title: French Version of the Short Form of Neurogenic Bladder Symptom Score: Cross-Cultural Adapta-tion and Validation.

summary:
Lower urinary tract symptoms (LUTS) are frequent in worldwide population. In neurogenic condition, LUTS can occur from beginning of neurologic disease (SCI, MS) or during its progression (MS). Neurogenic bladder may be responsible for upper urinary tract complications such as urinary tract infection or renal failure. It can also decrease quality of life and have an important socio-economic impact. For the last few years, patient-reported outcomes (PRO) have been the main way to assess functional urinary symptoms such as urinary incontinence or overactive bladder. Fortunately, Welk and al. developed and validated a new questionnaire in 2013 to allow a multimodal evaluation of LUTS specifically designed for a neurogenic population. The Neurogenic Bladder Symptom Score (NBSS) is composed of 24 items and explores 3 domains (urinary incontinence, bladder storage and voiding, consequences). In addition, NBSS includes two additional questions related to bladder management and quality of life. In 2020, Welk and al. developed a short version of NBSS (NBSS-SF), composed of 10 items exploring the 3 same domains as the NBSS original long version. However, there is no French-validated multi-dimensional questionnaire specifically assessing neurogenic LUTS, the USP questionnaire being a generic tool (Urinary Symptoms Profile (USP)).

The objective of our study was to validate the French linguistic version and the cross-cultural adaptation of the NBSS-SF.

METHODS:

The investigators conducted a prospective monocentric study between June and October 2020 in our neuro-urology clinic.

Step 1, translation and back-translation:

With the author's agreement, two bilingual translators (fluent in English and native French) created a French version of the NBSS. Both versions were combined and disagreement in wording or item redaction were resolved to maintain a better understanding. Next step was the back-translation with an native English translator.

Then, a bilingual expert committee, composed by urologists and neuro-urologists, compared the different versions to create a pre-final version of the questionnaire. Cross-cultural equivalence with analysis of the semantic, idiomatic, conceptual, and empirical equivalence of the source and pre-final versions of the NBSS-Short Form have been validated by the expert committee.

Step 2, Pilot study : n = 30 subjects. During this pilot study, acceptability and understanding were evaluated. Participant had to answer with a 3 level Likert scale (A: perfectly; B: good; C: poor) for each item. Comprehension and acceptation were considered as good if they answered A or B. All difficulties and remarks were collected to incorporate these comments in the final version after validation by a panel of experts.

Step 3, Validation stud:

To perform validation study, the investigators used the same inclusion criteria than Welk and al. and included patients with a neurogenic bladder due to multiple sclerosis (MS), spinal cord injury (SCI) or other neurologic condition such as spina bifida or Parkinson disease.

Validation study was performed to determine the psychometric properties of the questionnaire.

The investigators calculated the Cronbach's α coefficient, a measure of internal consistency (reliability) ranging from 0-1, with a coefficient greater than 0.7 considered as very good. The NBSS-short form is composed of 2 first items (covering quality of life and bladder management) and 8 items covering 3 subdomains (items 3, 4, 5 for urinary incontinence, items 6, 7, 8 for storage and voiding) and finally 2 items covering the consequences. The investigators calculated a Cronbach's α coefficient for each subscale and a coefficient for the whole questionnaire.

For test-retest reliability, the intraclass correlation coefficient (ICC) has been used. An ICC greater than 0.7 is considered as a good test-retest reproducibility. Participants completed the final version of the questionnaire and they had to mail the second questionnaire within 7 to 14 days. As this second questionnaire was completed at home, all participants were called to avoid missing data.

Correlations were computed between NBSS-SF scores obtained overall and for each domain on two different occasions, separated by a 7-14-day interval.

lead_sponsor: Pierre and Marie Curie University


title: Prevalence of Internet Addiction Among Adolescent

acronym: ADDICT-NET

summary:
Internet is now a tool available 24 hours a day, at a lower cost and accessible almost anywhere. Internet addiction could be defined as the inability to control one's Internet use and the continuation of this behavior despite the occurrence of negative consequences.

Adolescence is a time of vulnerability to addiction, due to social and neurobiological factors.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: Université de Reims Champagne-Ardenne

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study

acronym: POWELL

summary: While interdisciplinary weight loss intervention have been shown successful among adolescents with obesity, a weight regain is most of the time observed within the following weeks or months. The aim of the present project will be to better identify the independent role played by both the metabolic and mechanical load and their modification during weight loss, on the energy expenditure and energy metabolism of adolescents with obesity.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral

status_simplified: Completed


title: Feasibility of a Multi-site Screening Strategy in HPV+ Patients at High Risk of Cancer, With Characterization of the HPV Subtypes Involved by High Throughput Sequencing Technique: DEP-HPV

acronym: DEP-HPV

summary: The main risk of developing cervical cancer is the persistence of an High risk human papillomavirus (HPV-HR) infection, the mechanisms of which are still not understood. These chronically infected patients could develop multi-site lesions. The main objective is to assess the feasibility of setting up a personalized screening in patients at high risk of cervical cancer (chronically infected with HPV), by evaluating documenting the acceptability of these patients to be sampled from the ENT sphere and anal spheres for HPV analysis with next-generation sequencing.

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

intervention_type: Procedure


ipd_sharing: Undecided

status: Active, not recruiting

primary_purpose: Supportive Care

acronym: ARNCOMBI

intervention_type: Biological

title: Multicenter, Randomized, Open-label Trial Comparing the Immunological Efficacy of a Vaccine Regimen Combining Two Covid19 mRNA Vaccines (Pfizer-BioNTech and Moderna) With That of a Homologous Vaccination of Each Covid19 mRNA Vaccine: Non-inferiority Trial

lead_sponsor: Assistance Publique - Hôpitaux de Paris

type: EudraCT Number

source: euctr

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Janssen C, Cachanado M, Ninove L, Lachatre M, Michon J, Epaulard O, Maakaroun-Vermesse Z, Chidiac C, Laviolle B, Aumaitre H, Assaf A, Lacombe K, Schmidt-Mutter C, Botelho-Nevers E, Briere M, Boisson T, Loubet P, Bienvenu B, Bouchaud O, Touati A, Pereira C, Rousseau A, Berard L, Montil M, de Lamballerie X, Simon T, Launay O; ARNCOMBI Study Group. Immunogenicity and reactogenicity of heterologous and homologous mRNA-1273 and BNT162b2 vaccination: A multicenter non-inferiority randomized trial. EClinicalMedicine. 2022 Jun;48:101444. doi: 10.1016/j.eclinm.2022.101444. Epub 2022 May 12.

summary:
As part of the COVID 19 vaccine campaign, the two mRNA vaccines, BNT162b2 (COMIRNATY®) and mRNA-1273 COVID-19 vaccine Moderna, are administered in two doses in subjects without a history of SARS-CoV-2 infection . In accordance with the marketing authorization for vaccines, HAS recommends that subjects who have received one dose of an mRNA vaccine receive a second dose of the same vaccine with an interval between the 2 doses of 4 to 6 weeks. These two vaccines are based on very similar technologies but were developed independently. Given the similarities between these two vaccines, the choice between the two, for the moment, is based solely on the availability of doses and on logistical constraints. Since April 14, the interval between the two doses of the mRNA vaccines is 42 days.

WHO has announced that in the absence of available data, vaccine interchangeability cannot be recommended. However, to facilitate the organization of the vaccination campaign and allow faster vaccination of the population, it would be desirable to be able to use either one or the other mRNA vaccine for the 2nd dose.

In order to be able to recommend the interchangeability of the 2 mRNA vaccines, it is proposed to evaluate the immunogenicity of a scheme combining the two Covid 19 mRNA vaccines (i.e. a 2nd dose of vaccine with the Moderna vaccine after a first dose of the Pfizer vaccine or 2nd dose of Pfizer vaccine after a first dose of Moderna vaccine) compared to that of a standard vaccination schedule with two doses of the same Covid 19 mRNA vaccine.


title: Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer

acronym: EchoSurg

summary: Nowadays pancreatic cancer is one of the deadliest oncological pathologies. The only effective curative tool is the surgery. Before the intervention, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. In this study, the echoendoscopie will be extended to lymph node staging away from the surgical field in order to implement a simple classification of lymph nodes, based on non-invasive ultrasound criteria. This would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

ReferenceCitation: Kleeff J, Reiser C, Hinz U, Bachmann J, Debus J, Jaeger D, Friess H, Büchler MW. Surgery for recurrent pancreatic ductal adenocarcinoma. Ann Surg. 2007 Apr;245(4):566-72.

ReferenceCitation: Poruk KE, Firpo MA, Adler DG, Mulvihill SJ. Screening for pancreatic cancer: why, how, and who? Ann Surg. 2013 Jan;257(1):17-26. doi: 10.1097/SLA.0b013e31825ffbfb. Review.

ReferenceCitation: Butturini G, Stocken DD, Wente MN, Jeekel H, Klinkenbijl JH, Bakkevold KE, Takada T, Amano H, Dervenis C, Bassi C, Buchler MW, Neoptolemos JP; Pancreatic Cancer Meta-Analysis Group. Influence of resection margins and treatment on survival in patients with pancreatic cancer: meta-analysis of randomized controlled trials. Arch Surg. 2008 Jan;143(1):75-83; discussion 83. doi: 10.1001/archsurg.2007.17.

ReferenceCitation: Galasso D, Carnuccio A, Larghi A. Pancreatic cancer: diagnosis and endoscopic staging. Eur Rev Med Pharmacol Sci. 2010 Apr;14(4):375-85.

ReferenceCitation: Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. Epub 2007 Dec 4.

ReferenceCitation: Bhutani MS, Hawes RH, Hoffman BJ. A comparison of the accuracy of echo features during endoscopic ultrasound (EUS) and EUS-guided fine-needle aspiration for diagnosis of malignant lymph node invasion. Gastrointest Endosc. 1997 Jun;45(6):474-9. doi: 10.1016/s0016-5107(97)70176-7.

