title: Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy

acronym: MEDIIMYO

summary:
Anti-cancer immunotherapy, one of the therapeutic revolutions of recent years. It is based on the use of antibodies that block immune system checkpoints that have been hijacked by cancer cells to benefit themselves. Blocking these checkpoints, such as PD-1, unleashes the action of anti-cancer T cells that can then destroy the tumor. The efficacy of these targeted therapies is significant, with an average 40% response rate in patients with metastatic cancers.Immune checkpoint inhibitors (ICIs) are becoming a 1st line therapy in many oncology indications due to their therapeutic line in many oncology indications due to their favorable effect on the prognosis of various prognosis of various cancers Since checkpoints play a key role in controlling the intensity and duration of an immune response, their immune response, therefore, their inhibition exposes to adverse inflammatory or autoimmune effects inflammatory or autoimmune adverse effects that can be severe and sometimes lethal.Most side effects of ICIs occur within the first few months after initiation of treatment. The toxicity of immunotherapy is immunological, all organs including the heart can be including the heart, can be affected.

Cardiac autoimmune involvement in ICIs can involve the myocardium, pericardium, and/or vascular endothelium. These entities may be interrelated or, on the contrary, isolated.

In the last 5 years, the number of described cases of myocarditis associated with ICIstreatment has increased. Their incidence remains low, estimated between 0.5 and 2%. This probably represents the most serious cardiovascular complication, as the mortality attributed to it reaches almost 50%.

In recent years MRI has become very important in the noninvasive diagnosis of acute myocarditis. The latest update of the Lake Louise criteria in 2018 has thus confirmed cardiac MRI in its first place among noninvasive examinations for the diagnosis of myocarditis with a sensitivity of 87.5%, a specificity of 96.2%, and a positive predictive value of 97.2%.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Remote Assessment of Outpatient With SARS-CoV-2

acronym: EVIDENCE

summary:
Outpatient management of patients with a milder form of COVID may be associated to an unfavorable initial or deferred course in relation to the pathology.. Outpatients represent the bulk of patients with COVID-19. To know their evolution, their secondary complications and identifying a profile of "at risk" patients is essential for the prevention and care of future non-hospitalized patients, in an epidemic context still active.

This study could make it possible to redefine the follow-up of outpatients. The study consists of a simple questionnaire and possibly a teleconsultation.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Limoges

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Hearing Quality of Life of Children With Hearing Aids: Study Based on the PEACH Questionnaire

acronym: QaPEACH

summary:
There are few or no questionnaires in French on the hearing quality of life of children with hearing aids.

The objectives of the study are to measure the hearing quality of life of children with hearing aid and / or cochlear implants and to compare the hearing quality of life according to the type of hearing aid (hearing aid and / or cochlear implant).

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study

acronym: PIRAT

summary: ICU patients frequently face complicated recovery processes, including long-term anxiety disorders. Lung transplantation (LTx) offers people with terminal respiratory conditions both the hope of prolonged survival and a better quality of life related to health. Among the disorders usually encountered in the postoperative period of LTx are anxio-depressive disorders. These anxiety disorders affect the quality of life related to health and compromise the follow-up of the patient by phenomenon of psychological disinvestment. Other psychological disorders are also anchored in the patient's experience of this post-surgical ICU period (ie, depressive episodes and/or, at a distance, post-traumatic stress disorder (PTSD). Various models of management of anxio-depressive disorders and PTSD are proposed in the literature. To our knowledge, while many of them have shown their efficiency in the curative management of disorders, few have demonstrated their effectiveness in preventing them. Exposure therapies using virtual reality (ETVR) have in the past demonstrated their effectiveness in many areas of psychiatry. In our study, experimental arm patients will be offered ETRV support with a virtual reality headset. A scenario with progressively increasing stress levels linked to the ICU environment and different situational contexts (alarms, etc.) will be presented to patients. This habituation to the potentially anxiety context of ICU will reduce the occurrence of psycho-cognitive disorders by progressive extinction phenomenon.

study_start_date_type: Actual

status: Recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

ipd_sharing: Undecided

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hôpitaux de Marseille

intervention_type: Behavioral


title: Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care

acronym: ASPIC

summary:
Increasing emergence of multidrug resistant (MDR) bacteria worldwide is now considered one of the most urgent threats to global health. The association between increase of antibiotics consumption and resistance emergence has been well documented for all patients admitted to the Intensive care unit (ICU) who received antibiotic treatment and for patients treated for ventilator associated pneumonia (VAP).

Reduction of use of antibiotics is a major point in the war against antimicrobial resistance. VAP is the first cause of healthcare-associated infections in ICU and more than half of antibiotics prescriptions in ICU are due to VAP.

Once the diagnosis of pneumonia under MV has been made, initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration. In the case of a good clinical response to treatment, it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia (CAP).

The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.

The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.

This study will be a prospective, national multicenter (24 centers), phase III, comparative randomized (1:1), single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms:

Experimental group: Antimicrobial stewardship based on daily clinical assessment of clinical cure.

Control group: standard management: duration of appropriate antibiotic therapy for confirmed VAP according to guidelines.

primary_purpose: Health Services Research

intervention_type: Drug


title: Evaluation of Rheumatoid Arthritis at the Time of Telemedicine

acronym: ePRAT

summary: The purpose of this study is to optimize the care of patients with RA seen in virtual consultation.

location_facility: Rheumatology Department, Cochin Hospital


title: Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads

summary:
SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. .

The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Safety and Efficacy of a Strategy Extending Duration of Prone Position in COVID-19-related ARDS Patients. a Retrospective Monocentric Observational Study

summary: Prone position (PP) is standard of care for mechanically ventilated patients with severe acute respiratory distress syndrome in the intensive care unit (ICU). Recommendations suggest PP durations of at least 16 hours. In 2020, COVID-19 pandemic led to a great number of patients requiring mechanical ventilation and PP in the ICU. Risk of ICU staff viral contamination and work overload led to prolongation of PP duration up to 48 hours. Here investigators report outcomes of prolonged PP sessions in terms of skin complications (pression injuries) and ventilatory improvement.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: background

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

family: Guérin

full_name: Claude Guérin

given: Claude

sequence: first

family: Reignier

full_name: Jean Reignier

given: Jean

sequence: additional

family: Richard

full_name: Jean-Christophe Richard

given: Jean-Christophe

family: Beuret

full_name: Pascal Beuret

given: Pascal

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

family: Badet

full_name: Michel Badet

given: Michel

family: Mercat

full_name: Alain Mercat

given: Alain

family: Baudin

full_name: Olivier Baudin

given: Olivier

family: Clavel

full_name: Marc Clavel

given: Marc

family: Chatellier

full_name: Delphine Chatellier

given: Delphine

family: Jaber

full_name: Samir Jaber

given: Samir

family: Rosselli

full_name: Sylvène Rosselli

given: Sylvène

family: Mancebo

full_name: Jordi Mancebo

given: Jordi

family: Sirodot

full_name: Michel Sirodot

family: Hilbert

full_name: Gilles Hilbert

given: Gilles

family: Bengler

full_name: Christian Bengler

given: Christian

family: Richecoeur

full_name: Jack Richecoeur

given: Jack

family: Gainnier

full_name: Marc Gainnier

family: Bayle

full_name: Frédérique Bayle

given: Frédérique

family: Bourdin

full_name: Gael Bourdin

given: Gael

family: Leray

full_name: Véronique Leray

given: Véronique

family: Girard

title: Prone Positioning in Severe Acute Respiratory Distress Syndrome

ReferenceCitation: Papazian L, Aubron C, Brochard L, Chiche JD, Combes A, Dreyfuss D, Forel JM, Guérin C, Jaber S, Mekontso-Dessap A, Mercat A, Richard JC, Roux D, Vieillard-Baron A, Faure H. Formal guidelines: management of acute respiratory distress syndrome. Ann Intensive Care. 2019 Jun 13;9(1):69. doi: 10.1186/s13613-019-0540-9. Review.

ReferenceCitation: Nasa P, Azoulay E, Khanna AK, Jain R, Gupta S, Javeri Y, Juneja D, Rangappa P, Sundararajan K, Alhazzani W, Antonelli M, Arabi YM, Bakker J, Brochard LJ, Deane AM, Du B, Einav S, Esteban A, Gajic O, Galvagno SM Jr, Guérin C, Jaber S, Khilnani GC, Koh Y, Lascarrou JB, Machado FR, Malbrain MLNG, Mancebo J, McCurdy MT, McGrath BA, Mehta S, Mekontso-Dessap A, Mer M, Nurok M, Park PK, Pelosi P, Peter JV, Phua J, Pilcher DV, Piquilloud L, Schellongowski P, Schultz MJ, Shankar-Hari M, Singh S, Sorbello M, Tiruvoipati R, Udy AA, Welte T, Myatra SN. Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care. 2021 Mar 16;25(1):106. doi: 10.1186/s13054-021-03491-y.

ReferenceCitation: Sud S, Friedrich JO, Adhikari NK, Taccone P, Mancebo J, Polli F, Latini R, Pesenti A, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L, Guérin C. Effect of prone positioning during mechanical ventilation on mortality among patients with acute respiratory distress syndrome: a systematic review and meta-analysis. CMAJ. 2014 Jul 8;186(10):E381-90. doi: 10.1503/cmaj.140081. Epub 2014 May 26. Review.

