title: Biobank for the Identification of Diagnostic, Prognostic or Therapeutic (Response and Resistance) Biomarkers in Lung Cancer (Early and Advanced Stages of Lung Cancer Cohort of the BIRD (Biomarkers in Respiratory Disease) Biobank)

acronym: BIRD-NK

summary: The BIRD biobank aims at collecting clinical and biological data from patients suffering from a chronic respiratory disease. The lung cancer subpopulation will be divided into two cohorts to identify biomarkers of cancer. One cohort will include patients with supra-centimetric lung nodule(s) whether surveillance, bronchoscopic or radio-guided biopsy or surgery is indicated, patients suspected of lung cancers requiring diagnostic and/or therapeutic bronchial endoscopy and patients with a known early stage lung cancer (early-stage cohort). The second cohort will include known advanced stage lung cancers (III-IV).

lead_sponsor: University Hospital, Toulouse


title: Effectiveness of the Spa Therapy Program of Royat in Chronic Venous Insufficiency

summary:
The aim of this clinical trial is to assess the efficacy of the balneotherapy program (therapeutic orientation: Phlebology) in terms of chronic venous disease improvement and related quality of life, in patients presented with advanced chronic venous insufficiency (i.e., with C4-C5 of severity classification).

The multicenter randomized controlled trial (RCT) "Thermes & Veines" that aimed at evaluating balneotherapy in patients with advanced chronic venous insufficiency is considered as the reference study. The French National Academy of Medicine encourages the re-use of data of published RCT when available. In this context, the current study is designed as a single-arm prospective study with indirect comparison using propension score. The Control group consists of the 197 patients which were allocated to the Control group of the "Thermes & Veines".

All patients enrolled in the current study benefit of 18-days of spa treatment with Mineral Water of Royat, and examination with vascular practitioner at enrollment and 6 months after the beginning of spa treatment.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

ipd_sharing: No

lead_sponsor: CEN Biotech

sponsor_collaborators:
CEN Biotech
TOWN HALL OF ROYAT

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Joint Aspiration in Dysfunctional Hip, Knee or Shoulder Prostheses (Chronic Infection or Implant Failure) "JAD-Pro"

acronym: JAD-Pro

summary:
After a hip, knee or shoulder arthroplasty, the evolution is not always favorable. It can be marked by an infectious or non-infectious complication, most often implant failure. In this context, joint fluid aspiration (JFA) is indicated to document a prosthetic joint infection (PJI) or to bring to light arguments for implant failure. Nevertheless, opinions differ on its indication for microbiological identification. Some teams perform it systematically when faced with a prosthesis dysfunction. Others, only in the presence of suggestive signs of PJI. Finally, others never perform it.

Based on clinical, radiological and biological (CRP) signs, at the preoperative stage and before JFA, we classify our patients into 3 groups: supposedly septic (chronic joint infection), supposedly aseptic (implant failure) or intermediate (Unknown). This last group, often encountered in consultation, poses a diagnosis problem more than the others.

In our experience, JFA is an essential diagnosis tool in these 3 groups of patients. It helps to choose the surgical strategy. In addition, the dosage of biomarkers in the joint fluid as the alpha defensin, the leucocyte esterase and the CRP could provide an additional argument to investigate the infectious origin or not, in particular in difficult cases.

In summary, the disagreement on the usefulness of JFA in case of PJI suspicion and any other prosthetic dysfunction, the lack of data on large prospective studies and our questioning about the contribution of JFA in the aseptic and intermediate group of patients, motivated us to set up this study to evaluate the interest of the JFA for the preoperative diagnosis, as well as that of the dosage of biomarkers in the joint fluid.

status: Recruiting

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Groupe Hospitalier Diaconesses Croix saint Simon

intervention_type: Other

lead_sponsor_type: academique


title: A French Monocenter, Interventional Pilot Clinical Investigation to Evaluate the Technical Performance and Safety of a Prototype of Sensor to Measure Ventilator-derived Parameters in Intubated and Mechanically Ventilated Patients

summary: Recently, the threat of viral pandemics (Covid-19, severe acute respiratory syndrome, avian flu H5N1, and H1N1), which might result in thousands of patients requiring mechanical ventilation, has accelerated the need for mechanical ventilation equipment. Disaster may create thousands of critically ill patients requiring mechanical ventilation and may force difficult allocation decisions when demand greatly exceeds supply. Creating a new monitor will only add one more product to the one already used and create confusion for the user. Therefore, the aim is now to develop an independent ventilation module, compatible with the already existing cardiac monitors, which integrates advanced ventilation monitoring functions (mechanical ventilation and RCP). This module could be used by the teams already equipped with multiparametric monitors and be a real added value as the monitoring of the ventilation is critical, especially in emergency situations. Then, it could answer to the clinical need and massively equip every hospital care center in the event of mass casualty incident or viral pandemic. Moreover, this device could be used by emergency teams during daily operations. The aim of this study is to validate a prototype of sensor intended to monitor ventilator parameters of ventilated patients and guide healthcare professionals to provide safe ventilation.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Archeon

intervention_type: Device


title: The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases

acronym: ISOHYPE

summary:
Polyclonal hypergammaglobulinaemia is characterized by increased levels of immunoglobulins and is a common feature observed in various diseases such as autoimmune diseases, chronic infectious diseases or lymphoid hemopathy. Some autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis or Sjögren's syndrome are frequently associated with polyclonal hypergammaglobulinaemia. Recent data have suggested that the distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia may be disease-specific. However, isotype repartition in polyclonal hypergammaglobulinaemia remains poorly understood.

The investigators will investigate the distribution of immunoglobulin isotype in patients with autoimmune disease and polyclonal hypergammaglobulinaemia. Moreover, the investigators will evaluate the isotype repartition as predictor of lymphoma or monoclonal gammopathy among patients with autoimmune diseases.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Predictive Value of Right Atrial Strain in Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

acronym: ODFAPO

summary:
The incidence of postoperative atrial fibrillation (POAF) after cardiac surgery is around 30%. POAF increases the risk of developing permanent atrial fibrillation and raises the risk of cardiac decompensation, stroke, acute myocardial infarction, and death. While the role of the left atrium (LAF) in the pathophysiology of POAF is now well-established, the part of the right atrium (RA) remains poorly understood. Recent studies suggest a correlation between RA function and POAF.

RA function can be assessed by transthoracic echocardiography (TTE) with dedicated software for measuring the RA strain (RAS). RA function is thus divided into three phases: reservoir (RASr), conduit, and contraction. Numerous studies have demonstrated that a significant alteration in RAS predicts POAF in various clinical contexts. Therefore, it is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.

It is essential to investigate whether alterations in RA function assessed by 2D-STE (RAS) are associated with an increased occurrence of FAPO after cardiac surgery.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Marfan&Moves (M&M's) : an Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Marfan Syndrome: an Interventional, Prospective, Monocentric Study.

acronym: M&M's

summary: This research study aims to evaluate the effect of a 6-month adapted physical activity program (APA) on the endurance capacities (evaluated as the maximum oxygen consumption [VO2 peak] on a cardiopulmonary exercise test) of children and adolescents with Marfan syndrome or related.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Prevention


title: Determination of the Thickness Truly Applied of the SPRAY50+ on Different Areas of the Face Estimated by a Multispectral Imaging Method, After Application of the Product With and Without Recommendations of Use by a Group of Healthy Subjects

summary:
The aim of the study is to determine:

the thickness of the RV4369A truly applied on different areas of the face after single application of the product determined by a multispectral imaging method.
the influence of a second application of the product 15 to 30 minutes after the first application on the product thickness determined by multispectral imaging method.
the influence of the recommendations of use provided to the subjects before application of the product on the product thickness determined by multispectral imaging method .

status: Completed

study_completion_date_type: Actual

lead_sponsor: Pierre Fabre Dermo Cosmetique

status_simplified: Completed


title: Use of Laparoscopy in the Treatment of Pelvic Ring Ruptures

acronym: PELVICOELIO

summary: Case series to describe the use of laparoscopy for the treatment of pelvic ring disruption.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Magnetoencephalography by Optical Pumping Magnetometer

acronym: MEG OPM

summary:
MagnetoEncephaloGraphy (MEG) is a method of recording brain activity with high temporal resolution and good spatial resolution, compared to current recording techniques such as ElectroEncephaloGraphy (EEG). The main limitation of MEG is its cost due to the sensors used, the Super Quantum Interference Devices (SQUID). These require a complex infrastructure from an instrumentation point of view to operate, requiring liquid helium, most often at a loss, at increasing cost. Optical Pumping Magnetometers (OPM) type sensors represent a promising alternative to SQUIDs sensors, especially since they do not require helium cooling.

The purpose of this project is to Identify biomarkers in Magnetoencephalography of normal brain development in healthy adults, premature and term newborns from "a priori" obtained by the classical technique of High Resolution EEG performed.


title: Intratumoral Gemcitabine, Paclitaxel, Carboplatine and Intravenous Nivolumab for Locally Recurrence of Head and Neck Cancers

acronym: NIVOCHIMLOC

summary:
Patients with locally recurrent squamous-cell carcinoma of the head and neck (SCCHN) after Chemotherapy and immunotherapy have a very poor prognosis and limited therapeutic options.

Intratumoral chemotherapy (ITC) with cisplatin and epinephrine in order to increase the local cisplatin retention lead to a 50 % response rate in several studies but was given up due to the poor local tolerance with frequent necrosis of the peritumoral tissues. Gemcitabine, carboplatin and paclitaxel (GCP) are used in advanced SCCHN. These chemotherapies seem to be interesting options for intratumoral infusion: their different effect could lead to avoid chemotherapy resistance with a good tolerance profile, without tissue necrosis profile. The other major option for recurrent SCCHN is immunotherapy by Nivolumab, an anti PD-1 with a 13% mediane response rate. Nevertheless, the failure of this treatment stay unclear, but immunosuppressive action of the tumour is suspected. The presence of tumoral antigen could lead to better response to immunotherapy; association of chemotherapy and immunotherapy seems a promosing association to avoid treatment resistance as cytotoxic release tumoral antigen; it could also be associated to an abscopal effect.

