title: Multidisciplinary Care Pathway With Electronic Patient Reported Outcomes (ePRO) Post-operative Follow-up of Breast Cancer Surgery Complications to Optimize Patient Quality of Life

summary:
This project is a follow-on study of the BEAUTIFY-2 study (NCT04957186). The "BEAUTIFY" (BrEast cAncer qUaliTy of lIfe aFter surgerY) program was built by a committee of experts on the basis of reflections carried out within 2 focus groups. An application was developed to track patient reported outcome measures.

The study investigators now wish to evaluate the feasibility and impact on pain and quality of life of the "BEAUTIFY" care pathway on a larger cohort. The study hypothesis is that multidisciplinary care organization will improve the management and the quality of life post-breast cancer surgery.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: The Diagnostic Observatory: Combating Diagnostic Wandering and Impasse Within the AnDDI-Rares Network

acronym: Obs du Diag

summary:
The Direction Générale de l'Organisation des Soins (DGOS) and the Banque Nationale de Données Maladies Rares (BNDMR) have launched a call for a letter of commitment for the implementation of a diagnostic observatory in order to fight against diagnostic wandering and impasse. In this context, the AnDDI-Rares network proposes 3 work packages (WP) to respond to the missions entrusted to it.

Work package 1 of the diagnostic observatory includes a retrospective and prospective study to evaluate how diagnostic wandering and impasse has evolved within the network, with regard to the integration of new technologies, and the expectations of patients and their families.

Work package 2 of the diagnostic observatory includes a reassessment of sporadic copy number variations (CNV) of unknown significance of more than 1 Mb obtained since the beginning of CGH array analyses in the territory.

Work package 3 of the diagnostic observatory aims to help put an end to diagnostic wandering for patients with certain emblematic syndromes by proposing genome and RNA analysis, which provides a certain diagnosis and negative targeted molecular study.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Ongoing


title: Comparative Study of General Anesthesia With or Without Opioid on the Cardiac Index During Total Hip Arthroplasty

acronym: OFFLOW

summary:
General anesthesia used to be based on the association of hypnotics and opioid drugs. But recent studies showed that opioids may be related to a many different complications, like respiratory distress, hyperalgesia.

Opioid free anesthesia (OFA) aim is to control de cardiovascular nociceptive response to the surgical stimulation. The scientific literature is not clear yet on the cardiovascular effect of the OFA. Optimization of the cardiac index proved its worth in reducing morbidity and mortality.

The purpose of this study is to increase our understanding of the impact of opioid free anesthesia on the cardiovascular system and to evaluate the effectiveness and the security of the technic.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20. Review.

ReferenceCitation: Yi P, Pryzbylkowski P. Opioid Induced Hyperalgesia. Pain Med. 2015 Oct;16 Suppl 1:S32-6. doi: 10.1111/pme.12914. Review.

ReferenceCitation: Lavand'homme P, Estebe JP. Opioid-free anesthesia: a different regard to anesthesia practice. Curr Opin Anaesthesiol. 2018 Oct;31(5):556-561. doi: 10.1097/ACO.0000000000000632. Review.

ReferenceCitation: Mauermann E, Ruppen W, Bandschapp O. Different protocols used today to achieve total opioid-free general anesthesia without locoregional blocks. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):533-545. doi: 10.1016/j.bpa.2017.11.003. Epub 2017 Nov 24.

ReferenceCitation: Mulier JP. Is opioid-free general anesthesia for breast and gynecological surgery a viable option? Curr Opin Anaesthesiol. 2019 Jun;32(3):257-262. doi: 10.1097/ACO.0000000000000716. Review.

ReferenceCitation: Beloeil H. Opioid-free anesthesia. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):353-360. doi: 10.1016/j.bpa.2019.09.002. Epub 2019 Sep 26. Review.

ReferenceCitation: Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878. Review.

ReferenceCitation: Bugada D, Lorini LF, Lavand'homme P. Opioid free anesthesia: evidence for short and long-term outcome. Minerva Anestesiol. 2021 Feb;87(2):230-237. doi: 10.23736/S0375-9393.20.14515-2. Epub 2020 Aug 4.

ReferenceCitation: Lavand'homme P, Steyaert A. Opioid-free anesthesia opioid side effects: Tolerance and hyperalgesia. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):487-498. doi: 10.1016/j.bpa.2017.05.003. Epub 2017 May 17. Review.

ReferenceCitation: Kharasch ED, Clark JD. Opioid-free Anesthesia: Time to Regain Our Balance. Anesthesiology. 2021 Apr 1;134(4):509-514. doi: 10.1097/ALN.0000000000003705.

ReferenceCitation: Forget P. Opioid-free anaesthesia. Why and how? A contextual analysis. Anaesth Crit Care Pain Med. 2019 Apr;38(2):169-172. doi: 10.1016/j.accpm.2018.05.002. Epub 2018 Sep 13. Review.

ReferenceCitation: Bakan M, Umutoglu T, Topuz U, Uysal H, Bayram M, Kadioglu H, Salihoglu Z. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study. Braz J Anesthesiol. 2015 May-Jun;65(3):191-9. doi: 10.1016/j.bjane.2014.05.001. Epub 2014 Jun 3.

ReferenceCitation: Tempe DK, Sawhney C. Opioid-Free Anesthesia for Thoracic Surgery: A Step Forward. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3041-3043. doi: 10.1053/j.jvca.2020.07.022. Epub 2020 Jul 10.

ReferenceCitation: Siu EY, Moon TS. Opioid-free and opioid-sparing anesthesia. Int Anesthesiol Clin. 2020 Spring;58(2):34-41. doi: 10.1097/AIA.0000000000000270.

ReferenceCitation: Chakravarthy M. Opioid free cardiac anesthesia - A flash in the pan? Ann Card Anaesth. 2020 Apr-Jun;23(2):113-115. doi: 10.4103/aca.ACA_68_19.

ipd_sharing: No

lead_sponsor: Centre Hospitalier de Montauban

intervention_type: Drug


status: Not yet recruiting

primary_purpose: Prevention

title: Prenatal Treatment of Congenital Cytomegalovirus Infection With Letermovir Randomized Against Valaciclovir (Step 2)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

type: EudraCT Number

source: euctr

study_start_date_type: Anticipated

summary:
The investigators' hypothesis is that maternal treatment with Letermovir will inhibit fetal CMV replication better than Valaciclovir in infected fetuses and lead to a higher proportion of negative CMV PCR at birth in cord blood.

The main objective is to demonstrate that Letermovir administered to women carrying a CMV infected fetus following a maternal infection of the first trimester increases the proportion of neonates with a negative CMV PCR in neonatal blood collected in the first day of life or in cord blood in case of termination of pregnancy (TOP) compared to Valaciclovir.

In each group , the proportion of asymptomatic neonates and the number and type of long-term sequelae at 2 years will also be assessed and compared.


title: Contribution of PET/CT With Gallium 68 Citrate (68Ga-PET/CT) for the Diagnosis of Prosthetic Valve Infective Endocarditis

acronym: CiGal-EI-TEP

summary: CiGal-EI-TEP is an exploratory study that aim to assess the diagnostic performance of 68Ga Positron emission tomography (PET) / Computed Tomography (CT) for the diagnosis of prosthetic valve infective endocarditis in comparison with the final diagnosis established according to the ESC 2015 criteria, after 3 months of follow-up, by a panel of experts.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux


title: Comparison of a Low Dose to a Standard Dose of Insulin in Adult Diabetic Ketoacidosis in ICU to Reduce Metabolic Complications : a Randomized, Controlled Study

acronym: LOSTINDIAB

summary:
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria and thus major losses of water, glucose, sodium and potassium as well as a metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss).

Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more a matter of insulin resistance than an absolute deficiency. However, international guidelines recommend a similar dose of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.

During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.

The research hypothesis is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.

primary_purpose: Treatment

ipd_sharing: Undecided


title: Is a THA Stem in Varus a Risk Factor of Long-term Mechanical Complication

acronym: PTHVarus

summary: The objective of this study is to compare the long-term survival as well as the functional and radiographic results of the rods in the alignment of the varus to the stems in the neutral alignment by comparing 2 groups of implanted Total Hip Arthroplasty. 1 group of stems implanted in varus position. 1 group of stems implanted in neutral position

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Batailler C, Fary C, Servien E, Lustig S. Influence of femoral broach shape on stem alignment using anterior approach for total hip arthroplasty: A radiologic comparative study of 3 different stems. PLoS One. 2018 Oct 5;13(10):e0204591. doi: 10.1371/journal.pone.0204591. eCollection 2018.

ReferenceCitation: Murphy CG, Bonnin MP, Desbiolles AH, Carrillon Y, Aїt Si Selmi T. Varus will have varus; a radiological study to assess and predict varus stem placement in uncemented femoral stems. Hip Int. 2016 Nov 10;26(6):554-560. doi: 10.5301/hipint.5000412. Epub 2016 Oct 15.

