title: Development of a Real-time Signal Processing Algorithm, for Beat-beat Measurement of Fetal Heart Rate and Uterine Contractions by Coupling Non-invasive ABDOminal Sensors

acronym: RCF-ABDO

summary:
The CIC-IT 1403 laboratory of the University Hospital of Lille has developed a technological solution for acquiring and synchronizing abdominal ECG, acoustic and Doppler signals.

The purpose of this clinical trial is to build a database of signals issued from this device to develop signal processing algorithms to allow optimization of the fetal heart rate calculation.

This study will be carried out in the maternity ward of the Jeanne de Flandre Hospital in the maternal-fetal pathology department Doppler, ECG and acoustic sensors will be placed on the mother's abdomen to capture the heart rate of the fetus and mother as well as uterine contractions.

For each of the participants, we will make two 15-minute recordings: one with conventional ECG electrodes and one with ECG textile electrodes.

This procedure will not affect the usual care of the patient


type: Registry Identifier

title: Chronic Non-inflammatory Pains in Rheumatopediatrics

acronym: RHUMEDOL

summary:
The purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity.

Secondary objectives are, first to determine intensity of pain and its repercussion in daily life and second to determine risk factor of chronic pain.

study_start_date_type: Anticipated

status: Withdrawn

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007 Mar 3;369(9563):767-778. doi: 10.1016/S0140-6736(07)60363-8. Review.

ReferenceCitation: Consolaro A, Ravelli A. Paediatric rheumatology: Juvenile idiopathic arthritis--are biologic agents effective for pain? Nat Rev Rheumatol. 2013 Aug;9(8):447-8. doi: 10.1038/nrrheum.2013.108. Epub 2013 Jul 2.

ReferenceCitation: Tupper SM, Rosenberg AM, Pahwa P, Stinson JN. Pain intensity variability and its relationship with quality of life in youths with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):563-70. doi: 10.1002/acr.21850.

ReferenceCitation: Lalloo C, Stinson JN. Assessment and treatment of pain in children and adolescents. Best Pract Res Clin Rheumatol. 2014 Apr;28(2):315-30. doi: 10.1016/j.berh.2014.05.003. Review.

ReferenceCitation: Duffield SJ, Miller N, Zhao S, Goodson NJ. Concomitant fibromyalgia complicating chronic inflammatory arthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2018 Aug 1;57(8):1453-1460. doi: 10.1093/rheumatology/key112. Review.

ReferenceCitation: McErlane F, Beresford MW, Baildam EM, Chieng SE, Davidson JE, Foster HE, Gardner-Medwin J, Lunt M, Wedderburn LR, Thomson W, Hyrich KL; Childhood Arthritis Prospective Study (CAPS). Validity of a three-variable Juvenile Arthritis Disease Activity Score in children with new-onset juvenile idiopathic arthritis. Ann Rheum Dis. 2013 Dec;72(12):1983-8. doi: 10.1136/annrheumdis-2012-202031. Epub 2012 Dec 20.

ReferenceCitation: Reynolds CR. Concurrent validity of "What I think and feel:" the Revised Children's Manifest Anxiety Scale. J Consult Clin Psychol. 1980 Dec;48(6):774-5.

ReferenceCitation: Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8.

ReferenceCitation: Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39.

ReferenceCitation: Drake C, Nickel C, Burduvali E, Roth T, Jefferson C, Pietro B. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children. Sleep. 2003 Jun 15;26(4):455-8.

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Functional Unit of "Pain and Palliative Medicine"- Necker-Enfants malades Hospital

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Unknown


title: Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets and Evaluation of the Potential Impact of Concomitant Food Intake on the Relative Bioavailability of GKT137831 in Healthy Male Subjects

summary:
The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets.

This will be a randomized three-way open cross-over study.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: Calliditas Therapeutics AB

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures

summary: The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.

status: Unknown status

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Sonnery-Cottet B, Pioger C, Vieira TD, Franck F, Kajetanek C, Fayard JM, Thaunat M, Saithna A. Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. Orthop J Sports Med. 2020 May 1;8(5):2325967120918490. doi: 10.1177/2325967120918490. eCollection 2020 May.

lead_sponsor: Ascopharm Groupe Novasco

location_facility: Hôpital Privé Jean Mermoz - Centre Paul Santy

intervention_type: Procedure


status: Recruiting

primary_purpose: Diagnostic

acronym: TIGRE

intervention_type: Other

title: Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.

lead_sponsor: Hospices Civils de Lyon

type: EudraCT Number

source: euctr

summary:
Pseudoprogression is a phenomenon related to post-treatment rearrangements (including radiation necrosis). It appears early in the first year after treatment and accounts for 30 to 50% of patients followed with glioblastoma. On MRI (current gold standard with international therapeutic response evaluation criteria RANO 2010), pseudoprogression is manifested by a progression of morphological abnormalities (contrast enhancement, FLAIR hypersignal) and can simulate tumor recurrence, even though the corticosteroid improved or kept clinical symptoms stabilized. In view of prognosis, the current diagnostic tools have not enough diagnosis accuracy for differentiation between pseudo-progression and early tumor recurrence, and are based on MRI retrospective analysis (2-3 months after). Recurrence of glioblastoma, is characterized by a higher amino acid metabolism than pseudoprogression, also 11C-Methionine (11C-MET), positron emitting radiotracer, showed promising results to differentiate these two entities. To date, hybrid 11C-MET PET-MRI studies remains limited to small sample size (a few dozen patients), and none focuses exclusively on glioblastoma.

Hypothesis of our study is that 11C-MET PET-MRI may be performed as a first-line MRI for suspected pseudoprogression and may changes therapeutic decision making and also patient prognosis.

The main objective is to evaluate the performance of hybrid PET-MRI imaging with 11C-MET to differentiate pseudoprogression from glioblastoma recurrence in patients treated with surgery and radiochemotherapy, compared to multimodality MRI).

status_simplified: Ongoing


title: Assessment of the Efficacy of Closed-loop Insulin Therapy (Artificial Pancreas) on the Control of Type 1 Diabetes in Prepubertal Child in Free-life: Comparison Between Nocturnal and 24-hour Use on 18 Weeks, Followed by an Extension on 18 Weeks

acronym: FREELIFE-KID

summary: The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier

intervention_type: Device


type: Other Identifier

title: Can we Predict COronary Resistance By EYE Examination ?

acronym: COREYE

summary:
Prospective interventional study, open, non-comparative and non-randomized. The research concerns physiological parameters of the coronary and ocular blood circulation.

At the coronary level, the curves of pressure and Doppler flow will be extracted from ComboMap® (Philips). The coronary microvascular resistances, basal and hyperemic, will be determined by the average ratio of the distal pressure and flow.

At the ocular level, a fundus oculi and an OCTA (angiography by tomography in optical coherence) examination will be performed. The measures of the FFR and the coronary microvascular resistance will be determined by a guidewire allowing measures of pressure and by a guidewire allowing measures of Doppler flow (ComboWire®, Volcano or Flowire®, Volcano combined with Verrata Plus), in 150 patients with intermediate stenosis of the left anterior descending artery (LDA). Topological parameters characterizing the retinal area and choriocapillaries will be determined by statistical approaches and mathematical morphology.

To establish a predictor of the coronary microvascular resistance from the eye vascular parameters, we shall use a non-linear regression by supervised machine learning. The main cardiovascular risk factors (hypertension, diabetes, dyslipidemia, age, sex) will be part of predetermined input features for the machine learning.

location_facility: Hospices Civils de Lyon - Hopital de la Croix Rousse


title: Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia : a Serie of 3 Cases Report

summary:
Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe, unusual headaches associated with multifocal segmental vasoconstriction of the intracerebral arteries. In addition to headache, focal neurological deficit and/or seizures are quite frequently described, but anterograde amnesia seems to but extremely rare. Indeed, to date, only one case of RCVS associated with transient global amnesia (TGA) has been published. In case of an atypical presentation of TG, associated with brutal headaches, it is important not to ignore an assocation with RCVS because management, treatment, evolution and prognosis are different. Indeed, TGA is a monophasic phenomenon of less than 24 hours duration, without associated complications, which does not require any particular treatment. On the other hand, RCVS, although most often of excellent prognosis, can have severe complications such as intracerebral hemorrhage, subarachnoid hemorrhage, posterior reversible encephalopathy syndrome and cerebral infarction. In order to limit headaches and potential complications, RCVS require special management, including symptomatic treatments for headaches, complete rest, removal of precipitin factors and introduction of calcium channel blockers for a few weeks.

This study aim to described three cases of patient who presented with concomitant TGA and RCVS, and to discuss pathogenic mechanism which may be similar in both these pathologies.

time_perspective: Retrospective

ipd_sharing_description: NC


title: Slow Expiratory Technique Efficacy on 24 Hours Food Ingestion in Children Under Than 12 Months, Hospitalized for Bronchiolitis : a Randomized Controlled Study

acronym: BRONCHIOL-EAT

summary: The purpose of this study is to determine wether a single chest physiotherapy session with slow expiratory technique (SET) improves infants with viral bronchiolitis quality of life (food intake and sleep) on the next 24 hours.

ReferenceCitation: Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742. Erratum in: Pediatrics. 2015 Oct;136(4):782.

ReferenceCitation: Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.

