title: Measurement of the Plasmatic TFPI Level in Haemophilia Patients and Correlation With Thrombin Generation Assay (TGA) Parameters

summary:
The goal of this study is to measure the TFPI plasma level, a molecule involved in the regulation of the coagulation system, in haemophilia patients. The second objective is to assess the effects of TFPI inhibition on thrombin generation. Indeed, there is sparse data on the physiological and pathological changes of TFPI levels in human and particularly in hemophilia patients. Yet, TFPI inhibitors may become one of the new by-passing treatments of haemophilia. Until now, published data mainly reports in vitro pharmacodynamics and pharmacokinetics of TFPI inhibitors. Hence, in vivo effects of TFPI inhibition remain unclear, especially in haemophilia patients.

The clinical development of such molecules requires a dedicated biological monitoring. Thrombin Generation Assay (TGA) in Poor Platelets Plasma (PPP) is a good candidate since it is sensitive to Factor VIII and Factor IX deficiencies as well as to TFPI. However, TGA results are very dependent on experimental conditions (i. e. Tissue Factor and phospholipids concentrations) and the relationship between TFPI plasma level and TGA parameters has not been studied yet. This study should provide with original data on TFPI plasma levels and the effect of TFPI on thrombin generation in haemophilia patients. This should help to define the monitoring of TFPI inhibitors in Haemophilia.


title: Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study"

acronym: NELI

summary:
This study includes 30 patients with Meniere's disease confirmed with AAO-HNS criteria.

The aim of this study is to compare the new optimized 3D FLAIR sequence developed at our site with a standard 3D FLAIR sequence performed 4h after a single intravenous dose of macrocyclic gadolinium-based contrast agents for the detection of endolymphatic hydrops.

The patients will be explored with the new 3D FLAIR optimized sequence before injection (method to validate) and again 4 hours after contrast media administration with the same sequence 3D FLAIR

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Impact of the Implementation of a qSOFA Score on the Care of Adult Patients Referred to the Emergency Department for Suspected Infection

summary: The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score <2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Procedure


title: Evaluation of Biological Response to SARS-COV2 in Patients With Pre-existing Neurological Disease or With New Neurological Manifestations of COVID-19

summary: Patients with neurological or psychiatric symptoms or pre-existing disease will be sampled (blood for serum and DNA or saliva for DNA) at inclusion and at M6 (blood) and M12 (blood) depending on their pathology. Sampling will be done either at hospital if patient is on site for routine care or at home if no consultation is scheduled at hospital.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Louapre C, Ibrahim M, Maillart E, Abdi B, Papeix C, Stankoff B, Dubessy AL, Bensa-Koscher C, Créange A, Chamekh Z, Lubetzki C, Marcelin AG, Corvol JC, Pourcher V; COVISEP and Bio-coco-neuroscience study group. Anti-CD20 therapies decrease humoral immune response to SARS-CoV-2 in patients with multiple sclerosis or neuromyelitis optica spectrum disorders. J Neurol Neurosurg Psychiatry. 2021 Aug 2. pii: jnnp-2021-326904. doi: 10.1136/jnnp-2021-326904. [Epub ahead of print]

family: Louapre

full_name: Céline Louapre

given: Céline

sequence: first

family: Ibrahim

full_name: Michella Ibrahim

given: Michella

sequence: additional

family: Maillart

full_name: Elisabeth Maillart

given: Elisabeth

family: Abdi

full_name: Basma Abdi

given: Basma

family: Papeix

full_name: Caroline Papeix

given: Caroline

family: Stankoff

full_name: Bruno Stankoff

given: Bruno

family: Dubessy

full_name: Anne-Laure Dubessy

given: Anne-Laure

family: Bensa-Koscher

full_name: Caroline Bensa-Koscher

family: Créange

full_name: Alain Créange

given: Alain

family: Chamekh

full_name: Zina Chamekh

given: Zina

family: Lubetzki

full_name: Catherine Lubetzki

given: Catherine

family: Marcelin

full_name: Anne-Geneviève Marcelin

given: Anne-Geneviève

family: Corvol

full_name: Jean-Christophe Corvol

given: Jean-Christophe

family: Pourcher

full_name: Valérie Pourcher

given: Valérie

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Impact of Moderate to Severe Pain in the Post-intervention Monitoring Room After Hemorrhoidectomy on the Length of Stay in the Outpatient Surgery Unit

summary:
The target rate for outpatient surgery has been set by the Ministry of Health at 70% for 2020. To achieve this objective, this requires increasing the panel of eligible outpatient procedures to more mutilating surgeries and usually performed in conventional hospitalization. This switch from conventional hospitalization to an outpatient stay increases the risk of converting stays into unscheduled hospitalization. Postoperative pain is one of the main factors in converting outpatient stays. Poor control is associated with increased length of stay, and unscheduled consultations and readmissions. In addition, the increased time spent with severe pain during the first 24 hours postoperatively is a risk factor for chronicization.

Proctology, and, in particular, hemorrhoidal surgery is the perfect example. Outpatient management of open pedicle hemorrhoidectomy is increasing year by year, but the rate of conversion to unscheduled hospitalizations remains high. Urine retention, postoperative hemorrhage and poor pain control are the main causes. Within the Paris Saint Joseph Hospital Group, hemorrhoidal surgery has the highest rate of conversions from hospitalization to proctology (8% in 2019), despite the implementation since 2015 of a dedicated, developed according to the current recommendations of the SNFCP.

The pain after hemorrhoidal surgery is always severe in the absence of analgesics and appears upon arrival in the post-interventional monitoring room (SSPI). Despite the administration of analgesics or the implementation of locoregional analgesia techniques (pudendal block), moderate to severe pain is frequently observed in the post-intervention monitoring room. In the medical literature, there is little data evaluating the means of management of postoperative pain in this surgery, and even less the effect of the different associations.