The aim of the study is to evaluate the efficacy of ITC using GCP in LOCAL recurrent SCCHN treated by nivolumab.

primary_purpose: Treatment

intervention_type: Drug


title: Prospective Monocentric Study of the Detection of Sarcopenia in Clinical Practice in Patients With Ovarian or Endometrial Cancer Requiring Systemic Oncological Treatment

acronym: SARCO-GYN

summary:
Prospective monocentric study, non-randomized of the detection of sarcopenia in clinical practice in patients with ovarian or endometrial cancer requiring systemic oncological treatment.

main question : Identify the criteria correlated with the presence of sarcopenia (defined by the measurement of the IMS by the CT-X method in L3) among the impedancemetry and the HAS malnutrition criteria.

Data collection will be done at 6 months, 12 months after the date of inclusion.

lead_sponsor: Centre Hospitalier Metropole Savoie

intervention_type: Diagnostic Test


title: Prognostic Factors and Therapeutic Management of ESBL Enterobacteriaceae in the ICU

acronym: BLSE-REA

summary: Multicenter retrospective study conducted in the intensive care units of Tourcoing, Roubaix, and Lille hospitals. Patients hospitalized in the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU will be selected from microbiology laboratory data. Patient demographics and clinical data will be collected from the medical record. Microbiological results will be collected from the laboratory data.

ipd_sharing: Undecided

lead_sponsor: Tourcoing Hospital


title: Evaluation of Acute Endovascular Treatment in Symptomatic Isolated Cervical Internal Carotid Artery Occlusion Within 24 Hours of Last Seen Well

acronym: ETICA

summary: Our main hypothesis is that acute EVT associated with best medical treatment is superior to best medical treatment alone, for improving clinical outcomes at 90 days, in patient with mild or severe AIS and diffusion-perfusion or clinical-imaging mismatch, secondary to CICAO.

design_allocation: Randomized

lead_sponsor: University Hospital, Montpellier

location_facility: Department of Neurology/ Stroke Unit, Hôpital Gui de Chauliac


type: Registry Identifier

title: Success Rate Comparison of Venipuncture in Children With and Without Near-infrared Light

acronym: ALPIVEINE

summary: The purpose of this study is to determine whether the act of venipuncture is more successful on the first attempt using near infrared light compared to a standard puncture on children or newborn whose venous access is considered difficult due to lack of visibility of the veins.

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Does Diabetes Related Distress Impact on Balance Glycemic ?

acronym: DDS

summary:
The main objective is to assess the overall diabetes distress score in adult patients with diabetes during their hospitalization in a diabetes ward, using the Diabetes Distress Scale (DDS-17).

The correlation between the overall diabetes distress score and the patient's glycosylated haemoglobin will then be assessed.

location_facility: Diabetology department - Hospital of Pitié Salpêtrière - APHP


title: Survey on the Management of Occasional or Anticipatory Stress by Consumers of a Food Supplement Based on L-theanine, Passionflower and Rhodiola Extracts and Satisfaction With This Supplementation

acronym: MELIM

summary:
Volunteers will fill out an initial questionnaire which will describe their current situation, their pathologies and current treatments, their medical history.

Finally, they will complete three questionnaires on the day of their stressful event which will describe their state of stress just before taking the product, 20 minutes after taking the product; their tolerance and satisfaction with the product will be described at the end of the day.

lead_sponsor: Larena SAS


type: Other Identifier

title: Development of an Artificial Intelligence Algorithm to Detect Pathological Repolarization Disorders on the ECG and the Risk of Ventricular Arrhythmias

summary:
The objective of this study is to prospectively validate in real life cohorts from various departments of the APHP our artificial intelligence (deep-learning) models allowing for :

automatic measurement of various ECG quantitative features,
identification and typing of LQT and risk of TdP.

collaborators: UMMISCO - Institute of Research for Development (IRD)

location_facility: Centre d'Investigation Clinique Paris-Est/Hôpital Pitié-Salpêtrière


title: Fluid Challenge Impact in the Portal Vein Pulsatility Depending on the Fluid Responsivness Status

acronym: FLUID-REVENGE

summary: Portal vein pulsatility index is a marker of venous congestion evaluated by point of care ultrasound. It is associated with acute kidney injury, especially in critically ill patients. It may be considered as a dynamic marker. The investigators hypothesized that portal vein pulsatility index is higher after a fluid challenge only in patient without preload dependence in critically ill patients with cardiovascular insufficiency.

lead_sponsor: Hospices Civils de Lyon


title: Association Between Prenatal Anesthesia Exposure and Neurodevelopmental Outcome : an Ambi-directional Cohort Study

summary:
In 2016, the US Food and Drug Administration raised concerns about the potential negative effects of anesthesia exposure on neurodevelopment in children during pregnancy or before the age of three.

The impact of exposure to anesthetic agents on neurodevelopmental outcome however remains debated: clinical studies on the subject do not allow for unequivocal conclusions to be drawn, given their methodological heterogeneity and the numerous confounding environmental factors.

To this date, only two studies have focused on the potential neurodevelopmental effects of general anesthesia during the prenatal period, even though general anesthesia for non-obstetric surgery during pregnancy affects up to 3% of pregnant women.

This observational ambidirectional study would be the first to investigate the potential neurodevelopmental effects of prenatal exposure to anesthesia, whether general or regional, for surgery during pregnancy. It would thus differentiate between the contribution of surgical stress and that of anesthetic agents in any observed modifications.

The aim of the study is:

Are there any subtle modifications of executive functions associated with prenatal exposure to anesthesia during non-obstetric surgery during pregnancy?

To investigate this, parents of the participating children will be asked to complete a standardized parental telephone questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF). This parental questionnaire allows for evaluating children's behaviors related to executive functions.

Researchers will compare the score derived from the "BRIEF" parental questionnaire (BRIEF score) between three groups of children aged from 5 to 12 years old, born between 2011 and 2018 at Caen University Hospital:

The " General anesthesia " group: children whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy (N: 62).
The " Locoregional anesthesia " group: children whose mothers underwent regional anesthesia for non-obstetric surgery during pregnancy (N: 31).
The " Control " group: children whose mothers did not undergo any surgical intervention during pregnancy (N: 62).

The first aim of our study is to investigate the presence of a significant difference in the BRIEF score between the three groups.

The seconds aims are to assess the cognitive functioning of patients in their daily lives (school, parental home, and extracurricular activities).

time_perspective: Other

ReferenceCitation: Salaun JP, Chagnot A, Cachia A, Poirel N, Datin-Dorriere V, Dujarrier C, Lemarchand E, Rolland M, Delalande L, Gressens P, Guillois B, Houde O, Levard D, Gakuba C, Moyon M, Naveau M, Orliac F, Orliaguet G, Hanouz JL, Agin V, Borst G, Vivien D. Consequences of General Anesthesia in Infancy on Behavior and Brain Structure. Anesth Analg. 2023 Feb 1;136(2):240-250. doi: 10.1213/ANE.0000000000006233. Epub 2022 Oct 27.

ReferenceCitation: Bleeser T, Devroe S, Lucas N, Debels T, Van de Velde M, Lemiere J, Deprest J, Rex S. Neurodevelopmental outcomes after prenatal exposure to anaesthesia for maternal surgery: a propensity-score weighted bidirectional cohort study. Anaesthesia. 2023 Feb;78(2):159-169. doi: 10.1111/anae.15884. Epub 2022 Oct 25.

ReferenceCitation: Shi Y, Hu D, Rodgers EL, Katusic SK, Gleich SJ, Hanson AC, Schroeder DR, Flick RP, Warner DO. Epidemiology of general anesthesia prior to age 3 in a population-based birth cohort. Paediatr Anaesth. 2018 Jun;28(6):513-519. doi: 10.1111/pan.13359. Epub 2018 Mar 13.

ReferenceCitation: Marchesini V, Disma N. Anaesthetic neuroprotection in children: does it exist or is it all just bad? Curr Opin Anaesthesiol. 2019 Jun;32(3):363-369. doi: 10.1097/ACO.0000000000000723.

ReferenceCitation: Paule MG, Li M, Allen RR, Liu F, Zou X, Hotchkiss C, Hanig JP, Patterson TA, Slikker W Jr, Wang C. Ketamine anesthesia during the first week of life can cause long-lasting cognitive deficits in rhesus monkeys. Neurotoxicol Teratol. 2011 Mar-Apr;33(2):220-30. doi: 10.1016/j.ntt.2011.01.001. Epub 2011 Jan 15.

ReferenceCitation: Andropoulos DB, Greene MF. Anesthesia and Developing Brains - Implications of the FDA Warning. N Engl J Med. 2017 Mar 9;376(10):905-907. doi: 10.1056/NEJMp1700196. Epub 2017 Feb 8. No abstract available.

ReferenceCitation: Walkden GJ, Gill H, Davies NM, Peters AE, Wright I, Pickering AE. Early Childhood General Anesthesia and Neurodevelopmental Outcomes in the Avon Longitudinal Study of Parents and Children Birth Cohort. Anesthesiology. 2020 Nov 1;133(5):1007-1020. doi: 10.1097/ALN.0000000000003522.

ReferenceCitation: Sun LS, Li G, Miller TL, Salorio C, Byrne MW, Bellinger DC, Ing C, Park R, Radcliffe J, Hays SR, DiMaggio CJ, Cooper TJ, Rauh V, Maxwell LG, Youn A, McGowan FX. Association Between a Single General Anesthesia Exposure Before Age 36 Months and Neurocognitive Outcomes in Later Childhood. JAMA. 2016 Jun 7;315(21):2312-20. doi: 10.1001/jama.2016.6967.

ReferenceCitation: Warner DO, Zaccariello MJ, Katusic SK, Schroeder DR, Hanson AC, Schulte PJ, Buenvenida SL, Gleich SJ, Wilder RT, Sprung J, Hu D, Voigt RG, Paule MG, Chelonis JJ, Flick RP. Neuropsychological and Behavioral Outcomes after Exposure of Young Children to Procedures Requiring General Anesthesia: The Mayo Anesthesia Safety in Kids (MASK) Study. Anesthesiology. 2018 Jul;129(1):89-105. doi: 10.1097/ALN.0000000000002232.