ReferenceCitation: Gajdos V, Beydon N, Bommenel L, Pellegrino B, de Pontual L, Bailleux S, Labrune P, Bouyer J. Inter-observer agreement between physicians, nurses, and respiratory therapists for respiratory clinical evaluation in bronchiolitis. Pediatr Pulmonol. 2009 Aug;44(8):754-62. doi: 10.1002/ppul.21016.

lead_sponsor: Groupe Hospitalier du Havre


title: Optimization of Performances During Thrombectomy Through In Situ Simulation

acronym: OPTISS

summary:
The thrombectomy is an emergency care provided as soon as possible to selected patients suffering from ischemic strokes. Many steps are necessary to prepare this specialized procedure of interventional neuroradiology, including installation and preparation of the patient for this act. This first and essential time required the intervention of many health professionals.

The approach consists of a series of formation through in situ simulations for these health professionals, in order to improve and optimize this first step of the procedure (from the installation of the patient to the percutaneous punch by the neuroradiologist).

time_perspective: Prospective

location_facility: Hôpital neurologique, Centre Hospitalier Universitaire


title: A Study of the Effect of Intracerebral Electrical Stimulation on the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy (StiMiC)

acronym: StiMiC

summary: Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.

lead_sponsor: University Hospital, Toulouse

intervention_type: Diagnostic Test


title: The Performance of the Synek Score to Predict Poor Neurological Outcome in Postanoxic Comatose Patients Treated With Induced Hypothermia

summary:
Resuscitated cardiac arrest (CA) is a frequent cause of admission in intensive care unit (ICU). Neurological state of postanoxic comatose patients can evolve either towards the absence of awakening or towards a more or less altered state of consciousness, ranging from the vegetative state to the full recovery of cognitive functions. Most of the deaths result from active withdrawal of life-sustaining treatment, based on poor neurological outcome prediction. Neurological prognostication needs therefore a multimodal approach based on reliable parameters, which should be easy to access and available at the early stage of care, in attempt to limit false poor outcome prognostication and help to not prolong futile active care in patient with severe post anoxic cerebral lesions. Nowadays the prediction of neurological outcome relies on a multimodal strategy including clinical examination, biomarkers and electroencephalography (Guidelines ESICM 2015). Early standard electroencephalography (EEG) is currently recommended and some features, notably absence of reactivity, status epilepticus or burst suppression after rewarming are strongly predictive of poor outcome. But those features require a precise analyze of the EEG usually performed by specialist. EEG patterns can be simplified and classified in five grades according to the Synek classification, ranging from dominant reactive alpha activity (grade 1) to isoelectric encephalogram (grade 5). Grade 1 and two are considering as good prognostic, grade 3 as intermediate and grade 4 to five as poor prognostic. Nevertheless, few data are available on the performance of this classification since generalization of TTM use.

We hypothesize that a multimodal strategy combining clinical examination, NSE concentration and the Synek score would bring a high degree of prediction. We aimed to assess the performances of the combination of clinical examination, NSE analysed at 48-72h and the Synek score to predict hard outcome defined by a cerebral performance category (CPC) 3-5, in postanoxic comatose patients treated with induced hypothermia

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.

acronym: FIMOUV 1

summary:
Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.

The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.

Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Study of Left Ventricular Function of Patients With Type 2 Diabetes Without Cardiovascular Disease

acronym: DIACAR

summary:
Type 2 diabetes is associated with high cardiovascular risk. Recent meta-analyzes suggest that the risk of hospitalization for heart failure in the diabetic is increased by 20% for each hemoglobin A1c point and that the risk of death from all causes or cardiovascular cause and the risk of hospitalization is significantly increased by 30 to 40% in patients with acute or chronic heart failure with diabetes.

Systematic analysis of cardiac function is not currently proposed in international recommendations even though some antidiabetic drugs have been associated with an increased risk of heart failure in large randomized controlled trials or an increase in adverse events in proof-of-concept studies of heart failure with or without diabetes. Observational studies suggest that hypoglycemic sulfonamides may increase the risk of developing heart failure. In contrast, two sodium-glucose cotransporter type 2 inhibitors (empagliflozin and canagliflozin) have recently demonstrated a significant reduction in hospitalizations for heart failure in two large randomized controlled trials.

The detection of subclinical left ventricular dysfunction is therefore essential to better assess the risk of cardiac decompensation and to identify the existence of possible contraindications to the use of certain classes of drugs used in diabetes. Recent studies suggest that the left ventricular ejection fraction measured on three-dimensional acquisitions is a prognostic value index greater than the ejection fraction measured by Simpson biplane method in two-dimensional ultrasound. Similarly, it seems that the analysis of global longitudinal deformation is a prognostic factor superior to the analysis of the ejection fraction (two-dimensional or three-dimensional). The investigators will analyze these different parameters to confirm these data.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Non Randomised Multi-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy

acronym: SAFARI

summary: The purpose of this study is to evaluate the safety and effectiveness of a novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

status: Terminated

lead_sponsor: Ciliatech


title: Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa

acronym: ANOSTOOL

summary: Anorexia nervosa is an eating disorder whose symptomatology induces a modification of the intestinal microbiota. To date, studies have shown variable profiles without linking them to metabolic and neuropsychological energy phenotyping. This intestinal dysbiosis could be involved in the maintenance of the disorders. Bidirectional communication channels exist between the microbiota, the intestine and the brain. Anomalies in these pathways could explain the impact of the microbiota on the pathophysiology of anorexia nervosa. Therapeutic interventions would then be possible to restore the microbiota in anorexia nervosa and influence the treatment of this disease. This study aims to explore the hypothesis of disruption of the microbiota-intestinal-brain axis transversely and measuring the intestinal microbiota, urinary metabolome, biological factors nutritional, immunological and physiological plasma plasma of the intestine, and finally, the psychological dimensions characteristic of anorexia nervosa.

intervention_type: Biological


title: Ultrasound Study of the Diaphragm Evolution Under ECMO

acronym: DIAG-ECMO

summary: Evaluate the evolution of diaphragmatic muscle effort in cardiogenic shock in ECMO patient with ultrasounds during the first weaning attempt in intensive care patients.

ipd_sharing_description: futur participation in respiratory protocols may include our datas.

lead_sponsor: Association Pro-arte


title: Cryoneurolysis of Arnold's Nerve and Follow-up by Tractography: Feasibility Study

acronym: CRYOARNOLD

summary:
According to the World Health Organization (WHO), headaches are one of the most common nervous system disorders. The therapeutic strategy is well established for certain subcategories of headache. On the other hand, when headaches become refractory, some nerves may become the target of targeted therapies. This is the case of the Arnold nerve, also called the great occipital nerve, which is involved in certain pathologies, both physiopathologically and therapeutically. The Arnold nerve infiltration has a relatively short duration of effectiveness (about 1 month on average), some teams have reported the interest of achieving a destruction of the Arnold nerve by radio frequency, with extended durations of efficiencies to several months. The use of cryoneurolysis has been known for a long time and its effectiveness in the management of cranio-facial pain is already reported. It is thus possible to obtain, at the end of the cryoanalgesia needle, very low temperatures around -40 ° C, which leads to the formation of an ice cube and, where appropriate, the freezing of the structures (nerves among others) to the needle contacts. This induces the formation of microcrystals leading to irreversible lesions of vasa-nervorums resulting in an endoneural edema. In the long run, it appears a Wallerian degeneration without destruction of this endoneurum. This is associated with the lack of destruction of the structure of the Schwann cell. Nerve regeneration is possible.

The diffusion MRI study allows tractographic reconstruction of the nerves. This is the only imaging technique that focuses on the fibrillar structure of the nerves, thus enabling the detection of nerves throughout its path. It is a morphological imaging technique nevertheless it also allows a quantitative analysis of the nerve through certain parameters.

The Investigators hypothesize that the cryoneurolysis of the Arnold nerve will result in the disappearance of visualization of the nerve by MRI tractography. The effect of cryoneurolysis on Arnold nerves, as on other peripheral nerves through diffusion MRI has never been described. The follow-up of MRI patients who had undergone cryoneurolysis would make it possible to study the behavior of these nerves after cryoneurolysis, and to correlate the aspect in tractography with the clinical data. Painful recurrence can then be correlated with visualization of the nerves by MRI.

lead_sponsor: University Hospital, Grenoble


title: Diagnosis of Muscular Weakness Syndrome After a Stay in Intensive Care : Measurement by Ultrasound

acronym: FIBER

summary:
The objective is to diagnose earlier and more precisely the occurrence of a weakness neuromuscular syndrome at the end of intensive care, or within 28 days if the stay is longer than 28 days. The amyotrophy has been shown to be proportional to muscle strength in healthy subjects. The amyotrophy can be reliably evaluated by measuring the cross-sectional area of the right femoral muscle. The hypothesis is that amyotrophy measured by muscle ultrasound can allow an early and reliable diagnosis of neuromuscular weakness syndrome (NMWS), even though the measurement of the MRC score (the Gold Standard), has shown its limitations in intensive care in terms of reliability and delayed diagnosis.

Moreover, this syndrome is associated with a loss of functionality and a deterioration of long-term quality of life. One of the objectives is thus to determine if the muscular ultrasound allows a prediction of the occurrence of these alterations far from the intensive care.

Early rehabilitation has shown a benefit on mortality, duration of stay, mechanical ventilation and on functional alteration after intensive care. This is why an earlier and more precise means of diagnostic of this pathology is searched.

The target population is therefore patients from 18 to 80 years hospitalized in intensive care for prolonged stay (> 5 days), and prolonged ventilation (> 48H).

ipd_sharing_description: There is not a plan to make IPD available to other researchers


title: Continuous Non-invasive Cardiac Output, an Evaluation of ccNexfin© in a Pregnant Population

acronym: CoNex

summary:
Variations of cardiac output are frequent in pregnant women during obstetrical procedures, and may participate to poor foetal outcomes through decrease of uteroplacental bloodflow. Thus, monitoring maternal cardiac output appears of major interest, as it would open the way to early initiation of hemodynamic supportive management.

