title: SKAMo-2: the Real-life Test of Continuous Photoacoustic Signal by Neogly in Patients With Type I Diabetes

summary:
Diabetes is one of the very common and chronic diseases in the present world, which affects children and adults. Diabetes is characterized by hyperglycemia. Hence, diabetic patients need to precisely monitor their blood sugar level regularly a few times a day. Currently, the solutions for self-monitoring blood glucose are invasive (finger prick method, continuous glucose monitoring (CGM) using microneedle).The fully non-invasive CGM approaches still are in high demand.

The medical device is developed, ultimately, to continuously measure the blood glucose level from continuous in-vivo photoacoustic signal.

For this study, the goal is to check if the signal collected by the investigational device is relevant and exploitable in patients with type I diabetes.

The main task of participants is to wear the investigational device during one week.

primary_purpose: Device Feasibility

lead_sponsor: Eclypia


title: Evaluation of the Treatment of Symptomatic Proximal InterPhalangeal (PIP) Joint Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition

summary: The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of PIP joint osteoarthritis.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: TBF Genie Tissulaire

location_facility: Institut Chirurgical de la Main et du Membre Supérieur

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia

acronym: HITSTREAM

summary: The investigators would like to analyze platelet/leukoplak activation, quantify and morphologically characterize these aggregates using in vitro analysis, directly on whole blood from adult patients with suspected HIT. This would enable to better describe the in vivo pathophysiology of the HIT-suspect patient, and eliminate the need for platelet donors to perform the usual confirmatory techniques, whose inter- and intra-individual variability is very high. What's more, the SRA test, evaluated as the reference test, requires the use of radioisotopes and is therefore only carried out in a few biological expertise centers, resulting in a very long delay in the delivery of results. It should also be noted that, in practice, HÉPARINE is immediately stopped in patients with suspected HIT, and they are put on an expensive anticoagulant (DANAPAROIDE SODIQUE or ARGATROBAN) in curative doses until the results of the confirmatory tests are back. In this serious, life-threatening condition, it is essential to have a sensitive, specific test to confirm HIT as quickly as possible. Each patient with suspected HIT (rapid >30% reduction in platelet count after initiation of heparin therapy) should have 4 tubes of 3.2% citrated whole blood (2.7ml) collected at the time of suspected HIT (D0) and before any therapeutic switch (or 24 h max after switch). A new sample (4 citrated tubes) will be taken at D4, D7 and D14 during hospitalization, in patients who test positive for anti-PF4/H Ac. All patients with suspected HIT will follow the standard diagnostic pathway, i.e. a screening test (immunological test for anti-PF4/heparin antibodies, total Ig, ACL TOP, Werfen) followed by a confirmatory test (platelet aggregation on TA-8V, STAGO and/or SRA). Doppler ultrasonography of the lower limbs will be performed in HIT-suspect patients with a positive anti-PF4/H antibody test, as currently performed as part of routine care.

study_start_date_type: Actual

status: Recruiting

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire, Amiens

lead_sponsor_type: academique


title: Prevalence of Tapia's Syndrome in Weaning Unit and Associated Factors After Orotracheal Intubation in the ICU

acronym: PRESTIO

summary:
Tapia syndrome is a rare and poorly understood pathology. It is defined by a concomitant attack of the recurrent (branch of X) and hypoglossal (XII) nerves of peripheral or central origin. It is characterized by the paralysis of a vocal cord and the ipsilateral half of tongue. This damage is most often unilateral but it can also be bilateral. It results in dysphonia and swallowing disorders.

Tapia syndrome is a rare and poorly understood pathology. To date, less than 100 cases have been described in the literature. Previous works are mainly case reports and literature reviews. No prevalence study has been performed to date. Furthermore, disagreements persist regarding the semiology. Indeed, the involvement of the soft palate is not always described.

status: Enrolling by invitation

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Lykoudis EG, Seretis K. Tapia's syndrome: an unexpected but real complication of rhinoplasty: case report and literature review. Aesthetic Plast Surg. 2012 Jun;36(3):557-9. doi: 10.1007/s00266-011-9849-y. Epub 2011 Dec 17.

ReferenceCitation: De Luca P, Cavaliere M, Scarpa A, Savignano L, Cassandro E, Cassandro C, Iemma M. Rehabilitation Protocol for Unilateral Laryngeal and Lingual Paralysis (Tapia Syndrome): Comment About "A Challenging Case of Tapia Syndrome After Total Thyroidectomy" By Ildem Deveci, Mehmet Surmeli, and Reyhan Surmeli. Ear Nose Throat J. 2021 Sep;100(5_suppl):734S-737S. doi: 10.1177/0145561320907433. Epub 2020 Feb 23.

ReferenceCitation: Boga I, Aktas S. Treatment, classification, and review of Tapia syndrome. J Craniofac Surg. 2010 Jan;21(1):278-80. doi: 10.1097/SCS.0b013e3181c678f0.

ReferenceCitation: Caranti A, Bianchini C, Corazzi V, Pelucchi S, Ciorba A. Tapia's Syndrome: keep it in mind! Minerva Anestesiol. 2022 Apr;88(4):293-299. doi: 10.23736/S0375-9393.21.16037-7.

ReferenceCitation: Decavel P, Petit C, Tatu L. Tapia syndrome at the time of the COVID-19 pandemic: Lower cranial neuropathy following prolonged intubation. Neurology. 2020 Aug 18;95(7):312-313. doi: 10.1212/WNL.0000000000010011. Epub 2020 Jun 9. No abstract available.

lead_sponsor: Hopital Forcilles

intervention_type: Diagnostic Test

status_simplified: Unknown


title: Does Bedside Ultrasound Clot Elasticity Measurement Reduce Intraoperative Transfusion During Double-lung Transplantation?

acronym: QUANTRANS

summary:
Transfusion in lung transplantation is common, and despite improved techniques and limitations in the use of mechanical circulatory support (MCS), the incidence of massive transfusion has remained stable over the years. The consequences of blood transfusion (blood cells, plasma, platelet concentrates) are deleterious for patients and increase primary graft dysfunction and mortality risk.

Whole blood viscoelastic testing devices have shown its effectiveness in monitoring coagulation and fibrinolytic function during cardiac surgery, liver transplantation or trauma. So far, few delocalized biology tools have been evaluated in lung transplantation.

The main objective of this study is to determine if the use of a transfusion algorithm based on whole blood viscoelastic test with Quantra® test reduce transfusion during lung transplantation.

design_allocation: Randomized

primary_purpose: Diagnostic

ReferenceCitation: Herrington CS, Prekker ME, Arrington AK, Susanto D, Baltzell JW, Studenski LL, Radosevich DM, Kelly RF, Shumway SJ, Hertz MI, Bittner HB, Dahlberg PS. A randomized, placebo-controlled trial of aprotinin to reduce primary graft dysfunction following lung transplantation. Clin Transplant. 2011 Jan-Feb;25(1):90-6. doi: 10.1111/j.1399-0012.2010.01319.x. Epub 2010 Aug 19.

ReferenceType: result

ReferenceCitation: Triulzi DJ, Griffith BP. Blood usage in lung transplantation. Transfusion. 1998 Jan;38(1):12-5. doi: 10.1046/j.1537-2995.1998.38198141492.x.

ReferenceCitation: Cernak V, Oude Lansink-Hartgring A, van den Heuvel ER, Verschuuren EAM, van der Bij W, Scheeren TWL, Engels GE, de Geus AF, Erasmus ME, de Vries AJ. Incidence of Massive Transfusion and Overall Transfusion Requirements During Lung Transplantation Over a 25-Year Period. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2478-2486. doi: 10.1053/j.jvca.2019.03.060. Epub 2019 Mar 30.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

version: publishedVersion

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Huddleston SJ, Jackson S, Kane K, Lemke N, Shaffer AW, Soule M, Hertz M, Shumway S, Qi S, Perry T, Kelly R. Separate Effect of Perioperative Recombinant Human Factor VIIa Administration and Packed Red Blood Cell Transfusions on Midterm Survival in Lung Transplantation Recipients. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3013-3020. doi: 10.1053/j.jvca.2020.05.038. Epub 2020 Jun 3.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Seay T, Guinn N, Maisonave Y, Fuller M, Poisson J, Pollak A, Bryner B, Haney J, Klapper J, Hartwig M, Bottiger B. The Association of Increased FFP:RBC Transfusion Ratio to Primary Graft Dysfunction in Bleeding Lung Transplantation Patients. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):3024-3032. doi: 10.1053/j.jvca.2020.05.043. Epub 2020 Jun 7.

ReferenceCitation: Cimic N, Tulleken JE, Zijlstra JG, van der Bij W, Boonstra PW. Recombinant factor VIIa for refractory hemorrhage after lung transplantation. Transplantation. 2005 Mar 27;79(6):741-2. doi: 10.1097/01.tp.0000147319.66838.71. No abstract available.

ReferenceCitation: Felten ML, Fischler M. Intraoperative use of activated recombinant factor VII for refractory bleeding in complicated lung transplantations. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):382-3. doi: 10.1053/j.jvca.2009.06.006. Epub 2009 Aug 19. No abstract available.

ReferenceCitation: Detterbeck FC, Egan TM, Mill MR. Lung transplantation after previous thoracic surgical procedures. Ann Thorac Surg. 1995 Jul;60(1):139-43.

ReferenceCitation: Ius F, Kuehn C, Tudorache I, Sommer W, Avsar M, Boethig D, Fuehner T, Gottlieb J, Hoeper M, Haverich A, Warnecke G. Lung transplantation on cardiopulmonary support: venoarterial extracorporeal membrane oxygenation outperformed cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1510-6. doi: 10.1016/j.jtcvs.2012.07.095. Epub 2012 Aug 31.

ReferenceCitation: Hoechter DJ, Shen YM, Kammerer T, Gunther S, Weig T, Schramm R, Hagl C, Born F, Meiser B, Preissler G, Winter H, Czerner S, Zwissler B, Mansmann UU, von Dossow V. Extracorporeal Circulation During Lung Transplantation Procedures: A Meta-Analysis. ASAIO J. 2017 Sep/Oct;63(5):551-561. doi: 10.1097/MAT.0000000000000549.