Retrospectively and, from the data collected in our information systems, we wish to assess the impact on the length of stay of the presence of moderate to severe pain in the IPSS after a two-way or tri-pedicle hemorrhoidal surgery open on our cohort of patients operated in outpatient surgery. Our hypothesis is that the presence of moderate to severe pain in PPSS increases the total length of stay, placing the patient at an increased risk of conversion. The purpose of our study is also to identify predictive factors (aggravating or protective) of the onset of moderate to severe pain immediately after surgery, in order to establish a strategy to limit its frequency.

status: Active, not recruiting

study_type: Observational

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030.

journal_name: Anesthesiology

oa_host_type: publisher

license: cc-by

license_normalized: cc-by

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Practice Guidelines for Acute Pain Management in the Perioperative Setting

ReferenceCitation: Vinson Bonnet B, Juguet F; French National Coloproctology Society. Ambulatory proctologic surgery: Recommendations of the French National Coloproctology Society (SNFCP). J Visc Surg. 2015 Dec;152(6):369-72. doi: 10.1016/j.jviscsurg.2015.10.001. Epub 2015 Nov 5.

family: Vinson Bonnet

full_name: B. Vinson Bonnet

given: B.

family: Juguet

full_name: F. Juguet

given: F.

journal_name: Journal of Visceral Surgery

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Joshi GP, Neugebauer EA; PROSPECT Collaboration. Evidence-based management of pain after haemorrhoidectomy surgery. Br J Surg. 2010 Aug;97(8):1155-68. doi: 10.1002/bjs.7161. Review.

name: Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical School, Dallas, Texas, USA

family: Joshi

full_name: G P Joshi

given: G P

name: Institute of Research in Operative Medicine, University of Witten-Herdecke, Cologne, Germany

family: Neugebauer

full_name: E A M Neugebauer

given: E A M

journal_name: British Journal of Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Sammour T, Barazanchi AW, Hill AG; PROSPECT group (Collaborators). Evidence-Based Management of Pain After Excisional Haemorrhoidectomy Surgery: A PROSPECT Review Update. World J Surg. 2017 Feb;41(2):603-614. doi: 10.1007/s00268-016-3737-1. Review.

family: Sammour

full_name: Tarik Sammour

given: Tarik

name: on behalf of the PROSPECT group (Collaborators)

family: Barazanchi

full_name: Ahmed W. H. Barazanchi

given: Ahmed W. H.

family: Hill

full_name: Andrew G. Hill

given: Andrew G.

journal_name: World Journal of Surgery

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


type: Other Identifier

title: Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic

acronym: ONCOBIOTICS

summary: Multicentric prospective study with collection of biological samples as part of type II research

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


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

lead_sponsor: CHU de Reims

status_simplified: Unknown


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.

lead_sponsor: Hospices Civils de Lyon


title: Uterine Rupture During Labor Among Women With a Prior Cesarean Delivery : Risks Factors, Maternal and Perinatal Outcomes

summary:
Although a rare event, uterine rupture during labour is one of the most serious obstetric complications because of the dramatic maternal-fetal consequences that can result.

Identifying the risk factors associated with uterine rupture would enable gynecologists to provide patients with risks of uterine rupture in the event of attempted vaginal delivery.

The aim of our study is to determine risks factors for uterine rupture during labour in patients with a previous cesarean delivery who have not given birth since and to assess the occurrence of maternal-fetal comply-cations compared to patients with a previous cesarean delivery without uterine rupture.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


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: Suspended


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

lead_sponsor_type: industriel


title: Assessment in a Randomized Controlled Trial of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.

acronym: ARCACHON

summary:
Due to the lack of randomized controlled trials, the best follow-up strategy of asymptomatic patients after coronary artery revascularization is controversial. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival. Moreover, stress testing per se or additional procedures which can be performed with regard of stress testing results can cause unexpected complications.

ARCACHON is a national, multicenter, randomized, open label trial, that will evaluate the non-inferiority of a clinical follow-up as compared to a systematic stress testing strategy after coronary revascularization.

design_allocation: Randomized


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.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


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.


title: Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation

acronym: TAVI-Geriatrie

summary: This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).


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.

status: Not yet recruiting

lead_sponsor: University Hospital, Rouen

intervention_type: Genetic


title: Validity of the French Version of Deafness Questionnaires for Children and Adolescents

acronym: SSQ-PEACH

summary:
The care of deafness in children is difficult and the relevance of interventions is difficult to evaluate based on audiometric measurements alone.

Generic pediatric quality of life tools have been validated and used, among other things, to assess the quality of life of children with deafness. However, these non-specific tools do not make it possible to precisely target which factors and interventions are the most important for the quality of life in this population.

Achieving a score to monitor the quality of life objectively over time is fundamental to verify the effectiveness of interventions, and assess the impact on the child. There is currently no validated test in French for any of these uses and populations.

The objective of the study is to adapt the questionnaires "PEACH", "SSQ child (SSQ-C)" and "SSQ parents (SSQ-P)" to the French child, and statistically measure their internal and external validity by comparing them to a control group.

The validation of these three tests (PEACH, SSQ-P, SSQ-C) would make it possible to assess the hearing performance and quality of life of almost the entire pediatric population, for use in both clinical and academic practice.


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

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.


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.

lead_sponsor: University Hospital, Grenoble

intervention_type: Device


title: Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma

acronym: GYNECO-IMM&CO

summary: GYNECO-IMM&Co is a prospective clinical and biological cohort ; this study aims to identify immune surveillance and escape mechanisms and also predictive biomarkers for survival patients who suffer from ovarian and breast carcinoma.

lead_sponsor: Centre Leon Berard


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


title: Emotional Proactive Processing in Bipolar Disorder

summary: The main objective of this project is to identify behavioral specificities of the proactive emotional brain among bipolar patients, compared to healthy subjects. These could contribute to some of the emotional processing biases that can be observed in these patients. To achieve this goal, two behavioral tasks will be administer (emotional stroop and emotional stimuli categorization task) to bipolar patients and control subjects, and their performances will be compared.