ReferenceCitation: Fottner A, Woiczinski M, Kistler M, Schröder C, Schmidutz TF, Jansson V, Schmidutz F. Varus malalignment of cementless hip stems provides sufficient primary stability but highly increases distal strain distribution. Clin Biomech (Bristol, Avon). 2018 Oct;58:14-20. doi: 10.1016/j.clinbiomech.2018.07.006. Epub 2018 Jul 5.

lead_sponsor: University Hospital, Brest

intervention_type: Procedure

status_simplified: Completed


type: Other Identifier

title: A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Finland

acronym: PIONEER REAL

summary: The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 8-10 months. Participants will be asked to complete a questionnaire about how they take their Rybelsus® tablets. Participants will complete this questionnaire during their normally scheduled visit with the study doctor.

status: Enrolling by invitation

ipd_sharing: Yes

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Multicentric, Single Arm, Phase II Trial Assessing the Efficacy of Niraparib as First Line Therapy for Patients With Metastatic Homologous Repair-deficient Pancreatic Cancer

acronym: PARPi-PANC

summary: This trial is a single arm open-label, phase II aiming to assess the clinical activity of niraparib in chemotherapy-naïve biomarker-selected pancreatic cancer patients.

lead_sponsor: Centre Leon Berard


title: Toxicological Analysis in Chemical Submission

acronym: TANCS

summary: The purpose of this study is to carry out a systematic toxicological analysis of all the patients, examined at the UMJ of the Hôtel-Dieu following a complaint for suspected chemical submission. By comparing the toxicological data with the clinical examination data (e.g. treatment intake), the investigators could determine the number of confirmed chemical submissions and the substances involved.

intervention_type: Other


title: Sarcopenia and Short Bowel Syndrome: the Microbiota-gut-muscle Axis

acronym: SARCO-SGC

summary: Sarcopenia or the loss of skeletal muscle is highly prevalent in many diseases, including short bowel syndrome (SBS). While adaptation is more likely in SBS patients with a colon-in-continuity, the consequences and underlying mechanisms are unclear. An overabundance of fecal Lactobacillus was found but not yet linked to adaptation or sarcopenia. The objectives are to study the evolution of sarcopenia and the link with intestinal adaptation in SBS.

location_facility: Service de Coprologie Fonctionnelle Hôpital Pitié-Salpêtrière


title: TULIP et MASC : Premiers Usages

acronym: TEMPUS

summary:
The aim of this work is to propose two new questionnaires (TULIP and MASC) which are simple to complete by the patient, quick to analyze and can be calculated directly by the physician, adapted to the general population, whether during an initial evaluation or for follow-up.

The TULIP questionnaire aims to characterize the symptoms suggestive of Thoracic Outlet Syndrome (TOS). The MASC questionnaire aims to assess the functional maintenance of TOS in a simpler way (fewer questions) than the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and in a lateralized way.

lead_sponsor: University Hospital, Angers


title: Morbidity and Mortality in Operating Room: Surgery and Standardized Communication

acronym: HIATUS

summary: The primary objective of the study is to evaluate the efficacy of standard handover with AnesList© between physician anesthesists in operating room, for a complete transmission for a patient, on the occurence of event as death, serious complications or rehospitalization in month of postoperative after major surgery.

ReferenceCitation: Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672.

ReferenceCitation: Jullia M, Tronet A, Fraumar F, Minville V, Fourcade O, Alacoque X, LeManach Y, Kurrek MM. Training in intraoperative handover and display of a checklist improve communication during transfer of care: An interventional cohort study of anaesthesia residents and nurse anaesthetists. Eur J Anaesthesiol. 2017 Jul;34(7):471-476. doi: 10.1097/EJA.0000000000000636.

ReferenceCitation: Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.

location_facility: Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP


title: Tissue Factor Pathway Inhibitor (TFPI) and Haemorrhagic Manifestations in Haemophilia A and B Patients

summary: Studies have shown, in haemophilia patients, the effectiveness of Anti TFPI antibody (aTFPIAb) to prevent joint and muscular bleeding (tissues poor in Tissue Factor (TF)). However, cases of cerebral thrombosis (tissues rich in TF) have been observed in some patients treated with this antibody. Because an inter-individual variation in thrombin generation correction by aTFPIAb, an aTFPIAb concentration effective at low TF concentration could be at the same time thrombogenic at high TF concentration.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Modeling Bronchial Epithelium in Severe Asthma With Human Induced Pluripotent Stem Cells (iPSC)

acronym: MOSAIC

summary:
Asthma is severe when it cannot be controlled with maximum-dose inhaled therapies while management of comorbidities and other precipitating or aggravating factors has been optimized. Allergic bronchopulmonary aspergillosis (ABPA) is a complex bronchopulmonary disease resulting from immunological reactions against Aspergillus Fumigatus.

The development of a model of bronchial epithelium generated from patients with chronic lung disease will allow the modeling of bronchial tissue to understand the formation of these mucus plugs. This study aims to validate this model

The investigators propose to verify the feasibility of obtaining and comparing two epithelia in two populations based on the following experiments:

Differentiation of an Induced Pluripotent Stem cell (iPSC) clone derived from blood sample (Peripheral Blood Mononuclear Cells) of Type 2 inflammation (T2) severe asthma and Allergic Bronchopulmonary Aspergillosis (ABPA) in order to obtain differentiated bronchial epithelia in vitro.

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 will be made available to persons who address a reasonable request to the study director.

Individual participant data (and an accompanying data dictionary) will be deidentified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

lead_sponsor: University Hospital, Montpellier


title: Planned Mode of Delivery After Caesarean: a Comparative Prospective National Population-based Cohort Study

acronym: CICAMODA

summary:
In women with one previous caesarean, the choice of mode of delivery is determined by a shared decision-making process between the women and the obstetrician, with the two options being a trial of labour after caesarean (TOLAC) or an elective repeat caesarean delivery (ERCD).

To date, the scientific literature has reported of higher perinatal morbidity-mortality with TOLAC, although with low absolute risks and discordant results about maternal morbidity-mortality. These studies suffer from limitations, as they include women with more than one previous caesarean or with high rates of failed TOLAC, which are two risk factors for uterine rupture, and the definition of planned versus effective mode of delivery is not precise in most studies.

However, scientific societies recommend that most women with one previous caesarean should be offered TOLAC because of the low absolute perinatal risk of this option and the high maternal and perinatal risk associated with an ERCD in the short- and long-term.

Conversely, the investigators hypothesise that TOLAC would be not inferior to ERCD in women with one previous caesarean in terms of perinatal morbidity-mortality.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Evaluating the Efficacy of Para-discal Infiltration in Patients With Lateralized MODIC 1 Inflammatory Disc Disease: Pilot Study (IPAD)

acronym: IPAD

summary:
Degenerative disc disease (DDD) is a major cause of chronic low back pain (> 40%). It can be defined by specific magnetic resonance imaging (MRI) features, with a strong correlation between pain and the inflammatory aspect of the disc, resulting in active disc disease (AD). The Modic classification based on MRI of the lumbar spine is considered a reference.

The management of low back pain in patients with inflammatory disc disease generally involves intra-disc corticosteroid infiltration, which has been widely proven to be effective in reducing pain [4-6]. However, this procedure can be painful and invasive and sometimes impossible to perform due to severe disc impingement.

The aim of this study is to evaluate the efficacy on pain of para-disc infiltration of corticosteroids in contact with the inflammatory MRI signal abnormality (Modic 1) when it is lateralized.

This variant of infiltration is easier to perform (no catheterisation of the disc and therefore quicker), would entail less risk of disc infection and would be accessible to more radiologists.

It is already practised but, to our knowledge, has never been the subject of a study to evaluate its effectiveness on pain.

If successful, more patients could be treated and the range of treatment could be extended.


title: Evaluation of the French Translation of Gothenburg Trismus Questionnaire (GTQ)

acronym: TRISMUS

summary: A monocentric Study to evaluate the french translation of Gothenburg Trismus Questionnaire (GTQ).

status: Active, not recruiting

lead_sponsor: Centre Hospitalier de Valence


title: Chronic Inflammatory Rheumatism: Management of Comorbidities in Ambulatory Medicine

acronym: SCORIC-A

summary: Identification of factors limiting compliance with the recommendations established during the evaluation of the SCORIC population by the rheumatology department of the CHU Grenoble Alpes

lead_sponsor: University Hospital, Grenoble


title: Effectiveness of Functional Rehabilitation With HUBER Platform Compared to a Standard Program, on the Flexion/Extension Ratio of the Spine, in Patients With Non-specific Chronic Low Back Pain

summary: The objective of this study is to evaluate the effectiveness of centre-based program of 6 weeks with HUBER platform on the spine flexion-to-extension ratio at 60 and 120˚/s, pain and trunk flexibility in individuals with chronic low back pain (CLBP). A total of 70 individuals with Non-specific Chronic Low Back Pain will be randomised into 2 intervention arms (1:1 ratio) that will be blindly evaluated: 1/ standard rehabilitation group and 2/ HUBER rehabilitation group. Both programs are centre-based and will last 6 weeks, with 4 sessions of 2 hours each per week.

lead_sponsor: Thibaut Guiraud

location_facility: CLINEA - Centre de Rééducation fonctionnelle de Treboul

intervention_type: Behavioral


title: Study of the Correlations Between the Ocular Dominance Depth, the Angle Lambda and the Fixation Disparity in Healthy Individuals

acronym: EPOLAF

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

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

The aim of the study is to analyze the correlation between the angle lambda and the ocular dominance depth in healthy individuals without ophthalmologic disorder.

Then, seconds goals were defined as the study of the relation between the value of the angle lambda and the fixation disparity quantified with the Rousseau test.

Relation between ocular dominance measured with the Guillon's test and the Hole-in-car test will also studied.


title: Evaluation of Proprioceptive Abilities While Wearing an Elastic Orthosis in Patients With Proprioceptive Knee Deficits

acronym: CAPROG

summary: The objective of the study is to compare, with or without wearing an elastic proprioceptive knee brace, the functional proprioceptive capacity of the knee in patients suffering from proprioceptive deficit.

ReferenceCitation: Riemann BL, Lephart SM. The Sensorimotor System, Part II: The Role of Proprioception in Motor Control and Functional Joint Stability. J Athl Train. 2002 Jan;37(1):80-4.

ReferenceCitation: Johansson H, Sjölander P, Sojka P. Receptors in the knee joint ligaments and their role in the biomechanics of the joint. Crit Rev Biomed Eng. 1991;18(5):341-68. Review.

ReferenceCitation: Wikstrom EA, Tillman MD, Chmielewski TL, Borsa PA. Measurement and evaluation of dynamic joint stability of the knee and ankle after injury. Sports Med. 2006;36(5):393-410. Review.

