réhabilitation Respiratoire

intervention_type: Behavioral


title: Development of a Monocentric and Prospective Clinical and Biological Database in Sarcoma

acronym: BCBSarcome

summary: A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical data to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to Sarcoma

ReferenceCitation: Ducimetière F, Lurkin A, Ranchère-Vince D, Decouvelaere AV, Péoc'h M, Istier L, Chalabreysse P, Muller C, Alberti L, Bringuier PP, Scoazec JY, Schott AM, Bergeron C, Cellier D, Blay JY, Ray-Coquard I. Incidence of sarcoma histotypes and molecular subtypes in a prospective epidemiological study with central pathology review and molecular testing. PLoS One. 2011;6(8):e20294. doi: 10.1371/journal.pone.0020294. Epub 2011 Aug 3.

ReferenceCitation: Mastrangelo G, Coindre JM, Ducimetière F, Dei Tos AP, Fadda E, Blay JY, Buja A, Fedeli U, Cegolon L, Frasson A, Ranchère-Vince D, Montesco C, Ray-Coquard I, Rossi CR. Incidence of soft tissue sarcoma and beyond: a population-based prospective study in 3 European regions. Cancer. 2012 Nov 1;118(21):5339-48. doi: 10.1002/cncr.27555. Epub 2012 Apr 19.

ReferenceCitation: Crago AM, Singer S. Clinical and molecular approaches to well differentiated and dedifferentiated liposarcoma. Curr Opin Oncol. 2011 Jul;23(4):373-8. doi: 10.1097/CCO.0b013e32834796e6. Review.

ReferenceCitation: Lokka S, Scheel AH, Dango S, Schmitz K, Hesterberg R, Rüschoff J, Schildhaus HU. Challenging dedifferentiated liposarcoma identified by MDM2-amplification, a report of two cases. BMC Clin Pathol. 2014 Jul 28;14:36. doi: 10.1186/1472-6890-14-36. eCollection 2014.

ReferenceCitation: Marine JC, Lozano G. Mdm2-mediated ubiquitylation: p53 and beyond. Cell Death Differ. 2010 Jan;17(1):93-102. doi: 10.1038/cdd.2009.68. Review.

ReferenceCitation: Ray-Coquard I, Blay JY, Italiano A, Le Cesne A, Penel N, Zhi J, Heil F, Rueger R, Graves B, Ding M, Geho D, Middleton SA, Vassilev LT, Nichols GL, Bui BN. Effect of the MDM2 antagonist RG7112 on the P53 pathway in patients with MDM2-amplified, well-differentiated or dedifferentiated liposarcoma: an exploratory proof-of-mechanism study. Lancet Oncol. 2012 Nov;13(11):1133-40. doi: 10.1016/S1470-2045(12)70474-6. Epub 2012 Oct 17.

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


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.

lead_sponsor: Poitiers University Hospital


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.

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.

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.

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.

ReferenceType: derived

ReferenceCitation: Shi R, Ayed S, Moretto F, Azzolina D, De Vita N, Gavelli F, Carelli S, Pavot A, Lai C, Monnet X, Teboul JL. Tidal volume challenge to predict preload responsiveness in patients with acute respiratory distress syndrome under prone position. Crit Care. 2022 Jul 18;26(1):219. doi: 10.1186/s13054-022-04087-w.

lead_sponsor: Bicetre Hospital


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 four 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 3) and EG (rxperiement 4) 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.

primary_purpose: Basic Science

location_facility: Centre de Recherche en Neuroscience de Lyon


title: Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Secondary Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.

acronym: RMR

summary: Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240 patients with a reconstruction with latissimus dorsi flap, or in immediate reconstruction, or during secondary reconstruction.

design_allocation: Non-Randomized

lead_sponsor: Institut Paoli-Calmettes


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: Pain Monitoring After Breast Biopsy: Benefit of E-health

acronym: BIO-PSY

summary:
Each year, approximately 1500 breast biopsies (1000 microbiopsies and 500 macrobiopsies) are performed in the radiologic department of the Montpellier Cancer Institute (ICM). This exam, which is relatively easy for the radiologist, can however lead to major anxiety for patients. Indeed, previous studies show that about 50% of women undergoing a breast biopsy have significant anxiety affects.

Anxiety associated with the risks of biopsy, potential breast cancer diagnosis and/or lack of routine sedation procedures increase patient concerns. Distress prior to biopsy is associated with greater pain and discomfort during the procedure. The psychological distress that persists after the biopsy is related to a worse psychological management of side effects of the biopsy breast (e.g., sensitivity, skin irritation).