The ccNexfin© is a non-invasive hemodynamic monitoring device, whose relevance for continuous monitoring of cardiac output has been reported in a non-pregnant population.

The hypothesis is that ccNexfin© gives acceptable measurement of maternal cardiac output in pregnant women.

ReferenceCitation: Bonnin P, Constans B, Duhamel A, Kyheng M, Ducloy-Bouthors AS, Estevez MG, Tavernier B, Gaudet A. Accuracy and trending ability of finger plethysmographic cardiac output monitoring in late pregnancy. Can J Anaesth. 2022 Nov;69(11):1340-1348. doi: 10.1007/s12630-022-02297-y. Epub 2022 Aug 4.

lead_sponsor: University Hospital, Lille


title: Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer Using Geometric Indexes

acronym: DEMETER

summary:
The initial staging of locally advanced prostate cancer is made with Computed Tomography scan (CT), Magnetic Resonance Imaging (MRI), and bone scan (BS).

For this type of cancer, reference treatment is radiotherapy combined with hormone therapy.

The added value of MRI in the delineation of volumes for radiotherapy is known, especially for the definition of extra-prostatic extensions and prostatic apex. However, its regular use is difficult. Indeed, acquisition of Magnetic Resonance Imaging parameters for diagnostic are not adapted to be fused with the planning Computed Tomography.

The literature shows that Positron Emission Tomography-Computed Tomography with Fluorocholine is better in terms of diagnostic performance compared to bone scan for bone metastases and to pelvic Magnetic Resonance Imaging for nodal extension.

It would therefore improve staging for these patients with a high risk of locoregional and metastatic invasion even if its use is currently not recommended in the initial staging.

Thanks to Magnetic Resonance Imaging acquisition parameters adapted to Radiotherapy and additional functional information, an acquisition in tri-modality Positron Emission Tomography/computed Tomography/ Magnetic Resonance Imaging could have an impact on the volumes definition for radiotherapy or even on the therapeutic strategy.

The aim of the study is to evaluate the volume modifications obtained on the trimodality evaluation, compared to the standard initial staging (geometric comparison).

In addition, it would be a preliminary study for a project using Prostate-specific membrane antigen (PSMA) in trimodality, and / or for a therapeutic interventional study.

lead_sponsor: Centre Henri Becquerel


title: Cryogenic Preservation of Spermatozoa : Comparative Study Between Both Dry and Liquid Phase Nitrogen Storages

summary: The reference technique for the conservation of gametes is storage in liquid nitrogen but new vats of nitrogen vapor (storage over liquid nitrogen) or in dry phase (storage in an insulated compartment of liquid nitrogen in a tank Liquid nitrogen) also allow the storage of flakes. The purpose of this work is to evaluate the dry-phase cryopreservation technique of liquid nitrogen compared with liquid-phase storage, depending on the duration of cryopreservation.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Modulation of Protein Intake to Target Gut-microbiota Derived Metabolites of Amino Acids in Individuals With Type 2 Diabetes From Varying Ethnic Backgrounds

acronym: MICRODIET

summary:
Context and justification:

There is growing evidence that the gut microbiota is a key element in the pathophysiology of cardio-metabolic diseases (CMD) such as Type 2 Diabetes (T2D). One hypothesis is that gut-derived metabolites (from diet) have an important role in the host metabolism. Preliminary results show that imidazole propionate (ImP), a degradation product of the essential amino acid histidine, is produced by the gut microbiota of T2D patients, but not healthy subjects. The gut microbiota itself is strongly influenced by diet and ethnicity. However, most dietary intervention studies have focused on the role of fiber intake and the effect of dietary protein on the gut microbiota composition and metabolite production is not well known. Our hypothesis is that, depending on the baseline gut microbiome composition, a diminution in protein intake could decrease the microbial production of metabolites such as ImP and improve the metabolism of the host. We also hypothesize that the effects of such an intervention could depend the ethnic background.

Objective:

To study the effects of a high protein (HP) vs a low protein (LP) diet on gut microbiota composition and production of pro-diabetic metabolites in type 2 diabetes (T2D) patients from Caucasian and Caribbean ethnicity depending on baseline metagenomics richness.

Study design:

Randomized controlled three months dietary intervention study

Study Population:

T2D patients from Caucasian (N=80) and Caribbean (N=40) background who are on a stable dose of metformin and do not use insulin or proton-pump inhibitors.

Intervention:

Subjects will be randomized to either a high protein (HP) or low protein (LP) diet for three months. Individuals of Caucasian ethnicity, will also be stratified according to either a high or low gut microbiota gene richness. All subjects will receive pre-cooked meals 6 days per week and daily food packages. Subjects are required to keep food diaries three days a week and will also have weekly contact with an Pitié-Salpêtrière dietician.

Outcome measures:

Primary endpoint is the change in glycemic excursion (area under the curve) after a mixed meal test between baseline and 12 weeks after the beginning of the intervention. Furthermore, we will study oral and fecal microbiota composition changes as well as serum levels of intestinal metabolites, such as ImP, body weight and body composition at baseline and after 12 weeks.

Sample Size:

It is calculated that a total of 20 patients per arm are needed so 120 patients in total.


title: EYE-Mobile TRACKer IN the Diagnosis of Minimal Hepatic Encephalopathy

acronym: EyeMTRACKIN-HE

summary:
Hepatic encephalopathy (HE) corresponds to the neurological or the neuropsychological symptoms caused by an acute or chronic liver disease and/or porto-systemic shunt. Many patients present neurological symptoms even if their liver disease is stabilized. Furthermore, HE is associated with an altered quality of life and an increased mortality. Its incidence is high with 30 to 80% of cirrhotic patients that will display according to retained diagnostic criteria. HE symptoms are going from subtle neuropsychological abnormalities detected only on neuropsychological testing, minimal HE, to altered consciousness, overt HE. Recently, the therapeutic armamentarium has increased with now several drugs (rifaximin, ammonia lowering agents) that are able to prevent new bouts of HE. Unfortunately, the diagnosis of minimal HE is difficult and no gold-standard is available. None of the proposed test is rapid and easily performed at bedside.

Recently, different studies suggest the potential interest of the study of the ocular movements in HE. Abnormalities in ocular saccades could be an early predictor of cortical impairment. In a pilot feasibility study using an eye-tracker, we could show that cirrhotic patients with minimal HE had, compared to healthy controls, increased latencies, decreased speed of voluntary and reflex saccades, more errors in anti-saccades, more anticipations saccades and more difficulties to fix the target.

Our hypothesis was that the use of the eye-tracker will enable the diagnosis of minimal HE by studying the characteristics of saccades and anti-saccades.

Since no gold-standard is available for the diagnosis of minimal HE, we will use the conclusion of an adjudication committee formed by 2 experts. Their clinical judgment will take into account the results of medical history, clinical examination, neuropsychological testing, PHES, Critical Flicker Frequency test (CFF), ammonemia levels, EEG and brain MRI with spectroscopy.


title: Biological Diagnosis of Granulomatous Pneumocystis Pneumonia

acronym: NC

summary:
The intra-alveolar form of Pneumocystis jiroveci pneumonia (PjP) is a common pathology in immunocompromised patients, particularly those infected with HIV. The diagnosis is based on the detection of Pj in a LBA. Intra-tissue granulomatous form (PGP) is a rare entity observed in non-HIV immunocompromised patients. In this case, the LBA is mostly non-contributory and the diagnosis is based solely on the detection of cysts on histological examination on biopsy of a pulmonary nodule. For many years, it has been clearly demonstrated that the use of a specific PCR clearly improves the biological diagnosis of PcP. However, in case of granulomatous form this method is not implemented because the diagnostic hypothesis is not mentioned.

In 2018, two cases of PGP were diagnosed at 3-month intervals at Montpellier University Hospital Center. The diagnostic confirmation was obtained with PCR Pj. In this context the investigators will investigate the interest of implementing PCR Pj on biopsies on pulmonary nodules from hospitalized patients between 2015 and 2018. In all selected patients, histopathological aspect of the nodule was compatible with a PGP and, no other diagnosis has been confirmed (infectious, tumoral, inflammatory ...). Finally, 17 patients were selected to check retrospectively, if the presence of Pj could be at the origin of the pathology.


title: Evaluation of the Efficacy of a Topical Analgesic Treatment With ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa

acronym: EBROPI

summary: The purpose of this study is to determine whether topical application of Ropivacaine is effective for treating refractory pain during dressing changes and so improve quality of life of patients (newborn, child, adolescent or adults under 21) suffering from hereditary epidermal epidermolysis bullosa.

ReferenceType: result

ReferenceCitation: Moreno Artero E, Schinkel N, Chaumon S, Corset I, Rabeony T, Elie C, Bellon N, Bodemer C, Greco C. Efficacy of topical ropivacaine in children and young adults with hereditary epidermolysis bullosa. Br J Dermatol. 2021 Mar;184(3):550-552. doi: 10.1111/bjd.19551. Epub 2020 Nov 2. No abstract available.


title: Continuation of Breastfeeding After Management of Breast Abscesses by Ultrasound-guided Punctures

acronym: PONCTABCESEIN

summary:
Several breast diseases can complicate breastfeeding : 4% of women develop a mastitis and 1% develop an abscess.

The study deals with cases of breast abscess that have been treated according to a defined protocol (Parisian Perinatal Health Network), by a multidisciplinary team (center of Medical Imaging Duroc) trained in breastfeeding and ultrasound-guided punctures.

