title: Prospective, Randomized, Double Blinded Crossover Study Comparing Spinal Cord Stimulation (SCS) vs Dorsal Root Ganglion Stimulation (DRGS) vs Association of Both (DUAL) in Patients With Refractory Chronic Lower Limb Neuropathic Pain and/or Back Neuropathic Pain

acronym: BOOST DRG

summary:
Neuropathic pain is described as a "pain initiated or caused by a primary lesion or dysfunction in the nervous system". It is thus often a chronic affection, as a difficult-to-treat condition. As such, there is growing proportion of patients with inefficient pain relief. The prevalence of chronic neuropathic pain has been estimated from 6.9 to 10% in the general population and represents a heavy financial burden for the health care systems. Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain (SCS is a reversible treatment option which leads to improve pain relief and quality of life Using conventional SCS, the prerequisite to target any pain relief is to obtain an appropriate coverage of the painful area with induced paresthesia.

Despite its effectiveness, conventional SCS has some limitations (Selectivity, Energy consumption …) and in order to address these limitations and challenges, medical devices and neuromodulation industries have developed the Dorsal Root Ganglion (DRG) stimulation. DRG stimulation appears to be a promising technology that can be proposed to patients with chronic neuropathic pain for several reasons: DRG stimulation has shown promising results in pathologies generating focal pain with more selectively than SCS, lead localization appeared to be less discriminative than SCS. Consequently, DRG seems more stable and efficient to relief pain with lower energy consumption than SCS (therapy can be delivered with very low amplitude compared to SCS).

Last but not least, Abbott technology has moved forward to Burst stimulation a couple of years ago and validated this new way of delivering electrical stimulation through several major publications. To our knowledge, applying new waveforms to DRG has not been yet validated. This will represent a fantastic opportunity to refine the design of the next generation of Internal Pulse Generators (IPGs).

To date, the baseline study comparing DRG stimulation to SCS is the ACCURATE study. This is a high quality prospective, multicenter, randomized comparative trial conducted in 152 patients implanted with either SCS or DRG stimulation system. Although ACCURATE study is well designed, it has some limitations.

To bridge this gap, the investigators propose to conduct a randomized controlled trial (RCT) with a crossover design, where SCS and DRG stimulation will be used within patient in three conditions: (i) SCS alone, (ii) DRG stimulation alone (DRGS), (iii) combination of SCS and DRGS (DUAL).

Our goal will be to compare SCS vs DRGS vs DUAL therapies in order to establish the superiority of DRG stimulation over SCS in a crossover design, assess the added value of hybrid stimulation (DUAL) over the separate standalone stimulation types, compare the different cortical pathways involved in both techniques, by functional imaging, incl. MRI, analyze energy consumption by optimizing neural targeting. assess the added value of applying Burst on these different targets, after a 3-month follow-up and to reinforce the perception of neurostimulation techniques through the pain community, as the investigators will demonstrate their benefits on pain relief, functional capacity and quality of life, with objectives measures and a randomized design. This study represents a unique opportunity to boost the rationale of SCS/DRGS since each arm of treatment will be blinded for the patient and the implanter.


title: Physical Activity of Staff on Medical Duty in a Department of Anesthesia and Critical Care During Guards

acronym: AMAC

summary:
On-call work is an integral part of senior and junior patricians in a critical care department.

Several studies have examined the effect of sleep deprivation on physicians on call and the impact of sleep deprivation on the quality of patient care.

Some of these studies have shown that practitioners' concentration capacities have deteriorated as the guard progresses.

However, few studies have looked at the physical activity of practitioners over a period of on-call time (distance covered, number of steps,...), as well as other parameters than the time spent in communication over the telephone.

The age and seniority of practitioners seem to be factors that can influence these different parameters, and there are few figures in the literature.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: CHU de Reims

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: NeuroCognitive Bases of Tool Use

acronym: TECHNITION

summary: Tool use is considered to be the hallmark of complex cognitive adaptations that humans have achieved trough evolution, that provides an adaptive advantage to the human species. Even if nonhuman species do use tools too, human tool use is much more complex and sophisticated. If humans have special abilities for tool use, it has to be grounded in a specific neuroanatomical substrate. Humans and nonhumans share a similar prehension system located within the superior parietal lobe and the intraparietal sulcus. However, there is a human specificity: the supramarginal gyrus within the left inferior parietal lobe is unique to humans, and could play a central role in tool use. This project aims to study the neurocognitive bases of human tool use with functional Magnetic Resonance Imaging (fMRI), to precise the cognitive mechanisms through which humans are able to use tools.

study_start_date_type: Actual

status: Recruiting

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

sponsor_collaborators:
Hospices Civils de Lyon
Université Lumière Lyon 2

intervention_type: Other

status_simplified: Ongoing


title: Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.

acronym: EDEN

summary: To assess the diagnostic accuracy of Shear Wave elastography (SWE) for the diagnosis of pancreatic adenocarcinoma.

ipd_sharing: No

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

intervention_type: Diagnostic Test

lead_sponsor_type: industriel


title: Evolution of Fecal Incontinence in Patients With Rectal Static Disorder

acronym: NATUROSTATIQ

summary:
This study evaluate the rate of occurrence of fecal incontinence in patients who had surgery for posterior pelvic static disorder versus those with medical management.

The aim is also to assess the natural history of constipation symptoms and quality of life in patients with posterior pelvic static disorder.

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital


title: NoL Monitor Performances of Nociceptive and Non-nociceptive Stimuli Discrimination During Robotic Surgery Under Propofol-remifentanil Anaesthesia

acronym: ROBOTNOL

summary:
Anesthesia quality and safety have improved over the past decades, thanks to improved monitoring devices. No nociception monitoring is currently part of the standard of care. Usually, hemodynamic parameters are used to evaluate nociception (heart rate, HR, and mean arterial pressure, MAP), but none of them are specific. However, nociception evaluation is critical. Indeed, where excess of nociception can lead to arterial hypotension and respiratory depression, insufficient nociception can lead to acute postoperative pain, which is followed by persistent chronic pain in 10-50% of patients. Different monitoring devices have been developed but none of them are still used in current practice. Recently developed, the nociception level (NoL) index (MEDASENSE BIOMETRICS Ltd®, Ramat Gan, Israel) is an index of nociception, based on a nonlinear algorithm combination of heart rate, heart rate variability, photoplethysmograph wave amplitude, skin conductance, skin conductance fluctuations, and their time derivatives.

Robotic surgeries have started to spread over the world 20 years ago, claiming to be mini-invasive with less hemorrhage complications, with better success based on the technical advantages of the robot allowing better access during anatomical challenges procedures. Robotic surgery has been suggested to decrease pain during surgery and post-operatively, because of the decreases abdominal wall constraints induced by the robotic arms compared to the surgeon arms.

This observational prospective non-interventional monocentric study intend to evaluate the performance of the NoL index to discriminate protocol-defined nociceptive from non nociceptive stimuli during robotic surgery.

All patients, scheduled for a robotic surgery procedure, will be orally informed about the study during the anesthesia consultation. During the procedure, the anesthesia procedure will be the same for all patients, as part of the usual care in our department. The NoL monitor will be added for the purpose of this study, but the results will be hidden from all physicians. All settings will be left the physician in charge. At the end of the surgical procedure, before transfer to the recovery room, data for the monitor will be extracted on a dedicated universal serial bus (USB) key. Files will be safely stored under RedCap before analysis.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Completed


title: Clinical Benefits of TeleRehabilitation in Chronic Respiratory Failure Patients.

acronym: e-mouv

summary: It is widely described in the literature that exercise training improves patients' exercise tolerance, quality of life, symptoms, anxiety and depression, regardless of the location. Despite overwhelming evidence of the benefits of exercise training, only a very small percentage of eligible people have ever completed a program. Alternative modes of exercise training are needed to improve equity of access for patients with chronic respiratory disease. So TeleRehabilitation, using information and communication technologies to provide distance exercise training services, may be an answer.

lead_sponsor: SOS Oxygene Mediterranee

location_facility: Cabinet de pneumologie Clinique des Cèdres


title: Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)

acronym: CAPEOS®

summary: The main objective of this study is to compare pelvimetric measurements performed by Magnetic Resonance Imaging (MRI) and by the EOS imaging system.

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Aubry S, Padoin P, Petegnief Y, Vidal C, Riethmuller D, Delabrousse E. Can three-dimensional pelvimetry using low-dose stereoradiography replace low-dose CT pelvimetry? Diagn Interv Imaging. 2018 Sep;99(9):569-576. doi: 10.1016/j.diii.2018.02.008. Epub 2018 Mar 19.

lead_sponsor: University Hospital, Grenoble


title: Objective Measurements of the Opacification of the Lens After Vitrectomy

acronym: MOCVIT

summary:
Cataract is the opacification of the lens. Usually cataract occurs slowly, causing progressive vision loss over several months or years.