ReferenceCitation: Kanamori A, Hirooka Y, Itoh A, Hashimoto S, Kawashima H, Hara K, Uchida H, Goto J, Ohmiya N, Niwa Y, Goto H. Usefulness of contrast-enhanced endoscopic ultrasonography in the differentiation between malignant and benign lymphadenopathy. Am J Gastroenterol. 2006 Jan;101(1):45-51. doi: 10.1111/j.1572-0241.2006.00394.x.

ReferenceCitation: Giovannini M, Thomas B, Erwan B, Christian P, Fabrice C, Benjamin E, Genevieve M, Paolo A, Pierre D, Robert Y, Walter S, Hanz S, Carl S, Christoph D, Pierre E, Jean-Luc VL, Jacques D, Peter V, Andrian S. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: a multicenter study. World J Gastroenterol. 2009 Apr 7;15(13):1587-93. doi: 10.3748/wjg.15.1587.

ReferenceCitation: Nawaz H, Fan CY, Kloke J, Khalid A, McGrath K, Landsittel D, Papachristou GI. Performance characteristics of endoscopic ultrasound in the staging of pancreatic cancer: a meta-analysis. JOP. 2013 Sep 10;14(5):484-97. doi: 10.6092/1590-8577/1512.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne

intervention_type: Diagnostic Test


title: Behavioral Adaptation to Negative and Positive Social Signals in Healthy Volunteers

summary:
Social interactions are part of our daily lives. Communicating with others is a recurring choice which is based on emotional cues, such as facial expression. Our action must be adapted to the emotional state of our interlocutor, otherwise the investigators will have poor quality interactions An emotional stimulus would cause a conditioned response (innate reaction). Thus, the presence of an angry person would automatically trigger flight behavior. More recently, however, it has been envisioned that this same avoidance behavior could be the result of a goal-directed behvior. In this case, the avoidance behavior would be the result of an evaluation of the consequences of the selected action. These goal-directed behaviors are guided by a mental representation of consequences The project aims to study behavioral choices (approach and avoidance) in response to negative and positive social cues (anger and joy) in 40 healthy volunteers using a computerized neuropsychological task, and to determine wheter these choices are the result of goal-directed behavior.

The study also aims to assess the modulation of behavioral adaptation by the level of impulsivity, lonilness, empathy, and by the capcity to understand others' intenstions.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: ODORAJA:Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology

acronym: ODORAJA

summary: The appearance of unpleasant body odors in adolescent Young adult (aya) wille be evaluated undergoing chemotherapy

time_perspective: Prospective

lead_sponsor: Institut Curie


title: Compares Changes in Pulmonary ITV Secondary to Vascular Filling to Reference Values Represented by Changes in Subaortic ITV in the Management of Sepsis in the Emergency Department.

acronym: CIAOP

summary:
This is a multicenter study conducted in the emergency department of the Nantes University Hospital and the Confluent Private Hospital, over a period of 5 months, based on hemodynamic ultrasound.

For each patient admitted to an emergency department with a sepsis syndrome requiring vascular filling, the pulmonary ITV and the aortic ITV were measured at each phase of vascular filling.

This is a non-interventional study, the management of patients will not differ from usual practices and vascular filling should not be delayed in any case. Emergency doctors who are already experts in ultrasound, monitoring vascular filling by measuring the aortic ITV, will have to measure the pulmonary ITV after each filling of 250cc of Ringer's Lactate in 10 minutes with a limited amount of time.

The evolution of ITV measurements and vital parameters should be recorded for each patient.

In order to ensure quality, the emergency doctors will first receive a short training (presentation of the study and review of the measurements requested). In addition, measurement records will be analyzed at random.

At the end of this study, the correlation between the variation of the aortic and pulmonary ITV could be compared. The objective would be to promote the monitoring of these unstable patients via the pulmonary ITV. This measurement would be easier to perform than the aortic ITV, which is currently only performed by emergency doctors who are experts in hemodynamic ultrasound.

lead_sponsor: Nantes University Hospital


title: MEDIBIOTE 3: Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

acronym: MEDIBIOTE 3

summary:
Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs. Classically, SpA has been classified into several subtypes, such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD)-associated.

Several studies have shown specific changes in the gut microbiota during SpA. A recent, uncontrolled study suggested that the therapeutic response to anti-TNFα (Tumor Necrosis Factor) therapy could be predicted by analysis of the gut microbiota.

The purpose of the study MEDIBIOTE 3 is to confirm that in SpA, the composition of the intestinal microbiota at the initiation of treatment is predictive of the response to treatment with biotherapy (anti-TNFα / anti-IL17).

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Hôpital Européen Marseille


title: Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life

summary:
Chorda tympani nerve (CTN), is a branch of nerve VII, and has two componants: taste sensation from the anterior two thirds of the tongue and salivary secretion from submandibular and sublingual salivary glands.

CTN go throw middle ear between malleus and incus. Due to it anatomic localization, CTN is frequently damage during otologic surgery.

Taste disturbance after middle ear surgery has been describe in literature but results of the various studies are very heterogenous. Moreover, there is no consensus to preserved or sacrificed a traumatize CTN.

We will use questionnaire to evaluate frequency, duration and characteristics of taste disturbance after ear surgery and the impact on the quality of life for those with symptoms.

We will evaluate the Influence of type of CTN injury on taste disturbance.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: The Role of the Embedded Participant on Learners' Performance During High- Fidelity Simulation

summary:
Simulation in medicine is a powerful and effective teaching tool that has become essential for the training of students and health professionals.

In this context, simulation instructor training have been implemented in recent years, where many subjects are addressed, such as the main principles of pedagogy, the integration of simulation, the construction of a scenario, briefing and debriefing.

However, scenario facilitation, in particular the role of the embedded participant (EP), is only vaguely discussed. The EP of a high-fidelity simulation session plays a very important role in driving the scenario. Indeed, he/she guides the learner in order to achieve all the educational objectives set by the main instructor of the scenario. He/she also manages unexpected behavior and possible technical issues that may arise. Finally, the EP supervises the physical and psychological risks inherent in the simulation in order to maintain a safe environment.

All of these key roles suggest that the EP can influence the performance of the learners. Little is known about the relationship between Facilitation and Learner Performance.

In this observational study, investigators aim to explore the influence of the embedded participant on learners' technical and non-technical performances during high-fidelity simulation by analysing previously recorded sessions.

ReferenceCitation: Cooke JM, Rooney DM, Fernandez GL, Farley DR. Simulation center best practices: A review of ACS-accredited educational institutes' best practices, 2011 to present. Surgery. 2018 Apr;163(4):916-920. doi: 10.1016/j.surg.2017.11.004. Epub 2017 Dec 19.

ReferenceCitation: Paige JB, Graham L, Sittner B. Formal Training Efforts to Develop Simulation Educators: An Integrative Review. Simul Healthc. 2020 Aug;15(4):271-281. doi: 10.1097/SIH.0000000000000424.

ReferenceCitation: Lewis KL, Bohnert CA, Gammon WL, Hölzer H, Lyman L, Smith C, Thompson TM, Wallace A, Gliva-McConvey G. The Association of Standardized Patient Educators (ASPE) Standards of Best Practice (SOBP). Adv Simul (Lond). 2017 Jun 27;2:10. doi: 10.1186/s41077-017-0043-4. eCollection 2017.

ReferenceCitation: Boyer TJ, Mitchell SA. Utilization of Embedded Simulation Personnel in Medical Simulation. 2022 Jul 25. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562294/

lead_sponsor: Claude Bernard University


title: Clinical Study of the Hyperviscosity Syndrome in Waldenström Macroglobulinemia

acronym: SLPRaresHvisc

summary:
Walsdenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. Clinical manifestations of the hyperviscosity syndrome (HVS) are related to the large amount of IgM in circulating blood or to some physicochemical characteristics such as the presence of a cryoglobulin property. Although HVS is one of the most frequent criteria for initiating therapy in WM, few studies focused on its description and no diagnostic criteria are available.

The present study aims to identify a diagnostic system for HVS, taking into account objective symptoms such as bleedings, fundoscopic findings and also subjective symptoms such as fatigue and comorbidities that may influence the severity of symptoms.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: A Pilot Open-label, Feasibility Study to Assess safEty, Tolerability, Radiation Dosimetry, and Imaging Properties of 89Zr-labeled giRenTuximab (89Zr-Girentuximab) in patIents With Non-musclE-iNvasive Bladder CancEr (NMIBC)

acronym: PERTINENCE

summary: The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT radiopharmaceutical for the imaging of Non-muscle-invasive bladder cancer (NMIBC) patients.

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Drug

lead_sponsor_type: industriel


title: Use of 2D-Speckle Tracking Echocardiography in a Pediatric Population With Chronic Renal Disease: a Multicentre Cross-sectional Controlled Study (SPECKLE-KIDNEY-PED)

acronym: SPECKLEKIDNEY

summary: The SPECKLE- KIDNEY-PED is a multicentre observational controlled trial aiming to evaluate the 2D-Speckle tracking in a population of 85 patients aged from 6 to 17 years old with a chronic renal disease and to compare the results to those of 85 age and gender-matched healthy subjects. The secondary objective is to assess the conventional echocardiographic parameters and the level of exercice capacity.


title: Persistent Left Bundle Branch Block After Rapid-Deployment Aortic Valve Replacement: Incidence, Long-term Prognostic and Predictive Factors

summary:
This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis.

It was an observational, retrospective and single-center study. Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent RD-AVR with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. Incidence, prognosis and predictive factors of new-onset of persistent LBBB were evaluated.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Evaluation of a CPAP Telemonitoring Algorithm for Newly Treated Patients: the TELEAP1 Multicenter Cohort Pilot Study

summary: TELEAP1 is a multicenter cohort pilot-study designed to evaluate the impact of a published SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm on the CPAP-compliance of newly treated patients with obstructive sleep apnea..


title: Modulation of Cognitive Control Via Transcranial Continuous Electrical Stimulation of Additional Motor Areas in Parkinson's Patients

acronym: STAR-PARK

summary:
In Parkinson's disease (PD), recent work has shown that dopaminergic treatments alter one of the two aspects of impulsivity: they do not alter the propensity to produce "automatic" responses, but deteriorate the ability to inhibit and correct (that is, control) them. In healthy subjects, the investigator's team has also demonstrated that transcranial direct current "cathodal" electrical stimulation (tDCS) of Supplementary Motor Areas decreases the frequency of behavioral errors by improving the ability to "correct" responses.