The aim of the study is to define the risk factors for the onset of a breast abscess, to evaluate the indications and methods of management of abscess by ultrasound puncture, and to provide arguments motivating the continuation of breastfeeding.


title: Follow-up of Malnutrition Screening in Neurovascular Intensive Care Unit

acronym: DENUTRITION

summary: This aim of the study is to set up a procedure for screening for undernutrition in the neurovascular intensive care unit. This screening procedure follows a specific work concerning undernutrition in thrombolyzed patients (NCT03303820). This work was motivated by the fact that, despite a high frequency of undernutrition in the hospital (at least 30% of patients), undernutrition in neurovascular unit is studied very little. A cohort of thrombolysed patients in 2014 was studied retrospectively. Patients malnourished at the entrance had a non-significant, less good recovery of their stroke (+ 1 Rankin score point at 3 months in malnourished patients at the entrance).


title: Analysis of Antalgic Efficacy of an Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis by Perfusion MRI:a Superiority, Randomized, Controlled, Double Blind Study

acronym: TOXART

summary: We believe we can demonstrate a link between the analgesic action of intra-articular injection of botulinum toxin and synovial inflammation by Dynamic Contrast Enhancement (DCE) perfusion Magnetic Resonance Imaging (MRI).

lead_sponsor: Lille Catholic University


title: Causality of Poisoning of the Elderly: Prospective Study Based on Data From the Poison Control Centre of Bordeaux Over 5 Months

acronym: GERIATOX

summary:
Elderly is often associated with social, physiological and psychic changes. However, no study has examined accidental poisoning-induced changes.

The objective of the study is to identify and analyze the various causes of potentially toxic accidental exposure of the elderly to determine preventable causes and propose prevention strategies.

lead_sponsor: University Hospital, Bordeaux


title: Benign Gynecologic Laparoscopic Surgery: Comparison of Conventional Trocars to the Teleflex® MiniLap® System in Length of Hospitalization, Pain and Aesthetics, a Randomized Study.

acronym: MiniTroc

summary:
During laparoscopy, trocars are essential: they allow the passage of instruments through the wall. In gynecology, with exception, trocars 5mm (used for the passage of endo-scissors and forceps) and 10 to 12mm are used (especially for optics).

Trocars are responsible for complications, such as vascular wounds, digestive wounds, pain, infections or postoperative hernias, or aesthetic sequelae, and should be chosen with caution: most complications of laparoscopy are essentially due to their placement, and the complications at the introduction of the first trocar are the most frequent.

The MiniLap® system developed by Teleflex does not require trocars in the case of a single forceps, or a single 5mm trocar with the necessary forceps change (this is the Percuvance® system). The aim of the latter is to make minimally invasive surgery even less invasive, thanks to a reduction in the number of trocars used (in many cases, elimination of two trocars), smaller incisions (percutaneous use of instruments, with a diameter of 2,4mm) thus reducing the complications

primary_purpose: Prevention


title: Effects of Endoscopic Sinus Surgery on Sleep Disorder in Patients With Chronic Rhinosinusitis With Polyps

acronym: POLYSOMNO

summary: Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.


title: Assessment of the Performance of the V2 Version of the Dreem Headband for EEG Sleep Monitoring Compared to a Gold Standard Polysomnography.

summary: This study aims to evaluate the accuracy of automated sleep analysis by the Dreem dry-EEG headband and deep learning algorithm in comparison to the consensus of 5 sleep technologists' manual scoring of a gold-standard clinical polysomnogram (PSG) record in healthy adult volunteers during an overnight clinic-based sleep study.

ReferenceCitation: Arnal PJ, Thorey V, Debellemaniere E, Ballard ME, Bou Hernandez A, Guillot A, Jourde H, Harris M, Guillard M, Van Beers P, Chennaoui M, Sauvet F. The Dreem Headband compared to polysomnography for electroencephalographic signal acquisition and sleep staging. Sleep. 2020 Nov 12;43(11). pii: zsaa097. doi: 10.1093/sleep/zsaa097.

ipd_sharing_description: We plan to share de-identified physiological data in an open-source format to the public. However, this will only occur if the data files are of sufficient quality and likely to be of use to the scientific community. This decision may also depend on certain legal or business constraints.

lead_sponsor: Dreem

location_facility: Institut de Recherche Biomédicale des Armées


acronym: CLONIPREM

title: Premedication by Clonidine Intranasal in Pediatric Surgery

summary:
There are few studies using intra nasal way to dispense premedication in pediatrics.

This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo.

Two groups, randomized,

Total of 150 patients (75 in each group) :

Involvement in study for one patient : 7 days Duration of study including inclusion and data analysis : 18 months (inclusion 12 months; data analysis 6 months)


title: Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked

acronym: STREAM

summary:
The aim is to evaluate the performance of Cardioskin and Neuronaute, two connected medical devices CE-marked, manufactured by Bioserenity.

It's an open monocentric comparative clinical study, where subjects will test the Cardioskin device and/or the Neuronaute device.

design_allocation: Non-Randomized

lead_sponsor: BioSerenity


title: Haemodynamics Variations of Transcutaneous Oxygen in Patient With Arterio-venous Leg Ulcers Under Venous Compression (COMPULCE Study)

summary:
Arterio-venous leg ulcers are real problems when it comes to public health because it has a major cost and leads to social and professional handicap.

The management of leg ulcers is not clear and can be venous compression or surgery.

The aim of the study is to evaluate the variation of the transcutaneous oxygen with compression.

The second aim is to see how tolerate is the compression and the quality of life.

lead_sponsor: University Hospital, Caen


title: Evaluation of the Impact of an Optimized Communication Between Hospital and Community on the Readmission at the Emergency Department for an Adverse Drug Event : Randomized Controlled Trial

acronym: URGEIM

summary:
Emergency departments (EDs) are a crucial element of health care systems as they constitute the interface between hospital and communities. The goals of the ED are to make an initial diagnosis and deliver urgent and critical care 24 hours per day and 365 days a year. Also, many Adverse Drug Events (ADEs) are not identified by emergency physicians. ADEs are injuries resulting from a drug related medical intervention. Their detection, documentation and reporting are essential for adequate medical care and knowledge of risk/benefit profiles of medication throughout their lifecycle. However, a number of studies indicate that in clinical practice the under-reporting of ADEs is a pervasive and widespread problem. The main reasons for under-reporting were difficulty in determining the cause of the ADE, lack of time, poor integration of ADE-reporting systems and uncertainty about reporting procedures. Successful treatment of ADEs depends on the ability of physicians to attribute ADEs to a medication. Some studies have reported that not only pharmacists but also pharmacy student were one of the best health care providers to establish medication history and detected ADEs.

It has also been shown that a clinical pharmacist, within the emergency medical team, can improve the detection of ADE through drug expertise and reliable drug history. This approach has been adopted at Montpellier University Hospital since November 2011. During the initial diagnosis of the ADE, the revision of a drug treatment at risk cannot be carried out in emergency department by the emergency physician. Indeed, the latter intervenes punctually but he is not the patient's referring doctor. Guidance and follow-up of the patient throughout the care journey is the responsibility of the referring physician, sometimes accompanied by the pharmacist. It is therefore very important that a relevant information detected at the hospital can be passed on to the referring health professionals who will review and adapt the treatment. The city-hospital link is essential to guarantee the continuity and the consistence of the care process. When a patient is discharging with the emergency department, the outgoing mail often mentions only the reason for admission, and the information concerning the detection or suspicion of an ADE is not systematically stipulated. However, this information is essential to trigger a process of therapeutic revision (therapeutic modification, therapeutic education, referral to specialized consultations ...) that will prevent the recurrence of the ADE and therefore the readmission to emergency department. To date, the rate of readmission to emergency department after a first visit related to an ADE is between 3.6 and 18.7%.

Our goal is to evaluate the impact at 6 months of a medical-pharmaceutical follow-up and the optimization of the city-hospital link following an admission at emergency department for ADE, on the readmission to emergency department for the same ADE.

This is a single-center randomized, controlled, open-label, two-arm, parallel, "usual information transmission" or "optimized information transmission" study. The duration of a patient's follow-up is 6 months.

Each patient with an occurring ADE detected during emergency department admission could be participating in the study.

Specific management of the experimental group: Sending to the community referring physician by the emergency department an discharge report containing the reason for emergency consultations (report currently made as part of the treatment). Within 72 hours (working hours), the Emergency Clinical Pharmacist contacts the referring physician and the patient's community pharmacist to discuss how to manage the ADE. In parallel, a second report, summary of the ADE (ADE-report), is sent to them. The ADE-report, written and validated by the investigators (emergency physician and clinical pharmacist), includes the type of ADE, the suspected drug(s) and other recommendations: therapeutic modification, referral to specialized consultations (geriatrics ...)

Control group: The emergency department sends to the referring doctor a letter to inform him about the reason of consultations in the emergency department (mail currently realized as part of the care process).

Primary outcome measure: Percentage of patients who had at least one readmission for the same reason in the emergency department within 6 months of the initial exit. This information will be collected during a telephone call with the patient and the referring physician.

primary_purpose: Health Services Research

ReferenceCitation: Breuker C, Faucanié M, Laureau M, Perier D, Pinzani V, Marin G, Sebbane M, Villiet M. Impact of a medico-pharmaceutical follow-up and an optimized communication between hospital and community on the readmission to the emergency department for an adverse drug event: URGEIM, study protocol for a randomized controlled trial. Trials. 2021 Aug 6;22(1):521. doi: 10.1186/s13063-021-05501-4.

lead_sponsor: University Hospital, Montpellier


title: Evaluation of Heart Rate Variations of Golf Fans During the 2018 Edition of the Ryder Cup : the Ryder Heart Study

acronym: RyderHeart

summary: Ryder Heart is an exploratory study of the heart rate variations of golf fans during the 2018 edition of the Ryder Cup. The main objective is to evaluate the impact of stress and strong emotions on heart rate variations and the occurrence of rhythmic anomalies in golf fans during this high-level golf competition. Such data are actually poorly described in medical and scientific literature.