ReferenceType: background

ReferenceCitation: Beffara B, Wicker B, Vermeulen N, Ouellet M, Bret A, Molina MJ, Mermillod M. Reduction of interference effect by low spatial frequency information priming in an emotional Stroop task. J Vis. 2015;15(6):16. doi: 10.1167/15.6.16.

ReferenceCitation: Golden, C. (1978). Diagnosis and Rehabilitation in Clinical Neuropsychology. College of Psychology: Faculty Books and Book Chapters. https://nsuworks.nova.edu/cps_facbooks/48

ipd_sharing_description: If the patient accepts all the characteristics useful for the study will be available in our results.

intervention_type: Behavioral


title: Exploratory Study Evaluating the Relevance of [68Ga]Ga -PentixaFor for Initial Staging and Therapeutic Evaluation of Symptomatic Multiple Myeloma Patients in First Line Treatment

acronym: PentiMyelo

summary: The aim of our study is to confirm the relevance of PET using [68Ga]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga -PentixaFor/FDG discordances explored.

lead_sponsor: Nantes University Hospital

intervention_type: Drug


title: Cohort Study on Sleep Architecture and Regulation, Cognitive Performance and Metabolism in Children With Narcolepsy

acronym: COSACM

summary: Narcolepsy is a rare disease that affects 0.05% of the general population. It is characterized by a dysregulation of the sleep wake regulation that leads to uncontrolled sleep episode during day and a disorganized sleep during night. These symptoms are due to a loss of hypocretin neurons in the brain leading to an inability to maintain wake properly. The physiopathology of this rare disease still needs investigations. Since we are a reference center for this disease, we propose to use patients files to better describe and document the sleep characteristics of these children, the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children.

location_facility: : Sleep pediatric unit , Woman Mother Child Hospital, Hospices Civils de Lyon


title: Feasability of Foot Reflexology to Alleviate Anxiety in Palliative Care Unit : a Pilot Randomised Double Blind Study

acronym: RPASP

summary: The primary purpose of the study is to know if foot reflexology can be accepted by patients hospitalized in palliative unit care (assessed by the number of patient who accept to participate), and if it is feasible (assessed by the realization of one session in normal condition : duration of 15-20 min, in supine position/seated or half-seated position).The investigators make the hypothesis that patients will accept to receive foot reflexology, and maybe feel less anxious after one session.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Clermont-Ferrand


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: 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


title: Anxious School Refusal in Adolescents: Efficiency of a Cognitive and Behavioral Therapy (CBT) Day Hospital Program

acronym: RSA-Coll

summary: Anxious school refusal (ASR) is a common disorder which concerns more and more adolescents who are at worse completely absent from school. A specific ambulatory cognitive and behavioral therapy (CBT) program has been established to gradually reintegrate the child back into the school environment with a multidisciplinary team. Alongside school reintegration assessment, the child's overall ability to function and anxiety levels will be measured before and after the program with additional assessments made after a further 6 and 12 months have elapsed.


title: Micro-sleep During Maintenance Wakefulness Tests

summary: During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) < 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.


title: Impact of Intraoperative Fluid Challenges Administration on Macro and Microcirculation in Patients Undergoing High-risk Abdominal Surgery and Situated in the Gray Zone of Pulse Pressure Variation

acronym: FC

summary: The goal of this prospective observational study is to assess the impact of fluid challenge administration on macro and microcirculation in patients situated in the gray zone during a high risk abdominal surgery

lead_sponsor: Erasme University Hospital


title: Comparisons of gaIt aNalyses pERformance Between the Gaitrite walkwaYs

acronym: CINERGY

summary:
The GAITRite® system is an instrumented with resistive pressure sensors gait analyzer. It was first validate in 2001 against paper-and-pencil (intraclass correlation coefficient [ICC] > 95%) for spatial measures and against video-based (ICC > 93%) for temporal measures, and was thus a reliable tools to measure step lengths and times in both walkway center and left-of-center measurements. It was considered as one of the gold standards in gait analyses. This gait analyze system may distinguish prospectively faller and non-faller older adults, but it can detect spatial, temporal, and spatiotemporal measures of gait and greater variability of gait parameters which were associated with and predictive of both global- and domain-specific cognitive decline. Moreover, spatiotemporal gait parameters analyzed using GAITRite® were more disturbed in the advanced stages of dementia, and more affected in the non-AD dementia than in AD suggesting that quantitative gait parameters could be used as a surrogate marker for improving the diagnosis of dementia.

Nevertheless, GAITRite® is not a unique system and it comprises different walkways. One of these technologies was a roll-up system (platinum plus classic, RE, Basic and Safari), and the other was a system composed by a changeable association of plates (CIRFACE). In order to ensure a good comparability between studies using these different walkways, it appears important to compare the performances of these walkways in gait analysis. Thus, the main aim of this study was to compare the performances in gait analyze between the GAITRite® platinum plus classic and the GAITRite® CIRFACE among older adults. Secondary aims were to compare these parameters among patients with cognitive complaint, minor or major neurocognitive disorder (NCD) related to Alzheimer disease.


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: Yes

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.

lead_sponsor: Centre Hospitalier Universitaire Dijon


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.

lead_sponsor: University Hospital, Lille


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.


title: Complicated Grief in ICU in the Aftermath of COVID-19

acronym: DEPARTS

summary:
An increased proportion of deaths occur in the intensive care unit (ICU). Some amenable factors such as end-of-life practices may contribute to complicated grief.