ReferenceCitation: Davidson AJ, Disma N, de Graaff JC, Withington DE, Dorris L, Bell G, Stargatt R, Bellinger DC, Schuster T, Arnup SJ, Hardy P, Hunt RW, Takagi MJ, Giribaldi G, Hartmann PL, Salvo I, Morton NS, von Ungern Sternberg BS, Locatelli BG, Wilton N, Lynn A, Thomas JJ, Polaner D, Bagshaw O, Szmuk P, Absalom AR, Frawley G, Berde C, Ormond GD, Marmor J, McCann ME; GAS consortium. Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial. Lancet. 2016 Jan 16;387(10015):239-50. doi: 10.1016/S0140-6736(15)00608-X. Epub 2015 Nov 4. Erratum In: Lancet. 2016 Jan 16;387(10015):228.

ReferenceCitation: McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14. Erratum In: Lancet. 2019 Aug 24;394(10199):638.

ReferenceCitation: DiMaggio C, Sun LS, Li G. Early childhood exposure to anesthesia and risk of developmental and behavioral disorders in a sibling birth cohort. Anesth Analg. 2011 Nov;113(5):1143-51. doi: 10.1213/ANE.0b013e3182147f42. Epub 2011 Mar 17.

ReferenceCitation: Zhang H, Du L, Du Z, Jiang H, Han D, Li Q. Association between childhood exposure to single general anesthesia and neurodevelopment: a systematic review and meta-analysis of cohort study. J Anesth. 2015 Oct;29(5):749-57. doi: 10.1007/s00540-015-2030-z. Epub 2015 May 23.

ReferenceCitation: Clausen NG, Kahler S, Hansen TG. Systematic review of the neurocognitive outcomes used in studies of paediatric anaesthesia neurotoxicity. Br J Anaesth. 2018 Jun;120(6):1255-1273. doi: 10.1016/j.bja.2017.11.107. Epub 2018 Feb 3.

ReferenceCitation: Walkden GJ, Pickering AE, Gill H. Assessing Long-term Neurodevelopmental Outcome Following General Anesthesia in Early Childhood: Challenges and Opportunities. Anesth Analg. 2019 Apr;128(4):681-694. doi: 10.1213/ANE.0000000000004052. Erratum In: Anesth Analg. 2020 Feb;130(2):e44.

ReferenceCitation: Yuki K, Matsunami E, Tazawa K, Wang W, DiNardo JA, Koutsogiannaki S. Pediatric Perioperative Stress Responses and Anesthesia. Transl Perioper Pain Med. 2017;2(1):1-12.

ReferenceCitation: Wilder RT, Flick RP, Sprung J, Katusic SK, Barbaresi WJ, Mickelson C, Gleich SJ, Schroeder DR, Weaver AL, Warner DO. Early exposure to anesthesia and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Apr;110(4):796-804. doi: 10.1097/01.anes.0000344728.34332.5d.

ReferenceCitation: Balinskaite V, Bottle A, Sodhi V, Rivers A, Bennett PR, Brett SJ, Aylin P. The Risk of Adverse Pregnancy Outcomes Following Nonobstetric Surgery During Pregnancy: Estimates From a Retrospective Cohort Study of 6.5 Million Pregnancies. Ann Surg. 2017 Aug;266(2):260-266. doi: 10.1097/SLA.0000000000001976.

ReferenceCitation: Devroe S, Bleeser T, Van de Velde M, Verbrugge L, De Buck F, Deprest J, Devlieger R, Rex S. Anesthesia for non-obstetric surgery during pregnancy in a tertiary referral center: a 16-year retrospective, matched case-control, cohort study. Int J Obstet Anesth. 2019 Aug;39:74-81. doi: 10.1016/j.ijoa.2019.01.006. Epub 2019 Jan 12.

ReferenceCitation: Vujic J, Marsoner K, Lipp-Pump AH, Klaritsch P, Mischinger HJ, Kornprat P. Non-obstetric surgery during pregnancy - an eleven-year retrospective analysis. BMC Pregnancy Childbirth. 2019 Oct 25;19(1):382. doi: 10.1186/s12884-019-2554-6.

ReferenceCitation: Reitman E, Flood P. Anaesthetic considerations for non-obstetric surgery during pregnancy. Br J Anaesth. 2011 Dec;107 Suppl 1:i72-8. doi: 10.1093/bja/aer343.

ReferenceCitation: Bleeser T, Van Der Veeken L, Fieuws S, Devroe S, Van de Velde M, Deprest J, Rex S. Effects of general anaesthesia during pregnancy on neurocognitive development of the fetus: a systematic review and meta-analysis. Br J Anaesth. 2021 Jun;126(6):1128-1140. doi: 10.1016/j.bja.2021.02.026. Epub 2021 Apr 6.

ReferenceCitation: Zou S, Wei ZZ, Yue Y, Zheng H, Jiang MQ, Wu A. Desflurane and Surgery Exposure During Pregnancy Decrease Synaptic Integrity and Induce Functional Deficits in Juvenile Offspring Mice. Neurochem Res. 2020 Feb;45(2):418-427. doi: 10.1007/s11064-019-02932-z. Epub 2019 Dec 20.

ReferenceCitation: Wu Z, Li X, Zhang Y, Tong D, Wang L, Zhao P. Effects of Sevoflurane Exposure During Mid-Pregnancy on Learning and Memory in Offspring Rats: Beneficial Effects of Maternal Exercise. Front Cell Neurosci. 2018 May 3;12:122. doi: 10.3389/fncel.2018.00122. eCollection 2018.

ReferenceCitation: Dong C, Rovnaghi CR, Anand KJ. Ketamine exposure during embryogenesis inhibits cellular proliferation in rat fetal cortical neurogenic regions. Acta Anaesthesiol Scand. 2016 May;60(5):579-87. doi: 10.1111/aas.12689. Epub 2016 Jan 29.

ReferenceCitation: Creeley CE, Dikranian KT, Dissen GA, Back SA, Olney JW, Brambrink AM. Isoflurane-induced apoptosis of neurons and oligodendrocytes in the fetal rhesus macaque brain. Anesthesiology. 2014 Mar;120(3):626-38. doi: 10.1097/ALN.0000000000000037.

ReferenceCitation: Sprung J, Flick RP, Wilder RT, Katusic SK, Pike TL, Dingli M, Gleich SJ, Schroeder DR, Barbaresi WJ, Hanson AC, Warner DO. Anesthesia for cesarean delivery and learning disabilities in a population-based birth cohort. Anesthesiology. 2009 Aug;111(2):302-10. doi: 10.1097/ALN.0b013e3181adf481.

ReferenceCitation: Robbins LS, Blanchard CT, Biasini FJ, Powell MF, Casey BM, Tita AT, Harper LM. General anesthesia for cesarean delivery and childhood neurodevelopmental and perinatal outcomes: a secondary analysis of a randomized controlled trial. Int J Obstet Anesth. 2021 Feb;45:34-40. doi: 10.1016/j.ijoa.2020.08.007. Epub 2020 Aug 25.

ReferenceCitation: Ing C, Landau R, DeStephano D, Miles CH, von Ungern-Sternberg BS, Li G, Whitehouse AJO. Prenatal Exposure to General Anesthesia and Childhood Behavioral Deficit. Anesth Analg. 2021 Sep 1;133(3):595-605. doi: 10.1213/ANE.0000000000005389.

ReferenceCitation: Baron IS. Behavior rating inventory of executive function. Child Neuropsychol. 2000 Sep;6(3):235-8. doi: 10.1076/chin.6.3.235.3152. No abstract available. Erratum In: Child Neuropsychol. 2016;22(6):761.

lead_sponsor: University Hospital, Caen


title: Optimisation du Parcours de Soins Des Patients Atteints de Douleurs Chroniques : étude randomisée évaluant l'intérêt de l'intégration Des spécialistes du Sommeil

acronym: DOLOREPIT

summary: DOLOREPIT is an interventional, RIPH 2, multicenter, randomized, controlled, open-label study comparing two care pathways for the management of patients with chronic pain.

lead_sponsor: Centre Hospitalier Emile Roux


title: Optimization of the Diagnosis of Bone FRACtures in Patients Treated in the Emergency Department by Using Artificial Intelligence for Reading Radiological Images in Comparison With Traditional Reading by the Emergency Doctor.

acronym: FracturIA

summary:
As part of the management of a patient with suspected bone fractures, emergency physicians are required to make treatment decisions before obtaining the imaging reading report from the radiologist, who is generally not available only a few hours after the patient's admission, or even the following day. This situation of the emergency doctor, alone interpreting the radiological image, in a context of limited time due to the large flow of patients to be treated, leads to a significant risk of interpretation error. Unrecognized fractures represent one of the main causes of diagnostic errors in emergency departments.

This comparative study consists of two cohorts of patients referred to the emergency department for suspected bone fracture. The first will be of interest to patients whose radiological images will be interpreted by the reading of the emergency doctor systematically doubled by the reading of the artificial intelligence. The other will interest a group of patients cared for by the simple reading of the emergency doctor.

All of the images from both groups of patients will be re-read by the establishment's group of radiologists no later than 24 hours following the patient's treatment.

A centralized review will be provided by two expert radiologists. Also, patients in both groups will be systematically recalled in the event of detection of an unknown fracture for hospitalization.

lead_sponsor: Elsan

sponsor_collaborators:
Elsan
Clinique Esquirol Saint Hilaire


title: A Combination Retrospective and Prospective Natural History Study of Participants With Sanfilippo Syndrome Mucopolysaccharidosis Type IIIC (MPS IIIC)

acronym: MPSIIIC

summary: Sanfilippo syndrome type C is a ultra rare syndrome with limited available natural history data. This study is planned to document, through retrospective and prospective data collection, syndrome progression in children and young adults with Sanfilippo syndrome type C. The results from this study may inform future clinical studies in targeted therapies for patients with Sanfilippo syndrome type C and may serve as an external control since there are very few patients with Sanfilippo syndrome type C.

time_perspective: Cross-Sectional

ipd_sharing_description: The data collected as part of the observational study may be analyzed and published. Phoenix Nest recognizes the importance of communicating medical study data and therefore encourages the publication of these data in reputable scientific journals and at seminars or conferences. The details of the processes of producing and reviewing reports, manuscripts, and presentations based on the data from this study will be described in the Clinical Trial Agreement between Phoenix Nest and the Investigator/institution. Consideration for authorship of all publications will be based on compliance with the Uniform Requirements for Manuscripts Submitted to Biomedical Journals ("Uniform Requirements") of the International Committee of Medical Journal Editors (http://www.icmje.org/ethical_1author.html) and Good Publication Practices.

lead_sponsor: Phoenix Nest

sponsor_collaborators:
Phoenix Nest
Vaincres Les Maladies Lysosomales
Association Sanfilippo Sud
Aparito Ltd.


title: New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.

acronym: GLYCAGEST

summary: Gestational diabetes mellitus (GDM) increases the risk of macrosomia and other adverse pregnancy outcomes. Screening strategies are debated: universal vs. selective, and macrosomia may begin before the time of screening, suggesting that glycation markers may have an interest. The objective of this trail is to compare novel markers: skin autofluorescence and glycated albumin, to HbA1c (reference) as predictors of GDM, macrosomia and other adverse outcomes, in pregnant women.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Société Francophone du Diabète


title: Risk Factors for Postoperative Complications in Major Non-cardiac Surgery: Post-hoc Analysis of the OPHIQUE Multicentre Study

acronym: MULTIPAS

summary:
Post-operative morbidity and mortality is related to many factors related to the patient's condition, the intra-operative period and the optimisation of intra-operative haemodynamic and respiratory parameters. Many studies have looked at the determinants and factors that increase postoperative complications. However, these have been randomised studies looking at one parameter in particular.

