title: The Inclined Position in Case of Respiratory Discomfort in the One Year Less Infant : Study on the Profits and the Risks in the Home

acronym: PROCLIVE

summary:
The inclined position at 30 ° in case of transient respiratory discomfort is recommended since the consensus conference of September 2000. This recommendation is based on a low level of evidence (grade C). This advice is found in the health book, and in many tips for parents. However, it does not comply with the recommendations of the American Academy of Pediatrics for sleeping on the back, on a firm mattress and without other objects in the bed.

70% of pediatricians advise this position in a specific medical context according to a study of Bellaïche conducted in 2013. 40% of parents use it for no particular reason.

Anatomically, the upper airways of infants are of reduced caliber, and therefore at risk of obstruction.

A study by Bergougnioux on the cases of MIN in infants wearing a wrap-around sling shows that the flexion of the neck causes the chin to be positioned against the chest and contributes to the suffocation of the infant. This is especially important in infants under 3 months whose neck muscles do not yet support the weight of the head.

The 2009 InVS national survey of unexpected infant deaths shows that bed crashes accounted for 11.1% of all deaths reported. Among unexplained deaths, maladaptive bedding was a contributing factor, including the use of a pillow in the bed in 24.3% of cases.

It was observed in the study by Kornhauser Cerar et al in 2009 that half-sitting in a car seat for an extended duration was at the origin of a significant desaturations rate, which was also found in the car bed group. The control group "hospital bed" was not subject to these desaturations. These results support the fact that only an adapted bedding that complies with the recommendations protects against asphyxiation.

Since 2016, INPES recommends in its advice sheet on bronchiolitis for parents, a flat bed on the back.

Hypothesis :

The inclined position in infants under one year of age is at risk of unexpected death of the infant by obstruction of the upper airways, because of the changes of position that it entails, including a risk of slipping at the bottom of the bed and of asphyxiation under the covers.

location_facility: Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône


title: Feasibility of Adapted Physical Activity Based on a Walking Platform in Hospitalized Old Patients for Cancer

acronym: APPAHOCA

summary: The investigator propose to evaluate the interest of the provision of a suitable treadmill offering fall protection and verticalization assistance.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU
Centre François Baclesse

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: MILAR, is a Controlled, Randomised, Comparative, Prospective, Multi-center, Superiority French Clinical Trial Comparing the MacGrath MAC Videolaryngoscope and the MacIntosh Laryngoscope for Oro-tracheal Intubation by Patients With Less Than 2 Criteria of Difficult Intubation in Elective Surgery.

acronym: MILAR

summary: The MILAR trial is a multicenter randomised , prospective, controlled, single-blind, superiority French clinical trial, with a 1: 1 distribution of patients to compare intubation during the first laryngoscopy between the MacGrath MAC videolaryngoscope and the MacIntosh laryngoscope for patients with less than 2 criteria of difficult intubation in elective surgery.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.

ReferenceCitation: Hasegawa K, Shigemitsu K, Hagiwara Y, Chiba T, Watase H, Brown CA 3rd, Brown DF; Japanese Emergency Medicine Research Alliance Investigators. Association between repeated intubation attempts and adverse events in emergency departments: an analysis of a multicenter prospective observational study. Ann Emerg Med. 2012 Dec;60(6):749-754.e2. doi: 10.1016/j.annemergmed.2012.04.005. Epub 2012 Apr 28.

ReferenceCitation: Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.

ReferenceCitation: Sakles JC, Javedani PP, Chase E, Garst-Orozco J, Guillen-Rodriguez JM, Stolz U. The use of a video laryngoscope by emergency medicine residents is associated with a reduction in esophageal intubations in the emergency department. Acad Emerg Med. 2015 Jun;22(6):700-7. doi: 10.1111/acem.12674. Epub 2015 May 20.

ReferenceCitation: Kaplan A, Goksu E, Yildiz G, Kilic T. Comparison of the C-MAC Videolaryngoscope and Rigid Fiberscope with Direct Laryngoscopy in Easy and Difficult Airway Scenarios: A Manikin Study. J Emerg Med. 2016 Mar;50(3):e107-14. doi: 10.1016/j.jemermed.2015.06.070. Epub 2015 Dec 22.

ReferenceCitation: Ruetzler K, Imach S, Weiss M, Haas T, Schmidt AR. [Comparison of five video laryngoscopes and conventional direct laryngoscopy : Investigations on simple and simulated difficult airways on the intubation trainer]. Anaesthesist. 2015 Jul;64(7):513-9. doi: 10.1007/s00101-015-0051-5. Epub 2015 Jul 15. German.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Chartres Hospital Center
Orleans Hospital Center

intervention_type: Device

lead_sponsor_type: academique


title: Effects on an Experimental Dyspnea by Thoraco-abdominal Elastic Strapping of the High Flow Nasal Cannula

acronym: EDEN

summary: To develop an experimental model of dyspnea by external thoraco-abdominal elastic strapping at rest in order to study the mechanisms involved in the relief of dyspnea by the administration of high flow by nasal cannula (HFNC).

primary_purpose: Treatment

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

location_facility: Service de Pneumologie et Réanimation Médicale

location_facility: Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation


type: Other Identifier

title: Expiratory Fow Assessment in ARDS Patients

acronym: FLAIR

summary: This study intended to assess the expiratory flow limitation (EFL) during tidal breath in patients intubated in intensive care unit (ICU) for moderate or severe acute respiratory distress syndrome (ARDS). EFL is defined as the lack of increase in expiratory flow in response to an increase in alveolar-to-atmospheric pressure gradient. It reflects airway closure. Early studies have been done using the Negative expiratory pressure (NEP) technique, which is no longer available. We proposed in present study a new method, which consists of diverting manually the expiratory flow to the atmosphere by-passing the expiratory valve. We aimed at assessing EFL at positive expiratory pressure (PEP) 5 cmH2O in semi-recumbent then in supine position together with measurement of trans-pulmonary pressure and regional lung ventilation. Higher PEP levels will be tested, namely 10, 15 and a trans-pulmonary PEP of 3 cmH2O, in semi-recumbent position.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Hospices Civils de Lyon

location_facility:
CHU Grenoble Alpes
Hôpital de la Croix Rousse


title: Medico-economic Evaluation of a "IsereADOM" Package of Services Versus Conventional Health and Social Monitoring, in the Care of a Population of People With Heart Failure in Isère.

acronym: CardIC

summary:
The goal of this study is to evaluate the health and social benefit of innovative management - IsereADOM - versus conventional follow-up in patients with heart failure.

There is a medico-economic goal too, is to perform a cost-utility analysis of the service bundle (IsereADOM) versus conventional 6-month community-based follow-up in a population with heart failure.

primary_purpose: Health Services Research

ReferenceCitation: Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.

ReferenceCitation: Desai AS, Stevenson LW. Rehospitalization for heart failure: predict or prevent? Circulation. 2012 Jul 24;126(4):501-6. doi: 10.1161/CIRCULATIONAHA.112.125435. No abstract available.

ReferenceCitation: McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology; Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012 Aug;14(8):803-69. doi: 10.1093/eurjhf/hfs105. No abstract available. Erratum In: Eur J Heart Fail. 2013 Mar;15(3):361-2.

ReferenceCitation: Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735. No abstract available.

ReferenceCitation: Takeda A, Taylor SJ, Taylor RS, Khan F, Krum H, Underwood M. Clinical service organisation for heart failure. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD002752. doi: 10.1002/14651858.CD002752.pub3.

ReferenceCitation: Krumholz HM, Merrill AR, Schone EM, Schreiner GC, Chen J, Bradley EH, Wang Y, Wang Y, Lin Z, Straube BM, Rapp MT, Normand SL, Drye EE. Patterns of hospital performance in acute myocardial infarction and heart failure 30-day mortality and readmission. Circ Cardiovasc Qual Outcomes. 2009 Sep;2(5):407-13. doi: 10.1161/CIRCOUTCOMES.109.883256. Epub 2009 Jul 9.

ReferenceCitation: Powell LH, Calvin JE Jr, Richardson D, Janssen I, Mendes de Leon CF, Flynn KJ, Grady KL, Rucker-Whitaker CS, Eaton C, Avery E; HART Investigators. Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial. JAMA. 2010 Sep 22;304(12):1331-8. doi: 10.1001/jama.2010.1362.

ReferenceCitation: Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. doi: 10.1002/hec.944.

lead_sponsor: University Hospital, Grenoble

location_facility:
CHU Grenoble-Alpes
Groupe Hospitalier Mutualiste


title: Evaluation of the Frequency of Occurrence of Joint Pain With Bevacizumab in Patients With Ovarian, Colorectal or Bronchopulmonary Cancer

summary:
Self-administered questionnaire survey to determine the presence or absence of joint pain during bevacizumab treatment for lung, ovarian, colorectal cancers.

The principal end-point is the frequency of arthralgia after 6 months of treatment with Bevacizumab.

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Vauleon E, Behal H, Lebellec L, Desbarbieux R, Baldacci S, Simon N, Pannier D, Vieillard MH, Turpin A. Does bevacizumab increase joint pain in patients with cancer? Results of the prospective observational BEVARTHRALGIA study. Cancer Chemother Pharmacol. 2021 Apr;87(4):533-541. doi: 10.1007/s00280-020-04226-6. Epub 2021 Jan 12.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Lille

location_facility:
Centre Oscar Lambret
Hôpital Huriez. CHRU


title: Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps

summary:
This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy.