In ophthalmic clinical practice, repeated objective quantitative measurements of lens opacity may be necessary to document its progression and support a surgical indication.

The subjective methods of evaluating the opacification of the lens have limitations, in particular due to the lack of reproducibility between observers. Thus, innovative objective techniques with precise and reproducible cataract classification results have been developed, such as the Objective Scatter Index (OSI) on the Optical Quality Analysis System (OQAS), Visiometrics SL in 2010 and, more recently, Average Lens Density (ALD) on the IOLMaster® 700 device. Cataract is diagnosed as mature when the OSI is ≥ 2 and / or when the ALD is ≥ 74 pixel units.

Vitrectomy is a surgery of the posterior segment of the eye indicated for retinal detachment, epimacular membranes, macular holes, vitreous hemorrhage. The incidence of post-vitrectomy cataract varies among studies, and the methodology is often retrospective. Age has already been identified as a risk factor for progression since in a study of 28 eyes of patients under 50 years old, only 7% developed cataracts secondarily, compared to 79% in the 'over 50' group.

To date, there is no prospective study describing the progression kinetics of lens opacification according to precise and reproducible quantitative objective criteria in patients treated by vitrectomy. It also involves confirming the age and preoperative lens status as a risk factor for postoperative cataract progression.

status: Active, not recruiting

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Procedure


title: Evaluation of the Value of 18F-fluorodeoxyglucose Positron Emission Tomography (FDG PET) and Brain Perfusion Computed Tomography (CT Perfusion) for Predicting the Efficacy of Anti-angiogenic Therapy (Bevacizumab) in Patients With Recurrent Glioblastoma

acronym: EVA DOPA

summary: In this pilot study, the study evaluators will evaluate the ability of positron emission tomography (PET) with 18F-fluorodeoxyglucose (FDG PET) and the computed tomography (CT) perfusion scanner, individually and combined, to predict the effectiveness of anti-angiogenic treatment.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Foley Catheter Versus Prostaglandin E2 (Propess) Inserts for Induction of Labor in Women With Term Premature Rupture Of Membranes : Mode of Delivery and Maternal and Fetal Outcomes

summary:
Premature rupture of membranes at term is a rupture that occurs at term (>37SA) before the start of labor. It complicates 5 to 10% of pregnancies and 6 to 22% of term pregnancies.

Althought some studies support efficacy of the Foley catheter for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with premature rupture of membranes at term.

The aim of this retrospective study at the Montpellier University Hospital is to evaluate the effect of the Foley catheter compared to Propess in women with premature rupture of membranes at term, on the induction of labor and the maternal and fetal complications.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Wideband Tympanometry for Monitoring Intracranial Pressure in Adult Patients in Intensive Care, Operated on for an Intracranial Lesion After Traumatic Brain Injury, or With Intracranial Hemorrhage

acronym: TYMPIC

summary:
Intracranial pressure is usually measured by invasive methods requiring an intracranial sensor. There is no non-invasive monitoring method recognized as a gold standard. Tympanometry would make it feasible to evaluate intracranial pressure through sensitive and specific changes in the energy absorbance of the middle ear. It could represent a non-invasive method of monitoring intracranial pressure.

This is a prospective monocentric longitudinal study. All adult patients in intensive care for head trauma, intracranial hypertension, or after cranial surgery and requiring invasive monitoring of ICP will be included after their non-opposition has been collected.

In a group of 10 controls, multifrequency tympanometry will be performed in the standing position, in the 0° supine position and in the Tredelenburg position at -17°.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Risk of Recurrence of de Novo Mutations: Research and Quantification of Paternal Germinal Mosaicism by the Combined Use of Genomic Tools

acronym: RRMUT

summary:
Inclusion of 5 families Inclusions will be made by the clinical genetics department of the Rouen University Hospital (monocentric study) and will correspond to trios of parents + child with unexplained developmental abnormalities. The inclusion of patients will be integrated in routine care and will have as immediate benefit for the included families the extensive analysis of the proband and their parents' genomes by short and long read sequencing techniques, which represent the most comprehensive diagnostic tests for developmental diseases, and which are not currently routinely available. Inclusion in clinical genetics by clinicians accustomed to prescribing genome-wide analyses will allow clear and complete information to families. Collection of consents. The trio's DNA will already be available at the molecular genetics laboratory, and a new blood sample may be proposed if necessary. Collection of sperm from the father.
Identification of a large set of de novo mutations. Extraction of blood DNA and sending for sequencing of the complete genome to the National Centre for Research in Human Genomics (CNRGH, Evry), in the framework of a collaboration already initiated. Analysis of the sequencing data thanks to the already existing expertise in Rouen. Identification of about 40-120 de novo mutations per trio. At this stage: interpretation of the variations identified with the secondary objective of identifying the cause of the disease in children. Long read genomes will allow to phase the de novo variants to the paternal or to the maternal haplotype.
Search for de novo mutations in paternal sperm samples. Extraction of spermatic DNA. Design of a sequencing panel targeting the genetic variations identified in the different trios. Preparation of the libraries, targeted high throughput sequencing at great depth thanks to the techniques and equipment already operational. Specific search for the de novo variations identified in the probands (in 2.), with for each evaluation of (i) the presence of the variation in the sperm sample, (ii) the quantity of mosaicism, reflecting the proportion of carrier spermatozoa and therefore the risk of recurrence, (iii) the presence of my variation in the blood sample of both parents in deep sequencing.

lead_sponsor: University Hospital, Rouen

intervention_type: Genetic


title: Pleiotropic Role of TRPV1 in Psoriasis Inflammation

acronym: TRIP

summary:
Widely expressed in the sensory nerve endings of the skin, Transient Receptor Potential Vanilloid 1 (TRPV1) is a receptor that plays an important role in the perception of pain and pruritus but also in skin inflammation, primarily by inducing the local release of several neuropeptides.

Although the mechanisms by which TRPV1-sensitizing inflammatory mediators in damaged skin have received considerable attention, the role of TRPV1 in psoriasis has so far been little explored.

However, two studies have reported that ablation of sensory nerves expressing TRPV1 reduced psoriasiform skin inflammation, demonstrating the neuronal contribution to inflammation in psoriasis.

However, the expression of TRPV1 is not limited to neurons alone. TRPV1 is also expressed by epidermal keratinocytes and skin microvessels.

For example, in 2018, transcriptomic analysis of psoriatic patient skins (by definition devoid of neuron nuclei) revealed that TRPV1 expression was increased in the skin of psoriatic patients suffering from itching (pruritus).

Regarding human keratinocytes, it is recognized that the activation of TRPV1 present on their surface induces the release of pro-inflammatory factors such as cyclooxygenase-2. In addition, the investigators have demonstrated that TRPV1 has a pivotal role in the keratinocyte production of inflammatory mediators, which is mediated by the protease-activated receptor-2 (PAR-2). However, the role of vascular TRPV1 in inflammation is not described.

The investigators hypothesize that in addition to neuronal TRPV1, non-neuronal TRPV1 receptors of non-neuronal cells (keratinocytes and endothelial cells) may be involved in the vicious circle of the inflammatory process characteristic of psoriasis. Putting TRPV1 at the center of the deregulation of the homeostatic balance including epithelial, neuronal and vascular inflammation in psoriasis is totally innovative.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit

acronym: MS-COUGH

summary:
In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress.

This insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology

design_allocation: Randomized

primary_purpose: Supportive Care


title: Physiopathology and Sequelae of COVID-19 Infection

acronym: SEQ-COV-PHYSIO

summary:
The data obtained from Covid-19 infections seem to suggest that the immunogenesis of Covid-19 could in some cases be the result of immune dysregulation. On the other hand, endocrine damage is possible at the tile of Covid-19 infection (mainly thyroid,adrenal, and hypothalamus). These disorders are autoimmune or linked to degeneration.

The main objective is to assess the thyroid function (thyrotropic axis) as well as the corticotropic adrenal function of patients who have had Copvid-19 pneumonia. The secondary objectives is to describe the pathophysiological mechanisms of pulmonary and vasculothrombotic involvement of Covid-19

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Biological


title: Kinetics of COVID-19-neutralising Antibodies in Patients Residing in EHPAD / USLD: Influence of Immunosenescence

acronym: SERO-CoV-OLD

summary:
This study aims to determine how long COVID-19 neutralizing antibodies can be detected in an elderly institutionalized population presenting fragility factors.