This analysis would be the first to investigate the determinants of postoperative complications in a large population of patients undergoing major non-cardiac surgery. This is a post-hoc analysis of patients included in the OPHIQUE study, whose main objective was to evaluate intraoperative haemodynamic management guided by a marker of tissue hypoperfusion (the respiratory quotient).


title: Gut Microbiota: a Player in the Patients Pain's Sensitization With Rheumatoid Arthritis?

acronym: MiSenDol

summary:
Although rheumatoid arthritis (RA) treatments are very effective in reducing inflammation, chronic pain persists in 20 to 30% of patients.

The intestinal microbiota can participate on the pain pathways and a decrease in Faecalibacterium has been associated with chronic pain and chronic fatigue. RA patients have an altered gut microbiota or dysbiosis. Among the bacteria that are most often differentially represented between RA and control, Faecalibacterium, was also found less abundant in RA patients.

The composition of the gut microbiota has never been evaluated in relation to the clinical phenotype of RA patients and in particular to the presence of a diffuse pain. In this study, investigators will test whether the gut microbiota of RA patients, and in particular the decrease of Faecalibacterium, would promote pain sensitization phenomena, and thus, chronic pain despite the control of joint inflammation.

location_facility: CHU montpellier - department of rheumatology


title: DetectFoG : Detection of Gait Freezing Episodes in Parkinsonian Patients Using Inertial

acronym: DetectFoG

summary:
Parkinson's disease is the second most common neurodegenerative disease in the world. One of these manifestations is the freezing of gait (FOG) which affects 50 to 80% of Parkinsonian patients. It is defined as a brief and episodic absence or marked reduction in the forward progression of the feet despite the intention to walk. FOG is one of the most disabling symptoms causing a greater risk of falling and a loss of autonomy for these patients. This symptom is little or not dopamine-sensitive and little improved by surgery (deep brain stimulation).

Although this symptom is common and debilitating, it is difficult to assess clinically. The objective assessment of the presence and severity of FOG episodes can be done with tests such as the New-Freezing of Gait Questionnaire (N-FOGQ) with however limitations. Indeed, this filmed examination is scored a posteriori and the accumulation of the administration times which makes it difficult to use in routine clinical practice. To overcome these limitations, the use of a diary completed by the patient himself is a simple alternative to assess this symptom, but studies show that patients abandon this practice in the long term and that it is not used by patients with cognitive impairment.

Recent advances in miniaturization have made it possible to create light and compact sensors to assess these events objectively. Inertial measurement units have been widely used in the literature to detect FOG episodes. The choice of the detection algorithms are a major issue in the scientific community. To date, due to the heterogeneity of the protocols, no method is currently required as a reference.

The objective is to evaluate the accuracy of a new algorithm to detect the number of FOG episodes in Parkinsonian patients. This evaluation will be done on the freeze-inducing walking path.

lead_sponsor: Rennes University Hospital


title: Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery

acronym: R-HTM-R

summary:
The objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy.

This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy.

lead_sponsor: Groupe Hospitalier Nord-Essonne


title: METHOXYFLURANE or Virtual Reality Headset vs Standard Analgesic Management for the Reduction of Anterior Shoulder Dislocation

summary:
Anterior shoulder dislocation is a pathology frequently encountered in emergency medicine.

The success in reducing anterior shoulder dislocations depends on muscle relaxation, which is itself conditioned by the patient's pain and apprehension. However, there is no consensus on the optimal technique for reducing anterior shoulder dislocation or the analgesia associated with it.

Analgesia with METHOXYFLURANE showed a greater reduction in post-traumatic pain compared to standard analgesic treatment and faster action of METHOXYFLURANE. A retrospective study which has compared analgesia with METHOXYFLURANE and analgesic sedation with PROPOFOL found a shoulder reduction success rate of 80% and a reduction in the average length of stay in the emergency department.

Finally, the use of virtual reality in pain management is emerging in our practices by allowing pre- and per-procedure hypno-sedation-analgesia. However, the use of virtual reality headsets has not been studied in the management of anterior shoulder dislocation.

The use of these two techniques could therefore limit the use of procedural sedation in the context of shoulder dislocation reduction.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Prognosis of Geriatric Patients With Non-bedded Night in the Emergency Department: a Multicenter Cohort Study

acronym: NoBedNight

summary:
Retrospective, multicenter, French cohort study. Data from patients over 75 years of age who visited the emergency department on 12 and 13 December 2022 could be collected until their discharge from hospital and for a maximum of 30 days. Data from patients who spent the night on a stretcher (stretcher group) as well as from a group of patients who spent the night in a bed (hospital bed group) after a visit to the emergency department will be collected.

The characteristics of the patients and their stay in the emergency room will be collected, and their hospital stay (truncated at 30 days) will be analyzed in terms of morbidity and mortality.

Main objective:

To study the truncated 30-day in-hospital mortality of patients who spent a night on a stretcher in the emergency department.

Secondary objectives:

To describe the characteristics and hospital stay of patients who spent a night on a stretcher To compare the morbidity and mortality of patients who spent the night on a stretcher with patients who spent the night in an inpatient bed after an emergency visit;

location_facility: Emergency department Hospital Pitié-Salpêtrière


title: Evolution of the Maturation of Orofacial Functions and of the Masticatory Function During a Rehabilitation Program, in Children With Different Types of Deterioration in Oral Health

acronym: KIDYCROC

summary:
This project aims at studying the evolution of masticatory function (food bolus granulometry, masticatory behavior, muscle activity and masticatory performance) during oral rehabilitation, in children with different types of oral health impairment.

Secondary objectives are to study the relationships between children masticatory function (food bolus granulometry, masticatory behavior, muscle activity and masticatory performance) and its evolution during oral rehabilitation, and:

their type of oral health alteration
their eating behaviors
their height and weight status

During examination the following parameters are collected:

Various clinical indicators of oral health
The child's weight and height
Frequency and nature of orofacial dysfunctions
The oral health related quality of life of children and their families
Chewing tests are performed (chewing gum, natural food such as carrot, cereals, and cheese samples, samples of gelatins of different hardness)

Examination and differents tests are performed every six months for a total of 5 years (per participant)

The dental care procedures performed during the study were carried out in the usual way.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Centre de Recherche en Odontologie Clinique UR4847


title: Local Fields Potentials of the Subthalamic Nucleus in Patients With Parkinson's Disease and Neuropsychiatric Fluctuations

summary: Neuropsychiatric fluctuations are frequent and debilitating non-motor disorders in Parkinson's disease. Subthalamic stimulation is an effective treatment for motor and non-motor neuropsychiatric fluctuations in Parkinson's disease, which has also allowed to better characterize the electrophysiological activity of the subthalamic nucleus in patients with Parkinson's disease. Numerous studies have been carried out on electrophysiological activity correlated with motor disorders, showing that akinesia is correlated with an abnormal synchronization in the beta frequency band (13-30Hz) in the dorsal motor part of the subnucleus. thalamic. This abnormal synchronization is reduced when the akinesia improves with dopaminergic treatment. On the cognitive-behavioural non-motor side, electrophysiological studies are less numerous, but suggest an involvement of the subthalamic nucleus (with an abnormal synchronization in the lower frequency bands). Currently, the electrophysiological correlates of neuropsychiatric fluctuations are unknown. In addition, all studies on electrophysiological activity are carried out immediately after the intervention, and before the implantation of the pacemaker. It is unknown whether the electrophysiological correlates of motor and non-motor fluctuations change following their transient improvement observed in the setting of chronic stimulation of the subthalamic nucleus and chronic reduction of dopaminergic treatment. The new PERCEPT stimulators (Medtronic) available on the market make it possible to record long-term electrophysiological activity for the first time. With this study we want to define the electrophysiological markers of neuropsychiatric fluctuations and their change over time.

lead_sponsor: University Hospital, Grenoble


title: InterventionPredictive Factors for the Outcome of Emotional and/or Behavioural Disorders in 18- to 48 Month-old Children After Psychotherapeutic Intervention

summary:
Behavioral disorders and emotional disorders represent frequent reasons for consultation in young children.

Their prevalence is between 7% and 13% depending on the studies. Behavioral disorders, and to a lesser extent emotional disorders, tend to persist through childhood and adolescence and are a risk factor for disorders in adulthood.

There is still little research on psychotherapies concerning children and even less on parent(s)-young child therapies, despite a certain interest of clinicians for these.

In a previous study, three independent factors appeared predictive of the unfavorable child's outcome : the frequency and intensity of behavioral problems and fears, as well as the absence of the father at more than 2/3 of the consultations. The only independent factor associated with the outcome of the mother was her anxiety score at the start of treatment.

The study presented here will take these elements into account and will include an assessment of both parents.

The main objective is to identify predictive factors of behavioural and emotional disorder outcome in children aged 18 months to 48 months after parent-child psychotherapy. The secondary objectives are to study predictive factors of the outcome in parents (anxiety/depression symptoms) and parent-child relationship.

