title: Combination of Baricitinib and Adalimumab vs. Baricitinib in Patients With Rheumatoid Arthritis: a Randomized Placebo-controlled Phase III Trial

acronym: CRI-RA

summary:
As stated by the European League Against Rheumatism (EULAR) and the Société Française de Rhumatologie (SFR), treatment of patients with rheumatoid arthritis (RA) should target sustained remission or at least low disease activity. However, despite significant advances based on various combinations of conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and biologic DMARDs, RA therapies meet treatment goals only in some patients:

40 to 50% of patients with early RA, treated with methotrexate (MTX) monotherapy as first-line therapy,
20 to 30% of patients treated with a combination of MTX and biologic as second-line therapy.
Less than 10% of patients treated with a combination of MTX and another targeted DMARD, such as baricitinib, as third-line therapy.

Therefore, new strategies targeted at achieving a higher percentage of remission are needed, that do not require waiting for multiple failed therapies. Combinations of biologics have shown synergistic improvement of symptoms in murine models of RA relative to the improvement observed with either agent alone. However, in RA patients, only five randomised clinical trials (RCTs) have explored the efficacy and safety of combining tumour necrosis factor (TNF) inhibitor with another biologic (anakinra, abatacept, rituximab or bimekizumab).

Baricitinib is a selective, reversible and competitive inhibitor of Janus kinases (Jaki). This treatment is efficient in a number of therapeutic scenarios in RA and showed a clinical superiority over adalimumab in one RCT (RA-BEAM study in MTX inadequate responders). Of note, baricitinib inhibits many of the pro-inflammatory cytokines involved in the pathogenesis of RA but does not block signalling downstream of TNF. Owing to the interest in combining different mechanisms of action, the investigators plan to assess the efficacy and safety of combination therapy with baricitinib and a TNF inhibitor (adalimumab). The investigators are aware that combining targeted therapies is not recommended due to a potential increase in the frequency of serious adverse events. However, several case series on patients treated with a combination of targeted therapies have been published, suggesting a certain efficacy in patients with refractory RA. The first ones focused on inflammatory bowel diseases and psoriasis, but more recently, combination of tofacitinib (which belongs to the same Jaki family as baricitinib) with various biologics has been reported in a sample of RA patients. No serious adverse effects were reported over a mean of approximately 11 months of therapy. The clinical improvement was mild but noticeable in these refractory RA cases.

Recently, data of interest from the RA-BEAM study have been reported. Patients who switched from adalimumab to baricitinib showed improvements in disease control. Because the switch from adalimumab to baricitinib occurred without a washout period, and because adalimumab has a mean circulating half-life of approximately 14 days, patients would have received several weeks of dual TNF and Jak1/Jak2 inhibition in the course of the change of treatment. The observation of increased efficacy, with no apparent acute safety issues during the weeks when patients were exposed to both adalimumab and baricitinib, is of interest, and supports our strategy to combine the two treatments for patients with refractory RA.

The investigators consider that there is a need for investigation into the addition of adalimumab to baricitinib in patients suffering of refractory RA (inadequate response to TNF inhibitors). The investigators hypothesize that in this population, based on ACR50 score, this combination therapy will decrease disease activity more efficiently than a switch to another targeted DMARD, such as baricitinib.

location_country: France Monaco

location_facility: Hôpital Saint-Joseph - service de rhumatologie

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille - service de rhumatologie

location_facility: CHU de Toulouse - service de rhumatologie

location_facility: AP-HP - Hôpital Cochin - service de rhumatologie

location_facility: CHU de Saint-Etienne- service de rhumatologie

location_facility: Clinique de l'Infirmerie - service de rhumatologie

location_facility: Polyclinique de Limoges - service de rhumatologie

location_facility: CH de Saint-Malo - service de rhumatologie

location_facility: AP-HP - Hôpital Bichat - service de rhumatologie

location_facility: AP-HP - Hôpital Saint-Antoine - service de rhumatologie

location_facility: CHU de Clermont-Ferrand - service de rhumatologie

location_facility: Nouvel Hôpital Orléans La Source - service de rhumatologie

location_facility: CHU de Montpellier - service de rhumatologie

location_facility: service de Rhumatologie - CH Princesse Grace

location_facility: Hospices Civils de Lyon - service de rhumatologie

location_facility: AP-HP - Hôpital La Pitié-Salpetrière - service de rhumatologie

location_facility: AP-HP - Hôpital Kremlin-Bicêtre - service de rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie

location_facility: CHRU de Strasbourg - service de rhumatologie


title: Risk of Morbidity, Mortality and Long-term Monitoring of Antiretroviral Treatment in People Living With HIV: The ANRS CO3 Aquitaine Cohort - AquiVIH-NA

acronym: AquiVIH-NA

summary:
HIV infection is now a chronic disease in countries where antiretroviral treatments (ART) are largely available. Long-term follow-up is required to describe and understand the evolution of morbidities and complications as well as new treatments side effects.

The main objective of the cohort is to describe and study the evolution of HIV infection in ART-treated individuals.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Barger D, Hessamfar M, Neau D, Vareil MO, Lazaro E, Duffau P, Rouanes N, Leleux O, Le Marec F, Erramouspe M, Wittkop L, Dabis F, Bonnet F. Assessing the psychometric properties of the French WHOQOL-HIV BREF within the ANRS CO3 Aquitaine Cohort's QuAliV ancillary study. Health Qual Life Outcomes. 2020 Jul 10;18(1):220. doi: 10.1186/s12955-020-01451-8.

ReferenceCitation: Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Wittkop L, Dabis F, Bonnet F. Web-Based Module for the Collection of Electronic Patient-Reported Outcomes in People Living With HIV in Nouvelle Aquitaine, France: Usability Evaluation. JMIR Form Res. 2019 Dec 18;3(4):e15013. doi: 10.2196/15013.

ReferenceCitation: Barger D, Leleux O, Conte V, Sapparrart V, Gapillout M, Crespel I, Erramouspe M, Delveaux S, Dabis F, Bonnet F. Integrating Electronic Patient-Reported Outcome Measures into Routine HIV Care and the ANRS CO3 Aquitaine Cohort's Data Capture and Visualization System (QuAliV): Protocol for a Formative Research Study. JMIR Res Protoc. 2018 Jun 7;7(6):e147. doi: 10.2196/resprot.9439.

lead_sponsor: University Hospital, Bordeaux

location_facility: service de maladies infecteieuses - CH Saint-Cyr

location_facility: service de médecine interne et maladies infectieuses - Hôpital Saint-André

location_facility: service de médecine interne et maladies infectieuses - CH de Périgueux

location_facility: service de médecine inter et maladies infectieuses - Hopital Saint André

location_facility: service de médecine interne et maladies infectieuses - CH de Dax

location_facility: service de médecine interne - CH d'Arcachon

location_facility: service de maladies infectieuses - CH de la Côte Basque

location_facility: service de maladies infectieuses et médecine tropicale - Hôpital Pellegrin

location_facility: service de médecine interne et maladies infectieuses - CH de Pau

location_facility: service de médecine interne - CH de Mont de Marsan

location_facility: Médecine Interne - CH de Saint-Jean-D'Angely

location_facility: service de médecine interne - CH d'Orthez

location_facility: service de médecine interne et maladies infectieuses - Groupe hospitalier Sud

location_facility: Médecine interne et Maladies Infectieuses - CHU de Poitiers

location_facility: service de médecine interne - CH de Libourne

lead_sponsor_type: academique

status_simplified: Ongoing


title: The MOVE-study: Morning Versus Evening Administration of 500 mcg Roflumilast Once Daily for 6 Weeks in Patients With Asthma

summary:
Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma.

The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. Roflumilast will be administered orally either in the morning or in the evening at one dose level. The study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Bateman ED, Bousquet J, Aubier M, Bredenbröker D, O'Byrne PM. Roflumilast for asthma: Efficacy findings in non-placebo-controlled comparator and dosing studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S11-9. doi: 10.1016/j.pupt.2015.10.002. Epub 2015 Oct 8.

lead_sponsor: AstraZeneca

location_country:
Belgium
Spain
Australia
France
South Africa

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies

lead_sponsor: Vertex Pharmaceuticals Incorporated

source: euctr

enrollment_type: Actual

location_country:
Canada
Puerto Rico
United States
France
Germany

location_facility:
South Carolina
Colorado
Georgia
New York
Michigan
Texas
California
New Mexico
Canada
Alabama
Maryland
France
North Carolina
Florida
Ohio
Massachusetts
Virginia
Germany
Puerto Rico
Missouri

summary: Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.


title: Multicentre Trial, With Stepped Wedge Randomized Controled Clusters, on Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease

summary: This medico-economic research project (PRME) aim to analyse NeLLY service efficiency for not on dialysis severe chronic kidney disease (DFG < 30ml/mn) patients care. NeLLY is a service that includes telemonitoring, educational therapy and support for patients with severe chronic kidney disease.

study_start_date_type: Anticipated

status: Unknown status

primary_purpose: Health Services Research

ipd_sharing: No

lead_sponsor: Calydial

location_facility: Centre hospitalier Saint Joseph Saint Luc

intervention_type: Device

status_simplified: Unknown


title: Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial

acronym: DC-SCENIC

summary:
Critical care patients experience systemic aggression, which may be the result of trauma, infection or other systemic inflammatory mechanisms. The initial phase of their illness is characterized by metabolic instability and increased catabolism. Nutrition goals in these patients are therefore, on the one hand, to provide sufficient caloric intake to cover energy expenditure while limiting the risks of inappropriate under-feeding, overfeeding- or re-feeding syndrome, and on the other hand, to meet the protein requirements linked to hypercatabolism. In the absence of contraindication, current recommandations state that an intensive care patient who cannot be fed orally, shoul receive continuous enteral nutrition over 24 hours by gastric tube within 48 hours of admission.

However, this 24-hour continuous nutrition method does not correspond to the physiological habit of the human species which includes a physiological nighttime fasting period.This fasting period induces a metabolic switch that regulates several pathways, including glycemic control, oxidative stressresistance and DNA repair. Furthermore, it takes part un the synchronization of cellular circadian rhythms.