This study also aims to stratify seroconversion by immunological profiles of the elderly patients residing in the EHPAD. This stratification requires the measurement of immunological marker levels already described in immunosenescence and also involved in the development of certain chronic infectious diseases more common in the elderly population. This analysis will enable the investigators to describe an immunological, clinical and biological profile representing a patient who has developed an immunity against COVID 19. It will also help the investigators to understand the different mechanisms leading to a reduced immune response after a potential administration of a vaccine. Finally, it will help describe the immune profiles of elderly residents who presented with non-severe forms of COVID-19.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Approche représentationnelle de l'Hippocampe Dans la Cognition : Étude en IRMf

acronym: SHIP

summary: Although traditional neuropsychological models associate medial temporal lobe (MTL) regions to memory, and the hippocampus to episodic memory, there is growing evidence supporting an alternative view. The representational view of the MTL proposes that such regions depends on the representations processed rather than the cognitive processes. The aim of this project is to characterise the role played by MTL areas, and particularly the hippocampus, in mnemonic and non-mnemonic cognition. Hypotheses stemming from the representational view will thus be tested, using functional MRI among young healthy participants.

collaborators: Laboratoire de Psychologie et NeuroCognition

intervention_type: Device


title: Study of the Antipodal Capsular Fold and Its Potential Role in Antero-inferior Glenohumeral Instability - Instabio

acronym: INSTABIO

summary: In schoulders instabilty, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. This research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
Ramsay santé


title: Development of a Virtual Reality Application for the Diagnosis of Childhood ADHD: an Exploratory Study

summary: The aim of this study is to develop an application in order to identify the most relevant cognitive and behavioral parameters for the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) in conditions closer to reality

lead_sponsor: University Hospital, Bordeaux


title: Place of Connected Tools in the Follow-up of the Bariatric Patient: Can They Allow Rapid Management of Complications and Reduce Lost of Follow-up During Postoperative Period?

summary: The aim of this study is to assess the safety (in terms of post-operative complications) of the use of connected devices for the monitoring of patients operated on by longitudinal laparoscopic gastrectomy (LSG) and discharged 24 hours after surgery according to the protocol Enhanced Recovery After Surgery (ERAS).

primary_purpose: Prevention

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ReferenceCitation: Malczak P, Pisarska M, Piotr M, Wysocki M, Budzynski A, Pedziwiatr M. Enhanced Recovery after Bariatric Surgery: Systematic Review and Meta-Analysis. Obes Surg. 2017 Jan;27(1):226-235. doi: 10.1007/s11695-016-2438-z.

ReferenceCitation: Khorgami Z, Petrosky JA, Andalib A, Aminian A, Schauer PR, Brethauer SA. Fast track bariatric surgery: safety of discharge on the first postoperative day after bariatric surgery. Surg Obes Relat Dis. 2017 Feb;13(2):273-280. doi: 10.1016/j.soard.2016.01.034. Epub 2016 Feb 2.

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ReferenceCitation: Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.

ReferenceCitation: Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.

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ReferenceCitation: Svensson M, Nilsson U, Svantesson M. Patients' experience of mood while waiting for day surgery. J Clin Nurs. 2016 Sep;25(17-18):2600-8. doi: 10.1111/jocn.13304. Epub 2016 Jun 27.

ReferenceCitation: Michard F. Smartphones and e-tablets in perioperative medicine. Korean J Anesthesiol. 2017 Oct;70(5):493-499. doi: 10.4097/kjae.2017.70.5.493. Epub 2017 Sep 28.

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ReferenceCitation: Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4.

ReferenceCitation: Oosterveen E, Tzelepis F, Ashton L, Hutchesson MJ. A systematic review of eHealth behavioral interventions targeting smoking, nutrition, alcohol, physical activity and/or obesity for young adults. Prev Med. 2017 Jun;99:197-206. doi: 10.1016/j.ypmed.2017.01.009. Epub 2017 Jan 25.

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ReferenceCitation: Stephenson A, McDonough SM, Murphy MH, Nugent CD, Mair JL. Using computer, mobile and wearable technology enhanced interventions to reduce sedentary behaviour: a systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2017 Aug 11;14(1):105. doi: 10.1186/s12966-017-0561-4.

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ReferenceCitation: te Riele WW, Boerma D, Wiezer MJ, Borel Rinkes IH, van Ramshorst B. Long-term results of laparoscopic adjustable gastric banding in patients lost to follow-up. Br J Surg. 2010 Oct;97(10):1535-40. doi: 10.1002/bjs.7130.

ReferenceCitation: Althoff T, White RW, Horvitz E. Influence of Pokemon Go on Physical Activity: Study and Implications. J Med Internet Res. 2016 Dec 6;18(12):e315. doi: 10.2196/jmir.6759.

ReferenceCitation: Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;40(9):2065-83. doi: 10.1007/s00268-016-3492-3.

ReferenceCitation: Moorehead MK, Ardelt-Gattinger E, Lechner H, Oria HE. The validation of the Moorehead-Ardelt Quality of Life Questionnaire II. Obes Surg. 2003 Oct;13(5):684-92. doi: 10.1381/096089203322509237.

ReferenceCitation: Nini E, Slim K, Scesa JL, Chipponi J. [Evaluation of laparoscopic bariatric surgery using the BAROS score]. Ann Chir. 2002 Feb;127(2):107-14. doi: 10.1016/s0003-3944(01)00688-5. French.

lead_sponsor: Elsan


title: Identifying Functional and Psycho-social Complaints After Hospitalization for Severe SARS-CoV-2 Infection (COVID19)- REPERCOV

acronym: REPERCOV

summary:
Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019).

It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care.

Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured.

In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection.

The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.

primary_purpose: Other

lead_sponsor: Centre Hospitalier le Mans


title: Additive Value of Physiology Coronary in Clinical Practice

acronym: PRINCIPE

summary:
The important evidence of coronary microcirculation for the management of patients with coronary artery disease is only increasing. Thus, in recent years, a number of studies have shown that the demonstration of coronary microvascular disease (CMVD) contributes to cardiovascular morbidity and mortality increases independently of epicardial damage. This has been shown in stable coronary artery disease with screening for CMVD when there is no significant epicardial involvement and allowing the implementation of an adapted treatment then reducing the symptoms and improving the quality of life of our patients. (1). The prognostic nature of CMVD has also been identified in stable disease after coronary angioplasty (2) but also in patients with infarcts reperfused by coronary angioplasty (3).

The complete exploration of the epicardial and microvascular coronary vascularization is grouped under the name of the subspecialty: coronary physiology. Thus, an internationally recognized algorithm for exploring coronary physiology has been published (4).

However, this algorithm is still little followed. The PRINCIPE registry aims to assess the prevalence of CMVD with the use of a standardized algorithm for exploring coronary physiology by coronary angiography in our center in current practice.


title: Elucidating the Symptomatic, Explanatory and Prognostic Characteristics of GERIAtric Patients Hospitalized for COVID-19

acronym: GERIA-COVID

summary:
Statement :

The emerging Coronavirus 2019 (COVID-19) disease, linked to the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pathogen, has been spreading worldwide since December 2019, affecting millions of people and causing hundreds of thousands of deaths, particularly among the elderly.
The first epidemiological evidence available reveals a different expression of the disease in the elderly, associated with a high risk of delayed diagnosis and implementation of protective measures and a particularly high morbidity and mortality, especially among the frailest.
To date, there is no effective model for predicting the severity of COVID-19 in an individual.

The investigators hypothesize that there are specificities of COVID-19 in the elderly, both etiological, diagnostic and prognostic, all of which are not yet known and understood.

time_perspective: Other

lead_sponsor: University Hospital, Angers


title: Effect of Inhaled Aromatherapy on Chemo-Induced Nausea Vomiting (NCVI): CINVAROM (Chemotherapy Induced Nausea Vomiting and AROMatherapy)

acronym: CINVAROM

summary:
The investigator wish to provide a blend of two essential oils with comparable antiemetic properties; Peppermint essential oil (Mentha x Piperita) and lemon tree essential oil (Citrus Limon). Dry inhalation of these essential oils is safe, but effectiveness has not been determined. Studies on the subject present a questionable methodology. This is why we are proposing this study to measure the effectiveness of this mixture of essential oils on chemo-induced nausea and vomiting.