The main objective of this project is to determine whether cathodal tDCS of Supplementary Motor Areas in PD patients under dopaminergic treatment improves the control and correction of errors about to be made and compensates for the deficits induced by the treatment.

All participants will perform a reaction time task of choice (Simon's task), with and without ("sham" session) tDCS. The experimental design of this single-center, single-blind, randomized study will be that of 3 parallel groups (treated Parkinson's disease, untreated Parkinson's disease patient, and matched control subjects) with cross-over application of tDCS. All participants will be blind to the operating mode of the tDCS (either functional or in "sham" mode corresponding to a control condition). The order of the sessions (with and without tDCS) will be randomized within each of the 3 groups of subjects. The analysis of errors about to be made but inhibited in time (known as "early errors") will be carried out through electromyographic (surface) recording of muscle activities involved in motor responses.

tDCS is expected to improve the ability of treated patients to correct their errors about to be made. This study will thus provide a better understanding of the mechanisms of action control and possibly propose a new therapeutic approach for treatment-induced impulsivity disorders in Parkinson's disease.

primary_purpose: Treatment

location_facility: Service Neurologie et pathologies du mouvement

intervention_type: Device


title: Quality of Life 3 Months After Cervical Ripening

acronym: MATUCOL-QOL

summary:
Women's experience of childbirth differs with type of labor, mode of delivery and parity. Induction of labor (IOL) is associated with lower satisfaction of women than spontaneous labor.

A Nigerian study of 252 women with induced labor, irrespective of parity and device used for IOL and a French cohort study of 3042 women with IOL have been published. Theses latter identified several determinants of maternal dissatisfaction.

However, no published study has reported the assessment of quality of life of women at long term after cervical ripening according to the device required for cervical ripening.

The aim of this study is to characterize the quality of life of women after cervical ripening according to parity and device required, and to assess possible factors associated with this quality of life at long-term after delivery.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Chronic Intestinal Pathologies Analytical Cohort at TouLouse

acronym: CAPITOL

summary: In the general population, the percentage of people with at least one digestive disease is 16.7%. Among these digestive diseases, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and patients who should benefit from digestive examinations as part of a screening oriented either by the patient's family history or following the performance of an immunological screening test ( FIT) in the stool will be studied. The aim of this project is to build a biological collection with associated clinical data for research projects.


title: Prospective, Observational Study Evaluating the Feasibility of a Systematic and Standardized Assessment of Supportive Care Needs in Patients With Advanced Solid Cancer at the Inclusion in a Therapeutic Trial at the Institut Curie

summary: The purpose of the study is to assess the supportive care needs of patients enrolled in a therapeutic trial for metastatic cancer.


title: Evaluation of the Efficacy of the Photobiomodulation on the Pelvi-perineal Pain in Patients in Immediate Post-partum Situation

summary: Photobiomodulation (PBM), evaluated in this study, will be delivered by a CE marked class IIa medical device (MILTA technology), composed of a panel that gathers 18 emitters. This is an innovative, alternative, soft technology, based on a cross action of LED light emission, a low intensity nanopulsed laser and a magnetic tunnel. The sessions last 10 minutes each, in total in the study two sessions will be delivered.

ReferenceCitation: Persico G, Vergani P, Cestaro C, Grandolfo M, Nespoli A. Assessment of postpartum perineal pain after vaginal delivery: prevalence, severity and determinants. A prospective observational study. Minerva Ginecol. 2013 Dec;65(6):669-78.

ReferenceCitation: Morin C, Leymarie MC. La douleur périnéale en post-partum: revue de la littérature. La Revue Sage-femme (2013) 12; 263-268

ReferenceCitation: Manresa M, Pereda A, Bataller E, Terre-Rull C, Ismail KM, Webb SS. Incidence of perineal pain and dyspareunia following spontaneous vaginal birth: a systematic review and meta-analysis. Int Urogynecol J. 2019 Jun;30(6):853-868. doi: 10.1007/s00192-019-03894-0. Epub 2019 Feb 15.

ReferenceCitation: Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204.

ReferenceCitation: Turmo M, Echevarria M, Rubio P, Almeida C. Development of chronic pain after episiotomy. Rev Esp Anestesiol Reanim. 2015 Oct;62(8):436-42. doi: 10.1016/j.redar.2014.10.008. Epub 2014 Dec 30. English, Spanish.

ReferenceCitation: HAS. Douleur chronique: reconnaître le syndrome douloureux chronique, l'évaluer et orienter le patient. Consensus formalisé - December 2008

ReferenceCitation: Skovlund E, Fyllingen G, Landre H, Nesheim BI. Comparison of postpartum pain treatments using a sequential trial design. I. Paracetamol versus placebo. Eur J Clin Pharmacol. 1991;40(4):343-7.

ReferenceCitation: Behotas S, Chauvin A, Castiel J, Martin A, Boureau F, Barrat J, Lienhart A. [Analgesic effect of ibuprofen in pain after episiotomy]. Ann Fr Anesth Reanim. 1992;11(1):22-6. French.

ReferenceCitation: Gabelle C, Cassa S, Bouvard M, Knoepffler F. Intérêts des anti-inflammatoires non stéroïdes dans les douleurs périnéales du post-partum. J Gyneco. Obst. Biol. Reprod (2004) 33(1): 67 (10)

ReferenceCitation: Wehrle M. Prise en charge de la douleur post-épisiotomie en suites de couches: Analyse des pratiques professionnelles à la Maternité Régionale Universitaire de Nancy. Mémoire Université de Lorraine (2015) hal-02110831.

ReferenceCitation: Battut A, Nizard J. [Impact of pelvic floor muscle training on prevention of perineal pain and dyspareunia in postpartum]. Prog Urol. 2016 Mar;26(4):237-44. doi: 10.1016/j.purol.2015.09.006. Epub 2015 Oct 9. Review. French.

ReferenceCitation: Golka M. Haute fréquence et douleur périnéale du post-partum. Mémoire Université d'Aix Marseille (2017) dumas-01646228

ReferenceCitation: Boureau F, Luu M. Méthodes d'évaluation de la douleur. Douleur et Analgésie (1988) 6; 1(2): 65-78.

ReferenceCitation: Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361. doi: 10.3934/biophy.2017.3.337. Epub 2017 May 19.

ReferenceCitation: Moreira Rocha Jr A. Et al. Effects of Low-Level Laser Therapy on the progress of wound healing in humans: the contribution of in vitro and in vivo experimental studies. J. Vas. Bras 2007; 6(3): 258-266

ReferenceCitation: Luo L, Sun Z, Zhang L, Li X, Dong Y, Liu TC. Effects of low-level laser therapy on ROS homeostasis and expression of IGF-1 and TGF-β1 in skeletal muscle during the repair process. Lasers Med Sci. 2013 May;28(3):725-34. doi: 10.1007/s10103-012-1133-0. Epub 2012 Jun 20.

ReferenceCitation: Cidral-Filho FJ, Mazzardo-Martins L, Martins DF, Santos AR. Light-emitting diode therapy induces analgesia in a mouse model of postoperative pain through activation of peripheral opioid receptors and the L-arginine/nitric oxide pathway. Lasers Med Sci. 2014 Mar;29(2):695-702. doi: 10.1007/s10103-013-1385-3. Epub 2013 Jul 6.

ReferenceCitation: Enwemeka CS, Parker JC, Dowdy DS, Harkness EE, Sanford LE, Woodruff LD. The efficacy of low-power lasers in tissue repair and pain control: a meta-analysis study. Photomed Laser Surg. 2004 Aug;22(4):323-9.

ReferenceCitation: Ahangar FA et Al. Efficace of nano-pulsed magneto infrared Laser Therapy with a fixed dose combination tablet of oral Ibuprofen and paracetamol on the reduction of endodontie pain: a clinical study. Contemporary Med. Res. (2017); 4(8): 1782-1787

ReferenceCitation: Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13. Review. Erratum in: Lancet. 2010 Mar 13;375(9718):894.

ReferenceCitation: Ezzati K, Fekrazad R, Raoufi Z. The Effects of Photobiomodulation Therapy on Post-Surgical Pain. J Lasers Med Sci. 2019 Spring;10(2):79-85. doi: 10.15171/jlms.2019.13. Epub 2019 Feb 25. Review.

ReferenceCitation: FDA, Multiple Endpoints in Clinical Trials Guidance for Industry, January 2017

lead_sponsor: Elsan


title: 3D Personalized Modelization of the Hand Using EOS Imaging System

summary: This study aims to compare the quality of 3D hand modelization with EOS imaging with gold-standard computed tomography

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome : a Case Series and Systematic Review

summary:
ANCA vasculitis and Sjögren syndrome are two rare diseases, and even more rarely associated. These two conditions have specific organ involvements, and specific follow-up.

The Investigators hypothesise that patients with co-occurrence of these two diseases may have a singular clinical course.

ReferenceType: result

ReferenceCitation: Guellec D, Cornec-Le Gall E, Groh M, Hachulla E, Karras A, Charles P, Dunogué B, Abad S, Alvarez F, Gérard F, Devauchelle-Pensec V, Pers JO, Puéchal X, Guillevin L, Saraux A, Cornec D; CRI (Club Rhumatismes et Inflammation) and the French Vasculitis Study Group. ANCA-associated vasculitis in patients with primary Sjögren's syndrome: detailed analysis of 7 new cases and systematic literature review. Autoimmun Rev. 2015 Aug;14(8):742-50. doi: 10.1016/j.autrev.2015.04.009. Epub 2015 Apr 24. Review.

ReferenceCitation: Lee SB, Choi H, Kim MK, Jung SM, Song JJ, Park YB, Lee SW. Can antineutrophil cytoplasmic antibody positivity at diagnosis predict the poor outcomes of Sjögren's syndrome? Rheumatol Int. 2020 Jul;40(7):1063-1070. doi: 10.1007/s00296-019-04476-5. Epub 2019 Nov 12.

