title: YUflyma® (Adalimumab), Patient Experience After Switching to adaliMumab biosimilAr High concenTration, Low Volume (40mg/0.4mL) (Yuflyma®) by Taking Patient pERception of Treatment Into Account: The YU-MATTER Study

acronym: YU-MATTER

summary:
Patient preference and experience can impact patients' adherence and persistence regarding a treatment, especially when switching. A number of factors contribute to this, including their beliefs, fears, expectations, and overall knowledge. This is compounded by the fact that many switched patients are not trained on how to use the new injection device.

Specifically, some patients report a degraded experience with current adalimumab biosimilars (40mg/0.8mL) as compared to the originator: injections appear more painful and seem to cause more bruising. Indeed, treatment-related factors such as treatment volume or the presence of citrate have the potential to negatively impact patient experience and contribute to local reactions at or around the injection site, such as pain and swelling.

Yuflyma® (CT-P17 adalimumab), developed by Celltrion Inc., is a biosimilar of the anti-TNF treatment adalimumab, having obtained a marketing authorisation from the European Commission on 11th February 2021 (addressed to Celltrion Healthcare).

Yuflyma® is the first high-concentration adalimumab biosimilar (40mg/0.4mL) available in France, which makes the product similar to the currently available adalimumab originator formula in terms of drug concentration.

Studying patient experience over the course of a switch involves querying patients at the time of prescription, while they are still under the previous treatment, and for the following 3 months, during which they have been able to pick up their prescribed medication from a pharmacy and have started using the new treatment. Describing patient experience over the course of a switch from another adalimumab (originator or biosimilar) to Yuflyma® would contribute to identifying significant factors which contribute to patient experience and satisfaction.

Our primary objective is to assess patients' overall satisfaction with the injection after the switch to the high-concentration adalimumab biosimilar Yuflyma®, at 3 months following the initiation, compared to their experience with the previous adalimumab.

Overall satisfaction with the injection (7-level likert) before initiation
Overall satisfaction with the injection (7-level likert) 3 months after initiation

lead_sponsor: Celltrion HealthCare France

location_facility:
Private practice GB
Private Practice - ES


title: A Randomized Trial to Evaluate Effectiveness of Acetazolamide in COPD Patients Developing Metabolic Alkalosis During Invasive Mechanical Ventilation

acronym: DIABOLO

summary: The purpose of this study is to determine whether acetazolamide are effective to reduce the length of mechanical ventilation in decompensated Chronic Obstructive Pulmonary Disease (COPD) patients developing pure or mixed metabolic alkalosis.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Heming N, Faisy C, Urien S. Population pharmacodynamic model of bicarbonate response to acetazolamide in mechanically ventilated chronic obstructive pulmonary disease patients. Crit Care. 2011;15(5):R213. doi: 10.1186/cc10448. Epub 2011 Sep 14.

ReferenceCitation: Chang WT, Thayer DW. The cellulase system of a Cytophaga species. Can J Microbiol. 1977 Sep;23(9):1285-92.

ReferenceType: derived

ReferenceCitation: Faisy C, Meziani F, Planquette B, Clavel M, Gacouin A, Bornstain C, Schneider F, Duguet A, Gibot S, Lerolle N, Ricard JD, Sanchez O, Djibre M, Ricome JL, Rabbat A, Heming N, Urien S, Esvan M, Katsahian S; DIABOLO Investigators. Effect of Acetazolamide vs Placebo on Duration of Invasive Mechanical Ventilation Among Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):480-8. doi: 10.1001/jama.2016.0019.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Cytomegalovirus in Perilymphatic Fluid During Cochlear Implantation of Children Presenting a Sensorineural Hearing Loss

acronym: CMVP

summary: In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceCitation: Chebib E, Vauloup-Fellous C, Benoit C, Noël Petroff N, Van Den Abbeele T, Maudoux A, Teissier N. Is CMV PCR of inner ear fluid during cochlear implantation a way to diagnose CMV-related hearing loss? Eur J Pediatr. 2022 Nov 12. doi: 10.1007/s00431-022-04691-6. [Epub ahead of print]

ipd_sharing: No

intervention_type: Biological

status_simplified: Ongoing


title: A Multicentre Post Marketing Study in France Evaluating the Safety and Efficacy of the eCLIPs™ Family of Products for the Treatment of Bifurcation Intracranial Aneurysms at the Carotid and Basilar Terminus

acronym: EESIS-Fr

summary: The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms.

ReferenceCitation: Fiorella D, Arthur AS, Chiacchierini R, Emery E, Molyneux A, Pierot L. How safe and effective are existing treatments for wide-necked bifurcation aneurysms? Literature-based objective performance criteria for safety and effectiveness. J Neurointerv Surg. 2017 Dec;9(12):1197-1201. doi: 10.1136/neurintsurg-2017-013223. Epub 2017 Aug 10. Review.

lead_sponsor: Evasc Medical Systems Corp.

location_facility: CHU de Montpellier - Hôpital Guy de Chauliac

location_facility: AP-HP - HU Pitié-Salpêtrière - Charles Foix

intervention_type: Procedure

lead_sponsor_type: industriel


title: Cross-cultural and Psychometric Validation Version of the Xerostomia Inventory Into French Language

acronym: XIvf

summary: The main objective of this study is to achieve cross-cultural and psychometric validation of the Xerostomia Inventory initially developed in English language into French Language. This will be achieved in two stages: First, cross-cultural validation, and a second, psychometric validation The cross-cultural validation will be performed according to the methodology of the Institute for Work and Health, according to the recommended six phases. In a second step, the psychometric validation will be done using longitudinal study. Indeed, an observational, longitudinal, and prospective study will be set up. Analysis of the results will help define the feasibility and acceptability of the tool, its validity (content validity, perceived validity, construct validity, concurrent validity, and discriminant validity), its reliability (internal consistency and reproducibility over time). Longitudinal follow-up of patients is expected to also assess the predictive validity and responsiveness.

study_type: Observational

time_perspective: Prospective

lead_sponsor: CHU de Reims

intervention_type: Other


title: Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue

acronym: ASTA

summary: This is a randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study. It aims to assess gingival abrasion by the comparison of pre- to- post-brushing after a single brushing and after 12 weeks of daily home brushing using a macro-relief scoring based on photographs of the gingiva. The study also aims to assess plaque removal, gingival inflammation, gingival recession and gingival color after 12 weeks. To enter the study, adult male and female subjects attending the service of odontology at Rothschild hospital (Paris, France) will refrain from all oral hygiene procedures for 24 hours. Subjects will have the study procedure explained to them both orally and by written instructions. Eligible patients will give their written consent to participate before being included into the study. Following a baseline clinical examination for collection of the following periodontal parameters: plaque control record (PCR), bleeding on probing (BOP), gingival recession (REC), and probing pocket depths (PD), the subjects will be randomized into two balanced groups, test group assigned to the Sonicare ProtectiveClean® HX6848/92 with C2 Optimal Plaque Defense head HX9022/10 (electric toothbrush) and control group assigned to the Pierre Fabre Inava 20/100, a reference manual toothbrush. Subjects will be instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) with a low level of abrasion to minimize bias due to toothpaste abrasivity. After brushing, they will again be evaluated for primary and secondary outcomes (post-brushing). Subjects will be dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects will be instructed to brush for two minutes during each tooth brushing. The subjects will report to the study site after 12 weeks of product use, at which time they will be re-evaluated for gingival abrasion, as well as for plaque removal, gingival inflammation, gingival recession and gingival color. Data (photographs and clinical measurements) will be collected, i.e. primary and secondary variables of each patient, by blinded examiners.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

lead_sponsor: Philips France Commercial


title: Markers of Vascular Aging and Coronary Syndrome

acronym: MAVASCOR

summary:
Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of " non-enzymatic post-translational modifications ". They often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to the formation of complex compounds (post-translational modifications derived products, PTMD) that can accumulate in tissues and be responsible for deleterious effects. The specific role of these compounds in the pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and cellular mechanisms implicated.

This project is based on the hypothesis that non-enzymatic post-translational modifications may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD could therefore constitute relevant biomarkers in this specific clinical situation.

To explore these potential new biomarkers, the investigators designed a study in patients having experienced an acute coronary syndrome and followed during a year. The concentrations of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac rehabilitation will be assessed.

This should help to identify new (and non-traditional) biomarkers of coronary heart disease and determine some of the implicated pathophysiological mechanisms.

primary_purpose: Basic Science


title: Randomized Controlled Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection for the Treatment of Painful Knee Osteoarthritis

acronym: GOTOX

summary:
In France, osteoarthritis affects about 10 million people and knee osteoarthritis represents 35% of cases. It is thought that more than 2.5 million people older than 65 years have knee osteoarthritis.

Currently, osteoarthritis management is based on three major axes:

Non-pharmacological means, such as patient education, loss of weight and physical activity
General pharmacological treatments: mainly paracetamol and then schedule II and III painkillers as well as nonsteroidal anti-inflammatory agent.