ReferenceCitation: Spitters CE. Cardiovascular events during World Cup soccer. N Engl J Med. 2008 May 29;358(22):2408; author reply 2409.

ReferenceCitation: Vallerand RJ, Ntoumanis N, Philippe FL, Lavigne GL, Carbonneau N, Bonneville A, Lagacé-Labonté C, Maliha G. On passion and sports fans: a look at football. J Sports Sci. 2008 Oct;26(12):1279-93. doi: 10.1080/02640410802123185.

ipd_sharing: Yes

ipd_sharing_description: All collected IPD, all IPD that underlie results in a publication.

lead_sponsor: University Hospital Center of Martinique


title: Feasibility and Therapeutic Method of Endoscopic Treatment of Bronchial Carcinoid Tumors: 22 Years Experience of Saint-Etienne

summary: Carcinoid tumors of the lung are considered to be a low-grade malignancy. Surgical resection is considered the standard approach. Recent data has shown that a complete endoscopic treatment could be considered. An endoscopic treatment is can be a alternative to invasive surgery.


title: Peripheral Artery Disease: Gated P-31 Magnetic Resonance Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)

acronym: SPECTROAOMI

summary: To explore the reliability of P-31 MR spectroscopy mitochondrial function in patients with peripheral arterial occlusive disease.


title: Multistability: Perception is Inspired by Noise

acronym: MUSPIN-B

summary: Some stimuli, such as sinusoidal networks in motion, or the best known, Necker's cube, are simple visual stimulations generating interpretations of unstable and oscillatory shapes or movements, mutually exclusive. Currently, the explanatory models of these perception phenomena are based on adaptation and learning mechanisms as well as the importance of noise in the perceptual and decision-making system. Often noise is a harmful component, but it can also be a facilitator in perceptual systems: the investigator's eye is always in motion, it is the micro-movements during eye fixation (phase of eye stability). In particular, the role of micro-eye movements has been identified in perceptual systems, and it will be necessary here to relate these micro-movements to the perceptive tilts facing multisable stimuli. However, how to access the perceptive states is a real question, since it has been shown that the participant's transfer of his perceptual state by means of a motor response can alter the very state of the percept. This is why the EEG activity will be analyzed to learn to discriminate the different percepts over time, without disruption of the participant's perceptual exploration endogenous activity.

primary_purpose: Basic Science


title: Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans

acronym: STRECH

summary:
The links between systemic inflammation, endothelial dysfunction and endoplasmic reticulum (ER) stress in pre-clinical models make it an interesting potential therapeutic target, but there are no data describing SRE during severe inflammation in humans .

For an approach to the study of SRE in humans in a situation of systemic inflammation, the analysis of patients benefiting from an extra-corporeal circulation for a programmed cardiac surgery would allow a study under well described conditions of inflammation, standardized, with the possibility for each patient to be his own witness. Compared to a situation of secondary inflammation (sepsis, acute pancreatitis, trauma ...) the analysis of the patients under CEC allows more precise description of the kinetics of the activation of the SRE because the beginning of the inflammatory mechanism is known with precision.

lead_sponsor: University Hospital, Rouen


title: Is the Distance of Patients From Rouen University Hospital Influencing the Time Between Colectomy and First Chemotherapy Cure for Colon Cancer?

acronym: DICHIMIO

summary: This project has for objective to demonstrate that the increase of the distance "Patient home - center of treatment" may be associated with significant, other noticeable, noted events. This distance may also be available in the Rouen University Hospital. The study of the association in this distance and the delay in initiating chemotherapy after surgery in patients treated at the CHU correspond to a pilot study prior to the completion of the analysis at the regional scale.


title: Use of Neural Functional Electrical Stimulation for the Recovery of Grasping Movements for Patient With Quadriplegia.

summary: Functional electrical stimulation (FES) has been used for decades in rehabilitation centers. Having demonstrated efficacy for prevention of muscle atrophy following spinal cord injury (SCI), FES can also be considered for functional restoration of hand movements in the patients with complete tetraplegia belonging to group 0 or 1 of the classification of Giens. However, the majority of the systems using the FES directly stimulates the muscles (surface electrodes, intramuscular or epimysial), which increases the number of components and requires more electrical energy for the muscle activation. Nerve stimulation would activate more muscles through a reduced number of electrodes, limiting the number of internal components, reduces the risk of spreading infections and require less electrical energy for its operation.

primary_purpose: Device Feasibility

ReferenceCitation: Tigra W, Dali M, William L, Fattal C, Gélis A, Divoux JL, Coulet B, Teissier J, Guiraud D, Azevedo Coste C. Selective neural electrical stimulation restores hand and forearm movements in individuals with complete tetraplegia. J Neuroeng Rehabil. 2020 May 19;17(1):66. doi: 10.1186/s12984-020-00676-4.

lead_sponsor: Clinique Beau Soleil


acronym: PROPOSURF

title: Evaluation of the Neonatal Autonomic Stress During Intubations Under Propofol in a Population of Premature Infants Under 33 w'GA

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

summary:
Hyaline membrane disease is one of the leading causes of morbidity and mortality in premature newborns in industrialized countries. For 30 years, the management of the hyaline membranes disease has been transformed by intratracheal administration of exogenous surfactant (Curosurf®) at birth or in the following hours. In order to limit the harmful effects in terms of barotrauma of mechanical ventilation, several methods have been developed over the last decades, aiming at limiting the mechanical ventilation to the profile of non-invasive ventilation: Thus the administration of surfactant has become faster (although invasive) and if possible followed by immediate extubation following the INSURE (INtubation / SURfactant / Extubation) or LISA (Less-Invasive Surfactant Administration) procedure.

Given the fragility of the children concerned and their low weight, this invasive gesture has long been carried out without premedication. However, taking into account the pain induced and potential hemodynamic consequences of the gesture, neonatal societies now recommend the use of anesthetic before intubation, with a short duration sedative.

Propofol is a general anesthetic that combines these conditions and is widely used in pediatric anesthesia.

In that way, since 2016, the invetigators have modified the sedation protocol for intubation in our department and have recommended Propofol as first-line treatment for term and preterm newborn. A lot of study showed its hemodynamic safety in preterms. However, the investigators lack data on the autonomic stress really observed during intubation in this population. The investigators therefore propose to evaluate these physiological data in a non-randomized prospective observational study in premature infants under 33 weeks of gestational amenorrhea (GA), during a sedation protocol for intubation and surfactant administration according the INSURE or LISA technique, with standardized doses of propofol : 1mg/kg for preterm infants with a birthweight less than 1.5kg and 1.5mg/kg for higher birthweight.


title: ENCAPSID Study : Encapsulated Bacterial Infection and Primary, Secondary Immunodeficiency

acronym: ENCAPSID

summary:
Background : The occurrence of Primary immune deficiencies (PID) is rare in adults. Antibody deficiencies were the first PID to be diagnosed in adulthood and are mainly represented by common variable immune deficiency. The main manifestation of these PID are encapsulated bacterial infection which used to be recurrent and/or invasive, lead to hospitalization and have high rates of morbidity and mortality. Diagnosis of PID in adulthood may be supported by six warning signs from the European Society of Immunodeficiencies (ESID). However, their guidelines do not comprehensively describe symptoms of PID, even for patients with infections. The guidelines recommend screening adults for PID after at least two severe bacterial infections. The aim of this study is to screen for PID adult admitted to our hospital for encapsulated infection without any predisposal factor.

Material and methods :

Monocentric study. Inclusion between September 218 and September 2021

Inclusion criteria :

Age 18 to 65 years old
Invasive encapsulated infection (Streptococcus pneumoniae, Streptococcus pyogènes, Haemophilus influenzae, Neisseiria meningitidis or Neisseria gonorrhoeae )

Exclusion criteria :

Medical history of PID
Medical history of Secondary immune deficiency (SID)
Local-regional factor that could predispose them to infection
Hospital-acquired infection
PID screening included the following: complete blood count, blood smear, immunoglobulin (Ig) isotype (IgA,M, G) and IgG subclass levels, total hemolytic complement and complement fractions (C) 3 and 4, alternative complement pathway (AP50) in case of Neisseria meningitidis (NM) infection, quantitative immunophenotyping of T, B and natural killer cells, specific antibody response to diphtheria, tetanus and pneumococcal vaccine and HIV serology. The clinical and laboratory diagnostic criteria used to identify PID were based on guidelines from the ESID and the Pan-American Group for Immunodeficiency (PAGID)
A consultation in the infectious Diseases Department or Internal Medicine will be scheduled the hospitalization 3 months later to include patients and perform PID screening.

ReferenceCitation: Conley ME, Notarangelo LD, Etzioni A. Diagnostic criteria for primary immunodeficiencies. Representing PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies). Clin Immunol. 1999 Dec;93(3):190-7.


title: Demonstrating the Diagnostic Power of an Electronic Nose: Pilot Study on Exhaled Air Samples

acronym: OLFADIAG

summary:
The investigators don't know yet how the nose and the brain decode the smells. Scientific studies in neuroscience have shown that people who have tumors may have changes in the smell of secretions. Dogs are extremely efficient at detecting these changes, even before imaging studies. A review of the recent literature shows the different work done on the diagnosis of dogs on human pathologies, especially oncology. It is now known that the smell of exhaled gases is representative of the intestinal biotope and that a large number of pathologies are related to the type of microbial populations that inhabit the intestines.