ReferenceCitation: Ramos-Casals M, Brito-Zerón P, Font J. The overlap of Sjögren's syndrome with other systemic autoimmune diseases. Semin Arthritis Rheum. 2007 Feb;36(4):246-55. Epub 2006 Sep 22. Review.


title: Effects of Shoe Longitudinal Bending Stiffness on Changes in Energy Cost of Running During a 21 km Run

acronym: FAT-FLEX

summary: Carbon plates inserted in competitive running shoes have been increasingly used in the past 2-3 years and several investigations have shown that these plates increase the longitudinal bending stiffness (LBS) of the shoe. It leads to a redistribution of muscle work and to a modification of the force generation conditions, which may reduce the energy cost of running (Cr) and improve performance.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Unités de Myologie et de Médecine du Sport


title: Comparison of Power Wheelchair Driving Performance in a Physical Simulator With CAVE, Immersive Helmet and Non-immersive Screen in a Population of Drivers With Neurological Disorders: Pilot Study

summary: This study aims to assess the impact of the choice of visual feedback solution (immersive via CAVE and VR headset; non-immersive via screen only) on driving performance and quality of experience on a physical driving simulator and its acceptability to wheelchair drivers with neurological disorders.

lead_sponsor: Pôle Saint Hélier


title: Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children: a Prospective Study

summary: Calcaneonavicular coalition represents approximately 1% of the population between 8 and 12 years. They are manifested by repeated ankle sprains or by pain. - The diagnosis is radiological on an X-ray of the foot in oblique-3/4 incidence as well as magnetic resonance imaging. Treatment is second-line surgery after failure of orthopedic treatment. This surgery is either by direct approach or by arthroscopy, by performing a bone resection to recreate sufficient space in the joint in question. The patients in this study will only be operated on openly.

lead_sponsor: University Hospital, Limoges


title: Association Between Treatment Perception and Treatment Adherence in Obstructive Sleep Apnea Patients Treated by Continuous Positive Airway Pressure (SEMSAS Study)

acronym: SEMSAS

summary: The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.

lead_sponsor: Thibaut Gentina


title: Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine : Effects on Low Back Pain, Sagittal Alignment and Lipomatosis.

acronym: SPINOB

summary: The purpose of this study is to determine how an important weight loss after bariatric surgery affects obese patients ' spine, and the effects it has on low back pain, sagittal alignment and lipomatosis .

ReferenceCitation: Briggs MS, Givens DL, Schmitt LC, Taylor CA. Relations of C-reactive protein and obesity to the prevalence and the odds of reporting low back pain. Arch Phys Med Rehabil. 2013 Apr;94(4):745-52. doi: 10.1016/j.apmr.2012.11.026. Epub 2012 Nov 24.

ReferenceCitation: Khoueir P, Black MH, Crookes PF, Kaufman HS, Katkhouda N, Wang MY. Prospective assessment of axial back pain symptoms before and after bariatric weight reduction surgery. Spine J. 2009 Jun;9(6):454-63. doi: 10.1016/j.spinee.2009.02.003. Epub 2009 Apr 8.

ReferenceCitation: Koulischer S, Cadière B, Cadière GB, Fabeck L. [Evolution of low back pain after bariatric surgery]. Rev Med Brux. 2015 May-Jun;36(3):147-51. French.

ReferenceCitation: de Mello AP, Martins GCDS, Heringer AR, Gamallo RB, Martins Filho LFDS, de Abreu AV, Carvalho ACP, Gama MP. Back pain and sagittal spine alignment in obese patients eligible for bariatric surgery. Eur Spine J. 2019 May;28(5):967-975. doi: 10.1007/s00586-019-05935-0. Epub 2019 Mar 15.

ReferenceCitation: Beckworth WJ, McCarty EJ, Garcia-Corrada JE, Holbrook JF. Epidural Lipomatosis and Associated Spinal Stenosis-The Impact of Weight Loss: A Case Report. Am J Lifestyle Med. 2017 Jan 12;11(6):511-514. doi: 10.1177/1559827616686764. eCollection 2017 Nov-Dec.

ReferenceCitation: Joaquim AF, Helvie P, Patel AA. Bariatric Surgery and Low Back Pain: A Systematic Literature Review. Global Spine J. 2020 Feb;10(1):102-110. doi: 10.1177/2192568219826935. Epub 2019 Feb 5. Review.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prognostic Value of Circulating Tumoral DNA After the First 6 Months of Treatment in Patients With Waldenström Macroglobulinemia

acronym: SLP-rares

summary:
Waldenström Macroglobulinemia (WM) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin M (IgM) in blood. This chronic lymphoproliferative disorder requires treatment only in case of symptoms, according to accurate criteria described during the second Workshop on WM i.e. in case of cytopenia, bulky organomegaly, immunological or physicochemical consequences of the presence of IgM in circulating blood. A MYD88 mutation, typically a MYD88(L265P), is found in 90% of WM patients. Other gene abnormalities have been observed, the most frequent is a mutation in the CXCR4 gene. Overall, gene mutations in WM involve only a limited number of signalling pathways, yielding the activation of NFkB, namely : the TLR and MYD88 pathway (with an activation of NFkB and BTK in case of MYD88(L265P) mutation), the BCR pathway (involving btk and associated with activations of both NFkB, and erk akt pathway) and the CXCR4 pathway (CXCR4 is a receptor of CXCL12, it is also associated with activations of ERK/MAPK and PI3K). Abnormalities of some of genes, such as TP53, of the expression of the protein CXCL13 and genes involved in the interleukin 6 secretion have been associated with some clinical characteristics.

The purpose of this project is to define the prognostic role of the detection of circulating tumoral DNA (ctDNA) at the end of treatment for the progression/relapse risk within the first 3 years after the first 6 months of treatment.


title: Interest of Peticate Syneo Infant Formula in Children Allergic to Cow's Milk Protein: Real Life Study

acronym: PEPSY

summary: Nutricia wants to launch a real-life study, to see how the presence of prebiotics and probiotics in the boosted protein hydrolyzate can improve symptoms in the first weeks of use, and supplement the efficacy and safety data of the drug. formula, collected during clinical trials, with real life use. The target population will be children with a definite or suspected diagnosis of APLV, who have never taken a hypoallergenic formula, for whom the doctor decides to prescribe the Pepsicate Syneo formula, regardless of the clinical manifestation of the allergy. These children will be included before the age of 8 months and will be seen again 4 weeks after the prescription. The data from this real-life study will also better characterize the profile of infants taking Pepsicate Syneo. Finally, the perception of the formula by the parents will be collected.

lead_sponsor: Nutricia Nutrition Clinique

intervention_type: Dietary Supplement


title: Impact of the Rapid Normalization of Chronic Hyperglycemia and the Practice of Moderate Physical Activity on the "Receptor Activator of Nuclear Factor-kappa B Ligand / Osteoprotégérine (RANKL / OPG) System in Patients Living With Type II Diabetes

acronym: RANKL-GLYC

summary:
The rapid normalization of hyperglycemia can cause a neuropathy called Diabetes Treatment-Induced Neuropathy (NITD). This phenomenon induces the presence of hyper vascularization and inflammation in contact with the nerve ends.

In another register in patients living with diabetes, it has been observed the development of a rare and devastating complication for the joints called the so-called neuroarthropathy of Charcot (CN).

lead_sponsor: Centre Hospitalier Sud Francilien


title: Impact of SARS-CoV-2 (COVID-19) Infection, Treated in Ambulatory Care, on Long-term Quality of Life in a Parisian Military Population

summary: In April 2020, a meta-analysis on the long-term sequelae of respiratory syndromes related to seasonal coronaviruses (SARS and MERS) showed a significant alteration in quality of life, with in particular a decrease in physical and emotional capacities and a deterioration of social life. An improvement of the quality of life is evidenced after 6 months but without reaching the level usually observed in healthy people. The impact of SARS-CoV-2 infection on quality of life can be explained by the persistence of pleomorphic symptoms in the medium to long term. In the military population, the majority of SARS-CoV-2 cases present minor to moderate forms of the disease. Military personnel have living conditions that differ from those of the general population, in particular because of their geographic mobility, which may be responsible for isolation from the family. This isolation can be regular (we speak of "geographical celibacy" when the soldier is posted in a geographical area far from the family unit) and/or occasional, during missions on the national territory or outside. This singularity justifies a study on the impact of SARS-CoV-2 (COVID-19) infection on the quality of life in this specific population.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Use of Virtual Reality to Reduce Morphine Consumption in Adolescents Undergoing Scoliosis Surgery: A Prospective Randomized Open-label Study. Virtual Reality for Analgesia in Spine Surgery

acronym: ViRAgeSS

summary: The objective is to evaluate the effect of the association of virtual reality sessions with usual management on the cumulative consumption of morphine equivalent post-operatively in adolescents aged 13 to 18 years who have undergone scoliosis surgery.

lead_sponsor: University Hospital, Toulouse


title: Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer

acronym: Pied-REM

summary: To evaluate the benefit of multidisciplinary specific follow-up of patients with a healed diabetic foot ulcer at the rate of two annual consultation on wound recurrence.

ReferenceCitation: van Netten JJ, Price PE, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Bus SA; International Working Group on the Diabetic Foot. Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:84-98. doi: 10.1002/dmrr.2701. Review.

ReferenceCitation: Bus SA, van Netten JJ, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Price PE; International Working Group on the Diabetic Foot. IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:16-24. doi: 10.1002/dmrr.2696. No abstract available.

ReferenceCitation: Bus SA, Waaijman R, Arts M, de Haart M, Busch-Westbroek T, van Baal J, Nollet F. Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial. Diabetes Care. 2013 Dec;36(12):4109-16. doi: 10.2337/dc13-0996. Epub 2013 Oct 15.

ReferenceCitation: Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. Review.


type: Registry Identifier

title: Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance

acronym: H-ICMUS

summary:
The primary objective of this pilot study aims to describe the modifications of subcutaneous impedancemetry induced by dialysis.