This study is a first step before a possible study to compare the effects of essential oils with those of a placebo.

primary_purpose: Treatment

lead_sponsor: Centre Francois Baclesse

intervention_type: Drug


title: Interest of Ultrasound in the Diagnosis of Severity of Lateral Ankle Sprain

summary: Ankle sprain is a frequent and widely trivialized trauma. Misdiagnosed or poorly treated, it can recur and thus develop into chronic ankle instability. It can be associated with complications which, if not detected early, can lead to long-term sequelae.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Placental Expression of EG-VEGF and Its PROKR1 and PROKR2 Receptors in Preeclampsia Patients.

acronym: PRE-EVE

summary:
The pathophysiology of preeclampsia (PE) is thought to be endothelial dysfunction responsible for the maternal signs of de novo hypertension and proteinuria after 20 weeks. Current concepts suggest that the pathophysiology of preeclampsia and intrauterine growth retardation results from an imbalance of angiogenic factors.

A new angiogenic factor EG-VEGF (Endocrine Gland- Derived Vascular Endothelial Growth Factor) also known as Prokineticin 1 (PROK1) appears to be emerging in the pathophysiology of PE. EG-VEGF is a circulating factor which belongs to the family of prokinetics. Dr Alfaidy's MAB2 team at the Cancer and Infections Biology Laboratory (U1292 Biosanté INSERM / UGA / CEA, CEA Grenoble) demonstrated its key role in the control of key processes in placental development and provided evidence through the development of an animal model of preeclampsia. EG -VEGF is directly involved in the development of Pre-Eclampsia. Few studies have evaluated the expression of EG-VEGF in the human placenta.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Assessment of the Relationship Between Sleep Apnea Syndrome and Patent Foramen Ovale Among Young Subjects Victims of Cryptogenic Ischemic Stroke

summary: Obstructive sleep apnea syndrome (OSAS) and patent foramen ovale (FOP) are considered as risk factors for stroke. OSAS generates a pressure increase in the right cavity during inspiratory efforts, which increases the number of right-left shunt embolus and therefore the risk of stroke. OSA and FOP are often thought as two separate entities, however, due to their high frequencies, they sometimes coexist and can influence the pathophysiology of each other. More researches are needed in this area to confirm this complex association and its role in triggering stroke.


title: Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a Retrospective French Multicenter Study

summary:
After developing in pediatric hematology and nephrology, therapeutic apheresis is increasingly used in pediatric neurology despite a sparse level of evidence.

There are a few retrospective series with a small number of patients, concerning mainly autoimmune diseases (encephalitis, myasthenia gravis, polyradiculoneuritis).

The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.


title: Evaluation of the Experience of Lock Down Related to the Covid-19 Epidemic and Its Impact on the Project of Parenthood of the Couples Followed in Assisted Reproduction

acronym: CONFIN-AMP

summary: Observational, descriptive, cross-sectional, monocentric study, This Study is proposed to all couples followed in Assisted Reproduction and CECOS Nord for whom the protocols were stopped when they entered into confinement related to the Covid-19 epidemic on 13 March 2020.

lead_sponsor: University Hospital, Lille


title: Use of Extracorporeal CO2 Removal in Case of Moderate to Severe Acute Respiratory Distress Syndrome to Apply an Ultraprotective Mechanical Ventilation Strategy

summary: The extracorporeal CO2 removal (ECCO2R) has been recently proposed in case of Acute Respiratory Distress Syndrome (ARDS) in order to reduce pulmonary injuries induced by the mechanical ventilation. A reducing of tidal volume and/or respiratory rate is thus expected using this extracorporeal respiratory support. However, most of existing devices of ECCO2R can apply only a limited extracorporeal flow, often less than 1L/min, which limits the CO2 exchanges and does not allow to reach an ultraprotective ventilation. An extracorporeal flow higher should logically maximalize CO2 removal and allow reducing intensity of mechanical ventilation. Works focused on high-flow ECCO2R (2-3 L/min) in setting of ARDS are therefore mandatory to better understand apprehend the phenomena of gazes changes with this device and confirm the added-value in management of these specific patients.

ipd_sharing_description: identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected


title: Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status

acronym: RECOVIDS

summary: In this study, the investigators are attempting to evaluate the influence of socio-economic factors on the functional recovery (physical and psychological) of patients who developed ARDS after a COVID-19 infection, with the aim of offering personalized medical and social follow-up and support measures in order to avoid medium- and long-term complications, which can result in handicaps, reduced quality of life, and a higher risk of death.

ReferenceType: derived

ReferenceCitation: Declercq PL, Fournel I, Demeyere M, Ksiazek E, Meunier-Beillard N, Riviere A, Clarot C, Maizel J, Schnell D, Plantefeve G, Ampere A, Daubin C, Sauneuf B, Kalfon P, Federici L, Redureau E, Bousta M, Lagache L, Vanderlinden T, Nseir S, La Combe B, Bourdin G, Monchi M, Nyunga M, Ramakers M, Oulehri W, Georges H, Salmon Gandonniere C, Badie J, Delbove A, Monnet X, Beduneau G, Artaud-Macari E, Abraham P, Delberghe N, Le Bouar G, Miailhe AF, Hraiech S, Bironneau V, Sedillot N, Hoppe MA, Barbar SD, Calcaianu GD, Dellamonica J, Terzi N, Delpierre C, Gelinotte S, Rigaud JP, Labruyere M, Georges M, Binquet C, Quenot JP; RECOVIDS trial investigators. Influence of socioeconomic status on functional recovery after ARDS caused by SARS-CoV-2: a multicentre, observational study. BMJ Open. 2022 Apr 22;12(4):e057368. doi: 10.1136/bmjopen-2021-057368.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal


title: Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer: a Randomized, Multicenter, Controlled Pilot Study (EmoVie-K2)

summary: Emotional skills are the ability to use emotions cleverly in daily life. Good emotional skills are associated with better mental and physical health in healthy and clinical populations. However, to our knowledge, cancer patients have never benefited from an intervention aiming at increasing their emotional skills. Our goal was thus to design and test such an intervention. A prospective, multi-center, randomized controlled trial (RCT) will be conducted in esogastric and lung cancer patients after antineoplastic treatments. Forty-three patients are expected in each arm. The primary outcome is the change in emotional skills assessed using a patient-reported validated questionnaire between the start and two weeks after the end of the intervention and at 2-month follow-up. The experimental arm will have to follow three individual sessions on emotional skills (i.e. identification, understanding, expression and regulation of emotions) while the control arm will have to follow three sessions of relaxation. In each arm, the first session can be held face to face or over the phone and the last two sessions will be held over the phone. Patients have exercises to practice in between sessions.It is hypothesised that the experimental group will experience a greater increase in emotional skills than the control group.

sponsor_collaborators:
University Hospital, Lille
SCALab UMR CNRS 9193

intervention_type: Behavioral


title: Impact of Web Application Support Versus Standard Management on Compliance With Adjuvant Hormone Therapy at 18 Months in Patients Treated for Breast Cancer

acronym: WEBAPPAC

summary: The investigators hypothesize that the implementation of a Web-application in patients initiating adjuvant hormone therapy for breast cancer brings a benefit on treatment adherence and quality of life.

appel_a_projets: PREPS

region: Normandie

nom_etablissement: CRLCC FRANCOIS BACLESSE - CAEN

type_etablissement: CLCC

acronyme: WEBAPPAC

titre: Impact d'un accompagnement par webapplication versus prise en charge standard sur l'observance de l'hormonothérapie adjuvante à 18 mois chez les patientes traitées pour un cancer du sein.

discipline_principale: organisation des soins

nom_porteur: GERNIER

prenom_porteur: François


title: Idiopathic Purpura Fulminans Associated With Anti-PS Antibodies in Children: a French Multicenter Retrospective Study

summary: Idiopathic purpura fulminans by anti-protein S antibody is a very rare but potentially extremely serious entity. The data in the literature are poor with only isolated report boxes and a single series of less than 10 boxes. The creation of a larger series of cases would make it possible to better understand this pathology and to offer assistance in diagnosis and management.


title: A Protocol Investigating the Impact of Lungpacer PROTECT Diaphragm Pacing Therapy on Gas Exchange, Hemodynamics, Regional Lung Ventilation and Atelectasis in Patients Presenting With Moderate ARDS

acronym: PIRAT

summary: The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. The purpose of the PROTECT DPTS is to improve gas exchange, regional lung ventilation, and hemodynamics, and decrease atelectasis in patients presenting with acute respiratory distress syndrome (ARDS).

lead_sponsor: Lungpacer Medical Inc.


title: High Resolution Electroencephalography Exploration of Tactile Prediction Development

acronym: DECODE

summary: This project aims to measure repetition suppression and tactile prediction using high-resolution electroencephalography in preschoolers, in order to describe the responses as a function of age, gestational age of birth and the presence of a neurodevelopmental disorder. We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. We will perform several behavioral evaluations to analyze the results in view of the quality of development.

lead_sponsor: University Hospital, Caen


title: Creation of a Pleural Carcinomatosis Tissue Bank

acronym: TICP

summary:
Malignant pleural effusion is a common evolution of various cancers and is associated with poor prognosis and quality of life. About 28% of patients with primary malignancy will develop pleural metastasis. Malignant pleural effusion mostly occurs in lung, breast, ovarian and gastric cancers. Median survival ranges from 3 to 13 months according to primary malignancy. Currently, the therapeutic approach is mainly palliative with videothoracoscopic talc pleurodesis or indwelling pleural catheters insertion eventually associated with systemic chemotherapy if patient's general condition allows.