The NBI is a so-called "virtual" electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention.

The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).

status: Terminated

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Centre Hospitalier Départemental Vendée
Centre Hospitalier Universitaire Nantes

status_simplified: Unknown


title: Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study

summary: The aim of the study is to compare the efficiency on respiratory failure regression of high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ED for de novo acute respiratory failure.

primary_purpose: Supportive Care

lead_sponsor: Poitiers University Hospital

sponsor_collaborators:
Poitiers University Hospital
Centre Hospitalier de Niort

location_facility:
CHG de Niort
CHU Poitiers


title: Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer

acronym: NIVEAL

summary:
To assess the relationship between progression free survival of patients treated with nivolumab for metastatic non small cell lung carcinoma or a metastatic renal cell carcinoma and nivolumab blood concentration.

Collection of standard data prospectively.

lead_sponsor: University Hospital, Tours

location_facility: Medical oncology department, University Hospital, Tours

location_facility: Pneumology department, University Hospital, Tours


title: Transfer of Frozen Embryos in NATural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate - Bicentric Prospective Open Randomized Controlled Trial

acronym: TECNAT

summary: The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Nimes
CHU Arnaud de Villeneuve


title: Validation of the Dosage of Asymmetric Dimethylarginine (ADMA) Plasma in the Assessment of Endothelial Dysfunction During Growth Hormone Deficiency and Intrauterine Growth Retardation

acronym: GAMMA

summary:
Principal objective : Validation of a handy biochemical parameter, plasma concentration of Asymmetric DimethylArginine (ADMA), based on a recognize biochemical parameter, the dilation of the brachial artery, at ultrasound examination, after the deflation of a cushion to evaluate artery dysfunction (vascular suffering) in growth diseases, growth hormone deficiency (GHD) and intrauterine growth retardation (IUGR)

Secondary objectives:

Comparison of ADMA plasma concentrations with dose of matched healthy control children
Investigation of the mechanisms of arterial dysfunction, inflammation, oxidative stress and insulin resistance.

status: Unknown status

study_completion_date_type: Anticipated

location_facility: Hôpital Jeanne de Flandre - CHRU de Lille

intervention_type: Diagnostic Test


title: Multicenter, Randomized, Pilot Study Evaluating the Efficacy and the Tolerance of Pelvic-prostatic Hypo-fractionated Radiotherapy Followed by Boost (Stereotaxic External Radiotherapy or High Dose Rate Brachytherapy) in Patients With Prostate Adenocarcinoma Adverse Intermediate Risk or High Localized Risk

acronym: SHORT

summary:
The standard treatment of high-risk prostatic adenocarcinoma is based on pelvic-prostatic external radiotherapy combined with concomitant and adjunctive hormone therapy for a total of 3 years.

Prostatic stereotactic radiotherapy in 5 sessions is a therapeutic option currently delivered and described in multiple cohorts of patients with a tolerance comparable to normo-fractional treatments. This therapeutic scheme makes it possible to deliver a higher equivalent biological dose than during a treatment carried out with a conventional fractionation.

The results with a follow-up of 9 years are extremely encouraging and do not show any excess toxicity compared to other irradiation techniques. They confirm that urinary and digestive toxicities are acceptable. All these studies did not involve pelvic irradiation. Several trials have also demonstrated the feasibility of normofractionated pelvic irradiation associated with hypofractionated prostatic irradiation using an integrated boost technique.

The primary objective is to evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:To evaluate, for localized high-risk prostate cancers (unfavorable intermediate or high risk), the rate of digestive and urinary toxicity cumulated at 3 months of the association of a pelvi-prostatic irradiation contracted in 5 sessions, with:

a prostatic boost in brachytherapy with high dose rate (HDR) or
an integrated boost in stereotaxis (in case of contraindication to brachytherapy)

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Georges François Leclerc
CGFL

intervention_type: Radiation

status_simplified: Ongoing


title: Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure: Impact on Prognosis: A Monocentric Observational Before-after Study

acronym: CAREHEMA

summary:
Over the last two decades, the number of patients with hematological malignancies (HMs) admitted to the ICU increased and their mortality has dropped sharply. Patients with HMs increasingly require admission to the intensive care unit (ICU) for life-threatening events related to the malignancy and/or treatments, with immunosuppression being a major contributor. Whether the increase in ICU admissions is related to increased referrals by hematologists and/or to increased admissions by intensivists is unknown. The criteria used for ICU referral and admission decisions have not been extensively evaluated. Finally, the links between admission policies and treatment-limitation decisions are unclear, but ICUs with broad admission policies may change the treatment goals based on the response to several days of full-code management.

The aim of this study is to evaluate the impact of a systematic evaluation by an intensivist of HMs patients presenting with acute respiratory and/or hemodynamic failure.

location_facility: Intensive Care Unit - Hospital Grenoble-Alpes

location_facility: Hematologic unit - Hospital Grenoble Alpes


title: How Participants Perceive Biomedical Research in Pulmonology

summary: The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

ipd_sharing: Yes

ipd_sharing_description:
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

Data will be made available on a not-for-profit, free platform that allows access control: zenodo.

A link on osf.io/pxnhc will point towards the zenodo upload.

lead_sponsor: University Hospital, Montpellier

location_facility: CHRU Montpellier - Hôpital Arnaud de Villeneuve


type: Registry Identifier

title: Randomized Comparison of Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation Due to Leaflet Prolapse

acronym: REVERSE-MR

summary:
Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be surgically repaired in the vast majority of patients. Despite the efficacy of mitral valve repair, an ongoing international controversy exists regarding the need to perform early surgery in asymptomatic patients with severe MR and no sign of LV dysfunction in whom the probability of successful and durable repair is very high. In this group of patients, differing views of the risks of uncorrected severe MR exist: considered as benign by those supporting medical "watchful waiting" or associated with significant excess mortality/morbidity by those advocating early surgery. This controversy can only be resolved by a randomized controlled trial which is still lacking.

The main objective is to demonstrate the superiority of early mitral valve repair in patients with asymptomatic severe MR due to leaflet prolapse compared to an initial conservative management in terms of all-cause death and cardiovascular morbidity during five years follow-up.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Centre Cardiologique du Nord
CHU Amiens-Picardie

intervention_type: Procedure

appel_a_projets: PHRCN

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

type_etablissement: CH

acronyme: REVERSE-MR

titre: Comparaison randomisée entre la réparation valvulaire précoce et "l'attente armée" dans l'insuffisance mitrale sévère asymptomatique dégénérative par prolapsus

discipline_principale: cardiologie///

nom_porteur: TRIBOUILLOY

prenom_porteur: Christophe


title: Validation of the Rest Respiratory Function Monitoring of Pulmonary Transplants at Home to Anticipate Unplanned Hospitalizations

acronym: TRANSADOM

summary: Acute cellular and/or humoral rejection and early graft infections after pulmonary transplant (<2.5 years) are common and can lead to chronic dysfunction of the transplanted organ or Chronic Lung Allograft Dysfunction, CLAD. These complications increase the number of unplanned and life-threatening hospitalizations. Regular multi-weekly monitoring of respiratory function is necessary to detect these complications early and to make their management more effective and less costly. Monitoring by micro spirometers with forced expirations at home proved difficult to perform (patient and effort dependent), often poorly coordinated (transmission of data to practitioners) and not sensitive in the prediction of post-transplant complications. Aqsitania has developed an innovative analysis of resting respiratory signals. This innovative analysis is called "Anharmonic Morphological Analysis of Respiratory Signals (AMARS)". This automated analysis is based on a measurement of the respiration collected by a spirometry device communicating and allowing a remote home monitoring (Ventilotel®). We hypothesize that this Anharmonic Morphological Analysis of Respiratory Signals at rest could predict unplanned hospitalizations and allow for more reliable monitoring of pulmonary transplant patients. Inclusion visit: Explanation of the study and collection of consent, measurement of resting breath and explanation on the mode of use of the measuring device at home, clinical examination, respiratory functional exploration. Follow-up at home for 12 months with a resting breath measurement for 2 to 3 min, in the morning on waking and in the evening before bed, 2 days / week with automatic sending of data on the Aqsitania server. The first month, a visit at home can be made if the subject feels the need. At each measurement, Aqsitania transmits the data in the e-CRF, a report that gives the anonymised values of the markers and the current personal respiratory profile. In order to avoid "motivational" bias, patients will have instructions to use the device but no "coaching" call will be made during the study. Patients will have their monthly or quarterly follow-up visits, including clinical examination, respiratory functional exploration and an analysis of adverse events. No additional search-specific visits will be carried out.

collaborators:
Aqsitania SAS
AGIR à Dom

sponsor_collaborators:
University Hospital, Grenoble
Aqsitania SAS
AGIR à Dom

location_facility:
Grenoble University Hospital
Lyon University Hospital


title: Evaluation of Heterologous Fecal microbiotA Transfer in ICU Patients: a FeasibilitY and SafetY StudY

summary: ICU patient's complications are notably due to multiple infections with high risks of sepsis. Those infections would be worsened by any antibiotic resistance mechanism. Thus, reducing MDR portage in health care unit is a global strategy that will benefit for the patients and the health system organization. Fecal Microbiota transfer and restoration is a promising strategy to achieve this purpose.

lead_sponsor: MaaT Pharma

location_facility:
Salengro hospital
Bichat Hospital

intervention_type: Drug


title: MRI of Sacroiliac Joints: Evaluation of Accuracy of Dixon Sequences in the Diagnosis of Axial Spondyloarthritis

acronym: SPADIX

summary: The investigators hypothesize that the T1 Dixon post-Gadolinium and T2 Dixon sequences will show good diagnostic performances for active sacroiliitis compared to the reference test (Short tau inversion recovery) and clinical-biological criteria, which will allow a better diagnosis of active sacroiliitis

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Lapeyronie
CHU Nimes


title: Influence of Emotions on Decision-making in Parkinson's Disease

summary:
Parkinson's disease mainly affects the dopaminergic neurons of the Substancia nigra, which project on the striatum. Neuronal death within this structure leads to a decrease in dopamine levels. Dopamine is a neurotransmitter essential to the proper functioning of the basal ganglia highly involved in the control of voluntary and involuntary movements.