The main predictive factors will be the presence of the father at the consultations, the therapeutic alliance (subject to validation), the type of disorder of the child and the parental psychopathology.

intervention_type: Behavioral


title: Evaluation of a Therapeutic Education Program for Multiple System Atrophy Patients : MSA Feasibility

summary: Multiple system atrophy (MSA) is a rare neurodegenerative disorder that leads to major disability, forcing patients and caregivers to adapt their environment and lifestyle. Once they receive the diagnosis, patients and caregivers need to understand the symptoms, cope with them, to digest the diagnosis... All these needs are not completely addressed by the current model of care so we created a therapeutic educational program (TEP) program that will last 12 months, involving both patients and caregivers, including a mixed model of in-person visits and continuous on-line activities. Our project aims to target early MSA patients and their caregivers, proposing to test the feasibility (primary objective) of an innovative therapeutic educational program (TEP) for MSA patients.

lead_sponsor: University Hospital, Toulouse


title: Prediction of Lung Cancer Characteristics Using PET/CT Radiomics

summary: Therapeutic progress for subgroups of Non Small Cell Lung Cancer can largely be attributed to the accumulation of molecular knowledge and the development of new drugs that specifically target molecular abnormalities. An understanding of the immune landscape of tumors, including immune-evasion strategies, has also led to breakthrough therapeutic advances.These new options require prior treatment tumoral sampling to identify patients who have neoplasms with specific genomic aberrations or favorable immune environment. Medical imaging and radiomic approach may provides surrogate markers non invasively.The objective of the present retrospective study is to build and validate a predictive model of common molecular alterations and PD-L1 expression in NSCLC using pre treatment PET/CT derived radiomics.

lead_sponsor: Poitiers University Hospital


title: Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients

acronym: EPRAPAC

summary:
Direct oral anticoagulants (DOACs) are now recommended as a first-line option in cancer patients with venous thromboembolism or atrial fibrillation. However, current international clinical practice guidelines and product inserts suggest caution and/or avoidance in using DOACs in case of potential potential drug-drug interactions (DDI), including DDI with anticancer therapies. Indeed, potential important DDIs can affect the efficacy and safety of DOACs and/or anticancer therapies and/or other interfering medications in these patients. Data about the pharmacokinetics (PK) of DOACs in cancer patients are scarce. By using a PK approach, this study aims :

to describe the PK profile of rivaroxaban and apixaban in adult cancer patients with venous thromboembolism or atrial fibrillation from a real-world setting
to identify factors (age, weight, renal function, co-morbidities, etc) influencing the PK profile of rivaroxaban and apixaban in adult cancer with venous thromboembolism or atrial fibrillation from a real-world setting.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière


title: Durvalumab/Tremelimumab in Neoadjuvant and Adjuvant Setting in Patients With HCC Treated by Electroporation Ablation in Curative Intent: French Multicenter Phase 2 Therapeutic

acronym: DUMELEP

summary:
This project is a Phase 2 trial testing the safety and efficacy of treatment with Durvalumab/Tremelimumab in neoadjuvant and Durvalumab in adjuvant setting in patients with BCLC A HCC treated by percutaneous irreversible electroporation (IRE) in a curative intent.

DUMELEP is a Multicentre, Phase 2 trial

Eligible patients will receive consecutively:

1 Durvalumab 1500 mg/Tremelimumab 300 mg infusion in a neoadjuvant setting
IRE procedure in a curative attempt at Day 30
11 monthly Durvalumab 1500 mg infusions.
Classical follow-up during an additional year (every 3 months)

ReferenceCitation: Trinchet JC, Bourcier V, Chaffaut C, Ait Ahmed M, Allam S, Marcellin P, Guyader D, Pol S, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Goria O, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Buffet C, Bacq Y, Wartelle C, Dao T, Benhamou Y, Pilette C, Silvain C, Christidis C, Capron D, Thiefin G, Hillaire S, Di Martino V, Nahon P, Chevret S; ANRS CO12 CirVir Group. Complications and competing risks of death in compensated viral cirrhosis (ANRS CO12 CirVir prospective cohort). Hepatology. 2015 Sep;62(3):737-50. doi: 10.1002/hep.27743. Epub 2015 Mar 20.

ReferenceCitation: N'Kontchou G, Mahamoudi A, Aout M, Ganne-Carrie N, Grando V, Coderc E, Vicaut E, Trinchet JC, Sellier N, Beaugrand M, Seror O. Radiofrequency ablation of hepatocellular carcinoma: long-term results and prognostic factors in 235 Western patients with cirrhosis. Hepatology. 2009 Nov;50(5):1475-83. doi: 10.1002/hep.23181.

ReferenceCitation: Nault JC, Sutter O, Nahon P, Ganne-Carrie N, Seror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13.

ReferenceCitation: Seror O. Ablative therapies: Advantages and disadvantages of radiofrequency, cryotherapy, microwave and electroporation methods, or how to choose the right method for an individual patient? Diagn Interv Imaging. 2015 Jun;96(6):617-24. doi: 10.1016/j.diii.2015.04.007. Epub 2015 May 14.

ReferenceCitation: Seror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15.

ReferenceCitation: Sutter O, Calvo J, N'Kontchou G, Nault JC, Ourabia R, Nahon P, Ganne-Carrie N, Bourcier V, Zentar N, Bouhafs F, Sellier N, Diallo A, Seror O. Safety and Efficacy of Irreversible Electroporation for the Treatment of Hepatocellular Carcinoma Not Amenable to Thermal Ablation Techniques: A Retrospective Single-Center Case Series. Radiology. 2017 Sep;284(3):877-886. doi: 10.1148/radiol.2017161413. Epub 2017 Apr 28.

ReferenceCitation: Cheng RG, Bhattacharya R, Yeh MM, Padia SA. Irreversible Electroporation Can Effectively Ablate Hepatocellular Carcinoma to Complete Pathologic Necrosis. J Vasc Interv Radiol. 2015 Aug;26(8):1184-8. doi: 10.1016/j.jvir.2015.05.014. Epub 2015 Jun 26.

ReferenceCitation: Niessen C, Beyer LP, Haimerl M, Schicho A, Stroszczynski C, Wiggermann P, Jung EM. Percutaneous irreversible electroporation of hepatocellular carcinoma: Contrast-enhanced ultrasound-findings during 1-year follow-up. Clin Hemorheol Microcirc. 2019;72(1):85-93. doi: 10.3233/CH-180449.

ReferenceCitation: Niessen C, Beyer LP, Pregler B, Dollinger M, Trabold B, Schlitt HJ, Jung EM, Stroszczynski C, Wiggermann P. Percutaneous Ablation of Hepatic Tumors Using Irreversible Electroporation: A Prospective Safety and Midterm Efficacy Study in 34 Patients. J Vasc Interv Radiol. 2016 Apr;27(4):480-6. doi: 10.1016/j.jvir.2015.12.025. Epub 2016 Feb 26.

ReferenceCitation: Niessen C, Thumann S, Beyer L, Pregler B, Kramer J, Lang S, Teufel A, Jung EM, Stroszczynski C, Wiggermann P. Percutaneous Irreversible Electroporation: Long-term survival analysis of 71 patients with inoperable malignant hepatic tumors. Sci Rep. 2017 Mar 7;7:43687. doi: 10.1038/srep43687.

ReferenceCitation: Bhutiani N, Philips P, Scoggins CR, McMasters KM, Potts MH, Martin RC. Evaluation of tolerability and efficacy of irreversible electroporation (IRE) in treatment of Child-Pugh B (7/8) hepatocellular carcinoma (HCC). HPB (Oxford). 2016 Jul;18(7):593-9. doi: 10.1016/j.hpb.2016.03.609. Epub 2016 May 1.

ReferenceCitation: Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

oa_host_type: closed

ReferenceCitation: El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

unpaywall_oa_status: green

ReferenceCitation: Behm B, Di Fazio P, Michl P, Neureiter D, Kemmerling R, Hahn EG, Strobel D, Gress T, Schuppan D, Wissniowski TT. Additive antitumour response to the rabbit VX2 hepatoma by combined radio frequency ablation and toll like receptor 9 stimulation. Gut. 2016 Jan;65(1):134-43. doi: 10.1136/gutjnl-2014-308286. Epub 2014 Dec 18.

ReferenceCitation: Zerbini A, Pilli M, Laccabue D, Pelosi G, Molinari A, Negri E, Cerioni S, Fagnoni F, Soliani P, Ferrari C, Missale G. Radiofrequency thermal ablation for hepatocellular carcinoma stimulates autologous NK-cell response. Gastroenterology. 2010 May;138(5):1931-42. doi: 10.1053/j.gastro.2009.12.051. Epub 2010 Jan 11.

ReferenceCitation: Bulvik BE, Rozenblum N, Gourevich S, Ahmed M, Andriyanov AV, Galun E, Goldberg SN. Irreversible Electroporation versus Radiofrequency Ablation: A Comparison of Local and Systemic Effects in a Small-Animal Model. Radiology. 2016 Aug;280(2):413-24. doi: 10.1148/radiol.2015151166. Epub 2016 Jan 27.

ReferenceCitation: Lee JH, Lee JH, Lim YS, Yeon JE, Song TJ, Yu SJ, Gwak GY, Kim KM, Kim YJ, Lee JW, Yoon JH. Adjuvant immunotherapy with autologous cytokine-induced killer cells for hepatocellular carcinoma. Gastroenterology. 2015 Jun;148(7):1383-91.e6. doi: 10.1053/j.gastro.2015.02.055. Epub 2015 Mar 4.

ReferenceCitation: Iida N, Nakamoto Y, Baba T, Nakagawa H, Mizukoshi E, Naito M, Mukaida N, Kaneko S. Antitumor effect after radiofrequency ablation of murine hepatoma is augmented by an active variant of CC Chemokine ligand 3/macrophage inflammatory protein-1alpha. Cancer Res. 2010 Aug 15;70(16):6556-65. doi: 10.1158/0008-5472.CAN-10-0096. Epub 2010 Jul 27.

ReferenceCitation: Kelley RK, Sangro B, Harris W, Ikeda M, Okusaka T, Kang YK, Qin S, Tai DW, Lim HY, Yau T, Yong WP, Cheng AL, Gasbarrini A, Damian S, Bruix J, Borad M, Bendell J, Kim TY, Standifer N, He P, Makowsky M, Negro A, Kudo M, Abou-Alfa GK. Safety, Efficacy, and Pharmacodynamics of Tremelimumab Plus Durvalumab for Patients With Unresectable Hepatocellular Carcinoma: Randomized Expansion of a Phase I/II Study. J Clin Oncol. 2021 Sep 20;39(27):2991-3001. doi: 10.1200/JCO.20.03555. Epub 2021 Jul 22.