ReferenceCitation: Labeau SO, Afonso E, Benbenishty J, Blackwood B, Boulanger C, Brett SJ, Calvino-Gunther S, Chaboyer W, Coyer F, Deschepper M, François G, Honore PM, Jankovic R, Khanna AK, Llaurado-Serra M, Lin F, Rose L, Rubulotta F, Saager L, Williams G, Blot SI; DecubICUs Study Team; European Society of Intensive Care Medicine (ESICM) Trials Group Collaborators. Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study. Intensive Care Med. 2021 Feb;47(2):160-169. doi: 10.1007/s00134-020-06234-9. Epub 2020 Oct 9. Erratum in: Intensive Care Med. 2021 Apr;47(4):503-520.

ReferenceCitation: Gaudry S, Tuffet S, Lukaszewicz AC, Laplace C, Zucman N, Pocard M, Costaglioli B, Msika S, Duranteau J, Payen D, Dreyfuss D, Hajage D, Ricard JD. Prone positioning in acute respiratory distress syndrome after abdominal surgery: a multicenter retrospective study : SAPRONADONF (Study of Ards and PRONe position After abDOmiNal surgery in France). Ann Intensive Care. 2017 Dec;7(1):21. doi: 10.1186/s13613-017-0235-z. Epub 2017 Feb 24.

location_facility: Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris


title: Primary Care in AURA for Covid-19: Implementation of a Regional Practice-based Surveillance Network

acronym: SOPRAC

summary: As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.

time_perspective: Other

lead_sponsor: Research on Healthcare Performance Lab U1290

lead_sponsor_type: industriel

status_simplified: Completed


title: DENTAL CARE OF PATIENTS LIVING WITH HIV, OR COINFECTED HIV / HBV OR HIV / HCV, FOLLOWED IN THE INFECTIOUS DISEASES DEPARTMENT OF CHU CLERMONT-FERRAND

acronym: DENTA-VIH

summary: This study is perform to identify oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL

summary: The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL.

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: Ramsay Générale de Santé

intervention_type: Procedure


title: Hemodynamic Estimation Per Procedure of the Result of the MitraClip Technique: Interest of the Ratio of Mean Arterial Pressure (MAP) to Pressure of the Mean Left Atrium (POG)

acronym: MitraPOG

summary:
this research is based on the hypothesis that the measurement of the ratio of mean arterial pressure to mean left atrium pressure and of its evolution during the procedure, would make it possible to assess the immediate success of the procedure by supplementing the results of the ultrasound.

The main objective of this research is to define the percentage of improvement in the mean arterial pressure / mean left atrium pressure ratio at the end of the procedure to validate the success of the MitraClip procedure.

primary_purpose: Other


title: Clinical Signs and Activity Limitations Associated With Dural Ectasia in Patients With Marfan Disease: Cross-sectional Case-control Study.

acronym: MARFANLOMB

summary:
Primary outcome is to compare the frequency and clinical features of spinal symptoms between Marfan patients with dural ectasia (cases) and those without (controls).

/ Frequency of orthostatic headaches
/ Frequency of low back pain due to orthostasis
/ Frequency of low back pain during Vasalva maneuvers
/ Frequency of lumbar claudication
/ Frequency of root claudication

Secondary outcomes are to compare activity limitations, quality of life and intensity of low back and radicular pain between Marfan patients with dural sac ectasia (cases) and those without (controls).

/ Average intensity of back pain measured on a self-administered digital scale (0 = no pain and 100 = maximum pain)
/ Average intensity of radicular pain measured on a self-administered digital scale (0 = no pain and 100 = maximum pain)
/ Activity limitations specific to the lumbar spine measured using the self-administered Oswestry Disability Index questionnaire (ODI, 0 = no limitations and 100 = maximum limitations)
/ Physical component of quality of life measured using the physical component of the self-administered questionnaire 12-Item Short Form Health Survey (SF-12, 9.95 = worst quality of life imaginable, 70.02 = worst quality of life imaginable )
/ Mental component of the quality of life measured using the mental component of the SF-12 self-administered questionnaire (5.89 = worst quality of life imaginable, 71.97 = worst quality of life imaginable)

time_perspective: Cross-Sectional

ReferenceCitation: Böker T, Vanem TT, Pripp AH, Rand-Hendriksen S, Paus B, Smith HJ, Lundby R. Dural ectasia in Marfan syndrome and other hereditary connective tissue disorders: a 10-year follow-up study. Spine J. 2019 Aug;19(8):1412-1421. doi: 10.1016/j.spinee.2019.04.010. Epub 2019 Apr 15.

ReferenceCitation: Chuzel Q, Dupuis-Girod S, Rousset M, Decharry C, Decullier E, Pialat JB. Assessment of Dural Ectasia Using Computed Tomodensitometry as a Criterion in Marfan Syndrome. J Comput Assist Tomogr. 2019 Mar/Apr;43(2):282-287. doi: 10.1097/RCT.0000000000000822.

ReferenceCitation: Foran JR, Pyeritz RE, Dietz HC, Sponseller PD. Characterization of the symptoms associated with dural ectasia in the Marfan patient. Am J Med Genet A. 2005 Apr 1;134A(1):58-65.

ReferenceCitation: Nguyen C, Papelard A, Schnitzler A, Mangione P, Poiraudeau S, Rannou F. Congenital lumbar spinal stenosis associated with Marfan syndrome. Joint Bone Spine. 2012 Mar;79(2):199-200. doi: 10.1016/j.jbspin.2011.07.007. Epub 2011 Oct 1.


title: Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders

acronym: S'TIM 1

summary: This study proposes to improve the management of dysexecutive syndrome by a serious game (SG) in addition to the usual management including work in occupational therapy and neuropsychology.

intervention_type: Device


title: EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial.

acronym: AXIOS-CPRE

summary: The main objective is to compare the EUS-BD with the insertion of a LAMS vs. traditional ERCP to restore biliary patency. Although ERCP has been the primary treatment for many years, it is associated with a significant risk of procedural complications and possible stent blockage. EUS-BD has been shown to be potentially safer and is associated with a lower risk of stent blockage. We seek with our study to determine whether EUS-BD may be the most effective treatment modality.

primary_purpose: Treatment


title: Constitutive Study of a Serum Bank and Plasma Bank of Healthy Subjects Comparators to Dialysis Subjects (SPSSCD)

acronym: SPSSCD

summary: To be able to evaluate the predictive value of glycosylated ferritin as a predictive marker of hepatic iron stock in dialysis patients, we need to validate these results with a cohort of healthy volunteers.

intervention_type: Biological


title: Skin Preparation of Patients Before Orthopedic Surgery : A Randomized Controlled Study on the Efficacy of Chlorhexidine Cloths Versus Chlorhexidine Soaps

acronym: POL

summary: Surgical site infections (SSI) in orthopedic surgery are rare events but associated with great morbidity as well as a significant additional cost. The World Health Organization (WHO) recently carried out meta-analyzes on all the existing prophylactic measures and could not rule on the use of chlorhexidine (CHX) cloths due to the low number of studies available. CHX cloths could actually benefit patients for whom preoperative showering is not possible, whether in emergency or trauma settings due to pain-induced functional impotence. A randomized controlled clinical study aimed at evaluating the in vivo microbiological efficacy of CHX cloths in a population of orthopedic surgery patients while evaluating the psycho-social determinants of adherence to a new preoperative preparation technique seems essential.

lead_sponsor: University Hospital, Grenoble


title: Prospective, Open Label, Post Marketing Study of the Safety and Effectiveness of HArmonyCa Injectable Gel for Mid-face Soft Tissue Augmentation

acronym: HArmonyCa EUMD

summary: Prospective, open label, post marketing study of the safety and effectiveness of HArmonyCa injectable gel for mid-face soft tissue augmentation

ipd_sharing: Yes

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: Allergan


title: Prevalence of Sensitization to Peach and/or Cypress in Potato Sensitized Patients in Occitania

acronym: CYPPOT

summary:
The aim of the study will be to investigate the prevalence of of sensitization to peach and/or cypress in potato sensitized patients, based on the collection of medical data from patient records consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital.

Some Gibberellin-regulated protein (GRP) in fruits and pollens have been identified as allergen, and peach GRP (peamaclein) has recently emerged as a relevant food allergen in cypress pollen-hypersensitive patients. Multiple fruit allergies might be related to cross-reactivity between GRPs. Peamaclein shares 82% identity with snakin-1 from potato. Thus, because of this hight homology the investigators want to determine the prevalence of cosensitization between these 3 allergens potato, peach and cypress.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. A Before-after Study.

acronym: Early Dry

summary:
Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.

We have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital cardiologique Louis Pradel - HCL


title: Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle: A Cross-sectional Observational Multicenter Prospective Study

summary:
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex. As a result of the improved patient care over the last decades, the number of children and adults with single ventricle is increasing significantly. Today, the main challenge is to ensure an optimal follow-up of these new patients in order to improve their life expenctancy as well as their quality of life (QoL). Currently, echocardiography and cardiopulmonary exercice test (CPET) are central in management of patients with single ventricle as part of good clinical practice guidelines.

Single ventricle volumes and function are very difficult to asses with conventional echocardiography because of their complex geometry. Indeed, single ventricle size and morphology vary depending on the patient characteristics and on the initial CHD (before surgical repair). That's why conventional 2D echocardiographic parameters are not reliable for single ventricle assessment.