Investigator hypothetises that diurnal cyclic enteral nutrition may improve the prognosis of severe intensive care patients compared to continuous enteral nutrition.

status: Not yet recruiting

primary_purpose: Other

lead_sponsor: Centre Hospitalier le Mans

location_facility:
CHU Angers
CHRU Tours
Centre Hospitalier Du Mans

intervention_type: Other


title: First-In-Human, Open Label, Dose Escalation Study to Evaluate Safety, PK and PD of ABD-3001 as Monotherapy in Relapsed/Refractory Acute Myeloid Leukemia or High/Very-high Risk Myelodysplastic Syndromes Patients, Ineligible for Intensive or New Generation Targeted Therapy.

acronym: ODYSSEY

summary: This First In Human (FIH) study is a prospective, open-label, multicenter, Phase 1 study, with a dose escalation design, followed by an optimized design. It will consist in a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part followed by a "Regimen optimization" part with an extension cohort.

design_allocation: Non-Randomized

lead_sponsor: Advanced BioDesign

location_facility:
Centre Hospitalier Lyon Sud
Hôpital Saint-Louis
Hôpital de la Timone


title: Development of a Microsampling Approach for Personalized Monitoring of Kinase Inhibitor Targeted Therapies

acronym: MISTIK

summary: The MISTIK project aims at clinically validating the technique of oral anticancer drugs determination by volumetric absorptive micro-sampling and at comparing the results to measurements performed on venous samples.

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility: Institut de cancérologie Strasbourg Europe


title: Validation of the New Vibration-guided FibroScan Examination

summary: This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 100 adults patients will be included. The study objective is to compare the applicability between the Research FibroScan and the reference FibroScan examination performed on the liver.

lead_sponsor: Echosens

location_facility:
Hôpital Beaujon
Hospices Civils de Lyon - Lyon Sud
CHU de Nancy


title: Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

acronym: COLODIAG

summary: The aim of the study is to validate the value of value of peripheral blood protein biomarkers in colorectal cancer screening, and to identify new ones

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Rouen

location_facility:
Dijon University Hospital
Caen University Hospital
Clinique du Cèdre

intervention_type: Diagnostic Test


title: A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports

summary: The purpose of this study is to evaluate performance and safety of POLYSITE® and SEESITE® implantable ports allowing repeated and prolonged access to the venous system for the administration of chemotherapy, antibiotics, antiviral drugs, parenteral nutrition, and for blood transfusion or blood derivatives transfusion.

time_perspective: Retrospective

lead_sponsor: Perouse Medical

location_facility:
IGR
CHR d'Orléans
Hopital Foch


title: Evaluation of the Value of Perianal Infiltration During Thermodestruction of Haemorrhoidal Disease by Radiofrequency

acronym: RAFAELOCAL

summary:
Haemorrhoidal disease is a common and benign condition (1). Anatomically, there is an external and internal component. Only internal haemorrhoidal disease is managed by radiofrequency. Different levels of severity of internal haemorrhoidal disease have been defined by the Goligher classification (1). According to the recommendations for clinical practice established by the French National Society of ColoProctology (SNFCP), grade I and II haemorrhoidal disease should be managed instrumentally after failure of medical treatment. Grade III and IV haemorrhoidal disease is an indication for surgical management in the first instance or after failure of instrumental treatments. The standard technique is the Milligan and Morgan procedure (pedicle haemorrhoidectomy) described in 1937 (2). This technique consists of the removal of the 3 internal haemorrhoidal bundles. It remains the most effective but is responsible for postoperative complications, in particular pain, haemorrhage, anal strictures and anal incontinence (3), (4). Less aggressive techniques have been developed (Longo technique, HAL-RAR technique). The Longo technique is a circular stapling haemorrhoidopexy. The haemorrhoidal packets are brought up into the anal canal with the help of a circular aggravating forceps removing a collar of rectal mucosa. This removal of the mucosa also allows the vascularisation of the haemorrhoidal venous network to be interrupted. The HAL- RAR technique is a non-resection technique consisting of arterial ligation of the haemorrhoidal packets in order to interrupt the vascularisation supplying the haemorrhoidal packets. This technique can be performed with or without Doppler guidance. Recently, Renshaw et al. described a technique for coagulation of haemorrhoidal bundles using a radiofrequency probe (5).

This technique has shown satisfactory results and is an interesting option in the management of haemorrhoidal disease (6) with low postoperative pain (7).

In order to limit patients' postoperative pain and reduce their apprehension during defecation episodes, a perianal block has been shown to reduce postoperative pain in patients with a haemorrhoidectomy technique (8,9). In 2019, a prospective randomised trial (10) confirmed the value of this perianal block without a neurostimulator during a haemorrhoidal pack resection procedure. A perianal infiltration of 40 ml of 0.5% Ropivacaine was performed. These 40ml were divided into 4 injections of 10ml each in the left and right antero-lateral position and in the left and right postero-lateral position in relation to the anal margin.

The hemorrhoidal pack resection technique is known to induce postoperative pain. Haemorrhoidal radiofrequency (RAFAELO® procedure) is a new minimally invasive technique that reduces postoperative pain and is usually performed on an outpatient basis (6). Currently, peri-anal infiltration is routinely performed for all haemorrhoidal surgery whether or not there is a haemorrhoidal resection. No studies have evaluated the relevance of maintaining peri-anal infiltration in non-resected haemorrhoidal surgery and in particular during radiofrequency haemorrhoidal packets. In addition, ropivacaine infiltration is not without risks. Local anaesthesia has potential risks for the patient:

Adverse reaction or hypersensitivity to local anaesthetics and components
Infection at the injection site or infiltration
Haematoma at the injection or infiltration site The aim of our study is to demonstrate the non-inferiority of discontinuing perianal infiltration in patients with thermodestructive haemorrhoidal surgery.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Centre Hospitalier Universitaire de Nantes


title: A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses

summary:
POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device.

PMCF Study.

location_facility:
CHU CAEN
CHU La Pitié Salpétrière
CHU de NANTES

intervention_type: Procedure


title: Tolerance and Efficacy of Amiklin Administration During Nosocomial Infections Complicating COVID-19 in the ICU

summary:
The most severe infectious episodes are managed in intensive care. Classically, a distinction is made between sepsis, an infection associated with an inappropriate, excessive response of the immune system, responsible for organ dysfunction, and septic shock, during which, within the potential dysfunctions, hemodynamic alteration is central, requiring the introduction of catecholamines. The seriousness of these disorders, particularly because of their potential short-term severity, requires immediate treatment. The treatment of severe infections is based on the control of microbial proliferation, particularly bacterial. In this context, the speed of antibiotic therapy is associated with patient prognosis. If the administration of antibiotic therapy is an emergency during severe infections, particularly in situations of septic shock, its choice is decisive in the effectiveness of management and in the prognosis of the patient. Prior to microbiological results, antibacterial treatment is probabilistic. In spite of these numerous parameters, failure of probabilistic antibiotic therapy, due to a spectrum unsuited to the pathogens, is described in 15 to 30% of cases. In order to limit the risk of inappropriate treatment, it is recommended that broad-spectrum antibiotic therapy be used in states of shock of infectious origin. Because of their bactericidal properties, their kinetics of effectiveness, their marked post-antibiotic effect, their bioavailability in the plasma sector, and their synergy with beta-lactams, aminoglycosides are often recommended in combination in the initial probabilistic treatment. Despite numerous studies and extensive international experience with aminoglycosides, their real value in the management of severe infections remains uncertain, leading to contradictory information depending on whether one is interested in their benefit in the treatment of identified infections or in the probabilistic treatment of severe conditions.

During the management of severe intensive care patients, the pharmacokinetics of drugs, especially antibiotics, are considerably modified. As a result, monitoring of plasma, or better, tissue concentrations of antibiotics is suggested by learned societies, although their practical realization is still very limited by numerous obstacles.

Misuse of aminoglycosides is associated with a risk of acute renal failure, centered on the tubular toxicity of the antibiotic. While the risks associated with inappropriate frequency of administration are currently modest, those associated with high peak concentration, responsible for an increase in the duration of renal exposure, are not well known.

COVID-19 is also associated with a high risk of impaired renal function. The effect of aminoglycoside administration in the context of COVID-19 remains unknown. Our goal is to determine whether the presence of COVID-19 associates with an elevated risk of renal failure when prescribing aminoglycoside.

status: Active, not recruiting

ReferenceType: background

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

ReferenceCitation: Prescott HC, Angus DC. Enhancing Recovery From Sepsis: A Review. JAMA. 2018 Jan 2;319(1):62-75. doi: 10.1001/jama.2017.17687. Review.

ReferenceCitation: Brun-Buisson C, Meshaka P, Pinton P, Vallet B; EPISEPSIS Study Group. EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units. Intensive Care Med. 2004 Apr;30(4):580-8. Epub 2004 Mar 2.

ReferenceCitation: Pletz MW, Blasi F, Chalmers JD, Dela Cruz CS, Feldman C, Luna CM, Ramirez JA, Shindo Y, Stolz D, Torres A, Webb B, Welte T, Wunderink R, Aliberti S. International Perspective on the New 2019 American Thoracic Society/Infectious Diseases Society of America Community-Acquired Pneumonia Guideline: A Critical Appraisal by a Global Expert Panel. Chest. 2020 Nov;158(5):1912-1918. doi: 10.1016/j.chest.2020.07.089. Epub 2020 Aug 25. Review.

ReferenceCitation: Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96.

ReferenceCitation: Kumar A. Early antimicrobial therapy in severe sepsis and septic shock. Curr Infect Dis Rep. 2010 Sep;12(5):336-44. doi: 10.1007/s11908-010-0128-x.

ReferenceCitation: Seymour CW, Kahn JM, Martin-Gill C, Callaway CW, Yealy DM, Scales D, Angus DC. Delays From First Medical Contact to Antibiotic Administration for Sepsis. Crit Care Med. 2017 May;45(5):759-765. doi: 10.1097/CCM.0000000000002264.

ReferenceCitation: Whiles BB, Deis AS, Simpson SQ. Increased Time to Initial Antimicrobial Administration Is Associated With Progression to Septic Shock in Severe Sepsis Patients. Crit Care Med. 2017 Apr;45(4):623-629. doi: 10.1097/CCM.0000000000002262.

ReferenceCitation: Skorup P, Maudsdotter L, Lipcsey M, Larsson A, Sjölin J. Mode of bacterial killing affects the inflammatory response and associated organ dysfunctions in a porcine E. coli intensive care sepsis model. Crit Care. 2020 Nov 14;24(1):646. doi: 10.1186/s13054-020-03303-9.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
Groupe Hospitalier Paris Saint-Joseph
Centre Hospitalier Bicetre
Hôpital Cochin


title: Randomized Phase II Trial Evaluating Compliance With Monitoring Conducted Either by a Hospital-based Physician in Person or by a Nurse in Remote Monitoring

acronym: SUR-CAN

summary: This is a multicenter, interventional, randomized study among adult patients recently diagnosed with a rare tumor (<12 months). The study will aim to compare compliance with the personalized post-treatment surveillance plan, established for each patient according to national guidelines, when the surveillance is conducted in person by a hospital-based physician (control arm) or remotely by a trained nurse (experimental arm).