It also leads to cognitive and behavioral changes. Among these changes, the investigators will mainly remember the idea of the emergence of difficulties to make the right decisions, for example at the financial, medical .... This disruption would be the result of executive dysfunction. By definition, executive functions allow us to evaluate, plan and organize our actions to achieve a goal.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Saint Etienne
CHU de Grenoble Alpes


title: Secondary Prophylaxis After CMV Disease in Kidney Transplant Patients Targeted by γδ T

acronym: SPARCKLING

summary: In kidney transplant patients, CMV infection remains the leading infectious cause of morbidity and mortality. Clinical and virological relapses are common and are involved in chronic graft dysfunction. To date, it is not certain that secondary prophylaxis allows reducing these relapses, although this prophylaxis is part of the current recommendations. Our team has recently shown that the expansion of γδ T cells in peripheral blood during CMV infection was correlated with the absence of virological and clinical relapses. Indeed, the absence of relapse was associated in 94.7% of cases with the presence of γδ T cells expansion while relapses occurred in about 90% of cases in the absence of γδ T cells expansion. These results suggest that the indication and duration of secondary prophylaxis after the curative treatment of CMV infection in kidney transplantation could be guided by the immune surveillance of γδ T cells.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Edouard Herriot - Hospices Civils de Lyon


title: Controlled Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites

acronym: CICAFAST

summary:
Cell-based engineered skin substitutes are promising to treat difficult-to-heal acute and chronic wounds such as large/deep burns, ulcers resistant to conventional therapies or surgical wounds. Cultured autologous epidermal cell-based therapy is used for more than two decades as permanent wound coverage for large burns. Although this technique has been shown to improve outcomes in patients with large burn injuries, its clinical use is limited by the creation of a second wound at the donor site, the three-week delay needed to obtain sufficient amounts of cells, and the absence of a dermal component resulting in low graft take and wound contraction.

Concurrently, allogeneic cell-based engineered skin substitutes have been proposed. Where they offer off-the-shelf temporary wound coverage acting as biologically active dressings releasing growth factors, cytokines and extra cellular matrix components essential for proper wound healing, they are susceptible of immune rejection that is their major weakness Fetal skin, before the third trimester of gestational age, heals rapidly without scar formation conversely to adult skin. Minimal inflammation, specific cytokine and growth factor profiles, and faster and organized deposit and turnover of Extra Cellular Matrix (ECM) components during fetal wound healing have been proposed to explain the absence of scar formation. Because of their low immunogenicity, and their unique regeneration properties, fetal skin cells represent an attractive alternative to the commonly used autologous and allogenic cutaneous grafts.

The investigators developed a new healing dressing constituted by a collagen sponge seeded with a specific ratio of active fetal fibroblasts and keratinocytes producing a variety of wound healing growth factors and cytokines which increase the speed of wound healing, induce an immunotolerant state, with a low inflammatory reaction.

This prospective randomized controlled study aims to compare wound healing of CICAFAST versus conventional treatment (JELONET®) in the treatment of split-thickness skin graft donor site at D8. The patient will be his own control.

ReferenceCitation: Poinas A, Perrot P, Lorant J, Nerriere O, Nguyen JM, Saiagh S, Frenard C, Leduc A, Malard O, Espitalier F, Duteille F, Chiffoleau A, Vrignaud F, Khammari A, Dreno B. CICAFAST: comparison of a biological dressing composed of fetal fibroblasts and keratinocytes on a split-thickness skin graft donor site versus a traditional dressing: a randomized controlled trial. Trials. 2019 Oct 28;20(1):612. doi: 10.1186/s13063-019-3718-4.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_normalized: HAL

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

lead_sponsor: Nantes University Hospital

location_facility:
CHU de Nantes
Chu de Nantes

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

acronyme: CICAFAST

titre: Comparaison contrôlée et en double aveugle d'un pansement traditionnel versus un pansement biologique constitué de fibroblastes et kératinocytes ftaux associés à une matrice de collagène, sur sites donneurs de greffes

discipline_principale: dermatologie

nom_porteur: DRENO

prenom_porteur: Brigitte


title: Optimization of the Patient Care Pathway in Immuno-oncology

acronym: OPTIMMUNO

summary:
This study compares the care pathway of melanoma patients treated by immunotherapy in two ambulatory care structures. The aim is to measure if a care structure specialized in immuno-oncology could rationalize the care of patients.

This protocol will be based on two different follow-up during the treatment period:

dedicated and coordinated e-follow-up (IUCT-O in Toulouse)
standard follow-up (University Hospital Center in Bordeaux)

Patients will be followed from the first cycle of immunotherapy until 3 months after the initiation treatment.

lead_sponsor: Institut Claudius Regaud

location_facility:
Hôpital Saint André, CHU de Bordeaux
Institut claudius regaud IUCT ONCOPOLE


title: Prehospital High-Flow Nasal Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: A Randomized, Open-label, Bi-center, Pilot Study

summary: The purpose of the present project is to compare High-Flow Nasal Oxygen therapy with Standard Oxygen therapy, initiated in the prehospital setting in patients with acute hypoxemia respiratory failure, in terms of oxygenation at arrival to the hospital and need of mechanical ventilation during the subsequent 28 days

ReferenceCitation: Prekker ME, Feemster LC, Hough CL, Carlbom D, Crothers K, Au DH, Rea TD, Seymour CW. The epidemiology and outcome of prehospital respiratory distress. Acad Emerg Med. 2014 May;21(5):543-50. doi: 10.1111/acem.12380.

ReferenceCitation: Kelly AM, Holdgate A, Keijzers G, Klim S, Graham CA, Craig S, Kuan WS, Jones P, Lawoko C, Laribi S; AANZDEM study group. Epidemiology, prehospital care and outcomes of patients arriving by ambulance with dyspnoea: an observational study. Scand J Trauma Resusc Emerg Med. 2016 Sep 22;24(1):113. doi: 10.1186/s13049-016-0305-5.

ReferenceCitation: Stiell IG, Spaite DW, Field B, Nesbitt LP, Munkley D, Maloney J, Dreyer J, Toohey LL, Campeau T, Dagnone E, Lyver M, Wells GA; OPALS Study Group. Advanced life support for out-of-hospital respiratory distress. N Engl J Med. 2007 May 24;356(21):2156-64. doi: 10.1056/NEJMoa060334.

ReferenceCitation: Fontanari P, Burnet H, Zattara-Hartmann MC, Jammes Y. Changes in airway resistance induced by nasal inhalation of cold dry, dry, or moist air in normal individuals. J Appl Physiol (1985). 1996 Oct;81(4):1739-43. doi: 10.1152/jappl.1996.81.4.1739.

ReferenceCitation: Sim MA, Dean P, Kinsella J, Black R, Carter R, Hughes M. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia. 2008 Sep;63(9):938-40. doi: 10.1111/j.1365-2044.2008.05536.x. Epub 2008 Jun 6.

ReferenceCitation: Li J, Fink JB, Ehrmann S. High-flow nasal cannula for COVID-19 patients: low risk of bio-aerosol dispersion. Eur Respir J. 2020 May 14;55(5):2000892. doi: 10.1183/13993003.00892-2020. Print 2020 May.

ReferenceCitation: Leonard S, Strasser W, Whittle JS, Volakis LI, DeBellis RJ, Prichard R, Atwood CW Jr, Dungan GC 2nd. Reducing aerosol dispersion by high flow therapy in COVID-19: High resolution computational fluid dynamics simulations of particle behavior during high velocity nasal insufflation with a simple surgical mask. J Am Coll Emerg Physicians Open. 2020 Jun 11;1(4):578-591. doi: 10.1002/emp2.12158. eCollection 2020 Aug.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Brigade des Sapeurs Pompiers de Paris
CHR d'ORLEANS


title: Intra-laryngeal Implant for Treatment of Chronic Aspirations

summary: This study evaluates the medical device Newbreez LD is designed to protect the lower airways from saliva, liquids and food aspirations in tracheotomized patients suffering from chronic aspirations that require specific care and may lead to complications, including inhalation pneumonia.

status: Withdrawn

primary_purpose: Device Feasibility

lead_sponsor: ProTiP Medical

location_facility:
CHU Toulouse
CHU Strasbourg


title: VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.

acronym: Vire-Brachy

summary: This randomized phase III multicenter trial aims to evaluate the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain and anxiety.

collaborators: Gustave Roussy, Cancer Campus, Grand Paris

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Influence of Hyperoxia and Hypobaria on Atelectasis Occurrence and Mitigation of Atelectasis Formation

summary:
The primary aim of this project is to get further knowledge of the physiology of flight atelectasis and its prevention. We seek to: 1) assess whether low levels of positive pressure breathing can prevent atelectasis formation in humans during exposure to hyperoxia and +Gz-accelerations. 2) get further knowledge on the effects of hypobaria on regional ventilation and perfusion.