Limiting apprehension, worry and anxiety induced by the uncertainty linked to the biopsy results and the biopsy-related pain should be an integral part of the medical care through the patient follow-up during, after and until the diagnosis is announced. In light of these challenges, new alternative methods are emerging to enhance patient knowledge, develop procedural skills, improve confidence and mitigate procedural anxiety. However, to our knowledge, few methods have been developed during this period of 'waiting-time'. Currently, only care instructions and a consultation to announce the results (about 10 days after the procedure) are proposed to patients at the end of biopsy. Patients are also encouraged to call if they suspect complications such as infection or bleeding.

In this context, the investigators propose to integrate a pain management after biopsy via e-health system through the patient's medical care. Radiologist/patient communication could have an impact on patients' anxiety and health-related issues, given the challenging nature of discussions around need for breast biopsy and potential implications of the results. Indeed, paying attention and focusing on symptoms as patients experience them improves their empowerment and their adjustment to the disease.

Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been shown to prompt clinicians to intensify symptom management, to improve symptom control and to enhance patient-clinician communication patient satisfaction, as well as well-being. In addition, it is known that improved communication between patients and medical staff to less anxiety after a biopsy and that anxiety is related to pain.

Taken as a whole, these elements encourage the integration of e-health and e-PRO for the management of pain and anxiety in patients undergoing a biopsy. The benefits of e-PRO are still being discussed in terms of quality of life (Qol) and psychological distress. The investigator propose to integrate two types of e-health intervention: 1/e-PRO collected by connected objects (smartphone or tablet) as they were used in previous studies, and 2/ e-PRO collected by a phone consultation, which values human communication between the medical staff and the patient.

In case of significant pain, the collection of e-PRO by any of these e-health interventions will generate an alert and a reactive and responsive care.

In fine, the purpose of this research is to improve the medical organization and care of post-biopsy patients by proposing an innovative connected patient technology, regardless of their remoteness from the hospital.

Social inequalities will be reduced by lending a tablet to patients who do not have such a device with a 4G key.

primary_purpose: Supportive Care

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ReferenceCitation: Lampic C, Thurfjell E, Bergh J, Sjödén PO. Short- and long-term anxiety and depression in women recalled after breast cancer screening. Eur J Cancer. 2001 Mar;37(4):463-9.

ReferenceCitation: Iwamitsu Y, Shimoda K, Abe H, Tani T, Okawa M, Buck R. Anxiety, emotional suppression, and psychological distress before and after breast cancer diagnosis. Psychosomatics. 2005 Jan-Feb;46(1):19-24.

ReferenceCitation: Grimm LJ, Shelby RA, Knippa EE, Langman EL, Miller LS, Whiteside BE, Soo MSC. Patient Perceptions of Breast Cancer Risk in Imaging-Detected Low-Risk Scenarios and Thresholds for Desired Intervention: A Multi-Institution Survey. J Am Coll Radiol. 2018 Jun;15(6):911-919. doi: 10.1016/j.jacr.2018.02.010. Epub 2018 Mar 30.

ReferenceCitation: Dorfman CS, Lamb E, Van Denburg A, Wren AA, Soo MS, Faircloth K, Gandhi V, Shelby RA. The relationship between holding back from communicating about breast concerns and anxiety in the year following breast biopsy. J Psychosoc Oncol. 2018 Mar-Apr;36(2):222-237. doi: 10.1080/07347332.2017.1395939. Epub 2018 Jan 11.

ReferenceCitation: Andrykowski MA, Carpenter JS, Studts JL, Cordova MJ, Cunningham LL, Beacham A, Sloan D, Kenady D, McGrath P. Psychological impact of benign breast biopsy: a longitudinal, comparative study. Health Psychol. 2002 Sep;21(5):485-94.

ReferenceCitation: Mema E, Cho E, Ryu YK, Jadeja P, Wynn R, Taback B, Ha R. In the Setting of Negative Mammogram, Is Additional Breast Ultrasound Necessary for Evaluation of Breast Pain? Curr Probl Diagn Radiol. 2019 Mar - Apr;48(2):117-120. doi: 10.1067/j.cpradiol.2017.12.007. Epub 2018 Jan 9.

ReferenceCitation: Roark AA, Ebuoma LO, Ortiz-Perez T, Sepulveda KA, Severs FJ, Wang T, Benveniste AP, Sedgwick EL. Impact of Simulation-Based Training on Radiology Trainee Education in Ultrasound-Guided Breast Biopsies. J Am Coll Radiol. 2018 Oct;15(10):1458-1463. doi: 10.1016/j.jacr.2017.09.016. Epub 2017 Dec 6.

ReferenceCitation: Denis F, Lethrosne C, Pourel N, Molinier O, Pointreau Y, Domont J, Bourgeois H, Senellart H, Trémolières P, Lizée T, Bennouna J, Urban T, El Khouri C, Charron A, Septans AL, Balavoine M, Landry S, Solal-Céligny P, Letellier C. Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients. J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx029. Erratum in: J Natl Cancer Inst. 2018 Apr 1;110(4):436.