ReferenceCitation: Kimman ML, Bloebaum MM, Dirksen CD, Houben RM, Lambin P, Boersma LJ. Patient satisfaction with nurse-led telephone follow-up after curative treatment for breast cancer. BMC Cancer. 2010 Apr 30;10:174. doi: 10.1186/1471-2407-10-174.

ReferenceCitation: Moloney J, Partridge C, Delanty S, Lloyd D, Nguyen MH. High efficacy and patient satisfaction with a nurse-led colorectal cancer surveillance programme with 10-year follow-up. ANZ J Surg. 2019 Oct;89(10):1286-1290. doi: 10.1111/ans.15333. Epub 2019 Jul 7.

ReferenceCitation: Martin E, Persaud S, Corr J, Casey R, Pillai R. Nurse-led active surveillance for prostate cancer is safe, effective and associated with high rates of patient satisfaction-results of an audit in the East of England. Ecancermedicalscience. 2018 Jul 25;12:854. doi: 10.3332/ecancer.2018.854. eCollection 2018.

ReferenceCitation: Keshava HB, Tan KS, Dycoco J, Huang J, Berkowitz A, Sumner D, Devigne A, Adusumilli P, Bains M, Bott M, Isbell J, Downey R, Molena D, Park B, Rocco G, Sihag S, Jones DR, Rusch VW. Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. J Thorac Cardiovasc Surg. 2022 May;163(5):1645-1653.e4. doi: 10.1016/j.jtcvs.2021.11.026. Epub 2021 Nov 20.

ReferenceCitation: Ferrua M, Minvielle E, Fourcade A, Lalloué B, Sicotte C, Di Palma M, Mir O. How to Design a Remote Patient Monitoring System? A French Case Study. BMC Health Serv Res. 2020 May 19;20(1):434. doi: 10.1186/s12913-020-05293-4.

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre François Baclesse
Centre Oscar Lambret
CHU Amiens


title: Pilot Study of Personalized First-line Chemotherapy Choice for Patients With Advanced Pancreatic Adenocarcinoma Using Transcriptomic Signatures (PACsign)

acronym: PACsign

summary: The aim of this study is to assess the clinical value of 5 transcriptomic signatures prognostic of chemotherapeutic sensitivity to improve the Objective Response Rate (ORR) of first-line (L1). Chemotherapy regimen (FOLFIRINOX vs Gem-nabP) will be selected based on transcriptomic signatures applied to the pre-therapeutic liver biopsy of newly diagnosed PDAC patients.

lead_sponsor: Institut Curie

location_facility:
Hôpital Beaujon
Institut Curie
Hôpital Claude Hurriez


title: An Open-label, Non-comparative, Multicentre Study to Evaluate the Acceptability of a New Paediatric Formulation of Hydroxycarbamide in Children With Sickle Cell Disease.

summary: This is a prospective, interventional, phase II, open-label, multicentre, national, non-comparative study of a single administration of the new dispersible form of hydroxycarbamide at the usual dose in children with sickle cell disease who are already treated with the current form of hydroxycarbamide (Siklos® 100 mg and/or 1000 mg film-coated tablets).

lead_sponsor: ADDMEDICA SASA

location_facility: InterCommunal Hospital Centre of Creteil


title: Lost Children Society (LCS), Metacognitive Training Integrated Into an Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients : a Pilot Study on Feasibility

acronym: TTRPG

summary:
The Lost Children Society (LCS) is a Therapeutic TableTop Role-Playing Game specifically developed for early-onset schizophrenia patient.

It is performed online via a secure teleconsultation and videoconference platform.

Patients are connected from their home, on their personal computer or tablet, equipped with headsets with microphone.

This study aims to validate the feasibility of this online Therapeutic TableTop Role Playing Game.

location_facility:
Centre Hospitalier Régional
Centre Hospitalier Georges Mazurelle
Centre Hospitalier Universitaire

intervention_type: Behavioral


title: Clinical Validation of the Use of Blood Biomarkers for the Diagnosis and Monitoring of Alzheimer's Disease

acronym: ALZAN

summary:
Alzheimer's disease (AD) has gradually become one of the major global public health issues due to its prevalence, which increases with age and life expectancy, and the economic cost of caring for patients whose cognitive decline progressively leads to loss of functional autonomy.

The diagnosis of AD is based on a multidisciplinary approach, involving, among other things, evaluation of the medical history together with clinical symptoms and signs, neuropsychological tests and neuroimaging. The quantification of cerebrospinal fluid (CSF) core biomarkers (amyloid beta peptides [Ab1-40 and Ab1-42], total tau [t-tau] and its phosphorylated form on threonine 181 [p-tau(181)]) has progressively proven utility for the diagnosis of AD and its prodromal forms. CSF biomarkers are now included in international guidelines for the diagnosis of AD in research settings and clinical practice and the Alzheimer's Association appropriate use criteria for the use of lumbar puncture and CSF testing in the diagnosis of AD have been published. Such biochemical diagnostics are currently implemented in many specialized centers around the world.

Recent progress in the biological diagnosis of AD is considerable, with the possibility, thanks to ultra-sensitive tests realized notably with the SIMOA technology, of having Ab1-40, Ab1-42, t-tau and p-tau(181) also detectable in the blood using commercial kits. The performance for AD detection has been evaluated by many groups including on retrospective samples.

It is now essential to evaluate the interest of blood-based biomarkers of AD, prospectively and in real life condition to confront them with pre-analytical and analytical variabilities. It is also important to position them in relation to CSF analysis and AD management, from risk assessment, diagnosis, to therapeutic strategies.

ReferenceType: result

ReferenceCitation: Delaby C, Alcolea D, Hirtz C, Vialaret J, Kindermans J, Morichon L, Fortea J, Belbin O, Gabelle A, Blennow K, Zetterberg H, Lleó A, Lehmann S. Blood amyloid and tau biomarkers as predictors of cerebrospinal fluid profiles. J Neural Transm (Vienna). 2022 Feb;129(2):231-237. doi: 10.1007/s00702-022-02474-9. Epub 2022 Feb 15.

ReferenceCitation: Lleó A, Zetterberg H, Pegueroles J, Karikari TK, Carmona-Iragui M, Ashton NJ, Montal V, Barroeta I, Lantero-Rodríguez J, Videla L, Altuna M, Benejam B, Fernandez S, Valldeneu S, Garzón D, Bejanin A, Iulita MF, Camacho V, Medrano-Martorell S, Belbin O, Clarimon J, Lehmann S, Alcolea D, Blesa R, Blennow K, Fortea J. Phosphorylated tau181 in plasma as a potential biomarker for Alzheimer's disease in adults with Down syndrome. Nat Commun. 2021 Jul 14;12(1):4304. doi: 10.1038/s41467-021-24319-x.

ReferenceCitation: Alcolea D, Delaby C, Muñoz L, Torres S, Estellés T, Zhu N, Barroeta I, Carmona-Iragui M, Illán-Gala I, Santos-Santos MÁ, Altuna M, Sala I, Sánchez-Saudinós MB, Videla L, Valldeneu S, Subirana A, Pegueroles J, Hirtz C, Vialaret J, Lehmann S, Karikari TK, Ashton NJ, Blennow K, Zetterberg H, Belbin O, Blesa R, Clarimón J, Fortea J, Lleó A. Use of plasma biomarkers for AT(N) classification of neurodegenerative dementias. J Neurol Neurosurg Psychiatry. 2021 Nov;92(11):1206-1214. doi: 10.1136/jnnp-2021-326603. Epub 2021 Jun 8.

lead_sponsor: University Hospital, Montpellier

location_facility:
Nîmes University Hospital
Montpellier University Hospital
Perpignan Regional Hospital


title: What Are the Terms of Use of Analgesics for Acute Pain on a Patient Before a Consultation With a General Practitioner: Descriptive Epidemiological Study of Patients in General Practice in Rhône-Alpes

acronym: AAPAC

summary: What are the terms of use of analgesics for acute pain on an outpatient basis before a consultation with a general practitioner? Descriptive epidemiological study of patients in general practice in Rhône-Alpes

lead_sponsor: Hospices Civils de Lyon

location_facility:
Maison de santé de Malissol
MSP Hauteville
MSPU bel-air


title: Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors to Improve the Driving Confidence of Elderly People in EHPAD

summary: The device which is the subject of this investigation is a robotic assistance module for the driving of a semi-autonomous electric wheelchair (FRE). It's intended to accessorize the FRE to improve the safety conditions during the driving of a FRE, making it possible to decrease the rate of accident in wheelchair on the one hand, increase the confidence of driving on the other hand, and facilitate the access to the FRE of people not being able to aspire to it without the use of a device of safety of this type.

primary_purpose: Prevention

lead_sponsor: Pôle Saint Hélier

location_facility:
CCAS Saint-Etienne
Pôle Saint-Hélier
USLD Saint Etienne


title: Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal Intensive Care

summary: This study aims to describe a dose-effect relationship of morphine alone and morphine and midazolam administered as continuous infusion in neonates hospitalized in Neonatal intensive care unit and undergoing mechanical ventilation, through PKPD modelling.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CH SUd Francilien
CHI Créteil
CHRU Morvan


title: Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)

summary: The objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with type 2 diabetes (T2D) treated with insulin pumps.

lead_sponsor: Diabeloop

location_facility:
CHU Grenoble Alpes
CH Métropole Savoie
CH Annecy-Genevois


title: Upper Limb Rehabilitation Using Virtual Reality in Children With Cerebral Palsy

acronym: RV-REEDUC

summary: This study aims to evaluate the effect of a virtual reality rehabilitation protocol on visuo-motor coordination and upper limb functional abilities in children with unilateral or bilateral cerebral palsy.

lead_sponsor: Slb Pharma

location_facility: Institute of Motor Education (IEM) François Xavier Falala

location_facility: Physical Medicine and Rehabilitation Center for Children and Adolescent La Clairière


title: Use and Acceptability Study of Swallis DSA™ Device for Distanced Swallowing Assessment for Older Adults In Nursing Home

acronym: SWALL EHPAD

summary: SWALL EHPAD is a multicenter, prospective study on the use and Acceptability Study of Swallis DSA™ Medical Device for Distanced Swallowing Assessment for Older Adults In Nursing Home

lead_sponsor: Swallis Medical

location_facility:
EHPAD L Espérance
Ehpad St Jacques
Ehpad La Résidence


title: Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy

acronym: PROLIFE

summary:
Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital.

Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient.

Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally.

Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Institut cancerologie du Gard
ICM
CHU de Nîmes


type: EudraCT Number

title: Phase I Trial Assessing the Safety of the Repeated Ultrasound-induced Opening of the Blood-brain Barrier in Pediatric Patients With Refractory Supra-tentorial Malignant Brain Tumors Before Chemotherapy Administration

acronym: SONOKID

summary:
Purpose : the aim of this study is to assess the feasibility and safety of ultrasound-induced opening of the blood-brain barrier (BBB) with the SonoCloud-9 implantable ultrasound device in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor treated with carboplatin.

Study hypothesis : the blood-brain barrier can be transiently and safely opened with pulsed low intensity ultrasound immediately prior to intravenously delivered chemotherapy. The opening of the BBB with the SonoCloud-9 system will increase the tumor exposure to carboplatin and increase progression-free and overall survival in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor.

ReferenceCitation: Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.

ReferenceCitation: Idbaih A, Canney M, Belin L, Desseaux C, Vignot A, Bouchoux G, Asquier N, Law-Ye B, Leclercq D, Bissery A, De Rycke Y, Trosch C, Capelle L, Sanson M, Hoang-Xuan K, Dehais C, Houillier C, Laigle-Donadey F, Mathon B, André A, Lafon C, Chapelon JY, Delattre JY, Carpentier A. Safety and Feasibility of Repeated and Transient Blood-Brain Barrier Disruption by Pulsed Ultrasound in Patients with Recurrent Glioblastoma. Clin Cancer Res. 2019 Jul 1;25(13):3793-3801. doi: 10.1158/1078-0432.CCR-18-3643. Epub 2019 Mar 19.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de neurochirugie Pédiatrique - Hôpital Necker- Enfants Malades


type: Other Identifier

title: Assessment of the echOpen Ultra-portable Ultrasound Device in Daily Use by Clinicians. Part II: Detection of Pyelocaliceal Dilation and Hepatic Steatosis

acronym: CLIN-ECHO-II

summary:
In recent years, portable and ultra-portable ultrasound devices are increasingly used by the non radiologists, notably cardiologists or obstetrician gynecologist, at the patient's bedside to visualize and measure anatomical structures and fluid and provide the clinical examination with additional signs allowing quicker and more confident clinical decisions.

This innovative approach is slowed down by the accessibility of these miniaturized devices, the price of which remains high.

The echOpen device includes an ultra-portable ultrasound probe and a mobile application that allows the image to be displayed on a smartphone via a WIFI protocol.

The objective of the clinical investigation is to show that the echOpen device, using three frequencies 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, allows identifying the semiological signs or anatomical structures of interest located at several depths of the body, with a performance similar to other devices routinely used in clinical departments.

primary_purpose: Screening

location_facility: Avicenne Hospital - APHP- Hepatology Department

location_facility: APHP COCHIN HOSPITAL / Emergency Department

location_facility: Paul Brousse Hospital - APHP - Hepatobiliary Center


title: Evaluation of the iFuse Bedrock Technique in Association With Posterior Lumbosacral Fusion With Iliac Fixation.

summary: The purpose of this study is to describe the impact of the iFuse Bedrock technique to decrease post-operative pains in patients who underwent multilevel posterior lumbosacral fusion.

lead_sponsor: Polyclinique Bordeaux Nord Aquitaine

location_facility:
Polyclinique Bordeaux Nord Aquitaine
CHU de Poitiers - Site Milétrie
Hôpitaux Universitaires de Marseille


title: Assessment and Follow-up of Patients With KRAS G12C-mutated Metastatic Non-Small Cell Lung Cancer Who Received Sotorasib as Part of the French Early Access Program (ATU)

summary: The purpose of the IFCT2102 Lung KG12Ci study is to closely monitor cohort ATU applications in order to collect retrospectively, as soon as possible after inclusion and under real-life conditions, the efficacy data on sotorasib (AMG 510) as well as the demographic and molecular characteristics of patients.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Rouen - CHU
Paris - Hôpital Cochin
Strasbourg - CHU


title: Study Comparing a Therapeutic Lens Used Alone to a Therapeutic Lens Used in Association With an Amniotic Membrane Treated by the AMTRIX Process in Postoperative Care After Photorefractive Keratectomy (PRK)

summary: The purpose of this open controlled multicenter trial is to assess the impact of use of an amniotic membrane on post PKR recovery.

lead_sponsor: TBF Genie Tissulaire


title: Evaluation of the Role of Systolic Dysfunction in Weaning Failure Related to Weaning-induced Pulmonary Edema: the SystoWean Study

acronym: SystoWean

summary: The purpose of this study is to determine if the left and right ventricular systolic function is involved in the development of weaning failure related to weaning-induced pulmonary edema.

ipd_sharing_description: No plan is established

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Hôpital Cochin
CHU de Dijon
CHU de NICE


title: Is Myocardial Stunning Induced by Continuous Renal Replacement Therapy a Reality in Critically Ill Patients?

acronym: MS-CRRT

summary:
Myocardial stunning during chronic intermittent hemodialysis is a well-described phenomenon. Little case series of patients presenting myocardial stunning during renal replacement therapy for acute kidney injury in critically ill patients are reported, with intermittent hemodialysis and continuous renal replacement therapy. However, the small sample sizes and the absence of a control arm limit their interpretation, mainly whether the myocardial stunning may be related to cardiac loading conditions variations and whether it may impact the hemodynamic.

The investigator hypothesize that myocardial stunning induced by renal replacement therapy is frequent, independent from cardiac loading conditions and associated with peripheral hypoperfusion.

location_facility: Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel Groupe Hospitalier Est


type: Registry Identifier

title: Phase III Study Evaluating a Non-drug Intervention (NDI) Program by Fixed-frequency Guided Breathing (Cardiac Coherence) Associated With Medical Hypnosis on Preoperative Anxiety in Oncological Surgery

summary: The investigator proposes to use the cardiac coherence technique (Cardiac Coherence) coupled with a hypnosis session to reduce pre-operative anxiety.

ReferenceCitation: Pekcan M, Celebioglu B, Demir B, Saricaoglu F, Hascelik G, Yukselen MA, Basgul E, Aypar U. The effect of premedication on preoperative anxiety. Middle East J Anaesthesiol. 2005 Jun;18(2):421-33.

ReferenceCitation: Shevde K, Panagopoulos G. A survey of 800 patients' knowledge, attitudes, and concerns regarding anesthesia. Anesth Analg. 1991 Aug;73(2):190-8.

ReferenceCitation: Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307.

ReferenceCitation: Miller SM. Coping with impending stress: psychophysiological and cognitive correlates of choice. Psychophysiology. 1979 Nov;16(6):572-81.

ReferenceCitation: Miller SM, Mangan CE. Interacting effects of information and coping style in adapting to gynecologic stress: should the doctor tell all? J Pers Soc Psychol. 1983 Jul;45(1):223-36.

ReferenceCitation: Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12.

ReferenceCitation: Jamison RN, Taft K, O'Hara JP, Ferrante FM. Psychosocial and pharmacologic predictors of satisfaction with intravenous patient-controlled analgesia. Anesth Analg. 1993 Jul;77(1):121-5.

ReferenceCitation: Kulik JA, Mahler HI, Moore PJ. Social comparison and affiliation under threat: effects on recovery from major surgery. J Pers Soc Psychol. 1996 Nov;71(5):967-79.

ReferenceCitation: Muñoz HR, Dagnino JA, Rufs JA, Bugedo GJ. Benzodiazepine premedication causes hypoxemia during spinal anesthesia in geriatric patients. Reg Anesth. 1992 May-Jun;17(3):139-42.

ReferenceCitation: Agelink MW, Majewski TB, Andrich J, Mueck-Weymann M. Short-term effects of intravenous benzodiazepines on autonomic neurocardiac regulation in humans: a comparison between midazolam, diazepam, and lorazepam. Crit Care Med. 2002 May;30(5):997-1006.

ReferenceCitation: Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.

ReferenceCitation: Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.

ReferenceCitation: Jiang H, White MP, Greicius MD, Waelde LC, Spiegel D. Brain Activity and Functional Connectivity Associated with Hypnosis. Cereb Cortex. 2017 Aug 1;27(8):4083-4093. doi: 10.1093/cercor/bhw220.

ReferenceCitation: McCraty R, Atkinson M, Tiller WA, Rein G, Watkins AD. The effects of emotions on short-term power spectrum analysis of heart rate variability . Am J Cardiol. 1995 Nov 15;76(14):1089-93. Erratum in: Am J Cardiol 1996 Feb 1;77(4):330.

ReferenceCitation: Amraoui J, Pouliquen C, Fraisse J, Dubourdieu J, Rey Dit Guzer S, Leclerc G, de Forges H, Jarlier M, Gutowski M, Bleuse JP, Janiszewski C, Diaz J, Cuvillon P. Effects of a Hypnosis Session Before General Anesthesia on Postoperative Outcomes in Patients Who Underwent Minor Breast Cancer Surgery: The HYPNOSEIN Randomized Clinical Trial. JAMA Netw Open. 2018 Aug 3;1(4):e181164. doi: 10.1001/jamanetworkopen.2018.1164.