Magnetic resonance imaging (MRI) is more effective in assessing single ventricle volumes and function. Nevertheless, MRI is not universally available, is not practical in many situations, is expensive, and is a relative contraindication in patients with pacemakers.

Over the past decade, the use of the 3D echocardiography has increased. This is an available tool that can assess ventricular function and volumes in few seconds. Recent studies shown a good correlation between 3D echocardiography and MRI for assessment of ventricular volumes and function in patient with CHD and especially in those with single ventricle.

Moreover, according to some authors, CPET parameters are strongly correlated with risk of hospitalization, risk of death, physical activity and quality of life, especially in patients with single ventricle.

To date, there is no study performed about the relationship between 3D echocardiography and CPET parameters in patients with single ventricle.


title: Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors

summary: The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.

lead_sponsor: Smart Immune SAS

location_facility: CIC Paris Est, Hôpital Pitié Salpêtrière


title: Evaluation of Pétale® (Small Hearing Test Equipment for Children) for the Screening of Hearing Disorders in Children From 9 Months to 3 Years Old by the General Practitioner or Pediatrician

acronym: PETALE

summary: The aim of this study is to confirm the value of this new version of Pétale® ((small equipment for testing the child's hearing) in the daily practice of general practitioners or pediatricians for the screening of hearing disorders in very young children.

primary_purpose: Prevention


title: The Effect of the Consumption of 4 Botanical Extracts (Acerola, Panax Ginseng, Echinacea, Quillaja) on the Innate and Adaptive Immune Response in Healthy Adults: a Pilot Randomized Placebo-controlled Clinical Trial

summary: This study will evaluate the capacity of botanical extracts to modulate immune mechanisms compared to a placebo group in healthy volunteers.

lead_sponsor: Naturex SA

intervention_type: Dietary Supplement


title: ANALYSIS OF INFLAMMATORY REACTIONS OBSERVED IN BRONCHOALVEOLAR LAVAGES (BALS) PERFORMED FOR INFILTRATIVE LUNG DISEASE THAT COMPLICATE ANTI PD-(L)1 IMMUNOTHERAPIES

acronym: LBA-PI

summary:
Immunological toxicities associated with immune checkpoint inhibitor (ICI) monoclonal antibodies are unpredictable autoimmune and inflammatory pathologies that can affect all treated patients. Some of these events are severe and occur in 15-20% of patients treated with Programmed Death 1 (PD-1) antibodies.

The study of cellular immunological characteristics within tissues affected by toxicities and the interactions between the different actors of these toxicities aims at improving the knowledge concerning the mechanisms of these toxicities, but also at being able to specify the unexpected effects of ICIs on cells of the immune system, outside the tumor microenvironment.

Diffuse infiltrative lung disease is one of the most frequent and severe toxicities encountered in patients treated with anti PD-(L)1; either for bronchial cancer, melanoma or any other type of cancer. Patients developing this type of complication benefit from cytological, bacteriological, mycological and molecular analyses of intra-alveolar constituents obtained by bronchoalveolar lavage (BAL) performed during bronchial fibroscopy as part of their routine care. These analyses help to confirm the diagnosis of alveolitis, to specify the cellular characteristics of alveolar inflammation and to eliminate differential diagnoses of ICI toxicity.


title: SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-national Cohort Study

acronym: SKIN-ICU

summary:
Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few prospective studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. The "SKin and soft tissue necrotizing INfections in the ICU" (SKIN-ICU) study is a multinational prospective non-interventional cohort study that will include patients admitted to the ICU/intermediate care unit for NSTI or not.

The objectives of the study are :

To assess hospital (i.e., ICU and hospital mortality) and medium-term (day-90 mortality, functional outcomes and health-related quality of life scores, HR-QoL) outcomes
To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life

ReferenceCitation: Stevens DL, Bryant AE. Necrotizing Soft-Tissue Infections. N Engl J Med. 2017 Dec 7;377(23):2253-2265. doi: 10.1056/NEJMra1600673. Review.

ReferenceCitation: Urbina T, Canoui-Poitrine F, Hua C, Layese R, Alves A, Ouedraogo R, Bosc R, Sbidian E, Chosidow O, Dessap AM, de Prost N; Henri Mondor Hospital Necrotizing Fasciitis Group. Long-term quality of life in necrotizing soft-tissue infection survivors: a monocentric prospective cohort study. Ann Intensive Care. 2021 Jul 2;11(1):102. doi: 10.1186/s13613-021-00891-9.

ReferenceCitation: Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014 Jul 15;59(2):147-59. doi: 10.1093/cid/ciu296. Epub 2014 Jun 18.

ReferenceCitation: Peetermans M, de Prost N, Eckmann C, Norrby-Teglund A, Skrede S, De Waele JJ. Necrotizing skin and soft-tissue infections in the intensive care unit. Clin Microbiol Infect. 2020 Jan;26(1):8-17. doi: 10.1016/j.cmi.2019.06.031. Epub 2019 Jul 5. Review.

ReferenceCitation: Madsen MB, Skrede S, Bruun T, Arnell P, Rosén A, Nekludov M, Karlsson Y, Bergey F, Saccenti E, Martins Dos Santos VAP, Perner A, Norrby-Teglund A, Hyldegaard O. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT): protocol and statistical analysis plan. Acta Anaesthesiol Scand. 2018 Feb;62(2):272-279. doi: 10.1111/aas.13024. Epub 2017 Oct 29.

lead_sponsor: Henri Mondor University Hospital


title: Analysis of Emergency Department Visits and Activity in Montpellier Dental University Hospital : Study Protocol

acronym: EOTDES

summary: The main objective will be to evaluate the type of care performed and the main reasons for consulting patients for an odontological emergency in order to better adapt to the flow and expectations of patients.


title: Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care

acronym: IDSein

summary: The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.


title: Genetic Study of Idiopathic Scoliosis in a Cohort of Families

acronym: SCOGEN

summary: This study will focus on a large cohort of multiplex families, to precisely identify candidate genes. The fact of have a large database (fifty families, collected by the principal investigator for more than two decades), will contribute to the discovery of genes of interest. It will also allow testing for the presence or absence of mutations found in other cohorts in previous studies. The main objective of this study is to identify genetic abnormalities associated with the presence and severity of idiopathic scoliosis, in families of scoliosis.


title: ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure

acronym: I-SWEAR

summary: Observational study in two medical-surgical intensive care units of the Clermont-Ferrand University Hospital to develop a composite score for prediction of 72h-extubation failure in patients at risk of extubation failure.


title: Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis: an Exploratory Study

acronym: PsyHistio

summary:
Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. However, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.The aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult PLCH patients.

This study should allow:

to assess the prevalence of psychiatric disorders co-morbid in PLCH patients
a targeted and more effective management of patients
a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.

location_facility: Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie


title: From Micro- to Macro-vessels : Water, Salt, Heart and Kidneys

acronym: ConcentRatio

summary: Hypertension is a public health concern and affects nearly a third of the French population. It can be complicated by visceral impact (including brain, heart and kidney complications) as well as on vessels especially large arteries, responsible for arterial stiffening. There are close interactions between heart and kidneys, as well as between large arteries and micro-vessels. These relationships also involve the water and salt balance and its regulatory mechanisms. Urinary concentration abilities are closely linked to the renal medullary blood flow, which in itself depends on the integrity of renal micro vessels, thus influencing the water and salt balance. Few previous studies evaluated the interconnections between renal urinary concentration abilities and blood pressure. A previous-one reported a positive relation between pulse pressure and urinary concentration in men, suggesting that subjects with higher urinary osmolarity could present a higher cardiovascular risk. Carotid-femoral pulse wave velocity represents the gold standard for non-invasive arterial stiffness assessment and constitutes an arteriosclerosis infra-clinical marker recommended by the European Society of Cardiology- European Society of Hypertension. It is considered as an independent predictor for global and cardiovascular mortality, coronary heart disease and fatal stroke among patients with hypertension, diabetes or end stage kidney disease. The purpose of this study is to evaluate the relations between fasting urinary osmolarity and arterial stiffness assessed by carotid-femoral pulse wave velocity (CF-PWV) among patients with hypertension.

location_facility: Centre Interdisciplinaire de Thérapeutique et d'Education APHP- Hôtel Dieu Hospital


title: Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy. NEWBORN NEURO-DIGITAL STUDY

acronym: NewbornDS

summary: The project aims at designing a machine learning solution able to recognize characteristics signals patterns of brain damages in full term babies born within a context of Hypoxic Ischemic Encephalopathy (HIE)


type: Registry Identifier

title: LIPId Profile Changes in Inflammatory Conditions Induced by SARS-CORoronavirus-2 : LIPICOR Study

acronym: LIPICOR

summary:
In late 2019, a new coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the cause of COVID-19 (COronaVIrus Disease-2019) in Hubei Province, China. COVID-19 has become a pandemic with approximately 4.1 million confirmed cases as of May 2020 resulting in 280,000 deaths worldwide. Between 5 and 20% of patients hospitalized with SARS-CoV-2 infection are admitted to the ICU with a mortality ranging from 25 to 60% depending on the series. At present, there is no effective targeted therapy against this viral infection.

High-density lipoproteins (HDL) are nanoparticles made up of apolipoproteins, mainly apoA1, associated with phospholipids whose main function is the reverse transport of cholesterol from peripheral tissues to the liver. This property gives HDL a major cardiovascular protective effect. In addition to this effect, studies have highlighted a number of properties such as anti-inflammatory, anti-apoptotic, anti-thrombotic and anti-oxidant effects of these particles. Furthermore, it has been shown that HDL is able to bind and neutralize bacterial lipopolysaccharides (LPS), promoting their elimination.