Because of the COVID-19 pandemic, visitor restrictions in health care facilities have been implemented. Families were also unable to implement usual funerals. The investigators hypothesize that these policies and practices may impact grief during covid-19 pandemic. The aim of this study is to evaluate the prevalence of complicated grief after death of a relative in the ICU during the COVID-19 pandemic.


title: An Appraisal of Minimal Invasive Surgery for Thoracic Child Neurogenic Tumour. A Multicentric Study

acronym: DIUOP

summary:
Mediastinal neurogenic tumors are relatively rare in children. Surgical resection is essential. Minimal invasive surgery is more and more used in pediatric population, but his evaluation for resection of thoracic neurogenic tumors is little studied.

Thoracotomy has specific long terms post operative complications. When compared to thoracotomy, thoracoscopy shows less operative blood loss, shorter duration of chest tube ans length of stay.

Recently, the indications of thoracoscopic approach have been assessed according to the presence or absence of image-defined risk factors (IDRF) at diagnosis and after preoperative chemotherapy in a monocentric retrospective study.

The investigators aimed to conduct a multicentric retrospective study to assess the role of thoracoscopy in neurogenic thoracic tumours according to the presence or absence of IDRF at diagnosis, the surgical complications and outcome.

lead_sponsor: Fondation Lenval


title: Follow-up CoViD-19 Patients Hospitalized in Reims University Hospital Between the 01/03/2020 and 30/04/2020

acronym: COVID-Reims

summary:
Medical context: Follow-up of a retrospective cohort of 499 cases of CoViD-19, hospitalized at the University Hospital of Reims during the health crisis, prospectively up to two years of follow-up.

Possible intervention for serological monitoring, leading to a change from category 3 to category 2 (French law on human person research)

Aim of the study: To know the factors of gravity of CoViD-19, to know its prognostic factors, to see how the evolution of the treatments implemented have influenced the fate of the patients.

Material and methods:

Type of study: cohort study Population: Patients in the CoViD-19 cohort - Reims Calendar: September 2020 - July 2022

Expected results: Better knowledge of the cares of patients with CoViD-19

lead_sponsor: CHU de Reims


title: Collection of Clinical and Biometrological Data in Adult Subjects Suffering From Atopic Dermatitis (AD) During a Three-month Period

summary:
Atopic dermatitis represents a real challenge in public health as it affects a large percentage of children and adults. Affected individuals must cope with a significant psychosocial burden, in addition to dealing with the medical aspects of the disease.

The purpose of this exploratory study is to collect clinical severity AD data, using PO-SCORAD (self-assessment by the subjects), SCORAD evolution, instrumental measurements and treatment follow up of subjects.

The future objective is to develop a personalised prediction model of AD flares in order to improve management of AD by more accurate severity evaluations by the subject and the physician. Development of a method of early detection of flares will open new treatment pathways for AD management.

lead_sponsor: Pierre Fabre Dermo Cosmetique


title: Evaluation of the Effects of Personalized Training at Home Combining Endurance and Resistance in Patients Suffering From Marfan Syndrome

acronym: MARF'HOME

summary:
Marfan syndrome (MS) is an autosomal dominant genetic disorder caused by a mutation in the fibrillin-1 gene (FBN1) encoding the protein fibrillin-1. Fibrillin is the main component of microfibrils, elements found in all of the body's tissues, and this pathology is characterized by the multitude of its clinical manifestations. These patients may develop aneurysms in the aortic root and one of the main factors of morbidity in patients with MS is aortic dissection. Prevention mainly involves preventive aortic surgery. However, the repercussions are global and can affect the functioning of other tissues such as skeletal muscle tissue, bone tissue, lung tissue and the eyes. The association of skeletal (scoliosis, hyperlaxity), muscular and ocular disorders is clearly associated with an impairment in the quality of life. These disorders are associated with pain and disability which affect professional activity, leisure and family life.

Physical activity could represent a relevant alternative for these patients. A recent animal study suggests that moderate training is beneficial.

lead_sponsor: French Cardiology Society

location_facility: Groupe Hospitalier Bichat - Claude Bernard


title: Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma

acronym: CONDORE

summary:
Glaucoma is one of the most common chronic pathologies and affects several millions patients. Among these, many have a poorly controlled glaucoma, damaging vision and leading to blindness.

One between principal reasons for poor glaucoma medication adherence is forgetfulness. To improve this issue, digital tools may benefit both ophthalmologists and patients by monitoring eye drop administration.

lead_sponsor: Laboratoires Thea


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. Review.

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. Review.

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. Review.


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


type: Registry Identifier

title: Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain

summary: Thigh muscles flexibility deficits contribute to handicap in chronic low back pain patients. The study aims to evaluate the immediate effect of thigh muscles stretching in patients with chronic low back pain. The investigation team suppose that flexibility improvement could be detected by instrumented clinical measurements and such difference could be related to psycho-social factors evaluated by questionnaires.


title: Nation-wide Health Resource Consumption and Costs Associated With Mepolizumab (Nucala): a French SNDS Database Study

acronym: Resala

summary:
Currently, no study has addressed real-life data describing changes in health resource consumption and related costs attributable to mepolizumab treatment. The aim of the current study is to fill this knowledge gap by performing an exhaustive extraction of data for patients receiving mepolizumab in the French single-payer health care system. The change in real-life health-resource usage and costs observed for these patients would provide the first evidence that mepolizumab is changing the care landscape for eligible severe asthma patients.

The overall objectives of this study are: (i) using the SNDS French national database, to identify a representative, nation-wide population of patients treated with mepolizumab with a follow-up period of at least 12 months, (ii) to describe the initial one-year changes in health resource use before and after the initiation of mepolizumab treatment and (iii) to estimate the change in associated costs for the first year of treatment. These initial data will additionally serve as a basis for the design of longer-term studies.