Intra-articular pharmacological treatments:

Intra-articular injections of corticosteroids: they are recommended during hydarthrotic flare-ups
Intra-articular injections of hyaluronic acid (HA) (viscosupplementation) in the absence of intra-articular effusion. However, their efficacy is questioned by most experts in the case of symptomatic knee osteoarthrosis.
Sometimes, surgery is the only therapeutic option. However, besides the fact of exposing patients, who are sometimes frail, to several peri- and post-operative complications, the recovery rate (variable according to the prosthesis type and ranging from 5% to 25% at 9 years) in an ageing population justifies waiting as much as possible before surgery. Therefore, it is important to test new therapeutic options for symptomatic osteoarthrosis that will allow postponing the surgical treatment.
The use of botulinum toxin (BoNT-A) could thus represents an interesting alternative. BoNT-A is habitually used by intra-muscular injection for its myorelaxant effect in the management of painful reactive periarticular muscle contractures. However, BoNT-A has also antalgic activity independently of the myorelaxant effect. This allows explaining in part the antalgic effect of intra-articular BoNT-A injection. In the literature, six randomized controlled studies (RCS) have compared BoNT-A and intra-articular injections of corticosteroids, hyaluronic acid, or placebo. Only two RCS concerned knee osteoarthritis and compared BoNT-A to corticosteroids and a placebo, respectively, with a significant antalgic effect only in the groups treated with BoNT-A. No study has compared yet the intra-articular injection of BoNT-A to the viscosupplementation by HA in knee osteoarthritis and this is the aim of this trial.

status: Active, not recruiting

lead_sponsor: University Hospital, Strasbourg, France

intervention_type: Device


title: Prevalence, Characterization and Risk Factors of Acquiring Qnr Genes in Extended Spectrum Beta-lactamase Producing Enterobacteriaceae Isolated in East Inter-region.

summary:
Enterobacteriaceae are bacteria of the gastrointestinal tract which are also the most frequently involved in bacterial infections, especially urinary tract infections. Because of their presence in the gut, these bacteria are the most exposed to antibiotic treatment administered to patients.

Therefore, many antibiotic resistance mechanisms are observed in some of them. Quinolone antibiotics are often used because of their distribution in the body, of the great number of bacterial species that are sensitive to these antibiotics and the possibility to give oral treatments.

For a long time no transferable resistance gene to quinolones from one bacterium to another had been observed. This phenomenon has been demonstrated in 1998 in a bacterium of the Klebsiella pneumoniae species carrying a qnrA gene which encodes a protein that protects the target of the antibiotic in the bacteria. Since several genes have been observed. These genes reduce the sensitivity of the bacteria without ever reach detectable resistance levels on the tests commonly used in the laboratory. However, these genes are often found among enterobacteria in combination with other mechanisms of resistance to other classes of antibiotics including beta-lactam antibiotics that are widely used antibiotics.

Moreover, it is considered that quinolone administration to bacteria carrying these qnr genes could promote the emergence of mutants resistant to quinolones to a more high-level. That furthers multiresistance emergence when the bacteria is already resistant to beta-lactam antibiotics.

The aim of this study performed between April 2008 and March 2009 was to collect strains resistant to beta-lactams because of the production of enzymes, called extended-spectrum beta-lactamase to determine quinolone resistance gene frequency in these bacteria.

Meanwhile, control patients were selected to seek the emergence of these genes risk factors.

The clinical study failed to identify specific risk factors, however, the biological study enhanced the knowledge on this issue with the setting-up of a method for rapid detection of these plasmidic mediated quinolones resistance genes and the description a new plasmid containing a qnr gene, qnrD, whose study is still ongoing.


title: Abatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority Trial

acronym: SUNSTAR

summary:
Rheumatoid arthritis (RA) is the most common inflammatory rheumatoid disease in France, affecting 0.3% of the general population. Without effective treatment, the persistent inflammation causes invalidating pain and joint destruction, leading to major functional disability.

Biological agents have been proposed for patients with RA who have the most severe form of the disease and that are inadequate responder patients to conventional synthetic Disease-modifying antirheumatic drugs (csDMARDs). TNF inhibitors (TNFi) are historically proposed as the first biological DAMRD for inadequate responder patients to csDMARDs. A diverse therapeutic arsenal has become available in recent years with the development of non-anti-TNFα drugs whose mechanisms of action are different from the classical TNFi. This new biotherapy class includes tocilizumab and abatacept, two drugs recently available for subcutaneous administration that enables ambulatory care for patients who would otherwise require repeated in-hospital care.

The role of these new treatments in the therapeutic strategy has been emphasized by studies that demonstrated their efficacy as first-line treatments. However, in clinical practice, TNFi remain the most common first-line treatment for the majority of patients, non-anti-TNFα biological agents being reserved for inadequate responder patients.

In second line, several studies have investigated therapeutic strategies for inadequate responder patients to TNFi. Current data suggest that it could be wise to change the therapeutic target after failure of a first-line treatment with TNFi.

Data about the comparative efficacy of different biologics proposed after failure of a first-line treatment with TNFi are in progress. Meta-analyses from registries and academic trials conducted in France and The Netherlands suggest that non-anti-TNFα agents would have equivalent or superior efficacy compared with a second TNFi. This finding suggests clinicians to switch for an alternate therapeutic target after failure of a first-line TNFi.

Data comparing different non-anti-TNFα biologics in inadequate responder patients to TNFi are scare. Industrial trials have demonstrated sustained biological efficacy of non-anti-TNFα biologics after failure of a TNFi. However, there is very little solid data on the direct comparison between them.

status: Unknown status

lead_sponsor: Lille Catholic University

status_simplified: Unknown


title: Frail Elderly Subjects: Inhospital Pathways and Adverse Outcome After Hospitalisation Via Emergency Department

acronym: SAFES Cohort

summary: This was a prospective multicenter cohort study of elderly people admitted to medical wards via emergency departments. Subjects were followed up to 36 months. It aimed to study the inhospital pathways and adverse geriatric outcomes. In all, 1306 subjects were included : 85+/-5 years, and mainly women (65%).

ReferenceType: result

ReferenceCitation: Tardieu É, Mahmoudi R, Novella JL, Oubaya N, Blanchard F, Jolly D, Dramé M. [External validation of the short emergency geriatric assessment (SEGA) instrument on the SAFES cohort]. Geriatr Psychol Neuropsychiatr Vieil. 2016 Mar;14(1):49-55. doi: 10.1684/pnv.2016.0592. French.

ReferenceCitation: de Boissieu P, Mahmoudi R, Hentzien M, Toquet S, Novella JL, Blanchard F, Jolly D, Dramé M. Predictors of Long-Term Mortality in Oldest Old Patients (90+) Hospitalized to Medical Wards via the Emergency Department: The SAFES Cohort. J Nutr Health Aging. 2015 Jun;19(6):702-7. doi: 10.1007/s12603-015-0515-y.

ReferenceCitation: Lang PO, Mahmoudi R, Novella JL, Tardieu E, Bertholon LA, Nazeyrollas P, Blanchard F, Jolly D, Dramé M. Is obesity a marker of robustness in vulnerable hospitalized aged populations? Prospective, multicenter cohort study of 1 306 acutely ill patients. J Nutr Health Aging. 2014 Jan;18(1):66-74. doi: 10.1007/s12603-013-0352-9.

ReferenceCitation: Narbey D, Jolly D, Mahmoudi R, Trenque T, Blanchard F, Novella JL, Dramé M. Relationship between anticholinergic drug use and one-year outcome among elderly people hospitalised in medical wards via emergency department: the SAFES cohort study. J Nutr Health Aging. 2013 Sep;17(9):766-71. doi: 10.1007/s12603-013-0349-4.

ReferenceCitation: Dramé M, Lang PO, Novella JL, Narbey D, Mahmoudi R, Lanièce I, Somme D, Gauvain JB, Heitz D, Voisin T, de Wazières B, Gonthier R, Ankri J, Saint-Jean O, Jeandel C, Couturier P, Blanchard F, Jolly D. Six-month outcome of elderly people hospitalized via the emergency department: the SAFES cohort. Rev Epidemiol Sante Publique. 2012 Jun;60(3):189-96. doi: 10.1016/j.respe.2011.11.004. Epub 2012 May 16.

ReferenceCitation: Dhaussy G, Dramé M, Jolly D, Mahmoudi R, Barbe C, Kanagaratnam L, Nazeyrollas P, Blanchard F, Novella JL; SAFES Group. Is health-related quality of life an independent prognostic factor for 12-month mortality and nursing home placement among elderly patients hospitalized via the emergency department? J Am Med Dir Assoc. 2012 Jun;13(5):453-8. doi: 10.1016/j.jamda.2011.10.002. Epub 2011 Nov 13.

ReferenceCitation: Dramé M, Novella JL, Jolly D, Lanièce I, Somme D, Heitz D, Gauvain JB, Voisin T, De Wazières B, Gonthier R, Jeandel C, Couturier P, Saint-Jean O, Ankri J, Blanchard F, Lang PO. Rapid cognitive decline, one-year institutional admission and one-year mortality: analysis of the ability to predict and inter-tool agreement of four validated clinical frailty indexes in the SAFEs cohort. J Nutr Health Aging. 2011 Aug;15(8):699-705.

ReferenceCitation: Lang PO, Dramé M, Mahmoudi R, Jolly D, Lanièce I, Saint-Jean O, Somme D, Heitz D, Gauvain JB, Voisin T, de Wazières B, Gonthier R, Jeandel C, Couturier P, Ankri J, Blanchard F, Novella JL. [Frailty: learnings from the SAFEs cohort study and future perspectives for the research]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Jun;9(2):135-49. doi: 10.1684/pnv.2011.0279. Review. French.

ReferenceCitation: Dramé M, Fierobe F, Lang PO, Jolly D, Boyer F, Mahmoudi R, Somme D, Laniece I, Heitz D, Gauvain JB, Voisin T, De Wazieres B, Gonthier R, Ankri J, Saint-Jean O, Couturier P, Jeandel C, Blanchard F, Novella JL. Predictors of institution admission in the year following acute hospitalisation of elderly people. J Nutr Health Aging. 2011 May;15(5):399-403.

ReferenceCitation: Dramé M, Lang PO, Jolly D, Narbey D, Mahmoudi R, Lanièce I, Somme D, Gauvain JB, Heitz D, Voisin T, de Wazières B, Gonthier R, Ankri J, Saint-Jean O, Jeandel C, Couturier P, Blanchard F, Novella JL. Nursing home admission in elderly subjects with dementia: predictive factors and future challenges. J Am Med Dir Assoc. 2012 Jan;13(1):83.e17-20. doi: 10.1016/j.jamda.2011.03.002. Epub 2011 Apr 13.