During bacterial sepsis, a rapid decrease in plasma HDL cholesterol (HDL-C) concentration has been demonstrated, but also an inverse correlation between mortality and HDL-C concentration. In addition to the quantitative decrease in HDL during sepsis, dysfunctions of these particles have been described, such as major differences in size, or a notable alteration in protein composition with, in particular, more pro-inflammatory proteins. In this context of both quantitative and qualitative alteration of HDL, authors have tested the efficacy of injection of either reconstituted HDL (apoA1 + phosphatidylcholines) or peptides structurally similar to ApoA1 in animal models of sepsis and have demonstrated a protective effect on morbidity and mortality, with in particular a decrease in the inflammatory state induced by sepsis.

Low-density lipoproteins (LDL) can also neutralize LPS and observational studies have shown a decrease in the concentration of LDL cholesterol (LDL-C) during sepsis. The authors also showed that low LDL-C was associated with a poor prognosis in patients with sepsis.

During COVID-19-induced sepsis, a few studies have demonstrated a decrease in lipoprotein (HDL and LDL) concentration. More specifically, some authors have found an association between low lipoprotein concentrations and increased disease severity. To the best of the knowledge of the investigators, no study has specifically investigated particulate dysfunction of lipoproteins and in particular HDL during severe COVID-19 infections. On the other hand, as it has been described that lipoproteins and particularly HDL can bind bacterial components (LPS or LTA) favoring their clearance, it can be envisaged that these particles can also bind SARS-CoV-2 components, and this, in a more or less strong way depending on the virus strain.

The preliminary results of the investigators show that in sepsis, serum amyloid A (SAA) protein tends to replace apolipoprotein A1, making HDL dysfunctional. In addition, paraoxonase-1, an antioxidant enzyme mainly carried by HDL, is almost absent or degraded in septic patients. The SAA/PON-1 ratio could allow to assess the severity of COVID-19 damage and to reinforce a possible therapeutic strategy based on the supplementation of severe patients with apolipoprotein A1 and PON-1 rich HDL nanoparticles.

Main objective: To evaluate the functionality of HDL as a prognostic marker of mortality in COVID-19 patients in ICU. To do so, a quantification of the SAA/PON-1 ratio at plasma level and on isolated lipoproteins will be performed by ELISA.


title: Process Evaluation of the Effectiveness of Two Transdiagnostic Interventions on Emotion Regulation : Compassion Focused Program and Emotion Competence Training Program

acronym: INTREC

summary:
Emotional regulation (ER) appears today as a fundamental skill for the adaptation of an individual to his environment. Indeed, functional and efficient ER is crucial for mental well-being, but also for physical health, for the maintenance of satisfying social relationships , and for work performance. Many research studies have shown that difficulties with ER are central to the development of many mental disorders. Consequently, this skill can be the target of psychological interventions , the effectiveness of which can be tested as well as the mechanisms underlying that effectiveness. Various "mechanisms of effectiveness" have been advanced in the literature. Of these, this project will specifically test cognitive flexibility and feelings of self-efficacy.

Although a growing number of interventions attempt to target emotional regulation, few are evaluated in subclinical populations and few are protocolized. Similarly, there is little research evaluating the effectiveness processes of these interventions. To date, two types of interventions show particular promise: emotion competence based interventions and compassion focused therapy. This research will therefore be based on the evaluation of two interventions in a randomized controlled trial: Emotion Competence Training Program and Compassion Focused Program that will take place over 12 two-hour sessions in a subclinical and clinical population.

status: Active, not recruiting

lead_sponsor: University Grenoble Alps


title: Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device

acronym: SIGMA

summary:
The electroencephalogram or EEG is a painless and non-invasive exploratory examination routinely performed in clinical and experimental medicine and has various applications. It is therefore relevant to develop application-specific EEG measurement devices.

The clinical development of therapies based on brain control has led to the emergence of numerous EEG devices that aim to allow mobile, autonomous, and easy use for users.

Data from the literature have proven the ability of neurofeedback (a form of biofeedback in which subjects respond to a display of their own brainwaves in order to improve their health or performance) to improve brain function in healthy or pathological subjects.

These therapeutic applications are offered in hospital settings with conventional systems and in the presence of a therapist.

The EEG measurement device URGOnight was developed with the aim of offering autonomous neurofeedback exercises at home. URGOnight is a portable device. It uses passive electrodes (which do not send an electric current) and so-called dry electrodes, i.e. no gel or conductive paste is required.

Therefore, the SIGMA study aims to evaluate the quality of the EEG signal collected by URGOnight and compare it with an electroencephalography device commonly used in clinical and research settings.

We will also evaluate the quality of the brain wave measurement usually retained in comparative studies of EEG systems.

primary_purpose: Basic Science

lead_sponsor: Urgotech


title: AI for Allograft Diseases Diagnosis and Prognosis After Kidney Transplantation

summary:
Kidney transplantation is the treatment of choice for patients with end stage renal disease. One of the major challenges is to better diagnose the attacks undergone by the kidney transplant in order to increase its longevity. Multiple attacks are caused by non-immune and immune mechanisms, first and foremost the acute rejection of the transplant.

Biopsy, an invasive method, remains the "Gold Standard" for diagnosing rejection and other pathologies affecting the kidney transplant.

The invasive nature of these biopsies limits their use and alternative biomarkers have been evaluated in order to diagnose kidney transplant pathologies in a non-invasive manner. It is in this context that the nephrology and renal transplantation department of the Necker hospital and Inserm U1151 have carried out several studies leading to the identification of the diagnostic and prognostic potential of acute rejection, by the determination of urinary concentrations of two chemokines, CXCL9 and CXCL10.

The most recent study conducted within these teams demonstrated that the diagnostic potential of urinary chemokines could be improved by taking into account standard clinicobiological parameters in multiparametric models.

The main objective of the study is to develop, train and validate artificial intelligence models including urinary chemokines, efficient, robust, explainable and interpretable for the diagnosis and non-invasive prognosis of acute renal transplant rejection, trained on a data set made up of clinical and biological parameters.


title: Altération Des Fibres élastiques Dermiques au Cours Des Dermatoses Calcifiantes : étude Structurelle en Microscopie Multiphoton

acronym: Calciphoton

summary: The spectrum of pathologies accompanied by tissue mineral deposits is wide. In dermatology, several pathologies are associated with calcium mineral deposits, such as calciphylaxis and pseudoxanthoma elasticum (PXE). However, few studies have been carried out on the chemical characteristics of these deposits, their implication on the pathophysiology and their consequences. This motivated our two previous studies on the characterization of skin mineral deposits during calciphylaxis and sarcoidosis. We have shown that these deposits were most often composed of carbapatite and preferentially localized to elastic fibers. Most calcifying dermatoses are preceded by an inflammatory skin condition. Some authors suspect the digestion of elastin by metalloproteinase (MMP) of the extracellular matrix, thus creating nucleation nuclei favoring phosphocalcic deposits. We thus wish to study the structural alteration of dermal elastic fibers during calcifying dermatoses using multiphoton microscopy, a tool available at the Laboratoire d'Optique et Biosciences (LOB) at the Ecole Polytechnique. Multiphoton microscopy presents several contrast modes that can be used in parallel and without marking. This makes it possible to identify constituent elements of tissues without the use of artificially added fluorescent dyes or proteins, for example fibrillar collagen by the so-called "SHG" contrast and elastin by its intrinsic fluorescence. It is then possible to deeply image an intact tissue, without staining, by specifically visualizing its various components. Used in several studies on the skin, including the LOB, multiphoton microscopy has shown its interest in the characterization of dermal fibers, in particular elastin and collagen fibers, but also in the structural study of these and of their possible alteration. It has thus been applied to the study of skin aging, but also of pathologies leading to degeneration of elastic fibers (PXE) or collagen (Marfan syndrome). The main objective of our project is to characterize the structural alterations of elastic fibers during calcifying dermatoses. The secondary objectives are to study the consequences of skin inflammatory phenomena on the deterioration of elastic fibers and to identify a possible nucleus of phospho-calcium deposits within elastic dermal and vascular fibers. We will thus study human skin biopsies already carried out in the context of the diagnosis of these calcifying dermatoses, skin biopsies from the murine model of PXE and in control, human biopsies of healthy skin from patients of different ages (excision margin of skin tumors). This project should provide a better understanding of the genesis of skin phosphocalcic deposits and provide therapeutic avenues for treating them and limiting their occurrence.

location_facility: Service de gériatrie plaies et cicatrisation


title: Retrospective Study on the Management of Pediatric Anaphylaxis and Clinical Signs of Allergy in the Pediatric Emergency Department of Montpellier University Hospital

acronym: Ana-Ped

summary: Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. The diagnosis can be difficult, and recommendations for follow up and prescription for an emergency kit are rarely provided after emergency visit. The Investigators will evaluate the management of pediatric anaphylaxis and clinical signs of allergy in the pediatric emergency department of Montpellier University Hospital


title: Health-related Quality of Life (HRQoL) and Physical, Psychological and Cognitive Impairments After Intensive Care Unit (ICU)Discharge A Longitudinal Cohort Study

summary:
Diagnostic and therapeutic progress of the last twenty years has been accompanied by an evolution in the morbidity and mortality of intensive care unit (ICU) patients. While there has been an overall decrease in mortality in the ICU, nearly 20% of patients die within one year after ICU discharge and survivors are marked by an increase in morbidity.