A secondary aim is to evaluate the effect of anti G-trouser inflation on ventilation and regional perfusion.

primary_purpose: Basic Science

ReferenceCitation: Dussault C, Gontier E, Verret C, Soret M, Boussuges A, Hedenstierna G, Montmerle-Borgdorff S. Hyperoxia and hypergravity are independent risk factors of atelectasis in healthy sitting humans: a pulmonary ultrasound and SPECT/CT study. J Appl Physiol (1985). 2016 Jul 1;121(1):66-77. doi: 10.1152/japplphysiol.00085.2016. Epub 2016 Apr 21.

ReferenceType: result

ReferenceCitation: Borges JB, Hedenstierna G, Bergman JS, Amato MB, Avenel J, Montmerle-Borgdorff S. First-time imaging of effects of inspired oxygen concentration on regional lung volumes and breathing pattern during hypergravity. Eur J Appl Physiol. 2015 Feb;115(2):353-63. doi: 10.1007/s00421-014-3020-9. Epub 2014 Oct 17.

publisher_dissemination: Springer

lead_sponsor: Direction Centrale du Service de Santé des Armées

collaborators:
Uppsala University Hospital
Percy Hospital

location_facility: Armed Forces Biomedical Research Institute


title: Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69

acronym: METACTIV

summary: The aim of the study is to describe an immune activation profile of people at risk of insulin resistance based on a wide range of markers which will allow easy identification of patients at risk.

location_facility: Centre d'examen de santé de la Sécurité Sociale de Nîmes


title: Evaluation of Biomarkers Combination Performance for the Diagnosis of Neonatal Sepsis in NICU Hospitalized Newborns

acronym: EMERAUDE

summary:
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments).

Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be linked to other neonatal conditions, such as prematurity and birth defects are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity.

Excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality.

The primary objective is to identify, on a cohort of 250 patients, the optimal biomarker combination with good diagnostic performance (i.e. with maximal Area Under the ROC Curve) to early exclude a LOS diagnostic in newborns of at least 7 days of life with suggestive signs.

This identification will be carried out, as a secondary objective, with a sub-group of pre-term neonates whose birth weight is less than 1500 grams. The diagnostic value of the clinical signs that are suggestive of LOS will also be determined (sensitivity, specificity, negative and positive predictive values).

Once identified, the biomarker combination is expected to reduce unjustified antibiotic use.

lead_sponsor: Hospices Civils de Lyon

location_facility:
CHU de Nantes
Hospices Civils de Lyon

intervention_type: Biological


title: Role of the Striatum and Hippocampus on Different Time Scales

acronym: e-Time

summary: Time processing is fundamental to survival and goal reaching in humans. Different time scales (seconds, minutes, and beyond) are processed through specific cognitive processes involving different neural representations. It is generally agreed that time scale in seconds-to-minutes range named "interval timing" would be anatomically linked to the striatum. Indeed, it is possible to demonstrate a deficit of interval timing processes in patients suffering from striatal damage (Huntington's disease). However, recent findings show involvement of a second brain structure, the hippocampus, in interval timing processing in the minutes range, suggesting an interaction between the striatum and hippocampus. Presumably, patients with hippocampal damage (Alzheimer's disease) would specifically show a decrease in performance for this minutes-range time scale. This study aims to provide a better understanding of the role of the striatum in the treatment of time and its interactions with other brain structures such as the hippocampus. More specifically, it is unclear whether the striatum plays a platform role that would always be involved regardless of the time scale, as suggested by the unified model of time or whether different brain structures is solicited according to the time scale, as suggested by the modular system model. In order to elucidate these issues, a potential double dissociation between brain structures and time scales will be tested.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - Hôpital Henri Mondor


title: Hypnosis: a Path to Appeasement

acronym: HYCVA

summary:
Hypnosis is a technique allowing the patient to focus his mental attention on a thought or a sensation, with the aim of reducing or modulating the intensity of a negative feeling or an ordeal encountered during the course of treatment. This tool can be used when patients are faced with chronic disorders (pain, anxiety, ...) or iatrogenic effects (nausea, asthenia, ...).

The patient is referred to hypnosis care by the doctor, psychologist or paramedics who follow him, when they detect a need.

Several scientific studies have shown the effectiveness of hypnosis in improving the quality of life of patients with breast cancer and in reducing pain during invasive procedures. On the other hand, in hematology, no research has measured the evolution of anxiety, over time, in patients receiving hypnotherapy.


title: Immune Checkpoint Inhibitors Neurotoxicity: Long-term Outcomes, Predictors, and Survival.

acronym: LOPF - NIRAES

summary:
Immune-checkpoint inhibitors (ICIs) have radically changed the therapy of cancer in recent years. ICIs promote antitumor immune response inhibiting one of the following immune checkpoints: cytotoxic T-lymphocyte antigen-4 (CTLA-4; ipilimumab), programmed death-1 (PD-1: pembrolizumab, nivolumab, and cemiplimab), and programmed death ligand-1 (PD-L1: atezolizumab, durvalumab, and avelumab). Despite the desired effect as cancer treatment, ICIs can break immune tolerance to self-antigens and induce specific toxicities known as immune-related adverse events (irAEs), that may affect both peripheral and central nervous system (Neurological immune mediated adverse events, NirAEs). The pathogenic mechanisms underlying NirAEs are probably heterogeneous, as reflected by the variety of clinical phenotypes and severity.

NirAEs are rare, but there is some concern that the incidence may increase in the next future, in particular because ICIs are being used more and more for cancers commonly associated with paraneoplastic neurological syndromes (e.g. small-cell lung cancer). Moreover, NirAEs are usually severe, and often fatal. Indeed, irAEs-related complications are the most common cause of death among these patients. On the other hand, these patients usually have a good tumor response to immunotherapy. There is some evidence that irAEs may predict ICIs efficacy and consequently NirAE surivors are likely to have longer life expectancy than non-NirAE patients.

Therefore, it is of utmost importance to better characterize the long-term outcomes of NirAE patients in terms of neurologic disability and mortality, and to identify predictors of severe NirAEs. So far, only few studies with sufficient follow-up have been published on the topic, and they included only small number of patients.

The aims of our study is to characterize the main clinical and paraclinical features of NirAEs in a large cohort of NirAE patients, to assess long-term outcomes and to identify prognostic factors. This study will help define new guidelines regarding NirAE prediction and management.

time_perspective: Retrospective

location_facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes


title: Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage

summary:
Hyponatremia is a frequent complication of subarachnoid hemorrhage (SAH) with a prevalence of 30 to 50% in patients with this condition. This hydro-electrolytic disorder is responsible for an increase in morbidity with the appearance of neurological disorders.

Also, it has been shown that there are ionic changes in the cerebrospinal fluid and a probable alteration of the blood-brain barrier in patients with SAH. The kinetics and relationship between hyponatremia and these changes remain unknown.

The main objective of the study is to determine whether the change in cerebrospinal fluid (CSF) composition, precedes the development of hyponatremia. For this, the investigators propose to study the evolution of the CSF ionogram with the blood ionogram. Furthermore, they will perform additional analyses on the basis of a control group (CSF of patient with normal pressure hydrocephalus) to determine the effect of SAH on ionic changes.

The hypothesis of the study is that there is a correlation between the change in CSF blood ionogram and the development of hyponatremia between day 0 and day 14.


title: Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure

acronym: CPAPDROWNING

summary: The purpose of this study is to assess the Non-Invasive Ventilation-Continuous Positive Airway Pressure efficacy (experimental group) for drowning related Acute Respiratory Failure compared to Oxygen Supply by face mask (15Liters/minutes) (control group).

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Lipid Characterisation of Plasma Microparticles in a Large Population of Healthy Donors

acronym: MicroLipids

summary:
Extracellular vesicles (EVs) are membrane structures containing numerous mediators categorised according to their size and mode of production. Among them, microparticles (MPs) are EVs between 100 nm and 1 μm in size that are produced by budding at the plasma membrane of different cell types following different mechanisms of cell activation or death. MPs include a large pool of bioactive molecules, such as lipids, proteins or nucleic acids. This makes them important mediators of intercellular communication, increasingly recognised for their role in various biological processes such as inflammation, coagulation, immune response and tumour progression. Their ability to transmit molecular signals between cells may have implications for disease pathogenesis and cellular interactions in pathological microenvironments. These MPs therefore appear to be an innovative biomarker, potentially useful in the early management of disease, both in terms of diagnosis and as a therapeutic target.

The main techniques used to analyse these MPs include flow cytometry, which enables surface markers to be quantified and determined, and electron microscopy, which provides a direct view of their morphology and structure. Molecular biology, such as the quantitative PCR technique, is also an approach used by several teams, notably to search for RNA or DNA fragments involved in various biological processes. However, few studies have focused on the lipid composition of these MPs. Since MPs are membrane vesicles, they are a major lipid reservoir. In addition, lipids represent a significant population of molecules with extensive properties, whether in inflammation, cell proliferation, energy metabolism, etc.