Primary objective: To estimate the change in associated costs for the first year of treatment

ipd_sharing_description: SNDS data are accessible only by specially trained and qualified individuals. Due to regulatory constraints, they cannot be made available to the public.

lead_sponsor: University Hospital, Montpellier


title: Bacterial Infections in People Who Inject Psychoactive Substances

summary: Bacterial infections in people who inject psychoactive substances


title: Long-term Maintenance Benefits of a Pulmonary Rehabilitation Program Using a Mobile Digital Solution: a Prospective, Randomized, Controlled, Multicenter Study in a Population of COPD Patients

acronym: m-Rehab COPD

summary:
Chronic obstructive pulmonary disease (COPD) is a public health problem: high prevalence; increasing morbidity and mortality; impact on health costs. Pulmonary rehabilitation (PR) is a multidisciplinary intervention combining exercise training, therapeutic education, psychosocial and behavioral interventions. Its effects are beneficial in the short and medium terms but are limited in time, between 6 and 12 months, for patients who do not pursue regular physical activity (PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.

In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.

(PA) in post-rehabilitation and who do not adopt behavioral changes for health, by loss of motivation. Maintaining the long-term benefits acquired during a short-term PR program is therefore a major issue in the management of COPD. The recent development of remote rehabilitation is a promising approach that has been studied in few studies.

In a randomized, controlled and multicenter study, we propose to test the hypothesis that the use of a mobile telerehabilitation solution will allow COPD patients to mainain at long-term the benefits acquired during a short-temr programm and therfore improve their quality of life.

ReferenceCitation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1:CD013040. doi: 10.1002/14651858.CD013040.pub2.

name: Institute for Breathing and Sleep; Melbourne Australia

name: Allergy, Clinical Immunology and Respiratory Medicine; Monash University; Melbourne Australia

family: Cox

full_name: Narelle S Cox

given: Narelle S

name: Graduate Program in Rehabilitation Sciences; Nove de Julho University; São Paulo Brazil

family: Dal Corso

full_name: Simone Dal Corso

given: Simone

name: Respiratory Research Unit; Department of Respiratory Medicine, Copenhagen University Hospital Hvidovre; Hvidovre Denmark

family: Hansen

full_name: Henrik Hansen

given: Henrik

name: Department of Medicine; University of Melbourne; Melbourne Australia

name: Department of Respiratory and Sleep Medicine; Austin Hospital; Melbourne Australia

family: McDonald

full_name: Christine F McDonald

given: Christine F

name: Department of Physiotherapy; Austin Hospital; Melbourne Australia

full_name: Catherine J Hill

given: Catherine J

name: Norwegian Centre for E-health Research; University Hospital of North Norway; Tromsø Norway

name: Department of Clinical Medicine, Faculty of Health Sciences; UiT The Arctic University of Norway; Tromsø Norway

family: Zanaboni

full_name: Paolo Zanaboni

given: Paolo

name: Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health; The University of Sydney; Sydney Australia

name: Allied Health Research and Education Unit; Sydney Local Health District; Sydney Australia

family: Alison

full_name: Jennifer A Alison

given: Jennifer A

name: School of Psychology and Public Health; La Trobe University; Melbourne Australia

family: O'Halloran

full_name: Paul O'Halloran

given: Paul

name: Community Rehabilitation; Wimmera Health Care Group; Horsham Australia

family: Macdonald

full_name: Heather Macdonald

given: Heather

name: Physiotherapy; Alfred Health; Melbourne Australia

family: Holland

full_name: Anne E Holland

given: Anne E

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Centre hopsitalier universitaire de Montpellier


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.

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, Schuhbäck A, Rixe J, Möllmann 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). pii: 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.

ReferenceCitation: Li Y, Xu N, Zhang J, Li M, Lu Z, Wei M, Lu B, Zhang Y. Procedural success of CTO recanalization: Comparison of the J-CTO score determined by coronary CT angiography to invasive angiography. J Cardiovasc Comput Tomogr. 2015 Nov-Dec;9(6):578-84. doi: 10.1016/j.jcct.2015.07.005. Epub 2015 Jul 23.

ReferenceCitation: Opolski MP, Achenbach S. CT Angiography for Revascularization of CTO: Crossing the Borders of Diagnosis and Treatment. JACC Cardiovasc Imaging. 2015 Jul;8(7):846-58. doi: 10.1016/j.jcmg.2015.05.001. Review.

ReferenceCitation: Chen Y, Lu B, Hou ZH, Gao Y, Yu FF, Yin WH, Wang ZQ. Predicting successful percutaneous coronary intervention in patients with chronic total occlusion: the incremental value of a novel morphological parameter assessed by computed tomography. Int J Cardiovasc Imaging. 2015 Aug;31(6):1263-9. doi: 10.1007/s10554-015-0679-x. Epub 2015 May 17.

ReferenceCitation: Opolski MP, Achenbach S, Schuhbäck A, Rolf A, Möllmann H, Nef H, Rixe J, Renker M, Witkowski A, Kepka C, Walther C, Schlundt C, Debski A, Jakubczyk M, Hamm CW. Coronary computed tomographic prediction rule for time-efficient guidewire crossing through chronic total occlusion: insights from the CT-RECTOR multicenter registry (Computed Tomography Registry of Chronic Total Occlusion Revascularization). JACC Cardiovasc Interv. 2015 Feb;8(2):257-267. doi: 10.1016/j.jcin.2014.07.031.

ReferenceCitation: Takimura H, Muramatsu T, Tsukahara R. CT coronary angiography-guided percutaneous coronary intervention for chronic total occlusion combined with retrograde approach. J Invasive Cardiol. 2012 Jan;24(1):E5-9.

ReferenceCitation: Rodríguez-Granillo GA, Rosales MA, Llauradó C, Ivanc TB, Rodríguez AE. Guidance of percutaneous coronary interventions by multidetector row computed tomography coronary angiography. EuroIntervention. 2011 Jan;6(6):773-8. doi: 10.4244/EIJV6I6A131. Review.