ReferenceCitation: Fremerey RW, Lobenhoffer P, Zeichen J, Skutek M, Bosch U, Tscherne H. Proprioception after rehabilitation and reconstruction in knees with deficiency of the anterior cruciate ligament: a prospective, longitudinal study. J Bone Joint Surg Br. 2000 Aug;82(6):801-6.

ReferenceCitation: Han J, Waddington G, Adams R, Anson J, Liu Y. Assessing proprioception: A critical review of methods. J Sport Health Sci. 2016 Mar;5(1):80-90. doi: 10.1016/j.jshs.2014.10.004. Epub 2015 Feb 3. Review.

lead_sponsor: Thuasne

intervention_type: Device


title: Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS): Systematic Intermittent Catheterization Versus Bladder Scan Guided Catheterization in the Post Anesthesia Care Unit: a Prospective Randomized Double-blind Study

acronym: URICATHOR

summary: General anesthesia, thoracic epidural, and morphine inhibit the urination process and promote postoperative Acute Urinary Retention (AUR) after thoracic surgery. Indwelling bladder catheterization prevents this risk, but is associated with other complications (urinary tract infection, delayed mobilization). With the rise of enhanced recovery after surgery (ERAS) protocols, bladder catheterization is being questioned. The current protocol in the department is to catheterize only patients with a high bladder volume in the post anesthesia care unit (defined as a bladder volume > 400 ml on bladder scan). Preliminary results from the "AirLeaks" study show a high rate of early postoperative AUR (approximately 50%). The investigators believe that a "systematic intermittent catheterization" (SIC) strategy is superior to the current "bladder scan-guided catheterization in the post anesthesia care unit" (BSGC) strategy in preventing the risk of postoperative AUR. To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic accelerated rehabilitation protocol.

primary_purpose: Supportive Care


title: Complex Ocular Infection, Optimization of Microbiological Diagnosis

acronym: ICODIA

summary:
The purpose of this study is to evaluate the impact of different technique to optimize the microbiological diagnosis of the COI.

Metagenomic for the endophtalmitis
Multiplex polymerase chain reaction for corneal abscesses

location_facility: Equipe mobile d'infectiologie, Cochin hospital

intervention_type: Diagnostic Test


title: Comparison of the Removal of Uremic Toxins With Medium Cut-off and Super High-flux Vitamin E-coated Dialyzers The E-FLUX Randomized Study

acronym: E-FLUX

summary:
End-stage renal disease (ESRD) induces an accumulation of uremic toxins responsible for increased morbidity and mortality. These toxins cover a wide range of molecules, classified according to their molecular weight as small-size (< 500 Da), middle-size (500 Da-60 kDa), and protein-bound toxins.

Specific complications have been associated with the accumulation of middle-size toxins, including beta2-microglobulin (12 kDa), myoglobin (17 kDa), prolactin (23 kDa), alpha1-microglobulin (33 kDa), alpha1-glycoprotein (44 kDa), kappa (22 kDa) and lambda (45 kDa) free light chains (FLC). Moreover, mediators of oxidative stress such as asymmetric dimethylarginine, malondialdehyde, oxidative-LDL and inflammatory cytokines such as Interleukin-6 (IL)-6, IL1-β, TNF-α have been involved in atherosclerosis, malnutrition, cardiovascular events and mortality.

Hemodialysis (HD) remains the main standard modality of renal replacement therapy in ESRD. In the past decade, low-flux hemodialysis was most commonly used, providing effective clearance of small solutes through diffusion, but negligible clearance of middle molecules. This limitation was insufficiently improved by the development of high-flux (HF) dialyzers due to their cut-off pores size values of approximately 15-20 kDa. In fact, most of middle molecules cannot be efficiently removed by HF-HD because of their molecular radii larger than that of membrane pores. Thus, HF dialyzers were used in post dilution on-line hemodiafiltration (OL-HDF) mode with high convection volumes and achieved greatest clearance of middle molecules. However, OL-HDF is generally not available in most HD centers and needs additional hardware technology. Therefore, several super high-flux (SHF) dialyzers integrating higher cut-off size pore value and achieving Beta2-microglobulin clearance > 70 ml/min were developed for HD mode. These SHF dialyzers used in HD (SHF-HD) provides similar middle molecules depuration compared to OL-HDF.

The recently developed medium cut-off (MCO) dialyzer (Theranova 500™, Baxter healthcare Corporation Deerfield, USA; surface area 2 m², ultrafiltration coefficient: 59 ml/h/mmHg) differs from conventional HF membranes by higher and controlled porosity resulting in a steep sieving curve with a cut-off value approaching that of albumin. MCO-HD has demonstrated efficient depuration of middle uremic toxins as compared to HF-HD, similar to that of OL-HDF. MCO-HD and SHF-HD are two new large pore size dialyzers currently used nowadays in HD.

In addition, the interaction between blood and membrane surface play a key role in generating oxidative stress and inflammation. Antioxidants such as vitamin E work by inhibiting LDL oxidation and by limiting cellular response to oxidized LDL. In HD patients, vitamin E may be integrated as a part of the HD procedure in the form of bioreactive dialysis membranes, in which the blood surface has been modified with alpha-tocopherol. Dialysis with vitamin E-coated membranes has been associated with an improvement in biocompatibility including circulating lipid peroxidation biomarkers and cytokine induction. In small studies, vitamin E coated dialyzers have been associated with reduced red blood count fragility and improvements in erythropoietin resistance index and erythropoietin requirements in HD.

VieX (Polysulfone, surface area: 2.1 m², sterilization gamma, ultrafiltration coefficient: 104.3 ml/h/mmHg, Asahi Kasei Medical, Japan), a novel SHF vitamin E-coated (SHVE) dialyzer, which has larger pore size than HF dialyzer, might provide higher middle molecules removal and biocompatibility improvement.

The aim of the present study was to compare the efficiency of the SHFVE dialyzer (VieX™) versus the MCO dialyzer (Theranova 500™) on the removal of beta2-microglobulin and other middle molecules in a non-inferiority fashion, and their respective effects on inflammation, oxidative stress and biocompatibility parameters.

lead_sponsor: Poitiers University Hospital


title: Study of the Performance of VCO2 Variation as an Indicator of Fluid Responsiveness in Intensive Care Unit

acronym: CRAC

summary:
The increase of cardiac output resulting from increased blood volume (systolic ejection volume) during intravenous fluid administration defines a state of fluid responsiveness.

Fluid responsiveness in intensive care patients with circulatory failure (shock) needs to be carefully evaluated because only half of the patients are fluid responsive and excessive fluid administration is harmful.

To reliably assess this state, it is currently necessary to perform either invasive cardiac output monitoring or ultrasound evaluation before and after a fluid administration (called fluid challenge). It is either an invasive procedure or a time-consuming technique (that might depend on operator experience and patient echogenicity).

The investigators foresee a potential benefit for an objective quick-answering screening tool that does not require additional monitoring.

Instantaneous CO2 production rate (VCO2) calculated automatically by the most recent ventilators (Hamilton C5-C6) via the analysis of exhaled gases.

There is an established physiological link between cardiac output, arterial oxygen transport to cells and CO2 production by cell metabolism.

The variation in End-Tidal CO2 (another parameter derived from exhaled CO2) is conventionally monitored in the operating room; it can show sudden changes in cardiac output. In intensive care, the EtCO2 variation is probably less sensitive than the variation in VCO2 to detect changes in cardiac output.

The aim of this study is to show that the variation in VCO2 as shown on ventilators during a fluid challenge test has satisfactory diagnostic performance in the detection of fluid responsiveness in patients with circulatory failure in intensive care.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot, Anesthésie-réanimation


title: Study of the Metabolic Reprogramming of CLL Cells in Ex-vivo Models of the Lymphatic Niche

summary: Chronic lymphoid leukemia (CLL) is the most common adult leukemia that is characterized by a malignant monoclonal accumulation of tumoral and quiescent B cells in the peripheral blood. In advanced stages of the disease (Binet stage C), this population invades the bone marrow (BM) and proliferate into the lymphoid organs that results in widespread adenopathy. Richter's transformation is a most aggressive serious complication of CLL (transformation of the disease into an aggressive lymphoma) detected based on TEP/CT (Positron Emission Tomography/ computerized tomography) that shows highly derived glucose consumption by cancer cells. Clinical data from CLL patients with disease acutisation showed hypermetabolic lymphadenopathy with high standardized uptake value (SUV) whereas there is low grade tracer uptake into BM. We supposed that the tumor microenvironment of the lymphatic niche promotes the proliferation and glycolytic activity of CLL cells which become particularly resistant to treatment. The development of an ex-vivo tumor model that reproduces the microenvironment of the lymph node niche appears essential to identify and validate new therapeutic targets because despite the therapeutic arsenal available some patients still relapse or are refractory to treatment. Our objectives are to i / Characterize this niche of resistance by the development of an ex-vivo tumor model and ii / Evaluate in-vitro the effectiveness of the association of current treatments (RFC, Ibrutinib or Venetoclax) with anti-metabolic therapies (inhibitors of glycolysis) Our lab is developing an ex-vivo models of the lymphatic niche in CLL based on co-cultures of leukemic cells from patients stimulated with CpG ODN and IL2 with primary human lymphatic fibroblasts (HLF) (EC 12PP15). This co-culture has never been described in the literature and allows us to study the lymphatic niche of CLL patients. Lymph node (LN) exploration in CLL requires invasive access and does not bring any additional information in initial diagnosis. Then, we validated our co-culture model using complementary approaches: increased viability, proliferation, and resistance to Ibrutinib, associated with increased production of anti-apoptotic proteins such as MCL1 and BCL2 after 48 hours of co-culture. Secondly, we studied the metabolism in this resistance niche. We find an increased production of lactate and an acute consumption of glucose, associated with a strong metabolic activation detected by SEAHORSE and by the production of glycolysis enzymes such as hexokinase 2. Our study constitutes an original project because it characterized the energy metabolism of the CLL lymphatic niche by developing an original ex-vivo model and enhanced our understanding of the contribution of the specific microenvironment in the dissociation of metabolic activity using SUV max in BM and lymphatic niche. Anti-metabolic therapies are efficient on co-culture CLL cells and could be an alternative for refractory or relapsed patients under current treatment.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA® Medical Device, on Filling the Superficial Wrinkles and on Skin Quality: HEBE2 Study

summary: The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking. It is a viscoelastic injectable solution of 1% hyaluronic acid (10mg/ml), non-crosslinked of non-animal origin, obtained by biofermentation, resorbable, opalescent, sterile and apyrogenic. NCTF135HA is an anti-aging viscoelastic solution for the revitalization and intense hydration of tired or dull skin, the treatment of wrinkles and the redensification of mature or sagging skin. This hyaluronic acid solution is intended to be injected into the superficial dermis to compensate for the loss of moisture. Given the expected impact of the injection procedure of the biorevitalization solution on wrinkles, the primary endpoint was chosen to evaluate the effectiveness of the treatment on wrinkles.