ReferenceCitation: Basch E, Artz D, Dulko D, Scher K, Sabbatini P, Hensley M, Mitra N, Speakman J, McCabe M, Schrag D. Patient online self-reporting of toxicity symptoms during chemotherapy. J Clin Oncol. 2005 May 20;23(15):3552-61.

ReferenceCitation: Berry DL, Blumenstein BA, Halpenny B, Wolpin S, Fann JR, Austin-Seymour M, Bush N, Karras BT, Lober WB, McCorkle R. Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. J Clin Oncol. 2011 Mar 10;29(8):1029-35. doi: 10.1200/JCO.2010.30.3909. Epub 2011 Jan 31.

ReferenceCitation: Chen J, Ou L, Hollis SJ. A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Serv Res. 2013 Jun 11;13:211. doi: 10.1186/1472-6963-13-211. Review.

ReferenceCitation: Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. Erratum in: JAMA. 2003 Feb 26;289(8):987..

ReferenceCitation: Kotronoulas G, Kearney N, Maguire R, Harrow A, Di Domenico D, Croy S, MacGillivray S. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol. 2014 May 10;32(14):1480-501. doi: 10.1200/JCO.2013.53.5948. Epub 2014 Apr 7. Review.

ReferenceCitation: Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4. Review.

ReferenceCitation: Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24.

ReferenceCitation: Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16;312(3):240-8. doi: 10.1001/jama.2014.7689.

ReferenceCitation: Santana MJ, Feeny D, Johnson JA, McAlister FA, Kim D, Weinkauf J, Lien DC. Assessing the use of health-related quality of life measures in the routine clinical care of lung-transplant patients. Qual Life Res. 2010 Apr;19(3):371-9. doi: 10.1007/s11136-010-9599-3. Epub 2010 Feb 10.

ReferenceCitation: Seow H, Sussman J, Martelli-Reid L, Pond G, Bainbridge D. Do high symptom scores trigger clinical actions? An audit after implementing electronic symptom screening. J Oncol Pract. 2012 Nov;8(6):e142-8. doi: 10.1200/JOP.2011.000525. Epub 2012 Aug 21.

ReferenceCitation: Atkinson TM, Ryan SJ, Bennett AV, Stover AM, Saracino RM, Rogak LJ, Jewell ST, Matsoukas K, Li Y, Basch E. The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer. 2016 Aug;24(8):3669-76. doi: 10.1007/s00520-016-3297-9. Epub 2016 Jun 3. Review.

ReferenceCitation: Miller LS, Shelby RA, Balmadrid MH, Yoon S, Baker JA, Wildermann L, Soo MS. Patient anxiety before and immediately after imaging-guided breast biopsy procedures: impact of radiologist-patient communication. J Am Coll Radiol. 2013 Jun;10(6):423-31. doi: 10.1016/j.jacr.2012.11.005. Epub 2013 Mar 15.

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ReferenceCitation: Wilkie D, Lovejoy N, Dodd M, Tesler M. Cancer pain intensity measurement: concurrent validity of three tools--finger dynamometer, pain intensity number scale, visual analogue scale. Hosp J. 1990;6(1):1-13.

ReferenceCitation: Chen PY, Yang CM, Morin CM. Validating the cross-cultural factor structure and invariance property of the Insomnia Severity Index: evidence based on ordinal EFA and CFA. Sleep Med. 2015 May;16(5):598-603. doi: 10.1016/j.sleep.2014.11.016. Epub 2015 Feb 12.

ReferenceCitation: Elkins G, Staniunas R, Rajab MH, Marcus J, Snyder T. Use of a numeric visual analog anxiety scale among patients undergoing colorectal surgery. Clin Nurs Res. 2004 Aug;13(3):237-44.

ReferenceCitation: Hodkinson B, Maheu E, Michon M, Carrat F, Berenbaum F. Assessment and determinants of aesthetic discomfort in hand osteoarthritis. Ann Rheum Dis. 2012 Jan;71(1):45-9. doi: 10.1136/ard.2011.153965. Epub 2011 Sep 6.

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ReferenceCitation: Manne S, Myers S, Ozga M, Kissane D, Kashy D, Rubin S, Heckman C, Rosenblum N. Holding back sharing concerns, dispositional emotional expressivity, perceived unsupportive responses and distress among women newly diagnosed with gynecological cancers. Gen Hosp Psychiatry. 2014 Jan-Feb;36(1):81-7. doi: 10.1016/j.genhosppsych.2013.10.001. Epub 2013 Oct 9.

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title: Brain MRI Characteristics in Stroke Patients With Intracardiac Thrombus

acronym: BRAIN IRM

summary: Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke patients with AF.