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

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

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Institut régional du cancer de Montpellier


title: QUALHYBOM : Hypnosis Versus Equimolar Mixture of Oxygen and Nitrous Oxide (MEOPA) During a Bone Marrow Biopsy

acronym: QUALHYBOM

summary: The Osteo-Medullary Biopsy (BOM) is a procedure performed by means of a trocar and makes it possible to obtain a bone core. This gesture is usually performed by performing local subcutaneous anesthesia at the puncture site of the postero-superior iliac crest. Patient comfort is improved by the concomitant use during the examination of mouthpiece inhalation of gas in the form of Equimolar Mixture of Oxygen and Nitrous Oxide (MEOPA). Despite these analgesia precautions, this biopsy procedure causes acute pain at the puncture site, which is only partially relieved. Performing BOM under hypnosis represents an alternative that can provide additional comfort to the patient through better tolerance and reduced pain perception, compared to MEOPA. During hypnosis, stimulation of sleeping and awake cortical areas has been shown to reduce the pain experienced by the patient. Thanks to a retrospective study carried out in the hematology service of the Rennes University Hospital, we observed a net benefit of hypnosis on the comfort and pain felt during the realization of a bone marrow biopsy, associated with a decrease in anxiety, and this in the absence of use of MEOPA. In addition, the number of cubicles obtained during the examination (proportional to the size of the biopsy core) was better. Obtaining more than 10 stalls (figure required by pathologists for a quality examination) was observed in 78% of cases with hypnosis versus 53% with Equimolar Mixture of Oxygen and Nitrous Oxide (MEOPA). Lastly, the doctor taking the sample reported better operational comfort when accompanied by the nurse hypnotherapist.

lead_sponsor: Rennes University Hospital

location_facility:
Tours University Hospital
Orléans Hospital
Rennes University Hospital


title: Effect of Music and Rhythm Training Delivered Through a Serious Game on the Reading Skills of Children With a Specific Learning Disorder Impacting Reading, a Multicentric Double-blind and Placebo-controlled Study (Mila-Learn-01)

summary:
Mila-Learn-01 is a double-blind clinical study (meaning that neither the patient nor the doctor or his/her team will know which game the child has), which enables us to see the effect of a serious game on the child's reading skills.

The patients who will participate in this research will receive, at random, one of the two serious study games, the experimental game (Mila-Learn) or the placebo game (Mila-Placebo). The tasks designed in the placebo game mirror those of Mila-Learn.

Each game comprises eight tasks to be completed on a touchscreen tablet. Each session lasts 25 minutes (±20%); five training sessions lasting 25 minutes are planned per week for eight weeks.

lead_sponsor: Mila (bMotion Technologies)

location_facility: Centre médical pluridisciplinaire CogCharonne


title: Low Risk Non ST Elevation Myocardial Infarction With or Without Intensive Care Unit Admission : a Randomized Study

acronym: SELECTNSTEMI

summary: Favourable in-hospital outcome is observed in numerous patients after Non ST myocardial infarction (NSTEMI) with invasive strategy but European guidelines proposed systematic intensive care unit monitoring up to 24 h in lower risk patients (grade 1, level of evidence C). Regarding absence of prospective study supporting this strategy, we assessed the hypothesis that the lower risk NSTEMI patients identified through simple medical criteria and after coronary angiography evaluation may not require intensive care unit admission.

ReferenceCitation: Harvey S, Harrison DA, Singer M, Ashcroft J, Jones CM, Elbourne D, Brampton W, Williams D, Young D, Rowan K; PAC-Man study collaboration. Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial. Lancet. 2005 Aug 6-12;366(9484):472-7.

ReferenceCitation: Bonnefoy-Cudraz E, Bueno H, Casella G, De Maria E, Fitzsimons D, Halvorsen S, Hassager C, Iakobishvili Z, Magdy A, Marandi T, Mimoso J, Parkhomenko A, Price S, Rokyta R, Roubille F, Serpytis P, Shimony A, Stepinska J, Tint D, Trendafilova E, Tubaro M, Vrints C, Walker D, Zahger D, Zima E, Zukermann R, Lettino M. Editor's Choice - Acute Cardiovascular Care Association Position Paper on Intensive Cardiovascular Care Units: An update on their definition, structure, organisation and function. Eur Heart J Acute Cardiovasc Care. 2018 Feb;7(1):80-95. doi: 10.1177/2048872617724269. Epub 2017 Aug 17.

ReferenceCitation: Collet JP, Thiele H, Barbato E, Barthélémy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Jüni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. Erratum in: Eur Heart J. 2021 May 14;42(19):1908. Erratum in: Eur Heart J. 2021 May 14;42(19):1925. Eur Heart J. 2021 May 13;:.

location_facility:
UH Toulouse
UH Montpellier
UH Nîmes


title: Iron, Transferrin and Retinopathy of Prematurity (ROP): Towards New Pathophysiological Mechanisms.

acronym: Fer-ROP

summary:
The purpose of this study is to determine whether increased transferrin saturation in plasma (that reflects iron overload and/or low transferrin) is an independent risk factor for ROP development and severity.

Preterm infants born at <31 week's post-menstrual age (PMA) or ≤1250g of birth weight will be included. Iron parameters in plasma will be measured during the first month of life. Retinopathy of prematurity (ROP) will be screened as currently recommended. The relationship between plasma iron parameters and ROP development and/or severity will be established.

ReferenceCitation: de Verdier K, Ulla E, Löfgren S, Fernell E. Children with blindness - major causes, developmental outcomes and implications for habilitation and educational support: a two-decade, Swedish population-based study. Acta Ophthalmol. 2018 May;96(3):295-300. doi: 10.1111/aos.13631. Epub 2017 Nov 23.

ReferenceCitation: Manley BJ, Kuschel CA, Elder JE, Doyle LW, Davis PG. Higher Rates of Retinopathy of Prematurity after Increasing Oxygen Saturation Targets for Very Preterm Infants: Experience in a Single Center. J Pediatr. 2016 Jan;168:242-244. doi: 10.1016/j.jpeds.2015.10.005. Epub 2015 Nov 6.

ReferenceCitation: BOOST II United Kingdom Collaborative Group; BOOST II Australia Collaborative Group; BOOST II New Zealand Collaborative Group, Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, Deshpande S, Donoghoe M, Doyle L, Fleck BW, Ghadge A, Hague W, Halliday HL, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, Brocklehurst P. Oxygen saturation and outcomes in preterm infants. N Engl J Med. 2013 May 30;368(22):2094-104. doi: 10.1056/NEJMoa1302298. Epub 2013 May 5.

ReferenceCitation: Sapieha P, Joyal JS, Rivera JC, Kermorvant-Duchemin E, Sennlaub F, Hardy P, Lachapelle P, Chemtob S. Retinopathy of prematurity: understanding ischemic retinal vasculopathies at an extreme of life. J Clin Invest. 2010 Sep;120(9):3022-32. doi: 10.1172/JCI42142. Epub 2010 Sep 1. Review.

ReferenceCitation: Howarth C, Banerjee J, Aladangady N. Red Blood Cell Transfusion in Preterm Infants: Current Evidence and Controversies. Neonatology. 2018;114(1):7-16. doi: 10.1159/000486584. Epub 2018 Mar 16. Review.

ReferenceCitation: Hesse L, Eberl W, Schlaud M, Poets CF. Blood transfusion. Iron load and retinopathy of prematurity. Eur J Pediatr. 1997 Jun;156(6):465-70.

ReferenceCitation: Dani C, Reali MF, Bertini G, Martelli E, Pezzati M, Rubaltelli FF. The role of blood transfusions and iron intake on retinopathy of prematurity. Early Hum Dev. 2001 Apr;62(1):57-63.

ReferenceCitation: Inder TE, Clemett RS, Austin NC, Graham P, Darlow BA. High iron status in very low birth weight infants is associated with an increased risk of retinopathy of prematurity. J Pediatr. 1997 Oct;131(4):541-4.

ReferenceCitation: Hirano K, Morinobu T, Kim H, Hiroi M, Ban R, Ogawa S, Ogihara H, Tamai H, Ogihara T. Blood transfusion increases radical promoting non-transferrin bound iron in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2001 May;84(3):F188-93.

ReferenceCitation: Daruich A, Le Rouzic Q, Jonet L, Naud MC, Kowalczuk L, Pournaras JA, Boatright JH, Thomas A, Turck N, Moulin A, Behar-Cohen F, Picard E. Iron is neurotoxic in retinal detachment and transferrin confers neuroprotection. Sci Adv. 2019 Jan 9;5(1):eaau9940. doi: 10.1126/sciadv.aau9940. eCollection 2019 Jan.

ReferenceCitation: Hellström A, Engström E, Hård AL, Albertsson-Wikland K, Carlsson B, Niklasson A, Löfqvist C, Svensson E, Holm S, Ewald U, Holmström G, Smith LE. Postnatal serum insulin-like growth factor I deficiency is associated with retinopathy of prematurity and other complications of premature birth. Pediatrics. 2003 Nov;112(5):1016-20.

ReferenceCitation: Luo XQ, Zhang CY, Zhang JW, Jiang JB, Yin AH, Guo L, Nie C, Lu XZ, Deng H, Zhang L. Identification of Iron Homeostasis Genes Dysregulation Potentially Involved in Retinopathy of Prematurity Pathogenicity by Microarray Analysis. J Ophthalmol. 2015;2015:584854. doi: 10.1155/2015/584854. Epub 2015 Oct 18.

location_facility: Pediatrics and noenatal intensive care department - Necker-Enfants Malades Hospital

location_facility: Pediatrics and neonatal intensive care department - Cochin hospital - Port Royal Maternity

location_facility: Ophtalmology department _ Necker Enfants Malades Hospital

intervention_type: Biological


title: A Randomized Placebo-controlled Study to Assess Safety and Preliminary Efficacy of BGP345A in Patients With Constipation Due to the Use of Opioid-based Medications for the Management of Chronic Non Cancer Pain

summary: The purpose of this study is to assess safety and preliminary efficacy of BGP345A in patients with constipation due to the use of opioid-based medications for the management of chronic non cancer pain.

lead_sponsor: BioGaia Pharma AB

location_facility:
CHU d'Amiens
CH de Valenciennes
CHU DE NANTES (Hôpital Nord Laennec)


title: Long-term Iron Chelation in the Prevention of Secondary Remote Degeneration After Stroke

acronym: CHEL-IC

summary:
Stroke is a major cause of disability over the world. While acute therapies have made huge progresses, the number of survivors leaving with clinical consequences of stroke is increasing. Beyond stroke itself, secondary neurodegeneration of disconnected areas, especially of central hubs such as the substantia nigra or the thalamus, could significantly impact the overall outcome of the patients. Data have identified iron accumulation within the disconnected areas as potentially accelerating neurodegeneration. In this research, the main objective is test whether long-term chelation through Deferiprone (Ferrirpox®, Chiesi) administered daily from 3-to-5 days following stroke to 6 months could avoid iron accumulation as measured with Magnetic resonance imaging (MRI) within disconnected areas (substantia nigra).

MRI imaging methods such as the quantification of the transverse relaxation rate R2* provide highly correlated information to the histologically measured iron load

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Lille
CHU de Montpellier
CHU Bordeaux


title: Amyloidosis TTR Flow Reserve Evaluation

acronym: AMYTRE

summary:
Anginal symptoms and signs of ischemia have been reported in some patients with cardiac amyloidosis (TTR) without obstructive epicardial coronary artery disease (CAD).