lead_sponsor: Laboratoires FILLMED


title: Structural Description of Skin Biopsies With Dynamic Full-field Optical Coherence Tomography on Suspected Basal Cell Carcinoma Lesions, a Pilot Study

acronym: DOCTOBA

summary:
Basal cell carcinoma (BCC) are the most frequent skin cancers. Their incidence is constantly increasing. BCC diagnosis is first clinically suspected and then confirmed following histological examination of either a skin biopsy or the excisional specimen. Surgery is the first-line treatment and some procedures (notably Mohs surgery) require extemporaneous histological analysis of the edges to ensure a complete excision. Such on-site histopathological examination can be time consuming and associated with decreased sensitivity. Skin imaging techniques have already been tested to overcome these limitations and seem promising. Although some of them - such as confocal microscopy - are already even used in vivo, there is to date no report of the use of full-field optical coherence tomography for the diagnosis of BCC.

The DOCTOBA study intends to describe direct histopathological examination of fresh skin biopsy or excisional specimen with dynamic full-field optical coherence tomography.

lead_sponsor: Centre Hospitalier William Morey - Chalon sur Saône


title: Factors Associated With Hospitalization for Dengue and Dengue Severity: Hospital-based Cohort Study on Reunion Island

acronym: DENGUE-RUN

summary:
In recent years, dengue has become endemic on La Réunion island, which has led to subsequent increase of secondary dengue infections, higher severity and higher mortality of the cases referred to the hospital.

This project will investigate the factors associated with the hospitalization for dengue and the factors associated with dengue severity in a hospital-based cohort study conducted over two dengue seasons, as well as the long-term outcomes over aN18-month follow-up.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: In Vitro Study of the Efficacy of Different Immunomodulators on the Th17/Treg Balance in a Cohort of Relapsed Membranous Nephropathy

acronym: BIOGEM

summary: In order to propose the best therapeutic option to relapsed MN patients with strong activation of the Th17 pathway, the investigators propose to study in vitro the effect of different immunomodulators on the Th17/Treg balance, assessed by cytokine profile and lymphocyte phenotyping using flow cytometry.

ipd_sharing_description: IPD is not planned to be shared with other researchers than the investigators

location_facility: Centre Hospitalier Universitaire de Nice


title: Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis. A Randomized Controlled Trial With an Independent Efficacy Assessor.

acronym: SEQUENS-RA

summary:
In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX). In case of contra-indication or intolerance to MTX, leflunomide is an alternative. If the treatment target is not achieved with csDMARD strategy, addition of a biological DMARD (TNF inhibitors, anti-Interleukin 6 (anti-IL6)), abatacept, or rituximab) or a targeted synthetic (ts) DMARD (JAK inhibitors) is considered.

Current practice is to start a bDMARD (biologic Disease Modifying Antirheumatic Drugs) and especially TNF inhibitors (etanercept or monoclonal anti-TNF antibodies) with the benefit of hindsight. However, abatacept and TNF inhibitors have demonstrated similar efficacy in patients with insufficient response to csDMARD (AMPLE trial).

Although abatacept has shown a very good tolerance profile that might be superior to other bDMARDs rheumatologists might be reluctant to use it as a first line bDMARD as there is a belief of a slower efficacy compared to other bDMARDs or JAK inhibitors. Indeed, in real world study, compared to TNF inhibitors it seems that discontinuation of abatacept is more related to lack of effectiveness than safety issues.

Investigators have hypothesized that first rapidly controlling the inflammation phase, using TNF inhibitors followed by abatacept to induce an immunological remission would optimize response and tolerance of ACPA positive patients with RA. To demonstrate our hypothesis, the investigaors propose a randomized controlled trial with one arm receiving an induction therapy for three months with a TNF inhibitor followed by a cell-targeted bDMARD (abatacept) and the other arm, receiving TNF inhibitors.

location_facility: Centre Hospitalier Universitaire de Montpellier


title: A Multicenter, Open-label, Proof of Concept Phase II Aiming to Assess the Clinical and Biological Activity of Anti-netrin-1 (NP137) as Add on Therapy in Patients With Advanced/Metastatic Solid Tumors Treated by Standard Immunotherapies

acronym: IMMUNONET

summary:
This study is a multicenter, open-label, proof-of-concept study aiming to assess the clinical and biological impact of NP137 when added to standard PD-1/PD-L1 blockade therapy in 3 independent cohorts of advanced or metastatic solid tumors with various sensitivity to anti-PD-1/PD-L1:

Cohort 1 [Stable Disease]: Patients with a radiological documentation of SD according to RECIST V1.1 criteria following at least 12 weeks under standard anti PD-1/PD-L1 therapy. The initial evidence of SD is to be confirmed by a second assessment, no less than 4 weeks from the date of the first documented SD.
Cohort 2 [primary refractory]: Patients with documented radiological PD according to RECIST V1.1 but with clinical benefit under anti PD-1/PD-L1 standard therapy.
Cohort 3 [secondary refractory]: Patients with documented radiological PD following an initial Objective Response according to RECIST V1.1, with clinical benefit under standard anti-PD-1/PD-L1.

design_allocation: Non-Randomized


title: Assessment of the Reliability of Changes in Plethysmography Variability Index During Tidal Volume Challenge for Predicting Fluid Responsiveness in Intensive Care Unit Patients

summary: The aim of this study is to assess whether changes in the plethysmography variability index, during a tidal volume challenge, can reliably detect simultaneous changes in arterial blood pressure pulsatility, in patients hospitalized in intensive care unit. If results will be positive, this will allow the test to be performed even in the absence of an invasive arterial catheter.

ReferenceCitation: Marik PE, Monnet X, Teboul JL. Hemodynamic parameters to guide fluid therapy. Ann Intensive Care. 2011 Mar 21;1(1):1. doi: 10.1186/2110-5820-1-1.

ReferenceCitation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network, Wiedemann HP, Wheeler AP, Bernard GR, Thompson BT, Hayden D, deBoisblanc B, Connors AF Jr, Hite RD, Harabin AL. Comparison of two fluid-management strategies in acute lung injury. N Engl J Med. 2006 Jun 15;354(24):2564-75. Epub 2006 May 21.

ReferenceCitation: Myatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.

ReferenceCitation: Alvarado Sánchez JI, Caicedo Ruiz JD, Diaztagle Fernández JJ, Amaya Zuñiga WF, Ospina-Tascón GA, Cruz Martínez LE. Predictors of fluid responsiveness in critically ill patients mechanically ventilated at low tidal volumes: systematic review and meta-analysis. Ann Intensive Care. 2021 Feb 8;11(1):28. doi: 10.1186/s13613-021-00817-5. Review.

ReferenceCitation: Feissel M, Teboul JL, Merlani P, Badie J, Faller JP, Bendjelid K. Plethysmographic dynamic indices predict fluid responsiveness in septic ventilated patients. Intensive Care Med. 2007 Jun;33(6):993-9. Epub 2007 Mar 29.

ReferenceCitation: Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53.

ReferenceCitation: Natalini G, Rosano A, Taranto M, Faggian B, Vittorielli E, Bernardini A. Arterial versus plethysmographic dynamic indices to test responsiveness for testing fluid administration in hypotensive patients: a clinical trial. Anesth Analg. 2006 Dec;103(6):1478-84.

ReferenceCitation: Cannesson M, Attof Y, Rosamel P, Desebbe O, Joseph P, Metton O, Bastien O, Lehot JJ. Respiratory variations in pulse oximetry plethysmographic waveform amplitude to predict fluid responsiveness in the operating room. Anesthesiology. 2007 Jun;106(6):1105-11.

ReferenceCitation: Cannesson M, Desebbe O, Hachemi M, Jacques D, Bastien O, Lehot JJ. Respiratory variations in pulse oximeter waveform amplitude are influenced by venous return in mechanically ventilated patients under general anaesthesia. Eur J Anaesthesiol. 2007 Mar;24(3):245-51. Epub 2006 Oct 23.

ReferenceCitation: Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.

ReferenceCitation: Landsverk SA, Hoiseth LO, Kvandal P, Hisdal J, Skare O, Kirkeboen KA. Poor agreement between respiratory variations in pulse oximetry photoplethysmographic waveform amplitude and pulse pressure in intensive care unit patients. Anesthesiology. 2008 Nov;109(5):849-55. doi: 10.1097/ALN.0b013e3181895f9f.

ReferenceCitation: Liu T, Xu C, Wang M, Niu Z, Qi D. Reliability of pleth variability index in predicting preload responsiveness of mechanically ventilated patients under various conditions: a systematic review and meta-analysis. BMC Anesthesiol. 2019 May 8;19(1):67. doi: 10.1186/s12871-019-0744-4.