The aim of this project is to develop a reliable and robust method for analysing plasma MP concentration, phenotype and lipid composition in a population of healthy volunteers. These parameters will subsequently provide a comparator for studying MPs in populations of patients suffering from cardiovascular and/or inflammatory diseases.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Hearing and Cognition in Aging Adults

acronym: ACAV

summary: This cohort study is expected to provide valuable insights into the complex interplay between auditory and cognitive functions and how they change over time. The results of this study will have important implications for the prevention, diagnosis, and treatment of age-related hearing and cognitive disorders

lead_sponsor: University Hospital, Toulouse


title: Evaluation of Physiological Effects of Noninvasive Mechanical Ventilation and High-flow Oxygen Therapy for Acute Exacerbations of Interstitial Lung Diseases

acronym: IRAPIDPhysio

summary: The objectives of this study are to compare the physiological consequences of high-flow oxygen therapy and noninvasive mechanical ventilation on ventilation, respiratory work and hemodynamics during acute respiratory failure in diffuse interstitial pneumonia.

lead_sponsor: ADIR Association


title: Physical Activity and Fibrosing Interstitial Lung Disease

acronym: AP-PID

summary: Fibrotic interstitial lungs diseases (ILD) are a group of chronic and rare diseases characterized by an altered blood oxygenation in the lung, leading to dyspnea and physical limitation. Physical training is efficient to fight vicious circle of physical deconditioning observed in ILD. Eccentric cycling is an interesting modality of endurance training, allowing better exercise tolerance and adherence while developing cardiorespiratory function. Feasibility and efficacity of eccentric cycling were shown in chronic obstructive pulmonary disease but never in ILD. The primary aim of our work is to compare concentric and eccentric cycling training on physical capacities in ILD. Moreover, we will study the effects of training on the different steps of oxygen transport at exercise, from the lung to the muscles through the blood transport. Our second goal is then to characterize the physiological mechanisms underlying the benefits of exercising in ILD patients. Evaluations will be led during one year to study the long-term effects of training


title: Longitudinal Evaluation of Leucoaraiosis Using Multimodal MRI With Fingerprinting Technique

acronym: LEUKOPRINT

summary:
Leukoaraiosis (LA) corresponds to an alteration of the encephalic white matter, linked to chronic hypoxia. Its pathophysiology, which has been partially elucidated, is underpinned by chronic changes in the walls of small-caliber perforating arteries, leading to chronic hypoperfusion of the white matter, associated with dysfunction of the blood-brain barrier. In affected areas, this process leads to myelin rarefaction, axonal loss, perivascular alterations and the appearance of cavitation zones. Its existence is mainly linked to the presence of vascular risk factors, most notably arterial hypertension.

MR fingerprinting is an innovative Magnetic resonance Imaging (MRI) technique allowing to obtain a multiparametric MRI sequence in a non-invasively way and in a single acquisition, generating not only multiple contrasts, but also absolute longitudinal relaxation time (T1) and transverse relaxation time (T2) mappings (T1 and T2 mapping). However, the prognostic role of these T2 values, in terms of ischemic, hemorrhagic and cognitive risk, has never been studied. The objective of this study is to study and compare changes in T1 and T2 values of White Matter Hyperintensities (WMH) and Normal Appearing White Matter (NAWM) in subjects with LA.

time_perspective: Other

lead_sponsor: Lille Catholic University

sponsor_collaborators:
Lille Catholic University
University Hospital, Lille

location_facility: Grupement des Hôpitaux de l'Institut Catholique de Lille


title: The Impact of Pericardial Closure on the Grafts, in the Context of Coronary Artery Bypass Grafting

summary:
Once the pericardium is closed, there is no information on the hemodynamics of the grafts after coronary artery bypass grafting. This would be the reason for different opinions on pericardial closure: some teams do not close the pericardium and others close it.

In the department Cardiovascular Surgery of the University Hospital of Saint-Etienne, the Medistim machine is used in routine and the hemodynamic properties of the grafts are recorded immediately after the bypass surgery, before the closure of the pericardium.


title: Evaluation of the Analgesic Effect of Transcranial Direct Current Stimulation (tDCS) for Sedated Patients in Intensive Care Unit.Randomized, Placebo-controlled, Double-blind Study.

acronym: REASTIM

summary:
Pain management for sedated ICU patients is complex, partly because of the difficulty of assessing pain in non-communicative patients, and partly because of the side effects associated with excessive use of morphine.

In this context, the use of another non-pharmacological approach, transcranial direct current stimulation (tDCS), could be of interest. With tDCS, neuronal activity is modulated by inducing a weak electric current through the cerebral cortex between two electrodes applied to the surface of the scalp. Although the mechanisms of action of tDCS are not yet fully understood, the medium-term effects are thought to be linked to the activation of N-methyl-D-aspartate receptors, glutamate-activated receptors involved in cellular memory. The use of tDCS as an analgesic therapy for chronic pain has produced encouraging results in patients suffering from fibromyalgia, migraine and central pain following spinal cord injury, Its use in sedated intensive care patients is unknown. To assess the possible analgesic effect of tDCS in these patients, we will use quantitative pupillometry, a technique already used in routine intensive care, to quantify nociception during a standardized nociceptive simulation.

ReferenceCitation: Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

ReferenceCitation: Pinto CB, Teixeira Costa B, Duarte D, Fregni F. Transcranial Direct Current Stimulation as a Therapeutic Tool for Chronic Pain. J ECT. 2018 Sep;34(3):e36-e50. doi: 10.1097/YCT.0000000000000518.

ReferenceCitation: Payen JF, Bru O, Bosson JL, Lagrasta A, Novel E, Deschaux I, Lavagne P, Jacquot C. Assessing pain in critically ill sedated patients by using a behavioral pain scale. Crit Care Med. 2001 Dec;29(12):2258-63. doi: 10.1097/00003246-200112000-00004.

lead_sponsor: University Hospital, Grenoble


title: Validation du Questionnaire d'Evaluation de la Perception de l'Activité Physique (EPAP) adapté à la Lombalgie Chronique

acronym: EPAP-LOMB

summary:
Physical exercise has a fundamental position in the chronic low back pain treatment. However, the physical activity level is often low in these patients and the adherence to the care program is not enough in the long term. The French Evaluation of the Perception of Physical Activity (EPPA) is a valid and reliable questionnaire, developed by N. Coste et al in 2020, that assesses the perceived barriers to and facilitators of physical activity in patients with knee osteoarthritis. To our knowledge, there is no valid and reliable instrument allowing such an assessment in chronic low back pain.

The main objective of this study is to adapt the EPPA to chronic low back pain and to evaluate its psychometric properties.

This validation would allow its use in current practice to adapt the care strategy, to personalize rehabilitation of each patient with chronic low back pain in order to have a better adherence to rehabilitation programs.

ReferenceCitation: Oliveira CB, Maher CG, Pinto RZ, Traeger AC, Lin CC, Chenot JF, van Tulder M, Koes BW. Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview. Eur Spine J. 2018 Nov;27(11):2791-2803. doi: 10.1007/s00586-018-5673-2. Epub 2018 Jul 3.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

unpaywall_oa_status: hybrid

ReferenceCitation: Bailly F, Trouvin AP, Bercier S, Dadoun S, Deneuville JP, Faguer R, Fassier JB, Koleck M, Lassalle L, Le Vraux T, Liesse B, Petitprez K, Ramond-Roquin A, Renard JF, Roren A, et al. Recommandations et arbre décisionnel sur la prise en charge de la lombalgie avec ou sans radiculalgie. Revue du Rhumatisme. 2022 ; 89 : 345-353.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Centre de Rééducation Fonctionnelle de Notre-Dame, Chamalières


title: Exercise-snacks: an Effective Strategy to Break Sitting Time and Improve Cardiometbaolic Health in Sedentary Overweight Office Workers

summary: The main objective is to measure the effects of intense brief exercise program in the workplace of administrative staff on the cardio-metabolic health

lead_sponsor: University of Avignon


title: "Contribution of Metagenomic Analysis of Faecal Microbiota Combined With Artificial Intelligence for the Prediction of Colorectal Cancer Risk; Study in Patients Scheduled for Colonoscopy".

summary: Colorectal cancer (CRC) is the second most common type of cancer worldwide. The European Union recommends national CRC screening for people aged between 50 and 74. Generally, an immunological test called FIT (Fecal Immunochemical Test), based on the quantitative detection of human haemoglobin, is performed on a stool sample. If the haemoglobin level is above the recommended threshold, a colonoscopy is recommended to detect colorectal lesions. Recent studies have identified potential microbiota signatures associated with colon cancer. In this study, we will analyze the microbiota of a population aged 50 to 75 years undergoing colonoscopy as part of routine care in order to confirm the presence of microbiota signatures associated with the presence of adenomas, advanced adenomas and CRC.