ReferenceCitation: Lang PO, Dramé M, Jolly D, Novella JL, Blanchard F, Michel JP. [What do we learn from the SAFEs cohort to fit hospital care models for aged inpatient?]. Presse Med. 2010 Nov;39(11):1132-42. doi: 10.1016/j.lpm.2010.05.009. Epub 2010 Jul 1. French.

ReferenceCitation: Somme D, Lazarovici C, Dramé M, Blanc P, Lang PO, Gauvain JB, Voisin T, Gonthier R, De Wazières B, Jeandel C, Couturier P, Blanchard F, Saint-Jean O. The geriatric patient: use of acute geriatrics units in the emergency care of elderly patients in France. Arch Gerontol Geriatr. 2011 Jan-Feb;52(1):40-5. doi: 10.1016/j.archger.2010.01.018. Epub 2010 Mar 3.

ReferenceCitation: Lang PO, Zekry D, Michel JP, Drame M, Novella JL, Jolly D, Blanchard F. Early markers of prolonged hospital stay in demented inpatients: a multicentre and prospective study. J Nutr Health Aging. 2010 Feb;14(2):141-7.

ReferenceCitation: Dramé M, Dia PA, Jolly D, Lang PO, Mahmoudi R, Schwebel G, Kack M, Debart A, Courtaigne B, Lanièce I, Blanchard F, Novella JL. [Factors predictive of long-term mortality in patients aged 75 years or older hospitalized from the emergency department: the SAFES cohort]. Presse Med. 2009 Jul-Aug;38(7-8):1068-75. doi: 10.1016/j.lpm.2009.01.019. Epub 2009 Apr 18. French.

ReferenceCitation: Viatonou S, Dramé M, Jolly D, Morrone I, Lang PO, Voisin T, Boyer FC, Schwebel G, Somme D, Blanchard F, Novella JL. Predictors of rapid cognitive decline among demented subjects aged 75 or more: ('Sujet Agé Fragile--Evaluation et Suivi' Cohort-SAFES). Int J Geriatr Psychiatry. 2009 Jul;24(7):709-15. doi: 10.1002/gps.2183.

ReferenceCitation: Prudent M, Dramé M, Jolly D, Trenque T, Parjoie R, Mahmoudi R, Lang PO, Somme D, Boyer F, Lanièce I, Gauvain JB, Blanchard F, Novella JL. Potentially inappropriate use of psychotropic medications in hospitalized elderly patients in France: cross-sectional analysis of the prospective, multicentre SAFEs cohort. Drugs Aging. 2008;25(11):933-46. doi: 10.2165/0002512-200825110-00004.

ReferenceCitation: Dramé M, Novella JL, Lang PO, Somme D, Jovenin N, Lanièce I, Couturier P, Heitz D, Gauvain JB, Voisin T, De Wazières B, Gonthier R, Ankri J, Jeandel C, Saint-Jean O, Blanchard F, Jolly D. Derivation and validation of a mortality-risk index from a cohort of frail elderly patients hospitalised in medical wards via emergencies: the SAFES study. Eur J Epidemiol. 2008;23(12):783-91. doi: 10.1007/s10654-008-9290-y. Epub 2008 Oct 21.

ReferenceCitation: Drame M, Jovenin N, Novella JL, Lang PO, Somme D, Laniece I, Voisin T, Blanc P, Couturier P, Gauvain JB, Blanchard F, Jolly D. Predicting early mortality among elderly patients hospitalised in medical wards via emergency department: the SAFES cohort study. J Nutr Health Aging. 2008 Oct;12(8):599-604.

ReferenceCitation: Lanièce I, Couturier P, Dramé M, Gavazzi G, Lehman S, Jolly D, Voisin T, Lang PO, Jovenin N, Gauvain JB, Novella JL, Saint-Jean O, Blanchard F. Incidence and main factors associated with early unplanned hospital readmission among French medical inpatients aged 75 and over admitted through emergency units. Age Ageing. 2008 Jul;37(4):416-22. doi: 10.1093/ageing/afn093. Epub 2008 May 16.

ReferenceCitation: Lang PO, Meyer N, Heitz D, Dramé M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Couturier P, Lanièce I, Voisin T, de Wazières B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. Loss of independence in Katz's ADL ability in connection with an acute hospitalization: early clinical markers in French older people. Eur J Epidemiol. 2007;22(9):621-30. Epub 2007 Jul 25.

ReferenceCitation: Lang PO, Heitz D, Meyer N, Dramé M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Colvez A, Couturier P, Lanièce I, Voisin T, de Wazières B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. [Early indicators of prolonged hospitalization of the elderly: pilot study at Strasbourg University Hospital]. Presse Med. 2007 Mar;36(3 Pt 1):389-98. Epub 2007 Jan 17. French.

ReferenceCitation: Lang PO, Heitz D, Hédelin G, Dramé M, Jovenin N, Ankri J, Somme D, Novella JL, Gauvain JB, Couturier P, Voisin T, De Wazière B, Gonthier R, Jeandel C, Jolly D, Saint-Jean O, Blanchard F. Early markers of prolonged hospital stays in older people: a prospective, multicenter study of 908 inpatients in French acute hospitals. J Am Geriatr Soc. 2006 Jul;54(7):1031-9. Erratum in: J Am Geriatr Soc. 2006 Sep;54(9):1479-80.

intervention_type: Behavioral


title: Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

summary:
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows:

To assess functional clinical score's evolution,
To evaluate patient's satisfaction
To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15/02/2021 and 15/05/2021.

Patients were implanted and followed as per standard of care led in the investigational site.

The following regulation and guidelines were followed for this investigation:

Standard ISO 14155:2020 "Good Clinical Practice"undirectly applicable;
Regulation (UE) 2016/679 (RGPD) ;
Regulation (UE) 2017/745 (MDR) ;
MEDDEV 2.12.1;
Local regulation (loi " jardé ", loi " informatique et libertés "). As per its design, the investigation is considered as involving human beings, and therefore require submission to an ethic committee or declaration to a Competent Authority (ANSM) and CPP. This study was registered on CPP (CPP Ile de France VII).

lead_sponsor: Societe dEtude, de Recherche et de Fabrication


title: Endometrial Cancer: Evaluation of Genetic Imbalances in the Carcinogenesis Process

summary:
Medical context:

Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been dentified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...). It is thus conceivable that like that enable genomic tools used in breast cancer today (Oncotype DX, MammaPrint), correlation between the tumor profile and life project in the case of cancer the endometrium could be done. A study is already underway at the Reims University Hospital with funding from the League against cancer and AOL in 2010 CHU Reims. It should identify the specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome. To date, 39 patients with endometrial cancer and 15 patients with endometrial hyperplasia (patients 'cases') were included in the study. For this study, 10 patients exhibiting neither cancer nor endometrial hyperplasia were also included. Samples of these 10 patients 'witnesses' were pooled to serve as a reference for analyzing patients 'cases'.

objectives: In continuation of the study began in November 2009, refine the study of genomic imbalances highlighted hyperplasia and endometrial cancer by studying the in correlation between genomics and proteomics by immunohistochemical studies and analyzing the microsatellite instability.

To study the prognostic role of genetic factors in patients carriers of a disease endometrial (cancer or hyperplasia).

Material and methods :

Experimental Design: Cross-sectional study in inclusion prospective multi-center followed by a cohort study of patients 'cases'.

Population / patients: in total, it is planned to include 72 patients with hyperplasia or endometrial cancer (22 patients included in the pre-study part funded by the League against cancer 50 patients included in the scope of the study funded by the 2010 AOL Chu Reims).

Plan of investigation: the study includes two phases:

Sectional study:

The inclusion of 10 patients "witnesses" has already been completed in the first project.

During the consultation in the obstetrics and gynecology department of the Reims University Hospital and the surgical department of the institute Jean Godinot, terms and objectives of the study have been and will be presented to patients where cancer or hyperplasia endometrial was diagnosed by achieving endometrial biopsy.

If the patient agrees to participate in the study, the management of its pathology (hysterectomy, hysteroscopy and curettage resection) will not be changed.

The samples taken during the surgery were analyzed and will be as provided in the first research project. Tumor karyotype, DNA extraction are performed on each sample fresh. A comparative genomic hybridization is conducted using the DNAs thus obtained.

Additional analyzes (immunohistochemistry and analysis of microsatellite instability) will be performed on all samples already obtained and on future withdrawals.

time_perspective: Retrospective

intervention_type: Genetic


title: Post-Covid-19 Emotional Aspects of Hospital Staff

acronym: EMOCOV

summary:
The ongoing SARS-CoV2 or Covid-19 pandemic is causing a major global health crisis. In France, it prompted an urgent reorganization of the healthcare supply, mobilizing caregivers and hospital staff in a climate of uncertainty. Health services have been put to the test, some staff being on the front line, others having faced the reorganization of the health system necessitated by such a pandemic.

Frontline caregivers have been compared to "fighters on the front lines." They encountered many difficulties, such as direct exposure to patients with a high viral load, exposure to the risk of contamination, physical exhaustion, reorganization of workspaces, adaptation to rigid work organizations, the management of the shortage of materials, the unusually high number of deaths among patients, colleagues or relatives, ethical questions relating to decision-making in a strained healthcare system.

The psychological impact on these hospital staff is an indirect issue of such a pandemic in terms of mental health.

The investigators have little data in the literature on the incidence of psychiatric episodes in the post-epidemic period. Work on the impact of two major pandemics of influenza A H1N1 (2009) and SARS-CoV-1 (2003) on the mental health of caregivers and other staff working in hospitals reports increased rates of mental disorders after discharge from anxiety-type crisis, depression and post-traumatic stress. This over-representation of mental disorders was still found several years after the epidemic.