ReferenceCitation: Monnet X, Guérin L, Jozwiak M, Bataille A, Julien F, Richard C, Teboul JL. Pleth variability index is a weak predictor of fluid responsiveness in patients receiving norepinephrine. Br J Anaesth. 2013 Feb;110(2):207-13. doi: 10.1093/bja/aes373. Epub 2012 Oct 26.

ReferenceCitation: Coeckelenbergh S, Delaporte A, Ghoundiwal D, Bidgoli J, Fils JF, Schmartz D, Van der Linden P. Pleth variability index versus pulse pressure variation for intraoperative goal-directed fluid therapy in patients undergoing low-to-moderate risk abdominal surgery: a randomized controlled trial. BMC Anesthesiol. 2019 Mar 9;19(1):34. doi: 10.1186/s12871-019-0707-9.

ReferenceCitation: Taccheri T, Gavelli F, Teboul JL, Shi R, Monnet X. Do changes in pulse pressure variation and inferior vena cava distensibility during passive leg raising and tidal volume challenge detect preload responsiveness in case of low tidal volume ventilation? Crit Care. 2021 Mar 18;25(1):110. doi: 10.1186/s13054-021-03515-7.

lead_sponsor: Bicetre Hospital

location_facility: Service de médecine intensive-réanimation, Hôpital de Bicêtre


title: Real-life Study Evaluating the Performance of 2% Aqueous Eosin in Children With Diaper Rash

summary:
This study is being conducted to provide updated clinical data on safety and performance (demonstrated previously for CE marking under the Medical Devices Directive) Cooper Aqueous Eosin 2%. This is an observational study conducted under real-life conditions and as part of post-marketing surveillance activity for a device that has been on the market for a long time and a well-established technology, in accordance with the Medical Devices Regulations 2017 /745 (MDR) and MDCG 2020-6 guidelines.

The study will be a multicenter, national, observational, prospective study, with a 7-day follow-up (+/- 2 day). 60 patients are scheduled.

lead_sponsor: Cooperation Pharmaceutique Francaise


title: Prospective Single-centre Study to Evaluate the Feasibility of Ethanolization of Vein of Marshall With a Specific Catheter in the Ablation of Atrial Fibrillation

acronym: Innov Marshall

summary:
In patients with persistent AF (PsAF), ablation limited to pulmonary vein (PV) isolation is the most straightforward approach, but results only in 50% of arrhythmia freedom at 1 year follow-up. Substrate modification strategies have failed to demonstrate their superiority with variable reported success rate. The Marshall network is a highly arrhythmogenic structure that has not been systematically targeted so far, probably because of the absence of dedicated tools to make its ablation simple and easy. We sought to investigate the use of a specific catheter for visualization and ethanolization of vein of Marshall allowing to systematically include this target in the ablation set.

The main objective of this study is to demonstrate the feasibility to use the Targeted Endovascular Delivery (TED) catheter specifically for visualization and ethanolization of vein of Marshall.

lead_sponsor: University Hospital, Bordeaux


title: Differences in Quality of Life After Thoracic Outlet Syndrome Surgery

summary: Quality of life evaluation after thoracic outlet surgery with Quick-DASH and SF-36 forms

lead_sponsor: University Hospital, Angers


title: Study of the Relationship Between the Blood Levels of Soluble PDL1 and β2-microglobulin, and the Clinical Course of a Metastatic Solid Tumor Treated With a First-line Therapeutic of Checkpoint Immune Inhibitor

summary:
Exploratory interventional study of prognostic serum biomarkers of cancer progression.

Study of the relationship between the blood levels of soluble PDL1 and β2-microglobulin, and the clinical course of a metastatic solid tumor treated with a first-line therapeutic of checkpoint immune inhibitor.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Effectiveness of Tele-yoga in the Rehabilitation of Patients With Chronic Post-stroke Sequelae : a Randomized Controlled Trial

summary:
Stroke is a major health problem and can cause long-term disability. Among these sequelae, there are balance and mobility disorders, but also a higher rate of anxiety or depression disorders. This impairments impact activity of daily living, and social reintegration. That why the investigators need to explore options for long-term sustainable interventions that which takes into account the patient as a whole. In particular, regular physical activity is recommended, but it must be adaptable to the patient's impairments. Teaching yoga may be an interesting option. Indeed, yoga is a mind-body practice which become increasingly widespread in the world. Recent studies highlight positive effect of yoga for this population. However, accessibility to yoga classes can be limited by many factors: lack of transportation, lack of available health professionals, confinement requirements... Therefore, it seems relevant to evaluate the effectiveness of yoga delivered through tele-rehabilitation.

The main objective of this study is to evaluate the effectiveness of a tele-yoga program adapted to stroke survivors to improve their functional balance.

The secondary objectives are to evaluate the effectiveness of the adapted tele-yoga program in improving functional mobility, anxiety, depression and reintegration into normal life.

lead_sponsor: Hopital La Musse


title: An Open-label, Single Center, Single Arm, Clinical Trial to Assess the Consumption Effects of 6 Weeks TOTUM-070 on Lipid Metabolism and Cardiovascular Health in Individuals at Increased Cardio-metabolic Risk

acronym: OLALIP

summary: This clinical study aims to assess the efficacy of 6 weeks 2.5g dose of TOTUM-070, a mix of 5 plant extracts, on lipid metabolism and cardiovascular health in individuals at increased cardio-metabolic risk.

lead_sponsor: Valbiotis

intervention_type: Dietary Supplement


title: Efficacy of Propranolol for the Treatment of Central Nervous System Hemangioblastomas in Von Hippel-Lindau Disease: a Randomized Controlled Clinical Trial

acronym: PRO-HEB

summary:
Propranolol (beta-blocker), is successfully used for the treatment of infantile hemangiomas, the most common vascular tumor of newborns. The mechanism is related to its anti-angiogenetic and pro-apoptotic effects. Recently, in vitro studies demonstrated that propranolol decreased the expression of target genes of the HIF (hypoxia-inducible factor, of which the VHL gene is the main regulator) pathway in hemangioblastoma cells and affected their viability. The efficacy of propranolol (stabilization of all HB and decrease in serum VEGF levels) was demonstrated in a phase III study, but only in retinal BHs . The only study that evaluated the effect of propranolol on CNS HB was retrospective and involved a limited number of patients. Nevertheless, it showed a decrease in the growth rate of HBs. The investigator therefore propose to carry out a randomized controlled trial to study the effect of propranolol on the growth of CNS HB in patients with VHL disease (von Hippel-Lindau).

The hypothesis of the present work is the following: the use of propranolol in VHL patients with CNS HB allows to decrease and/or slow down the tumor growth.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor for Validation of a Cell Expansion Automaton Allowing the Simultaneous Production of Several Cell Grafts for Therapeutic Use

acronym: CARDIOSTEM

summary: Donation of whole blood by healthy volunteers after mobilisation by haematopoietic growth factor (rhu-G-CSF = Granocyte) for biological validation of a cell expansion automaton allowing the simultaneous production of several cell grafts for therapeutic use in the cardiac field - 2nd STAGE

lead_sponsor: CellProthera


title: Prospective, Multicenter, First Part Randomized, Placebo-controlled, Parallel-group, Double-blind Period Followed by Open-label Trial Period to Evaluate Clinical Safety & Efficacy of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease: Proof-of-concept Study

summary: This proof-of-concept study will assess safety, tolerance, and efficacy of NanoLithium® NP03 in patients with mild-to-severe Alzheimer's Disease (AD).

lead_sponsor: Medesis Pharma SA

location_facility: CHU Toulouse - Hôpital La Grave - Cité de la Santé


title: Throboxane Effect on Chondrocytes; Role in Osteoarthritis

summary: TXA2 inhibits the expression of the primary marker of thermogenesis (UCP1) while prostacyclin (PGI2), another metabolite derived from arachidonic acid, enhances its expression. Given the close relationship between the adipocyte and the chondrocyte, the study team hypothesises that thromboxane A2 controls chondrocyte formation and function and thus cartilage homeostasis. The study objectives are: i) to analyse the role of TXA2 on chondrocyte differentiation in vitro, ii) to determine the association between circulating and tissue TXA2 levels in a rat model of osteoarthritis, and iii) to correlate circulating and synovial fluid levels of TXA2 with the development of osteoarthritis in a small human cohort. The proposed research aims to better understand the mechanisms underlying the role of lipid metabolites in chondrocyte formation and function, paving the way for the development of nutritional and pharmacological therapies to combat OA and associated metabolic disorders.

ipd_sharing_description: not scheduled


title: Impact of Global Physiotherapy on Acute Respiratory Failure Within 7 Days After Extubation in Intensive Care Unit Patients With High Risk of Extubation Failure.

acronym: KINEXTUB

summary: This study aims to compare care provided by physiotherapists, combining respiratory care and early rehabilitation in intensive care unit, with standard care on the rate of acute respiratory failure within 7 days after extubation, in patients with high risk of extubation failure.


title: Retrospective Study of Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic

acronym: ERDFP

summary:
Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits.

In this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by T2* MRI in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.

lead_sponsor: Ramsay Générale de Santé


title: Preoperative Embolization of the Inferior Mesenteric Artery in Colorectal Surgery

acronym: EPAMIR

summary:
Preoperative embolization of the inferior mesenteric artery in colorectal surgery (EPAMIR).

This is a prospective, monocentric, non-randomized study.

ReferenceCitation: Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

ReferenceCitation: van der Pas MH, Haglind E, Cuesta MA, Fürst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.