ReferenceCitation: Tajti P, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Mahmud E, Choi JW, Burke MN, Doing AH, Dattilo P, Toma C, Smith AJC, Uretsky B, Holper E, Wyman RM, Kandzari DE, Garcia S, Krestyaninov O, Khelimskii D, Koutouzis M, Tsiafoutis I, Moses JW, Lembo NJ, Parikh M, Kirtane AJ, Ali ZA, Doshi D, Rangan BV, Ungi I, Banerjee S, Brilakis ES. The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1325-1335. doi: 10.1016/j.jcin.2018.02.036. Epub 2018 Apr 26.

ReferenceCitation: Maeremans J, Walsh S, Knaapen P, Spratt JC, Avran A, Hanratty CG, Faurie B, Agostoni P, Bressollette E, Kayaert P, Bagnall AJ, Egred M, Smith D, Chase A, McEntegart MB, Smith WH, Harcombe A, Kelly P, Irving J, Smith EJ, Strange JW, Dens J. The Hybrid Algorithm for Treating Chronic Total Occlusions in Europe: The RECHARGE Registry. J Am Coll Cardiol. 2016 Nov 1;68(18):1958-1970. doi: 10.1016/j.jacc.2016.08.034.

ReferenceCitation: Hunt CH, Hartman RP, Hesley GK. Frequency and severity of adverse effects of iodinated and gadolinium contrast materials: retrospective review of 456,930 doses. AJR Am J Roentgenol. 2009 Oct;193(4):1124-7. doi: 10.2214/AJR.09.2520.

ReferenceCitation: McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill WW. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med. 1997 Nov;103(5):368-75.

ReferenceCitation: Galassi AR, Sianos G, Werner GS, Escaned J, Tomasello SD, Boukhris M, Castaing M, Büttner JH, Bufe A, Kalnins A, Spratt JC, Garbo R, Hildick-Smith D, Elhadad S, Gagnor A, Lauer B, Bryniarski L, Christiansen EH, Thuesen L, Meyer-Geßner M, Goktekin O, Carlino M, Louvard Y, Lefèvre T, Lismanis A, Gelev VL, Serra A, Marzà F, Di Mario C, Reifart N; Euro CTO Club. Retrograde Recanalization of Chronic Total Occlusions in Europe: Procedural, In-Hospital, and Long-Term Outcomes From the Multicenter ERCTO Registry. J Am Coll Cardiol. 2015 Jun 9;65(22):2388-400. doi: 10.1016/j.jacc.2015.03.566.

ReferenceCitation: Patel VG, Brayton KM, Tamayo A, Mogabgab O, Michael TT, Lo N, Alomar M, Shorrock D, Cipher D, Abdullah S, Banerjee S, Brilakis ES. Angiographic success and procedural complications in patients undergoing percutaneous coronary chronic total occlusion interventions: a weighted meta-analysis of 18,061 patients from 65 studies. JACC Cardiovasc Interv. 2013 Feb;6(2):128-36. doi: 10.1016/j.jcin.2012.10.011. Epub 2013 Jan 23. Review.

ReferenceCitation: Hannan EL, Zhong Y, Jacobs AK, Stamato NJ, Berger PB, Walford G, Sharma S, Venditti FJ, King SB 3rd. Patients With Chronic Total Occlusions Undergoing Percutaneous Coronary Interventions: Characteristics, Success, and Outcomes. Circ Cardiovasc Interv. 2016 May;9(5):e003586. doi: 10.1161/CIRCINTERVENTIONS.116.003586.

ReferenceCitation: Brilakis ES, Banerjee S, Karmpaliotis D, Lombardi WL, Tsai TT, Shunk KA, Kennedy KF, Spertus JA, Holmes DR Jr, Grantham JA. Procedural outcomes of chronic total occlusion percutaneous coronary intervention: a report from the NCDR (National Cardiovascular Data Registry). JACC Cardiovasc Interv. 2015 Feb;8(2):245-253. doi: 10.1016/j.jcin.2014.08.014.

lead_sponsor: Eugenio LA SCALA


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.).

primary_purpose: Prevention

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

intervention_type: Diagnostic Test


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.

lead_sponsor: University Hospital, Caen


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.

.

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


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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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.

lead_sponsor: University Hospital, Grenoble


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


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.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: 5-HTSEP: Serotonin 5-HT7 Receptor Implication in the Inflammatory Mechanisms in Multiple Sclerosis

summary:
Multiple Sclerosis is a chronic autoimmune disease associated with inflammatory response harmful for the Central Nervous System. Immunological imbalance is involved with Th1 and Th17 cells in correlation with a disturbance of regulators mechanisms as Treg cells. Despite years of research, the mechanisms involved remain unclear.

Serotonin (5-HT) seems to be a therapeutic target to treat multiple sclerosis. Indeed, several studies have shown the anti-inflammatory potential of this neurotransmitter and also its vulnerability in inflammatory context. Moreover, a recent study has shown that 5-HT can reduced CD4 T cells proliferation and pro-inflammatory cytokines released in vitro.

5-HT protector effects have also demonstrated in Experimental Autoimmune Encephalomyelitis mouse model (EAE) with an inflammatory response reduction and also a decreased of spinal cord lesions.

The latest receptor discovered, the 5-HT7 receptor, has been identify as a promise target to treat neurological disorders associated with inflammatory context. Present in humans and mice, this receptor spreads on the surface of a large number of cells, such as T-lymphocytes, macrophages, dendritic cells and also neurons, astrocytes and microglia.

Given the importance of the positive cells for 5-HT7 receptor, in the inflammatory context observed in multiple sclerosis, The investigator propose to study the receptor expression in blood samples from multiple sclerosis patient.

ReferenceCitation: Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintoré M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21. Review.