As secondary objectives, the study aims to 1) describe the modifications of cutaneo-muscular impedancemetry induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events. 3) describe the relationship between modifications of cutaneo-muscular impedancemetry induced by dialysis and 1) describe the modifications of cutaneo-muscular impedance induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events.

location_facility: Service de Néphrologie, Hôpital Ambroise Paré, APHP


title: Early Detection of Patients at Risk of Developing Anthracycline Cardiotoxicity With TEP/CT -FDG

acronym: DETECT

summary:
Management of patients with lymphoma is based on the administration of a chemotherapy containing anthracyclines (ATC), and allows cure rates of 65% to 80% at 5 years. The administration of ATCs can lead to an increase in the risk of the Left Ventricular Systolic dysfunction (LVSD) which ranges from 6 to 15% at 1 year, and of heart failure from which impact at 3.5 years can reach 5%. The major issue in the management of this toxicity is the early identification of this population for monitoring and prevention. No pharmacological intervention strategy is currently recommended.

According to the recommendations of the European Society of Cardiology, this identification is based on the measurement of the left ventricular ejection fraction (LVEF) and the overall longitudinal strain (SLG) before and after the last administration of ATC ( at D84 or D126, depending on the duration of the chemotherapy protocol). Recent studies have evaluated the diagnostic performance of earlier strategies highlighting the benefit of SLG measured after 150 mg / m2 of ATC (D42). However, the tools are lacking to detect these patients as close as possible to the onset of ATC, a necessary condition for effective secondary prevention. The hypothesis is that an early assessment of myocardial binding of 18F-FDG, analyzed during the first routine PET / CT scan as part of the assessment of the response to chemotherapy (D42) should verify a population at risk of developing LVSD at 1 year.


title: Impact of COVID-19 Infection and Confinement on Diabetic Ulcer Management and Amputation Risk

acronym: COROPIEDIAB

summary:
In the context of the COVID-19 pandemic, a number of factors, including the lockdown that was imposed to limit the spread of infection, the fear of being contaminated during hospital consultations and the difficulty in accessing general practitioners may have led to delays in the referral of patients to facilities specialized in the management of diabetic ulcers. Since the beginning of the coronavirus pandemic and during the first lockdown, we observed a clear decrease in hospitalizations and consultations for diabetic ulcers. Patients who had regular follow-up for the management of their diabetic ulcers cancelled their scheduled appointments for fear of being contaminated in the hospital. It is feared that the current epidemic context has favored the delay of referral of patients with diabetic ulcers to specialized facilities, with consequences on the prognosis of these patients and the risk of lower limb amputation.

In this context, this project aims to evaluate the impact of confinement on emergency hospitalizations for foot wounds and the effects on the risk of amputation during the lockdown and the three months following the end of the lockdown.

Our hypothesis is that the lockdown led to a decrease in hospitalizations for foot wounds, resulting in a delay in the management of these patients, and potentially leading to an increase in the number of amputations in the three months following the end of the lockdown.

In parallel, we will also study the impact of confinement on deferrable hospitalizations (glycemic imbalance, assessment of diabetic complications...) or theoretically non-deferrable (diabetic comas, ketoacidosis, diagnosis of type 1 diabetes, acute coronary syndrome, stroke...) of diabetes mellitus. This will allow us to evaluate whether our findings relative to diabetic ulcers could be extended to other complications of diabetes.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Detection of Right Ventricular Dysfunction by Portal Vein Doppler After Cardiac Surgery

acronym: DVDDP

summary: Right ventricular (RV) failure after cardiac surgery is associated with morbidity and mortality, but is hard to diagnose with conventional echocardiographic means. RV dysfunction may be associated with hepatic congestion, which may have an effect on portal veinous flow, but this has not been extensively. The investigators aimed determine whether an increased pulsatility in the portal venous flow was associated with RV dysfunction, after cardiac surgery at risk of RV dysfunction: mitral and tricuspid valve procedures.

ReferenceCitation: Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: II. Pathophysiology, clinical importance, and management. Anesth Analg. 2009 Feb;108(2):422-33. doi: 10.1213/ane.0b013e31818d8b92. Review.

ReferenceCitation: Haddad F, Couture P, Tousignant C, Denault AY. The right ventricle in cardiac surgery, a perioperative perspective: I. Anatomy, physiology, and assessment. Anesth Analg. 2009 Feb;108(2):407-21. doi: 10.1213/ane.0b013e31818f8623. Review.

ReferenceCitation: Denault AY, Beaubien-Souligny W, Elmi-Sarabi M, Eljaiek R, El-Hamamsy I, Lamarche Y, Chronopoulos A, Lambert J, Bouchard J, Desjardins G. Clinical Significance of Portal Hypertension Diagnosed With Bedside Ultrasound After Cardiac Surgery. Anesth Analg. 2017 Apr;124(4):1109-1115. doi: 10.1213/ANE.0000000000001812.

ReferenceCitation: Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010.

lead_sponsor: CMC Ambroise Paré


title: Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)

acronym: AMYLYONCARP

summary: The purpose of this study is to evaluate the prevalence of amyloidosis in population of patient affected by suspect bilateral carpal tunnel with indication of surgery

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon


title: Study of End Tidal Carbon Dioxide (EtCO2) Variation After an End- Expiratory Occlusion Test as a Predictive Criteria of Fluid Responsiveness in Mechanically Ventilated Patients

acronym: CapnoPause

summary:
Hypovolemia is one of major factor of haemodynamic instability. Fluid administration is not totally riskless. Indeed, it can create or inflate pulmonary oedema, alter gaz exchanges and increase post operative respiratory complications. Furthermore, fluid administration is not always followed by a cardiac output increase.

Predicting preload responsiveness before administering fluid by reliable and reproductible methods is necessary in critically ill patients.

Dynamic indicators are approved at the bedside such as passive raising leg test, pulse pressure variation, respiratory variation of the diameter of the superior vena cava. However, all these tests cannot be used for all patients. For example in the cases of spine or pelvis injury, or traumatic brain injury, patients with difficult condition for transthoracic echography.

The investigators hypothesize that EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test could predict fluid responsiveness in mechanically ventilated patients in the intensive care units.

EtCO2 is a parameter which can be easy to collect, reproductible, and totally non invasive. This method could be especially appropriate for patients for whom the classical test of fluid responsiveness cannot be used

lead_sponsor: CHU de Reims


title: Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

summary: B-cells ensure humoral immune response against antigens (Ag) thanks to their receptor (BCR). V(D)J rearrangement, somatic hypermutation, immunoglobulin (Ig) class switch and locus suicide recombination are mutational/recombinational processes targeting Ig loci influencing BCR expression. Study of these events is essential for B cell function analysis. Our project will provide the normal reference values using high throughput sequencing-based protocols.

intervention_type: Genetic


title: A Clinico-biological Database on Atypical Venous Thrombosis in the Context of anticovid19 Vaccination

acronym: THROMBO-VAXCOV

summary:
In the context of anti-Covid19 vaccination, atypical thrombosis have occured and potential link with vaccination is under investigation.

This study collect clinical and biological data of all atypical thrombosis occurring within 4 weeks after antiCovid vaccination.

ipd_sharing: Yes

lead_sponsor: University Hospital, Lille


title: Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement (ToGiAC)

acronym: TOGIAC

summary: A French multicenter randomised and placebo-controlled study recruiting patients who present neurovascular involvement related to GCA (> 60 years) with symptomatic (stroke) or asymptomatic forms. The aim of this study is to assess the efficacy of tocilizumab to induce complete remission of GCA with cerebrovascular involvement (clinical and biological) and absence of clinical and MRI ischemic stroke recurrence at 24 weeks.

location_facility: Saint Antoine Hospital, Neurology Unit, Assistance Publique-Hôpitaux de Paris


title: Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm.

acronym: Algo Fréq

summary:
360 million people worldwide suffer from disabling hearing loss. The prevalence of hearing impairment, all stages combined, in the French population is 7% (4 million people), of which 9% have severe impairment and 3% have profound or total impairment.

Cochlear implants are indicated in severe to profound deafness in some cases. The principle of the cochlear implant is to directly stimulate the fibres of the auditory nerve via electrodes inserted into the cochlea. It stimulates the auditory nerve and sends electrical impulses to the brain where they are interpreted as sounds.

The steps in hearing rehabilitation are surgical placement of the cochlear implant, activation, and follow-up adjustments.

There is no formal consensus on the exact adjustment procedures during activation or follow-up, but principles are followed depending on the cochlear implant adjustment centers (jack). All centers focus on sound intensity adjustments to achieve the goals of tonal audiometry in open-field silence with cochlear implant alone between 20 and 40 db (30 db most frequently). However, it is common practice to observe that this means of assessment does not really represent the performance of the individual because hearing a sound does not mean that someone will be able to recognize it and interpret it. Some of the patients who achieve these goals have difficulty hearing well in a noisy environment. Speech audiometry in silence and especially in noise would be a better reflection of patient needs.

Bimodal hearing is having a cochlear implant and a contralateral hearing aid. In cochlear implants, having bimodal binaural hearing improves the patients ability to understand speech in silent and noisy contexts. It should thus be considered when a second cochlear implant is not indicated in the contralateral ear.

It has been shown that intelligibility and musical perception are altered when the frequency allocations are different from the manufacturer's default frequency allocations. The possible redundancy between the acoustic and electrical information on the contralateral ear can lead to metallic distortion of the voice, which is perceived as less natural. This is due to a different stimulation of the cochlear tonotopic zones concerning conversational frequencies, between the implanted side and the device side. However, the frequency distribution is not subject to adjustment in current practice. A modification of the frequency distribution is possible on cochlear implants, which could improve the intelligibility and comfort of the implanted patient.

This working hypothesis will be studied, and a simple protocol for frequency reallocation of the cochlear implant will be developed to optimize the daily hearing performance of the implanted patients. An evolutionary algorithm will be used. The search for new adjustment solutions will be carried out within the safety limits imposed by the adjusters (detection and comfort loudness threshold).


title: Strength Muscular Assessment and Prolonged Preoperative Rehabilitation Interest in the Anterior Cruciate Ligament Rupture - a Preliminary Study

acronym: ISO-LCA-PREOP

summary:
Rupture of the anterior cruciate ligament is a serious and common injury. In young athletes, surgical reconstruction of the anterior cruciate ligament by autograft with hamstrings or patellar ligament is widely used.

Despite relatively standardized medical, surgical, and paramedical management, the results after ACL ligamentoplasty are not entirely satisfactory in term of return to sport. Recovery of the quadriceps strength is recognized as one of the decision-making criteria allowing the return to sport; however, significant muscle deficits are frequent at the time of return to sport.