ReferenceCitation: Snijders HS, Wouters MW, van Leersum NJ, Kolfschoten NE, Henneman D, de Vries AC, Tollenaar RA, Bonsing BA. Meta-analysis of the risk for anastomotic leakage, the postoperative mortality caused by leakage in relation to the overall postoperative mortality. Eur J Surg Oncol. 2012 Nov;38(11):1013-9. doi: 10.1016/j.ejso.2012.07.111. Epub 2012 Sep 3.

ReferenceCitation: Posma LA, Bleichrodt RP, van Goor H, Hendriks T. Transient profound mesenteric ischemia strongly affects the strength of intestinal anastomoses in the rat. Dis Colon Rectum. 2007 Jul;50(7):1070-9.

ReferenceCitation: Ghelfi J, Brichon PY, Frandon J, Boussat B, Bricault I, Ferretti G, Guigard S, Sengel C. Ischemic Gastric Conditioning by Preoperative Arterial Embolization Before Oncologic Esophagectomy: A Single-Center Experience. Cardiovasc Intervent Radiol. 2017 May;40(5):712-720. doi: 10.1007/s00270-016-1556-2. Epub 2017 Jan 3.

ReferenceCitation: Manunga JM, Cragg A, Garberich R, Urbach JA, Skeik N, Alexander J, Titus J, Stephenson E, Alden P, Sullivan TM. Preoperative Inferior Mesenteric Artery Embolization: A Valid Method to Reduce the Rate of Type II Endoleak after EVAR? Ann Vasc Surg. 2017 Feb;39:40-47. doi: 10.1016/j.avsg.2016.05.106. Epub 2016 Aug 12. Review.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of Pain in the Course of in Vitro Fertilization: the Endalgofiv-2 Study

summary:
The ENDALGOFIV study of pain assessment during the IVF pathway at Lille University Hospital, conducted from November 2018 to July 2020, showed that endometriosis patients have intense pain, particularly of a neuropathic nature, even before starting their IVF pathway compared to patients without endometriosis, but without an increase in pain scores during the IVF pathway. As a result of this study, a new pain management protocol for all patients undergoing IVF have been implemented in our MPA center. The study will be evaluated the impact of this new management.

Main objective To evaluate the effect of the change in pain management protocol in all patients (endometriotic or not) undergoing IVF treatment during the study period by comparing them to the data of the ENDALGOFIV 1 study.

lead_sponsor: University Hospital, Lille


title: Association Between Live Birth Rate and Serum Progesterone on Frozen-thawed Embryo Transfer Day: Retrospective Study

acronym: PROGEVOL

summary:
Nowadays, frozen-thawed embryo transfers (FET) are expending. This practice avoids risk of ovarian hyperstimulation syndrome (OHSS), as well as allowing better synchronization between endometrium and embryo, which is fundamental for pregnancy.

There are several FET protocols, including hormonal replacement therapy cycle (HRT), which enable clinicians to adapt the day of embryo transfer.

However, increase in spontaneous miscarriages was observed with this latter protocol compared to fresh embryo transfers and the other endometrial preparations (natural and stimulated), in relation with the lack of physiological corpus luteum.

Then, Clinicians interrogate about measuring serum progesterone in order to adjust their treatment and/or transfer date. Various studies have shown thresholds below and/or above which pregnancy or live birth rate were lowered.

The main objective is to find a serum progesterone threshold on the day of embryo transfer above which live birth rate is increased. The secondary objectives are to analyze the factors associated with increased serum progesterone on the day of transfer, to analyze the miscarriage rate, and impact of change on luteal phase support on day 12.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Quantification of the Socio-economic Multifacet Burden of Alopecia Areata and Identification of the Associated Factors

acronym: PelBurd

summary: Alopecia areata (AA) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. It typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. Many patients with AA are dissatisfied with current medical treatments and use alternative therapies and cosmetics. This study will generate new data on the current situation of psychosocial and financial burden of AA. It will help to identify unmet needs and to understand the disease issues. It will also be the basis for the planification of future supporting measures.

lead_sponsor: University Hospital, Toulouse


title: Prospective Randomized Comparative Study Evaluating the Efficacy of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures

acronym: VirtuCardio

summary:
Immersion sedation in virtual reality could be an alternative to conventional pharmacological sedation, during interventional cardiology acts on pain and anxiety control.

The objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary angiography or angioplasty.

lead_sponsor: Elsan


title: Psychological Impact of Medical Evacuations on Families of Patients Admitted to Intensive Care Unit for Severe COVID-19

acronym: IPES-CoV

summary:
At the "Métropole Savoie" hospital, to deal with the daily influx of severe patients during the second wave of COVID-19, 23 patients had to be transferred away from their home city and far from their families as part of a medical evacuation (EVASAN).

The purpose of the study is to investigate whether there is an association between medical evacuations and the occurrence of psychological disorders such as post-traumatic stress, anxiety or depression occurring within 6 to 10 months in families of evacuated patients.

The investigators want to compare the prevalence of psychological disorders in the families of patients evacuated for a serious form of COVID-19 (cases) compared to that of families of patients not evacuated (controls) hospitalized for a serious form of COVID-19.

ipd_sharing_description: The individual participant data (IPD) collected in this study, will not be available to other researchers

lead_sponsor: Centre Hospitalier Metropole Savoie


title: Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients

acronym: MARMEFE

summary:
From a scientific point of view and for publication purposes, it therefore seems important to study the metabolism of iron and in particular to define its conditions of absorption, metabolism, elimination and storage in the body at course of advanced renal failure.

The study will follow the evolution of hormones regulating iron metabolism and put into perspective their links with phosphocalcic and hepatic metabolisms as well as inflammation in hemodialysis patients.

The main objective of this program is to study the evolution of hepcidin and erythroferrone levels in hemodialysis patients. These two biomarkers regulating iron metabolism are not performed routinely in dialysis centers and are not listed in the nomenclature.


title: Audio-vestibular Evaluation of Children and Young Adults With Osteogenesis Imperfecta

acronym: AVOI

summary: The aim is to determine whether vestibular deficits are present in OI, then to establish whether a correlation exists between genetic type, severity of OI and audiovestibular phenotype. OI patients aged 12 to 20 years will undergo an audiometric, immittance, and vestibular assessment. When hearing loss is conductive or mixed or in cases where vestibular deficits are identified, a CT scan without injection will be performed. In case of sensorineural hearing loss or abnormal CT results, an MRI will be performed.

time_perspective: Cross-Sectional


type: Registry Identifier

title: High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder

acronym: EE-TSA-LANG

summary:
The goal of this prospective observational multicentric cohort study is to evaluate the clinical prognostic value of the speech tracking score of language development in children with ASD aged from 3 years to 4 years and half at inclusion.

Participants will followed during 4 years with an annual visit. During these visits, each participant will be clinically evaluated (scales and tests) and performed an EEG-HR recording. Two groups will be formed, one with children diagnosed with ASD with language delay, and a control group composed of non-ASD children without language delay, matched on age and gender with the ASD group.

lead_sponsor: Etablissement Public de Santé Barthélemy Durand


title: Feasibility and Evaluation Study of the UPLUG Hemodialysis Connection Device

acronym: UPLUG-SAFE

summary:
The new Uplug° technology, interface between the end of the hemodialysis catheter and the dialysis circuit, makes it possible to limit direct access to the hemodialysis catheter during connections and disconnections.

Aim:

The investigators propose a feasibility study, in order to study the new Uplug° technology in real conditions of use.

Material and methods:

This study aim to include 15 hemodialysis patients in a center on a tunneled permanent central venous hemodialysis catheter. The Uplug° technology will be placed at the end of each patient's hemodialysis catheter for a period of one month.

Hypothesis tested:

The main endpoint is the proportion of hemodialysis sessions performed successfully with this technology, respecting the usual dialysis prescription.

primary_purpose: Device Feasibility

lead_sponsor: University Hospital, Caen


title: Individualization of Music-based Cueing During Gait in Parkinson's Disease. An Exploratory Cross-over Trial

acronym: MUSIGAIT

summary:
Spatio-temporal correction of the step is a key component of gait rehabilitation in Parkinson's disease. Walking rehabilitation techniques using visual or auditory cueing of the cadence or step length have been tested to prevent or correct the lack of consistency of the step. We propose to introduce an auditory cue of the duration of the step, encouraging it to be extended according to patient own capacities during gait. The cue is integrated into music and is presented in an open-loop approach.

The present study aimed to evaluate the effect of the individual music-based cueing of the step length on gait in Parkinson's disease.

lead_sponsor: Henri Mondor University Hospital

location_facility: Laboratoire Analyse et Restauration du Mouvement


title: Evaluation of Serum Clusterin and Serum PTX3 Assay During Febrile Aplasia in Children Treated in Pediatric Oncology

acronym: CluPPFeN

summary:
Febrile aplasia is a common occurrence in children/adults treated with chemotherapy for malignant blood diseases or solid cancers.

This acquired deficiency of immunity mainly causes susceptibility to bacterial and fungal infections, pathogens normally recognized by specific receptors of innate immunity (Pattern Recognition Receptor, PRR).

Thus, the febrile episodes in the context of post-chemotherapy neutropenia can be bacterial or fungal etiology, but can also frequently be related to viral infections, toxic phenomena or other etiologies. In the absence of a discriminating marker, treatment for all these children is based on early, broad-spectrum antibiotic therapy in hospital. Septic shock or even death by refractory septic shock remain, even if they are rare, real complications in pediatric oncology, requiring discriminatory markers for effective management, While trying to reduce the number and duration of hospitalizations for children at low risk for severe febrile aplasia.

It is therefore necessary to identify other markers allowing the earliest possible classification of episodes of febrile aplasia.