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Adelmann D, Koch S, Menger J, Opfermann P, Jaksch P, Hoetzenecker K, Kurz M, Mouhieddine M, Steinlechner B. Risk factors for early bleeding complications after lung transplantation - a retrospective cohort study. Transpl Int. 2019 Dec;32(12):1313-1321. doi: 10.1111/tri.13491. Epub 2019 Aug 30.

publisher_dissemination: Frontiers

ReferenceCitation: Kesten S, de Hoyas A, Chaparro C, Westney G, Winton T, Maurer JR. Aprotinin reduces blood loss in lung transplant recipients. Ann Thorac Surg. 1995 Apr;59(4):877-9. doi: 10.1016/0003-4975(95)00051-l.

ReferenceCitation: Balsara KR, Morozowich ST, Lin SS, Davis RD, Phillips-Bute BG, Hartwig M, Appel JZ, Welsby IJ. Aprotinin's effect on blood product transfusion in off-pump bilateral lung transplantation. Interact Cardiovasc Thorac Surg. 2009 Jan;8(1):45-8. doi: 10.1510/icvts.2008.178749. Epub 2008 Jul 31.

ReferenceCitation: Bittner HB, Richter M, Kuntze T, Rahmel A, Dahlberg P, Hertz M, Mohr FW. Aprotinin decreases reperfusion injury and allograft dysfunction in clinical lung transplantation. Eur J Cardiothorac Surg. 2006 Feb;29(2):210-5. doi: 10.1016/j.ejcts.2005.12.001.

ReferenceCitation: Bittner HB, Binner C, Dahlberg P, Mohr FW. Reducing ischemia-reperfusion injury in clinical lung transplantation. Transplant Proc. 2007 Mar;39(2):489-92. doi: 10.1016/j.transproceed.2006.12.005.

ReferenceCitation: Marasco SF, Pilcher D, Oto T, Chang W, Griffiths A, Pellegrino V, Chan J, Bailey M. Aprotinin in lung transplantation is associated with an increased incidence of primary graft dysfunction. Eur J Cardiothorac Surg. 2010 Feb;37(2):420-5. doi: 10.1016/j.ejcts.2009.08.007. Epub 2009 Sep 19.

lead_sponsor: Hopital Foch

intervention_type: Other


title: Clinical Impact of Patient Ventilator Asynchrony in Patients With Chronic Respiratory Failure on Long-term Ventilation : a Prospective, Monocentric, Open-label Epidemiological Study

acronym: INSPIRER

summary: The investigator wish to carry out this study to explore the link between patient-ventilator asynchrony with the efficiency and tolerance of NIV but also the quality of life in patients with chronic respiratory failure on long-term ventilation.

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

intervention_type: Device


title: Suicidology and Anthropology Research Protocol : Qualitative Study of Suicidal Recrudescence Among Adolescents in November 2021

acronym: Suicide-Covid

summary:
A qualitative study, combining psychiatric and anthropological perspectives, focused on the lived experiences of patients who had recourse to HPNCL emergencies during the period of November 2021, as well as the experiences and perceptions of those around them - such as their family, teachers or school and nursing staff. This multi-site approach will provide a multidimensional perspective on the experience of individuals and those around them, as well as a triangulation of data.

The hypotheses to explain the increase in the rate of suicidal crisis will be addressed through semi-structured interviews proposed to the participants of the study.

lead_sponsor: Fondation Lenval

intervention_type: Behavioral


type: Registry Identifier

title: Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial

acronym: FIRST

summary:
Post-extubation dysphagia (PED) is a frequent but still underestimated condition in the intensive care units (ICU). In the international literature, the manifestations and consequences of PED lead to intra- and post-intensive care comorbidities.

The exact etiology of PED is unknown, but considered multifactorial. Numerous causes, acquired during ICU, can lead to a delay in the reintroduction of intravenous nutrition, or even favor the development of inhalation pneumopathy. One of these causes is the presence of the nasogastric tube.

The incidence of ECD varies from 3 to 62%. Its presence impacts morbidity and mortality. Preventive strategies for PED have only been studied with questionable methodologies.

The goal of ICU therapists is to detect PED as early as possible in order to implement curative strategies such as adapted nutrition and early swallowing rehabilitation.

ReferenceCitation: McIntyre M, Doeltgen S, Dalton N, Koppa M, Chimunda T. Post-extubation dysphagia incidence in critically ill patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jan;34(1):67-75. doi: 10.1016/j.aucc.2020.05.008. Epub 2020 Jul 29.

ReferenceCitation: Leder SB, Warner HL, Suiter DM, Young NO, Bhattacharya B, Siner JM, Davis KA, Maerz LL, Rosenbaum SH, Marshall PS, Pisani MA, Siegel MD, Brennan JJ, Schuster KM. Evaluation of Swallow Function Post-Extubation: Is It Necessary to Wait 24 Hours? Ann Otol Rhinol Laryngol. 2019 Jul;128(7):619-624. doi: 10.1177/0003489419836115. Epub 2019 Mar 6.

ReferenceCitation: Zuercher P, Moser M, Waskowski J, Pfortmueller CA, Schefold JC. Dysphagia Post-Extubation Affects Long-Term Mortality in Mixed Adult ICU Patients-Data From a Large Prospective Observational Study With Systematic Dysphagia Screening. Crit Care Explor. 2022 Jun 8;4(6):e0714. doi: 10.1097/CCE.0000000000000714. eCollection 2022 Jun.

ReferenceCitation: Warner HL, Suiter DM, Nystrom KV, Poskus K, Leder SB. Comparing accuracy of the Yale swallow protocol when administered by registered nurses and speech-language pathologists. J Clin Nurs. 2014 Jul;23(13-14):1908-15. doi: 10.1111/jocn.12340. Epub 2013 Sep 6.

lead_sponsor: Centre Hospitalier Régional d'Orléans

intervention_type: Procedure


title: Exercise Tolerance After Venous Recanalization for Post-thrombotic Syndrome: ETERecaVSPT

acronym: ETERecaVSPT

summary: Post-thrombotic syndrome (PTS) is the most frequently observed chronic complication of deep vein thrombosis (DVT), with an estimated cumulative incidence of 20-50%. Endovascular venous recanalization with angioplasty and stenting of obstructive lesions is the recommended treatment option to reduce or correct the symptoms of DVT. However, its impact on the physical capacity and breathlessness of patients has not been fully demonstrated. The heterogeneous evidences of clinical improvement is probably related to the presence or absence of collateral veins developed in these patients with proximal venous obstruction (iliac or iliofemoral with or without inferior vena cava involvement), which ensure the cardiac venous return. The aim of this study is to compare changes in maximal oxygen uptake after endovascular venous recanalization in DVT patients and to evaluate the hemodynamic, respiratory and muscular improvement induced by the restoration of venous flow in the occluded segments.

lead_sponsor: University Hospital, Montpellier

location_facility: Hopital Arnaud de Villeneuve - CHU de Montpellier


title: METabolic PROFILE of Hepatocarcinoma and Pancreatic Tumors

acronym: PROMETHEP

summary:
Hepatic (hepatocellular carcinoma (HCC)) and pancreatic (pancreatic adenocarcinoma (ADKP); pancreatic neuroendocrine tumors (TNEP)) primary tumors are the most common malignant tumors of the hepato-bilio-pancreatic system and represent a major public health issue. At present, the management of these tumors is based on recommendations based on the existence of rudimentary prognostic and theranostics markers that do not sufficiently accurately reflect the heterogeneity of tumor biology. It therefore seems essential to identify new and more relevant markers in order to optimize the care of these patients in daily practice.

Metabolic reprogramming is now recognized as an essential feature of cancer cells, allowing them to fuel and maintain their proliferation and tumor growth. Such metabolic reprogramming requires modification of several energy pathways, the most commonly recognized being the transition from energy metabolism based on oxidative phosphorylation to energy metabolism based on glycolysis, even under aerobic conditions (Warburg effect). In this context, the investigators hypothesized that the consumption of nutrients by the tumor cell differs significantly from that of the normal cell in order to support its increased energy needs, and that this important and specific metabolic reprogramming would be correlated with the histo-prognostic and theranostics factors of these tumors. Preliminary analyses on surgical resection parts conducted by the various partners in 2019 made it possible to characterize the metabolic signatures of a series of HCC and ADKP resected using the Metafora biosystems technology platform. These signatures reflect a metabolic program characteristic of these tumors, which reveal strong specificities. Similarly, a candidate signature correlating with the presence of vascular microscopic invasion has been identified in HCC, and the level of activation of glycolysis and glutaminolysis by certain ADKP cells also appears as a trait of interest vis-à-vis the aggressiveness of this cancer.

Thus, the current project will aim to confirm the feasibility of identifying specific prognostic and theranostics metabolic signatures early, on biopsy samples and / or circulating blood cells.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study of the Impact of Frequency of Changing PICCline Dressings in Patients With Acute Leukemia

acronym: LEUKA-PICC

summary: Peripherally Inserted Central Catheters have been widely used for many years for the administration of chemotherapy to patients with cancer. However, its use entails significant infectious complications and high risks of death.The hypothesis is that increasing the rate of PICCline dressing changes will reduce the occurrence of catheter-related infections.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients

acronym: DART-REIN

summary:
Donor-derived cell-free DNA (dd-cfDNA) has been proposed as a potential diagnostic tool to monitor the rejection status of the kidney transplant. It has been suggested that dd-cfDNA is increasing in the blood of kidney transplant patient presenting a graft rejection. In this project, investigators proposed a different approach to predict and characterize kidney transplant rejection/dysfunction based on the quantification of epigenetic signatures present on the donor-cell-free DNA. In 2018, Moss et al. develops a deconvolution model capable of identifying the tissue origin of circulating DNA by taking advantage of its epigenetic properties. The study confirmed that the cell-free DNA circulating in healthy subjects comes mainly from blood cells and endothelial cells, but not from kidney cells.