In a early-disseminated tumor cells profile, metastatic cells can accumulate alterations at a distant site and have a different profil from the original tumor cells. Metastatic cells can also accumulate alterations in the course if systemic treatments. Consequently, they may respond differently to drugs.

Recently, EGFR mutations and ALK status discordance between primary tumors and pleural metastases have been demonstrated in a significant portion of lung adenocarcinomas. These studies, realized on malignant pleural effusion isolated cells, enabled us to hypothesize a possible intratumoral heterogeneity within pleural metastases, but no study has been carried out on pleural tissue.

Our aim is to create a biocollection with tissues from pleural carcinomatosis in order to subsequently allow multiomics and bioinformatics analyzes and to characterize a possible intratumoral heterogeneity in pleural metastasis.

lead_sponsor: Hospices Civils de Lyon


title: Comparison of Three Care Strategies in Cases of New-onset Supraventricular Arrhythmia During Septic Shock : a Randomized Controlled Trial

acronym: CAFS

summary:
New-onset supraventricular arrhythmia (NOSVA) is reported in 40 % of patients with septic shock and is associated with hemodynamic alterations and mortality. The lack of consensus regarding best practices for the management of NOSVA in this setting has led to major variations in practice patterns. Observational studies reported three usual strategies: (i) heart rate control (hereafter rate control) with the use of antiarrhythmic drugs, essentially based on low dose of amiodarone, (ii) rhythm control with the use of antiarrhythmic drugs, essentially based on high dose of amiodarone, and electrical cardioversionand (iii) modifiable NOSVA risk factors control (hereafter risk control) without using antiarrhythmic drugs.

Risk control would minimize adverse events of antiarrhythmic drugs. Rhythm control would rapidly improve haemodynamics via restoring diastole and decreasing cardiac metabolic demand, while minimizing exposure to anticoagulation. Rate control, would limit potential adverse events of high dose of amiodarone and of electrical cardioversion (only in patients intubated on mechanical ventilation), while controlling haemodynamics. Therefore, it seems important to compare these three strategies.

Our hypothesis is dual: first, that rate control and rhythm control each improve hemodynamics with in fine a decreased mortality, as compared to a risk control; second, that rhythm control outperforms rate control in this setting.

This is a multicenter, parallel-group, open-label, randomized controlled superiority trial to compare the effectiveness and safety of these three strategies (risk control, rate control and rhythm control) for NOSVA during septic shock.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Médecine Intensive Réanimation-Hôpital Tenon


title: Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

acronym: NAT-URE

summary: Hyponatremia is defined as a plasma sodium concentration below 135 mmol / L. This is a common occurrence (20-50%) during subarachnoid hemorrhage (SAH). Its appearance is often associated with vasospasm. It is associated with an increase in morbidity and mortality linked to induced neurological disorders. Hyponatremia is caused by two etiologies: the syndrome of inappropriate secretion of anti-diuretic hormone (SIADH), and the cerebral salt wasting syndrome, CSWS. Theoretically, these two entities are differentiated by the patient's volemia; in practice, this parameter is difficult to measure. In addition, the correction of hyponatremia is diametrically opposed according to its mechanism: water restriction in the case of SIADH, sodium intake in the event of CSWS. Urea is offered as a second-line treatment in the event of treatment failure to correct hyponatremia. However, the efficacy of this treatment is based on small, observational, retrospective studies. Moreover, the mechanism of action of urea remains poorly understood: it could be a hyperosmolar effect or passive renal reabsorption of sodium.

ReferenceCitation: Hall A, O'Kane R. The Extracranial Consequences of Subarachnoid Hemorrhage. World Neurosurg. 2018 Jan;109:381-392. doi: 10.1016/j.wneu.2017.10.016. Epub 2017 Oct 16.

ReferenceCitation: Mapa B, Taylor BE, Appelboom G, Bruce EM, Claassen J, Connolly ES Jr. Impact of Hyponatremia on Morbidity, Mortality, and Complications After Aneurysmal Subarachnoid Hemorrhage: A Systematic Review. World Neurosurg. 2016 Jan;85:305-14. doi: 10.1016/j.wneu.2015.08.054. Epub 2015 Sep 7.

ReferenceCitation: Hannon MJ, Behan LA, O'Brien MM, Tormey W, Ball SG, Javadpour M, Sherlock M, Thompson CJ. Hyponatremia following mild/moderate subarachnoid hemorrhage is due to SIAD and glucocorticoid deficiency and not cerebral salt wasting. J Clin Endocrinol Metab. 2014 Jan;99(1):291-8. doi: 10.1210/jc.2013-3032. Epub 2013 Dec 20. Erratum In: J Clin Endocrinol Metab. 2014 Mar;99(3):1096. Javadpur, M [corrected to Javadpour, M].

ReferenceCitation: Nakajima H, Okada H, Hirose K, Murakami T, Shiotsu Y, Kadono M, Inoue M, Hasegawa G. Cerebral Salt-wasting Syndrome and Inappropriate Antidiuretic Hormone Syndrome after Subarachnoid Hemorrhaging. Intern Med. 2017;56(6):677-680. doi: 10.2169/internalmedicine.56.6843. Epub 2017 Mar 17.

ReferenceCitation: Hoorn EJ, Zietse R. Diagnosis and Treatment of Hyponatremia: Compilation of the Guidelines. J Am Soc Nephrol. 2017 May;28(5):1340-1349. doi: 10.1681/ASN.2016101139. Epub 2017 Feb 7.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities

summary: To evaluate the reliability of different non-invasive skin probe measurements.

time_perspective: Cross-Sectional

ipd_sharing_description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

lead_sponsor: Allergan


title: Comparative Study of the PRAEVAorta Device in Patients With an Abdominal Aortic Aneurysm (AAA) : Percentage of Adequacy to the Gold Standard

summary:
Nurea wants to set-up a pivotal phase clinical study for its software PRAEVAorta, a decision-making support for diagnosis and follow-up of abdominal aorta aneurysm. This study is a comparative study. Its purpose is to demonstrate the adequacy of PRAEVAorta to the current Gold Standard in the care of patients with abdominal aortic aneurysm. The currently benchmark methods are the maximal diameter method (Hand-held measurement of maximum diameter on scan images) and the segmentation method for the aneurysm volume (manual segmentation of scan images, then calculation of the AAA volume by counting the pixels).

The hypothesis is that 90% of the segmented patients have a volume ratio and a diameter ration equal to or greater than 90%.

status: Withdrawn

ReferenceCitation: Schnitzbauer M, Guntner O, Wohlgemuth WA, Zeman F, Haimerl M, Stroszczynski C, Muller-Wille R. CT after Endovascular Repair of Abdominal Aortic Aneurysms: Diagnostic Accuracy of Diameter Measurements for the Detection of Aneurysm Sac Enlargement. J Vasc Interv Radiol. 2018 Feb;29(2):178-187.e3. doi: 10.1016/j.jvir.2017.09.012. Epub 2017 Dec 6.

ReferenceCitation: Kauffmann C, Tang A, Therasse E, Giroux MF, Elkouri S, Melanson P, Melanson B, Oliva VL, Soulez G. Measurements and detection of abdominal aortic aneurysm growth: Accuracy and reproducibility of a segmentation software. Eur J Radiol. 2012 Aug;81(8):1688-94. doi: 10.1016/j.ejrad.2011.04.044. Epub 2011 May 20.

ReferenceCitation: Lareyre F, Adam C, Carrier M, Dommerc C, Mialhe C, Raffort J. A fully automated pipeline for mining abdominal aortic aneurysm using image segmentation. Sci Rep. 2019 Sep 24;9(1):13750. doi: 10.1038/s41598-019-50251-8.

lead_sponsor: Nurea

location_facility: Hopital Universitaire Pellegrin Bordeaux


title: MESSAge Study : Ultrasound Measurement of Sarcopenia in the Elder Subject

acronym: MESSAGE

summary:
Sarcopenia is a generalized, progressive and multifactorial muscle impairment, causing multiple pathologies and their consequences such as falls, fractures, dependence, worsening of cognitive disorders and death. Interventions to combat the progression of sarcopenia should be introduced as soon as clinically suspected, based on functional tests to measure muscle strength. Diagnostic confirmation of sarcopenia can be done using several validated methods of estimating muscle mass: magnetic resonance imaging (MRI), computed tomography (CT), biphotonic absorptiometry (DEXA) or bio-impedanceometry. Their availability in clinical routine remains limited due to their high costs and/or lack of accessibility depending on the place of practice. On the other hand, there are certain pitfalls for carrying out these various examinations, in connection with several common clinical problems in the study population: mobility disorders and neurodegenerative disorders disabling for transport and access to the examination table for imaging examinations, hydration disorders distorting measures for bio-impedancetry.