ReferenceCitation: Sacramento PM, Monteiro C, Dias ASO, Kasahara TM, Ferreira TB, Hygino J, Wing AC, Andrade RM, Rueda F, Sales MC, Vasconcelos CC, Bento CAM. Serotonin decreases the production of Th1/Th17 cytokines and elevates the frequency of regulatory CD4(+) T-cell subsets in multiple sclerosis patients. Eur J Immunol. 2018 Aug;48(8):1376-1388. doi: 10.1002/eji.201847525. Epub 2018 Jun 6.

name: Post-graduate Program in Microbiology; Department of General Medicine Department, Federal University of the State of Rio de Janeiro; Rio de Janeiro Brazil

name: Department of Microbiology and Parasitology; Federal University of the State of Rio de Janeiro; Rio de Janeiro Brazil

family: Sacramento

full_name: Priscila M. Sacramento

given: Priscila M.

family: Monteiro

full_name: Clarice Monteiro

given: Clarice

family: Dias

full_name: Aleida S. O. Dias

given: Aleida S. O.

family: Kasahara

full_name: Taissa M. Kasahara

given: Taissa M.

family: Ferreira

full_name: Thaís B. Ferreira

given: Thaís B.

name: Post-graduate Program in Molecular and Cellular Biology; Federal University of the State of Rio de Janeiro; Rio de Janeiro Brazil

family: Hygino

full_name: Joana Hygino

given: Joana

name: Post-graduate Program in Neurology; Federal University of the State of Rio de Janeiro; Rio de Janeiro Brazil

family: Wing

full_name: Ana Cristina Wing

given: Ana Cristina

family: Andrade

full_name: Regis M. Andrade

given: Regis M.

name: Clinical of Diagnosis by Image, Barra da Tijuca Unity; Rio de Janeiro Brazil

family: Rueda

full_name: Fernanda Rueda

given: Fernanda

family: Sales

full_name: Marisa C. Sales

given: Marisa C.

family: Vasconcelos

full_name: Claudia Cristina Vasconcelos

given: Claudia Cristina

family: Bento

full_name: Cleonice A. M. Bento

given: Cleonice A. M.

journal_name: European Journal of Immunology

evidence: open (via free article)

title: Serotonin decreases the production of Th1/Th17 cytokines and elevates the frequency of regulatory CD4+T-cell subsets in multiple sclerosis patients

ReferenceCitation: Yuan XQ, Qiu G, Liu XJ, Liu S, Wu Y, Wang X, Lu T. Fluoxetine promotes remission in acute experimental autoimmune encephalomyelitis in rats. Neuroimmunomodulation. 2012;19(4):201-8. doi: 10.1159/000334095. Epub 2012 Mar 21.

family: Yuan

full_name: Xi-qiu Yuan

given: Xi-qiu

family: Qiu

full_name: Guang Qiu

given: Guang

family: Liu

full_name: Xiao-jia Liu

given: Xiao-jia

full_name: Shan Liu

given: Shan

family: Wu

full_name: Yongming Wu

given: Yongming

family: Wang

full_name: Xinyu Wang

given: Xinyu

family: Lu

full_name: Tianming Lu

given: Tianming

title: Fluoxetine Promotes Remission in Acute Experimental Autoimmune Encephalomyelitis in Rats

ReferenceCitation: Quintero-Villegas A, Valdés-Ferrer SI. Role of 5-HT(7) receptors in the immune system in health and disease. Mol Med. 2019 Dec 31;26(1):2. doi: 10.1186/s10020-019-0126-x. Review.

title: Role of 5-HT7 receptors in the immune system in health and disease


title: Evaluation of the Interest of Regional Locoregional Anesthesia by Perfusion Blocks in Continuous Infusion in Polytrauma Patients With Limb Fractures and Mechanical Ventilation. A Prospective Randomized Study

acronym: ALRréa

summary: Regional analgesia, based on its physiological effects and efficacy, is used for optimal perioperative pain relief. However, for acute pain in multiple trauma patients in a critical condition, it has not been prospectively studied. The use of regional anaesthesia in this group of patients extend to the management of trauma patients and of other painful procedures performed at the patient's bed. The use of RA in such patients must be analyzed in the light of associated conditions that can increase the risk of systemic toxicity and complications: coagulopathies, infection, immunosuppressive states, sedation and problems associated with mechanical ventilation. The investigators aim to assess the role of continuous peripheral nerve blocks (CPNB) in multiple trauma patients, in order to show the benefits in terms of opiates consumption decrease, sedation limitation, improvement in ventilator free days and patients outcome


title: Mechanisms of Resistance to 3rd Generation Thyrosine Kinase Inhibitors in Lung Cancer

acronym: RESTKI

summary:
In the management of non-small cell lung cancer of the adenocarcinoma type, different therapeutic strategies can be proposed. These strategies are defined according to the results of a biological analysis of blood and/or tissue samples from the lung tumor. Mutations in the tumor DNA are sought. Thus, patients with sensitizing mutations can benefit from a treatment with a 3rd generation tyroine kinase inhibitor (TKI) whose efficacy has been widely demonstrated. Patients without tumor mutations will not benefit. However, resistance to TKIs appears after a certain time, often linked to the appearance of new mutations in the tumor. For this reason, blood biologic analyses are regularly performed to search for the emergence of resistance mutations and to propose a therapeutic alternative as soon as possible.

These analyses are performed routinely in the laboratory. In the course of these analyses, the investigators have identified conventional mutations but also new mutations not previously described in the literature.