A previous study, conducted by our team, PTX3 and febrile aplasia, studied pentraxin 3 (PTX3), a soluble PRR of the pentraxin family that plays a key role in immune surveillance against pathogens. Preliminary results obtained from samples from a cohort of patients treated in adult hematology and pediatric onco-hematology support a prognostic character of PTX3 in the severity of aplasia, with higher elevations of serum protein during episodes of severe sepsis or septic shock (ongoing analyses and interpretations for the adult population). The available data to date on the pediatric cohort are insufficient to conclude on the value of using PTX3. The investigators therefore wish to create a new paediatric cohort, in order to evaluate the PTX3 levels for the paediatric population and also to perform the assay of a new marker, clusterin.

Clusterin (CLU) is an extracellular chaperone protein of constitutive expression. The Innate Immunity team of the National Institute of Health and Medical Research (INSERM) "1307-Scientific Research National Center (CNRS) 6075" unit has shown that Clu binds to extracellular histones and inhibits their inflammatory, thrombotic and cytotoxic properties. The investigators also observed (i) that in adults without severe sepsis neutropenics, low serum levels of Clu at intake and lack of normalization of rates are associated with higher mortality and (ii) Clu levels are inversely correlated with circulating histone levels. All these data suggest that Clu would have a protective role for histone-induced lesions during sepsis independently of antibiotic treatment, opening an innovative therapeutic pathway in the management of severe sepsis.

CluPPFeN is based on the hypothesis that, in a pediatric population with episodes of febrile aplasia, serum Clu and serum PTX3 levels would discriminate between febrile episodes caused by bacterial infection and other etiologies and, As a result, would reduce the consumption of antibiotics, which provide resistance, and the length of hospitalization.

lead_sponsor: University Hospital, Angers


title: Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition

acronym: OxMiTiAd

summary: The objective of this study is to adapt the oxygraphy technique on human adipocytes and to characterize respiration measurements according to patients' body mass index and white adipose tissue localization (subcutaneous vs visceral).

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Clermont-Ferrand


title: Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological

summary: The facial palsy is a frequent disease with a lot of etiologies. It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed treatments are based on surgery, physiotherapy and botulinum toxin injections. However, when recovery is incomplete, acceptance is more difficult, with an impacted quality of life. Thanks to Motion Capture and Electromyography, a quantification of the facial mimicry is now possible with a great precision. In addition with the quantification of the facial mimicry, eye-tracking, wich is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular, will be used to evaluate the visio of the patients on their pathology in function of the movement quantification measured with MoCap and Electromyography. The aim of this research is to measure in a combined way the action potentials by sEMG and the amplitudes of displacement of the markers in motion capture, for movements determined in a population of patients presenting a facial pathology, in order to compare them with reference values obtained in healthy subjects. In a second step, the aim will be to study if there is a link between the way the patient looks at his pathology and the results of his management (treatment, rehabilitation) which will be quantitatively evaluated thanks to MoCap and sEMG.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Actimeric Monitoring of the Use of the Paretic Upper Limb in the Activities of Daily Living of the Post-chronic Stroke Subject in a Home Environment

acronym: ParUse

summary:
After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment).

The investigators hypothesize the feasibility of quantifying functional use of the paretic upper limb by actimetry in clinical routine.

lead_sponsor: University Hospital, Montpellier


title: Evaluation of a Connected Interface (Rheumatologist, Physiotherapist, Patient) to Improve the Quality of Life and the Disability of Patients With Rheumatic Diseases

acronym: RHUMATO-APP

summary:
Musculoskeletal pathologies constitute a major public health problem. Rheumatologists, whether they practice in private or hospital settings, play a major role in the management of responsible for these ailments.

Due to the increase in life expectancy, an increase in the number of consultations can be expected. It is therefore imperative that the latter be more efficient, without losing quality.

Communication between doctor and patient is bound to evolve due to the multiplicity of IT tools available and those that are emerging, which are increasingly essential, including many smartphone applications. Each targeting a specific pathology (rheumatoid arthritis, ankylosing spondylitis, osteoporosis osteoarthritis, they will allow the patient to self-assess, thus becoming an actor in his own care.

A "facilitated" exchange between caregivers and patients would be relevant and would provide added value for all. This is the reason why there is a real need for an application listing precise information on the patient, in a sufficiently succinct way to optimize their transmission to the physiotherapist.


title: Evaluation and Validation of a Monitoring, Screening and Management Strategy for Conductive Disorders After TAVR (EVATAVI)

acronym: EVATAVI

summary:
Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement).

While pacemaker implantation rate was about 10-15%, new onset LBBB (Left bundle branch block) was observed in 30 % of patients after TAVR but resolved at discharge in the majority of them, with less than 20% progressed to complete AV (atrioventricular) block requiring permanent pacing at hospital discharge.

Higher implantation and improvement of the devices were associated with decline of pace maker implantation rate over the years in experienced teams.

While guidelines do not give definite recommendation regarding conductive disorder management and pacemaker indication, a strategy of selective telemetry monitoring (TM) after TAVR according to the risk of conductive disorders may be proposed to limit indication and lenght of stay of intensive care unit admission (ICU), allowing direct admission of lower risk patients in general cardiology ward (GCW) without TM, to decrease the duration of TM when a conductive disorder is stable or regressive and finally to decrease the rate of pacemakers implantation.

Potential benefit may also include limitation of ICU overload in high volume TAVR centers, investigators can also expect shorter hospitalization duration, with potential economic impact, in line with the development of algorithms for fast track procedures.

Therefore the main objective of our prospective study was to evaluate feasibility and safety of a strategy of management of conductive disorders after TAVR based on an algorithm of diagnosis, monitoring and therapeutic strategies based on ECG analysis.


title: Evaluation of the Evolution of Quality of Life in Relation to Naso-sinus Symptomatology Under Treatment With CFTR Modulators in Children Aged 6 to 11 Years With Cystic Fibrosis With Compatible Mutation

acronym: MUCOSINTRIO

summary:
Cystic fibrosis is a multi-organ disease. It most often results from a genetic mutation, the delta F508 mutation, which prevents the expression of the CFTR 'régulateur de conductance transmembranaire de la fibrose kystique) protein. If the poor prognosis of the disease is correlated to the pulmonary damage, we observe, at the naso-sinus level, a significant functional impact, with chronic rhino-sinusal damage that can alter the quality of life of patients. In addition to this functional impact, some studies suggest that these chronic naso-sinus attacks are involved in the creation of a bacterial reservoir that is secondarily responsible for pulmonary colonization and therefore partly responsible for the poor prognosis of the disease.

The clinical and paraclinical examinations can be used to determine the extent of these disorders. Their functional impact can be assessed using quality of life questionnaires such as the SN-5 scale.

Treatment with CFTR modulators in patients with mutations compatible with the treatment seems to transform their vital prognosis. The scientific rationale of this treatment consists in restoring the activity of the CFTR protein, allowing the recovery of the hydro-electrolytic balance of the mucous secretions, and thus reducing the viscosity of the biological fluids. The various studies carried out all prove a dramatic improvement in pulmonary parameters under treatment, with very limited toxicity.

A marketing authorization for this treatment has been issued on the European market for patients over 18 years of age in 2020, for children over 12 years of age in 2021, and will soon be issued for children aged between 6 and 11 years.

Since the pathophysiology of pulmonary and nasosinus involvement are similar, and since this treatment will be marketed for children between 6 and 11 years of age, we expect an improvement in rhino-sinus symptomatology. To date, clinical studies have focused primarily on pulmonary outcomes. There are only few publications dealing with the evolution of nasosinus symptomatology under treatment, and none concerning the pediatric population.

The aim of our study is to evaluate the evolution of naso-sinusal symptomatology under treatment with CFTR modulators in children aged 6 to 11 years. This will allow us to confirm or deny the interest of these treatments in the extra-pulmonary manifestations of the disease.

lead_sponsor: Hospices Civils de Lyon


title: Prognostic Value of Soluble Urokinase Plasminogen Activation Receptor (SUPAR) to Rule Out Complications in Patients Admitted in Emergency Department for Acute Abdominal Pain.

acronym: GRADIENT

summary:
Soluble Urokinase Plasminogen Activation Receptor (SUPAR) is a validated biomarker with applications in the study of inflammation and infection.

Elevated levels of SUPAR have recently been linked to a higher mortality in patients suffering from undifferentiated sepsis, pneumonia, and more recently, COVID-19 infection.

Large randomized controlled trials have been conducted on patients admitted to the emergency department (ER), regardless of the reason for admittance.

These studies have stratified risk based on three cutoffs at initial measurement:

Low risk : < 3 ng/mL
Intermediate risk : entre 3 et 6 ng/mL
High risk : > 6 ng/mL Low levels of SUPAR are associated with low risk of mortality in the short and long term in patients presenting to the ED, no matter the reason for admittance. Risk stratification could be an added decision-making tool for clinicians to comfort hospital discharge.

To the best of our knowledge, there is no available data on the added value of SUPAR for predicting mortality in abdominal sepsis and abdominal pain.

Abdominal pain is responsible for 10 to 30 % of ER admissions. Consequently, abdominal pain is then responsible for roughly 10 % of admissions into medical and surgical wards. Mortality varies depending on patient factors. Mortality is usually stratified on age. In patients under 50 years of age, it is near 8%, but it reaches 19 % in patients over 50.

Diagnostic accuracy also decreases drastically with age, reaching approximately 30 % patients over 75.