In this study, researchers investigate the evolution of blood renal-specific cell-free DNA amount in patient with chronic kidney disease before and after the transplantation surgery by testing a set of renal-specific epigenetic markers. The purpose of this study is to identify the biological noise of "native kidney" on renal-specific cell-free DNA and to compare it with signal coming from "transplanted kidney".

ipd_sharing: Yes

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

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

location_facility: Nephrology-transplantation department Pitié-Salpétriêre hospital

intervention_type: Genetic


title: Evaluation of the Effectiveness of Platelet-based and Microvesicle-based Assays to Predict Thrombotic and Bleeding Risk in Chronic Kidney Disease Patients With Acute Coronary Syndrome

acronym: INNOV CKD 1

summary: This study is part of the RHU INNOV-CKD, winner of the 2019 call for projects. Its aim is to develop two biomarker assays to assess the thrombotic and haemorrhagic risks in patients with stage 3A or more severe chronic kidney disease (CKD) treated with percutaneous coronary intervention (PCI) and antiplatelet therapy following an acute coronary syndrome (ACS). We believe that these tests will help to adapt antiplatelet therapy on an individual basis (in terms of intensity and duration of treatment) and thus reduce the risk of thrombotic and haemorrhagic events in this particularly fragile population. The first biomarker corresponds to an intra-platelet molecule, Rap1b in its active form (known as aRap1b). The second is the pro-antithrombotic balance of circulating endothelial microvesicles (patEMV), which reflects endothelial dysfunction. An automated method for measuring these biomarkers will be developed in partnership with the D.Stago and BioCytex industries during the course of the project.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Practice Analysis of Care, Paraclinical Exams and Treatments Received by Geriatric Patients Both During the Last Week and the Last 24 Hours of Their Lives.

summary: End-of-life care is a core topic for geriatricians. One of the key aspects of end-of-life management is deciding when to discontinue active care measures (for example blood pressure monitoring, blood tests and X-rays) in favor of exclusive comfort care. In this retrospective observational study, the investigators looked at the care measures, treatments and paraclinical exams received by geriatric patients both one week and 24 hours before their death.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


type: Other Identifier

title: Prospective Validation of the CLAD Score in Patients Admitted to an Emergency Facility for Renal Colic Pain

acronym: CLAD-V

summary:
Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions.

This study would validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

status_simplified: Completed


title: Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics

acronym: EFImôme

summary:
In current practice, there are various nutritional risk scores and diagnostic tools which are used in both inpatient and outpatient settings,however, in some cases, these tools cannot be used due to lack of data.

That's why a tool that doesn't require any anthropometric parameters, such as a visual food intake scale, could be useful to for medical and paramedical staff. In this way, a larger proportion of the paediatric population could benefit from nutritional screening.


title: Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers

acronym: HEALTHY-PRONE

summary:
Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory distress syndrome (ARDS). Despite the benefits of PP, this technique presents adverse effects such as an increased risk of bedsores, linked to the duration, which must be around 16 consecutive hours.

There are 2 PP techniques:

Positioning with arms alongside the body
Swimmer's position At present, no study compares or has compared prospectively, the impact of the type of position used during ventral decubitus on mortality and the incidence of pressure sores, nor on secondary effects in intensive care.

Pressure transducers are available for instantaneous measurement of pressures between 2 interfaces. The investigators have acquired a pressure-measuring device, a mattress topper which is attached to the resuscitation mattress and which, connected to a PC, provides a live display of the pressures between the patient and the mattress.

The investigators would like to use their device to measure pressures during these 2 PP in healthy volunteers, which would enable them to obtain the world's first data on the real pressures generated during PP.


title: Optimising Screening of Intermediate to High-risk Asymptomatic Sportsmen With Exercise Electrocardiogram. The SEEPRED Study.

acronym: SEEPRED

summary: The importance of exercise electrocardiogram (ECG) is still controversial in the prevention of cardiac events among sportsmen. The aim of this study was to assess the relevance of exercise electrocardiogram (ECG) as a significant prognostic marker for cardiovascular events when any cardiovascular disease (CVD) risk factors are present.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)

summary: Multiligamentar knee injury has consequences on knee function (instability, arthritis, life disagreement). Surgical reconstructions have known recent evolutions. The goal of this study is to evaluate functional and clinical results at one year of those new surgical technics. A clinical and functional follow up will be performed before the surgery, then at 6 months and one year.


title: Performance of Spectral CT-scan in Patients With Metastatic Colorectal Cancer: a Prospective Multicentre Study

summary: Spectral CT is a rapidly expanding imaging modality that allows a reduction in iodine dose and irradiation compared to conventional scanning. It uses the difference in attenuation of the material according to the two different energy levels of the incident x-ray beams. The dual-energy scanner has a wide range of clinical applications, particularly in abdominal imaging.


title: Role of Cancer-associated Fibroblast, MDSCs and Immune Cell Interplays in the Resistance of Non-small Cell Lung Cancer to Anti-PD1/PD-L1 Therapies

acronym: COCKPI-T

summary: Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to cellular and soluble immunosuppressive mechanisms. These immunosuppressive mechanisms will be better characterized and their involvement in therapeutic responses in non-small cell lung cancers (NSCLC). Indeed, large transcriptomic analysis of different subsets of immunosuppressive cells will performed, correlating them to clinical outcome in a cohort of stage III disease, treated by radiochemotherapy and immunotherapy as maintenance, and stage IV treated by immunotherapy as first-line treatment. Furthermore, we will analyse cellular mechanisms by in vitro studies, assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on phenotype and functions of lung cancer cell lines. The aim of this study is to better characterize immunosuppressive landscape of NSCLC and mechanisms involved in their protumor functions.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Hôpital Saint-André, Service d'Oncologie Médicale


title: Role of Myeloid Derived Suppressive Cells (MDSCs) and Cancer Stem Cells and Their Cross Talks in Non-Small Cell Lung Cancer (NSCLC)

acronym: MyéloLungSC

summary: Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to cellular and soluble immunosuppressive mechanisms. MDSC are one of the most important immunosuppressive cells, that also harbour non immunologic functions, favouring cancer invasion. These non immunologic functions of MDSC in lung cancer will be better characterized. Indeed, cellular mechanisms will be analysed by in vitro studies, assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on phenotype and functions of lung cancer cell lines. The aim of this study is to better characterize immunosuppressive landscape of NSCLC and mechanisms involved in their protumor functions.


title: Safety and Efficacy Assessments of NeoKidney®, a New Sorbent-based Hemodialysis Device, in ESRD Patients Treated With Short Daily Hemodialysis: a First in Human Use.

acronym: FIH Caen

summary:
The goal of this clinical investigation is to asses the safety and efficacy a new sorbent-based hemodialysis device, NeoKidney® in ESRD patients treated with short daily hemodialysis.

Participants (stable SDHD patients) will undergo hemodialysis treatement on the NeoKidney® device at the hospital on a progressive exposition to the device:

The first week, patient will be treated once with NeoKidney® on Wednesday
The 2nd week the patient will be treated two consecutive days with NeoKidney® (in the middle of the week)
On the 3rd week, after approval by the DSMB, the patients will be treated 6 consecutive days, in hospital, with the NeoKidney

All the other sessions will be performed with the patient's usual SDHD device at home except for two sessions prior to NeoKidney® sessions at Week 1 and 2.

lead_sponsor: Nextkidney S.A.

sponsor_collaborators:
Nextkidney S.A.
Monitoring Force Group


title: Impact of Epigenetic Age on Clinic-biological Presentation and Prognosis in Myeloproliferative Neoplasms Epigenetic Age in Myeloproliferative Neoplasms (EpiC)

acronym: EpiC

summary: Myeloproliferative Neoplasms (MPN) are hematological malignancies characterized by the excessive production of myeloid cells. MPN can be complicated by thrombosis and evolution into more aggressive diseases (myelofibrosis and acute leukemia). Aging remains the principal factor determining patients' survival in MPN. In recent years, DNA methylation has appeared as a mean to measure aging via the development of epigenetic clocks that have also been associated with the occurrence of thrombosis and cancer. The epiC project aims at determining epigenetic age of MPN patients and search for an association between this parameter and thrombotic/hematological complications.

location_facility: CHU de Bordeaux, service Hématologie Biologique


title: Study of Pharmacological and Clinical Correlates of Frontal Cortical Electroencephalographic (EEG) Signal During the Induction, Maintenance and Emergence Phases of Anesthesia in Children

acronym: SPECTRAL-PED

summary: Using data from a prospective cohort of children receiving general anaesthesia for surgery, this project will collect pharmacological correlates (doses and timing of administration of anaesthetic drugs) and clinical correlates (stimulations including nociceptive stimulation, possible responses such as movement/resumption of spontaneous ventilation during maintenance of anaesthesia/tachycardia/high blood pressure) of patients during the three phases of anesthesia (induction, maintenance, emergence).


title: Analysis of Volatile Organic Compounds in Expired Air in Healthy Volunteers: Comparison of Three Mass Spectrometry Techniques for the Characterization of Volatolome in Clinical Studies

acronym: VOC-COMPARE

summary: A major obstacle in precision medicine is the unavailability of biomarkers that are easy to access, non-invasive, measurable with high-performance techniques, fast, easy to use, reproducible, inexpensive and easily deployable on a large scale. The analysis of exhaled air (volatolomics) is an "omics" approach devoted to the analysis of volatile organic compounds (VOCs) eliminated by the pulmonary route with real-time detection, at the patient's bedside. The reference technology for the analysis of VOCs is mass spectrometry (MS). Several types of mass spectrometers can be used, and, in the absence of a consensual and standardized method, have practical methods for carrying out different analyzes which also lead to the generation of specific signals whose nature, complexity and exhaustiveness of information generated are heterogeneous. The clinical studies carried out to date use one of the analytical techniques available, without the choice necessarily being guided by objective factors. The objective of this study is to fill this gap and compare the information obtained by three mass spectrometry techniques available to our team (proton transfer reaction - mass spectrometry (PTR-MS), Soft Ionization by Chemical Reaction in Transfer (SICRIT) , two-dimensional gas chromatography-mass spectrometry (GCxGC-MS)) for volatolome analysis. The comparative analysis of the different signals will make it possible to determine the interests and limits of each technique and thus to direct preferentially towards one, the other, or combinations of them for the realization of future clinical studies. One of the main challenges also consists in establishing the concordance of the signals generated by the different technological approaches, some employing prior chromatographic separation, others not, and some employing soft ionization methods while those of others are on the contrary hard. Thus, the availability of datasets obtained on the same population with these complementary approaches will allow significant progress for the identification of the COVs of interest in clinical studies, beyond the simple comparison of the analytical performances of the different methods.