Copying the olfactory organs could thus be of major interest for the early diagnosis of pathologies. More and more works are interested in the diagnostic power of electronic noses. From a technical point of view, these are nano-sensors that mimic the olfactory receptors from the breath gas of the subjects. They analyze the molecules present and compare them with a database to establish a diagnosis according to a probabilistic algorithm.

The use of exhaled air for the diagnosis of cancerous pathologies has already been the subject of scientific work. A classification using the SVM (support vector machine) method using data from 320 sensors made it possible to differentiate patients with lung cancer from controls in 98.8% of cases. The differential diagnosis of obstructive bronchopneumopathy was also very well done in this same study. Another study shows equally encouraging results, highlighting sensitivities and specificities above 80%.

lead_sponsor: Nouvelle Clinique Bonnefon


title: Mitochondrial Genetics of Presbycusis

acronym: MITOPRES

summary: The main goal of this study is to identify mitochondrial mutations associated with presbycusis. Patients affected by severe presbycusis and normal hearing controls (according to ISO7029 norm) will be enrolled if satisfying inclusion criteria (aged from 40 to 80 years old) in existing biocollections in the University Hospital of Angers. After DNA extraction, the mitochondrial genome will be sequenced and data in silico analysed.

lead_sponsor: University Hospital, Angers


title: "Evaluation of the Effectiveness of the MDT Method (Mechanical Diagnosis and Therapy) in the Management of Low Back Pain in the Subacute Phase"

acronym: Mc-SubLomb

summary:
The investigators propose to carry out a study evaluating the effectiveness of the MDT method (mechanical diagnosis and therapy) in the subacute phase of common low back pain.

Few studies have specifically evaluated the effectiveness of the MDT method in the subacute phase, a phase that appears to be crucial before the chronicization of low back pain.

The main objective of this study will be to evaluate the pain of patients managed by the MDT method.

The analysis of the main criterion (Visual Analog Scale) will be done using a type individual clinical trial specific: the Single Case Experimental Design or SCED in lines of multiple bases.

This type of study makes it possible to carry out a comparative test on a single subject acting as its own witness in order to obtain an acceptable level of evidence response for that particular patient.

lead_sponsor: Nantes University Hospital

location_facility: Picasso physiotherapy cabinet (5 rue Nina Simone - 44 000 NANTES)


title: Monocentric Study on the Quality of Life Among Adolescents With Attention Deficit/Hyperactivity Disorder

acronym: QuaVAT

summary:
Attention Deficit Hyperactivity Disorder (ADHD) with a overall prevalence of 5.3% is one of the most common neurobehavioral disorders in children. In the foreign literature, many studies bring to light in children and adolescents the negative impact of ADHD on overall quality of life. Some of these studies were able to identify the fact that the higher the age of ADHD children or adolescents, the lower the quality of life. Currently, to our knowledge, only a few European studies have demonstrated the negative impact of ADHD on the quality of life of children and adolescents. In addition, these studies used only questionnaires intended for parents and not for children or adolescents.

During a regular follow-up consultation with their referent child psychiatrist, adolescents accompanied by at least one of their parents will be informed of the modalities of our study. A newsletter will be delivered to parents and one to the adolescent. If neither the adolescent nor the parents is opposed to participate, the child psychiatrist will register the patient on the list of study participants. He will also fill out a medico-social information sheet about the adolescent as to summarize the data in the medical record. At the end of this consultation, in the waiting room, adolescents will answer questionnaires KIDSCREEN-27 and MSPSS; their parents will complete the CBCL questionnaire. These questionnaires will be handed to the secretary who will put them back in the patient's record. The KIDSCREEN-27, MSPSS and CBCL questionnaires as well as the medico-social information sheet will be source documents. The principal investigator or one of the associates investigators will complete the case report form from these source documents. For this purpose the data will be entered anonymously into a data entry software on a computer server secured by the Centre Psychothérapique de Nancy (CPN). Then, anonymous data from the software will be forwarded to Dr. Epstein of the Clinical Investigation Center for statistical analysis. The study will begin when the favourable opinion of the Ethical Research Comittees will be obtained and the study will last one year.

lead_sponsor: Centre Psychothérapique de Nancy

location_facility: Consultation régionale de pédopsychiatrie / Centre Psychothérapique de Nancy


title: Essai Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie Hépatique

acronym: PERSEE

summary: This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.

lead_sponsor: Mauna Kea Technologies


title: Early Valve Surgery Versus Conventional Treatment in Infective Endocarditis Patients With High Risk of Embolism: a Randomized Superiority Clinical Trial

acronym: CHIRURGENDO

summary:
Infective endocarditis (IE) is associated with an overall in-hospital mortality rate of 15-25% and a high incidence of embolic events (20-50%). Leading causes of mortality are heart failure (HF) resulting from valve dysfunction, and stroke caused by vegetation embolization. The rate of symptomatic embolic events occurring after antibiotic initiation is around 15%. Valve surgery benefit has been clearly demonstrated in patients with periannular complications and moderate to severe HF resulting from acute valve regurgitation. The timing of surgery to prevent embolism is critical since the risk of new embolic event is highest during the first weeks of antibiotic treatment.

The primary objective is to compare clinical outcomes of Early Valve Surgery (as soon as possible within 72 hours of randomization) with those of a conventional management based on current guidelines in patients with native left-sided IE and high risk of embolism.

208 patients (104 patients per arm) will be included in a national multicenter (19 centers) prospective randomized open blinded end-point (PROBE) sequential superiority trial.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Randomized Controlled Pilot Study for Medico-economic Impact Evaluation in Telemedecine Follow-up in Complement of a Mobile Team in Patients With Neurological Disabilities (HANDI@CCESS)

summary: Access to care for people with traumatic or degenerative neurological disabilities is a current public health concern. New technological tools such as telemedicine can bring expertise to the place of life of people while promoting the city-hospital link.

lead_sponsor: Pôle Saint Hélier


title: Specificity of Early Maladaptive Schemas in Functional Movement Disorders

acronym: SCHEMAF

summary:
Functional neurological disorders (FND) are neurological symptoms that cannot be explained by a lesion or related to an identified dysfunction of the central nervous system. FND are under-diagnosed, although common and highly disabling. Childhood trauma events are found in 30% to 80% of FND patients, and are more common in people with functional neurological disorder than in healthy controls and patient controls. Overall, risks factors, perpetuating factors and maintaining factors have been described in FND, although none of the studies have analysed the prevalence of Early Maladaptive Schemas (EMS) in these patients. EMS, as measured with the Young Schema Questionnaire (YSQ), are proposed to underlie a variety of mental health problems, in particular Personality Disorders. We hypothesize that some of these early maladaptive schemas may participate in the psychopathology and severity of FND.

The main outcome of this study is to assess the prevalence of early maladaptive schemas in patients presenting with Functional Movement Disorders in comparison to patients presenting with Parkinson's Disease or Organic Dystonia. The secondary outcomes are to further analyse the underlying relation of these early maladaptive schemas and (i) the severity of the motor symptoms, (ii) anxiety and/or depression, (iii) the occurrence of childhood trauma events in our participants.


title: Pilot Study of the Metabolic Signature of 13C-enriched Wheat Bran Linked to Intestinal Fermentation in Humans: Identification of New Biomarkers

acronym: FITABLE

summary: It is a pilot study, conducting on 6 healthy women and aiming at defining new biomarkers related to wheat bran fermentation. For this, a breakfast, containing 5 biscuits enriched in 13-C wheat bran (which grown under 13-CO2 enriched atmosphere) is given to the subjects, then a following will be realized on 24h with breath, urine, fecal and blood samples. Analysis will be performed on these samples in order to determine potential biomarkers of fibers consumption to evaluate the metabolic effects of this consumption and to refine the relevance of nutritional recommendation regarding fibers for healthy subjects.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes


title: Multimodal Imaging of Hypoxia in Gliomas

acronym: GLIOXYMAGE

summary:
The imaging of cerebral oxygenation is an extremely important tool in understanding the pathophysiology of the tumor and for adaptation of therapies according to hypoxia. Currently, imaging of cerebral oxygenation is mainly performed by the use of Positron Emission Tomography (PET). Thus, the investigators have been able to show that the FMISO radiotracer can reveal tumor hypoxia (HypOnco study, promotor: Caen University Hospital, main investigator: J.S. Guillamo). After injection of the radiotracer, increased uptake is observed in the regions for which the tissue oxygen pressure is less than 10 mmHg (the healthy brain with a tissue oxygen pressure (ptO2) ≈ 40mmHg).

Although PET is a reference methodology, it is not widely practiced mainly because of radioactive sources. Magnetic Resonance Imaging (MRI) would bypass the previously mentioned PET limitations. The investigators have recently shown that a measure of local oxygen saturation could be obtained by MRI.

This methodology has also been implemented at a clinical scale on lower field MRI magnets, but its formal validation in a clinical situation remains to be demonstrated with respect to FMISO.

The major advantage of this methodology is that MRI is already performed in routine practice for patients. Measuring tissue oxygenation with MRI (SatO2-MRI) would not add additional examination for the patient. In addition, MRI is a non-ionizing methodology with a very good spatial resolution compared to PET, this should help to better understand intratumoral heterogeneity. Similarly, in preclinical studies, the investigators have shown in a context of mild hypoxia that SatO2-MRI may be more sensitive than PET.

The investigators propose a study to compare in patients with glial tumors, images obtained by 3 Tesla MRI of SatO2-MRI to the hypoxia maps obtained by FMISO PET. These imaging studies will be confronted with studies carried out in immunohistochemistry on biopsies / resection allowing to reveal and to quantify by image analysis the expression of the factors induced by hypoxia (HIF1, HIF2).