Taking this into account, integrating a measure of SUPAR levels into the current standard of care could stratify the risk of complications in patients admitted to the ER with abdominal pain.

lead_sponsor: Poitiers University Hospital


title: Evaluation of the Technical Feasibility of Testing Circulating Tumour DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.

acronym: PROMECI

summary: Evaluation of technical feasibility for Homologous Recombination (HR) genes variants research on circulating tumor DNA (ctDNA) from plasma and urine of patients with a metastatic prostate cancer.

lead_sponsor: University Hospital, Tours


title: A Phase 1/2 Study of ANV419 as Monotherapy or in Combination With Anti-PD-1 or Anti-CTLA-4 Antibody Following Anti-PD-1/Anti-PD-L1 Antibody Treatment in Patients With Unresectable or Metastatic Cutaneous Melanoma

summary: The purpose of this study is to evaluate the efficacy and safety of ANV419 monotherapy or the combination of ANV419 with anti-PD1 antibody or with anti-CTLA4 antibody in adult participants with advanced (unresectable or metastatic) cutaneous melanoma.

lead_sponsor: Anaveon AG


title: Combined Deep Brain Stimulation of the Substantia Nigra Pars Reticulata and of the Subthalamic Nucleus for Unresponsive Freezing of Gait in Parkinson's Disease: a Pilot Cross-over Study

acronym: SCP-FOG

summary: The study is a pilot study on Parkinson's disease patients to evaluate Combined deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus for unresponsive freezing of gait.


title: Assessment of an Early De-Escalation to a Low-potency Single Antiplatelet Therapy Guided by Genetics Versus a Systematic High-Potency Single Antiplatelet Therapy to Neutralize Bleeding Complications Beyond One Month After an Acute Coronary Syndrome

acronym: ADEN

summary:
Patients who suffered from acute coronary syndrome (ACS) are usually treated with a long-term dual antiplatelet therapy (DAPT) to reduce stent thrombosis and recurrent ischemic event. Nonetheless, recent important data have demonstrated the efficacy of a short term DAPT and an early single antiplatelet therapy in high bleeding and ischemic risk patients.

The bleeding risk is associated with a significant mortality. This risk is especially high in patients treated with potent P2Y12 inhibitors like ticagrelor or prasugrel after an ACS.

As a result of the abounding data regarding the safety of an early single antiplatelet therapy with high potency antiplatelet therapy (ticagrelor or prasugrel), it is likely that such strategy will soon be implemented in the guidelines.

The benefits of these high-potency P2Y12 inhibitors over clopidogrel mostly occur in patients with genetic polymorphisms of CYP2Y12 associated with a loss of function in clopidogrel metabolism.

Furthermore, the anti-ischemic benefit of potent P2Y12 inhibitors over clopidogrel occurs early, while excess bleeding events often arise during chronic treatment.

Our hypothesis is that a systematic and rapid genetic screening of CYP2C90 *2 or *17 polymorphism to guide an early single therapy with low potency antiplatelet (aspirin or clopidogrel) could lead to less bleeding events with a consistent efficacy towards cardiac events compared with high potency antiplatelet therapies (prasugrel or ticagrelor) in high bleeding risk patients treated for ACS.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Does Longitudinal Nursing Follow-up Improve Smoking Cessation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Screening

acronym: BPCO

summary: a monocentric study to evaluate the efficacy of a longitudinal nursing follow up in smoking cessation in patients screened for Chronic obstructive pulmonary disease (COPD).

lead_sponsor: Centre Hospitalier de Valence


title: A Phase II Double-blind Multi-center, Placebo-controlled Trial, to Assess the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients With Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)

acronym: SESAM

summary:
This study is a two periods multi-center Phase II trial, with a 6 months double-blind, placebo-controlled period followed by open label period. It will involve 16 participants with MCAP syndrome.

Assessment will be performed at baseline and after 24 months of treatment and will include MRI, biological and clinical results, attention, language, and Intellectual Quotient (IQ) assessment. Appropriate neuropsychological tests will be used according to the age of patients and their level of cognitive impairment.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Contribution of Animal-assisted Intervention in Oral Healthcare for Disabled Patients

acronym: YODA

summary: The purpose of this study is to determine whether animal-assisted therapy during 2 care sessions then facilitates conventional ambulatory management without animal assistance in anxious uncooperative children with autism.

location_facility: Hôpital Bretonneau - Service d'odontologie


title: Effect of High Flow Nasal Air on Dyspnea During Weaning From Mechanical Ventilation

acronym: FLOWEAN

summary: Detection and relief of dyspnea in mechanically ventilated patients is a priority. Optimization of mechanical ventilation settings is unfortunately often insufficient to relieve dyspnea in patients entering the weaning process. Pharmacological treatments are effective but their use is likely to delay separation with the ventilator. Promoting the development of non-pharmacological interventions is therefore an interesting avenue. The hypothesis is that the application of high-flow humidified nasal air in orotracheally intubated patients can decrease the work of breathing and relieve dyspnea at the time of weaning from mechanical ventilation. Patients will be exposed to stepwise increase in high flow nasal air (0 L/min, 30 L/min, 50 L/min and 70 L/min) before to undergo a 60 minutes spontaneous breathing trial. During the protocol, dyspnea, inspiratory effort, respiratory drive, respiratory muscles electromyogram (EMG) and patient's comfort will be assessed.

location_facility: Medical ICU R3S, Pitié-Salpétriêre Hospital


title: Management of Transitory Loss of Consciousness and Syncopes in the Emergency Department

summary:
The goal of this observational study is to examine the clinical presentations, the diagnostic tests performed and the management of patients presenting with transient loss of consciousness (TLOC)

The main questions it aims to answer are:

prevalence of TLOC
prevalence of different diagnoses leading to TLOC Demographic, clinical, paraclinical and biological data will be collected from the emergency medical file


title: Understanding the Measurement of Girdle Dissociation in the Fall of the Older People Subject. Case-control Study

summary: Falls, especially in the older people, are frequent with potential serious consequences. The strategy for preventing falls involves detecting the fall risk. Current tests to determine the risk of falling are too late indicators of gait disorder. Loss of gait dissociation is an element associated with the mechanism of the fall and appears earlier. Its diagnosis is particularly important as it is a reversible impairment if rehabilitation interventions can be proposed to correct this anomaly.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction

acronym: PARTURP

summary: It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients a Prospective Monocentric Study

acronym: EVITREC

summary:
Capillary refill time is the time it takes for the skin to regain its initial colour after moderate pressure. It is usually performed on the patient index finger, middle finger or ring finger with the examiner's thumb and index finger for five seconds, three measurements having to be averaged. Capillary refill time has a dependent operator character, but it has been shown to be accurately correlated with 14-day mortality in septic shock, hospitalisation need in pediatric population.

The purpose of this project is to show that capillary refill time obtained by a video-assisted method has a better inter- and intra-observer reproducibility than capillary refill time obtained by a visual method.


title: Diagnosis of Postoperative Atrial Fibrillation After Cardiac Surgery by a Smartwatch: an Open-label Randomized Controlled Trial

acronym: FAWATCH

summary:
The incidence of postoperative atrial fibrillation (POAF) after on-pump cardiac surgery remains high, at around 30%. POAF increases the risk of cardiac decompensation, stroke, acute myocardial infarction, and death, resulting in increased morbidity and mortality, hospital length of stay, and cost of patient management. Episodes of POAF are usually paroxysmal and asymptomatic, increasing the risk of developing permanent AF at five years by 4 to 5 times. POAF occurs between 3 and 4 days after cardiac surgery, mainly when the patient is hospitalized in a surgical ward without heart rate monitoring as opposed to critical care, where the patient benefits from continuous rhythmic monitoring. The diagnosis of POAF is therefore made with the help of a 12-lead electrocardiogram (ECG) when the patient presents clinical symptoms and when the medical staff notes a significant variation in heart rate. However, many patients with episodes of asymptomatic POAF have a higher risk of stroke and mortality than those with symptomatic POAF.

Faced with this public health problem, the development of tools for diagnosing AF is in full swing, mainly the marketing of smartwatches (SWs) that allow for the performance of 1-lead ECG. SW is also equipped with algorithms to analyze heart rate variability and diagnose asymptomatic atrial fibrillation (AF) episodes. The European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) recommend the use of smartwatches to detect AF, in particular, to reduce the economic impact of AF.

The aim of the study is to diagnose POAF within the first five days after patient discharge from the critical care unit for the cardiac surgery department.


title: Prognosis Criteria for Walking Independently Recovery After Stroke : Evaluation of the TWIST Algorithm

summary:
Based on a 2017 US study that developed an algorithm for predicting independent walking recovery after stroke, we propose a prospective study to assess the validity and applicability of this algorithm in the majority of stroke patients with walking dependence and to confirm its performance.

This study will therefore include adult patients, hospitalised in the Neurology Department of Caen University Hospital, and presenting a dependence on walking according to the FAC (Functional Ambulation Categories) scale in the first week after stroke.

Treated by M. Pierre-Alexis Rousseau (medical intern for Physical and Rehabilitation Medicine), under the direction of Dr. Alexis Ruet, and in collaboration with the physiotherapists of the Neurology Department (Delphine Lebreton and Daphne Scelles), this study is planned to include patients in the initial phase of the stroke, and to continue to follow up the patients until 6 months after their inclusion.

The aim of this work is to evaluate the performance of the TWIST algorithm in predicting walking recovery after stroke according to trunk control (using the Trunk Control Test) and hip extension strength (using the Medical Research Council score), and to analyse other factors that may potentially influence walking recovery (such as visual field amputation, neglect, ataxia, depression, undernutrition).

ReferenceCitation: Smith MC, Barber PA, Stinear CM. The TWIST Algorithm Predicts Time to Walking Independently After Stroke. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):955-964. doi: 10.1177/1545968317736820. Epub 2017 Nov 1.

ReferenceCitation: Williams LS, Brizendine EJ, Plue L, Bakas T, Tu W, Hendrie H, Kroenke K. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke. 2005 Mar;36(3):635-8. Epub 2005 Jan 27.


title: Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer

acronym: LURBIMUNE

summary: Multicenter, prospective, open-labeled, 2-arm, randomized non-comparative (2:1) phase II trial assessing the efficacy of lurbinectedin in association with durvalumab

lead_sponsor: Institut Bergonié


title: Biological Collection of Brain Tumors - GLIOLI Collection

acronym: GLIOLI

summary: The objective of this study is to build a collection of biological samples from patients with brain tumors.