primary_purpose: Health Services Research


title: Interest of Follicular Helper Lymphocytes / Regulatory Follicular Helper Lymphocytes Ratio to Characterize and Predict Poor Prognosis Forms in IgA Nephropathy: an Exploratory Proof-of-concept Study

acronym: LYMFONI

summary:
This study aims to investigate the relevance of the Tfh/Tfr (Follicular helper T cells/ Follicular regulatory T cells) ratio in patients with IgA nephropathy:

To identify a differential expression of the Tfh/Tfr ratio in patients considered stable or progressive
To predict, at diagnosis, the clinical evolution of the disease (progressive or stable form) in the first year.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Randomized Pilot Trial: Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

acronym: YOG-IC

summary: Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is often accompanied by anxiety and depression symptoms that can contribute to poor treatment compliance. The overall management of heart failure is currently part of the recommendations and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is an ancient practice, known to improve the emotional and physical well-being of individuals. There is no formal medical contraindication to this practice, which can be perfectly adapted to the patient's condition. However, very few patients with heart failure practice yoga. A few randomized trials with small numbers as well as the combined analysis of several studies have shown the benefit of yoga in heart failure. The main objective of the research is to demonstrate the improvement in the quality of life induced by the regular practice of yoga in the management of stabilized chronic heart failure patients. Secondly, we will evaluate the effectiveness of regular yoga practice on improving the clinical condition of chronic heart failure patients.

primary_purpose: Supportive Care

ReferenceCitation: Aggarwal M, Bozkurt B, Panjrath G, Aggarwal B, Ostfeld RJ, Barnard ND, Gaggin H, Freeman AM, Allen K, Madan S, Massera D, Litwin SE; American College of Cardiology's Nutrition and Lifestyle Committee of the Prevention of Cardiovascular Disease Council. Lifestyle Modifications for Preventing and Treating Heart Failure. J Am Coll Cardiol. 2018 Nov 6;72(19):2391-2405. doi: 10.1016/j.jacc.2018.08.2160.

ReferenceCitation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

repository_institution: University of Liège - Open Repository and Bibliography

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

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Pullen PR, Nagamia SH, Mehta PK, Thompson WR, Benardot D, Hammoud R, Parrott JM, Sola S, Khan BV. Effects of yoga on inflammation and exercise capacity in patients with chronic heart failure. J Card Fail. 2008 Jun;14(5):407-13. doi: 10.1016/j.cardfail.2007.12.007. Epub 2008 May 27.

ReferenceCitation: Pullen PR, Seffens WS, Thompson WR. Yoga for Heart Failure: A Review and Future Research. Int J Yoga. 2018 May-Aug;11(2):91-98. doi: 10.4103/ijoy.IJOY_24_17.

ReferenceCitation: Pullen PR, Thompson WR, Benardot D, Brandon LJ, Mehta PK, Rifai L, Vadnais DS, Parrott JM, Khan BV. Benefits of yoga for African American heart failure patients. Med Sci Sports Exerc. 2010 Apr;42(4):651-7. doi: 10.1249/MSS.0b013e3181bf24c4.

ReferenceCitation: Diez-Quevedo C, Lupon J, Gonzalez B, Urrutia A, Cano L, Cabanes R, Altimir S, Coll R, Pascual T, de Antonio M, Bayes-Genis A. Depression, antidepressants, and long-term mortality in heart failure. Int J Cardiol. 2013 Aug 20;167(4):1217-25. doi: 10.1016/j.ijcard.2012.03.143. Epub 2012 Apr 14.

ReferenceCitation: Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

ReferenceCitation: Chandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

ReferenceCitation: Galinier M, Roubille F, Berdague P, Brierre G, Cantie P, Dary P, Ferradou JM, Fondard O, Labarre JP, Mansourati J, Picard F, Ricci JE, Salvat M, Tartiere L, Ruidavets JB, Bongard V, Delval C, Lancman G, Pasche H, Ramirez-Gil JF, Pathak A; OSICAT Investigators. Telemonitoring versus standard care in heart failure: a randomised multicentre trial. Eur J Heart Fail. 2020 Jun;22(6):985-994. doi: 10.1002/ejhf.1906. Epub 2020 Jun 15.

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

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories_concat: HAL

publisher_dissemination: Wiley

ReferenceCitation: Nolte K, Herrmann-Lingen C, Wachter R, Gelbrich G, Dungen HD, Duvinage A, Hoischen N, von Oehsen K, Schwarz S, Hasenfuss G, Halle M, Pieske B, Edelmann F. Effects of exercise training on different quality of life dimensions in heart failure with preserved ejection fraction: the Ex-DHF-P trial. Eur J Prev Cardiol. 2015 May;22(5):582-93. doi: 10.1177/2047487314526071. Epub 2014 Mar 13.

ReferenceCitation: Giuliano C, Karahalios A, Neil C, Allen J, Levinger I. The effects of resistance training on muscle strength, quality of life and aerobic capacity in patients with chronic heart failure - A meta-analysis. Int J Cardiol. 2017 Jan 15;227:413-423. doi: 10.1016/j.ijcard.2016.11.023. Epub 2016 Nov 7.

ReferenceCitation: Peyre H, Leplege A, Coste J. Missing data methods for dealing with missing items in quality of life questionnaires. A comparison by simulation of personal mean score, full information maximum likelihood, multiple imputation, and hot deck techniques applied to the SF-36 in the French 2003 decennial health survey. Qual Life Res. 2011 Mar;20(2):287-300. doi: 10.1007/s11136-010-9740-3. Epub 2010 Oct 1.

location_facility: Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC


title: A Prospective Study in Creatine Transporter Deficiency (SLC6A8) Patients to Determine the Most Relevant Outcome Measures

summary:
Creatine transport deficiency (CTD) is a rare genetic disorder related to pathogenic variants in the SLC6A8 gene, located on chromosome Xq28. Clinical diagnosis of CTD is based on clinical presentation, an increased urinary creatine/creatinine ratio and a severe decreased creatine peak on 1H-MRS magnetic resonance spectroscopy.

A retrospective study with questionnaires identified that most CTD patients had moderate to severe intellectual disability. Less than one third of patients were able to speak in sentences. Seizures were present in 59% of the patients. 41% had autistic features. Motor dysfunction was mentioned in 58%, and gastrointestinal symptoms were reported in 35% of the patients.

Several new therapeutic avenues are currently emerging in this disease for which no treatment has been available until now : cyclocreatine (interesting but unfortunately with very little clinical applicability due to its toxicity; dodecyl creatine ester incorporated into lipid nanocapsules with intranasal administration; pharmaco-chaperoning (for the folding-deficient creatine transporter variants, Ultragenyx pharmaceuticals new prodrug designed to deliver creatine to the brain (UX068). These new pharmacological treatment options may offer future opportunities to improve cognition in CTD patients.

A key issue is to determine outcome measures that are accessible to these patients, despite the importance of their cognitive deficit. In a preliminary study (on 31 CTD patients), investigators showed for example, that 75% of patients were unable to perform a Wechsler scale, which is one of the most used neuropsychological test to determine patient IQ (intelligence quotient). Most of the existing cognitive tests were developed to distinguish typically developing persons and ID (intellectual disability) patients, leading to a floor effect in the latter who systematically fail these tests. Therefore, these tests are not adapted to capture the potential effect of a drug in ID patient group. The identification of reliable and sensitive outcome measures for use in clinical trials in ID patients was recognized as a priority in a meeting convened by the NIH. N-of-1 trials (also called Single-Case Experimental Designs or SCEDs) appear of great interest for rare diseases, statistical power coming from the number of repeated measures, which leads to choose outcome measures that can be repeated multiple times.

This innovative study will allow to efficiently preparing future therapeutic trials, by specifying the phenotype of the patients, and by determining the most adapted outcome measures taking into account their cognitive deficiency and the type of experimental design to be used in the context of rare diseases.

lead_sponsor: Hospices Civils de Lyon

location_facility: Woman, mother and child hospital, Hospices Civils de Lyon


title: Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation

acronym: FIMFos

summary: The aim of this study is to evaluate the correlation between the fat infiltration of the lumbar multifidus muscle and several parameters including the severity of the lumbar foraminal stenosis. The investigators will analyse lumbar MRI of patients previously included in a database of patients suffering from low back pain. Foraminal stenosis, muscle fat infiltration and other imaging lumbar parameters will be studied by 2D and 3D manuel segmentation, semi-automatic segmentation. Correlations between factors influencing the muscle fat infiltration will be studied by univariate and multivariate statistical analysis.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Combined Effects of Acute Sleep Restriction and Moderate Acceleration (+Gz) on Physiological and Behavioral Responses to High Mental Workload

acronym: CogPhyAero

summary:
Fighter pilots have to perform tasks requiring high mental workload during moderate-intensity acceleration phases (2 to 3G) that can last several minutes. When these accelerations are performed in the body axis (+Gz), they induce a redistribution of blood flow in the lower limbs associated with a decrease in cerebral blood flow, partially compensated by activation of the sympathetic nervous system (baroreflex).

The main hypothesis is that the effects of these prolonged accelerations, even of moderate intensity (<+4Gz), could impair pilots' ability to perform complex cognitive tasks, with potential consequences for flight safety and mission conduct.

Moreover, flight missions are often performed after sleep debt, which is known to induce cardiovascular responses, sympathetic nervous system activation and impaired mental performance.

The secondary hypothesis is that sleep debt (3h of time spent in bed) may increase the impairment of cognitive performance during prolonged acceleration.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Direct Transcranial Stimulation With Direct Current Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive

acronym: PPSTDCS-TOC

summary:
This is a single-center study about patients with severe resistant OCD.