Indeed, independently of the initial disease, it is currently recognized that an admission to the ICU can be experienced as a traumatic situation, with potential physical, psychological and cognitive impairments that can be described by the term "post-intensive care syndrome" (PICS). This results in a decrease in quality of life compared to the general population.

Health-related quality of life (HRQoL)has received increasing attention in the literature. Thus, many studies have been interested in its evaluation, in particular in certain pathologies such as acute respiratory distress syndrome (ARDS), sepsis, cardiac arrest or in patients with onco-hematological diseases.

Paradoxically, few studies have described the HRQoL and the elements of the PICS in the overall population of patients admitted to the ICU. However, a better understanding of these elements could allow us to propose improvement strategies to facilitate the rehabilitation of these patients.

lead_sponsor: Versailles Hospital


title: Analysis of the Kinematics of the Shoulder Complex in Sports "Overhead" Gestures Such as Kayaking Polo Throwing (Overhead)

acronym: Overhead

summary: The objective of this study is to analyze the throwing gesture specific to the kayak polo. A throw in a seated position with fixation of the pelvis (by the seat) and antepulsion of the hip ipsilateral to the throwing shoulder.

primary_purpose: Diagnostic


title: Securing the Immediate Perioperative Walk: Creating and Validating a Score.

acronym: Déambu

summary: The aim of this study is to set up a pre and postoperative ambulation score on a population of adult patients and undergoing outpatient surgery operated under locoregional anesthesia and sedation.


title: Pilot Epidemiological Study to Determine the Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome

acronym: RESTECH

summary:
The aim of the study is to find, using validated and efficient tools, a laryngopharyngeal reflux in patients receiving polysomnography for suspected obstructive sleep apnea syndrome.

It is proposed to carry out simultaneously, at the Sleep Center of the Polyclinique of Poitiers (CSPP), a polysomnography, a 24-hour Restech pharyngeal pH-metry (day and night), a Peptest (in the evening and in the morning of the polysomnography), with the RSS-12 questionnaire and the RSA score.

lead_sponsor: Elsan

location_facility: Centre du Sommeil de la Polyclinique de Poitiers


title: New Recommendations for Robertsonian Translocation Management After Preimplantation Genetic Testing of Structural Rearrangement (PGT-SR) Attempts: What Should be Done With Mosaic Embryos?

summary: to analyze if a probe strategy choice for PGT-SR studies of Robertsonian translocations (RT) influences the fate of embryos? Few studies discussed the importance of probe choices. However, those who did, demonstrated that analysis with locus specific probes improve a diagnosis of dubious results, and addition of a centromeric probe could affect the accuracy of diagnosis


title: Monitoring of Progesterone Administered in Infertile Patients During a Cycle of Frozen Embryo Transfer: a Population Pharmacokinetic Study.

acronym: PEKAPROGE

summary: During an In Vitro Fertilization (IVF) attempt, several embryos are obtained but not all of them can be transferred to the uterus in the same cycle due to the risk of multiple pregnancies. Thus, it is very common for these couples to benefit from cryopreservation. Patients scheduled for frozen embryo transfer (TEC) receive estrogen and progesterone replacement therapy to prepare the endometrium for implantation. Data from the literature recently showed that low progesterone on the day of embryo transfer was responsible for a significantly higher rate of implantation failure and miscarriage.

lead_sponsor: University Hospital, Toulouse


title: Assessment of Patients' Quality of Sexual Life After Anal Cancer Treatment

acronym: SEQUOIA

summary: The purpose of this this study, to evaluate the quality of sexual life of patients treated for anal cancer treated by radiotherapy, during their treatment, then 3 months after treatment and, finally, 2 years after treatment. cancer diagnosis.

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

location_facility: Institut régional du Cancer de Montpellier


title: Randomized Propective Study Evaluating the Impact of an Acupuncture Session in Healthy Volunteers on the Kinetics of Cerebral Activity Using the Bispectral Index (BIS)

summary: To be able to have data on brain activity during an acupuncture session, this pilot study is necessary to evaluate the kinetics of the bispectral index. This research aims to evaluate the kinetics of the bispectral index in healthy volunteers during an acupuncture session, Sham acupuncture or resting in a lying position.


title: Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity : Observational Study (COFTASD)

acronym: COFTASD

summary: The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.


title: Comparison of Quadriceps Femoris Measurements in Critically Ill Children, Using Bedside Ultrasound and Magnetic Resonance Imaging

acronym: Echo-QF-IRM

summary:
A vast majority of children admitted to paediatric intensive care (PICU) present with faltering growth during their admission. Muscle mass loss is an early, intense and frequent phenomenon in this setting, which is associated with impaired outcomes. Recent international guidelines recommend monitoring both nutritional status and muscle mass throughout hospital stay. Recent studies have used quadriceps femoris (QF) measurements as a surrogate for lean mass assessment, and monitored them with bedside ultrasound (QF thickness and QF cross sectional area). However, ultrasound cross sectional area inter-operator reproducibility has not been validated so far, and none of these ultrasound measurements has been validated against their gold standard i.e. magnetic resonance imaging measurements. This validation process should be conducted to allow interpreting ultrasound muscle measurements, prior to the implementation of ultrasound measurments into clinical practice.

We hypothesise that ultrasound measurements of QF thickness and cross sectional area are reliable compared to the magnetic resonance imaging gold standard, and that QF cross sectional area has a reliable inter-operator reproducibility.

location_facility: Paediatric intensive care - Hospices Civils de Lyon


title: AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer

acronym: AAREN

summary: The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: OSV-IRM - Volunteer MRI Sequence Optimization

acronym: OSV-IRM

summary:
Optimization of magnetic resonance imaging (MRI) protocols on healthy volunteers and voluntary patients.

In MRI, a large number of technical parameters (sequence, parameters in sequence, antenna, reconstruction method, etc.) can be changed to optimize the diagnostic quality of the exam. Some optimizations can be performed on participants healthy volunteers, others need to be carried out on images pathological and acquired in voluntary patients.

lead_sponsor: Rennes University Hospital


title: Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

acronym: iGRAISSE

summary:
The goal is to have a small spectrometer (pocket size) , reliable and rapid tool that can be used during liver harvesting, which enables macrosteatosis to be evaluated reproducibly and selectively, at any time.

This tool must be minimally invasive, inexpensive and without significantly impacting the general organization of multi-organ harvesting.

In the operating room, the surgeon will perform an intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta. The surgeon will not be informed of the results of the spectrometer, and will carry out (or not) the biopsy. The spectrometers' results will be compared with definitive histological findings.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hépato Biliaire de l'hopital Paul Brousse


title: Intensive Gait Training Rehabilitation Protocol to Enhance Functional Parameters of Walking After Single-event Multi-level Surgery in Cerebral Palsy

acronym: ACTIV'MARCHE

summary: In the context of cerebral palsy, rehabilitation post Single-Event Multi-Level Surgery (SEMLS) is a long process. One year after surgery and rehabilitation, the functional benefits are usually less improved than the gait pattern. This may be caused by a lack of intensity in the final rehabilitation steps. Thus we created an intensive gait training rehabilitation protocole. This protocole associates 4 weeks of intensive rehabilitation in a healthcare center followed by 2 weeks of intensive rehabilitation at home. The objective of this study is to evaluate the efficiency of this protocol to improve walking speed and endurance, gross motor function et muscular strength.

lead_sponsor: Fondation Ellen Poidatz


title: Evaluation of a Free-breathing Cardiac Cine-MRI Sequence With Image Reconstructions Developed by Deep-Learning Compared to the Classic Apnea Cine-MRI Sequence in the Assessment of Ischemic Heart Disease.

acronym: CINEDL

summary:
Today, MRI is the gold standard for the precise assessment of left ventricular volume and function, but presents the drawback of having a long acquisition time and of generating motion artifacts, in particular respiratory artifacts, requiring repeated sequences in apnea to cover the whole cardiac volume. These apneas are difficult to achieve in patients with ischemic heart disease and may lead to degradation of the images, an increase in the duration of the examination by repeated acquisitions and therefore to diagnostic inaccuracies.

Artificial intelligence, already used in practice in cardiac MRI for automatic segmentation of the heart chambers, improves radiological interpretation with rapid and precise measurements. Deep-learning, which is part of artificial intelligence, would allow the reconstruction of cine-MRI sequences in free breathing, in order to overcome the artifacts from respiratory motions, and the improvement of diagnostic performance while improving examination conditions for patients.

Patients coming for a cardiac MRI for the assessment of ischemic heart disease will be eligible to the protocol. If the patient agrees to participate, a free-breathing cardiac cine-MRI sequence with Deep Learning based image reconstruction will be added to the usual protocol.

No follow-up will be required in this study.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: The Effects of Daily Supplementation of Nutriose® on the Fecal Microbiota in Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo Conrolled Pilot Study.

acronym: NUTRIBIOTE

summary: The effects of daily supplementation of the NUTRIOSE® on the fecal microbiota. The hypothesis of the study is that the NUTRIOSE® is able to modulate the intestinal microbiota in a positive way, compare to a placebo, in healthy volunteers.

lead_sponsor: Roquette Freres

location_facility: Clinical Investigation Unit of Biofortis


title: Platelet-rich Plasma Infiltration Versus Corticosteroid Infiltration (Prednisolone) in Treatment of Lumbar Facet Joint Syndrome

acronym: IAPRP

summary:
The prevalence of low back pain is estimated at 90% . Recent studies have shown that 15% to 52% of back pain is attributable to facet joint syndrome .