Similar results are emerging in recent studies involving hospital staff who were used in the Covid-19 crisis. These highlight a certain number of risk factors for the occurrence of these disorders (young age, nursing profession, underlying psychiatric pathology, exercise carried out in the first line of Covid).

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: 3 Dimensional Study of Lower Limbs and Feet of Children in Standing Position

summary:
The study will be in 3 parts: first one will be to address the key question of the lower limb frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays and foot morphology assessment. Indeed, a major issue in the management of lower limb disorders is the ability to correctly assess abnormal development and decide on the most adapted treatment option. In particular, the link between lower limb disorders and foot morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in children has been successfully assessed using low-dose biplanar X-rays.

Second part will be to assess the reproducibility of the 3dimensional reconstructions whether they are made by a radiology technician, or by a so-called expert through collecting datas from 3 centers of pediatric surgery where EOS Imaging system is daily used to get spine or lower limb X-Rays.

Last part will be to work on the recently developed weight-bearing foot 3D reconstruction method for clinical use using the Parametric Personalized Modelling approach (PPM). This will allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.

lead_sponsor: Fondation Lenval

location_facility:
Fondation Lenval
Hôpital Necker enfants Malades


title: Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps

summary:
Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often associated with cuff tendinopathy. The function of the LHB in the shoulder is still controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long head of the biceps permits pain relief and is very reliable in the literature. Two options are available for the remaining tendon : simple tenotomy or tenodesis which consists to reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this study was to compare the strength and the endurance of the biceps brachii during supination and flexion after tenotomy or tenodesis of the LHB.

the investigators proposed a prospective and randomized study. All the patients treated in our department for an arthroscopic rotator cuff repair were included in this study after signed consent. Participants will complete isokinetic strength and endurance testing for elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.


type: Other Identifier

title: A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy

acronym: RESPIRE

summary:
The mortality of severe pulmonary embolisms admitted to the resuscitation department for circulatory failure remains in the range of 30-40% at the acute phase. Hemodynamic failure is the leading cause of death. These patients frequently have a contraindication to thrombolysis. Surgical pulmonary arterial desobstruction still leads to significant hospital mortality and can't be implemented in all hospitals. Concerning advanced hemodynamic support techniques, they can't always reduce mortality on themselves. There is therefore a need for developing alternative approaches for less invasive pulmonary arterial desobstruction. Data on the efficacy and safety of percutaneous methods of desobstruction are still too limited to implement them in current practice.

AngioJet ™ PE is a device CE marked for intra-arterial desobstruction of pulmonary arteries. It has been successfully tested in more than 25 patients with pulmonary embolism in France. Before considering a request for reimbursement from the HAS it is necessary to have propective data of sufficient quality. This phase 2a prospective study is proposed to evaluate the efficacy and safety of the AngioJet ™ PE catheter use. The resulting data will allow us to submit a Phase 3 controlled study to an upcoming PHRC-type project call.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data that underlie results in publication could be shared Individual participant data detailed in meta analysis protocol could be shared

location_facility: AP-HP - Hôpital Européen Georges-Pompidou Paris


title: Prevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 Patients

acronym: ASAA

summary:
The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in patients with ankylosing spondylitis (AS).

The secondary objectives are: (1) To determine whether the presence of these antibodies is symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha therapy.


title: Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis

acronym: CALPRO-HAA

summary:
Severe alcoholic hepatitis, defined by a "Maddrey discriminant function" above 32, is associated with significant short-term mortality. In patients with liver disease, studies have shown alterations of intestinal bacterial flora and an increase in intestinal permeability leading to bacterial translocation across the intestinal barrier. The mechanism involved may be an activation of intestinal macrophages with a local release of cytokines like interleukin-8 (IL-8).

Calprotectin is a protein present in large amounts in the cytosol of neutrophils. Its presence in feces is related to neutrophil migration in intestinal lumen. Thus, fecal calprotectin may be used as a marker of intestinal inflammation. There is evidence that fecal calprotectin levels are increased in cirrhotic patients dependent on the severity of the disease. The predictive value of fecal calprotectin for the outcome of severe alcoholic hepatitis has never been evaluated.

The main objective of this study was to determine if the initial level of fecal calprotectin and its variation after 7 days had a predictive value for the outcome of severe alcoholic hepatitis. Secondary objectives were to determine if fecal calprotectin concentration was correlated with blood concentration of Lipopolysaccharide (LPS) binding protein and predictive of infections.


title: A Multicenter Randomized Study to Assess the Impact of SIMULation-bAsed Training on Transoesophageal echocardiOgraphy leaRning for Cardiology Fellows

acronym: SIMULATOR

summary:
Background:

Simulation-based training in transesophageal echocardiography (TEE) seems promising. However, data are limited to non-randomized or single-center studies.

Objectives:

This large multicenter randomized, parallel-group, unblinded, study will assess the impact of simulation-based versus traditional teaching on TEE knowledge and performance for medical fellows in cardiology.

Eligibility:

All consecutive fellows in cardiology of all training levels (year 1-4)
who have never performed a TEE alone

Design:

Multicenter, parallel-group, unblinded, randomized study with a prospective enrollment of all consecutive fellows in cardiology of all training level (year 1 to 4) who were recruited in 42 centers throughout France.
Randomization with stratification by center will be performed at the individual (fellow) level in 1:1 ratio to assign all the fellows to the traditional group or to the TEE simulation-based training group.
Each participant will complete two different tests during the study: 1) a pre-training test before starting the educational program; and 2) a final test performed 3 months after the end of the educational program. Each of these tests will include a theoretical test and a practical test on a TEE simulator.
The coprimary outcomes of the study to compare the two groups will be the scores in the final theoretical and practical tests after the training will be completed.

lead_sponsor: Groupe des jeunes de la filiale d'imagerie cardiovasculaire

intervention_type: Diagnostic Test


title: Study of the Attack Rate of COVID-19 Infection in Patients Infected With HIV and/or on Pre-exposure Prophylaxis (PrEP) and Possible Impact of Treatment With an HIV Protease Inhibitor

acronym: COVIDHIVPrEP

summary:
The SARS-CoV-2 epidemic was declared as a global pandemic by the WHO on March 12, 2020. France is affected with approximately 120,000 biologically confirmed cases, as of April 30, 2020, a figure probably very underestimated. Its distribution in different populations, in particular immunocompromised, has not yet been measured. The in vitro efficacy of lopinavir coupled with ritonavir, an HIV protease inhibitor, on SARS-CoV, responsible for SARS has been discussed and this therapeutic combination is currently being evaluated in patients infected with COVID-19. The possible protective role of treatment with Lopinavir / ritonavir or another HIV protease inhibitor has not been studied.

In addition, patients receiving HIV pre-exposure prophylaxis (PrEP) share certain epidemiological and behavioral characteristics with HIV-infected patients.

The objective was to carry out an epidemiological study aimed at determining the attack rate of COVID-19 infection in patients infected with HIV and or on PrEP and to analyze this attack rate according to the characteristics of these 2 populations and in particular the existence or not of an antiretroviral treatment comprising Lopinavir / Ritonavir or another inhibitor of the HIV protease.

Cross-referencing of Virology Laboratory data (positive or negative screening) and clinical-biological data can be easily carried out using a unique identification number in the 2 software programs and will allow an almost exhaustive epidemiological analysis in 2 well identified populations.

lead_sponsor: Hospices Civils de Lyon

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon


title: Phase II Study of Afatinib as Third- or Further-line Treatment for Patients With Stage IV Bronchial Adenocarcinoma, Harboring Wild-type EGFR, Expressing the Neurotensin - Neurotensin Receptor Complex

acronym: THEN

summary:
Lung cancer is the leading cause of cancer deaths in France, Europe and the world. 50% of lung cancers are of the adenocarcinoma subtype. 60% of patients present with a metastatic disease (stage IV) at the time of diagnosis. Approximately 10% of patients present with a mutation of the epidermal growth factor receptor (EGFR) requiring an EGFR tyrosine kinase inhibitor (EGFR-TKI), namely erlotinib, gefitinib or afatinib. For the majority of chemotherapy-naïve patients without addictive mutation, platinum-based chemotherapy, frequently the platinum - pemetrexed doublet, provides disease control rate of up to 70% and improves survival from approximately 4.5 with best supportive care alone to 15 months. However, patients with non-small cell lung cancer (NSCLC) usually relapse within 4 to 6 months and benefit from a second-line chemotherapy. Authorized drugs in this setting are pemetrexed, docetaxel and erlotinib. The prescription of erlotinib for unselected patients whose tumor does not harbor an EGFR mutation is questionable . In the second line setting, docetaxel provides less than 10% of partial responses and progression-free survival of 10 to 12 weeks. There are no standard options following failure of two previous lines of standard chemotherapy. In view of these modest results, new agents and therapeutic strategies are greatly needed for this patient population.