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

location_facility: Hopital Avicenne, Centre de Recherche sur Volontaire


title: Diagnostic Performances Assessment of Dynamic 99mTc- Tetrofosmin CZT-SPECT Myocardial Perfusion Imaging in Comparison With Invasive Intra-coronary Fractional Flow Reserve Measurement in Patients With Significant Residual Coronary Artery Stenosis After ST-elevation Myocardial Infarction : Dyna-MI Pilot Study.

acronym: Dyna-MI

summary: Dynamic 99mTc-Tetrofosmin CZT-SPECT myocardial perfusion imaging (MPI) is an advanced functional imaging technique giving important myocardial flow quantification added data in comparison with conventional MPI, especially in coronary multi vessel disease. A large-scale validation of diagnostic performances of myocardial flow reserve (MFR) estimated with Dynamic 99mTc-Tetrofosmin CZT-SPECT MPI would allow a non-invasive approach instead of invasive intra-coronary fractional flow reserve (FFR) measurement. The aim of this prospective study is to assess diagnostic performances of MFR calculated with dynamic 99mTc-Tetrofosmin CZT-SPECT MPI in comparison with invasive intra-coronary FFR measurement in patients with significant residual coronary arteries stenosis after ST-elevation myocardial infarction.


title: Post-emergency Management of Patients With Transient Ischemic Attack

summary:
A transient ischemic attack (TIA) is a momentary neurological dysfunction due to a brief cessation of blood flow to a region of the brain, resulting in typical signs of stroke (hemiplegia, aphasia, dysarthria), but whose clinical symptoms typically last less than an hour, with no visible lesion on imaging. This diagnosis remains difficult and is essentially based on the clinical judgment of the physician.

Because a TIA can be a "pre-alarm" for stroke in 20-30% of cases, it needs to be treated appropriately and as early as possible in the emergency department. Stroke rates after untreated TIA are 5% within 48 hours, 10% within one month and 20% within one year. This risk is calculated using the ABCD² score which is based on the patient's risk factors and the clinical manifestations of TIA. Patients with a score ≥ 3 should be hospitalized as soon as possible for a complete medical evaluation. However, this score has not been scientifically validated, and several specialists agree that all TIAs should be evaluated immediately. Preventing stroke is a major public health issue because it is a serious, disabling and sometimes fatal disease. Given the seriousness of the progression from TIA to stroke, the French National Authority for Health has issued a series of management recommendations. However, in practice, these guidelines remain complicated to follow and patients management may vary and be more or less effective.

Therefore, the aim of this study is to highlight the differences in how inpatients and outpatients are managed. Following these observations, solutions will be sought to make the care and management of these patients more efficient and more in line with recommendations.

lead_sponsor: Centre Hospitalier Henri Duffaut - Avignon


title: Cardiovascular Complications of Ibrutinib Therapy: a Single-center Cohort Study

acronym: CACIS

summary:
Ibrutinib, the first BTK inhibitor (BTKI) to be approved, improves progression-free survival (PFS) and overall survival (OS) over alternative therapies in relapsed/refractory and treatment-naive chronic lymphocytic leukemia (CLL). Ibrutinib has also been found to be effective in mantle cell lymphoma, Waldenström's macroglobulinemia and marginal zone lymphoma. However, ibrutinib treatment is associated with an increased risk of atrial fibrillation (AF), with an estimated 2-year AF rate of 16% in patients treated with ibrutinib during a median follow-up of 28 months. In most studies, AF was identified by reports as a treatment-related adverse event, and systematic screening for AF was not performed. As AF is often paroxysmal, the more intensive the screening, the higher the incidence. In a prospective cohort study of 53 patients treated with ibrutinib for CLL, patients were monitored by pulse palpation and ECG every 3 months. The cumulative incidence rate of ibrutinib-associated AF was 23% at 12 months and 38% at 2 years. The management of ibrutinib-associated AF is challenging due to difficulties in balancing the benefits of anticoagulation to mitigate the risk of stroke and the bleeding risk associated with ibrutinib. AF is a frequent reason for discontinuation of ibrutinib therapy, and can result in significant morbidity.

In addition to this arrhythmogenic effect, ibrutinib is also significantly associated with the onset or worsening of arterial hypertension. Finally, an increased risk of serious ventricular rhythm disorders has also been suggested by pharmacovigilance databases, but not yet confirmed by prospective clinical studies.

The study proposes a comprehensive cardiovascular approach, at baseline and during follow-up of patients on Ibrutinib, using innovative markers to anticipate patients most at risk of developing these cardiovascular effects, but also to detect them as early as possible in order to avoid the complications they may generate.


title: Identifying Imaging Biomarkers Predictive of Disability Progression in Alzheimer's Disease: Pilot Study

summary:
The pathophysiology of AD is complex. In addition to amyloid plaques and neurofibrillary degeneration, there is a metabolic alteration of the energy pathways, oxidative phosphorylation and glycolysis, which are involved in brain function. Several authors have shown a series of early metabolic dysregulations via an increase in phosphorylation at the origin of neuronal death.

Ultra-high field imaging (7T MRI) may allow, with its better spatial resolution and advanced imaging techniques, to shed light on the mechanisms of progression of Alzheimer's disease. A Magnetic Resonance Spectroscopy (MRS) examination can be coupled to brain MRI without additional risk for the patient. Multinuclear 1H-31P metabolic imaging is a promising tool that can provide information on the metabolic evolutionary profile of AD. Thus, we propose a longitudinal study in patients with early-stage AD on 7T MRI-MRS.

lead_sponsor: Poitiers University Hospital


title: In Silico and in Vitro Targeting of Healthy Gut Bacteria With Fiber Degrading Metabolic Potential

acronym: iTARGET

summary: The role of the intestinal microbiota on health is now well recognised, and diet is one of the factors influencing the maintenance of a healthy intestinal microbiota. More specifically, the consumption of fruit, vegetables and cereals is associated with good health and, in particular, with an increase in the relative abundance of bacterial groups described as beneficial. To date, a large number of bacterial species in the intestinal microbiota have yet to be isolated and cultivated, which limits the characterisation of their potential health benefits. In order to isolate and cultivate these intestinal bacteria, it is particularly relevant to recruit individuals with a high-fibre diet.

ipd_sharing_description: No sharing planned

sponsor_collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement


title: Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus in a Hospital Internal Medicine Consultation

acronym: LES-HYDROXY

summary:
The project focuses on non-compliance in patients with systemic lupus erythematosus taking Plaquenil. More than half of patients with chronic illness are not or only poorly compliant with their treatment and lupus is one of them.

The investigators want to use an already validated existing questionnaire in English, the Morisky Medication Adherence Scale 8 (MMAS 8). These results will make it possible, after a multivariate study with reference to the gold standard which is hydroxychloroquinemia, to see which exact questions in the questionnaire can be used in general medicine practices in order to detect less or non-compliant patients as early as possible.


title: Modulation of Auditory Externalization Abilities by Transcranial Stimulation of the Brain Area Specifically Involved

acronym: STUPEFIX

summary: The distinction between self-generated and external information is impaired in patients with schizophrenia, who are assumed to confuse imagination with real perceptions. To better understand the underlying mechanisms of these abnormalities, the investigator will investigate the brain mechanisms supporting auditory externalization. Auditory externalization is the ability to perceive whether a sound comes from inside or outside oneself. Our study, in healthy participants, will use functional brain imaging to identify the brain areas involved in the externalization of sound sources and to test whether neuromodulation of this area can modify this ability and provide a therapeutic lead in pathological populations

ipd_sharing: Undecided

lead_sponsor: Hôpital le Vinatier


title: Collection of Prospective Biological Samples for Biological Analysis in Current Clinical Practice

summary:
The increase in activity within medical biology laboratories linked to the arrival of new markers (in cardiology, oncology, infectious diseases, etc.) and the acceleration of technical progress have created a prominent place for automated systems and their reagent kits within these establishments.

It is in this context that CerbaXpert took the initiative to set up this research project for the collection of prospective biological samples and their analysis. It transcribes both a process of continuous improvement but also scientific development, making it possible to provide new and/or complementary data in order to improve the operation of automated systems and their reagents within medical biology laboratories. These data obtained in current practice via this study will also be compared with the technical information provided by the manufacturers of the reagents and their automatic devices.

lead_sponsor: CerbaXpert


title: Evaluation of the Physiological Stability Variability and Robustness of NIS4,a Serum Biomarker for the Diagnosis of Non-alcoholic Steaohepatitis

summary: Patients at higher risk of progression to cirrhosis and clinical deleterious outcomes are those that have a high grade of necroinflammation together with significant fibrosis. This defines a level of disease severity which is called "at-risk NASH". Currently registrational trials for NASH include only patients with at-risk NASH so it is predictable that when a drug will be approved for NASH it will be in patients with at-risk NASH. It is therefore important to be able to diagnose non-invasively patients with at-risk NASH. Also, the use of NIS4 in clinical trials or in the clinic has the potential to significantly reduce unnecessary liver biopsies by identifying patients with a lower risk of disease progression. GENFIT, a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, is developing an in vitro diagnostic test for at-risk NASH. The test is calledNIS4™ and integrates four independent biomarkers - miR-34a-5p, A2M, YKL-40 and HbA1c. The output is a score from 0 to 1 with threshold values that identify patients at low risk and high risk of at-risk NASH with intermediate values representing indeterminate results. The objective of the program is to complete the development of the predictive and usable NIS4 score and to evaluate the impact of fasting or not fasting on the physiological stability, variability and robustness of circulating biomarkers for the diagnosis of non-alcoholic steatohepatitis over a 30-day period.


title: Intestinal Microbiota Profiling in HAA Patients

acronym: HepatAlc-IM

summary:
In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial growth and ultimately bacterial translocation. The microbiota of a patient with alcoholic hepatitis is different from that of a patient without alcoholic hepatitis. Acute alcoholic hepatitis has a severe prognosis and corticosteroids are the only first line therapy option, with better survival at 28 days versus placebo. However, mortality remains high at 30% at 3 months, which highlights the importance of seeking intestinal microbiota profile on treatment response.