Being the only vertebral joints provided with a synovial membrane, the posterior inter-apophyseal joints are subject, like all other peripheral joints, to degenerative arthritis phenomena.

These phenomena most often result in the release of pro-inflammatory cytokines resulting in cartilage degradation.

PRP or platelet rich plasma is an autologous blood product obtained after centrifugation of a peripheral blood sample. The PRP has many anti-inflammatory properties. Numerous studies have shown the interest of intra-articular infiltration of PRP in osteoarthritis of the knee but also in tendinopathies of the shoulder and a few studies also suggest the use of PRP in the spine "intra-disc, epidural and posterior joints) .

Corticosteroid infiltrations in the posterior lumbar joints constituting the standard treatment in posterior inter-apophyseal osteoarthritis.

The goal is to obtain a new therapeutic weapon in the management of this frequent and invalid disease for patients who are often elderly and with other comorbidity.

lead_sponsor: CHU de Reims


title: Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy

acronym: SpecTum

summary:
In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery.

Techniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions.

Based on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Speckle Tracking Evaluation of the Impact of Inhaled Nitric Oxide on the Right Ventricle in Acute Respiratory Distress Syndrome

acronym: NOSPECKLE

summary:
Acute cor pulmonale is one of deadly complications of mechanically ventilated acute respiratory distress syndrome (ARDS), which can lead to right ventricular dysfunction and worsen the hemodynamics of the patient. For several years, transthoracic (TTE) and transesophageal echocardiography (TEE) have replaced the pulmonary artery catheter to monitor cardiac function reliably and non-invasively.

Speckle tracking is an echocardiographic technique that allows a two-dimensional strain (2D) analysis of right ventricular systolic function. Right ventricular global strain (RVGLS) is a strain parameter, allowing an early and more accurate diagnosis of right ventricular dysfunction than conventional parameters.

This project will consist of performing TTE and TEE measurements at H0, 30min, H1, H2, and H24 after iNO administration in patient with ARDS under mechanical ventilation. The patient will be declared responder to iNO, if there is an increase of more than 20% of the PaO2/FiO2. 30 minutes after a dose of 10ppm of iNO.


title: Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application

acronym: PhotodiVIN

summary: This study is a single-center propsective clinical trial to assess the ability of fluorescence techniques to mark high-grade vulvar intraepithelial neoplasias including high-grade vulvar squamous intraepithelial lesions and differentiated vulvar intraepithelial neoplasias following 3 hours Metvixia application.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Multicenter Prospective Cohort of Tumors With Pole/D1 Mutation

summary: Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined

lead_sponsor: Federation Francophone de Cancerologie Digestive


title: A Randomized, Single-center, Open-label, Single Dose, Two-period, Crossover Study to Investigate the Relative Bioavailability of Binimetinib 3 x15 mg and 45 mg Tablets in Healthy Participants

summary:
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration. For the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation, the recommended dosing regimen is 45 mg twice daily (bis in die, BID). No food effect with the commercial formulation of 15 mg was demonstrated.

In order to reduce the patient's burden, a new strength tablet containing 45 mg of binimetinib as active ingredient is being developed. As a result, the number of tablets to be taken by the patients will be reduced from 6 tablets (6 x 15 mg) to 2 tablets (2 x 45 mg) per day. The evaluation of the relative bioavailability of the 45 mg tablet in comparison to three 15 mg tablets intake is therefore required.

lead_sponsor: Pierre Fabre Medicament


title: Feasibility, Safety and Diagnostic Input of Interventional Cardiac MRI on a Series of 35 Patients With an Indication of Right Cardiac Catheterization.

acronym: IRM Cardiaque

summary: The aim of this study is to evaluate the feasibility of collecting hemodynamic data from right catheterization, all anatomical, functional, flow and substrate determination data under MRI navigation.

lead_sponsor: Ramsay Générale de Santé


title: Ventilation/Perfusion PET/CT With Galligas and 68Ga-MAA for Regional Lung Function Assessment After Pulmonary Embolism

acronym: EOLE

summary:
In patients with pulmonary embolism (PE), after three or six months of anticoagulation, persistent dyspnea and impairment of quality of life are observed in at least 30% of cases.

The "RAMBO" trial is a French academic, multicenter, randomized (1:1 ratio), parallel arm, controlled, that aimed to assess the efficacy of pulmonary rehabilitation (PR) on the quality of life in patients with an acute symptomatic PE treated with anticoagulant therapy during at least 3 months and who present an impairment of quality of life and/or persistent dyspnea despite anticoagulant therapy.

Ventilation/Perfusion (V/Q) PET/CT is a novel imaging modality for the assessment of regional lung function. The same carrier molecules as conventional V/Q imaging are used, but they are labeled with 68Gallium, a ß+ isotope, instead of 99mTc, allowing acquisition of images with PET technology.

The EOLE study is an ancillary pilot study of the RAMBO trial, in which patients will benefit, in addition to the extensive work up scheduled as per study protocol, from a V/Q PET/CT scan before and after PR. The aim of the study is to assess the impact of PR on regional lung function with lung V/Q PET/CT imaging.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: 4D Flow Cardiac MRI Velocity Mapping in Patients With Pulmonary Hypertension: Estimation of Pulmonary Arterial Pressure and Comparison With Right Heart Catheterization and Doppler Echocardiography

acronym: HTPFLUW

summary:
Due to radiation exposure and low but real risk of morbidity and mortality associated with right heart catheterization, non-invasive procedures to estimate mPAP are desired for the diagnosis of PH or to monitor treatment effectiveness. Echocardiography is used as a screening tool to estimate systolic pulmonary arterial pressure (sPAP), but due various limitations, this technique is not considered to be sufficiently accurate for the diagnosis of PH. The aim of 4D flow MRI is to evaluate the complete time-varying tridirectional velocity field in a volume of interest. It enables flow and velocity measurements in a vascular region of interest and visualization of vector plots of blood flow velocity fields. Previous studies have shown on the one hand, correlations between mPAP and hemodynamic parameters obtained by phase contrast MRI and, on the other hand, appearance of a vortical blood flow in the pulmonary artery in PH. More studies are required to confirm 4D MRI as a valuable tool for mPAP estimation in PH.

Following screening echocardiography, all patients will undergo right heart catheterization for PH assessment. Then, all patients will be referred for a complete cardiac MRI exam with the addition of a 4D Flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a Doppler-echocardiography. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study.


title: Subthalamic Nucleus Stimulation With Directional Leads on Patients With Parkinson Disease at Fluctuations and Dyskinesia Stage

acronym: NSTBOS

summary:
Patients with subthalamic nucleus have to go through a lot of examinations and tests, before and after surgery which is difficult, sometimes painful, for the patient.

The investigators used to chose the best plot of the leads for stimulation by a procedure long and exhausting for the patient and the examinator.

The investigators can chose the plot using a software (Guide Xt), which can delete the exhausting test.

The investigators would like to study the non inferiority of this tool to choose the best plot .


title: Cardiac ResynchronizatiOn and arrhythmiaS Sensing Via the LEFT Bundle. The CROSS LEFT Study.

acronym: CROSS LEFT

summary: Evaluation of ventricular arrhythmias sensing via a left bundle branch area pacing lead.

ipd_sharing_description: IPD may be shared with manuscript reviewers, upon reasonable request.

lead_sponsor: University Hospital, Tours


title: Impact of a Minimally Invasive Approach to Laparoscopic Hysterectomy on Postoperative Recovery

acronym: MIN-HYSTER

summary:
Background Managing perioperative stress, including endocrino-metabolic changes and, inflammatory and pain responses, is a major challenge to improve patient's recovery. Currently, minimally invasive surgical procedures combined with multimodal analgesia are commonly used to increase the quality of postoperative period.

Purpose To demonstrate that a minimally invasive approach including low insufflation pressure and minitrocars in laparoscopic hysterectomy improves postoperative recovery and reduces pain stimulation and opioid consumption in comparison with a conventional approach.

Methods After informed consent, all patients scheduled for a laparoscopic hysterectomy including those with carcinologic disease will be part of this monocentric prospective randomized double-blinded study.

At admission in our outpatient unit, patients will have to fill the Post-operative Quality of Recovery Scale assessment form, before to be randomized into one of the following two groups:

Conventional approach: laparoscopic procedure including standard trocars (3 trocars of 5 mm and a 10 mm-optic trocar) with insufflation pressures between 10 and 12 mmHg.
Mini-invasive approach : laparoscopic surgery using mini-trocars (3 trocars of 3 mm and a 5 mm-optic trocar) with insufflation pressures of less than 8 mmHg.

Both groups will have general anesthesia with a deep neuromuscular blockade (TOF = 0 at the thumb adductor) and will benefit of our enhanced recovery program. Patients and evaluators will be blind regarding the allocated group.

The primary outcome is a comparison of the postoperative recovery between the two groups through the Post-operative Quality of Recovery Scale.This evaluation will include pain data, nausea/vomiting evaluation and cognitive function 6 hours after surgery.

Secondary outcomes are morphine consumption surgical comfort and patient satisfaction.