Previous studies suggest that ultrasound may be as effective a tool as previous methods for diagnostic confirmation of sarcopenia. Because of its non-invasive and non-irradiating nature, its affordability, its short duration of realization, its availability and its low constraints of realization, the ultrasound could help to remove some of the current limits to the diagnostic confirmation of sarcopenia.

The investigators hypothesis is that ultrasound can be used to implement a simple and reliable protocol for assessing sarcopenia in the elderly. It could also be used to detect sarcopenia at an early stage ("presarcopenia") while the decrease in muscle mass is not yet accompanied by a decrease in skeletal muscle strength.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Bacterial Infections in People Who Inject Psychoactive Substances

summary: Bacterial infections in people who inject psychoactive substances

lead_sponsor: University Hospital, Montpellier


title: PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

acronym: PLATELETSTREAM

summary:
Platelets are essential blood elements to maintain hemostasis. Quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia [HIT]) troubles. Diagnosis of these pathologies is sometimes urgent and consists in delicate platelet functional assays that are mostly made in expert centers. These platelets functional assays measure platelets activation and/or aggregation in response to diverse inductors and may lack sensitivity. The investigators would like to propose a new diagnostic tool with the use of imaging flow cytometry which provides much more information than classic cytometer on cell morphology thanks to images collected by the optical channel of the ImageStream cytometer. The use of this cytometer offers an innovative approach.

This study is a monocentric prospective and non-interventional study. The investigators will analyze patient samples with the ImageStream cytometer and reference laboratory tests (light transmission aggregometry and serotonin release assay) in parallel and compare results from the different techniques. This new diagnostic technique will demonstrate a non-inferiority diagnosis compared to reference tests and maybe a better sensibility.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Interest of Coronary CT Scan Before Complex Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI).

acronym: CTS-C-CTOPCI

summary: The chronic total occlusion of a coronary artery is the most frequent cardiac disease in the developped countries. The percutaneous coronary intervention is one of the existing treatments. This procedure is long, expensive and uses a lot of contrast medium and X ray. With this study, the investigators want to adress the impact of CT scan performed before the surgical procedure. A better knowledge of the patient's anatomy could lead to a better success rate of the operation, with a lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.

ReferenceCitation: Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987 Jul;76(1):142-54. doi: 10.1161/01.cir.76.1.142.

ReferenceCitation: Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.

ReferenceCitation: Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv. 2011 Feb;4(2):213-21. doi: 10.1016/j.jcin.2010.09.024.

ReferenceCitation: Rolf A, Werner GS, Schuhback A, Rixe J, Mollmann H, Nef HM, Gundermann C, Liebetrau C, Krombach GA, Hamm CW, Achenbach S. Preprocedural coronary CT angiography significantly improves success rates of PCI for chronic total occlusion. Int J Cardiovasc Imaging. 2013 Dec;29(8):1819-27. doi: 10.1007/s10554-013-0258-y. Epub 2013 Jun 23.

ReferenceCitation: Yu CW, Lee HJ, Suh J, Lee NH, Park SM, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee SH, Choe YH, Kim SM, Choi JH. Coronary Computed Tomography Angiography Predicts Guidewire Crossing and Success of Percutaneous Intervention for Chronic Total Occlusion: Korean Multicenter CTO CT Registry Score as a Tool for Assessing Difficulty in Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Imaging. 2017 Apr;10(4):e005800. doi: 10.1161/CIRCIMAGING.116.005800.

ReferenceCitation: Singh S, Singh N, Gulati GS, Ramakrishnan S, Kumar G, Sharma S, Bahl VK. Dual-Source Computed Tomography for Chronic Total Occlusion of Coronary Arteries. Catheter Cardiovasc Interv. 2016 Oct;88(4):E117-E125. doi: 10.1002/ccd.25516. Epub 2014 May 27.

ReferenceCitation: Ghoshhajra BB, Takx RAP, Stone LL, Girard EE, Brilakis ES, Lombardi WL, Yeh RW, Jaffer FA. Real-time fusion of coronary CT angiography with x-ray fluoroscopy during chronic total occlusion PCI. Eur Radiol. 2017 Jun;27(6):2464-2473. doi: 10.1007/s00330-016-4599-5. Epub 2016 Sep 23.

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title: Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation

acronym: USOP

summary:
Operational conditions amplify soldier's constraints and stress factors, upsetting individual and collective adaptive landmarks. The soldier's resistance is strained by the high intensity of stressors, by the long duration of exposure and by their cumulative effect.

This may lead to a state of "operational strain" that refers to chronic stress and the allostatic load imposed by operational constraint.

The investigators believe that operational strain could manifest itself by a kind of accelerated aging of the organism due to the increased allostatic load without sufficient resource restoration (neurotransmitter precursors, partial and repeated sleep deprivation, etc.).

This aging mechanism would be reversible after a sufficient period of resource restoration (sleep, physical activity, adapted diet, etc.).

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Prevalence Of COVID-19 Among Health-workers in a French General Hospital

acronym: POCAH-COVID

summary: The aim of this study is to evaluate the prevalence of COVID-19 among the workers of our hospital and the factors that are likely to influence this prevalence. It must be underlined that our hospital is settled in two towns and both hospital sites had different missions regarding the admissions of COVID-19-infected patients.

lead_sponsor: Centre Hospitalier Sud Essonne


title: Markers of Executive Attention Development in Preschoolers

acronym: MEDiATE

summary: This project aims to identify precursors of executive attention that can serve as early markers of ADD.


title: Simplification de l'évaluation de l'Activité PHysique Par Interrogatoire Rapide

acronym: SAPHIR

summary: The purpose of this study is to test and validate a new questionnaire (SAPHIR) in order to get an evaluation of patients physical activity.


title: Impact of the Training of Nursing Staff on the Practice of Manual Expression of Early Colostrum in Neonatal Medicine

acronym: ORLIKID

summary:
Colostrum is an irreplaceable nutrient rich in protein and antibodies. Its taste and smell are similar to those of amniotic fluid (therefore rich for the senses of the baby separated from his mother). It should be offered to every newborn baby, regardless of term and the type of breastfeeding their mom wants. The early expression of colostrum, within the first 2 hours after childbirth, is an essential way to start lactation of a mother separated from her baby. The sooner and more often the mother stimulates her breasts, the more milk she will have for her baby in the weeks to come. Manual expression of milk is therefore an essential gesture to initiate lactation, maintain it, and giving colostrum to babies as early as possible is beneficial. Two studies carried out in the neonatal medicine department of Felix Guyon Hospital in premature infants <33 week of amenorrhea (PRE'OLACT study in 2015-2016 by Dr RAJAOFERA and Diploma from university (DU) breastfeeding brief in 2018-2019 by Dr GRONDARD) found the same results: the desire for breastfeeding is 80% but manual expression of colostrum before H24 is only achieved by 30% of mothers and before H6 in only 6% of cases.