The determination of one or more intestinal microbiota signatures associated with the treatment response Corticosteroids plus FMT or Corticosteroids plus placebo will allow the clinician to have a simple and rapid test obtained in 16S RNA analysis to predict the therapeutic response and potentially the best treatment to adopt and to address medical and medico-economic stakes.

The investigators will first characterize the alcohol-induced dysbiosis by a whole microbiota sequencing in the different groups. Specific bacterial species identify by DNA sequencing should be confirmed by qPCR of 16S rDNA to determine a fingerprint of sAH microbiota. Metabolic properties of intestinal microbiota, such as production of short chain fatty acids, will be analyzed by using HPLC. In the sAH group, evolution of intestinal microbiota will be observed by shotgun DNA sequencing between the day 0 and the day 7 of corticosteroids treatment.

The analysis of sAH patients' microbiota (day 0) will allow us to obtain a non-responder profile to corticosteroids that can be used as a prognostic marker to use in the clinic. The deliverable is the bacterial fingerprint of the treatment response and its valuation is its use as a predictive tool of the response.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results

acronym: BIOMAKA

summary:
The mechanical alignment technique (Mechanical Alignment - MA) of a total knee prosthesis (TKA) was developed with the aim of making the installation of a TKA simple and reproducible, and that the prosthetic biomechanics are acceptable, thus promoting good longevity of implants. This is a technique that does not aim to restore the constitutional anatomy of the knee; bone cuts are systematically made at fixed angles, in the 3 planes of space, in relation to the mechanical axes of the long bones (femur and tibia). This non-personalized implantation technique therefore systematically alters the anatomy, laxity and kinematics of the knee, causing up to 50% of residual symptoms after prosthetic implantation and 20% of dissatisfied patients.

In order to improve the clinical results of TKA, a new, more personalized and physiological technique was developed in 2007, called Kinematic Alignment (KA). This technique aims to restore the pre-arthritic anatomy, unique to each knee. Patients with severe constitutional deformity of the lower limb therefore retain this deformity after kinematic prosthetic replacement. The impact of the alignment technique on the biomechanics of the prosthetic knee remains poorly described. The main objective of this study is therefore to compare knee biomechanics between mechanical TKA and kinematic TKA.

lead_sponsor: Clinique du Sport, Bordeaux Mérignac


title: Verticalization Criteria for Pelvic Ring Tumor Lesions Treated by Percutaneous Screw Fixation and Cementoplasty: A Retrospective Multicentric Study

summary: Evaluate early functional outcomes following percutaneous screw fixation or cementoplasty for pelvic ring tumor lesions.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Rehabilitation by Multifactorial Approach After a Latarjet Procedure : Prospective Single-center Randomized Study (MATASI-L)

acronym: MATASI-L

summary: Kinesiophobia (fear of physical movement) is common after a previous shoulder dislocation and persists after one year, regardless of the occurrence of a recurrence. This kinesiophobia is associated with a lower level of physical activity and a lower return to sport. Increased kinesiophobia, combined with other psychological factors such as depression and fear of re-injury in patients with shoulder instability, results in poor outcomes after treatment. Given that there is currently no postoperative protocol that takes this psychological component into account, a new rehabilitation protocol focused on reducing kinesiophobia was recently designed as part of an international consensus study based on the method Delphi. This protocol includes a core set of evidence-based interventions aimed at regaining functional stability of the shoulder and reducing fear of recurrent dislocation and kinesiophobia. The goal of this study is to determine if we can reduce kinesiophobia in patients who have undergone stabilization surgery for anterior shoulder instability using this new rehabilitation protocol.

lead_sponsor: Clinique Générale dAnnecy


title: A Double-blind, Randomized, Phase III Study of Radiotherapy Combined With cetuXimab + Xevinapant Compared to Radiotherapy Combined With Cetuximab (Standard of Care) + Placebo in Patients With LA SCCHN, Unfit for High-dose Cisplatin

summary: Xevinapant is an antagonist of inhibitor of apoptosis proteins (IAPs) that has been shown both chemo-, radiosensitizing, and immunomodulatory activities in nonclinical in vitro and in vivo squamous cell carcinoma of the head and neck (SCCHN) models. In previously untreated patients with non-resected locally advanced SCCHN, the addition of xevinapant recently showed a significant improvement of progression-free survival (PFS), overall survival (OS) and loco-regional control at 3 years after completing treatment. Thus, the purpose of this Phase III study is to demonstrate the superior efficacy to the xevinapant when it is administered in combination with radiotherapy (RT)+cetuximab compared to radiotherapy+cetuximab (SoC) + placebo in previously untreated participants with LA-SCCHN, ineligible for high-dose cisplatin defined as ≥ 200 mg/m² (projective total cumulative dose) throughout the course of the radiotherapy.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou


title: Retrospective Study on the Evaluation of the Impact of Augmented Reality Usage in Gynecological Laparoscopy on Patients Operated Between 2017 and 2021

acronym: ImpactRA

summary: ImpactRA is an observational retrospective study. The management of the patient is not modified by this study. This study will be carried out based on the already existing data of the gynecological ward of CHU Clermont-Ferrand between 2016 and 2021. During this period of time, 17 patients have undergone laparoscopy, with surgical indication of myomectomy or adenomyomectomy, aided by augmented reality (AR). The investigators compared these 17 patients that underwent surgery with AR with 17 control patients that underwent the same surgery with the same indication but without AR.

status: Active, not recruiting


acronym: CERTIFY

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
Recurrent implantation failure (RIF), defined as the absence of clinical pregnancy after the transfer of three good-quality embryos, concerns up to 40% of IVF couples and is associated with a low success rate. The causes remain unexplained in over 50% of cases.

Various dysimmune changes (related to immune T cells profiles, pro-inflammatory cytokines levels) have been described in unexplained RIF as compared to fertile controls, and it has been estimated that such dysimmunity may occur in 50% of unexplained RIFs. Previous data on a benefit of general immune modulation by steroids or immunoglobulins are heterogenous and failed to demonstrate clinically significant benefit. The proinflammatory cytokine Tumor Necrosis Factor (TNF) α participates in the regulation of the immune balance of the endometrium, its peripheral blood and endometrial concentrations are increased in RIF patients as compared to fertile controls. In 2009, a pilot placebo controlled study showed that TNF-α antagonist treatment allowed a 56% live birth rate (versus 13% in controls) in 13 women with unexplained RIF. Due to the lack of maternal and fetal tolerance data, TNF-α antagonists were not further evaluated. Today, safety data issued from 1200 pregnancies are reassuring allowing the use of TNF-α antagonists during pregnancy (www.lecrat.org). In addition the TNF-α antagonist certolizumab does not cross the placental barrier.

We hypothesize that certolizumab may improve clinical pregnancy rates in women with unexplained RIF with a good safety profile.

title: Efficacy of Certolizumab in Women With Unexplained Recurrent Implantation Failure: a Double-blind Randomized Controlled Trial

type: EudraCT Number

source: euctr

ipd_sharing_description:
The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery

summary:
The sternotomy has some influence on the respiratory system after cardiac surgery, considerably increasing the risk of perioperative and postoperative breathing.

There is respiratory preparation before cardiac surgery using local physiotherapeutic guidelines.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Early Standing in Children and Adolescent Operated on for Idiopathic Scoliosis

acronym: LevPOS

summary: The implementation of an enhanced rehabilitation after surgery (ERAS) program in major orthopedic surgery and in scoliosis surgery in children and adolescents has become a marker of good practice. Investigators are already applying anesthetic, surgical, peri-operative medicine and rehabilitation techniques allowing accelerated and improved rehabilitation for scoliosis operated patients in the establishment. To improve patient care, the Investigators want to develop the ERAS program. The objective of this research will be to validate the feasibility of getting up early on D0 in post-anesthesia care unit (PACU) or ICU in children who have just had surgery for idiopathic scoliosis.

lead_sponsor: University Hospital, Toulouse


title: Monalizumab and MEDI5752 in Patients With MSI and/or dMMR Metastatic Cancer

acronym: MONAMI

summary:
MSI is a molecular indicator of defective DNA mismatch repair (dMMR). The MSI/dMMR status is observed in all tumor types, representing notably 5% of metastatic colorectal cancers (mCRC), 25% of advanced endometrial cancer and 8% of metastatic gastric cancer.