ReferenceCitation: Trandafir C, Sandiramourty S, Laurent-Chabalier S, Ter Schiphorst A, Nguyen H, Wacongne A, Ricci JE, Pereira F, Thouvenot E, Renard D. Brain Infarction MRI Pattern in Stroke Patients with Intracardiac Thrombus. Cerebrovasc Dis. 2021;50(5):581-587. doi: 10.1159/000515707. Epub 2021 Jun 17.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Assessing the Perception and the Personal Experience of the COVID19 Pandemic Among Infertile Couples Undergoing Assisted Reproductive Treatment (ART)

acronym: COVAPEX

summary:
Non-urgent medical care, such as fertility treatments, has been massively postponed during the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might cause anxiety and depression among infertile couples, who are already exposed to the distressing experience of infertility and for whom the wait for a baby already appears unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and foetus, or on fertility.

This study aims to assess the views of infertile couple regarding the potential risks of COVID during their fertility treatment and their personal experience of the COVID pandemic and their expectation for further treatment .

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Cardiac and Thoracic Imaging in Pediatric Patients With Evidence of Systemic Inflammation COVID19 Linked

acronym: CARDOVID

summary: To perform comprehensive cardiac and thoracic non invasive imaging assessment by MRI and/or CT scan including cardiac functional evaluation and myocardial tissue characterization of COVID_19 related disease in pediatric patients with cardiac involvement.

ReferenceCitation: Aeschlimann FA, Misra N, Hussein T, Panaioli E, Soslow JH, Crum K, Steele JM, Huber S, Marcora S, Brambilla P, Jain S, Navallas M, Giuli V, Rücker B, Angst F, Patel MD, Azarine A, Caro-Domínguez P, Cavaliere A, Di Salvo G, Ferroni F, Agnoletti G, Bonnemains L, Martins D, Boddaert N, Wong J, Pushparajah K, Raimondi F. Myocardial involvement in children with post-COVID multisystem inflammatory syndrome: a cardiovascular magnetic resonance based multicenter international study-the CARDOVID registry. J Cardiovasc Magn Reson. 2021 Dec 30;23(1):140. doi: 10.1186/s12968-021-00841-1.


title: Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement Operated at Dijon University Hospital

acronym: RVAOMITAVA

summary: Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution. The primary disease process for which patients are referred remains aortic stenosis. But more and more, we met older patients with both aortic stenosis and other cardiac pathology (coronary artery disease, other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is however important to have medical data and statistics in order to better understand the factors influencing morbi-mortality and thereby to continue this improvement.

ipd_sharing_description: All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes. Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.

lead_sponsor: Centre Hospitalier La Chartreuse

location_facility: Cardiovascular and thoracic surgery Unit - Dijon University Hopital


title: The Effect of an Adductor Longus Tenotomy on the Bent Knee Fall Out Test

summary:
The bent knee fall out test (BKFO) is a common test for hip adductor flexibility. It is unknown whether the BKFO actually tests the the adductors or potentially hip range of motion instead.

In this study, the BKFO test is performed in the operating theater before and after an adductor longus tenotomy.

ipd_sharing_description: There are currently no IPD plans. IPD data be obtained upon reasonable request

lead_sponsor: Aspetar


title: Interest of Improved Recovery After Surgery (IRAS) Management [RAAC in French] in Percutaneous Vertebroplasty

summary: This research aims to demonstrate the benefits of the RAAC program for patients undergoing cementoplasty, in particular on their level of anxiety and pain control throughout the perioperative phase.


title: Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System

acronym: Pectusdyn

summary: Pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since 2011, our team uses a dynamic compression system to treat this deformation. It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it. The local cohort is one of the largest in the world. The few previous publications have shown the validity of this method, but the prognosis factors for success of this innovative treatment are not yet identified.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


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.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19

summary:
Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients.

Many raised concerns regarding the potential cardiac toxicity of this association.

The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure.

The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.

lead_sponsor: Institut Mutualiste Montsouris


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.


title: The Life and Care of Patients With Colorectal Cancer Before Age 65 and Their Kindred

acronym: MACHROAPIK

summary: In a context the respect of the autonomy of the patients is important, it is necessary to pay a sustained attention to the experiences and the lived experience as well of the patients suffering or in remission of cancer as of their family. It is therefore, for the family, to deepen the synthesis carried out by the Societal Cancer Observatory which is a societal observatory of cancer


title: RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy

acronym: RESPIRE

summary:
Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting networks. It allows, without active participation of the patients, to identify and analyze the different functional brain networks. The analysis of r-fMRI can be done thanks to the graph theory, which is based on the based on the calculation of quantifiable parameters applied to the functional network studied, making it possible to assess its effectiveness.