Main assumption is that performing 10 tDCS sessions with the anode positioned at the level of the right orbitofrontal cortex, and the cathode at the level of the supplementary motor area, associated with the provocation of symptoms before each session is effective in the reduction in obsessive-compulsive symptoms.

After the inclusion visit, the treatment period is provided from D1 to D12 (one session per day from Monday to Friday, for two consecutive weeks, i.e. a total of ten sessions). Each tDCS session lasts 30 minutes at an intensity of 2 mA and is preceded by symptom provocation using a standardized procedure performed by trained personnel.

The patients are then assessed on D42 and D102 (i.e. 1 month and 3 months after the end of the tDCS sessions).

lead_sponsor: Centre Hospitalier Henri Laborit


title: Effect of Acute Exercise on Sensory and Hedonic Responses to a Fixed Meal in Adolescents With Obesity

acronym: SMASH

summary:
While long considered independently, energy expenditure and energy intake have been shown to interact. Fot the last 20 years, the litterature has been describing tyhe effects of an acute bout of exercise on subsequent energy intake and appetitive responses, indicating a potenital anorexigenic effect of intensive exercise in adolescents with obesity. These studies suggest a decrease in hunger, redcued satiety and modified food reward responses.

These results remain however obtained in studies using post exercise ad libitum test meals and this nature of the meal might ahve impact these responses.

The present work tends to assess the effect of acute exercise on subsequent appetite and food reward responses to a fixed meal, in adolescents with obesity.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of the Type 1 IFN Response in Viral Infections

acronym: Respiferon

summary:
Respiratory viral infections (RVIs) represent a major public health problem and a great burden in terms of morbidity and mortality in children and adults worldwide. To ascertain the source of an infection, microbiology laboratories routinely perform a crucial step: the search for the pathogen through Polymerase Chain Reaction (PCR). Due to the extensive variety of pathogens, testing for the existence of all potential viruses, bacteria, or fungi accountable for the infection is an impractical and time-intensive endeavor. Furthermore, the rise of novel pathogens, exemplified by those accountable for the recent SARS-CoV-2 pandemic, underscores the urgency of promptly developing new innovative diagnostic tests.

To address these needs, researchers have dedicated several years to developing indirect methodologies notably centered around utilizing markers derived from the host's immune system. Among these, one particularly promising approach focuses on measuring the expression of interferon-stimulated genes, which are uniquely triggered by viral infections, thereby facilitating viral diagnosis. This methodology's efficacy has been proven in the context of SARS-CoV-2 infections.

This study's objective is to assess the functionality of such a tool across a spectrum of Respiratory Viral Infections (RVIs) prevalent within a French population during the winter season.

location_facility: Infective Agents Institute, Croix rousse Hospital


title: Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer - Hypno-TEC Feasibility Study

acronym: Hypno-TEC

summary:
Assisted Reproduction Technology (ART) procedures are often long and particularly stressful for couples. The level of anxiety appears to persist throughout the entire process, particularly during embryo transfer, a pivotal and delicate stage in In Vitro Fertilization (IVF). Many women apprehend this maneuver, firstly, as it represents the culmination of the process and consequently elicits apprehensions regarding negative outcome, and secondly, as it instigates anxiety related to potential discomfort during the procedure.

Medical Hypnosis in Virtual Reality is a combination of hypnotherapy and immersion in a fictitious world, used in the medical field for anxiolytic and analgesic purposes. This fusion is made possible by a virtual reality headset coupled with an auditory device.

The diversion and relaxation conferred by this device can lead to a reduction in perceived anxiety and an indirect enhancement of compliance and cooperation during medical procedure. Several studies have already demonstrated a benefit on pre-operative and peri-operative anxiety, with reassuring safety data on the use of this medical device.

However, despite the common use of VRH in the medical field, encouraging data on anxiety reduction, and accessibility to these headsets within in certain ART departments, they are not routinely employed during embryo transfers. Various barriers to the implementation of this medical device in this indication seem to be present, encompassing organizational, technical, and practical aspects.

Consequently, the Hypno-TEC study aims to assess the feasibility of using virtual reality hypnosis (VRH) headset for anxiolytic purposes during frozen embryo transfer (FET).

Hypno-TEC will be a prospective interventional study, not comparative, and conducted at a single center, within the Reproductive Medicine Department of the Mother-Child-Woman Hospital in Lyon. This clinical investigation will fall under category 4.2 of medical device regulations, according to European Regulation 2017/745.

The enrolled patients, estimated to be 50 in number, will benefit from the device (VRH headset) during the execution of the FET procedure.

Besides assessing the feasibility of this usage, secondary outcomes will include: (i) evaluating the procedure's acceptability, (ii) patient and caregiver satisfaction with this application, (iii) effect on patient anxiety, and (iv) the pregnancy rates following the transfers concerned by the study.

The expected benefit is the potential to incorporate these headsets into routine practice, thereby would be enhancing patient adherence and tolerance to the transfer procedure.


title: NEAR-TSA : Adaptation of the NEAR (Neuropsychological and Educational Approach of Cognitive Remediation) Cognitive Remediation Method to Child and Adult Autism by Including Social Scenarios and Skills

acronym: NEAR-TSA

summary:
The investigators currently provide the NEAR method (neuropsychological educational approach to cognitive remediation) for people with neurocognitive difficulties, without distinguishing between ASD and schizophrenia.

However, the NEAR method does not address social cognition in the stimulated functions. The aim of this study is to add social scenarios to this neurocognitive method in order to improve not only neurocognitive functions, but also social cognition. Thus, NEAR would be in this adapted form a method that could be completely adapted to autism spectrum disorders in preadolescents and adults.

The study will include participants aged 13-40 years, with a diagnosis of ASD.

The NEAR TSA method will include 32 sessions:

one session (90-120 min, with one or two breaks) per week for 32 weeks (8 months), for minor participants.
two sessions (90 minutes each, with no breaks) per week for 16 weeks (4 months), for adult participants.

The method includes 30 minutes of computerized exercises, 15 minutes of discussion on the exercises performed and the strategies applied, and the rest of the time for "bridging groups".

Three evaluation are proposed:

an initial clinical and functional evaluation (T1), before the beginning of the program,
a second clinical, functional and neuropsychological evaluation (T2), within one month since the end of the program
a third clinical, functional and neuropsychologica evaluationl (T3), three months after the end of the program.

lead_sponsor: Centre Hospitalier St Anne


type: EudraCT Number

title: Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome : a Double-blind Multicenter Randomized Controlled Study

acronym: OBIRINS

summary: B-cell depletion with rituximab induces sustained remission in children with Steroid-Dependent or Frequent Relapsing Nephrotic Syndrome (SD/FRNS). However, most patients relapse after B-cell recovery and some do not achieve B-cell depletion. Obinutuzumab is a 2nd generation humanized monoclonal antiCD20 antibody, with enhanced B cell-depleting potential. It has been reported safe and efficient in different renal autoimmune diseases including childhood nephrotic syndrome. This double-blind, randomized multicenter study is designed to assess the efficacy and safety of a single infusion of low-dose obinutuzumab compared to a single infusion of rituximab in children with frequently relapsing nephrotic syndrome (FRNS) or steroid-dependent nephrotic syndrome (SDNS).

intervention_type: Drug


title: Characterization of the Immuno-inflammatory Response Involved in Bone Destruction During Periodontitis: Study on Biological Samples With Collection

summary:
Periodontitis is a major public health problem because it is widespread in the adult population. It leads to the irreversible destruction of the anchoring tissues of the teeth, and represents a modifiable risk factor for systemic inflammatory pathologies. This chronic inflammatory disease, which is associated with oral dysbiosis involving Porphyromonas gingivalis, is triggered by a permissive immune response. It is preceded by a reversible clinical phase, during which there is no bone resorption process: gingivitis. The understanding of the key mechanisms involved in the evolution from gingivitis to periodontitis, which will allow to early identify patient at risk of periodontitis, remain unclear at this time.

Neutrophils are the main cells of inflammation present within the periodontal pockets. The excess of certain neutrophils or the alteration of their functions is associated with the triggering of periodontitis, whereas their activity, finely orchestrated, would be a key to periodontal homeostasis. It is likely that some periodontal bacteria, including P. gingivalis, but also products of matrix catabolism could deregulate the physiological functions of neutrophils towards pro-inflammatory and catabolic profiles. Moreover, to date, the differentiation and role of neutrophil subsets in periodontal homeostasis as well as in gingivitis and its evolution into periodontitis remain poorly studied.

The investigators hypothesize that various subsets of neutrophils may play different roles during the development of periodontitis (evolution of gingivitis to periodontitis).

The primary objective is to characterize neutrophil subtypes associated with periodontal destruction during periodontitis.

Secondary objectives are :

Identify specific interactions of tissue-activated neutrophils with the matrix microenvironment during periodontitis
Identify specific interactions of tissue or oral (salivary) activated neutrophils with the oral microbiota during periodontitis
Identify specific oral (salivary) neutrophil subtypes in periodontal health, gingivitis and periodontitis
Evaluate the function, including pro-osteoclastogenic function, of oral neutrophils compared to blood neutrophils stimulated by infection

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

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


title: Evolution of Muscle Function, Breathlessness and Quality of Life Following Intra or Extra-Abdominal Sepsis in ICU Patients

acronym: EMBLemAticS

summary:
Sepsis is organ dysfunction secondary to an inappropriate host response to infection. In the most severe cases, circulatory failure necessitating the introduction of vasopressor therapy is called septic shock. Sepsis and septic shock are life-threatening systemic organ dysfunctions requiring hospitalization in a critical care unit. According to several studies, sepsis accounts for around 30% of patients in these units. In this patient population, mortality in the critical care unit or in hospital is 25.8% and 35.3% respectively.

Among the organ dysfunctions associated with sepsis, striated skeletal muscle damage is frequent and possibly severe. The literature refers to this as sepsis-induced myopathy, and describes three main mechanisms: mitochondrial dysfunction, exacerbated proteolysis and altered muscle membrane excitability.