MSI/dMMR cancers are highly immunogenic. MSI/dMMR tumors are characterized by a high tumor mutational burden with highly immunogenic neoantigens. These tumors are associated with an upregulation of immune checkpoints (PD1, PDL1, CTLA4, etc.) that protects MSI cancer cells from their hostile immune micro-environment, characterized by a high infiltration of activated cytotoxic T CD8+ and NK lymphocytes. Consequently, MSI/dMMR cancers are highly sensitive to ICIs, whatever the tumor location. MSI/dMMR status is a predictive biomarker for the efficacy of immunotherapy, regardless of the tumor type. Then, by several phase II and III studies The efficacy of immunotherapy has been demonstrated as front-line treatment for patients with chemotherapy-naive MSI/dMMR mCRC and gastric cancer. The phase III KEYNOTE-177 trial evaluating first-line treatment of pembrolizumab in patients with MSI/dMMR mCRC demonstrated its superiority over first-line chemotherapy, with a significant improvement of health-related quality of life. At final analysis, the median follow-up was 44.5 months. Median PFS was 16.5 versus 8.2 months (HR = 0.59; 95%CI 0.45-0.79). The hazard ratio favored pembrolizumab versus chemotherapy with a trend toward reduction in the risk of death (HR 0.74; 95% CI, 0.53-1.03; P=0.0359), despite a 60% effective crossover rate. Pembrolizumab has been approved by the FDA and the EMA for patients with newly diagnosed MSI/dMMR mCRC and is now the standard of care for this population. Also, the phase III CHECKMATE-649 trial reveal that the Combination of immunotherapy and cytotoxic chemotherapy is the new standard of care for patients with newly diagnosed metastatic oesogastric cancer. Importantly, results of the CHECKMATE-649 are outstanding for the subgroup population of MSI/dMMR gastric cancer patients (N = 44). Indeed, the unstratified hazard ratio for OS with nivolumab plus chemotherapy versus chemotherapy alone was 0.33 (95% CI 0.12-0.87) for patients with MSI/dMMR tumors. All in all, ICIs are the standard of care in first-line setting for patients with mCRC or metastatic oesogastric cancer. Besides, several phase II studies suggest that ICI combinations might overcome primary resistance to anti-PD1 monotherapy These data justify the development of bispecific monoclonal antibodies targeting both PD1 and CTLA4 such as MEDI5752. MEDI5752 has been developed based on the observation that there is a higher expression of PD-1/CTLA-4 on tumor resident versus peripheral T cells. Preclinical data show MEDI5752 fully suppresses PD-1 and preferentially inhibits CTLA-4 in the tumor versus the periphery, which is meant to uncouple CTLA-4 dependant peripheral toxicity from antitumor activity Natural killer cells are integral to the functioning of the innate immune system and play an important role in innate antitumor immunity. There is a growing body of evidence for targeting the NKG2A/HLA-E axis in combination with other ICIs to sensitize tumors to ICI therapy. NKG2A recognizes the non-classical HLA class I molecule HLA-E. The NKG2A receptor is found on peripheral NK cells and subsets of T cells in cancer patients. It is also present in tumor-infiltrating NK and cytotoxic T cells. Importantly, NK cells and the NKG2A/HLA-E axis play a crucial role in MSI/dMMR tumors. Therefore, a combined blockade of non-redundant checkpoint pathways to unleash NK and T cells seems particularly promising for MSI/dMMR neoplasms. Monalizumab specifically binds and blocks the inhibitory receptor NKG2A. Monalizumab has been investigated in combination with ibrutinib (in chronic lymphoid leukemia), cetuximab +/- durvalumab (in squamous cell carcinoma of the head and neck, and in solid tumors), durvalumab +/- FOLFOX (in solid tumors). In the first-in-human dose escalation of monalizumab plus durvalumab, a manageable toxicity profile was shown.

Taken together, these data provide a strong rational to combine an inhibitor of the NKG2A/HLA-E axis with a bispecific monoclonal antibody targeting both PD1 and CTLA4 for patients with metastatic MSI/dMMR cancers.

location_facility: Department of medical oncology - Saint-Antoine Hospital


title: Development of New Diagnostic Tools in Capsule Endoscopy

acronym: NOCE

summary: Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.

location_facility: Centre d'Endoscopie Digestive Hôpital Saint-Antoine


title: Luteal Phase Support With GnRH Agonist Alone After GnRH Agonist Triggering and Fresh Embryo Transfer Compared to the Reference Protocol (hCG Triggering and Progesterone Luteal Support): a Randomised Controlled Trial

acronym: SOLOAGO

summary: The development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox. It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal insufficiency) and a risk factor for complications such as ovarian hyperstimulation syndrome (OHSS).


title: Efficacy of Ginger and Lemon Essential Oil Inhalation on Chemotherapy-induced Nausea and Vomiting in Patients With Haematological Malignancies: a Multicenter, Double-blind, Randomised Controlled Trial

acronym: AROM-HEMATO

summary: This project will optimise the management of chemotherapy-induced nausea and vomiting, with improvements in nausea and vomiting scores, quality of life and appetite expected in participants benefiting from the intervention. In all cases, the use of complementary methods is recommended and improves the management of people with cancer because they offer a person-centred approach.

lead_sponsor: University Hospital, Limoges

intervention_type: Combination Product


title: A Phase I/II Study to Evaluate the Safety Clinical and Biological Activity of a Humanized Monoclonal Antibody Targeting Netrin-1 (NP137) in Combination With Standard AZACITIDINE+ VENETOCLAX in Patients With Refractory Acute Myeloid Leukemia

acronym: AML-NET

summary: The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with Azacitidine and Venetoclax in patients with refractory acute myeloid leukemia after 2 cycles of Azacitidine and Venetoclax.

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
NETRIS Pharma


title: National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan

acronym: ISACC

summary:
Heart failure in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, 3.

There are no specific recommendations for the management of heart failure in adults with congenital heart disease, whose management is based on "general cardiology" recommendations4,5.

Sacubitril/Valsartan is validated as a treatment for heart failure in adults with acquired pathological left ventricular dysfunction (left ventricular ejection fraction (LVEF) < 40%, New York Heart Association (NYHA) functional class II and III despite optimal heart failure therapy)7. Although this molecule is used in current practice in patients with congenital heart disease, published data are limited 6-10.

The aim of our work is to describe the efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on VDS and VU through an observational, prospective, multicenter registry.

The latest heart failure treatment guidelines, updated in 202111, recommend the addition of type 2 sodium-glucose co-transport inhibitors in heart failure patients with impaired ejection fraction (class IA recommendation). Two molecules are used in current practice: dapagliflozin and empagliflozin, at a single dosage of 10 mg/day.

We will also be collecting data on the efficacy and safety of iSGLT2. It should be noted that, for practical reasons, there may be a delay between the end of the 1st study period (ISACC1) of one year and the start of the 2nd study period (ISACC2).

Follow-up examinations carried out during the study period will not differ from those currently recommended in current practice5.

lead_sponsor: University Hospital, Grenoble


title: Pain Assessment and Transcranial Magnetic Stimulation Tolerability in Patients With a Functional Neurological Disorder

summary: Functional neurological disorders (FND) are motor, sensory or cognitive symptoms without an identified lesion. This is a very common reason for consultation in neurology. Transcranial magnetic stimulation (TMS) may be performed in these patients both for diagnostic purposes (in the context of motor evoked potentials) and for therapeutic purposes. The main objective of the study is to evaluate tolerability of TMS in patients with FND, in particular the pain caused by stimulation and the possible modification of painful or non-painful symptoms generated by this TMS. The secondary objectives are to assess chronic pain symptoms of these patients quantitatively and qualitatively, to assess expectations of these patients with regard to the performed examinations and to assess their expectations regarding magnetic stimulation performed for therapeutic purposes.

lead_sponsor: Explorations Fonctionnelles Avicenne


title: Stimulate One Hand to Improve Tactile Perception on the Other

acronym: HAND-HAND

summary: The study is a comparative study, to show that the administration of RSS stimulation on one hand compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the other hand in patients with tactile acuity impairment of the hand due to stroke.

lead_sponsor: Hospices Civils de Lyon

location_facility: Groupement Hospitalier du Sud - Hôpital Henry Gabrielle


title: Clinical and Radiological Outcomes of Medacta Shoulder System

summary: This is a post-marketing surveillance on Medacta Shoulder System

lead_sponsor: Medacta International SA


title: Efficacy of RGn600 in Patients With Mild-to-moderate Alzheimer's Disease: a Pivotal, Sham-controlled, Randomized, Double-blind, Multicentric Investigation (LIGHT4LIFE)

summary:
This is a controlled investigation, with randomization of the patients, which aims at demonstrating the efficacy of device RGn600 in treating patients with mild-to-moderate Alzheimer's disease (AD). RGn600 is a non-invasive medical device which is applied on the head (helmet) and on the abdomen (abdominal belt). It combines 2 technologies:

PhotoBioModulation (PBM), which involves exposure to light from the red to near-infrared wavelengths using lasers and Light Emitting Diodes (LEDs)
Static Magnetic Stimulation (SMS), which consists in the application of a static magnetic field.

Considering previous investigations, this innovative technology could reduce inflammation on the brain-gut axis, implicated in the development of Alzheimer's disease.

lead_sponsor: REGEnLIFE SAS

collaborators:
RCTs
University Hospital, Toulouse

sponsor_collaborators:
REGEnLIFE SAS
RCTs
University Hospital, Toulouse

location_facility: Toulouse University Hospital Gerontopole


title: Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)

acronym: VR-INVENT

summary: This study compares the use of virtual Reality versus the usual service protocol for the management of anxiety and pain related to In-Vitro fertilization (IVF) procedure

lead_sponsor: CMC Ambroise Paré


title: Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

acronym: DARIDOR-ALZ

summary: DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Idorsia Pharmaceuticals Ltd.


title: Assessment of Cardiovascular Risk in Digital Osteoarthritis: A Case-control Study.

acronym: RICARDI

summary: The goal of this cross-sectional case control study is to investigate the cardiovascular risk in digital osteoarthritis. This study aims to compare the cardiovascular risk between group of patients with digital osteoarthritis and control group of patients with non-osteoarthritis disease paired by measurement of carotid intima-media thickness. All participants will undergo an ultrasound scan to measure carotid intima media thickness, a clinical assessment with the rheumatologist and a cardiovascular risk assessment.

lead_sponsor: University Hospital, Clermont-Ferrand