To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data in order to obtain parameters useful for the useful parameters for the individual prognosis of children who have to be operation for drug-resistant lesional epilepsy.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


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.

lead_sponsor: Rennes University Hospital


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.

lead_sponsor: Hospices Civils de Lyon


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.


title: Validation of Standardized Test Protocols to Assess the Impact of Visual Pathologies in Daily Life Activities

acronym: PROST

summary:
the incidence of the disease of retinal degenerations with loss of photoreceptors (related to old age or genetic) on patients' daily lives, is poorly characterize without standardized means of measurement (usually performed with functional vision or reading tasks).

self-assessment by a quality of life questionnaire correlated with an assessment of emotional state and direct observation of patients during daily life tasks are the two ways used in a scientific framework to collect data on the difficulties encountered by patients in their daily life.

The aim of this project is to determine the behavioral effects of retinitis pigmentosa (RP) by the effects of performance reductions related to adapting to darkness and visual field restriction. Those assessments will be in real conditions but also in virtual reality (VR).

This tool can be used to measure a therapeutic benefit for new treatments (like gene therapy, retinal implants, intra vitreous injections …) for visual loss patients.

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

location_facility: Centre hospitalier national d'ophtalmologique de 15-20


title: Micro-environment Involvement in Muscle Alteration Induced by Copd Exacerbation

acronym: MicAMI-BPCO

summary:
Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of strengh and muscle mass) is one of comorbidities affecting 30% to 60% of patients and playing a key role in their prognosis. During exacerbation, some studies have suggested an association between muscle dysfunction and modifications of inflammatory circulating factors such as CRP, TNF-alpha, IL- 6, IL8, but no exhaustive study has identified precisely one (or more) biomarker(s) that can induce this muscle wasting during the exacerbation of COPD. Our hypothesis is that the serum of exacerbated COPD patients represents a deleterious microenvironment for the muscle cells which would amplify the mechanisms of atrophy linked to hospitalization. Our team has already developed a cell culture model to study the effects of the plasma microenvironment on atrophy of cultured myotubes. The investigators have shown that the serum of COPD patients can induce muscle atrophy.

The objectives of this study are : 1/ to evaluate the effects of circulating pro-inflammatory factors on atrophy and the myogenic capacities of muscle cells; and 2/ to identify one (or more) circulating biomarker (s) that may be responsible for the muscle damage induced by the microenvironment of hospitalized patients for exacerbation of COPD. First, myotubes and myoblasts of healthy subjects will be cultivated with 9 exacerbation copd patient serum or 9 copd patient serum or 9 healthy subject serum. Myotube diameters, atrophy, inflammatory and oxidative stress markers and alteration of the myogenic capacity of satellite cells will be compared between three groups. Second, the differential expression of circulating proinflammatory molecules will be compared in the serum of the three groups. Identifying circulating factors associated with muscle weakness is a necessary step to better understand the mechanisms and consider a personalized therapeutic approach that can improve the functional and clinical prognosis of disease.

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ReferenceCitation: Spruit MA, Gosselink R, Troosters T, Kasran A, Gayan-Ramirez G, Bogaerts P, Bouillon R, Decramer M. Muscle force during an acute exacerbation in hospitalised patients with COPD and its relationship with CXCL8 and IGF-I. Thorax. 2003 Sep;58(9):752-6.

ReferenceCitation: Crul T, Testelmans D, Spruit MA, Troosters T, Gosselink R, Geeraerts I, Decramer M, Gayan-Ramirez G. Gene expression profiling in vastus lateralis muscle during an acute exacerbation of COPD. Cell Physiol Biochem. 2010;25(4-5):491-500. doi: 10.1159/000303054. Epub 2010 Mar 23.

ReferenceCitation: Crul T, Spruit MA, Gayan-Ramirez G, Quarck R, Gosselink R, Troosters T, Pitta F, Decramer M. Markers of inflammation and disuse in vastus lateralis of chronic obstructive pulmonary disease patients. Eur J Clin Invest. 2007 Nov;37(11):897-904. Epub 2007 Sep 20.

ReferenceCitation: Catteau M, Gouzi F, Blervaque L, Passerieux E, Blaquière M, Ayoub B, Bughin F, Mercier J, Hayot M, Pomiès P. Effects of a human microenvironment on the differentiation of human myoblasts. Biochem Biophys Res Commun. 2020 May 14;525(4):968-973. doi: 10.1016/j.bbrc.2020.03.020. Epub 2020 Mar 12.


title: Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema

acronym: PAGODE

summary:
The presence of optic disc swelling at the fundus is a non-specific clinical sign that can occur in many ophthalmologic, neuro-ophthalmologic or encephalic pathologies. The diagnostic range is vast, including inflammatory pathologies of the optic nerve, infiltrative or compressive orbital pathologies, idiopathic or secondary intracranial hypertensions, not to mention the pseudo optic disc swelling found in drüsens.