ReferenceCitation: Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Ghassan K. Abou-Alfa, M.D., M.B.A. abou-alg@mskcc.org, George Lau, M.D., F.R.C.P., Masatoshi Kudo, M.D., Ph.D., Stephen L. Chan, M.D., Robin Kate Kelley, M.D., Junji Furuse, M.D., Ph.D., Wattana Sukeepaisarnjaroen, M.D., +24 , for the HIMALAYA Investigators*Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma. NEJM Evid 2022;1(8)

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
AstraZeneca


title: Determination of EEG Microstates Associated With Mental Disorders in At-Risk States (Détermination Des Microétats EEG associés Aux Troubles Psychiques Dans Les États à Risque - DEMETER)

acronym: DEMETER

summary:
The goal of this observational study is to compare subjects with at-risk-mental-state, early psychosis, schizophrenia, depression, and autism spectrum disorders, with healthy controls (N = 21 x 6). The main questions it aims to answer are:

are EEG microstate anomalies associated with diagnosis, clinical and functional prognosis, both in resting conditions and during sleep ?
are EEG microstates anomalies associated with differences in sensorimotor integration, prosodic and conversational, interoceptive, and narrative self ?
an ancillary study will be to see whether in healthy controls EEG microstate properties vary under light hypnosis conditions.

Participants will:

undergo deep phenotyping based on psychopathology and neuropsychological assessments
undergo a high-resolution EEG (64 electrodes) with a resting period and a sensorimotor task; and healthy controls will have a light hypnosis period.
undergo a recording of the characteristics of their voice (tone, prosody)
undergo a one-night polysomnography
undergo MRI and biological sampling for multi-omic analyses
undergo a virtual reality experience

ReferenceCitation: Iftimovici A, Marchi A, Ferat V, Pruvost-Robieux E, Guinard E, Morin V, Elandaloussi Y, D'Halluin A, Krebs MO, Chaumette B, Gavaret M. Electroencephalography microstates imbalance across the spectrum of early psychosis, autism, and mood disorders. Eur Psychiatry. 2023 May 29;66(1):e41. doi: 10.1192/j.eurpsy.2023.2414.

ReferenceCitation: Gavaret M, Iftimovici A, Pruvost-Robieux E. EEG: Current relevance and promising quantitative analyses. Rev Neurol (Paris). 2023 Apr;179(4):352-360. doi: 10.1016/j.neurol.2022.12.008. Epub 2023 Mar 10.

lead_sponsor: Centre Hospitalier St Anne

sponsor_collaborators:
Centre Hospitalier St Anne
Assistance Publique - Hôpitaux de Paris

location_facility: Centre de Recherche Clinique, Hôpital Sainte-Anne, GHU Paris Psychiatrie et Neurosciences


title: Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation

acronym: CFTR-EP

summary:
The aim of this observational study is to better understand the role and involvement of the regulatory elements of the CFTR gene, with the aim of better describing the 3D organisation of chromatin at the CFTR locus in epididymal cells in patients with male infertility of any kind, or with cystic fibrosis or bilateral agenesis of the vas deferens, requiring scheduled surgery.

The main questions it aims to answer are:

to better characterise this 3D organisation of the CFTR locus, the study of regulatory elements in primary epididymal cells is the most relevant and realistic model.
to gain a better understanding of the regulation of the CFTR gene in epididymal cells in order to gain a better understanding of the pathology of male infertility caused by bilateral agenesis of the vas deferens, a symptom and also a borderline form of cystic fibrosis.

Participants will Epididymal samples will be taken by a urologist for the AMP department during the planned surgery. The rest of the samples taken will be recovered for research purposes, with the aim of recovering the epididymal cells contained in the sample. This is in no way an additional procedure and will have no impact on the patient's health..

lead_sponsor: University Hospital, Brest


title: Temporal Variation of the Exposure to Pesticides in the Employees of the Limoges University Hospital

acronym: VESTAL

summary: In a sample of 300 employees of the Limoges University Hospital, it is proposed to explore the intraindividual and interindividual variability of urinary concentrations of glyphosate and 320 other pesticides. The employees will fill a questionary in which will allow to explore the relationships between the concentrations, lifestyle and dietary habits.

lead_sponsor: University Hospital, Limoges


title: Establishment of Pre-clinical Stem Line and Tumoroid Models of Brain Tumors

acronym: HITCH

summary:
Background: Primary or secondary brain tumors (metastases) remain associated with a very poor prognosis linked to significant therapeutic resistance. Thus, glioblastoma, which is the most common and aggressive primary brain tumor in adults, is associated with inevitable relapses within 7 to 10 months and median survival of approximately 12 to 14 months. At the same time, brain metastases are increasingly increasing following better systemic control of other metastatic sites and improvement in detection methods. However, they remain resistant to the latest therapeutic innovations such as immunotherapies or targeted therapies.

In this context, innovative strategies are necessary to identify new therapeutic targets and implement new treatments to overcome resistance phenomena in the clinic.

Objective: Our goal will be to generate tumoroids and stem-like cell lines (PDX) from patient tumor samples.

Methods: We will establish tumor tumoroids and stem cell lines from patient samples. These preclinical models will allow us to test a large number of drugs, quickly and efficiently thanks to models as close as possible to patient tumors and limiting the use of animal models (3R).

Overall, this project should enable major advances in the treatment of glioblastoma and brain metastases and enable the rapid testing of new molecules in clinical trials thanks to the homology of our models with our patients' diseases.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance publique hopitaux de marseille


title: Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance

acronym: IMMORTALLS

summary: Multimodal intraoperative minimal-invasive (laparoscopic or robotic) liver surgery images will be registered to each other. Explicitly, these are the ultrasound and laparoscope images. Once they are registered, they will reveal the hidden tumor's location to the surgeon in real time through augmented reality. The intraoperative augmentation will also be enriched with the preoperative data (e.g., CT or MRI). This will simplify minimal invasive liver surgery, improve surgical safety and accuracy. It will also shorten hospital stays and contribute to an overall better quality of life for the patient, which in return will reduce the health-care costs.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Interest of Acupressing in the Treatment of Preoperative Anxiety and Comfort of Patients Undergoing Oocyte Retrieval in Outpatient Surgery

acronym: ambauric

summary: The objective of this preliminary study is therefore to assess the feasibility, safety and reduction of perioperative anxiety thanks to acupressing. In addition, patients undergoing oocyte retrieval often present postoperatively with nausea, abdominal pain and discomfort. Acupuncture could also help these patients.

ReferenceType: result

ReferenceCitation: Villa G, Lanini I, Amass T, Bocciero V, Scire Calabrisotto C, Chelazzi C, Romagnoli S, De Gaudio AR, Lauro Grotto R. Effects of psychological interventions on anxiety and pain in patients undergoing major elective abdominal surgery: a systematic review. Perioper Med (Lond). 2020 Dec 8;9(1):38. doi: 10.1186/s13741-020-00169-x.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: University of Florence - Florence Research

repositories_concat: PubMed Central;flore.unifi.it

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Williams JB, Alexander KP, Morin JF, Langlois Y, Noiseux N, Perrault LP, Smolderen K, Arnold SV, Eisenberg MJ, Pilote L, Monette J, Bergman H, Smith PK, Afilalo J. Preoperative anxiety as a predictor of mortality and major morbidity in patients aged >70 years undergoing cardiac surgery. Am J Cardiol. 2013 Jan 1;111(1):137-42. doi: 10.1016/j.amjcard.2012.08.060.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

ReferenceCitation: Oleson TD, Kroening RJ, Bresler DE. An experimental evaluation of auricular diagnosis: the somatotopic mapping or musculoskeletal pain at ear acupuncture points. Pain. 1980 Apr;8(2):217-229. doi: 10.1016/0304-3959(88)90009-7.

ReferenceCitation: Usichenko TI, Hua K, Cummings M, Nowak A, Hahnenkamp K, Brinkhaus B, Dietzel J. Auricular stimulation for preoperative anxiety - A systematic review and meta-analysis of randomized controlled clinical trials. J Clin Anesth. 2022 Feb;76:110581. doi: 10.1016/j.jclinane.2021.110581. Epub 2021 Nov 12.

ReferenceCitation: Saku K, Mukaino Y, Ying H, Arakawa K. Characteristics of reactive electropermeable points on the auricles of coronary heart disease patients. Clin Cardiol. 1993 May;16(5):415-9. doi: 10.1002/clc.4960160509.

ReferenceCitation: Ceccherelli F, Gagliardi G, Seda R, Corradin M, Giron G. Different analgesic effects of manual and electrical acupuncture stimulation of real and sham auricular points: a blind controlled study with rats. Acupunct Electrother Res. 1999;24(3-4):169-79. doi: 10.3727/036012999816356309.

ReferenceCitation: He W, Wang X, Shi H, Shang H, Li L, Jing X, Zhu B. Auricular acupuncture and vagal regulation. Evid Based Complement Alternat Med. 2012;2012:786839. doi: 10.1155/2012/786839. Epub 2012 Nov 27.

ReferenceCitation: Usichenko TI, Mustea A, Pavlovic D. On ears and Head. Acupunct Med. 2010 Dec;28(4):165-6. doi: 10.1136/aim.2010.003244. No abstract available.

ReferenceCitation: Mora B, Iannuzzi M, Lang T, Steinlechner B, Barker R, Dobrovits M, Wimmer C, Kober A. Auricular acupressure as a treatment for anxiety before extracorporeal shock wave lithotripsy in the elderly. J Urol. 2007 Jul;178(1):160-4; discussion 164. doi: 10.1016/j.juro.2007.03.019. Epub 2007 May 17.

ReferenceCitation: Qu F, Zhang D, Chen LT, Wang FF, Pan JX, Zhu YM, Ma CM, Huang YT, Ye XQ, Sun SJ, Zheng WJ, Zhang RJ, Xu J, Xing LF, Huang HF. Auricular acupressure reduces anxiety levels and improves outcomes of in vitro fertilization: a prospective, randomized and controlled study. Sci Rep. 2014 May 22;4:5028. doi: 10.1038/srep05028.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Springer

ReferenceCitation: Williams VS, Morlock RJ, Feltner D. Psychometric evaluation of a visual analog scale for the assessment of anxiety. Health Qual Life Outcomes. 2010 Jun 8;8:57. doi: 10.1186/1477-7525-8-57.