Neurotensin (NTS) is a 13 amino acids peptide, present and biologically active in the central nervous system and in periphery. At the peripheral level, NTS is released by the endocrine cells of the intestinal mucosa after meals and acts as an endocrine hormone involved in the postprandial regulation of the motor functions of the gastrointestinal tract. The effects of NTS are mediated by three subtypes of receptor: NTSR1 and NTSR2 exhibit high and low affinity for NTS, respectively, and belong to the family of G protein receptors; NTSR3 is a single transmembrane domain receptor. Exogenous activation of NTSR1 leads to cell proliferation, survival, mobility and invasion in cancer cells from diverse origin. These effects are the result from the activation of kinases and effectors, such as PKC, MAPK, FAK, RHO-GTPase, RAS and Src. The PKC activation may induce MAPK by direct stimulation of Raf-1, or by transactivation of the EGFR. The activation of MAPK via NTSR1 is mainly associated with uncontrolled cell growth. Both NTS and NTSR1 are expressed in 40% of lung tumors, whereas they are never expressed in the normal tissue. NTSR1 high expression is a negative prognostic factor in stage I to III operated lung adenocarcinomas. Sustained stimulation of NTSR1 results in the activation of MMP1, the release of EGF "like" ligands such as HB-EGF as well as neuregulin 1 NGR1 (a specific ligand for HER3) followed by EGFR, HER2 and HER3 overexpression and activation. Accordingly, xenografted tumors expressing NTS and NTSR1 show a positive response to erlotinib, whereas tumors void of NTSR1 expression have no detectable response.

Afatinib (BIBW2992) is a small molecule, selective and irreversible erbB family blocker. In preclinical models it effectively inhibits EGFR, HER2 and HER4 phosphorylation resulting in tumour growth inhibition and regression of established subcutaneous tumours derived from four human cell-lines known to co-express ErbB receptors.

Our claim is that patients harbouring the NTS/NTSR complex, without EGFR mutation, will respond to afatinib due to the sustained activation of EGFR/HER2 under neurotensin activation.

Presently, only EGFR mutated tumors are eligible to receive EGFR TKI representing 10% of all lung cancer patients. The aim of this study is to evaluate the efficacy of afatinib, an EGFR TKI, on lung adenocarcinomas, EGFR wild-type, bearing the NTS/NTSR1 complex with a high level of expression. This subpopulation of patients represents approximately 20% of lung adenocarcinomas.

status: Withdrawn


title: Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer

acronym: AgElOn

summary:
The aim of the study is to evaluate frailty in patients aged ≥ 65 years with cancer. The elderly population is very heterogeneous, it is necessary to evaluate these elderly patients before treatment to assess the risk-benefit balance. To date, this assessment relies on subjective clinical methods often not optimal, and slow to implement. An innovative method of evaluation could be the determination of elastin peptides. Indeed, the rate of these peptides, which are linked to serious conditions associated with age, rising inexorably with age and dose could help determine more objectively the type of treatment to offer older patients.

Expected results : This study will allow better identification of the group of frail elderly through more relevant biological marker that clinical assessment, often subjective and not available within a period compatible with the treatment of newly diagnosed cancer. This biological assessment will also enable optimal management of elderly patients in particular by allowing the geriatrician better efficiency.


title: Interaction Emotion-cognition in the Study of Literal and Figurative Language in Schizophrenia and Bipolar Disorders: Behavioral and Electrophysiological Studies

acronym: ELISE

summary: The initial aim of the project was to gain an understanding of the comprehension of "language-oriented" emotions among schizophrenic and bipolar patients. By "language-oriented" emotions, the investigators mean the emotions that are conveyed by means of language, whether through the emotional valence of the words, the expression of an emotional state or emotional prosody. Although they involve different diagnostic categories, schizophrenic and bipolar disorders nevertheless share a number of symptoms, in particular in the emotional sphere, and do so to such an extent that the question of whether there may, at the clinical, cognitive and etiopathogenic levels, exist a continuum between these disorders is frequently raised. Taking this hypothesis of a clinical continuum as our starting point, the investigators explored the understanding of emotions contextualized by language in these two clinical populations, namely patients exhibiting schizophrenic and bipolar disorders. To these populations, the investigators also added the dimension of vulnerability in the form of non-clinical participants varying in terms of their traits of schizotypy and hypomania, thus orienting this project toward the early identification of cognitive-emotional markers and possibly also their prevention.

design_allocation: Non-Randomized

ReferenceCitation: Terrien S, Gobin P, Iakimova G, Coutté A, Thuaire F, Baltazart V, Mazzola-Pomietto P, Besche-Richard C. Electrophysiological correlates of emotional meaning in context in relation to facets of schizotypal personality traits: A dimensional study. Psychiatry Clin Neurosci. 2016 Mar;70(3):141-50. doi: 10.1111/pcn.12366. Epub 2015 Dec 22.

ReferenceCitation: Terrien S, Gobin P, Coutté A, Thuaire F, Iakimova G, Mazzola-Pomietto P, Besche-Richard C. Emotional Meaning in Context in Relation to Hypomanic Personality Traits: An ERP Study. PLoS One. 2015 Sep 22;10(9):e0138877. doi: 10.1371/journal.pone.0138877. eCollection 2015.

ReferenceCitation: Terrien S, Stefaniak N, Morvan Y, Besche-Richard C. Factor structure of the French version of the Hypomanic Personality Scale (HPS) in non-clinical young adults. Compr Psychiatry. 2015 Oct;62:105-13. doi: 10.1016/j.comppsych.2015.07.001. Epub 2015 Jul 8.


title: Profiles of Empathy and Emotional Intelligence Promoted by Written Examination Combined to Oral Interviews During the Selection of 1st Year Health Students at the Paris University of Medicine

acronym: PREMIS

summary:
As the interpersonal skills such as empathy and emotional intelligence take more and more importance in the medical education, the Paris University of Medicine has introduced for the first time in 2019 some multiple mini-interviews (MMI) in addition to the traditional written examination, to graduate the 1st year student in health studies.

The selection process aims at promoting students with high academic results but also with good interpersonal abilities. In this new selection process, MMI will be used in addition to written tests, but only to attribute the last places available after a first ranking based on academic results.

So after the written examination, students with the best written exam marks will directly graduate, others will require MMI to graduate and some will directly fail.

The main hypothesis is that this selection procedure may promote stronger interpersonal abilities profiles in the group that succeed to enter one of the health studies course than in the group that failed.

This study will measure the clinical empathy and emotional intelligence abilities of all the 1st year students applying for this new selection process, using validate self-administered questionnaires.

Then the investigators will compare the scores of empathy and emotional intelligence in the group that succeed the selection process, to the group that failed. Furthermore, in the success group, the investigators will compare the scores between students that directly graduated and students that required MMI. Scores will also be compared considering some sociodemographic data.

The result of that studies could give strong arguments to modify the selection process and extend the use of MMI in medical school in France.

lead_sponsor: University of Paris 5 - Rene Descartes


type: Registry Identifier

title: Monitoring Combining Neurostimulation and Ultrasound Guidance During the Realization of a Peripheral Nerve Block: Value of Objective Measurement of the Pressure of Injection of the Local Anesthetic

summary:
In clinical practice, local anesthetic injection pressure monitoring is performed manually or by a pressure transducer according to the availability of the equipment or preferences of clinicians. To date, no comparative study has measured the advantages of this measure during PNB.

The aim of this study is to evaluate injection pressure monitoring in order to reduce the risk of intraneural injection during peripheral nerve blocks

primary_purpose: Supportive Care

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier


title: Linguistic, Anatomic/Metabolic and Biologic Characterisation of the Three Main Variants of Primary Progressive Aphasia : Towards the Rationale for Drug Trials and Specific Language Rehabilitations

acronym: CAPP

summary:
Primary progressive aphasias (PPA) represent a challenging group of degenerative language diseases that has led to growing interest in the scientific and medical community. However, a full-blown cognitive/linguistic, anatomic and biologic characterization of the three main variants remains incomplete given that the available data derive from relatively small patient samples. Such a three-fold characterisation will be an major milestone with the prospective of providing the rationale for therapeutic interventions comprising specific rehabilitations protocols and pharmacological trials.

The present study addresses theses issues in the three PPA main variants through a cross-sectional and longitudinal investigation exploring 1) cognitive/linguistic features, 2) anatomic/metabolic specifications (MRI-VBM, MRI-fiber tracking, functional connectivity - MRI resting state, PET), and 3) biologic aspects (CSF biomarkers, genetic screening).

location_facility: Département de Neurologie - Centre des maladies neurologiques, cognitives et comportementales


title: Extern Validation of a Predictive Score of Brain Death in Patients With Severe Stroke and Unfavourable Prognosis Identified by Organ Procurement and Transplant Coordinations

summary: There is currently a shortage of organ in France, for patients with chronic diseases who are on the waiting list for an organ. The first source of organ donor in France is patients with brain death. 58% of patients in brain death are patients with a severe stroke ( ischemic or hemorrhagic). In order to identify which patient with a severe stroke and with unfavorable prognosis who can evolve to brain death, we have conducted a retrospective study in Lorrain, in France, and we have built a predictive score of brain death in these patients. It is important to validate this predictive score in a prospective study on a greater scale than the first study.

ReferenceCitation: Humbertjean L, Mione G, Fay R, Durin L, Planel S, Lacour JC, Enea AM, Richard S. Predictive factors of brain death in severe stroke patients identified by organ procurement and transplant coordination in Lorrain, France. Transpl Int. 2016 Mar;29(3):299-306. doi: 10.1111/tri.12695.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHU Besançon
CH de saverne
Ch de Compiègne
CH de Mulhouse
CH de Saint-Quentin
CHR Metz-Thionville
CH Nevers
CH Epinal
CHRU de Strasbourg
CH de Chalons-en-Champagne
CH de Vesoul
CH de Charleville-Mézières
CH Verdun
CH d'Auxerre
CH de Colmar
CHRU de Nancy
CH Troyes
CH de Macon
CHU de Reims
CH Sarreguemines
CH de Haguenau
Lons Le Saunier
CH de Laon
Hôpital Nord Franche
CHU de Dijon


title: Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers

summary: A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of dental cares. This openly clinical trial is done in 36 French primary care dental centers, especially on anxious and phobic patients but also on infants or mental deficient adults. At least 480 patients will be included in this clinical protocol.

lead_sponsor: Air Liquide Santé International


title: Health-economic Impact of Pulse Oximetry Systematic Screening of Critical Congenital Heart Disease in Asymptomatic Newborns

acronym: OXYNAT

summary:
Persistant hypoxemia in the newborn confers, even isolated, an abnormal clinical situation, that needs to be addressed for an adequate diagnosis and an optimal treatment.