MRI is increasingly being used as a first-line examination to obtain an etiologic diagnosis in a patient with optic disc swelling. It allows a rapid diagnosis to be made in cases of inflammatory pathology or compressive or infiltrative pathology. It can provide very suggestive elements in the case of intracranial hypertension. It appears to be potentially useful in diagnosing ischemic optic neuropathy or in directing towards an etiological diagnosis of Giant Cell Arteritis.

The development of new high-resolution MRI sequences has made it possible to obtain extremely fine resolutions of a few hundred microns in the plane. Apart from a few clinical cases and small series, there is no precise evaluation of the interest of these new sequences in the positive and etiological diagnosis of ophthalmological, neuro-ophthalmological and encephalic pathologies responsible for the presence of optic disc swelling.

The objective of our study is therefore to evaluate the diagnostic contribution and the gain in diagnostic confidence provided by these new sequences in the context of pathologies manifesting as optic disc swelling.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)


title: Baha Bone Conduction Implants and Magnetic Resonance Imaging

acronym: BAHA-IRM

summary: Bone conduction implants (BCI) are widely used in cases of conductive/ mixed hearing loss or single side deafness when surgical treatment or air hearing aids are not feasible. There are two types of BCI, abutments (which pass through the skin) and magnets (where a subcutaneous magnet is coupled to an external magnet). Pathologies (such as cholesteatoma) leading to the insertion of this hearing implant often require prolonged MRI follow-up. However, both the abutment and the magnet are responsible for imaging artifacts that limit its interpretation. Frequency and extent of these artifacts remain unclear in the literature. In our experience, the magnet, due to its size and composition, produces larger artifacts than the abutment. The main objective of our study is to compare MRI artifacts for each of these device types (abutment and magnet).


title: Descriptive Study on the Impact of Covid-19 Lockdown on Deviant Sexual Fantasies

summary:
Our society is going through an unprecedented situation: the COVID 19 Pandemic is forcing many populations, worldwide, into confinement for their own protection. The very characteristics of this confinement and of the disease (isolation, potential severity of the illness, being psychologically unprepared for such a circumstance) have a significant impact on one's psyche, like emotional disorders -anxiety/depression-, difficulties when returning to normal life, vicarious traumas… Confinement is paradoxical in as although well-intended to protect the individual, it leads to the isolation of the individual. This paradox is destabilizing one's feelings, because when the investigators feel the need for protection and reassurance, the investigators are left alone and feel abandoned. The investigators therefore understand that this confinement framework is in essence a situation that might revive unresolved deprivation situations from the childhood. How to react in front of this upsurge in anxiety? Strategies used may include, among others, escape in the imaginary through numerical tools or others, and /or going to the actual characterized by deviant sexual behaviours. The investigators know in fact that certain moments, like anxiety, depression, boredom, psychological unrest are propicious for acting, for violent sexual offenders. The investigators therefore pay extra attention to our patients in such periods favoring these kinds of trouble.

This study will enable us to understand if the confinement associated with COVID 19 has generated anxiety that lead sexual offenders or individuals with paraphilic disorders to engage into deviant fantasies or, potentially sexual activities.


title: Dynamics of Drug Resistance-associated Mutations in HIV-1 DNA Reverse Transcriptase Clearance During Effective Antiretroviral Therapy

acronym: MUTARESERVOIR

summary:
In view of the prolongation of patients living with HIV's life expectancy, the question of optimization of ART, which is still a life-long treatment, becomes central. While most patients achieve virological success, their treatments often need to be optimized in order to limit adverse events, drugs interactions and to improve adherence. The switch to dual regimen strategies represent one of the approaches for treatment optimization.

Circulating HIV-1 resistant variants can be archived in viral reservoirs, where they can persist for an unknown duration and reemerge in case of therapeutic selective pressure.

There is a need to assess the dynamic of archived Drug resistance associated mutations (DRAMs) clearance in cell-associated HIV DNA after a long period of virological control, in the perspective of ARVs recycling.

The investigators postulate that it could be interesting in the future to recycle ARV drugs (that where classified as "resistant" in the past) in subsequent regimen. The question is particularly important for 3TC/FTC for subsequent new regimen and for the use of dual regimen (disappearance of M184V).

Thus, the investigators propose a retrospective, longitudinal analysis on blood-cell-associated HIV-1 DNA samples in order to investigate by Sanger and Ultra Deep Sequencing the dynamics of decay and persistence of DNA HIV-1 variants harboring key drug resistance-associated mutations to NRTIs, in particular M184V, in patients with sustained virological control for at least 5 years under effective ART.

lead_sponsor: Association de Recherche en Virologie et Dermatologie


title: Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas

acronym: ICILOLA

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 (or his family member by telephone if the patient does not is not in a condition to give its consent).