It was found that coronary microvascular dysfunction was highly prevalent in subjects with cardiac amyloidosis, even in the absence of epicardial CAD. The investigators found lower stress and rest myocardial blood flow (MBF) and lower myocardial flow reserve (MFR) in their cardiac PET (Positron emission tomography) study (13N), including 21 patients.

The advances in SPECT technology including cadmium zinc telluride (CZT) detectors allow to evaluate the MBF and MFR estimation by SPECT as shown in both experimental animal models and also in clinical studies with comparison to PET.

SPECT is more widely available than cardiac PET. Thus, the investigators would like:

to confirm the results of Dorbala et al using SPECT, and
to go further with evaluation of the effect of Tafamidis on microvascular dysfunction.

ReferenceCitation: Dorbala S, Vangala D, Bruyere J Jr, Quarta C, Kruger J, Padera R, Foster C, Hanley M, Di Carli MF, Falk R. Coronary microvascular dysfunction is related to abnormalities in myocardial structure and function in cardiac amyloidosis. JACC Heart Fail. 2014 Aug;2(4):358-67. doi: 10.1016/j.jchf.2014.03.009. Epub 2014 Jul 9.

ReferenceCitation: Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.

ReferenceCitation: Al Suwaidi J, Velianou JL, Gertz MA, Cannon RO 3rd, Higano ST, Holmes DR Jr, Lerman A. Systemic amyloidosis presenting with angina pectoris. Ann Intern Med. 1999 Dec 7;131(11):838-41.

ReferenceCitation: Ogawa H, Mizuno Y, Ohkawara S, Tsujita K, Ando Y, Yoshinaga M, Yasue H. Cardiac amyloidosis presenting as microvascular angina--a case report. Angiology. 2001 Apr;52(4):273-8.

ReferenceCitation: Whitaker DC, Tungekar MF, Dussek JE. Angina with a normal coronary angiogram caused by amyloidosis. Heart. 2004 Sep;90(9):e54.

ReferenceCitation: Nam MC, Nel K, Senior R, Greaves K. Abnormal Myocardial Blood Flow Reserve Observed in Cardiac Amyloidosis. J Cardiovasc Ultrasound. 2016 Mar;24(1):64-7. doi: 10.4250/jcu.2016.24.1.64. Epub 2016 Mar 24.

ReferenceCitation: Vançon B, Bisson A, Courtehoux M, Bernard A, Bailly M. A study protocol for an observational cohort investigating cardiac transthyretin amyloidosis flow reserve before and after Tafamidis treatment: The AMYTRE study. Front Med (Lausanne). 2022 Aug 23;9:978293. doi: 10.3389/fmed.2022.978293. eCollection 2022.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHRU de TOURS
CHR d'Orleans
CHU d'ANGERS


title: Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis

acronym: ESPERANTO

summary: Chronic Recurrent Multifocal Osteomyelitis (CRMO) is a rare autoinflammatory bone disease in children. Studies evaluating the quality of life of patients with CRMO are small and heterogeneous. A better understanding of the impact of the disease on the quality of life of adult patients with CRMO beginning in childhood would allow better long-term management of these patients. Our study aims are to assess the clinical and socio-professional outcomes of adult patients who started CRMO at pediatric age.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Rhumatologie Centre Hospitalier Lyon Sud

location_facility: Service Rhumatologie Pédiatrique Centre De Référence Maladies Rares RAISE Hôpital Femme Mère Enfant

location_facility: Service de Rhumatologie Centre Hospitalier Edouard Herriot


title: Descriptive Analysis of Soft-tissue Urate Deposits, and Bone and Joint Destruction in Dual-energy Computed Tomography Exams of Adult Patients With Gout

acronym: DECTGOUT

summary: The main objective is to describe urate deposits (especially in terms of distribution and volume) in soft tissues and bone, and joint erosions and destruction, in adult patients with gout.

location_facility: Hôpital Lariboisière - Service d'Imagerie OstéoArticulaire, Viscérale et Vasculaire

location_facility: Hôpital Bichat - Service de Rhumatologie

location_facility: Hôpital Lariboisière - Service de Rhumatologie


title: Association Between TTV Viral Load and the Occurrence of Infections and Rejection in Heart Transplant Recipients

acronym: TTVCoeur

summary:
This prospective, multicenter, non-interventional trial aims to study the association between TTV viral load and the occurrence of rejection or infection during the first year after transplantation.

The TTV viral loads, taken once a month during the first year after the transplant, will be measured at the end of the study.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

location_facility:
Hôpital européen Georges Pompidou
CHU Strasbourg
CHU de Rennes


title: Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements

acronym: PRODALBA

summary: Osteoarticular infections associated with hip and knee prostheses require optimal surgical and medical management to maximize the rate of therapeutic success. Antibiotic therapy should be administered for a period of 12 weeks. Tolerance problems, difficulties in maintaining compliance over 12 weeks, bacterial multidrug resistance and sometimes intravenous administration are the main obstacles to appropriate antibiotic therapy and to limiting iatrogenicity. Dalbavancin is an antibiotic derived from teicoplanin (glycopeptide) with a long half-life, of punctual parenteral administration without a central line, active on staphylococci, and well tolerated. The data in the literature concerning its efficacy in Osteoarticular infections associated with hip and knee prostheses are limited and heterogeneous. Investigators would like to describe its efficacy in a homogeneous series of patients in terms of the type of infection, their surgical management and the methods of administration of the product in order to extend its use.

location_facility:
Centre Hospitalier de Tourcoing
AP-HP - Hôpital Ambroise-Paré
CHU de Nice


title: Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust

acronym: WARNING KD

summary:
Kidney disease in its chronic or acute form shares many risk factors for initiation, progression and prognosis with an increase in morbidity and mortality, the length of hospitalization and the cost associated with stages of increasing severity. Its overall estimated prevalence in the general population is 13% and 0.5% from stage 4, for which referral to a nephrologist is recommended to reduce mortality, slow progression of renal disease and better prepare for treatment by renal replacement. Acute kidney injury (AKI) is defined as a sudden increase in serum creatinine (Scr) with a prognostic classification of increasing severity. The population with chronic kidney disease (CKD) is often hospitalized and is frequently complicated by AKI, however CKD is asymptomatic for a long time, requiring structure screening in populations at risk.

Performing Scr assays during hospitalization is an opportunity to screen patients with severe CRD or ARI requiring specialized treatment during and after hospitalization. A nephrological opinion is recommended for patients with severe CKD and AKI.

Based on preliminary studies "MRC GARD" (NCT02938611) and "ARI TARGET" (NCT03192189), the study investigators identified the frequency of patients with increased Scr corresponding to stages ≥4 of CKD and to stage1b of ARI during their hospitalization. They found that 50% of patients hospitalized with a severe AKI had a CKD prior to their hospitalization.

The use of dosages of Scr during hospitalization has been studied for AKI but without targeting high-risk subgroups and with discordant results. The study investigators plan to carry out a pragmatic study to show that an intervention combining alerts with Scr dosage to detect severe forms of CRD and AKI during hospitalization associated with the systematic intervention of a specialized dedicated team associating nephrologist and pharmacist to the scale of a GHT will improve patient and renal survival 1 year after screening.

location_facility:
CH Bagnols-sur-Cèze
CH Alès Cévennes
CHU de Nîmes


title: A Randomized Study of Pant Type Absorbing Urinary Incontinence Products With Cross-over Design

summary: Pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population

lead_sponsor: Essity Hygiene and Health AB

location_facility:
LyREC
Intertek
Eurofins Optimed


title: Clinical Impact and Neuro-functional Substrate of Immersive Virtual Reality Sports Practice on Depression

acronym: DEPRIV

summary:
Depression is a major public health issue due to its frequency (prevalence of 7.5% in adults), its difficulties in therapeutic management (ineffective in 30% of cases and poor compliance) and its societal cost (170 billion euros per year). The most frequent clinical expression is a characterized depressive episode.

Physical activity, through better management of emotions and stress, has been proposed as a complementary therapeutic approach in depression. Studies have shown a decrease in depressive symptoms during a sports program of at least 2 weeks in addition to pharmacological treatment. Similarly, mindfulness meditation, because it reduces ruminations, could also improve the therapeutic management of depression. More recently, virtual reality (VR) exposure therapy has also been proposed in the treatment of anxiety and depression, with a benefit of multisensory stimulation induced by a virtual environment in cognitive and sensory-motor rehabilitation and emotion regulation. However, these therapeutic strategies, in addition to pharmacological treatments, have limits. There is thus a real challenge in designing innovative therapeutic programs for the treatment of depression that encourage motivated practice. A sports activity coupled with immersion in VR could combine the benefits of each of these treatments. With the emergence of new immersive technologies, VR allows the recreation of sensory experiences in an environment close to the ecological context. The use of physical activity on an indoor rower or other sensor-equipped device could thus intensify the psychological benefits of exercise and improve compliance. However, there is a lack of clinical evidence to recommend this coupled therapeutic approach in the additional treatment of depression. This approach is part of the embodied virtual medicine road map.

Furthermore, a better understanding of the biological, metabolomic, and cerebral mechanisms underlying this approach could improve its effectiveness. It would make it possible to propose and evaluate biomarkers for therapeutic and prognostic monitoring of depression. In particular, progress in the field of the "-omics" family includes new tools with great potential. This is more specifically the case of metabolomics. The analysis of metabolites present in the organism or released with natural secretions would allow to constitute a metabolomic signature evolving during the treatment. The interest in characterizing metabolomic biomarkers is an interesting avenue to meet the need to establish a biological diagnosis with quantified values, for better objectivity and follow-up. Functional imaging could also be used to highlight regional activity or connectivity anomalies and markers of response to therapy in relation to biology.