ReferenceCitation: Tian M, Huang Y, Wang X, Cao M, Zhao Z, Chen T, Yuan C, Wang N, Zhang B, Li C, Zhou X. Vaccaria segetalis: A Review of Ethnomedicinal, Phytochemical, Pharmacological, and Toxicological Findings. Front Chem. 2021 Apr 29;9:666280. doi: 10.3389/fchem.2021.666280. eCollection 2021.

publisher_dissemination: Frontiers

ReferenceCitation: Nielsen A, Gereau S, Tick H. Risks and Safety of Extended Auricular Therapy: A Review of Reviews and Case Reports of Adverse Events. Pain Med. 2020 Jun 1;21(6):1276-1293. doi: 10.1093/pm/pnz379.

publisher_dissemination: Oxford University Press

ReferenceCitation: Wang SM, Maranets I, Weinberg ME, Caldwell-Andrews AA, Kain ZN. Parental auricular acupuncture as an adjunct for parental presence during induction of anesthesia. Anesthesiology. 2004 Jun;100(6):1399-404. doi: 10.1097/00000542-200406000-00011.


title: Prevalence and Prognostic Value of Epstein Barr Virus (EBV) Infection in Patients With Radiologically Isolated Syndrome (RIS)

acronym: EBV-RIS

summary: The clinical course of RRMS patients is variable. Among RIS-Consortium international cohorts, one third of RIS patients progressed to MS at 5 years and 52.2% at 10 years. Biomarkers predictive of MS conversion are key elements to organize personalized medical care, for both follow-up and treatment strategies. EBV seems to be an interesting candidate regarding its involvement MS pathophysiology. It can be easily assess in blood sample in contrast to others prognostic biomarkers validated in RIS : oligoclonal bands and NfL levels in cerebrospinal fluid and serum. In RIS, treatment targeting EBV could significantly modify the course of the disease. The investigators aim to make the fisrt description of the EBV epidemiology (immunoglobulin (Ig)M and IgG anti-viral capsid antigen (VCA), IgG anti Epstein-Barr nuclear antigen (EBNA)) among RIS patients and to investigate a correlation between the different antibodies' titers (IgM VCA, IgG VCA, IgG EBNA) and the course of the disease (clinical conversion or evidence of disease activity (EDA)).

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Randomized Pragmatic, Cluster, Stepped-wedge Trial of Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services for Care Before 1 Year of Follow-up

summary: This study aims to compare two screening strategies for identifying infants with a potential risk of Autism Spectrum and Neurodevelopmental Disorders to provide early access to care and increase the likelihood of a favorable outcome

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: 1er secteur de psychopathologie de l'enfant et de l'adolescent du Val de Marne


title: The Effect of Increasing Post-Filter Ionized Target on the Efficacy of Regional Citrate Anticoagulation During Continuous Renal Replacement Therapy in Intensive Care: a Multicenter Randomized Controlled Non-Inferiority Trial

acronym: Ca-CIBLE

summary: Regional citrate anticoagulation (RCA) is the recommended method for anticoagulation in continuous renal replacement therapy (CRRT). However, the optimal post-filter ionized calcium (iCa) target level remains unclear. Currently, it is titrated to a post-filter iCa target ranging from 0.25 to 0.35 mmol/L, which is derived from a few underpowered trials. There are potential side effects associated with citrate administration, which may be increased in patient with liver failure and/or tissue dysoxia, such as alkalemia, acidemia, hypernatremia, hypocalcemia, hypomagnesemia, and citrate accumulation. Consequently, citrate anticoagulation is contraindicated in the most severe cases. The challenge is to use the minimum necessary dose of citrate to ensure both effective anticoagulation of the circuit and limit citrate administration to reduce the risks of metabolic complications and accumulation. This approach expands the indications for citrate, standardizes practice, and reduces financial costs. Investigators hypothesized that increasing the post-filter iCa target in RCA can limit the dose of citrate, thereby avoiding adverse effects (safety) without compromising the effectiveness of the treatment in preventing filter clotting. The aim of this study is to evaluate the impact of an increased post-filter iCa target from 0.25-0.35 to 0.35-0.45 mmol/L on the incidence of filter clotting for RCA-CRRT in critically ill patients. Investigators are designing a multicenter randomized controlled non-inferiority study.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Validation Study of the Coping, Motivation Ans Post-diagnosis Psychoeducation Program for Adults With Autism : a Randomized Controlled Trial

acronym: CoMPPAA

summary: The primary objective of the study is to evaluate the effectiveness of a post-diagnostic psychoeducational intervention in increasing the sense of self-efficacy of adults diagnosed with Autism Spectrum Disorder-Without associated Intellectual Disability

lead_sponsor: Centre Hospitalier Rouffach


title: Gingival Phenotype Prevalence of Lower Incisors and Associated Risk Factors in French Dental Students Population : a Cross-sectional Study

summary: Several types of gingival phenotype can be diagnosed in the general population and their evaluation is an essential clinical criterion in periodontal practice, whether the periodontal therapies are preventive or curative, non-surgical or surgical. Moreover, several authors have shown that the gingival phenotype varies from one dental sector to another, hence the interest of a meticulous and targeted diagnostic approach in relation to the established therapeutic objectives. To date, the gingival phenotype has been not studied extensively in the mandibular incisal area. Therefore, it seems relevant to conduct an observational cross-sectional study on a cohort of patients in good general health and with a healthy and intact periodontium to assess the prevalence of the gingival phenotype in this area. The secondary objective is to highlight the associated intrinsic and extrinsic risk factors for thin gingival phenotype, to anticipate a risk of gingival recession and to propose an early personal therapy.


title: Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients

summary:
In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy.

Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Biological


title: An Adaptive Randomized Controlled Trial (RCT) Comparing High-flow Nasal Cannula Oxygen and Noninvasive Ventilation to Standard Oxygenation in Non-selected Intensive Care Unit Patients Admitted for Hypoxemic Acute Respiratory Failure: The KISS Trial (Key Oxygenation Interventions in Surgical and Non-Surgical Patients)

acronym: KISS

summary: The goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (NIV and/or HFNO) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (ARF) patients.

lead_sponsor: University Hospital, Montpellier

location_facility: Montpellier University Hospital - Saint Eloi Hospital


title: A Randomized, Single-center, Open-label, Single Dose, Two-period, Crossover Pivotal Bioequivalence Study Comparing Binimetinib 3 x 15 mg and 45 mg Tablets in Healthy Participants

summary: The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration. For the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation, the recommended dosing regimen is 45 mg twice daily (bis in die, BID). No food effect with the commercial formulation of 15 mg was demonstrated. In order to reduce the patient's burden, a new strength tablet containing 45 mg of binimetinib as active ingredient is being developed. As a result, the number of tablets to be taken by the patients will be reduced from 6 tablets (6 x 15 mg) to 2 tablets (2 x 45 mg) per day. The evaluation of the bioequivalence between one 45 mg tablet and three 15 mg tablets is therefore required.

ipd_sharing_description: Pierre Fabre will provide access to individual de-identified data and related study documents [e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)] upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

lead_sponsor: Pierre Fabre Medicament

sponsor_collaborators:
Pierre Fabre Medicament
Biotrial


title: Dual IntraVenous Thrombolysis Approach (DIVA) in Patients With Medium-vessel-occlusion Strokes: a Retrospective Study

acronym: DIVArétro

summary: The purpose of this study (Dual IV thrombolysis Approach (DIVA) study) is to assess a new medical strategy for Medium-vessel-occlusion (MeVO) strokes, based on a second IV thrombolysis with tenecteplase (TNK) for persistent intracranial occlusion on MRI 1-2 hours after standard alteplase infusion. The DIVA-study results were compared with a similar cohort of MeVO strokes patients treated with standard therapy (single IVT with alteplase) during the same timeframe in another stroke unit.

lead_sponsor: Centre Hospitalier Sud Francilien


title: High Frequency Intraoral Ultrasound Probe for Early Diagnosis of Periodontal Diseases

summary: The goal of this clinical investigation is evaluation the agreement between the periodontal pocket depth measurement obtained by periodontal probing (gold standard) and the measurement obtained by the ultrasound device

lead_sponsor: University Hospital, Tours


title: Identification of Genomic Biomarkers for Rheumatoid Arthritis With Late Onset

acronym: BIOGENOPRAT

summary: Rheumatoid arthritis (RA) is a disabling disease leading to joint and bones destruction. This autoimmune disease is multifactorial, and some genetic and environmental risk factors are already described. However, a part of heritability is still unknown. Previous genomics studies dedicated to deciphering this missing heritability did not pay attention to age of onset. The purpose of this protocol is to determine genomic markers which are specific of RA with an age of onset above 65 years old. Indeed, clinical presentation, treatment tolerance and efficiency, and frequent comorbidities of this phenotype are particular. This signature of genomic biomarkers will be integrated in known molecular pathways to highlight specificities, helpful for biological targets identification.


title: Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children - An Observational Study

acronym: DysREAped

summary:
The Autonomic Nervous System (ANS) regulates the inflammatory response in real time, just as it controls heart rate and other vital functions.

Many studies have investigated induced stimulation of the vagus nerve and its therapeutic effect in inhibiting TNFα (Tumor Necrosis Factor alpha) secretion, and therefore the risk of hypotension, septic shock, organ dysfunction during inflammation.

While the anti-inflammatory effect of the autonomic nervous system on inflammation has been well studied, conversely, the effect of major inflammation on the balance of the autonomic nervous system is more difficult to understand. The inflammatory reflex could be overwhelmed and the regulatory centers of the brainstem dysregulated during situations of extreme inflammation.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography

acronym: TRACTOLCA

summary:
Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear.

The treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). However, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the ACL in case of partial tear. As a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. Any patient who undergo a posttraumatic knee MRI at the CHU Amiens Picardie will have an appointment at the 3T "Signa" MRI that has the knee-centric diffusion tractography sequence.


title: Development of a Therapeutic Serious Game in the Rehabilitation of Stroke Patient

summary: The growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. Investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency. Twelve patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Six patients assigned to a group received both serious game training and conventional rehabilitation, and after only conventional rehabilitation; and six patients assigned to another group received first conventional rehabilitation and then serious game training and conventional rehabilitation. The investigators compared the two groups after rehabilitation.

lead_sponsor: Hopitaux de Saint-Maurice


title: Feasibility of Implementing Yoga and Meditation in the Preoperative Period of Pediatric Idiopathic Scoliosis Surgery, an Exploratory Study

acronym: YOMEPOP

summary:
This study has to purpose Yoga and Meditation before surgery for idiopathic scoliosis.