If the postoperative management is well codified, focused on muscle strengthening and neuromuscular retraining, some studies have addressed the value of preoperative rehabilitation, and recommend a good preoperative muscular recovery of knee extensors and flexors, to obtain better postoperative results at the stage of the return to sports.

These results suggest that preoperative quadriceps strength should be considered as a predictor of the athletes' ability to return to sport activities.

It is estimated that around 10 to 30% of patients with preoperative deficits and could benefit from additional rehabilitation.

It can then be assumed that if the preoperative deficit is smaller, the postoperative deficit will also be smaller. This is the challenge of preoperative rehabilitation.

There are a few studies on preoperative rehabilitation which allow a gain in strength of knee extensors and flexors. However, the rehabilitation protocols applied to patients highly varied and there is no consensus on one protocol. The potential improvement is in the range of 10 to 20%.

The hypothesis of the study is that an optimal recovery of the strength of the preoperative knee extensors and flexors would reduce the postoperative deficit, thus improving the return to sport.

In the absence of reliable information on the frequency of muscle weakness in preoperative patients, we will conduct a preliminary study to obtain these data as well as the potential gain in strength with our preoperative rehabilitation protocol.


title: Osteoarticular Infections on Material in Children Under 16 Years Old at the CHU of Montpellier From 2014 to 2021

summary:
The management of osteoarticular infections on equipment is complex. In order to optimize the management of these infections, the French National Authority for Health (HAS) has published good practice recommendations for prosthesis infections in adults. However, in the pediatric population, this type of infection is rarer and their management less well codified.

The aim of this retrospective and descriptive monocentric study is to identify all osteoarticular infections in children under 16 years of age managed at the Montpellier University Hospital from 2014 to 2021, to study the epidemiology and bacterial ecology of these infections and to evaluate the effectiveness of the therapeutic strategy and side effects, long-term sequels

lead_sponsor: University Hospital, Montpellier


title: Pharmacokinetic Study of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease Under Stabilized Treatment.

acronym: PHARM-APO

summary: This monocentric and prospective trial aims firstly to assess the pharmacokinetic profile of continuous and diurnal subcutaneous apomorphine infusion in patients with Parkinson's disease under stabilized treatment and, secondly, to collect data highlighting the possible influence of pharmacogenetics.

lead_sponsor: Rennes University Hospital


title: Allergology: Information, Data and Knowledge Organization

acronym: ALLERGIDOC

summary:
Digital technology is essential in the field of health, via connected objects, the medical Internet or even telemedicine; and the info-communication practices (ways of getting information and communicating) of the actors go through digital devices. In addition, at present, the mass of activity documents to be managed in healthcare establishments and an abundant supply of documentary resources in health, available on the Internet, lead to infobesity, information pollution, and work overload. These phenomena lead to an increase in the time spent searching for relevant information and even to the burnout of healthcare professionals. A contextualization of the information communication systems through which the practices of health professionals pass therefore seems necessary so that the tools for managing, extracting and organizing knowledge can support these actors in their work.

In the field of allergies, there are many players, and the information that is useful to them is abundant and heterogeneous. This study is based on the hypothesis that a knowledge organization model, developed from existing practices, could make it possible to obtain satisfactory results when searching for information, and be integrated into the daily practices of actors by linking up with other already existing systems and tools.


title: Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial

acronym: OFACAR

summary:
Opioid-free anesthesia (OFA) is a general anesthesia based on the use of hypnotics and non-opioid analgesics (lidocaine, ketamine, dexamethasone, esmolol). This technique has been used for the past 10 years, during which randomized and non-randomized studies have demonstrated a number of positive effects on cardiac function:

better analgesia and decreased postoperative morphine consumption,
better respiratory function,
better hemodynamic stability,
better postoperative cognitive function.

The hypothesis of the present study is that the use of OFA during cardiac surgery is associated with:

Improved intraoperative hemodynamic stability
A decrease in the incidence of postoperative complications
A reduction in intensive care and hospital length of stay


title: Predictive Value of the Sialendoscopy in Treatment of Submandibular Gland Sialolithiasis: a Retrospective Study

acronym: SIAGLA

summary:
Salivary disorders are common reason for ENT specialist consultation. Sialolithiasis are the most frequent salivary obstruction disease and are characterized by the development of calcified structures in the salivary gland, especially in the submandibular gland.

The management of salivary obstruction has changed over the past 30 years. Sialendoscopy is considered as a minimally invasive procedure that allows endoscopic visualization of the salivary ductal system and is increasingly used in both diagnosis and treatment. Moreover, many studies have shown the effectiveness of this procedure.

Classification of lithiasis has been set up in 2008 to standardize the nomenclature and was used for patient care since 2009. The main objective of this study is to evaluate the relevance of the lithiasis's classification to predict the efficacy of sialendoscopy in treatment of sialolithiases.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients With Non Small Cell Lung Cancer Mass Tissue Imaging HyperIONTM

acronym: PREDICTION

summary:
Therapeutic antibodies that block the programmed death-ligand 1 (PD-L1)/programmed death-1 (PD-1) pathway have revolutionized immuno-oncology by inducing robust and durable responses in patients with various cancer including advanced non-small-cell lung cancer (NSCLC). However, these responses only occur in a subset of patients, even in case of PD-L1 overexpression. Elucidating the determinants of response and resistance but also of severe immune-mediated adverse events is key to improving outcomes and developing new treatment strategies. Biomarkers that predict immune checkpoint inhibitors efficacy and toxicity are urgently needed and could emerge from characterization of tumor microenvironment.

The purpose of PREDICTION project is to elucidate response and toxicity predictive immunophenotypic signatures using a new in situ multiplexed strategy with imaging mass cytometry Hyperion. Patients treated with anti-PD-1 pembrolizumab will be selected on their response and toxicity profiles. Then, tumor samples will be analysed with Hyperion technology, allowing delineation of cell subpopulations and cell-cell interactions, highlighting tumor heterogeneity and to determine correlations between response and toxicity features. The number of co-analysable markers enables global vision on the same tissue section. A better understanding of the tumor microenvironment complex system will lead to discover new predictive biomarkers potentially transferable to current practice.

lead_sponsor: University Hospital, Brest


title: Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.

acronym: EyeTrackingFP

summary:
The facial palsy concerns between 15 and 40 people per 100000 inhabitants. They are of various etiologies such as infectious, tumoral, traumatic or idiopathic.

It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed palliative treatments are based on surgery, physiotherapy and botulinum toxin injections. However, when recovery is incomplete, acceptance is more difficult, with an impacted quality of life. In this context, patients' expectations and feelings about their care may become difficult for clinicians to apprehend.

The eye-tracking is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular. Published studies focus on the gaze of photographs, excluding any notion of dynamics and by the analysis of the gaze of outside observers, ignoring the patient's gaze.The main objective is to evaluate the attention paid to the facial side with abnormal facial movement by patients with facial paralysis compared to healthy volunteers.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Studies of the Characteristics of the Angle Kappa and the Angle Alpha in the Healthy Individual. Studies of the Angle Kappa and the Angle Alpha

acronym: EKAPS

summary:
Anatomical ophthalmological connections and their dynamics are still debated in the scientific community. However, their considering is essential in many surgeries (strabismus, cataract, refractive...) or in clinical practice.

The correlation between these biometric values would make it possible to refine the knowledge related to these landmarks and thus offer better ophthalmological management by integrating these variables into the clinical examination.

The aim of the study is to analyze the correlation between the angle alpha and the angle kappa in a healthy individual without ophthalmologic disorder.


title: Phase I Study Testing the Injection of Lymphocytes From Haplo-identical Donor Following Chemotherapy in Patients With High-risk Acute Myeloblastic Leukemia Not Eligible for an Allogeneic Hematopoietic Stem Cell Transplantation

acronym: ILDA

summary: Patients with high risk AML non eligible for an intensive treatment and for an allogeneic transplantation will be treated with azacitidine and venetoclax. The fourth, fifth and sixth injection of azacitidine will be followed by injection of haplo-identical lymphocytes (HLI). This is a single-center phase I study to identify the dose of HLI with the most tolerable toxicity. TheBayesian continuous reassessment method (CRM) will be used

lead_sponsor: Nantes University Hospital


title: Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated With Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX

acronym: ECMORIX

summary:
The Oxiris membrane is an AN-69 membrane whose surface is treated with polyethyleneimine (PEI) grafted with heparin. This property allows the removal of lipopolysaccharide and cytokines from the blood. During septic shock, this membrane has shown its effectiveness and made it possible to decrease the doses of vasopressors administered, thus limiting the negative consequences of their use (low mesenteric flow in particular). Moreover, the literature suggests that the use of the Oxiris membrane does not lead to side effects or specific and serious complications, in comparison with conventional extra-renal purification membranes. To our knowledge (Pubmed, clinicaltrial) there are no data in patients in cardiogenic shock assisted by ECLS.

The research hypothesis is that the early addition of an Oxiris membrane to the ECLS circuit allows the removal of lipopolysaccharides and pro-inflammatory cytokines, thus controlling the inflammatory cascade and limiting vasoplegia and organ failure.

ReferenceCitation: Andrei S, Nguyen M, Berthoud V, Morgant MC, Bouhemad B, Guinot PG; ECMORIX Study Group. Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Single-Blind, Randomized Controlled Trial. Front Cardiovasc Med. 2021 Oct 11;8:738496. doi: 10.3389/fcvm.2021.738496. eCollection 2021.


title: Effects of Eccentric Pedaling at Different Rates on Neuromuscular Function

acronym: Exo-Mode 3

summary:
The recent appearance of ergocycles that can be used for eccentric pedaling (Cyclus type) has aroused a growing interest in the field of rehabilitation. The mechanical, metabolic, and cardiorespiratory characteristics of eccentric exercises make them an exercise of choice when the goal is to improve locomotor muscle function and exercise capacity. Despite its potential advantages, the optimal modalities of eccentric pedaling, in particular the choice of pedaling frequency, are still poorly understood, especially its effects on the neuromuscular system. Indeed, most training protocols impose a fixed pedaling power but with highly variable pedaling rates, ranging from 15 to 60 rpm (Besson et al., 2013; MacMillan et al., 2017). For a given pedaling power level (P), the choice of pedaling frequency (F) directly impacts the force torque (C) and thus the force applied to the pedals, since power is equal to the product of pedaling frequency and force torque (P = F.C). For frequencies varying from 15 to 60 rpm, the level of muscular tension during pedaling therefore varies from single to quadruple. These very large variations in force can influence the neuromuscular adaptations induced during a prolonged training period. For example, the use of low pedaling frequencies corresponding to high muscle tension could favor peripheral muscular adaptations (e.g. contractility) whereas higher pedaling frequencies could favor central (i.e. nervous) adaptations.