The MRI examination will be performed on a 3T multi-parametric MRI. If the neurological disorder presented by the patient does not require an injection as part of routine care, only a high resolution 3D T2 sequence on the nasosinus cavities and the olfactory tract, called bFFE-Xd for approximately 2 min.

If the neurological disorder presented by the patient requires an injection as part of current care, the examination will be completed with the nasosinus and olfactory 3D bFFE-Xd sequence, and the following additional sequences performed after post injection: a

3D FABIR 0.9 sequence covering the brain, dedicated to exploring the subarachnoid spaces;
a 3D T1 TSE 0.7 sequence covering the brain looking for meningeal or encephalic contrast enhancement,
FLAIR HR coronal sequence (high resolution) exploring the limbic system.
Optional: a 3D FLAIR "labyrinth" sequence in the event of hearing / balance problems; a DCE infusion sequence (T1-WI) on the olfactory tract if olfactory disorder, which will be the first sequence made at the time of injection.


title: A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Study Assessing the Safety and Immune Response of PPV-06 Vaccine in Patient With Inflammatory Knee Osteoarthritis (KOA)

summary:
PPV-06 immunotherapy targets interleukin-6 (IL-6), a key molecule of the immune system whose overproduction is implicated in many inflammatory and autoimmune diseases such as rheumatoid arthritis and osteoarthritis. The benefit of vaccination with PPV-06 is to induce, in response to immunizations, the production of antibodies directed against IL-6. The antibodies produced will neutralize the biological activity of IL-6 involved in the body's inflammatory process.

The primary objective is to evaluate the safety/tolerability of vaccination with PPV-06.

lead_sponsor: Peptinov SAS


title: Study of Conjunctival and Retinal Blood Vessels for the Evaluation of the Load of Small Vessel Disease in Patients With Transient Ischemic Attacks (TIAs) and Minor Strokes

acronym: EVACORMA

summary:
The purpose of the study is to use a simple photography of conjunctival vessels to search for an association between conjunctival vessels abnormalities and the load of small vessel disease as quantified by MRI in patients with TIA s and minor strokes.

The artificial intelligence (AI) tools will permit to classify abnormalities of conjunctival vessels that predict the load of small vessel disease in TIAs and strokes.

lead_sponsor: University Hospital, Toulouse


title: Prevalence of Rest Dyspnea and Impact of Non Invasive Ventilation on Breathing Sensations in Patients With Congenital Central Hypoventilation Syndrome

acronym: DyspnOndine

summary:
Congenital central hypoventilation syndrome (CCHS) is a neuro-respiratory disease characterized by lifethreatening sleep-related hypoventilation involving an alteration of CO2/H+ chemosensitivity. This suggests cortical activity during awakening to maintain breathing. Cortical activity to keep breathing is usually associated with breathing discomfort ; this is the case in healthy subjects under non invasive ventilation (NIV) or with expiratory charge as well as in patients with amyotrophic lateral sclerosis. This can suggest that CCHS may be breathless at rest and this discomfort could be reduced by NIV.

The objective is to evaluate dyspnea with a multi dimensional score, MDP, in CCHS patient at rest in every day life and during 1H session of NIV.

The investigators will perform a prospective, including 20 CCHS patients. MDP scores will be measure before and after 1H-non invasive ventilation as well as a visual scale of 100mm in order to evaluate variation of breathing discomfort before/after NIV.

The investigators expect that CCHS patients don't have rest dyspnea but NIV would improve breathing discomfort that would mean they have latent rest dyspnea.

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

location_facility: INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière


title: A Retrospective Study Comparing Failure and Complications Rates Between Propeller Flap and Random Flap for Pressure Ulcer

summary:
The Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of the Wound and Healing department, the first unit of this type to be created in Europe. The investigators quickly became the national leader in the management of pressure ulcers, especially in people with spinal cord injuries.

Our expertise has evolved over time as well as our surgical techniques for covering ulcers, gradually over time the investigators have gone from " random " flaps to " propeller " flaps, more reliable in terms of vascularization and more logical in terms of force distribution and skin tension.

The investigators found subjectively that the rate of complications was lower for the helical flaps. The investigators therefore seek to confirm this trend through a retrospective study on patients operated on in the department between January 1, 2015 and December 31, 2019.

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier


title: Mediolateral Episiotomy and Prevention of Obstetric Anal Sphincter Injuries in Instrumental Delivery: a Prospective Population-based Propensity Score Study

acronym: INSTRUMODA

summary:
Literature is contradictory about the impact of mediolateral episiotomy during operative vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of international guidelines. The investigators consider that a randomized trials does not appears feasible for both ethical and practical reason and so we suggest a large national observational study.

The investigators will include all nulliparous women that underwent an operative vaginal delivery within the 72h following the delivery at more than 34 weeks of amenorrhea. The investigators will collect data about the history of pregnancy, the course of labor, the mode of delivery, maternal immediate and one-year morbidity, neonatal immediate morbidity. The investigators expect a one-year study in 129 recruiting center with 15000 included women.