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lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Assessment of Emotional Memory During Transient Global Amnesia

acronym: EMOTICTUS

summary: There are few studies on the role played by emotions in transient global amnesia (TGA), in particular with regard to their impact on the functioning of memory. The study investigators wish to better understand the link between episodic memory, emotional state and psychogenic factors during TGA. It would be interesting to see if the patients suffering from TGA triggered by a psychological shock process emotional information differently from those whose TGA was triggered by an "organic" shock (physical effort, trauma, etc.). Finally, amnesic stroke is a good model for better understanding the function of the hippocampus, in particular of the CA1 region, in episodic memory.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI

acronym: HOMACHI

summary: The study aims (i) to identify which substances leading to hospitalizations at Mayotte are also called "chimique" and (ii) to correlate these substances with clinical pictures in order to favor a better approach of the treatments.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
ARS (Agence Régionale de Santé) Mayotte


title: Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis

acronym: HypnoArt

summary: The purpose of this study is to determine whether hypnosis intervention added to usual care is more effective than usual care alone to control pain during lavage procedure in patients with knee osteoarthrosis

location_facility: Cochin Hospital - Rheumatology department


title: Somesthesic Role of the Ventro-lateral Prefrontal Cortex in Speech Motor Learning fMRI Study

summary: These studies test the hypothesis that frontal areas of the brain participate in the cortical networks involved in the somotosensory processing that happens during speech motor learning.

sponsor_collaborators: Laboratoire de Psychologie et NeuroCognition


title: Visio-consultation Compared to Face-to-face Consultation During the Follow-up of Apneic Patients Treated by Continuous Positive Airway Pressure (CPAP)

acronym: VISIOSAS

summary: Prospective multicenter open-label randomized clinical trial comparing videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .

primary_purpose: Health Services Research

sponsor_collaborators:
University Hospital, Grenoble
University Hospital, Angers


type: EudraCT Number

title: Monocentric Phase 1 Study With Escalation of Doses of Tocilizumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients With Acute Myeloblastic Leukemia (AML) With Poor Prognosis: TOCILAM"

acronym: Tocilam

summary: This is a phase 1 dose escalation study testing the addition of an anti-IL6 (tocilizumab) to standard induction chemotherapy for high-risk AML.

lead_sponsor: Nantes University Hospital


title: Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients

acronym: NSpectroCovid

summary:
Viral pandemics, such as HIV and SARS-Cov-V1, have shown that they can lead to acute and / or delayed neurological complications. At the actual context of the pandemic Coronavirus disease 2019 (COVID-19), neurological manifestations seem to be confirmed since in 85% of COVID-19 patients, present neurological symptoms, including anosmia, ageusia, periorbital pain, dizziness, fatigue, even moderate headache, moderate memory and/or behavioral disorders.

However, these neurological manifestations are not well studied and their radiological features are not well described. It is therefore important to assess these potential neurological complications in COVID-19 patients. To the investigator knowledge, there is no previous study in the literature describing spectral brain changes in COVID + patients. Thus, the goal of this work is to describe the radiological semiology using MRI and particularly Magnetic Resonance Spectroscopic (MRS) biomarkers in the evaluation of acute and / or delayed brain damage in COVID + patients presenting a neurological manifestations that are initially related to the cranial nerves damage.


title: Cardiopulmonary Fitness in Children With Asthma Versus Healthy Children : VO2 Asthma

summary:
Asthma is the most common chronic disease in children worldwide. Asthma is characterised by a chronic inflammatory disorder of the airways,episodes of wheezing, breathlessness, chest tightness and coughing. There is a large variability of asthma prevalence between countries from 11 to 15% for children in developed countries.

Asthma may limit the patient's ability to be physically active and can lead to a sedentary lifestyle and affect patients' quality of life. Indeed, long-term goal of asthma management as any chronic disease is to control symptoms in order to ensure a normal quality of life to children with asthma In 1980, the World Health Organization stated that functional capacity explorations best reflect the impact of a chronic disease on the quality of life. Indeed, cardiopulmonary exercise test (CPET) has become the "gold standard" in functional evaluation of cardiorespiratory diseases in adults gradually extended to children. Physical fitness is evaluated by maximal oxygen uptake "VO2 max" during a CPET. CPET also allows to determine possible limiting factors (cardiac limitation, ventilatory limitation, muscular deconditioning) responsible for a lower VO2max.

There is actually contradictory evidence regarding the aerobic fitness levels of asthmatic children and it remains unclear whether significant differences exist between asthmatic children and their non-asthmatic counterparts. Few studies suggest ventilatory exercise limitations linked to the severity of bronchial obstruction whether others put in light the impact of muscular deconditioning in the asthmatic population.

In this context, the investigators aimed to compare the cardiopulmonary fitness of children with asthma with that of age-adjusted and gender-adjusted controls. The investigators also intended to identify clinical characteristics associated with VO2max in this population.


title: Comparative Study of the Histomolecular, Radiological and Prognostic Profiles Between Brain Gliomas of Children (0-14 Years) and Adolescents/Young Adults (15-25 Years) Treated in the Amiens University Hospital Between 2008 and 2020

acronym: BioMol GLIOMA

summary:
In the last decades, many advances have been made in the field of genetic abnormalities of glial and glioneuronal brain tumors. In the 2016 World Health organization (WHO) Classification of Tumors of the Central Nervous System, the concept of "integrated" diagnosis emerged: histological and genetic/molecular features now define many entities. Since 2016, six updates have been published by the c-IMPACT-NOW (the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy- Not Official WHO) to develop and clarify the "integrated" diagnosis. In the future WHO 2021 Classification of Tumors of the Central Nervous System, "integrated" diagnoses will take up even more importance. Even if they can have similar histological features, gliomas of children are very different from the "adult" gliomas in the molecular mechanism of oncogenesis. The histomolecular features of adolescents/young adults (AYAs) can have similarities with "pediatric-type" or "adult-type" gliomas, but few studies have focused specifically on the histomolecular profiles of gliomas in AYAs.

The investigators would like to study the cohort of patients treated for a glial and glioneuronal tumor diagnosed under the age of 25 in the Amiens University Hospital between 2008 and 2020. The investigators would like to compare the histomolecular profiles of gliomas in children (0-14 years) and AYAs (15-25 years).


title: Are Standard Dosing Regimens of Piperacillin-Tazobactam Suitable in Critically Ill Patients With Open Abdomen and Negative Pressure Wound Therapy? A Population Pharmacokinetic Study.

acronym: PK-LAP

summary:
For several years, open abdomen with temporary abdominal closure using Negative Pressure Therapy (OA/NPT) has become one of the leading strategies to treat or prevent intra-abdominal hypertension in critically ill surgical patients after a wide range of complex abdominal injuries and conditions.

According to current practice, piperacillin-tazobactam (PTZ) is widely used as part of empirical combined antibiotic therapy to treat severe abdominal infections in the critically ill patients. On the other hand, little is known about the impact of OA/NPT on antibiotics pharmacokinetics and pharmacodynamics (PK/PD) and the optimal dosing regimens in this population remain unclear.

As PTZ is a small hydrophilic molecule with a very low level of protein binding, invesitigators hypothesized that OA/NPT should lead to significant changes in volume of distribution (Vd) and/or drug clearance (CL

The main objective of this study was to assess the incidence of underdosing and the pharmacokinetics of piperacillin in critically ill patients with OA/NPT.

The secondary objective was to assess the appropriateness of recommended regimens for empirical minimum inhibitory concentration (MIC) coverage.


title: Pilot Study to Evaluate the Effectiveness of a Mixture of Ketamine / Lidocaine Administered by Mesotherapy in the Management of Neuropathic Pain in Complex Regional Pain Syndrome Type 1 (CRPS1). A Monocentric Randomized and Controlled Clinical Study

acronym: MESO-SDRC

summary:
Complex Regional Pain Syndrome type 1 (CRPS1) is a disabling pain syndrome. Its definitive treatment has not been established and the results of current treatments are often unsatisfactory.

The prognosis is difficult to establish because the vast majority of CRPS regresses within a few weeks. However, some forms are hyperalgesic with a major chronic painful picture, very debilitating and responding poorly to treatments with possible permanent sequelae.

The management of CRPS remains difficult and unsatisfactory and is symptomatic, multidimensional and multidisciplinary involving medical, paramedical and socio-professional workers. The priority therapeutic objectives are analgesia, maintenance or gain of joint range and maintenance or restoration of motor functions. This treatment is not the subject of a consensus and its implementation is sometimes the responsibility of specialized centers such as "pain relief" centers or even Physical Medicine and Rehabilitation (MPR) structures.

Previous studies using ketamine as a treatment for CRPS1 show encouraging results with a decrease in neuropathic pain. Ketamine is a low dose pain reliever. Ketamine has been studied as an adjuvant for the treatment of chronic pain, particularly neuropathic pain. The results suggest that ketamine decreases pain intensity and reduces opioid reliance when used as an adjunct to chronic and acute pain. Ketamine is believed to have a greater analgesic effect in patients with CRPS1 compared to other chronic pain syndromes. In these studies, ketamine was used intravenously, subcutaneously, orally, intranasally, or topically.

Mesotherapy allows microdose local treatment to be carried out limiting side effects, ensuring compliance and easy to implement. The injected solutions often contain a local anesthetic (procaine or lidocaine). It allows better local tolerance from the start of treatment. In addition, through its vasodilator effect on the microcirculation, it increases the effectiveness and tolerance of other injected products.