A better understanding of the neuromuscular adaptations induced by a period of eccentric pedaling at different cadences will allow for a more precise definition of training protocols for populations likely to undergo this type of training (e.g. elderly people, patients with heart failure).


title: Association Between Knee Isokinetic Testing and Lower Limb Functional Performance and Limb Symmetry

acronym: Pro-knee

summary:
This study aimed to evaluate the association between the isokinetic knee strength and/or proprioception performance with the functional performance on the functional Hop-tests and Y-balance test.

This study included 20 healthy individuals who performed an isokinetic assessment of knee proprioception (joint position sense, JPS and threshold to detection of passive motion, TDPM) and flexors/extensors strength. At the same time, they performed a functional testing consisting of three Hop-tests (single, triple and cross-over) and the Lower Quarter Y-Balance Test (YBT-LQ). We tested the correlation between the isokinetic and functional performances, and limb symmetry indexes.

lead_sponsor: University Hospital, Caen


title: X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device

summary:
Pectus excavatum (PE) and pectus carinatum (PC) are the most frequent chest wall deformities in humans. They are usually clinically recognized in early childhood or adolescence, with aggravation during the pubertal growth spurt. PE is a depression of the anterior chest wall, most frequently involving the lower sternum.

In this study we use simultaneously compared chest CT, MRI, and 3D scanning fro both PE and PC assessment .

The aim of this study is to compare a standard protocol using chest CT to a non-irradiant protocol with 3D scanning and MRI.

The primary endpoint was to assess the inter observer concordance and the correlation between the HI (Haller Index) evaluated with MRI and the EHI (External Haller index) evaluated with 3D scanning. The secondary endpoints were to assess the concordance with chest CT the variation of the HI evaluated in inspiration and expiration with MRI and also the correction index (CI) between chest CT and MRI in the PE group, .

lead_sponsor: University Hospital, Limoges


title: Description of the Vasculature Pattern of the Bronchial Tree During Infection With SARS-CoV2 by Narrow Band Imaging Bronchoscopy

summary: Vascular modifications have been described during SARS-CoV2 infection, especially a dilatation of the bronchial arteries. Within the airway wall, small branches of the bronchial arteries cross the muscle layer to develop a submucosal network. The Narrow Band Imaging technique is used during bronchoscopy to achieve a maximum contrast of vessels and the surrounding mucosa. Therefore, it enables to observe the microvessel structure and its distribution in the bronchial mucosa. The aim of this study is to describe the vasculature pattern of the bronchial tree during infection with SARS-CoV2.


title: Impact of an Olfactory Sensory Therapeutic Group in the Therapeutic Armamentarium for Adolescent Patients With Restrictive Anorexia Nervosa, Pilot Study

acronym: Sens'Orality

summary:
Anorexia nervosa is a severe eating disorder of multifactorial origin and for which there is, to date, no specific, standardized and protocolized management for anorexic patients or data on the superiority of anorexia. type of psychotherapy. The literature reports altered olfactory capacities in anorexia nervosa and the effectiveness of sensory-mediated therapies in several mental disorders.

This prospective, single-center, randomized and controlled study proposes the evaluation of the therapeutic impact of an olfactory sensory group carried out during the specialized care of patients aged 12 to 20 years, with anorexia. The main objective is to compare the clinical course of eating disorder, using the Eating Attitudes Test-40 (EAT-40) scale score performed at study inclusion and at 9 months at 9 months, of patients participating in an olfactory sensory therapeutic group compared to a body approach therapeutic group.

The secondary objectives of this study are to compare between a treatment associated with an olfactory sensory therapeutic group and a body approach therapeutic group, the evolution of the Body Mass Index at 9 months, overall functioning, evolution of cognitive and sensory capacities, and evolution of the therapeutic alliance at 9 months

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: Adherence Between Thromboprophylaxis Prescriptions and Guidelines During the Post-partum Period After the Institution of a Local Protocol

summary: The purpose of this study is to determine the current level of adequacy of the thromboprophylaxis prescriptions with the specific institutional protocol during the post-partum period. The institutional protocol is based on national and international guidelines.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Assessment of the Impact of Telemedicine in Insulin-dependent Diabetic Patients Through the ETAPES Program.

acronym: TLS-DIAB

summary: The purpose of this study is to assess glycemic control changes in insulin-treated patients with diabetes using a continuous glucose monitoring CGM system through the ETAPES telemedicine program.


title: Opinion Survey on Postpartum Pelvic Floor Rehabilitation According to the Quality of Information Provided by the Health Care Providers

acronym: PPFR

summary: The aim of this work is to evaluate the experience of Postpartum Pelvic Floor Rehabilitation (PPFR) according to the information given by the health care providers. There is to improve medical practice and to give the right information in at the right time to the patient.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Evaluation of the Impact of Non-slip Socks on Motor Recovery in the Elderly An Open Label, Single-center, Randomized, Controlled Pilot Study

acronym: CHARM

summary:
Some authors suggest a possible clinical interest of anti-slip socks. The scientific literature presents studies with methodological limitations. It is therefore not currently possible to judge the specific interest of anti-slip socks in an elderly hospitalized population.

The investigatorswould therefore like to know the interest of wearing non-slip socks in the management of these patients, and more particularly on the main objective of rehabilitation in geriatric physiotherapy: motor function.

status: Terminated

status_simplified: Unknown


title: Oral Low Doses Tolerance INduction Study for Peanuts

acronym: OLDTINYpeanut

summary:
Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded.

To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol.


title: Evaluation of Child Desire in Young Women With Premature Ovarian Failure

acronym: DESIOP

summary:
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired.

Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption.

The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Incidence, Clinical Characteristics and Prognosis of Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Spontaneous Coronary Reperfusion in the Modern Antithrombotic Strategy Area

acronym: STEMI

summary:
The rapid and complete restoration of coronary flow is a key issue in the management of STEMI. Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy associated with antithrombotic drugs.

In daily practice, it is not rare that some patients may achieve reopening of the culprit artery without undergoing any mechanical reperfusion therapy, which is called " spontaneous reperfusion ". The latter is associated with improved outcomes in several studies but none of these studies were done in the modern antithrombotic strategy area including new P2Y12 inhibitors. The aim of this study is to report the incidence, characteristics and outcomes of consecutive patients with STEMI admitted for coronary angiography with angiographic clinical evidence of spontaneous reperfusion in the modern medical antithrombotic strategy associated with primary PCI.


title: COVID-19 Patient Cohort: Retinal Damage in Non-invasive Retinal Imaging (OCTA)

summary: The objective of this research is to build a collection of non-invasive retinal imaging (OCT and OCTA) in order to investigate the incidence and impact of retinal damage in patients who have or have had COVID-19.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Deciphering a Specific Signature of the Immunosenescence Induced in COVID-19+ Patients Versus Rheumatoid Arthritis Patients

acronym: SENO-COVID

summary: Immune aging or immunosenescence is characterized by a loss of T cell clonal diversity and a contraction of naïve T cells with proliferative capacity associated with the functional impairment of many others immune cells as well as a chronic low degree of inflammation. A restrictive T cell repertoire is likely more prone to antigen-mediated exhaustion observed during chronic viral infections. Notably, lymphopenia is the most consistent laboratory abnormality in COVID-19 infected patients and both lung-resident and circulating T cells potently up-regulate markers of T cell exhaustion. It is not clear today if the association of COVID-19 disease severity with age is mainly related with the immunosenescence of infected patients. Interestingly, T cell exhaustion and premature immunosenescence have also been observed in chronic inflammatory diseases such as rheumatoid arthritis (RA). To better understand the immunological mechanisms involved in SARS-Cov-2 pathophysiology, the investigators propose to compare the immunosenescence patterns observed during RA, aging and SARS-Cov-2 infected patients in order to design improved therapeutic interventions.

ReferenceCitation: Wang R, Pan M, Zhang X, Han M, Fan X, Zhao F, Miao M, Xu J, Guan M, Deng X, Chen X, Shen L. Epidemiological and clinical features of 125 Hospitalized Patients with COVID-19 in Fuyang, Anhui, China. Int J Infect Dis. 2020 Jun;95:421-428. doi: 10.1016/j.ijid.2020.03.070. Epub 2020 Apr 11.

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

ReferenceCitation: Li X, Xu S, Yu M, Wang K, Tao Y, Zhou Y, Shi J, Zhou M, Wu B, Yang Z, Zhang C, Yue J, Zhang Z, Renz H, Liu X, Xie J, Xie M, Zhao J. Risk factors for severity and mortality in adult COVID-19 inpatients in Wuhan. J Allergy Clin Immunol. 2020 Jul;146(1):110-118. doi: 10.1016/j.jaci.2020.04.006. Epub 2020 Apr 12.

ReferenceCitation: Rockx B, Baas T, Zornetzer GA, Haagmans B, Sheahan T, Frieman M, Dyer MD, Teal TH, Proll S, van den Brand J, Baric R, Katze MG. Early upregulation of acute respiratory distress syndrome-associated cytokines promotes lethal disease in an aged-mouse model of severe acute respiratory syndrome coronavirus infection. J Virol. 2009 Jul;83(14):7062-74. doi: 10.1128/JVI.00127-09. Epub 2009 May 6. Erratum in: J Virol. 2009 Sep;83(17):9022.

ReferenceCitation: Maringer K, Fernandez-Sesma A. Message in a bottle: lessons learned from antagonism of STING signalling during RNA virus infection. Cytokine Growth Factor Rev. 2014 Dec;25(6):669-79. doi: 10.1016/j.cytogfr.2014.08.004. Epub 2014 Aug 24. Review.