This study should include 20 patients with glioma (15 high-grade patients and 5 low-grade patients) in pre-surgery. The aim is to show that SatO2-MRI is a relevant methodology (in terms of sensitivity, specificity) for assessing intratumoral oxygenation in a context of brain tumors. This fits perfectly into an era of personalized medicine where functional imaging finds its meaning.


title: Enhanced Effectiveness of Combined Eccentric and Concentric Exercise Over Traditional Cardiac Exercise Rehabilitation Program in Patients With Chronic Heart Failure: a Randomized Controlled Study

acronym: REX-HF

summary:
As part of the regular rehabilitation program for chronic heart failure (CHF) patients, the addition of dynamic eccentric endurance (ECC) exercise sessions to the conventional concentric cycling program (CON) would enable greater gains in functional capacity that the CON alone. Furthermore, in the case of severe heart failure, results of conventional exercise rehabilitation remains limited on account of the poor physical fitness and deconditioning. Dynamic ECC has been shown to enhance muscle mass and improve muscle strength in subjects with functional limitations comparable to those in CHF, but to date reports on effects on muscle endurance and overall functional capacity remain scarce or non-existent.

Investigator hypothesize that a combination of these two types of training will allow both an improvement in strength and oxidative muscle capacities. These benefits must be objectified at the level of the walking distance covered in 6 min (6-WT).

ReferenceCitation: Plaquevent-Hostache G, Touron J, Costes F, Perrault H, Clerfond G, Cuenin C, Moisa A, Pereira B, Boiteux MC, Eschalier R, Richard R. Effectiveness of combined eccentric and concentric exercise over traditional cardiac exercise rehabilitation programme in patients with chronic heart failure: protocol for a randomised controlled study. BMJ Open. 2019 Sep 26;9(9):e028749. doi: 10.1136/bmjopen-2018-028749.

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Single-center, Phase 1 Dose Escalation Study of Trametinib Combined With HDM201 in Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer.

acronym: TRAHD

summary:
Recent preclinical studies suggest that combining MEK and MDM2 inhibition synergize to induce apoptosis in RAS/BRAF-mutant and TP53 wild-type CRC models. In vitro, in RKO cell lines (poorly differentiated colon carcinoma cell line resistant to single agent targeting MDM2 and MEK and BRAF inhibition), the MDM2 plus MEK inhibitor combination generated a synergistic increase in apoptotic index. In vivo, in mice harboring human RKO colon tumor xenografts the combination of MDM2 plus MEK inhibition elicited 93% decreases in tumor volume.

This trial is to conduct a single-center, Phase 1 dose escalation study of trametinib combined with HDM201 (a HDM2 inhibitor) in patients with advanced/metastatic RAS/RAF mutant and TP53 wt CRC.

lead_sponsor: Centre Leon Berard


title: Study of Motor Control Mechanisms in DBS-implanted Parkinson's Disease Patients

acronym: PARKMOTEUR

summary: Akinesia is one of the most prominent symptom in Parkinson's Disease (PD) patients. It typically consists in a inability to initiate voluntary movement, and it affects patients' quality of life. This study aims at exploring the influence of Deep Brain Stimulation (DBS) in the quality of motor control, and particularly of voluntary movement initiation, and its neural correlates. They will be evaluated using behavioral and motor tasks together with Transcranial Magnetic Stimulation (TMS) and electrophysiology (EMG and EEG).

lead_sponsor: University Hospital, Grenoble


title: Acute Effects of a Passive Stretching Session on the Mechanical Properties of Medial Gastrocnemius Muscle in Children With Cerebral Palsy

summary: Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. This study assess efficacy of an acute high intensity and long-time stretching session of plantarflexors muscle on their viscoelasticity properties and maximal dorsiflexion angle gain. Single stretching session is characterized by high intensity and long time (5 minutes).

ReferenceCitation: Boulard C, Gautheron V, Lapole T. Acute passive stretching has no effect on gastrocnemius medialis stiffness in children with unilateral cerebral palsy. Eur J Appl Physiol. 2022 Nov 1. doi: 10.1007/s00421-022-05046-7. [Epub ahead of print]


title: A Prospective Single Centre Randomized Interventional Controlled Trial Comparing Patient and Staff Safety During Aorto-iliac Revascularization Procedures Under Automated Fusion Imaging Guidance With Controls

acronym: CYDAR ILIAC

summary:
Endovascular revascularization has revolutionized the field of vascular surgery and has become the first-choice treatment for peripheral arteries occlusive disease. However, the drawback of this technic is the X-ray exposure for both patients and staff and the iodinated contrast injection for the patient.

One way to reduce both radiation and contrast use is to use advanced imaging techniques allowing an overlay of a 3D vascular mask (from a pre-operative CT scan) onto the live X-ray image. This has been proven during endovascular aneurysm repair.

This advanced imaging application is currently available only in the latest expensive hybrid operating rooms, requires additional manoeuvre from the operator throughout the procedure, and may be X-rays and contrast consuming.

This trial will examine the clinical benefits based on patient and staff' radiation exposure during aorto-iliac revascularisation, of a new software imaging guidance, suitable for any theatre including those equipped with mobile C-arm, fully automated and with a radiation free overlay registration process.

location_facility: Nantes University Hospital, Vascular surgery, Institut du Thorax


title: Dynamic Stabilization of the Upper Cervical Spine in a Cohort of Rugby's Players Via Ergometer (Cervistab©)

acronym: Cervistab

summary:
Rugby players are often exposed to destabilisation of the upper cervical spine.This kind of trauma may lead to dramatic injuries, due to lesion of spinal cord.

CerviStab© is a device which evaluate the bio-mechanical and neuromuscular behavior of the upper cervical spine in rugby situation.

The aim of this study, is to evaluate the dynamic stabilization of the upper cervical spine in reaction to unexpected impact.


title: Descriptive Observational Study of the Evolution of the Lifestyle Alteration in Patients With Breast Cancer

acronym: SPENCER

summary:
Scientific context: With more than one million cases per year, breast cancer is the most common female cancer. All treatments such as surgery, chemotherapy, radiotherapy or hormone therapy lead to major changes patients' lifestyle. These treatments can lead to a decrease of physical activity due to fatigue and also changes in the diet. Sometimes, chemotherapy induces nutritional aversions and can cause weight gain that is known to increase the risk of recurrence. Cognitive complaints are also frequent, in particular in patients who received chemotherapy and can also lead to quality of life's alteration

Fatigue assessed with prevalence between 70 % and 100 % is usually a part of a series of symptoms including anxiety, depression, pain, sleep disturbance, decreased activity level, nutritional changes and pre-existent comorbidities. These symptoms can lead to an alteration of the quality of life. The chemotherapy involves disturbances at physiological, psychological and social levels and eating disorders leading to changes in eating habits which can lead to weight loss or weight gain. To limit these deleterious changes in lifestyle, increased physical activity, specialized counseling and nutritional monitoring may be recommended.

According to current knowledge there is no prospective study that evaluated different lifestyle changes according to different types of patients and the appearance of the installation of these symptoms during the patient pathway.

Research hypothesis: the study hypothesis is that description of the evolution of the quality of life and, physical, nutritional and cognitive parameters in a population of patients with non-metastatic breast cancer will better characterize these patients in order to propose an appropriate and personalized rehabilitation intervention.The investigators propose this feasibility study consisting of 2 cohorts of patients according to the adjuvant therapy given (+/- chemotherapy) after the primary breast surgery.


title: Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging

acronym: HYPNOTIC

summary: The prostatic biopsies echo-guided are a painful and stressful. The purpose is to test a new medical device created recently, " Hypnos-Pro ", wich uses connected technologies. This connected device is a mask with diodes coupled with an audio headset and a touch pad. This connected mask is an another option to induce an hypnotic state for our patients. the objective is to value hypnotic mask effectiveness, to reduce the level pain and anxiety for the patients who benefit a prostatic biopsies echo-guided with local anesthesia.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Lille


title: Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis

acronym: ULTRA

summary:
Giant cell arteritis (GCA) is the most common form of vasculitis after age 50. It is a vasculitis affecting the large vessels, in particular the aorta and its collateral vessels, especially those in the external carotid area.

Corticosteroids are the cornerstone of GCA treatment. They are very effective but are generally continued for 18 to 24 months or more since at least 30% of patients with GCA will relapse during their follow-up. Thus, the vast majority of patients treated for GCA have at least one adverse event from corticosteroid therapy, which is the main source of morbidity in these elderly patients.

Reducing the use of corticosteroids, especially during relapses, is therefore a major objective to improve the treatment of patients with GCA. Methotrexate, abatacept and tocilizumab have been shown to be effective during GCA. However, the therapeutic effect of the first two is modest. As for tocilizumab, its use has many limitations: suspensive effect, many contraindications and there are no biological parameters available for reliable monitoring of inflammatory syndrome in these patients.

Recent data have shown the major role of T helper (Th) Th1 and Th17 T cells in the pathophysiology of GCA. Th17 lymphocytes are sensitive to corticosteroid therapy but Th1 persists despite treatment and produces interferon-γ which activates macrophages and smooth muscle cells, leading to remodelling of the vascular wall responsible for ischemic GCA manifestations. Joint targeting of Th17 and Th1 responses is therefore necessary to fully treat the vascular inflammation that exists during GCA. Ustekinumab, which is a monoclonal antibody blocking the subunit common to IL-12 and IL-23 (p40), blocks the Th1 and Th17 responses, and could therefore be an excellent treatment for GCA.