The aim of this work is to determine the clinical impact of physical exercise in VR on a depressive state, and to study in biology, metabolomics and neuroimaging the functional substrates of such a practice in order to understand the mechanisms involved and to propose ways to improve the management of depression.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Prospective randomIzed Clinical Trial Assessing the Tolerance and Clinical Benefit of feCAl tranSplantation in patientS With melanOma Treated With CTLA-4 and PD1 Inhibitors

acronym: PICASSO

summary: Recent studies suggest that patients with metastatic melanoma whose gut microbiome is colonized by eubiotic bacteria have a stronger anti-cancer response to anti CTLA-4 and anti PD1. The hypothesis of this research is that a pooled standardized fecal microbiome transfer (FMT) will shift melanoma patients' gut microbiome towards a composition close to that associated with a better response, and will therefore increase the response to a combination of anti CTLA-4 and anti PD1, without affecting the safety of these drugs. The present trial is the first randomized trial of FMT in patients with unresectable or metastatic melanoma. It will include patients who have neither been exposed to anti CTLA-4 nor anti PD1 or PDL-1, prior to inclusion in the study. The pooled standardized fecal microbiome transfer administered in this study is an experimental drug MaaT013, a microbiome restoration biotherapeutic, produced by MaaT Pharma, and composed of pooled-donor, full-ecosystem intestinal microbiome. The MaaT013 product has a standardized richness (in number of species present) higher than a product obtained from a mono donor (455 species approximately against 274 on average) and contains bacteria species (mentioned in the rationale) associated with better response to anti- CTLA-4 and anti PD1.

location_facility:
Hôpital Gustave Roussy
Hôpital Nantes Hôtel Dieu
Hôpital Saint Louis


title: Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale (29BRC21.0082)

acronym: EPIC-FOPCohort

summary: stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?

ipd_sharing_description: All collected data that underlie results in a publication.

lead_sponsor: University Hospital, Brest

location_facility:
HIA
CHIC de Quimper
CHRU de Brest


title: AUTOGRAFI : Evaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial

acronym: AUTOGRAFI

summary:
Fecal incontinence is frequent and has a significant impact on the quality of life of individuals. Its therapeutic management is based primarily on transit regulation and rehabilitation and secondarily on neuromodulation of the sacral roots. However, this strategy is insufficient in more than one patient out of three. The patient and the clinician are often at a loss and the therapeutic possibilities are limited to the use of evacuating enemas and/or a colostomy.

The practice of autologous fat injections was initially developed in plastic surgery. The studies that have evaluated the efficacy of autologous fat injections in fecal incontinence in men are preliminary and old isolated observations. However, they have shown an improvement in episodes of fecal incontinence and in sphincter parameters. In the field of proctology and autologous fat injections, 2 recent small open studies have evaluated the efficacy and morbidity of this therapy in the treatment of anal fistulas related to Crohn's disease.

The primary hypothesis of the work is that autografting adipose tissue into the intersphincteric space can decrease episodes of fecal incontinence in patients with severe fecal incontinence due to sphincter failure. The secondary hypotheses are that autograft of adipose tissue in the intersphincter space improves resting anal pressures, is a well-tolerated technique for patients, and may improve their quality of life.

location_facility:
CHU Nantes
CHU Angers
CHU Rennes


title: Impact on Fluid Balance of an Optimised Restrictive Strategy Targeting Non-Resuscitative Fluids in Intensive Care Patients Hospitalised for Septic Shock: an Open-label, Multi-Centre, Randomised, Controlled Pilot Study.

acronym: OPTIFLUID

summary:
Intravenous fluids are one of the keystones in the initial management of patients with septic shock, but they inevitably lead to a fluid overload, which is associated with poor outcome.

So far no studies have evaluated the interest of a restrictive strategy for managing fluid intake targeting all non-resuscitative fluids (fluids for maintenance and drug dilution as well as nutrition) and especially the impact of this restrictive strategy on fluid overload.

The hypothesis of this research is that an optimised restrictive strategy targeting all non-resuscitative fluids in patients hospitalised in the intensive care unit for septic shock, will have an impact on fluid balance in these patients.

location_facility:
Nimes University Hospital
CHU de Montpellier
CHU de DIJON


title: Effects of Yoga in the Rehabilitation of Stroke Patients With Chronic Sequelea: A Randomized Controlled Trial.

summary:
Stroke is a major health problem and can cause long-term disability. Among these sequelae, there are balance and mobility disorders, but also a higher rate of anxiety or depression disorders. This impairments impact activity of daily living, and social reintegration. That why the investigators need to explore options for long-term sustainable interventions that which takes into account the patient as a whole. In particular, regular physical activity is recommended, but it must be adaptable to the patient's impairments. Teaching yoga may be an interesting option. Indeed, yoga is a mind-body practice which become increasingly widespread in the world. Recent studies highlight positive effect of yoga for this population. However, the levels of evidence are limited, and new studies are needed.

Primary objective of the study is to demonstrate the non-inferiority of a therapeutic yoga program, compared to a conventional physical activity program, to improve balance of patients with chronic stroke sequelae.

Secondary objectives are to demonstrate the non-inferiority of the therapeutic yoga program in improving muscle strength and functional mobility, as well as its superiority in improving anxiety, depression, social reintegration and adherence to treatment.

ReferenceCitation: Green E, Huynh A, Broussard L, Zunker B, Matthews J, Hilton CL, Aranha K. Systematic Review of Yoga and Balance: Effect on Adults With Neuromuscular Impairment. Am J Occup Ther. 2019 Jan/Feb;73(1):7301205150p1-7301205150p11. doi: 10.5014/ajot.2019.028944.

ReferenceCitation: Thayabaranathan T, Andrew NE, Immink MA, Hillier S, Stevens P, Stolwyk R, Kilkenny M, Cadilhac DA. Determining the potential benefits of yoga in chronic stroke care: a systematic review and meta-analysis. Top Stroke Rehabil. 2017 May;24(4):279-287. doi: 10.1080/10749357.2016.1277481. Epub 2017 Jan 19. Review.

ReferenceCitation: Edwards MK, Loprinzi PD. Comparative effects of meditation and exercise on physical and psychosocial health outcomes: a review of randomized controlled trials. Postgrad Med. 2018 Mar;130(2):222-228. doi: 10.1080/00325481.2018.1409049. Epub 2017 Nov 27. Review.

ipd_sharing_description: The data collected will be anonymized, computerized and stored by Maxime GILLIAUX. Only the investigators will have access to the anonymized data in order to carry out the statistical work of this research.

lead_sponsor: Hopital La Musse

location_facility:
City Hall of Corneville sur Risle
City hall of Broglie
Hopital La Musse


title: Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit - a Multicenter Observational Cohort Study

summary:
More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management.

A spectrum of neuropsychiatric sequelae, specific for the ICU exposure, was already described, including post-intensive care syndrome and persistent pain.

A growing body of evidence suggests the impact of SARS-COV2 exposure on the occurrence of neurological disorders and chronic pain syndrome development in COVID-19 patients.

Taking together, one can expect a large number of patients discharged from ICU after severe COVID-19 with high prevalence of persistent pain and psychological disorders. To date, no study has evaluated neither the incidence of persistant pains in ICU COVID-19 survivors, nor pain phenotypes.

The knowledge of such data is crucial in order to anticipate the management of such patients by specialized pain team, and to quantify the possible incurred burden of care.

Our study aims to evaluate the incidence of pain, pain localization and severity, associated pain-related psychological disorders, and to perform quantitative sensory testing in severe COVID-19 patients, admitted to the ICU for more than 48 hours and successfully discharged home during the first French pandemic wave.

time_perspective: Cross-Sectional

ReferenceCitation: Carfì A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.

ReferenceCitation: Needham EJ, Chou SH, Coles AJ, Menon DK. Neurological Implications of COVID-19 Infections. Neurocrit Care. 2020 Jun;32(3):667-671. doi: 10.1007/s12028-020-00978-4.

ReferenceCitation: Asadi-Pooya AA, Simani L. Central nervous system manifestations of COVID-19: A systematic review. J Neurol Sci. 2020 Jun 15;413:116832. doi: 10.1016/j.jns.2020.116832. Epub 2020 Apr 11.

ReferenceCitation: Lee AM, Wong JG, McAlonan GM, Cheung V, Cheung C, Sham PC, Chu CM, Wong PC, Tsang KW, Chua SE. Stress and psychological distress among SARS survivors 1 year after the outbreak. Can J Psychiatry. 2007 Apr;52(4):233-40.

ipd_sharing_description: individual participant data are the property of investigator's centers and will not be shared

lead_sponsor: Mikhail Dziadzko, MD, PhD

location_facility: Hopital de la Croix Rousse - Hospices Civils de Lyon


title: Prediction of the Response to Neoadjuvant Radiation Chemotherapy Through Texture Analysis Derived From Magnetic Resonance Imaging, Contrast Injection Computed Tomography and Positron Emission Tomography at 18-FDG in Locally Advanced Rectal Cancer

acronym: RECTOMICS

summary:
In patient with complete pathological response, surgery could be omitted without compromising progression-free or overall survival. A powerful prediction model is needed to guide management of this population.

Radiomics features provide complementary information about tumor heterogenity.

The aim of the investigators is to develop a model combining clinical and radiomic criteria able to predict complete pathological response.

ipd_sharing_description: All collected data that underlie results in a publication

location_facility:
ICO
CHRU de Brest (Morvan)
Centre Hospitalier de Cornouaille


title: Fluoropyrimidine Tailored-dose Based on Uracil Concentration in Patients Treated for Digestive Carcinomas: Evaluation of Clinical Practice

acronym: URACILMPACT

summary:
Digestive carcinomas chemotherapies regimen are mostly based on fluoropyrimidine drugs (5-Fluorouracil (5-FU) or capecitabine). 5-FU is mainly catabolised by dihydropyrimidine dehydrogenase (DPD) and partial or complete DPD deficiency can cause severe adverse reactions. Different strategies have been proposed to predict DPD deficiency; the two main approaches are phenotyping the enzyme activity (directly or indirectly), or genotyping the four main polymorphisms associated with 5-FU-toxicity. In February 2018, the French medicines agency (Agence nationale de sécurité du médicament et des produits de santé, ANSM) recommended DPD genotyping for all patients receiving fluoropyrimidine-based treatment to improve its safety as compared to the European Medicines Agency (EMA)13 and others pharmacogenetics working group.