ReferenceCitation: Nikolich-Žugich J. The twilight of immunity: emerging concepts in aging of the immune system. Nat Immunol. 2018 Jan;19(1):10-19. doi: 10.1038/s41590-017-0006-x. Epub 2017 Dec 14. Review. Erratum in: Nat Immunol. 2018 Oct;19(10):1146.

ReferenceCitation: Fulop T, Larbi A, Dupuis G, Le Page A, Frost EH, Cohen AA, Witkowski JM, Franceschi C. Immunosenescence and Inflamm-Aging As Two Sides of the Same Coin: Friends or Foes? Front Immunol. 2018 Jan 10;8:1960. doi: 10.3389/fimmu.2017.01960. eCollection 2017. Review.

ReferenceCitation: Tachikart Y, Malaise O, Mumme M, Jorgensen C, Brondello JM. Seno-suppressive molecules as new therapeutic perspectives in rheumatic diseases. Biochem Pharmacol. 2019 Jul;165:126-133. doi: 10.1016/j.bcp.2019.03.017. Epub 2019 Mar 13. Review.

ReferenceCitation: Oh SJ, Lee JK, Shin OS. Aging and the Immune System: the Impact of Immunosenescence on Viral Infection, Immunity and Vaccine Immunogenicity. Immune Netw. 2019 Nov 14;19(6):e37. doi: 10.4110/in.2019.19.e37. eCollection 2019 Dec. Review.

ReferenceCitation: Vicente R, Mausset-Bonnefont AL, Jorgensen C, Louis-Plence P, Brondello JM. Cellular senescence impact on immune cell fate and function. Aging Cell. 2016 Jun;15(3):400-6. doi: 10.1111/acel.12455. Epub 2016 Feb 22. Review.

ReferenceCitation: Campos C, Pera A, Sanchez-Correa B, Alonso C, Lopez-Fernandez I, Morgado S, Tarazona R, Solana R. Effect of age and CMV on NK cell subpopulations. Exp Gerontol. 2014 Jun;54:130-7. doi: 10.1016/j.exger.2014.01.008. Epub 2014 Jan 17.

ReferenceCitation: Appay V, Almeida JR, Sauce D, Autran B, Papagno L. Accelerated immune senescence and HIV-1 infection. Exp Gerontol. 2007 May;42(5):432-7. Epub 2007 Jan 8. Review.

ReferenceCitation: Goronzy JJ, Lee WW, Weyand CM. Aging and T-cell diversity. Exp Gerontol. 2007 May;42(5):400-6. Epub 2007 Jan 10. Review.

ReferenceCitation: Lin L, Lu L, Cao W, Li T. Hypothesis for potential pathogenesis of SARS-CoV-2 infection-a review of immune changes in patients with viral pneumonia. Emerg Microbes Infect. 2020 Dec;9(1):727-732. doi: 10.1080/22221751.2020.1746199.

ReferenceCitation: de Wit E, van Doremalen N, Falzarano D, Munster VJ. SARS and MERS: recent insights into emerging coronaviruses. Nat Rev Microbiol. 2016 Aug;14(8):523-34. doi: 10.1038/nrmicro.2016.81. Epub 2016 Jun 27. Review.

ReferenceCitation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.

ReferenceCitation: D'Antiga L. Coronaviruses and Immunosuppressed Patients: The Facts During the Third Epidemic. Liver Transpl. 2020 Jun;26(6):832-834. doi: 10.1002/lt.25756. Epub 2020 Apr 24.

ReferenceCitation: Giacalone VD, Margaroli C, Mall MA, Tirouvanziam R. Neutrophil Adaptations upon Recruitment to the Lung: New Concepts and Implications for Homeostasis and Disease. Int J Mol Sci. 2020 Jan 28;21(3). pii: E851. doi: 10.3390/ijms21030851. Review.

ReferenceCitation: Biswas SK, Mantovani A. Macrophage plasticity and interaction with lymphocyte subsets: cancer as a paradigm. Nat Immunol. 2010 Oct;11(10):889-96. doi: 10.1038/ni.1937. Epub 2010 Sep 20. Review.

ReferenceCitation: Nicolás-Ávila JÁ, Adrover JM, Hidalgo A. Neutrophils in Homeostasis, Immunity, and Cancer. Immunity. 2017 Jan 17;46(1):15-28. doi: 10.1016/j.immuni.2016.12.012. Review.

ReferenceCitation: Cloke T, Munder M, Bergin P, Herath S, Modolell M, Taylor G, Müller I, Kropf P. Phenotypic alteration of neutrophils in the blood of HIV seropositive patients. PLoS One. 2013 Sep 9;8(9):e72034. doi: 10.1371/journal.pone.0072034. eCollection 2013.

ReferenceCitation: Bowers NL, Helton ES, Huijbregts RP, Goepfert PA, Heath SL, Hel Z. Immune suppression by neutrophils in HIV-1 infection: role of PD-L1/PD-1 pathway. PLoS Pathog. 2014 Mar 13;10(3):e1003993. doi: 10.1371/journal.ppat.1003993. eCollection 2014 Mar.

ReferenceCitation: Li X, Geng M, Peng Y, Meng L, Lu S. Molecular immune pathogenesis and diagnosis of COVID-19. J Pharm Anal. 2020 Apr;10(2):102-108. doi: 10.1016/j.jpha.2020.03.001. Epub 2020 Mar 5. Review.

ReferenceCitation: Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248.

ReferenceCitation: Zheng M, Gao Y, Wang G, Song G, Liu S, Sun D, Xu Y, Tian Z. Functional exhaustion of antiviral lymphocytes in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):533-535. doi: 10.1038/s41423-020-0402-2. Epub 2020 Mar 19.


title: Diagnostic Performance of Arterial Time for CT Assessment of Parietal Enhancement Defect for the Diagnosis of Ischemia in Mechanical Small Bowel Occlusions: a Comparative Study With Portal Time

acronym: PORTOGRELE

summary:
Intestinal obstruction is a frequent cause of emergency room visits and represents about 4-7% of the causes of acute abdominal pain syndrome and up to 30% in adults over 60 years old.

Although 65 to 80% of patients are treated medically, small bowel obstruction remains a serious pathology, with a high mortality rate that can reach 25% in case of small bowel ischemia. It is necessary to systematically perform a CT scan in the initial workup of small bowel obstructions to confirm the diagnosis, identify the mechanism and detect signs of ischemia that would require emergency surgery.

The best sign for the diagnosis of ischemia is the defect or asymmetry of parietal enhancement of the dilated small bowel. In the literature, this sign is described almost exclusively at portal time. In case of suspicion of mesenteric ischemia (another serious pathology affecting the small bowel), it is recommended to perform an examination with three acquisitions (without injection, arterial time, and portal time).

The department's experience has shown that arterial time is sometimes more sensitive than portal time for visualizing a parietal enhancement defect of the small bowel in mechanical occlusions.

Very few studies have investigated the diagnostic performance of parietal enhancement asymmetry on arterial time in mechanical occlusions of the small bowel.

ReferenceCitation: Zins M, Millet I, Taourel P. Adhesive Small Bowel Obstruction: Predictive Radiology to Improve Patient Management. Radiology. 2020 Sep;296(3):480-492. doi: 10.1148/radiol.2020192234. Epub 2020 Jul 21.

ReferenceCitation: Millet I, Taourel P, Ruyer A, Molinari N. Value of CT findings to predict surgical ischemia in small bowel obstruction: A systematic review and meta-analysis. Eur Radiol. 2015 Jun;25(6):1823-35. doi: 10.1007/s00330-014-3440-2. Epub 2015 Apr 8.

ReferenceCitation: Ohira G, Shuto K, Kono T, Tohma T, Gunji H, Narushima K, Imanishi S, Fujishiro T, Tochigi T, Hanaoka T, Miyauchi H, Hanari N, Matsubara H, Yanagawa N. Utility of arterial phase of dynamic CT for detection of intestinal ischemia associated with strangulation ileus. World J Radiol. 2012 Nov 28;4(11):450-4. doi: 10.4329/wjr.v4.i11.450.

ReferenceCitation: Chuong AM, Corno L, Beaussier H, Boulay-Coletta I, Millet I, Hodel J, Taourel P, Chatellier G, Zins M. Assessment of Bowel Wall Enhancement for the Diagnosis of Intestinal Ischemia in Patients with Small Bowel Obstruction: Value of Adding Unenhanced CT to Contrast-enhanced CT. Radiology. 2016 Jul;280(1):98-107. doi: 10.1148/radiol.2016151029. Epub 2016 Feb 11.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Effect of Pressurised Intraperitoneal Aerosol Chemotherapy on the Survival Rate of Patients With Peritoneal Carcinomatosis of Gastric Origin

summary: Pressurised intraperitoneal aerosol chemotherapy is a new surgical technique, developed for the treatment of initially unresectable peritoneal carcinomatosis. The objective of this study was to compare the results of PIPAC associated with systemic chemotherapy with those of systemic chemotherapy alone in patients with gastric peritoneal carcinomatosis without metastasis other than peritoneal, and WHO performance status <3.

lead_sponsor: Association Francaise de Chirurgie


title: Analysis of Nutritional Biomarkers to Predict the Efficacy of Immunotherapy by Anti-PD/PDL1 Checkpoints Inhibitors in Metastatic Non-small Cell Lung Cancer Patients

acronym: ELY

summary:
CERTIM is a cohort created in July 2015 to set up a multidisciplinary follow-up of cancer patients treated with immune checkpoint inhibitors.

From the CERTIM cohort, we conducted a longitudinal, prospective, observational study (ELY) in two tertiary university centers (Cochin hospital and European Georges Pompidou Hospital), which included patients between August 2016 and October 2019 and ended follow-up in April 2020.

Patients were treated with nivolumab, at a dose of 3 mg/kg every 2 weeks, or pembrolizumab, at a dose of 2mg/kg every 3 weeks. The investigators report findings from an evaluation of rest energy expenditure (REE) assessed using indirect calorimetry in the outpatient setting before treatment with checkpoints inhibitors.

lead_sponsor: Hôpital Cochin


title: Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit : a Monocentric Randomized Trial

summary: The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.