Of all the striated skeletal muscles that can be affected, the diaphragm and the muscles of the thoracic and abdominal wall play a major role in breathing. The diaphragm remains the main muscle involved in breathing. Its physiology is twofold. Firstly, through its contraction, the diaphragm is responsible for the lateral movement of the lower ribs, thus increasing the transverse diameter of the thorax. This first action is commonly referred to as "insertional". At the same time, lowering the phrenic center of the diaphragm increases abdominal pressure. Its distinctive upwardly convex domed appearance means that it is intimately in contact with both the chest wall and the abdominal cavity. This particular area of contact is called the apposition zone. It is on this zone, under the action of the abdominal compartment, that positive pressure also generates an outward thrust from the medial face of the lower ribs, a second action commonly referred to as "appositional".

A number of studies, including that carried out by our team (US_DIAMONDS, NCT 02474797), have identified a high prevalence of diaphragmatic damage in patients with sepsis or septic shock. This can be as high as 60%. This diaphragmatic dysfunction would then be associated with a higher mortality rate in hospital and at D90 of discharge.

The clinical evolution of post-resuscitation patients remains a little-studied subject. However, patients may present muscle dysfunctions in the longer term after a stay in intensive care. In our study, we demonstrated that less than half of patients recovered from diaphragmatic dysfunction on discharge from the critical care unit. In addition, Borges RC et al. found a significant decrease in the cross-sectional area of the rectus femoris at discharge, compared with the same measurement taken at D+2 of admission to the critical care unit.

Finally, the impact of muscle dysfunction on dyspnoea during sepsis and after its resolution is uncertain. Similarly, the impact of muscle dysfunction and dyspnoea on quality of life is unknown. Sepsis is associated with muscle dysfunction of multiple mechanisms. The aim of this study is to assess the immediate and longer-term impact of muscle dysfunction on muscle, dyspnea and quality of life in patients with abdominal sepsis ("Abdominal sepsis" group) and patients with extra-abdominal sepsis ("Extra-abdominal" group). Depending on the location of sepsis, this study will enable us to assess and potentially confirm the preferential effect of abdominal sepsis on diaphragm function.

ReferenceCitation: Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Le Neindre A, Wormser J, Luperto M, Bruel C, Misset B, Bouhemad B, Philippart F. Diaphragm function in patients with sepsis and septic shock: A longitudinal ultrasound study. Aust Crit Care. 2023 Mar;36(2):239-246. doi: 10.1016/j.aucc.2022.01.003. Epub 2022 Mar 7.

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. doi: 10.1097/01.ccm.0000194725.48928.3a.

ReferenceCitation: Sakr Y, Jaschinski U, Wittebole X, Szakmany T, Lipman J, Namendys-Silva SA, Martin-Loeches I, Leone M, Lupu MN, Vincent JL; ICON Investigators. Sepsis in Intensive Care Unit Patients: Worldwide Data From the Intensive Care over Nations Audit. Open Forum Infect Dis. 2018 Nov 19;5(12):ofy313. doi: 10.1093/ofid/ofy313. eCollection 2018 Dec.

ReferenceCitation: Hadda V, Kumar R, Tiwari P, Mittal S, Kalaivani M, Madan K, Mohan A, Guleria R. Decline in diaphragm thickness and clinical outcomes among patients with sepsis. Heart Lung. 2021 Mar-Apr;50(2):284-291. doi: 10.1016/j.hrtlng.2020.12.014. Epub 2020 Dec 28.

ReferenceCitation: Borges RC, Soriano FG. Association Between Muscle Wasting and Muscle Strength in Patients Who Developed Severe Sepsis And Septic Shock. Shock. 2019 Mar;51(3):312-320. doi: 10.1097/SHK.0000000000001183.

ReferenceCitation: Bougle A, Rocheteau P, Sharshar T, Chretien F. Muscle regeneration after sepsis. Crit Care. 2016 May 19;20(1):131. doi: 10.1186/s13054-016-1308-3.

ReferenceCitation: De Troyer A, Boriek AM. Mechanics of the respiratory muscles. Compr Physiol. 2011 Jul;1(3):1273-300. doi: 10.1002/cphy.c100009.

ReferenceCitation: Chen Y, Liu Y, Han M, Zhao S, Tan Y, Hao L, Liu W, Zhang W, Song W, Pan M, Jiao G. Quantification of diaphragmatic dynamic dysfunction in septic patients by bedside ultrasound. Sci Rep. 2022 Oct 15;12(1):17336. doi: 10.1038/s41598-022-21702-6.

ReferenceCitation: Laghi FA Jr, Saad M, Shaikh H. Ultrasound and non-ultrasound imaging techniques in the assessment of diaphragmatic dysfunction. BMC Pulm Med. 2021 Mar 15;21(1):85. doi: 10.1186/s12890-021-01441-6.

ReferenceCitation: Solverson KJ, Grant C, Doig CJ. Assessment and predictors of physical functioning post-hospital discharge in survivors of critical illness. Ann Intensive Care. 2016 Dec;6(1):92. doi: 10.1186/s13613-016-0187-8. Epub 2016 Sep 20.

ReferenceCitation: Grassi A, Ferlicca D, Lupieri E, Calcinati S, Francesconi S, Sala V, Ormas V, Chiodaroli E, Abbruzzese C, Curto F, Sanna A, Zambon M, Fumagalli R, Foti G, Bellani G. Assisted mechanical ventilation promotes recovery of diaphragmatic thickness in critically ill patients: a prospective observational study. Crit Care. 2020 Mar 12;24(1):85. doi: 10.1186/s13054-020-2761-6.

ReferenceCitation: Goligher EC, Fan E, Herridge MS, Murray A, Vorona S, Brace D, Rittayamai N, Lanys A, Tomlinson G, Singh JM, Bolz SS, Rubenfeld GD, Kavanagh BP, Brochard LJ, Ferguson ND. Evolution of Diaphragm Thickness during Mechanical Ventilation. Impact of Inspiratory Effort. Am J Respir Crit Care Med. 2015 Nov 1;192(9):1080-8. doi: 10.1164/rccm.201503-0620OC.

ReferenceCitation: Lu Z, Ge H, Xu L, Guo F, Zhang G, Wu Y. Alterations in diaphragmatic function assessed by ultrasonography in mechanically ventilated patients with sepsis. J Clin Ultrasound. 2019 May;47(4):206-211. doi: 10.1002/jcu.22690. Epub 2019 Jan 22.

ReferenceCitation: Le Neindre A, Hansell L, Wormser J, Gomes Lopes A, Diaz Lopez C, Romanet C, Choukroun G, Nguyen M, Philippart F, Guinot PG, Buscher H, Bouhemad B, Ntoumenopoulos G. Thoracic ultrasound influences physiotherapist's clinical decision-making in respiratory management of critical care patients: a multicentre cohort study. Thorax. 2023 Feb;78(2):169-175. doi: 10.1136/thoraxjnl-2021-218217. Epub 2022 Mar 23.

publisher_dissemination: British Medical Journal

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Safety and Efficacy of the GUIDEX® Versus Launcher™ Guiding Catheter in Adults' Patients With Coronary Artery Disease (CAD) Requiring Percutaneous Coronary Intervention (PCI): a Non-inferiority and Randomized, Clinical Trial.

summary:
The goal of this clinical trial is to compare two guiding catheters in patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and Launcher™ coronary guide catheters (Medtronic). The main question[s] it aims to answer are:

Aren't the safety of medical devices inferior to each other?
Aren't the efficacyof medical devices inferior to each other? Participants will be randomized (1:1) and have a percutaneous coronary interventionwith one of the two guiding catheters.

ipd_sharing_description: Nothing

lead_sponsor: Tianjin Demax Medical Technology Co., Ltd


title: DIAPHRAGMATIC SPECKLE TRACKING DURING SPONTANEOUS BREATHING TRIAL

acronym: DIAST

summary: Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric balloons is the gold standard for the assessment of diaphragmatic effort. This technique is relatively invasive and its interpretation may be complex. The diaphragmatic longitudinal strain (LSdi) and strain rate (LSRdi) might provide additional information in the assessment of diaphragmatic effort and movement during SBT, allowing early detection of diaphragmatic dysfunction. Patients will be monitored during a 30-120 minutes SBT consisting of no assistance on the ventilator using CPAP with a pressure level of 0 cmH2O. Parameters to evaluate diaphragm function will include diaphragmatic strain (LSdi and LSRdi), diaphragmatic thickening fraction (TFdi), and airway occlusion pressure (ΔP0.1 and ΔPocc). These parameters will be measured immediately before ('baseline') the SBT, as well as 2 minutes ('early' assessment), 15 ('intermediate' assessment) and 30 minutes ('late' assessment) after the beginning of the SBT.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Interest of the Automated Management of Deep Neuromuscular Blockade Monitoring : A Pilot Pre-post Quasi Experimental Study (CURATP)

acronym: CURATP

summary:
Neuromuscular blockade (NMB) recommendations updated in 2018 by the Société Française d'Anesthésie et Réanimation (SFAR) recommend the use of NMB agents to facilitate surgical procedure during abdominal surgery by laparotomy or laparoscopy.

This study aims to evaluate deep NMB monitoring with automated management of NMB depth measurement (ATP mode) versus non-automated monitoring (PTC/TOF), in order to improve the maintenance of deep NMB during abdominal surgery.

ReferenceCitation: GRAY TC, HALTON J. Technique for the use of d-tubocurarine chloride with balanced anaesthesia. Br Med J. 1946 Aug 31;2:293-5. No abstract available.

ReferenceCitation: Ali HH. A new device for monitoring force of thumb adduction. Br J Anaesth. 1970 Jan;42(1):83-5. doi: 10.1093/bja/42.1.83. No abstract available.

ReferenceCitation: Dhonneur G, Kirov K, Motamed C, Amathieu R, Kamoun W, Slavov V, Ndoko SK. Post-tetanic count at adductor pollicis is a better indicator of early diaphragmatic recovery than train-of-four count at corrugator supercilii. Br J Anaesth. 2007 Sep;99(3):376-9. doi: 10.1093/bja/aem124. Epub 2007 Jun 7.