ReferenceCitation: Allam IS, Makled AK, Gomaa IA, El Bishry GM, Bayoumy HA, Ali DF. Total laparoscopic hysterectomy, vaginal hysterectomy and total abdominal hysterectomy using electrosurgical bipolar vessel sealing technique: a randomized controlled trial. Arch Gynecol Obstet. 2015 Jun;291(6):1341-5. doi: 10.1007/s00404-014-3571-3. Epub 2014 Dec 19.

ReferenceCitation: Cohen SL, Ajao MO, Clark NV, Vitonis AF, Einarsson JI. Outpatient Hysterectomy Volume in the United States. Obstet Gynecol. 2017 Jul;130(1):130-137. doi: 10.1097/AOG.0000000000002103.

ReferenceCitation: Penn CA, Morgan DM, Rice LW, Harris JA, Rauh-Hain JA, Uppal S. Timing of and Reasons for Unplanned 30-Day Readmission After Hysterectomy for Benign Disease. Obstet Gynecol. 2016 Oct;128(4):889-897. doi: 10.1097/AOG.0000000000001599.

ReferenceCitation: Wijk L, Franzen K, Ljungqvist O, Nilsson K. Implementing a structured Enhanced Recovery After Surgery (ERAS) protocol reduces length of stay after abdominal hysterectomy. Acta Obstet Gynecol Scand. 2014 Aug;93(8):749-56. doi: 10.1111/aogs.12423. Epub 2014 Jun 13.

ReferenceCitation: Wijk L, Franzén K, Ljungqvist O, Nilsson K. Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Gynecol Obstet Invest. 2016;81(5):461-7. doi: 10.1159/000443396. Epub 2016 Jan 23.

ReferenceCitation: Kyle EB, Maheux-Lacroix S, Boutin A, Laberge PY, Lemyre M. Low vs Standard Pressures in Gynecologic Laparoscopy: a Systematic Review. JSLS. 2016 Jan-Mar;20(1). pii: e2015.00113. doi: 10.4293/JSLS.2015.00113. Review.

ReferenceCitation: Sroussi J, Elies A, Rigouzzo A, Louvet N, Mezzadri M, Fazel A, Benifla JL. Low pressure gynecological laparoscopy (7mmHg) with AirSeal(®) System versus a standard insufflation (15mmHg): A pilot study in 60 patients. J Gynecol Obstet Hum Reprod. 2017 Feb;46(2):155-158. doi: 10.1016/j.jogoh.2016.09.003. Epub 2017 Jan 30.

ReferenceCitation: Carvalho GL, Paquentin EM, Redan JA, Shadduck PP. The Science Behind Mini-Laparoscopic Cholecystectomy. Surg Technol Int. 2016 Oct 26;29:93-98. Review.

ReferenceCitation: Redan JA, Humphries AR, Farmer B, Paquentin EM, Koh CH, Chung MK, Stringel G, McCarus SD, Carvalho G, Diaz RG, Shadduck PP. "Big Operations Using Mini Instruments": The Evolution of Mini Laparoscopy in the Surgical Realm. Surg Technol Int. 2015 Nov;27:19-30.

ReferenceCitation: de'Angelis N, Petrucciani N, Giannandrea G, Brunetti F. The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum. Updates Surg. 2018 Dec;70(4):553-556. doi: 10.1007/s13304-018-0591-8. Epub 2018 Aug 29.

ReferenceCitation: Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.

ReferenceCitation: Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery Society. Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations. Clin Nutr. 2012 Dec;31(6):801-16. doi: 10.1016/j.clnu.2012.08.012. Epub 2012 Sep 26. Review.

ReferenceCitation: Bonnet F, Marret E. Postoperative pain management and outcome after surgery. Best Pract Res Clin Anaesthesiol. 2007 Mar;21(1):99-107. Review.

ReferenceCitation: Wong M, Morris S, Wang K, Simpson K. Managing Postoperative Pain After Minimally Invasive Gynecologic Surgery in the Era of the Opioid Epidemic. J Minim Invasive Gynecol. 2018 Nov - Dec;25(7):1165-1178. doi: 10.1016/j.jmig.2017.09.016. Epub 2017 Sep 28. Review.

ReferenceCitation: Griffith KC, Clark NV, Zuckerman AL, Ferzandi TR, Wright KN. Opioid Prescription and Patient Use After Gynecologic Procedures: A Survey of Patients and Providers. J Minim Invasive Gynecol. 2018 May - Jun;25(4):684-688. doi: 10.1016/j.jmig.2017.11.005. Epub 2017 Nov 14.

ReferenceCitation: Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.

ReferenceCitation: Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Søreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1. Review.

ReferenceCitation: Fuchs-Buder T, Meistelman C. [Monitoring of neuromuscular block and prevention of residual paralysis]. Ann Fr Anesth Reanim. 2009 Sep;28 Suppl 2:S46-50. doi: 10.1016/S0750-7658(09)72487-6. Review. French.

ReferenceCitation: Samimi S, Taheri A, Davari Tanha F. Comparison Between Intraperitoneal and Intravenous Lidocaine for Postoperative Analgesia After Elective Abdominal Hysterectomy, a Double-Blind Placebo Controlled Study. J Family Reprod Health. 2015 Nov;9(4):193-8.

ReferenceCitation: Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.

ReferenceCitation: Le Gall L, David A, Carles P, Leuillet S, Chastel B, Fleureau C, Dewitte A, Ouattara A. Benefits of intraoperative analgesia guided by the Analgesia Nociception Index (ANI) in bariatric surgery: An unmatched case-control study. Anaesth Crit Care Pain Med. 2019 Feb;38(1):35-39. doi: 10.1016/j.accpm.2017.09.004. Epub 2017 Oct 12.

ReferenceCitation: Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

ReferenceCitation: Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6.

ReferenceCitation: Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, François G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23.

lead_sponsor: Institut Mutualiste Montsouris


title: Impact of Chemotherapeutic Treatments on Functional Autonomy and Quality of Life in Patients Aged 75 Years and Over Treated for Lymphoid Hematological Malignancy

acronym: LYMPHOLD

summary: The aim of the study is to assess the prevalence of functional decline in elderly patients treated with chemotherapy or immunochemotherapy for lymphoid hematologic malignancies. For this purpose, each patient benefits at inclusion (D0) of a standardized gerontological evaluation, and 3 and 6 months post-inclusion.


title: Study of the Functional Result of the Reinsertion of the Subscapular in Reverse Shoulder

acronym: CICASCAP

summary: This study is based on the hypothesis that the functional result is better if the subscapularis is reinserted and healed. The originality of the study therefore consists in systematically monitoring the healing of this tendon postoperatively, with sufficient follow-up, by ultrasound and by an intra-tendon marker, in order to differentiate the result depending on whether the tendon is healed or not.


title: Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C.

acronym: ERAV

summary: The main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of Occlusive Peripheral Arterial Disease (OPAD) in critical ischemia, in the absence of usable great saphenous vein.


title: Randomized Study on Akin Osteotomy: Fixation Versus Non-fixation

acronym: Fixakin

summary: We hypothesize that the Akin screw fixation osteotomy technique provides better postoperative mobility of the metatarsophalangeal hallux joint compared to the non-fixation technique.


title: Combining Executive Training and Anomia Therapy in Chronic Post-stroke Aphasia : a Single Case Experimental Design -SCED Preliminary Study

acronym: ETAT PSA

summary: Aphasia is a devastating acquired language impairment mainly caused by stroke, in which anomia is a quintessential clinical feature. If speech-language therapy (SLT) has been shown to be effective for persons with aphasia, the relative efficiency of one SLT strategy over another remains a matter of debate. The influential relationship between language, executive functions and aphasia rehabilitation outcomes has been addressed in a number of studies, but only few of them have studied the effect of adding an executive training to linguistic therapies.The aim of this study is to measure the efficiency of a protocol combining anomia therapy and executive training on naming skills and discourse in post-stroke aphasic persons at the chronic stage

lead_sponsor: University Hospital, Montpellier


title: Registre HEAR, Healthcare European Amyloidosis Registry

summary:
This is a non-interventional, prospective, retrospective, non-comparative, multi-center study.

In order not to interfere with patient management, the study is observational. Thus, no follow-up visit is imposed. The data collection will be limited to the data related to the management of the patients included throughout their follow-up.

This study is intended for all patients with a confirmed or suspected diagnosis of cardiac amyloidosis. Three cohorts will be identified: the HEAR (Healthcare European Amyloidosis Registry)-Retrospective Cohort, the HEAR(Healthcare European Amyloidosis Registry)-Retrospective-Prospective Cohort and the HEAR (Healthcare European Amyloidosis Registry)-Prospective Cohort.

lead_sponsor: Saving Lives Matters


title: The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables

acronym: REPROTOX 2

summary: The main embryotoxicity quality controls are the mouse embryo test (MEA = Mouse Embryo Assay) and the human sperm survival test (HSSA = Human Sperm Survival Assay). The HSSA test measures the survival (or mobility) of human sperm after exposure to the tested consumable for a predetermined period of time and compares it to that of unexposed sperm. It would appear that the HSSA is comparable in terms of sensitivity to the MEA test for the detection of toxicity.


title: Study of the Impact of a Physical Activity Programme on the Quality of Life of Patients With Inflammatory Bowel Disease

acronym: APMICI

summary: Regular physical activity at a mild to moderate intensity can control inflammation in general and intestinal inflammation in particular during IBD. The effectiveness of a physical activity programme has been evaluated during IBD, but the data are limited to a few studies. Overall, PA improves quality of life but also improves control of disease symptoms and fatigue . The aim of the present work is to evaluate the impact of a physical activity programme on quality of life in patients with IBD. This programme will also evaluate the impact of physical activity on 1) anxiety-depression, 2) fatigue (a frequent and difficult to manage symptom in IBD), 3) IBD activity, 4) smoking cessation.