If during the first hours of life, hypoxemia is frequent and often transient, beyond that, it is necessary to search the various etiological conditions such as a critical congenital heart disease (CCHD) or a non cardiac affection (sepsis, anemia, respiratory disease).

Newborn pulse oximetry screening identifies babies with critical congenital heart disease (CCHD) based on the rational that they frequently have a degree of hypoxemia that may be clinically undetectable. CCHDs are life-threatening forms of congenital heart disease (CHD) occuring in 2-3/1000 live births but accounting for 3%-7.5% of infant deaths.

Early detection is beneficial because of acute collapse, if not resulting in death, is associated with a worse surgical and neurodevelopmental outcome.

Currently, screening for CCHD involves antenatal ultrasound scanning and post-natal physical examination. Although antenatal detection rates have improved over recent years and can be as high as 70%-80% in some centers, this is not consistent. Indeed, in "Nouvelle Aquitaine" overall <50% of CCHDs are detected before birth. In addition, up to a third of infants with CCHD may be missed on post-natal examination. Pulse oximetry screening can help to close the "diagnostic gap' that is, increase the detection of babies who slip through the current screening net.

Several large European studies and a subsequent meta-analysis have shown that pulse oximetry screening is a highly specific (99.9%) and moderately sensitive (76.5%) test which increases CCHD detection rates. The high specificity results in a low false-positive rate 0.05% to 0.5%. But those babies with a Positive Test, if they may not have CCHD, they may be diagnosed with other causes of hypoxemia (congenital pneumonia, sepsis, persistent pulmonary hypertension,...). As with CCHD, delayed recognition of these conditions can result in postnatal collapse and significant morbidity and mortality. It is also more useful to consider these conditions as secondary targets of screening and to remember they constitute 30%-70% of false positives. In 2011, the US Health and Human Services Secretary recommended that pulse oximetry screening for CCHD be added to the Recommended Uniform Screening Panel. In Europe, implementation is advanced in such countries as North European Countries, and Switzerland. There isn't yet any European guidance. In France, the implementation is limited to local and transient experiments. The feasibility, usefulness and cost-effectiveness of routine pulse oximetry screening have not been evaluated so far. The French setting has two specificities : 1/ the antenatal detection rate is considered to be rather high. 2/ in contrast to a lot of other European countries, early discharge from the maternity ward before 48 hours of life is not common, decreasing the risk of discharging a baby with undiagnosed CCHD, but not saving babies from collapse.

- The Investigators hypothesis is that routine pulse oximetry screening in asymptomatic newborns would allow to reduce the incidence of complications related to CCHDs as well as those related to non cardiac pathologies for a reasonable cost for the French Health Care System.

lead_sponsor: University Hospital, Bordeaux

location_facility: Maison de Santé Protestante de Bordeaux Bagatelle

location_facility: Maternité Pernelle d'Aufrédy CH de La Rochelle - Ré - Aunis


title: Non-interventional Study Evaluating Plerixafor-based Mobilization for Salvage Autologous Hematopoietic Stem Cell Transplantation in Relapsed Myeloma

summary:
Multiple myeloma (MM) is an incurable disease that is characterized by the accumulation of clonal plasma cells in the bone marrow. While MM patients with relapsed disease may achieve responses to subsequent antimyeloma therapies, the duration of response decreases with successive relapses until resistant disease develops. Until recently, the median survival following relapse after induction therapy was approximately one year. The relatively recent US Food and Drug Administration (FDA) approvals of bortezomib (2003) and combination lenalidomide plus dexamethasone (2006) therapies for the treatment of previously treated MM has provided effective therapeutic options that give patients with relapsed or refractory MM the prospect for a prolongation of overall and progression-free survival times. However, MM remains an incurable disease. A clear unmet medical need still exists for additional novel therapeutic options for the treatment of previously treated MM.

Plerixafor reversibly inhibits CXCR4 binding to stromal cell derived factor (SDF)-1alpha and was recently discovered to be an effective agent to mobilize CD34+ cells into the peripheral blood. In normal volunteers, administering Plerixafor after 4-5 days of G-CSF resulted in a 3-3.5 fold increase in circulating CD34+ cells. Two phases 3 studies demonstrated that the combination of G-CSF and Plerixafor is superior to G-CSF alone for mobilizing hematopoietic progenitor cells in front-line or as salvage therapy in patients with multiple myeloma.

Nevertheless, almost all patients ultimately relapse, and no plateau is observed in the survival curves. At the time of disease recurrence, there is not one standard salvage approach, but instead, various therapeutic options are available, including novel agents-based therapy, administered for a fixed duration of time or until progression. In the pivotal trial for the approval of bortezomib as monotherapy in relapsed and refractory MM, the median PFS was 7 months, whereas in the pivotal trials for the approval of lenalidomide in combination with dexamethasone in the same group of patients, the median time to progression was approximately 11 months. A more recent prospective, randomized, phase 3 study has shown that a triplet combination of bortezomib, thalidomide and dexamethasone (VTD) achieved superior results compared to thalidomide dexamethasone (TD) alone in patients relapsing following ASCT, with a median time to progression of 19.5 versus 13.8 months, respectively. This study suggests that combinations consisting of both an IMiD and a proteasome inhibitor are a valuable option at the time of relapse.

However, when a frozen graft is available, it is also possible to repeat high-dose therapy in patients who previously responded to the frontline application of high-dose melphalan and ASCT. Over time, several reports have demonstrated the feasibility of this salvage strategy. The majority of data are available from retrospective studies and are based on single-centre experiences with small numbers of selected patients. In this setting, PFS has been shown to range from 7 to 22 months, and the treatment-related mortality (TRM) was acceptable, ranging from 0 to 8%. Various prognostic factors for prolonged PFS have been described, such as the duration of response to the first high-dose therapy, or the number of lines of therapy prior to salvage ASCT.

With this background, this prospective non-interventional multicentre study will aim to collect data on the feasibility of salvage ASCT using a Plerixafor-based stem cell mobilization in relapsed MM, according to Plerixafor label in France.

This is a non-interventional study; visit will be performed as usual, according to each center practices. No additional visits will be requested for the study purpose. The date for each visit and any data generated must be recorded on the appropriate eCRF.

The study will consist of 3 periods:

An early screening period
Autologous stem cell mobilization period
High dose melphalan therapy and autologous graft infusion and follow-up for12 months after salvage ASCT Inclusion visit

This visit may occur up to 28 days before Mozobil® administration. This visit will be performed during the visit of pre-transplant assessment. For the pre-transplant assessment, the procedures are performed routinely before ASCT even if the patient is not included in the study:

Stem cell mobilization phase The stem cell mobilization phase is performed according to standard practice of each participating centre.

Follow-up visits High dose melphalan administration and autologous graft infusion will be performed according to each centre standard practice. Patients will be followed according to each center practices. The follow-up of this non-interventional study will end 12 months after ASCT.

Subjects will be enrolled over a 2 years period. The total duration of the study will be 36 months

lead_sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation

location_facility: Hématologie Clinique, Hôpital Saint Antoine


title: Performance of Ultrasound in the Early Diagnosis of Vocal Cords Paralysis After Thyroidectomy or Parathyroidectomy (PECV)

acronym: PECV

summary:
Thyroid and parathyroid surgery concerns around 50 000 patients a year in France. One of its main complications is paralysis of vocal cords, and the consequences can be serious.

In this study, the main gold is to evaluate diagnostic performances of ultrasound for an early diagnosis (as soon as awakening of the patient) of vocal cords paralysis in the post-operative period in order to prevent at best complications.


title: PREPARE Work Package 3 -Development of a Serocorrelate of Protection Against GBS - Protocol Harmonisation.

summary: A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and France), with 3:1 (450) serotype matched healthy controls.

lead_sponsor: St George's, University of London

location_country:
United Kingdom
Italy
Uganda
Malawi
France
Netherlands

location_facility: Assistance Publique Hopitaux de Paris (AP-HP)

location_facility: MUJHU - Makerere University Johns Hopkins University Research Collaboration/MUJHU Care Ltd

location_facility: Azienda Ospedaliero-Universitaria di Modena (AOU)

location_facility: Academisch Medisch Centrum,Universiteit van Amsterdam

location_facility: Queen Elizabeth Central Hospital College of Medicine, P.O. Box 30096 Chichiri,


title: Stress Biomarkers Leading to Professional Burnout Among People Involved in a Mobile Intensive Care Unit During the COVID-19 Pandemic

acronym: AUTONOMIC

summary:
This study is aiming at investigating whether professional burnout in people involved in the mobile intensive care unit (in French: Element Mobile de Réanimation, EMR) in Mulhouse (France) can be predicted upstream by a low mindfulness level (as a protective factor) or by a dysregulation of stress pathways with a high level of perceived stress towards an emotional event (psychological index of allostatic load), i.e. an early and silent dysfunctional physiological response (measured by the electrophysiological and biological measurements of allostasis load and parasympathetic brake).

It is part of a global approach aiming at identifying levers to prevent the allostatic load of occupational stress related to large-scale health crises.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Acute Dose-response Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects: Randomized, Cross-over, Double-blind Clinical Study

summary:
It is well established that endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. Finding safe and effective product able to improve endothelial function is of public health interest.

Many clinical studies have shown that monomer of flavanols from cocoa significantly improved endothelial function, in particular endothelium-dependent flow-mediated dilation (ED-FMD) after a single dose. Grape is also a main source of flavanol monomers, that's why many human studies have shown significant effects of grape-derived products on endothelial function within 2 hours following a single dose intake.