ReferenceCitation: Kim HJ, Lee K, Park WK, Lee BR, Joo HM, Koh YW, Seo YW, Kim WS, Yoo YC. Deep neuromuscular block improves the surgical conditions for laryngeal microsurgery. Br J Anaesth. 2015 Dec;115(6):867-72. doi: 10.1093/bja/aev368.

oa_host_type: publisher

ReferenceCitation: Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gatke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014 Nov;119(5):1084-92. doi: 10.1213/ANE.0000000000000316. Erratum In: Anesth Analg. 2015 Apr;120(4):957. Dosage error in article text.

evidence: open (via free article)

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

ReferenceCitation: Madsen MV, Gatke MR, Springborg HH, Rosenberg J, Lund J, Istre O. Optimising abdominal space with deep neuromuscular blockade in gynaecologic laparoscopy--a randomised, blinded crossover study. Acta Anaesthesiol Scand. 2015 Apr;59(4):441-7. doi: 10.1111/aas.12493. Epub 2015 Mar 1.

ReferenceCitation: Kim MH, Lee KY, Lee KY, Min BS, Yoo YC. Maintaining Optimal Surgical Conditions With Low Insufflation Pressures is Possible With Deep Neuromuscular Blockade During Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Group Clinical Trial. Medicine (Baltimore). 2016 Mar;95(9):e2920. doi: 10.1097/MD.0000000000002920.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

ReferenceCitation: Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13.

ReferenceCitation: Koo BW, Oh AY, Seo KS, Han JW, Han HS, Yoon YS. Randomized Clinical Trial of Moderate Versus Deep Neuromuscular Block for Low-Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy. World J Surg. 2016 Dec;40(12):2898-2903. doi: 10.1007/s00268-016-3633-8.

publisher_dissemination: Springer-Nature

ReferenceCitation: Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park H, Bai SJ. The Intraocular Pressure under Deep versus Moderate Neuromuscular Blockade during Low-Pressure Robot Assisted Laparoscopic Radical Prostatectomy in a Randomized Trial. PLoS One. 2015 Aug 28;10(8):e0135412. doi: 10.1371/journal.pone.0135412. eCollection 2015. Erratum In: PLoS One. 2018 Oct 18;13(10):e0206339.

evidence: oa repository (semantic scholar lookup)

ReferenceCitation: Plaud B, Baillard C, Bourgain JL, Bouroche G, Desplanque L, Devys JM, Fletcher D, Fuchs-Buder T, Lebuffe G, Meistelman C, Motamed C, Raft J, Servin F, Sirieix D, Slim K, Velly L, Verdonk F, Debaene B. Guidelines on muscle relaxants and reversal in anaesthesia. Anaesth Crit Care Pain Med. 2020 Feb;39(1):125-142. doi: 10.1016/j.accpm.2020.01.005. Epub 2020 Jan 8.

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

ReferenceCitation: Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur M, Benson J, Newmark RL, Maher CE. Comparison of the TOFscan and the TOF-Watch SX during Recovery of Neuromuscular Function. Anesthesiology. 2018 Nov;129(5):880-888. doi: 10.1097/ALN.0000000000002400.

ReferenceCitation: Claudius C, Skovgaard LT, Viby-Mogensen J. Arm-to-arm variation when evaluating neuromuscular block: an analysis of the precision and the bias and agreement between arms when using mechanomyography or acceleromyography. Br J Anaesth. 2010 Sep;105(3):310-7. doi: 10.1093/bja/aeq162. Epub 2010 Jun 30.


title: Impact of Non-magnetic Screen Respiratory Self-guidance During MRI-guided Radiotherapy Sessions for Mobile Lesions

acronym: RespEcran

summary:
The patients eligible for the study are those treated by radiotherapy on Linac MRI for a mobile cancerous lesion (pancreas, liver, kidneys, adrenals, lung, adenopathy above or below the diaphragm ...).

After signing the consent form, each patient will be randomized to one of two treatment arms:

Standard arm : Radiotherapy treatment with Linac MRI without non-magnetic shielding
Experimental arm : radiotherapy treatment with Linac MRI with non-magnetic screen The aim is to evaluate the effect of using a non-magnetic screen visible to the patient in the bunker during radiotherapy sessions delivered by Linac MRI on decreasing the ratio between the actual treatment time and the treatment time predicted by the machine.

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Combination Product


title: To Study the Predictive Value of Th1, Th2 and Th17 Cytokine Serum Levels Produced After Non-specific Stimulation on the Success of Embryo Implantation

summary:
Infertility affects approximately 10-15% of the population. The number of assisted reproduction procedures has increased by a factor of 3 to 5.3 worldwide over the last 20 years. Despite recent techniques, pregnancy rates seem to be limited to 35% by embryo transfer. Embryo implantation depends on two factors: the quality of the embryo and the endometrial receptivity. Although good quality embryos are transferred, implantation may not occur. Changes in the maternal cytokine profile at the time of implantation may result in poor implantation or early abortions. Consequently, a misdirection of the immunological profile could be responsible for repeated implantation failure (RIF). The definition of RIF is not consensual, but most commonly refers to 3 failures after good quality embryo transfer, and would affect between 5 and 10% of patients.

The possibility of defining a predictive immune profile for RIF from a peripheral blood sample is debated. However, after stimulation of immune cells in peripheral blood, patients with RIF show an excessive pro-inflammatory profile.

Our objective is to assess the activation of T cells and innate immune cells (via an anti-CD3 agonist and a TLR7-8 ligand, respectively) from a blood sample to predict implantation success after frozen embryo transfer. This functional test is easy to use and applicable in a clinical routine.

ipd_sharing_description: Sharing data is not planned

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Biological Monitoring by a Nurse of Post-hospital Heart Failure Patients.

acronym: IC-SPEC

summary: The aim of this study is to evaluate the feasibility and safety of delegating remote biological monitoring in post-hospitalization for cardiac decompensation by a heart failure nurse.

ReferenceCitation: Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

ReferenceCitation: Khan MS, Sreenivasan J, Lateef N, Abougergi MS, Greene SJ, Ahmad T, Anker SD, Fonarow GC, Butler J. Trends in 30- and 90-Day Readmission Rates for Heart Failure. Circ Heart Fail. 2021 Apr;14(4):e008335. doi: 10.1161/CIRCHEARTFAILURE.121.008335. Epub 2021 Apr 19.

ReferenceCitation: Health Quality Ontario. Effect of Early Follow-Up After Hospital Discharge on Outcomes in Patients With Heart Failure or Chronic Obstructive Pulmonary Disease: A Systematic Review. Ont Health Technol Assess Ser. 2017 May 25;17(8):1-37. eCollection 2017.

ReferenceCitation: Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Kim SS, Koehler K, Lucke S, Honold M, Heinze P, Schweizer T, Braecklein M, Kirwan BA, Gelbrich G, Anker SD; TIM-HF Investigators. Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Eur J Heart Fail. 2010 Dec;12(12):1354-62. doi: 10.1093/eurjhf/hfq199.

ReferenceCitation: Jourdain P, Jondeau G, Funck F, Gueffet P, Le Helloco A, Donal E, Aupetit JF, Aumont MC, Galinier M, Eicher JC, Cohen-Solal A, Juilliere Y. Plasma brain natriuretic peptide-guided therapy to improve outcome in heart failure: the STARS-BNP Multicenter Study. J Am Coll Cardiol. 2007 Apr 24;49(16):1733-9. doi: 10.1016/j.jacc.2006.10.081. Epub 2007 Apr 2.

lead_sponsor: Hôpital NOVO

location_facility: Cardiology department - Hospital NOVO - Pontoise site


title: Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis

acronym: EchoPR

summary: The prevalence of Sjogren's syndrome (SS) in rheumatoid arthritis (RA) patients varies from 3.5 to 31%. Between 30% and 90% of patients with (RA) have dry eye and/or mouth syndrome. To date, no studies have assessed whether RA patients have echostructural changes in their salivary glands suggestive of SS and the factors associated with these changes.The aim of this study is to investigate if there are changes in the echostructure of the salivary glands of RA patients, especially in patients with dry syndrome.


title: Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)

acronym: JUMPresearchII

summary:
Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. One of the major challenges is the detection and management of treatment side effects for all patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. After the evaluation day, patients are referred to the most appropriate structures (Adapted physical activity, sports for health, and rehabilitation at Henry Gabriel Hospital).

JUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). This leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. Finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers.

This non-interventional research is classified as "research involving human subjects", class 3 .

The objective of this research is to evaluate the impact of cancer on the musculoskeletal system and to test ultrasound as a clinical examination for the detection of sarcopenia in this population.


title: Validation of a Clinical Assessment Scale Specific to Alternating Hemiplegia

acronym: TREAT-AHC

summary:
Alternating Hemiplegia of Childhood (AHC) is a very rare neurological disorder of genetic origin, combining paroxysmal episodes and neurodevelopmental impairment. The disease is generally sporadic, and its incidence has been estimated at 1 in 100,000 births, with around 500 cases published worldwide. The true prevalence of AHC may be underestimated due to a lack of understanding of the disease and a high degree of phenotypic heterogeneity.

It should be noted that, to date, it is difficult to assess the clinical characteristics of AHC patients in a homogeneous way. The lack of disease-specific clinical outcome measures therefore constitutes a critical node for advancing AHC research. In addition, recognition of the pattern of movement disorders and the ability to classify their severity are very important and useful for the clinician. Homogeneous disease assessment will help plan rehabilitative and pharmacological interventions, facilitate monitoring of treatment outcomes, and predict prognosis.

This is why an AHC assessment scale have been developed in collaboration with clinical teams from the IAHCRC consortium.

The scale has already been tested and validated on Italian and Spanish patients. The aim of this study is therefore to validate the use of this same scale on our French population of AHC patients. The hypothesis of the study is that the practical use of this scale specific to alternating hemiplegia is reproducible. To this end, all the items on the scale will be scored independently for each patient by 4 neuropediatricians with expertise in the disease, in order to observe the reproducibility of the results obtained with this scale. The scale will be used for twenty AHC patients of all ages.

location_facility: Service d'Epileptologie Clinique, des Troubles du Sommeil et de Neurologie Fonctionnelle de l'Enfant


title: Troponin to Detect Major Cardiovasculaire Advserse Events on Immune: a Case Control Retrospective Study

acronym: TILT

summary:
Recent guidelines suggest the use of troponin to detect immnune related cardiovascular advserse events in patients treated by immune checkpoint inhibitors for cancer.