ReferenceType: result

ReferenceCitation: Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1. Review.

family: Torres

full_name: Joana Torres

given: Joana

family: Mehandru

full_name: Saurabh Mehandru

given: Saurabh

family: Colombel

full_name: Jean-Frédéric Colombel

given: Jean-Frédéric

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Crohn's disease

ReferenceCitation: Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1. Review.

family: Ungaro

full_name: Ryan Ungaro

given: Ryan

family: Allen

full_name: Patrick B Allen

given: Patrick B

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

title: Ulcerative colitis

ReferenceCitation: Gower-Rousseau C, Vasseur F, Fumery M, Savoye G, Salleron J, Dauchet L, Turck D, Cortot A, Peyrin-Biroulet L, Colombel JF. Epidemiology of inflammatory bowel diseases: new insights from a French population-based registry (EPIMAD). Dig Liver Dis. 2013 Feb;45(2):89-94. doi: 10.1016/j.dld.2012.09.005. Epub 2012 Oct 27.

family: Gower-Rousseau

full_name: Corinne Gower-Rousseau

given: Corinne

family: Vasseur

full_name: Francis Vasseur

given: Francis

family: Fumery

full_name: Mathurin Fumery

given: Mathurin

family: Savoye

full_name: Guillaume Savoye

given: Guillaume

family: Salleron

full_name: Julia Salleron

given: Julia

family: Dauchet

full_name: Luc Dauchet

given: Luc

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

title: Epidemiology of inflammatory bowel diseases: New insights from a French population-based registry (EPIMAD)


title: DEPLIPIDO Study: Functional and Lipidomic Analysis of Plasma HDL in Patients With Depression Compared to Controls

acronym: DepLIPIDO

summary:
Depression is a disabling condition in terms of psychosocial alteration and also in terms of physical comorbidities. Depression doubles the risk of myocardial infarction compared with the general population, and this cardiovascular comorbidity leads to an increase in mortality in patients suffering from depression, even exceeding suicide-related mortality.

It is therefore important to better understand the mechanisms linking depression and cardiovascular disease.

Among the hypotheses that may account for the increased cardiovascular risk in patients with depression, lipid abnormalities are likely to play a crucial role.

Thus, qualitative and functional abnormalities in HDL lipoproteins are an important line of research, insofar as these lipid abnormalities have been recognized as important atherogenic abnormalities in populations at high cardiovascular risk, which is the case of patients with depression.

In this clinical, epidemiological and scientific context, a collaborative study undertaken by both the Department of Psychiatry of the Dijon Bourgogne University Hospital of and the INSERM LNC-UMR 1231 (PADYS) Laboratory of the UNIVERSITY OF BOURGOGNE FRANCHE-COMTE is an original translational research project, and the first study to perform a lipidomic analysis of HDL, coupled with a functional analysis of these lipoproteins in depression.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Measurement of Water-soluble Vitamins and Trace Elements Loss With Maintenance Post-dilution Haemodiafiltration Patient

acronym: VITAFLUX

summary:
End stage renal disease is a severe pathology in which some toxic waste and an excessive amount of water can accumulate in the human body with life threatening consequences. Maintenance hemodialysis is one of the possible treatment for this disease.

Hemodialysis filter the blood through a membrane according to a dialysis bath and so can be able to purify the blood of the toxic waste.

Otherwise, since the 1980s, the investigator know that patient in maintenance hemodialysis can have some deficiency in water soluble vitamins and trace elements. Mechanisms of the deficiency are multiple (a decreased of food intake, a diminution of the appetite, digestive malabsorption du to medics and comorbidities and loss in hemodialysis).

Impact of this deficiency have an important impact on vital prognosis for these patients. These nutrients are essential for AND synthesis, mechanism of inflammation, cells membranes synthesis, etc. DOPPs study in 2004 have shown a decreased of 16% in the mortality within 4 years with supplemented patients. Also, since this study, international recommendations were wrote in 2009, then in 2020, in order to supplement in vitamins and trace elements patients in maintenance conventional hemodialysis.

Despite these recommendations, some supplementary efforts are necessary, especially since online hemodiafiltration, a new process, is widely available and used in particular in Europe. This process combines 2 phenomena, diffusion and convection, through high-flux membranes. This process can remove a large quantity of molecule present in blood and especially the middle-molecule. In return, a more important quantity of water soluble vitamins and oligo-elements could be removed by this technique.

Also, the investigator would like to measure this loss of vitamins and trace-elements in patients with maintenance online post-dilution hemodiafiltration process with dialysate sample and blood concentrations measured (usual patient monitoring) during the session.

lead_sponsor: Hospices Civils de Lyon


title: Impact of Personalized Interventions to Raise Teleconsultation Awareness: The Case of the Cicat-Occitanie Network and Healthcare Professionals in Lozère's EHPADs

summary: The cicat-occitanie network offers expertise for health professionals concerning wound care, in particular through teleconsultations. This study aimed to understand the obstacles reported by healthcare professionals in Lozere's EHPAD related to the use of this network. This cluster randomized controlled trial also sought to evaluate the effect of personalized intervention for each EHPAD on the use of this network.


title: Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration

summary: A data collection of blood glucose values, insulin, meal composition will be performed for a period of two months, to evaluate the performances of an automated insulin titration algorithm


title: Interest of Speech Therapy in Children With Epilepsy: What Impairments of Cognitive Functions?

summary:
Since the proportion of language and attentional difficulties in patients with epilepsy is recognized, both in the literature and in the clinical experience of practitioners, it is appropriate to propose a complete speech-language assessment of oral language and attention.This study investigates these impairments through the taking of specific tests.

The general objective of this study is to observe possible oral language and attention disorders in children with epilepsy, by age and etiology of epilepsy.

The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.


title: Comparative Study of the Personality Profile of Children and Adolescents With Attention Deficit Hyperactive Disorder (ADHD) With or Without Emotional Dysregulation

summary:
Attention Deficit Hyperactivity Disorder (ADHD) is frequently associated with emotional dysregulation (ED). ED is characterized by excessive and inappropriate emotional reactions compared to social norms, uncontrolled and rapide shifts in emotion and attention focused on emotional stimuli.

According to research, there are strong correlations between personality traits and psychiatric disorder as ADHD. In a longitudinal study, the persistence of ADHD symptoms during adolescence is associated with high neuroticism, low agreeableness and low conscience. Studies show that these personality traits are factors of vulnerabilities for comordities associated with ADHD and are predictive of overall functioning difficulties. Studies show correlations between ADHD in childhood and personality disorders at adulthood .

ADHD is frequently associated with emotional dysregulation (ED) that is characterized by an inability to modulate emotional responses in a given context . ED is observed in 24% to 50% children with ADHD . Children with ADHD and ED are more likely to present a severe and complex symptomatology and are at risk for antisocial and bordeline personality disorders than children without ED. To date, there would be no studies which would have been interested in personality traits in children with ADHD and ED.

The main objective is to determine if children with ADHD and ED present from childhood traits of personality as low agreeableness, low conscience and high neuroticism that are predictive of personality disorders at adulthood. It would involve earl identification of children at increased risk of pejorative developmental trajectories.

The second objectives are:

Improve understanding of the heterogeneity of ADHD symptom expression;
Have a better understanding of the child's personalit and temperament traits to identify riks and protective factors;
Identify children with ADHD with profiles at risk of personality disorders in order to adapt the care according to the child's needs.


title: Hypertriglyceridemia Associated Acute Pancreatitis in Intensive Care Unit and Therapeutic Plasmapheresis: a Multicenter Retrospective Study

acronym: TRIPAN

summary:
Acute pancreatitis (AP) is a one of the potentially life-threatening complication of severe hypertriglyceridemia (HTG), with mortality around to 30%.

HTG-associated PA and their complications management has to be the same as the other pancreatitis, but they are associated with the worse clinical outcomes. Triglycerides levels are correlated with the risk of pancreatitis and severity.

Therapeutic plasma exchange (TPE) could provide positive effects in reducing triglyceridemia plasma levels during the acute phase of HTG-AP, and in prevention of recurrence. There is currently no difference about mortality in studies. Some authors have recommended its use only in severe HTG-AP and have precised the need of early initiation to have positive results.

Despite such promising findings from studies, the effects of therapeutic plasma exchange on HTG-associated PA have never been specifically assessed and its benefits in critically ill patients with AP remains uncertain.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)

acronym: REACIMALLOGV

summary:
The study investigators propose to perform a blood test before and after allograft placement in all patients receiving a cold-stored venous allografts at the University Hospital of Nîmes to study the occurrence of FVFA-related ASD in these patients.

The aim of this work is to characterize a possible immune reaction generated by the implantation of venous allografts prepared according to the BIOPROTEC method. In case of a proven immune reaction, the study will allow a modification of our current attitude and to exclude patients potentially eligible for renal transplantation at the time of venous allograft placement, or to perform in these patients an allo-compatibility test with the venous allograft preoperatively and thus protect these patients from an increased risk of subsequent organ transplant rejection.