The objective of this study is to assess the effect of 2 doses of a proprietary and standardised botanical blend rich in polyphenols (SBRP), on ED-FMD in fasting conditions, in comparison to a placebo, in healthy adults. This blend is made of two botanical extracts: a grape extract and a blueberry extract. In order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product, appropriate biological parameters and circulating metabolites will be assayed.

lead_sponsor: Activ'inside

location_facility: CIC Inserm 1405, University Hospital Clermont-Ferrand,

intervention_type: Dietary Supplement


title: Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

acronym: DATOR

summary: Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency of the graft in terms of restoration of ovarian function and live births. It will also allow us to carry out the patient follow-up after ovarian tissue cryopreservation and after autograft when achieved. In cases of neoplastic malignancies, minimal residual disease detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.

ReferenceCitation: Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.

ReferenceCitation: Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.

ReferenceCitation: Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. Epub 2007 Feb 20.

ReferenceCitation: Pretalli JB, Frontczak Franck S, Pazart L, Roux C, Amiot C; DATOR Group. Development of Ovarian Tissue Autograft to Restore Ovarian Function: Protocol for a French Multicenter Cohort Study. JMIR Res Protoc. 2019 Sep 30;8(9):e12944. doi: 10.2196/12944.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study

acronym: CONFI-DIAB

summary:
The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes.

The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care.

This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.

time_perspective: Cross-Sectional

ReferenceCitation: Ludwig L, Scheyer N, Remen T, Guerci B. The Impact of COVID-19 Lockdown on Metabolic Control and Access to Healthcare in People with Diabetes: the CONFI-DIAB Cross-Sectional Study. Diabetes Ther. 2021 Aug;12(8):2207-2221. doi: 10.1007/s13300-021-01105-y. Epub 2021 Jul 9.


title: Thermal Cures in the Treatment of Multiple Sclerosis: Effectiveness on the Quality of Life

acronym: SPA-SEP

summary: Multiple Sclerosis (MS) is a chronic, progressive disease with a high prevalence in France, with significant public health consequences. The benefit of spa treatments on the quality of life in this population has not been evaluated. The methods of study in clinical pharmacology can be a scientific methodological model for the evaluation of thermal practices and it is in this perspective that investigators want to lead this project.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility: Département de Médecine Physique et de Réadaptation, Hopital LAPEYRONIE


title: Attitude of Unscreened Women Face to Different Strategies to Participate in Cervical Cancer Screening by Vaginal Self-sampling : Home-mailed or Invitation to Remove to Their General Practitioner

summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus oncogene (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening.

primary_purpose: Screening

ReferenceCitation: Boyard J, Caille A, Brunet-Houdard S, Sengchanh-Vidal S, Giraudeau B, Marret H, Rolland-Lozachmeur G, Rusch E, Gaudy-Graffin C, Haguenoer K. A Home-Mailed Versus General Practitioner-Delivered Vaginal Self-Sampling Kit for Cervical Cancer Screening: A Cluster Randomized Controlled Trial with a Cost-Effectiveness Analysis. J Womens Health (Larchmt). 2022 Oct;31(10):1472-1480. doi: 10.1089/jwh.2021.0597. Epub 2022 Jul 13.

lead_sponsor: University Hospital, Tours


title: Is Tele-rehabilitation an Efficacious Alternative to Traditional Center Based Cardiac Rehabilitation After Acute Coronary Syndrome?

acronym: REMOTE-ACS

summary: Despite a clear indication of grade Ia, cardiac rehabilitation (CR) is dramatically underutilized after acute coronary syndrome with less than 30% of patients addressed in France. Mobile technology has the potential to overcome barriers to access to cardiac rehabilitation and may be a useful tool for increasing participation. However, studies have to prove this type of care is as effective as traditional center based cardiac rehabilitation.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Toulouse


title: The Influence of Age on Bispectral Index Associated With Propofol-induced Sedation

summary:
The bispectral index (BIS) is commonly used in anesthesia to evaluate the depth of sedation. Numerous studies in adults have shown good correlation between bispectral index values and depth of sedation regardless of the hypnotic drug used. Requirements of intravenous and inhalational hypnotic agents to suppress consciousness decrease with age. A study showed that the loss of consciousness (LOC) was obtained with lower concentrations of sevoflurane in elderly than in young adults, but at identical BIS values, so that BIS would predict depth of sedation better than drug monitoring. This result incited the use of bispectral index monitoring to overcome the significant pharmacological variability, especially in elderly. Nevertheless, another research with a comparable methodology during propofol-induced anaesthesia provided higher BIS values at LOC in elderly compared to younger patients. In these two trials, LOC was defined differently: either by absence of verbal response corresponding to loss of eyelash reflex (LOER) or by absence of response to prodding [(OAA/S) <2)]. Otherwise electromyographic activity (EMG) was not taken in account. As high EMG level (greater than 50 decibels) could create subtle artifact signal pollution without necessarily being displayed as artifacts, this would be misinterpreted by the BIS algorithm as EEG activity and assigned a spuriously increased BIS value.

The main objective of our study was to specifically evaluate BIS values according to age during propofol-induced sedation. LOC was measured by obtaining an OAA/S score <2 (OAA/S2), or a deeper sedation criterion: loss of eyelash reflex (LOER). The secondary objective was to specify the influence of EMG on the displayed BIS values and its age-related modifications.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP

acronym: PREPADROP

summary: LASIK is a refractive surgery technique widely used in France. Postoperatively, the classic treatment after LASIK consists of instilling drops to reduce dry eyes. REPADROP® is an innovative eye drops stimulating corneal innervation. To date no study has quantified the improvement in dry eye syndrome and thus the quality of life of patients using REPADROP®.


title: Epidemiological Study on the Vaccination Coverage of the Population Aged 75 Years and Over in Picardy. According to the Study of 200 Patients Followed by General Practitioners of the Somme in 2016.

acronym: PICARVAC

summary: In France, the vaccination coverage of seniors is clearly deficient. It seems to be a cultural specificity, dating back more than 100 years, and which does not exist in Scandinavia, nor in much of the Anglo-Saxon world. Only influenza vaccination is a success for seniors. The high public health council sets the objective of immunization coverage in patients over 65 years of age to 80% whether or not the patient is benefiting from an exonerative ALD. The data collections carried out with the various pension funds objective have a lower immunization coverage with a rate ranging from 48.8 to 64%. Thus any medical consultation should be an opportunity to update the vaccination schedule of adults and the elderly.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation à Six Mois du système de dénervation rénale Chez Les Patients Atteints d'Insuffisance Cardiaque

acronym: DENRENIC

summary:
Management of chronic heart failure (CHF) is a major public health problem. It is associated with high mortality, frequent hospitalization and represents a large cost to the health care system. Both pharmacological and non-pharmacological intervention haven't shown to be effective in reducing morbidity and mortality of these patients when able to modulate the activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data have emphasized the potential role of sympathetic renal denervation in patient with hypertension. CHF per se but even more CHF associated with comorbity lead to significant increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as chemo or baroflex abnormalities. These patients usually suffer from conditions which do not allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic heart failure affects around 100 million people worldwild imposing a significant burden on health care system throughout the world. Even though symptoms are improved by heart failure therapy, they remain significantly disabling for many patients. Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs. A new therapy directly targeting nerve traffic-renal artery denervation- has been shown to be effective in drug resistant hypertension, with an average drop in blood pressure of 33/12 mm hg.

The cardiologists team of the private hospital Arnault Tzanck is willing therefore to conduct a study in 12 patients with chronic systolic heart failure undergoing bilateral renal denervation with an intensive protocol of observation and assessment compring a 3 day hospital stay post procedure 3 and 6 months of regular outpatient follow-up.

lead_sponsor: Institute Arnault Tzanck, France


title: Cryotherapy Under Interventional Radiology Combined With in Situ Ipilimumab and a Flat Dose of Nivolumab in Stage IIIB/C Melanoma. Prospective Proof of Concept Study.

acronym: CRIRIN

summary:
Melanoma is the deadliest form of skin cancer and its incidence has doubled every 20 years in France, where this cancer is responsible of more than 1600 deaths each year.

Patients with early diagnosis have good prognosis and can be generally cured by surgery only. Advanced melanoma however has a very bad prognosis.

Loco-regional lymph nodes are usually the first distant localization in metastatic melanoma. Lymph node dissection is then the recommended treatment, although it's impact on survival has never been proven.

In the same way, the benefit risk profile of interferon as adjuvant treatment after lymph node dissection is still much debated.

Recently, new treatments either with immunotherapy (ipilimumab, nivolumab) or by the targeted therapy dabrafenib/trametinib in patients with BRAF mutation have shown an impact on survival in the adjuvant setting after lymph node dissection.

But, it has not yet been established if this strategy has a benefit gain compared to starting those treatments only in the metastatic setting after watchful follow-up.

Moreover, if these novel therapies (targeted therapies: TT, immunotherapies : IT) demonstrated for the first time a real benefit in terms of survival or of responses rates in melanoma, physicians and patients had to address new problems, such as the management of unusual adverse events.

Partial and dissociated responses can also be seen with those new treatments. Some patients will have complete response in some lesions, stabilization in others and progression in a few. It is to be expected that one of the real key points of this therapy is to be found here, as this situation is commonly seen, and it would probably be a poor choice to stop a treatment that is globally effective for progression of only 1 or 2 lesions, in a patient otherwise stabilized.

That is the context in which interventional radiology (IR) should be considered as an extremely efficient option. IR is a real medical revolution in the last 2 decades.

It provides not only the opportunity to determine the characteristics of residual lesion (fibrosis, necrosis, metastasis, or sarcoidosis,…) by biopsy, but allows also their targeted destruction through different technics (cryotherapy, radiofrequency, laser,…).