The primary objective is to assess the protective effect of mediolateral episiotomy against obstetric anal sphincter injury during instrumental delivery in nulliparous women according to the type of instrument used. The secondary endpoints are to investigate the effect of mediolateral episiotomy on one-year maternal morbidity, immediate maternal morbidity. The investigators also aim to develop a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery. Finally, the investigators will investigate the impact of fetal presentation ultrasound assessment immediately before instrumental delivery on the mode of delivery.

ReferenceCitation: Gachon B, Schmitz T, Artzner F, Parant O, De Tayrac R, Ducarme G, Le Ray C, Pizzoferrato AC, Garabedian C, Riethmuller D, Pierre F, Ragot S, Fritel X; GROG (Groupe de Recherche en Gynécologie Obstétrique). A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA). BMC Pregnancy Childbirth. 2021 Mar 25;21(1):251. doi: 10.1186/s12884-021-03603-0.

lead_sponsor: Poitiers University Hospital


title: Effect of " Sitting in a Chair " Versus " Conventional Semi-recumbent In-bed Position " on the Oxygenation Level for ICU Non-sedated Patients

acronym: FALCON

summary:
The positioning of the ICU patient is a daily concern of the medical and paramedical teams. Developments in emergency medicine and sedation and analgesia techniques have made it possible to reduce patient mortality. However, considered too unstable, patients were no longer mobilized outside the bed until the complete resolution of the symptoms that led to hospitalization or surgery.

Despite encouraging results for early mobilization, bed and rest remained the most widespread positioning technique worldwide with the emergence of intensive care units, mechanical ventilation and sedation/analgesia/curarization. The result is peripheral muscular amyotrophy and respiratory muscular amyotrophy, with increased length of stay and exacerbated morbidity/mortality several years after discharge from ICU.

Numerous studies have shown the value of early mobilization of the ICU patient to preserve functional and muscular capital.

However, few studies have evaluated the value of mobilizing the ICU patient from the bed in order to improve oxygenation. The lack of mobility outside the bed causes condensation of the pulmonary parenchyma at the bases and in the dorsal region when the patient is lying down or in a prolonged semi-seated position.

In awake spontaneously ventilated patients, whether intubated on ventilatory support (Pressure Support), non-invasive ventilation (NIV) or high flow nasal oxygen therapy (HFNO), the reference position is a semi-seated patient with the head of the resuscitation bed tilted at 30°. The problem with this position in the bed is that patients tend to slide toward the foot of the bed. This migration is due to gravity or the design of the ICU bed. The end result of this migration is that the inclination indicated by the bed head inclinometer does not correspond to the actual angulation between the patient's lower limbs and trunk. The patient finds himself "compressed" in the lower abdomen, which can lead to compression of the diaphragm and thus hypoventilation in the postero-caudal regions of the lungs.

Our hypothesis is that the chair position (outside the ICU bed) allows, without modification of the ventilatory parameters, to improve the alveolar ventilation and thus the oxygenation of the arterial blood, compared to the "natural" semi-seated position in the ICU bed, in patients with spontaneous ventilation (PS/NIV/HFNO).

ReferenceCitation: Domański Z, Niezabitowski K, Latawiec-Mazurkiewicz I. [Phlebography of the spermatic vein near the unpalpable testicle]. Rofo. 1980 Sep;133(3):322-4. German.

ReferenceCitation: Castellani G, Vincenzi G, Brugnolo E. [Reliability of parapulp support in the coronal reconstruction of silver amalgam in posterior teeth]. Dent Cadmos. 1983 Jun;51(6):25-32. Italian.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Venous Disease Thromboembolic and Amyotrophic Lateral Sclerosis

acronym: TESLA

summary:
Venous thrombo-embolic (VTE) rates could be high in patients with amyotrophic lateral sclerosis (ALS). Indeed, the rate of VTE in this specific population could be 7-fold higher in this population. Predictiv factors of VTE in patients with ALS are mobility reduction and neurological paralysis. However, to our knowledge, medical littérature is poor concerning VTE and ALS association.

Our first aim is to define annual rate of VTE in ALS population.Then we aim to identify predictiv factors of VTE in this specific population. The studied population is Brest universitary hospital cohort of ALS patient included between 2000 and 2019.


title: Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study

acronym: ONCOCARE-COV

summary: In december 2019, SARS-CoV2 and its clinical manifestations, COVID-19, appeared in China and caused a pandemic. It led decision makers to prioritize emergency and intensive care dedicated to infection management. Other conditions, such as cancer screening, diagnosis, and treatment, may have been delayed during the containment period. Consequences of this "distraction effect" are being.

lead_sponsor: CHU de Reims