In December 2018, a new guideline from the French cancer institute (Institut National Du Cancer, INCa) and the French health authority (Haute Autorité de Santé, HAS) recommended the measurement of the uracil blood level before genotyping DPD and dose adaptation if this level is greater than 16 ng/mL. The aim herein is to assess how this recommendation has been implemented in clinical routine. 5-FU displays a dose-response relationship regarding both its efficacy and its toxicity, did tailored-dose impair the treatment efficacy as it decreased the risk of toxicity? To address that matter we conducted a retrospective study to evaluate how fluoropyrimidine dosage is adapted to uracil concentration with an emphasis on how patients outcome were affected. We compared time to failure and overall survival between patients with an uracil concentration < 16 ng/mL and > or = 16 ng/mL.

location_facility: Hopital Edouard Heriot, Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]


title: Stress Post Traumatique, Signes de dépression et Syndrome d'épuisement Professionnel Chez le Personnel Des EHPAD en Occitanie Pendant la pandémie COVID-19 : étude Prospective

acronym: PSY-COEHPAD-OC

summary: Nursing home staff face multiple stresses during the Covid-19 pandemic including personal risk of infection, risk of transmission of the virus to residents and relatives, and risk of witnessing end-of-life scenarios under difficult contexts (absence of families). The hypothesis of this study is that the Covid-19 period is associated with an incidence of more than 30% of post-traumatic stress in nursing home staff.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes, Hôpital Universitaire Carémeau


title: Reproducibility of fNIRS Parameters During Walking in Stroke Patients and Healthy Subjects

acronym: REPROXY

summary:
Brain activation can be studied using the Functional Near InfraRed Spectroscopy (fNIRS). It was shown that CPF activation during walking and during dual task could be different in stroke patients and in healthy subjects.

To date, fNIRS reliability is not completely established during walking and during dual task. Therefore, this study will examine the reproducibility of fNIRS parameters during simple walking and during dual task in healthy subjects and in stroke patients.

ReferenceCitation: Hermand E, Tapie B, Dupuy O, Fraser S, Compagnat M, Salle JY, Daviet JC, Perrochon A. Prefrontal Cortex Activation During Dual Task With Increasing Cognitive Load in Subacute Stroke Patients: A Pilot Study. Front Aging Neurosci. 2019 Jul 2;11:160. doi: 10.3389/fnagi.2019.00160. eCollection 2019.

ReferenceCitation: Hawkins KA, Fox EJ, Daly JJ, Rose DK, Christou EA, McGuirk TE, Otzel DM, Butera KA, Chatterjee SA, Clark DJ. Prefrontal over-activation during walking in people with mobility deficits: Interpretation and functional implications. Hum Mov Sci. 2018 Jun;59:46-55. doi: 10.1016/j.humov.2018.03.010. Epub 2018 Mar 29.

ReferenceCitation: Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40.

ReferenceCitation: Pelicioni PHS, Tijsma M, Lord SR, Menant J. Prefrontal cortical activation measured by fNIRS during walking: effects of age, disease and secondary task. PeerJ. 2019 May 3;7:e6833. doi: 10.7717/peerj.6833. eCollection 2019.

location_facility: Centre de Réadaptation Fonctionnelle et d'Appareillage Le Coteau


title: Interest of an Auriculotherapy Session in Smoking Cessation Controlled, Randomized, Single-blind Study: Proof of Concept Study

acronym: StopAuric

summary: The aim of the study is to show that auriculotherapy is effective in smoking cessation.

lead_sponsor: Hopital Foch

location_facility:
Clinique de la Sauvegarde
Cabinet de l'Olivier
Espace Santé Simone Veil


title: Observational Study to Evaluate the Performance and the Safety of the HLS KneeTec Cementless or Hybrid Fixations in Total Knee Arthroplasty

summary: The aim of this study is to assess the long-term performance and safety of HLS KneeTec cementless and hybrid fixation knee prosthesis when used in standard medical practice.

time_perspective: Other

lead_sponsor: Corin

location_facility:
Centre Hospitalier Compiegne Noyon
Chu Angers
Clinique Du Parc


title: VIK-e2 - Observational, Multicenter Prospective Study Evaluating Parent-child Relationship With the Setting up of a Mobile Telepresence Robot for Patients With Children Aged 15 Years or Less and Hospitalised in Long-term Protective Isolation

summary: The intensive treatments of certain cancers and haemopathies require the implementation of a protective isolation from external micro-organisms for a period of several weeks. This isolation implies a limitation of visitors and sometimes prohibits access to young children. This raises questions concerning the maintenance of family links, and in particular the parent-child relationship as well as the psychological and emotional isolation of hospitalised patients and the resulting psychological effects.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Leon Berard
Institut Paoli Calmettes
Centre Hospitalier Lyon Sud


title: Diagnostic Value of Mass Spectrometry-based Proteomics in Microvascular Inflammation in Kidney Transplantation, the TranSpec Study.

acronym: TranSpec

summary: Microvascular inflammation, the hallmark histological criteria of antibody-mediated rejection in kidney transplantation, remains an issue in routine practice, due to a lack of reproducibility in its recognition by pathologists and an incomplete comprehension of its pathophysiology, leading to a poor treatment efficacy. The main objective of this study is to assess the performances of tissue proteic signatures designed for the diagnosis of microvascular inflammation in kidney transplantation, from formalin-fixed and paraffin-embedded (FFPE) allograft biopsies analyzed by mass spectrometry-based proteomics.

location_facility:
Hôpital Necker
Hôpital Pellegrin
Hôpital Edouard Herriot


title: Cancer Associated Thrombosis: What is the Proportion of Patients Ineligible to a Study as CARAVAGGIO (a Retrospective Multicenter Study)

summary:
Venous thromboembolism is a common and fatal disease closely related to cancer. The therapeutic challenge is major due to the high risk of recurrent thromboembolism and bleeding in patients with cancer.

Guidelines recommend the use of low molecular-weight heparin for the treatment of Cancer-Associated venous Thromboembolism (CAT) at least for 3 to 6 months of treatment.

However, recent advances through the results of several therapeutic trials such as CARAVAGGIO (NCT03045406) open the door to the use of Direct Oral AntiCoagulants (DOACs) as first-line therapy.

Nevertheless, extrapolation of its results may be limited owing to a large number of inclusion and exclusion criteria, which may have selected a reduced population.

The proportion of patients admitted with acute CAT who may not eligible to a trial as CARAVAGGIO is unknown.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU d'Amiens
Hôpital Louis Mourier
Chu Saint-Etienne


title: Impact of Neuropsychological Disorders on Visual Exploration, Walking Initiation and Walking in Multiple Sclerosis

acronym: SEVISEP

summary:
The study involves MS patients with and without neuropsychological disorders.

The patient will benefit from:

A routine neuropsychological assessment, including a cognitive and emotional assessment
A clinical examination
A three-dimensional analysis of movement

lead_sponsor: Lille Catholic University

location_facility: St Philibert hospital - Neurologial service

location_facility: St Vincent hospital - neurological service

location_facility: St Philibert hospital - Physical Medicine and Rehabilitation


title: Prospective Study to Investigate Neuropathy in Patients Monitored for Wild-type TTR Cardiac Amyloidosis (Non-mutated)

acronym: N-SAC

summary:
Transthyretin (TTR) amyloidosis is a rare disabling disorder that can be hereditary or sporadic. Depending on the form, various tissues are affected. While in hereditary cases, neuropathy is predominant, cardiac impairment is the main manifestation in the sporadic form.

The main objective of this project is to evaluate the proportion of patients with neuropathy in a population of patients with a non-mutated TTR amyloid cardiopathy condition.

location_facility:
CHU de Nantes
CHU de Toulouse
CHU de Bordeaux


title: Use of Virtual Reality Mask or Music Therapy for Analgesia and Anxiolytic Purpose When Totally Implanted Venous Access Device (IVAD) for Chemotherapy Under Local Anesthesia

acronym: REVCCI

summary: Evaluate 2 medical devices on pain average and/or anxiety average in the totally Implanted Venous Access Device (IVAD) procedure under local anesthesia.

lead_sponsor: Institut Curie

location_facility:
Institut Curie
Gustave Roussy


title: Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System : a Randomized, Multicenter, Double-blind N-of-1 Trial

summary:
The aim of this study is to evaluate the contribution of the vacuum suspension system in an ecological environment on the fitting's comfort compared to the vacuum suspension system inactive system in a multicenter prospective, randomized, double-blind, multiple N-of-1 trial.

In order to assess the therapeutic effect of the vacuum suspension system, given the heterogeneity of the population and the small number of patients eligible for the study, the multiple N-of-1 trial seems to us to be the methodology. The principle is to evaluate intensively and prospectively a small group of subjects, each case being its own comparator.

lead_sponsor: Össur Ehf

location_facility:
Chu Clermont Ferrand
Clinique de Provence-Bourbonne
La Tour de Gassie


title: Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections

acronym: PULSOV

summary:
Central retinal vein occlusion (CRVO) is the second most common retinal vascular disease after diabetic retinopathy. It induces circulatory slowdown and blood stasis, which can appear as retinal hemorrhages. CRVO has been classically separated into two clinical forms: ischemic CVRO (possibly associated with cotton wool spots) and non-ischemic CRVO, the former being considered the most serious due to neovascular complications. More recently, a new classification has been suggested by Pierru et al. distinguishing two types of CRVO: type A characterized by low acute blood flow and type B with a slower onset. Type A is particularly associated with younger age, the presence of acute paracentral middle maculopathy, concomitant cilioretinal artery occlusion, and/or pulsatile arterial filling. Type B is more likely to occur in elderly patients, usually with high blood pressure, and multiple hemorrhages are frequently found on fundus examination.

A retrospective study had shown a slight difference in favor of pulsatile CRVO in terms of the number of intravitreal anti-angiogenic injections required to treat macular edema and visual acuity changes. However, no statistically significant difference was observed.

The objective of this study is to prospectively investigate whether spontaneous retinal artery pulses (SPARs) in patients with type A or B CRVO can be considered as a prognostic factor for the evolution of CRVO.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre médical et chirurgical de la rétine Strasbourg


title: Evaluation of a Check-list Including Lung Ultrasound for the Management of Patients With Acute Respiratory Failure at the Emergency Department During the COVID-19 Era

acronym: CHECKIRA-COVID

summary:
The aim of the study is to evaluate if a check-list including lung ultrasonography can help to identify the etiology of the acute respiratory failure of patients managed at the emergency room.

Adult patients admitted to the emergency room for acute respiratory failure will be offered the study. The emergency physician will perform a systematic examination using a checklist, including pulmonary embolism prediction scores, structured clinical examination and lung ultrasound, in order to establish a diagnostic hypothesis.

A diagnostic hypothesis will be made after completion of the checklist. The emergency physician can perform additional examinations and treatment after completion of the checklist.

The final diagnosis will be checked by an adjudication committee which will have all the documents established during the emergency room consultation and any hospitalization following this hospitalization.

The main outcome will be the concordance rate between the diagnosis after the check-list and the final diagnosis.

lead_sponsor: Centre Hospitalier Metropole Savoie

location_facility:
CH Annecy Genevois
CHUGA
Centre Hospitalier Metropole Savoie