The investigators are fortunate to have in their institution one of the best IR department of the world (headed by Prof. Afshin GANGI), with a technical platform unique in Europe that allows IR through ultrasound, scan, petscan and MRI.

To the best of their knowledge, Immunotherapy associated with IR has not been performed so far.

This association could in theory:

Combine immunotherapy with tumoral necrosis, which inherently increases the effects of immunotherapy by massive tumoral leakage of danger signals and tumoral antigens;
Allow direct injection in targeted zones, where the beneficial effect is desired, and thus increase the expected immune response;
Reduce side effects related to immunotherapy, by reducing quantities injected; which seems particularly important in the (neo)-adjuvant setting.

That's why the investigators are willing to conduct this pilot project, the objectives of which are:

Providing a proof of the feasibility of this association,
Obtaining preliminary insights on the effects on non-targeted lesions,
Adding a translational research to establish the effect on tumor antigenic expression and the immune response.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Clinique Dermatologique/Radiologie Interventionnelle/Urologie/Gynécologie-CHU de Strasbourg/ICANS


title: Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)

acronym: Misoprostol

summary: In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. There are currently several studies on the subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of administration and gestational age differ in all studies. Currently, HAS recommends the vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to compare the different routes of administration of Misoprostol at the same dose to allow to change our French recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.


title: Cost-effectiveness Analysis Associated With the Use of Resorbable Biosynthetic Parietal Prostheses Compared to Biological Prostheses in Contaminated (mVHWG Grade 3) Abdominal Wall Reconstruction

summary:
Eventration corresponds to the dehiscence of the abdominal wall, with passage of peritoneum and / or intra-abdominal viscera, through an acquired orifice of the abdominal wall. It is secondary to an old incision and occurs in 10 to 20% of cases after a laparotomy. At present, if there is no debate on the type of prosthesis to implant in case of clean surgery: it is a synthetic prosthesis. But in the case of contaminated surgery (modified Ventral Hernia Working Group grade 3), there is no consensus.

Since the 1990s, biological prostheses have been recommended, but they represent significant expenses for health facilities. They are very numerous, and their prices vary between 3 000 € and 12 000 €. The choice is therefore difficult for the surgeon.

In 2016 the Strasbourg University Hospital general surgery team made the choice to use biosynthetic prostheses. This attitude does not seem consensual and is not based on any recommendations at present, either in France or internationally. The homogenization of practices requires the availability of clinical and medico-economic data, particularly in view of the price differences that exist between different types of prostheses.

The main objective of this study will be to compare the use of biosynthetic prostheses with biological prostheses in the treatment of curative surgical treatment of mVHWG grade 3 incisional hernias in terms of cost and serious complications at 6 months.

The secondary objective of the study will be to estimate the number of early recurrences at 6 months avoided, thanks to the use of biosynthetic prostheses compared to biological prostheses.

ReferenceCitation: Charleux-Muller D, Romain B, Boisson C, Velten M, Brigand C, Lejeune C. Cost-effectiveness analysis of resorbable biosynthetic mesh in contaminated ventral hernia repair. J Visc Surg. 2022 Aug;159(4):279-285. doi: 10.1016/j.jviscsurg.2021.06.001. Epub 2021 Jun 9.

location_facility: Service de Chirurgie générale et digestive


title: Behaviour and Experience of Communities Healthcare Professionals Facing the SARS CoV-2 Epidemic

acronym: COVecu

summary: The purpose of this study is to identify behaviours and experiences of communities healthcare professionals (doctors, nurses and physiotherapists) in the management of the SARS-CoV 2 epidemic by identifying the impact of the epidemic on their work, their personal life and the difficulties they had experienced.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Analyse de l'activité cérébrale intrinsèque Pendant le Coma et Lors du Retour à la Conscience

acronym: ACI-Coma

summary: Several studies in healthy volunteers have suggested that the synchronized functional connectivity in the DMN (Deafult-Mode Network) would sustain the mental content at rest, and when required, a switch in the activity between the DMN and other networks involved in specific congnitive functions, would occur. This interaction permit to make the hypothesis, that baseline brain activity is likely to shape our ongoing " stream of consciousness " and could correlate with conscious perception. The investigators hypothesized that DMN connectivity strength would be related to the level of consciousness of brain-damaged patients. The investigators will follow severely brain-injured patient in coma. Clinical examination using standardized behavioural scales: FOUR score (Full Outline of UnResponsivess), Coma Recovery Scale-Revised); and brain imaging assessesments using MRI (functional and anatomical connectivity, cortical thickness) will be performed at: 3 to 30 (visit 1), and 60 (visit 2) days after insult. If patient recover a normal conscious state between 30 and 60 days, an additional clinical and brain imaging assessment will be performed to identify related changes in brain activity (visit 1*) Monitoring of vital parameters will be performed in patients by a senior anaesthesiologist throughout the experiment.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Institut National de la Santé et de la Recherche Medicale, U825


title: Setting up a Website in Paediatric Surgery at the Rouen University Hospital for Parents and Children to Better Understand the Postoperative Prescription of Painkillers.

acronym: DOLIPAR

summary: Although outpatient surgery is increasing in France, particularly in paediatrics, compliance with analgesics prescriptions and pain management on return home remain poorly controlled parameters, although they are essential for optimal care. This is due, among other things, to parents' lack of knowledge and fears about the medicines prescribed to them. The paediatric anaesthesia unit of the Rouen University Hospital has set up a website for families to improve understanding of and compliance with the prescription of painkillers and thus improve the management of postoperative pain.

lead_sponsor: University Hospital, Rouen


title: Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients. Qualitative Approach

summary:
Systematic screening for cervical cancer stops in France at 65 years old. The incidence of certain types of gynecological neoplasia increases with age (endometrium, vulva). Diagnosis delay of 8 months has been described for uterine cancer and longer delays for vulvar cancer.

The aim of our study is to understand help-seeking behavior and its delay for this type of cancer among patients older than 65.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility: Institut de Cancérologie de Lorraine (ICL)


title: Development and Evaluation of a Therapeutic Education Intervention in Prostate Cancer Patients Treated With Radical Prostatectomy to Improve Their Sexuality

acronym: PRODUCAN

summary:
Prostate cancer is the most common cancer in France (54,000 cases in 2011). About 20,000 radical prostatectomies (PR) per year are performed. Despite the progress of PR over the past 20 years, the rate of erectile dysfunction post PR varies between 30 and 90% and only 16% of operated men recover their pre-treatment erections.

There is currently no validated post-prostatectomy rehabilitation protocol. The associations of patients, including the National Association of Prostate Cancer Patients have a very strong demand for treatment of sexual problems after treatment.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Centre Hospitalier Lyon Sud
Hôpital Hédouard Herriot


title: Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer

acronym: TEP Vessie

summary:
Bladder cancer is the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years.

Optimal staging of lymph nodes and metastasis is crucial for treatment decision of muscle invasive bladder cancer (MIBC).

Guidelines do not recommend FDG-Positron Emission Tomography (PET) Computed Tomography (CT), but rather CT for lymph node and metastatic staging, despite its low accuracy. We performed a retrospective analysis of patients undergoing PET CT for localized MIBC in two centers, to help define the utility of PET CT in this setting.

lead_sponsor: Institut Bergonié

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Interest of Routine Screening for Hepatitis B and C in Patients Receiving Chemotherapy for Solid Tumors

acronym: HepScreen

summary:
Immunosuppression induced by cancer treatment increases the risk of hepatitis B virus (HBV) and hepatitis C virus (HCV) reactivations. These viral reactivations may be asymptomatic but can cause fulminant hepatitis and death. More, they impact the treatment of cancer by chemotherapy delays or stops. They can occur during cancer treatment but also after stopping, at the immunological rebound. This risk persists for at least 6 months after cessation.

The key to the prevention, and the first step, is serological testing. It is also the main problem because international recommendations diverge. Hepatologists and infectious disease specialists recommend routine screening HBV of all candidates for immunosuppressive therapy. These recommendations are more implemented by hematologists, given the frequency of HBV reactivation associated to haematological malignancies. Clinical oncology societies guidelines suggest a selective screening in case of risk factors of hepatitis B or in patients with a strong immunosuppression (such as anti-CD20 based treatment, stem cell transplantation or lymphoma treatment).

The consequence of these differences is a sub-screening by oncologists and the persistence of fatal cases. Screening before cytotoxic chemotherapy for solid tumors in countries with low prevalence of HBV and HCV virus is questionable. Selective screening of patients at risk HBV and HCV can be assessed.

ReferenceCitation: Brasseur M, Heurgué-Berlot A, Barbe C, Brami C, Rey JB, Vella-Boucaud J, Dabouz F, Deslée G, Grange F, Volet J, Bouché O. Prevalence of hepatitis B and C and sensibility of a selective screening questionnaire in patients receiving chemotherapy for solid tumors. BMC Cancer. 2015 Dec 23;15:999. doi: 10.1186/s12885-015-2033-z.

lead_sponsor: CHU de Reims


title: Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease

summary: ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of cognitive training, reminiscence therapy and a "made-to-measure" program on the progression rate of dementia.

ReferenceCitation: Clare L, Woods RT, Moniz Cook ED, Orrell M, Spector A. Cognitive rehabilitation and cognitive training for early-stage Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2003;(4):CD003260. Review. Update in: Cochrane Database Syst Rev. 2013;6:CD003260.

lead_sponsor: University Hospital, Bordeaux

location_facility: CMRR & Neuropsychologie, Pavillon de Neurologie, CHU de Grenoble

location_facility: Association AA83 Alzheimer Aidants Var Etablissement " Les pensées "

location_facility: Centre Mémoire de Ressources et de Recherches de Bordeaux, CHU de Bordeaux