However, there is no proof that patients on immune checkpoint inhibitors benefit from this active surveillance strategy. The suspicion of cardiovascular events may lead to the interruption of cancer therapies.

The TILT study aims at assessing: (i) the efficiency of troponin measurments in asymptomatic patients to prevent the further advent of major cardiovascular events; (ii) its safety in terms of cancer therapy completion.

lead_sponsor: Institut Mutualiste Montsouris

sponsor_collaborators:
Institut Mutualiste Montsouris
Institut Curie


title: A Randomized, Double-Blind, Placebo-Controlled, Crossover, Pilot Stage Clinical Trial Evaluating CACIPLIQ20 in Wound Healing in Subjects With Epidermolysis Bullosa

acronym: MATHBULL

summary:
Epidermolysis bullosa (EB) is a group of inherited disorders characterized by fragility of the skin and mucous membranes within the basement membrane zone. It is characterized by moderate to excessive fragility of epithelial tissues with prototypic blistering or erosions following minimal trauma (mechanobullous dermatoses). The chronic pain associated with EB, the hardship placed on caregivers, and the high risk for complications places a considerable psychosocial burden on both patients and their families. Despite considerable research to advance the understanding of EB pathophysiology, no treatments have been approved by regulatory authorities to date.

Heparan sulfates are key elements of the Extra Cellular Matrix scaffold which act both as linkers, bridging structural matrix proteins such as collagens, laminin and as storage and protector sites to communication peptides, playing a pivotal role in the regulation of cell proliferation, migration and differentiation that are all required for tissue regeneration and repair. CACIPLIQ20 is a bioengineered structural analogue of heparan sulfate glycosaminoglycans. Numerous experimental studies have provided strong evidence that CACIPLIQ20 promotes tissue regeneration by reconstructing the cellular microenvironment following tissue injury. CACIPLIQ20 is currently a class III CE marked medical device (NSAI-0050 CE MARK ECDECNL-A4 (6) and EC Annex II of the directive. NL-A4 (7)) with the following indications: Chronic ulcers showing no tendency to heal after 6 months of standard care, or still unhealed after 12 months:

Pressure ulcers.
Peripheral arterial disease (such as Stage IV Leriche & Fontaine) ulcers.
Diabetic ulcers (including amputation).

Preliminary results from several published and unpublished case reports (Al Malak and Barritault, 2012; Bodemer, unpublished observations) suggest that CACIPLIQ20 is safe and can improve wound healing and reduce pain in patients with epidermolysis bullosa.

The goal of the MATHBULL study is to confirm preliminary observations in a placebo-controlled double-blind pilot study. The results of this pilot study will help to design a pivotal study.

lead_sponsor: Organ, Tissue, Regeneration, Repair and Replacement

collaborators:
Euraxi Pharma
ARANZ Medical


title: Multicentric Randomized Phase I/IIa Trial of the Safety and Immunogenicity of a Therapeutic Anti-HPV DC Targeting Vaccine in Patients With Human Papillomavirus (HPV)-Positive Oropharyngeal Cancer

acronym: HPVDCVax

summary:
This study is a multicentric double-blind placebo-controlled dose escalation trial of a CD40HVac vaccine (humanized anti-CD40 mAb fused to HPV16 E6/E7 oncoproteins) adjuvanted with poly-ICLC (Hiltonol) in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery and/or radiochemotherapy.

The primary objective is to determine the recommended phase 2 dose (RP2D) of a poly-ICLC(Hiltonol)-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40.HVac will be explored

1st dose level: CD40.HVac 1.0 mg, with 1.0 mg poly-ICLC
2nd dose level: CD40.HVac 3.0 mg, with 1.0 mg poly-ICLC The safety data will be reviewed by an IDSMB that will give recommendations.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Links Between Rhythmic Handwriting Deficits and General Rhythmic Abilities in Children With Developmental Coordination Disorder: a Pilot Study. TDC-Rythme

acronym: TDC-Rythme

summary:
Patients with Developmental Coordination Disorder (DCD), a neurodevelopmental disorder that affects motor skills and motor learning (APA, 2013), have been reported to manifest rhythmic deficits in handwriting domain, as well as general rhythmic deficits (i.e., regardless handwriting context per se) (Rosenblum & Regev, 2013). Accordingly, children with DCD struggle in tasks like synchronising to an external musical rhythm (in rhythm production tasks) or even in discrimination tasks such as detecting beat deviations, i.e., in rhythm perception tasks (INSERM collective expertise, 2019).

These rhythmic deficits which manifest in a variety of tasks and conditions support the hypothesis of a "generalised dysrhythmia" in DCD, according to which the rhythmic deficits - in perceptual tasks and motor production - could have a common source, namely a mechanism devoted to rhythm processing (a cerebral mechanism involved in the perception of rhythm) and independent of the effectors involved and the type of task considered.

However, the nature of the relationships between general rhythmic skills (perceptual and motor) and rhythmic abilities when engaged in handwriting movement is largely unknown in DCD. Whether a common source drives these diverse rhythmic deficits remains to explore. If this hypothesis were to be confirmed, this would pave the way for innovative therapeutic tools (e.g., serious games) for training a central rhythmic processing mechanism (rhythm perception), which could positively impact in turn rhythmicity of thandwriting movement in this population.

time_perspective: Other

ReferenceCitation: American Psychiatric Association (APA) (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.

ReferenceCitation: Dalla Bella S, Farrugia N, Benoit CE, Begel V, Verga L, Harding E, Kotz SA. BAASTA: Battery for the Assessment of Auditory Sensorimotor and Timing Abilities. Behav Res Methods. 2017 Jun;49(3):1128-1145. doi: 10.3758/s13428-016-0773-6.

ReferenceCitation: Danna J, Paz-Villagran V, Velay JL. Signal-to-noise velocity peaks difference: a new method for evaluating the handwriting movement fluency in children with dysgraphia. Res Dev Disabil. 2013 Dec;34(12):4375-84. doi: 10.1016/j.ridd.2013.09.012. Epub 2013 Oct 18.

ReferenceCitation: Expertise Collective INSERM (2019). Trouble développemental de la coordination ou dyspraxie, Paris : Les Editions EDP Sciences.

ReferenceCitation: Rosenblum S, Regev N. Timing abilities among children with developmental coordination disorders (DCD) in comparison to children with typical development. Res Dev Disabil. 2013 Jan;34(1):218-27. doi: 10.1016/j.ridd.2012.07.011. Epub 2012 Sep 6.

lead_sponsor: University Hospital, Montpellier

location_facility: Hôpital La Colombière - CHU de Montpellier


title: Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy

acronym: NALIRI-PANC

summary: The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Servier


title: Digital Extraction and Scientific Visualization of Clinical Characteristics From 3D Data From Intraoral Scanners for Dental and Periodontal Pathologies Research : Computer Formalization and Feasibility Study

summary: Periodontal diseases and dental pathologies are highly prevalent oral diseases. Thirty-three to fifty percent of adult population presented at least one untreated caries and more than 50% of French population are affected by severe periodontitis. These diseases affect dental organ or periodontal attached system but could have negative impact on general health, quality of life, word and individual well-being. Association between chronic diseases as diabetes, rheumatoid arthritis, cardiovascular diseases, and oral health have been well investigated. Dental and periodontal diagnosis is dependent of various clinical parameters time consuming and dependent operator. It represents a public health challenge. Informatic analysis detecting diseases could be a time gain and a more precise diagnosis tool. Today, any software or algorithm allow automatized detection, clinical qualitative or quantitative indices recording while these informations are present in numeric models

lead_sponsor: CHU de Reims


title: Validation of the Performance of the French Version of the Cerebellar Cognitive-Affective Syndrome Scale (CCASS) as a Screening Test for Cerebellar Cognitive-affective Syndrome: a National Multicenter Study

acronym: CCASS-FR

summary:
The primary objective of the study is to assess the performance of the French version of the Cerebellar Cognitive-Affective Syndrome Scale (CCASS) as a screening test for cerebellar cognitive-affective syndrome.

The primary endpoint will be the sensitivity of version 1A of the French scale. The result will be considered positive if the patient fails at least one of the scale's subtests. The diagnosis of a cerebellar cognitive-affective syndrome will be made on the basis of a pathological score in the executive, language, visuospatial or psychoaffective domains of the neuropsychological evaluation (gold standard).

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: Validation d'un Outil numérique d'évaluation Multidimensionnelle Pour Les Personnes âgées Dans un Contexte de Consultations gériatriques

summary: The aim of this study is to validate a digital multidimensional assessment tool for elderly people in geriatric consultations. The aim is to use a digital tablet to rapidly assess several risks (loss of functional independence, risk of falling, risk of malnutrition, risk of depression and risk of burden for the carer) in the context of hospital consultations.

lead_sponsor: RIVAGES

location_facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université


title: A Prospective, Open Study on the Safety and Effectiveness of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology) on Healthy Subjects

summary:
The current post-market clinical investigation has been designed to evaluate the efficacy and safety of CELLBOOSTER® Lift, a HA-based product marketed by SUISSELLE SA. For this purpose, healthy subjects with signs of skin aging with mild to moderate wrinkles, skin laxity, dry and dull skin on the face, received a 3-session treatment and were followed-up over a 4-month period after the initial injection.

Several objective measurements of skin quality were performed with different parameters: skin elasticity, density, dryness, microcirculation, wrinkles, color/homogeneity. Clinical improvement was also evaluated, as well as subject and investigator satisfactions.

The safety of the injections was also followed with injection site reactions and adverse events collection.

lead_sponsor: Suisselle


title: Evaluating the Contribution of Hypnosis on Image Quality During Cardiac Magnetic Resonance Imaging (MRI) in Anxious Patients

acronym: HYPNOLINE

summary: The present project aims to explore the effect of a hypnosis session performed on a patient with anxiety during a cardiac MRI examination on image quality.