There are no studies using ketamine administrated by mesotherapy. Based on the scientific literature, there are good reasons to believe that this treatment could be effective on the neuropathic pain of CRPS1 and well tolerated.

location_facility: Department of orthopedic surgery and trauma emergencies of the lower limb, Edouard Herriot Hospital, Hospices Civils de Lyon


title: Predicting Value of DWI Total Posterior-circulation Infarct Volume for Endovascular Treatment Outcomes of Acute Basilar Artery Occlusion

acronym: TPCIV-ABAO

summary: Preprocedural predictors of outcome in patients with acute basilar artery occlusion (ABAO) who underwent endovascular treatment (EVT) remain controversial. The Investigators aimed to analyse, in patients with ABAO treated by EVT, if pre-EVT DWI total posterior-circulation infarct volume (TPIV) was a predictor of 90-days outcomes


title: Physical Activity in Children With Inherited Cardiac Diseases : a Qualitative

summary:
Use lay language.

Current guidelines regarding physical activity in patients with inherited arrhythmia and cardiomyopathy are mostly dedicated to adult patients, with a special focus on sports competition. Their application to the pediatric population has been scarcely evaluated.

Physical activity is well known for its health benefits but may be dangerous in this population, which leads to confusion within the medical community and among patients. Actual physical activity of children with such inherited cardiac disorders is unknown.

This study aimed to assess the level of physical activity in children with inherited arrhythmia and cardiomyopathy, and the adherence to the current European guidelines on the subject. Secondary objectives aimed to assess through a qualitative analysis the impact of the disease on physical activity and daily life in this population.

The level of physical activity and adherence to current guidelines will be determined from interviews between the patient and the principal investigator. Each patient will be questioned in order to explore the experiences, motivations and feelings of participants regarding physical activity. The standardized questionnaire was created by the principal investigator and members of the clinical research team.

The investigators believe that many children practice physical activity outside the current guidelines and hope to identify the main determinants of physical activity in this population.

ReferenceCitation: Boisson A, De La Villeon G, Huguet H, Abassi H, Pasquie JL, Lavastre K, Matecki S, Guillaumont S, Requirand A, Calderon J, Amedro P. Physical activity and aerobic fitness in children with inherited cardiac diseases. Arch Cardiovasc Dis. 2021 Nov;114(11):727-736. doi: 10.1016/j.acvd.2021.07.004. Epub 2021 Oct 27.

collaborators: Paediatric Cardiology and Rehabilitation Unit, St-Pierre Institute


title: Prospective Randomized Comparison of Efficacy and Safety of Ultrasound-guided Axillary Vein Access Versus Cephalic Venous Cutdown for Implantation of Cardiac Electronic Devices

summary:
Venous access is a fundamental step in lead insertion for endovenous cardiac implantable electronic devices (CIED). Cephalic vein cutdown is the most widely used technique in Europe. Ultrasound-guided axillary vein access is a promising alternative but there is a lack of clinical evidence supporting this technique.

The purpose of this study is to compare the efficacy and safety of ultrasound-guided axillary vein access versus cephalic venous cutdown for implantation of endovenous CIED.

Half of patients is implanted using an ultrasound-guided axillary vein puncture. The other half is implanted using a cephalic vein cutdown. After venous access is achieved, implantation procedure is identical in the two arms.

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


title: Integrated Parkinson Care Networks: Addressing Complex Care in Parkinson Disease in Contemporary Society

acronym: ICARE-PD

summary: The researchers wish to determine what are patients/care partners priorities in terms of care delivery based at home/community and define the envisioning care delivery model that support both social care and medical care from the perspective of people living with Parkinson.

lead_sponsor: University Hospital, Toulouse


title: Post-traumatic Stress Disorder Occurrence in Parents of Neonate and Children Hospitalized in an Intensive Care Unit

acronym: POETIC

summary:
The elements that promote the development of post-traumatic stress in parents following hospitalization in pediatric resuscitation and thus the options for improving initial care at the time of hospitalization are unknown.

It is therefore important to describe the prevalence of post-traumatic stress disorder with current pediatric resuscitation management data, but also to possibly describe the factors associated with it in order to optimize initial management.


title: VIsual Cerebral ConnecTivity On Functional Magnetic Resonance Imaging in Patients With Hereditary REtinal Dystrophies

acronym: VICTOIRE

summary: The Rothschild Foundation A Hospital follows a cohort of approximately 300 patients with hereditary retinal dystrophy. These patients are followed in ophthalmology consultation every year. In order to plan the MRI on the day of the annual consultation and to avoid additional travel for patients, patients will be informed of the study before the consultation (transmission of an information letter and the information note from study). If patients agree to participate in the study, rMRI will be scheduled. During the follow-up ophthalmologic consultation, after checking the inclusion and non-inclusion criteria, the study information will be repeated, and patients who still agree to participate will sign the study consent.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Performance of Static and Dynamic Accessment of Inferior Vena Cava Diameter for the Diagnosis of Fluid Responsiveness

acronym: THEFRACS

summary:
Fluid expansion in critically ill patients following high risk surgery may induce fluid overload and worse outcome. Several tools have been developped to predict fluid responsiveness in such situation in order to avoid inappropriate fluid administration but with several limitations. Inferior vena cava (IVC) distensibility is one of those tools which has the advantage to be non-invasive, dynamic and safe, is usually measured by subcostal (SC)approach. In post surgical setting this acess is limited du to practical reasons (scar, dressing...), therefore a transhepatic (TH) approach is used but has not been validated as a fluid responsiveness prediction tool. The correlation between SC approach with the TH approach vary according to studies. Therefore the performances, the threshold identified for SC approach can not be translated to the TH approach. Further, fluid congestion status measured before IVC analyses, may be a useful confounder and safety endpoint for fluid responsiveness interpretation.

The primary objective of this study is therefore to study the performance of the IVC measured using TH approach (IVCth) in predicting of fluid responsiveness defined as an increased of 10% and over of stroke volume.

Secondary objectives intend to analyse the correlation between TH and SC approaches, to compared their performances for fluid responsiveness prediction, and to analyse the weight of venous congestion on fluid responsiveness prediction.

lead_sponsor: University Hospital, Lille

location_facility: Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille


title: Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells

acronym: QOLD CAR-T

summary:
CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials.

The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies.

This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique


title: Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention

acronym: AblaJ

summary: The value of cytobacteriological examination of urine (CBEU) before double J catheter removal has not been demonstrated. The aim of this study is to define the interest of this CBEU.

lead_sponsor: University Hospital, Tours

appel_a_projets: PHRCN

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: AblaJ

titre: Intérêt de l'examen cytobactériologique des urines réalisé avant l'ablation d'une sonde double J pour la prévention des infections urinaires post-opératoires: essai randomisé de non infériorité

discipline_principale: urologie

nom_porteur: BRUYERE

prenom_porteur: Franck


title: Evaluation of the Efficacy and Safety of Three Injectable Hyaluronic Acid-based Fillers: Art Filler® Fine Lines, Art Filler® Universal and Art Filler® Lips

summary:
The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume and the aging process. These fillers (also known as soft tissue augmentation medical devices) can correct the skin depressions/wrinkles, balance the disproportions or correct topographical anomalies.

In this context, it is proposed to carry out in post-CE marking, an open, prospective and non-comparative study in order to document an adequate aesthetic correction of the most frequent areas treated with Art Filler Fine Lines, Art Filler Universal and Art Filler Lips as well as their immediate and long-term tolerance.

lead_sponsor: Laboratoires FILLMED


title: Investigation of Social Cognition and Executive Functions as Cognitive Vulnerability Markers for the Development and Maintenance of Alcohol Use Disorders - a Transverse Study Design

acronym: COSEFEX-T

summary:
Over the past few years, researchers and clinicians have stressed the major role of executive and social cognition impairments in the development and the maintenance of Alcohol Use Disorders (AUD).

Executive functions are defined as functions for behavioral control that help us to adjust the investigator's behavior in a flexible way in non-familiar, non-routine situations. Executive functions encompass different cognitive processes, such as inhibition, mental flexibility, updating, planification, abstraction, rule deduction or organization. Studies comparing AUD patients to healthy controls have shown that AUD usually is associated with a large range of deficits. More recently studies have also emphasized a weakness of executive functioning among healthy participants with a positive family history of AUD.

Social cognition refers to all cognitive processes that enable us to communicate and to interact with social environment in an appropriate manner. Among the most common social cognition sub-components are theory of mind (defined as the capacity to understand other people's mental states as for instance beliefs and desires), empathy, and emotion recognition. Emotional and interpersonal difficulties have a high prevalence in AUD and chronic alcohol consumption is often linked to social conflicts, misunderstandings, a lack of social support and isolation. Indeed, AUD patients have difficulties in understanding their own mental states and emotions as well as those of their social environment.

Few studies have investigated the interdependency between these cognitive impairments in AUD while a better understanding of the link between executive functions and social cognition seems crucial in order to better characterize the nature of AUD patients' deficits and thus their caring.

lead_sponsor: CHU de Reims