Protocol's observance will tell the investigators if it is feasible and appropriate in a University hospital center.


title: Randomized Study Comparing the Combination Intraperitoneal Local Anesthetics, Maneuvers Alveolar Recruitment and Abdominal Compression Compared to Passive Exsufflation of the Pneumoperitoneum in the Prevention of Pain Shoulders After Laparoscopic Surgery

acronym: POPPLaS

summary: The purpose of this study is to assess shoulder pain at rest (average over the last 24 hours) assessed by visual analogue scale from 0 to 100mm on Day 1.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome: Prospective, Multicenter, Randomized, Controlled, Open-label, Phase III, Cluster Trial With Sequential Permutation

acronym: PARAVENT

summary: Acute respiratory distress syndrome (ARDS) is a frequent pathology in intensive care (around 10% of patients admitted to intensive care and almost a quarter of patients on mechanical ventilation) and a serious one, with a hospital mortality rate of 40%. The main measures that have an effect on mortality in ARDS involve adjustments to the ventilator, known as protective ventilation. In the most severe patients, adjuvant measures such as prone positioning and the use of curarisation in the initial phase of the disease can improve survival. All these measures have been included in the latest national and international recommendations. However, a vast observational study carried out in 50 countries revealed low compliance with these recommendations. More than a third of patients did not receive protective ventilation, and the majority did not receive prone positioning when this was indicated. During weaning from artificial ventilation, it has been widely demonstrated that replacing clinician judgement with the implementation of paramedical care protocols improved weaning and significantly reduced the duration of artificial ventilation. Therefore, investigators hypothesize that the implementation of a paramedical care protocol for ventilation in the acute phase of ARDS improves compliance with recommendations and thus reduces mortality and the duration of artificial ventilation. However, implementation of such a protocol requires operational training for all the nurses in the participating departments. Simulation appears to be the training method of choice, as it is a teaching technique that enables technical and non-technical skills to be passed on with good retention of what has been learnt, as well as assessing what has been learnt. To make it possible to train several dozen nurses within a tight timescale, a partially dematerialized simulation model incorporating innovative e-learning tools will be developed.

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

location_facility: Assistance Publique-Hôpitaux de Paris service de santé publique


title: Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) 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 STT osteoarthritis.

lead_sponsor: TBF Genie Tissulaire

location_facility: Institut Chirurgical de la Main et du Membre Supérieur (ICMMS)


title: Biobanking for Biomarkers In Respiratory Disease, Allergic Diseases and/or Mast Cell Disorders

acronym: BIRD-A

summary: This study aims to build up a clinico-biological bank of samples from patients suspected of or suffering from allergic diseases (including asthma) or mast cell diseases in order to support future research in the field of allergic diseases. The biobank will help to identify new prognostic, diagnostic and/or predictive biomarkers.

lead_sponsor: University Hospital, Toulouse


title: Influence of Compressive Cryotherapy Compared to Conventional Cryotherapy on Articular, Trophic and Functional Recovery After Total Knee Arthroplasty: a Randomized Controlled Study

summary: In the postoperative period of a total knee arthroplasty, subjects present limitations of articular amplitudes, swelling, pain and functional limitations. Functional rehabilitation is unanimously recommended, including the use of cryotherapy. However, there is no consensus regarding the methods of application of cryotherapy. Thus the objective of the study is to compare 2 cryotherapy techniques associated with a classic rehabilitation on the improvement of mobility, swelling, pain and functional parameters. The 2 cryotherapies were a compressive cryotherapy and a so-called classic cryotherapy by cold pack.

lead_sponsor: Institut de Formation en Masso-Kinésithérapie Saint Michel


title: Comparison of Methods for Teaching Simple Skin Sutures to Medical Students: a Randomized Blinded Controlled Study

acronym: E-SUTURE

summary:
Learning the simple skin suture is part of the surgical basics required for all medical students, including future general practitioners.

However, there is no data in the educational literature to help choose the best learning technique.

Several teams have offered video learning showing the correct technique. Level n+1 peer learning was also proposed, without and with supervision by an expert.

The investigators propose to carry out a prospective study comparing the quality of sutures and knowledge according to the chosen learning method.

lead_sponsor: University Hospital, Clermont-Ferrand


title: TocilizuMab discontinuAtion in GIant Cell Arteritis

acronym: MAGICA

summary:
Giant cell arteritis (GCA) is a large-vessel vasculitis that typically occurs in people over the age of 50.

Corticosteroids (GC) are the cornerstone of treatment for GCA. French guidelines recommend starting at 0.7 or 1 mg/kg/day at diagnosis, depending on the occurence of ischemic complication(s). Then, it is recommended to gradually decrease their dose to achieve withdrawal in 12 to 24 months.

Despite this treatment, 47% of patients relapse. Relapses are favored by rapid reduction of corticosteroid doses and large vessel involvement at diagnosis. Fortunately, relapses are severe in only 3.3% of cases and ischemic complications are very rare. However, this contributes to prolonging the duration of corticosteroid treatment and thus the risk of cortico-induced adverse events, which have not been significantly reduced in the last 20 years. The main risk factors for the development of steroid-related complications are advanced age and cumulative steroid dose.

For this reason, the development of cortisone-sparing strategies is necessary to improve the management of patients with GCA. Thanks to major advances in the understanding of the pathophysiological mechanisms of GCA, new therapeutic targets have been discovered. For example, the efficacy of tocilizumab (TCZ), an anti-IL-6 receptor monoclonal antibody, has been demonstrated in two phase 2 trials and one phase 3 trial, leading to its approval for the management of patients requiring rapid reduction in corticosteroid doses and/or those relapsing repeatedly on prednisone >7.5 mg/day. In recently published US guidelines, TCZ can even be used at diagnosis to reduce the need for corticosteroid therapy.5 Indeed, TCZ appears to be remarkably effective in controlling GCA activity and saves approximately 2000 mg of prednisone in cumulative dose.

At present, the place of TCZ compared to methotrexate in the therapeutic strategy is still being evaluated, notably through the METOGiA study (PHRC-N 2017), which is being conducted by our team. Inclusions for METOGiA ended in March 2023 with results expected in 2025. Outside of this study, approximately 1500 patients are currently receiving TCZ treatment for GCA (data from ROCHE-CHUGAI).

There is no doubt that TCZ treatment is effective and rather well tolerated in the elderly population, but it generates problems that are not solved to date:

the cost (~900€/month)
the difficulty monitoring these patients because the biological markers usually used to monitor GCA (CRP, ESR, fibrinogen) can no longer be measured since TCZ blocks their production by the hepatocytes. Monitoring of disease activity therefore requires very careful clinical examination and the use of expensive imaging tests such as PET scans because GCA can be active despite normal ESR, CRP and fibrinogen levels. Some studies suggest that monitoring serum IL-6 may help identify patients with active disease, but this test is not readily available and the threshold above which relapse should be suspected is unclear because TCZ induces an increase in serum IL-6 levels by blocking IL-6 receptors, even in patients in remission.
For the same reasons, infections are difficult to detect in patients treated with TCZ.

This raises the question of how to discontinue this treatment, especially since other treatments that do not interfere with CRP, ESR, or fibrinogen measurements are being evaluated.

This shows that this treatment tends to be prolonged well beyond one year when the disease is often in remission without corticosteroids. This is probably related to two factors: 1/ the fear of relapse after treatment withdrawal; 2/ the absence of a scheme for withdrawing TCZ.

The risk of relapse after stopping TCZ has been reported in several studies, in particular the long-term follow-up of phase 2 and 3 trials that demonstrated the efficacy of TCZ for the treatment of GCA. Overall, regardless of the duration of TCZ treatment, the risk of relapse is approximately 40% 6 months after the last injection of TCZ, and the risk of relapse is higher if the large arteries (aorta and its branches) are involved.

Thus, although the available data are limited, it appears that tapering rather than immediately stopping TCZ limits the risk of relapse after full withdrawal.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Metagenomic Analysis of Bacterial Microbiota in Breast Milk

summary: The aim of this study is to determine the extent to which bacteria in the breast milk microbiota represent an infectious risk for premature infants, by investigating whether they possess virulence genes, and if so, whether these are expressed or repressed.


title: Study of the Association Between the Discordance in the Evaluation of Suicidal Intentionality Between Parents and Adolescents After a Suicide Attempt in Adolescence and the Evolution of the Suicidal Crisis at 3 Months: a Mixed Study

acronym: discord-Ados

summary:
The goal of this mixed-methods study is to describe the association between the level of parent/adolescent discordance in the assessment of the adolescent's level of suicidal intentionality after a suicid attempt and the evolution of the suicidal crisis by assessing the evolution of the adolescent's suicidal intentionality between T0 and 3 months.

The main questions it aims to answer are:

To show the association between the level of parent/adolescent discordance in the assessment of the adolescent's level of suicidal intent after a suicid attempt and various markers of the evolution of the suicidal crisis at 3 months.
Explore the experience of adolescents and their parents regarding the elements they consider relevant in assessing the adolescent's suicidal intent.

Participants will be asked to complete various self- and hetero-questionnaires at T0 and T3


title: Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women in Case of a Desire for Physiological Delivery

summary: Women are showing a growing interest in less medicalized childbirth. According to the french 2021 perinatal survey, 52.2% of women want to limit medical procedures and 38.2% of women want childbirth without epidural anesthesia. Between 77 and 82% of deliveries nevertheless lead to an epidural anesthesia. The painful feeling seems to be the main motivation for using this mode of anesthesia.


title: Première Evaluation Clinique de la Transplantation Cardiaque de Greffons préservés à l'Aide d'un Système de Perfusion Ex-vivo prolongée

acronym: PEGASE

summary: The main objective of PEGASE is to validate the recovery of a satisfactory cardiac function of a transplanted heart after a prolonged period of preservation by an ex-vivo perfusion device. This recovery of cardiac function will have to happen within 15 days after transplantation.

primary_purpose: Basic Science

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data regulatory authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not allow 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.

collaborators: Centre Hospitalier Universitaire de Pointe-a-Pitre

collaborators: University Hospital Center of Martinique