This study aims to evaluate the efficacy of ustekinumab for the treatment of GCA relapses.

Very little data is available on the use of ustekinumab during GCA. Recently, 14 patients with refractory GCA, defined as the occurrence of at least 2 relapses and the inability to reduce the prednisone dose below 10 mg/d, received ustekinumab treatment. No patients relapsed during treatment while the median dose of prednisone was reduced from 20 to 5 mg/d.

Ustekinumab has also been used successfully in a patient with refractory GCA. Under treatment, the patient did not have a new relapse and the dose of prednisone was reduced. In addition, there was a major decrease in the percentages of circulating Th1 and Th17 lymphocytes.

However, to date, no controlled studies have been conducted to confirm the efficacy of ustekinumab during GCA relapses.

This guarantees the originality and innovation of this study.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of a Strategy Based on the Unyvero® Testing System on Appropriate and Targeted Antimicrobial Treatment in Patients With Suspected VAP or HAP Requiring Mechanical Ventilation: a Randomized Controlled Unblinded Trial

acronym: VAPERO

summary: VAPERO is a randomized, unblinded, controlled study to measure the impact of a strategy based on the Unyvero® multiplex PCR test on the adjustment of antimicrobial therapy in patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation. The gold-standard microbiological diagnostic method for pneumonia in the ICU is still culture-based identification and antimicrobial susceptibility testing (AST) despite being more than a hundred years old, with results turnaround time spanning over several days, exposing patients to potentially inappropriate broad-spectrum antimicrobial therapy. The investigators aim to measure the impact of the Unyvero® testing strategy to improve the percentage of patients with VAP or HAP receiving early targeted antimicrobial therapy compared to standard care.

ReferenceCitation: Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713. Review.


title: Comparison of McGrath and Macintosh Laryngoscopes for Insertion of a Double Lumen Tube by Residents

acronym: MacGrathDES

summary: The insertion of double lumen tube is difficult even more if it is a resident with no experience. we think that using videolaryngoscopes for novice ones would facilitate insertion of double lumen tube thanks to the visualization on a LCD screen of the laryngeal structure.


title: A Phase II Study to Evaluate the Safety and the Efficacy of a Blinatumomab Based Consolidation and Maintenance in Patients With High-risk B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL). GRAALL-QUEST

acronym: GRAALL-QUEST

summary:
The GRAALL-QUEST study is a Phase 2 study nested in the GRAALL-2014/B study (NCT02617004). The GRAALL-QUEST study evaluates the safety and the efficacy of blinatumomab-containing consolidation and maintenance therapy in patients aged 18-59 years old with high-risk B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in first complete hematologic remission after one induction course of standard chemotherapy and no central nervous system (CNS) involvement at diagnosis.

High-risk patients are defined as patients with KMT2A/MLL gene rearrangement, and/or IKZF1 (Ikaros) intra-genic deletion and/or high post-induction Ig-TCR minimal residual disease (MRD) level (≥10-4). In such patients not receiving blinatumomab, 3-year hematologic relapse incidence and relapse-free survival (RFS) are estimated at 60-65% and 50% only, respectively, on the basis of historical results.

A large subset of these high-risk patients (i.e. those with post-induction MRD level ≥10-3 and/or post-consolidation MRD level ≥10-4), but not all, will also be considered as candidates for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in first hematologic remission. The primary objective of the GRAALL-QUEST study is to evaluate the efficacy of adding blinatumomab to consolidation and eventually maintenance therapy in term of Relapse Free Survival (RFS). Secondary objectives are overall survival, comparison of RFS and Overall Survival (OS) in transplanted versus non-transplanted patients, MRD response and safety. Blinatumomab will be given as monthly cycles at the daily dose of 28 microg/d continuous IV infusion, together with 3 triple intra-thecal (IT) chemotherapy injections. The first cycle will start after completion of the first consolidation chemotherapy phase (corresponding to the MRD2 time-point). Patients receiving allo-HSCT will receive successive blinatumomab cycles until allo-HSCT. Patients not receiving allo-HSCT will receive a first blinatumomab cycle (cycle 1) during the second consolidation chemotherapy phase, followed by late intensification, then the third consolidation chemotherapy phase including another blinatumomab cycle (cycle 2) and maintenance chemotherapy including three additional blinatumomab cycles (cycles 3 to 5), for a total of 5 blinatumomab cycles maximum.


title: Otologic and Rhinologic Outcomes in Children With Cleft Palate at Age 10 Years

acronym: Clef Palate

summary:
OBJECTIVE:

To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft.

DESIGN:

Monocentric retrospective and prospective analysis of medical reports.

PATIENTS, PARTICIPANTS:

All consecutively treated patients affected by a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.

INTERVENTIONS:

Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated.

MAIN OUTCOME MEASURE(S):

The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.

lead_sponsor: University Hospital, Montpellier


title: Pitch Perception and Memory: Deficits and Training

summary: Pitch perception and memory are central in auditory cognition, in particular for sound source segregation and recognition, speech prosody and music processing. Here the investigator assess pitch perception and memory in hearing-impaired listeners wearing cochlear implant(s) and listeners with congenital amusia, both compared with control listeners. Behavioral, EEG, and MEG measures are collected in audio and audio-visual contexts to characterize pitch processing deficits, and test a pitch training program.


title: Post-SOPHrology Cancer Patients' anxieTY Report

acronym: SOPHTY

summary:
Cancer is pathology with a high impact on patients and relatives quality of life. Most of the time, it is a stressful trial. Professionals have often resort to pharmaceutical solutions, but sometimes, it is not sufficient. So, patients resort to alternative and complementary medicines, as sophrology. In Lucien Neuwirth Cancer Institute, patients can benefit from sophrology.

Anxiety levels have never been reported before and after sessions. Indeed, the present study wants to report anxiety levels before, after, and one and three weeks after session. Levels of satisfaction will also be reported.

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Randomized, Placebo-controlled Double Blind Study to Evaluate the Effects of Dietary Supplementation With Short-chain Fructo-oligosaccharides (scFOS) on Nincrease in Stool Frequency in Constipated People

acronym: CONSYST

summary: The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.

lead_sponsor: Syral

intervention_type: Dietary Supplement


title: The Treatment of Addictions in the Course of Care in Oncology: an Inventory of Fixtures Among Paramedical Professionals

acronym: PREFACE

summary: Nowadays, guidance is given on the implementation of innovative approaches to promote autonomy and user participation through strategies designed to strengthen the patient's empowerment. [SNS 2018-2022, Ministère des Solidarités et de la Santé] The 2014-2019 Cancer Plan calls for the systematic support of smokers during smoking cessation. This means that health workers need to be trained to help with smoking cessation, as well as the motivational attitude that reinforces the patient's smoker's self-esteem as well as his desire to off-load this addiction. [Perriot, Underner, Peiffer, Dautzenberg, 2018] It is recommended that these interventions be included from the beginning of the management, once the diagnosis of Cancer is made. It seems legitimate then to wonder about the place of choice the Motivational Interview (EM) could have in the course of cancer care, for the management of addictions during the treatment of cancer. We therefore wish to carry out descriptive qualitative research in the Lucien Neuwirth Oncology Institute in order to try to define the management of addictions in the oncology care course. Thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.

ReferenceCitation: Verot E, Regnier Denois V, Macron C, Chauvin F. Managing unresolved issues of addiction during cancer treatment: A qualitative study about cancer care providers' representations. PLoS One. 2020 Nov 24;15(11):e0242693. doi: 10.1371/journal.pone.0242693. eCollection 2020.

lead_sponsor: Institut de Cancérologie de la Loire


title: Study of Two Fasting Procedures Before Gastroscopy: 6 Hours Versus 2 Hours for Clear Fluids

acronym: GASTROPREP

summary:
Upper gastrointestinal endoscopy is the key examination for screening for precancerous and cancerous lesions of the esophagus and stomach. This study aims to describe the quality of the visualization of the esophageal and gastric mucosa, the safety of use of two fasting procedures before gastroscopy and the feeling of patients. The population evaluated here concerns cirrhotic patients, at high risk of developing a precancerous lesion of the upper gastrointestinal tract.

The investigator carries out a prospective, monocentric (Besançon CHRU), interventional and randomized study according to two fasting procedures before gastroscopy: 6 hours (F6 group) versus 2 hours (F2 group) for clear fluids. The primary endpoint was to describe and compare the quality of visualization of the esophageal and gastric mucosa, graded from A (good quality) to C (poor quality) according to a score. developed by Elvas et al. (Endoscopy 2017).

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Integrated Discovery of New Immuno-Molecular Actionable Biomarkers for Tumors With Immune-suppressed Environment

acronym: IDeATIon

summary: The explosion of novel therapies targeting tumor mutations or immune molecules requests to define or better characterize the mutational profiles of tumors that are none or insufficiently explored so far. This is particularly the case for tumors arising in immune-suppressed individuals or environments which have been poorly, if any, analyzed so far with modern molecular methods. The goal of the translational research program, Ideation, is to define novel biomarkers such as the tumor mutational profiling and immunomutanome in such contexts and to compare the results obtained to those observed in immune competent individuals. In addition, this approach will allow to characterize novel key non-invasive diagnostic and prognostic biomarkers such as circulating tumoral DNA and cells. Altogether results will provide novel biomarkers to better adapt therapeutic strategies in these cancers, to monitor response to treatment as well as to define new molecular targets of potential therapeutic strategies.


title: Fever Infants and Therapeutic Education in Emergency Department

summary: To evaluate the effect of a therapeutic education session on fever versus a control education session on household accidents on the behavior and knowledge of families concerning the management of infant fever between day 4 and day 7 after the intervention