Our objective is to list all the molecular abnormalities revealed during blood biological analyses, to determine their frequency and to study whether certain abnormalities can be linked to resistance to TKI.


title: Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.

acronym: PEPS

summary: The purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery.

lead_sponsor: Institut Mutualiste Montsouris


title: Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy for Lung Cancer Management

acronym: PTOP-RT

summary: (Chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. While some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and esophageal toxicity, remains insufficiently accurate. Current dose-volume histograms (DVH) do not account for spatial dose distribution and strict application of current dose constraints does not prevent toxicity events in some of the treated patients. The goal of this work was to investigate the added predictive value of the radiomics approach applied to dose maps regarding acute and late toxicity in both lungs and the esophagus.

lead_sponsor: University Hospital, Brest


title: Assessment of the Impact of an Ultratrail on the Knee Cartilage by Using T2 MRI: a Pilot Study

summary: Long-distance mountain running is increasingly popular among European and North America countries. Long-distance races are organized in various mountains and can reach up to 160 km (100 miles) with several thousands meters of climbing. The pathophysiological consequences of such extreme effort is still a matter a debate. From a muskelo-skeletal perspectives, the potential lower-limb join damage is a major health issue. The present study aims to use objective magnetic resonance imaging (MRI) techniques to describe the consequences of performing long-distance mountain running races on the knee cartilage.


title: Clinical and Biological Characteristics of Critically Ill Patients With COVID-19 Admitted to Pediatric Intensive Care Unit

acronym: CLOVIS

summary: In this prospective longitudinal cohort the investigators reported the clinical, and biological characteristics of all critically ill patients admitted in the pediatric intensive care unit (PICU) of Bicêtre Hospital during the 2019 coronavirus disease (COVID-19) pandemics. Patients were older than 37 weeks of gestational age. No upper limit was set as the unit was transiently converted into a pediatric "adult COVID-19" intensive care unit.

lead_sponsor: Bicetre Hospital

location_facility: Pediatric Intensive Care and Neonatal Medicine, Bicêtre Hospital, AP-HP PAris Saclay University


title: Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study.

acronym: ACCOUPIV

summary: Severe complications of childbirth are common. Many factors have been studied to assess their imputability in the occurrence of perineal tears. While women subjectively have different push profiles in terms of intensity, frequency and duration of each push effort, no study has evaluated this variability in a relevant, simple and reproducible way. Through this work, it is expected to establish a qualitative evaluation of the expulsive efforts during childbirth in term nulliparous women by measuring the intra bladder pressure which testifies of the pressure exerted on the perineal tissues due to maternal pushing efforts

lead_sponsor: Poitiers University Hospital


title: Usefulness of Biomarkers in the Management of Mild Traumatic Brain Injury in Adults

acronym: Biotraumap

summary:
The indication of cranial computed tomography (CCT) is difficult to define for patients with mild traumatic brain injury (mTBI). For mTBI patients with a medium risk of intracranial complications, CCT scans are indicated although 90% of them are normal.

The interest of the S100B protein has been widely demonstrated in the management of mTBI in adults. Its serum concentration (for blood sampling drawn less than 3 hours after trauma) can accurately predict a normal CCT scan for mTBI patients with a medium risk of intracranial complications. That's why, serum assay of the S100B protein is routinely used in the Emergency Department of Clermont-Ferrand University Hospital for the treatment of patients with mTBI.

The objective of the study is to optimize the management strategy for mTBI patients by blood testing of new brain biomarkers. These biomarkers are synthesized by brain cells and are released into the blood in case of intracranial lesions.

ReferenceCitation: Allouchery G, Moustafa F, Roubin J, Pereira B, Schmidt J, Raconnat J, Pic D, Sapin V, Bouvier D. Clinical validation of S100B in the management of a mild traumatic brain injury: issues from an interventional cohort of 1449 adult patients. Clin Chem Lab Med. 2018 Oct 25;56(11):1897-1904. doi: 10.1515/cclm-2018-0471.

ReferenceCitation: Biberthaler P, Linsenmeier U, Pfeifer KJ, Kroetz M, Mussack T, Kanz KG, Hoecherl EF, Jonas F, Marzi I, Leucht P, Jochum M, Mutschler W. Serum S-100B concentration provides additional information fot the indication of computed tomography in patients after minor head injury: a prospective multicenter study. Shock. 2006 May;25(5):446-53.

ReferenceCitation: Bouvier D, Oddoze C, Ben Haim D, Moustafa F, Legrand A, Alazia M, Jehle E, Schmidt J, Sapin V. [Interest of S100B protein blood level determination for the management of patients with minor head trauma]. Ann Biol Clin (Paris). 2009 Jul-Aug;67(4):425-31. doi: 10.1684/abc.2009.0347. French.

ReferenceCitation: Calcagnile O, Undén L, Undén J. Clinical validation of S100B use in management of mild head injury. BMC Emerg Med. 2012 Oct 27;12:13. doi: 10.1186/1471-227X-12-13.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Randomized Controlled Study of the Effectiveness of a Self-education Program When Walking by Rhythmic Auditory Stimulation Adapted Music, Delivered by BeatPark, in People With Parkinson's Disease

acronym: BeatPark

summary:
Physical activity has beneficial effects on the quality of walking for persons with Parkinson's disease (PD). However, regular physical activity is still limited in most patients' daily lives.

The rhythm of music makes you want to move whether you are sick or not. In addition, it has been found that in people with PD, it can also improve walking by helping the participant to regain the regularity of alternating steps and a better walking dynamic (i.e. better position, better arm swinging, etc.). Studies have shown that music allows persons with PD to walk faster, with bigger steps.

However, if the tempo of the music does not correspond to the participant's walking pace, instead of helping him, it can disturb him. So it seems necessary for music to help people with PD to walk better if the tempo of the music is set to match their steps.

BeatPark is a smartphone application which makes it possible to synchronize the tempo of the music with the participant's walking rhythm detected thanks to feet insoles. Once synchronized to the participant's walking pace, BeatPark imperceptibly accelerates the tempo of the music to help the participant's acceleration.

This clinical trial proposes to study the effects of walking rehabilitation depending on the use of music synchronized to the participant's step with BeatPark, music with random tempo or without music.

lead_sponsor: Clinique Beau Soleil


title: Risk Factors for Necrotic Cholecystitis During COVID-19 Pandemic: the ChoCO-WSES Prospective Observational Multicenter International Study.

acronym: ChoCO-W

summary:
Gangrenous cholecystitis is the most common complication of acute cholecystitis.

Preliminary data showed that COVID-19 patients have a high risk to present necrotic cholecystitis.

The Cholecystitis under COVID-19 pandemic WSES (ChoCO-W) study aims to investigate risk factors and high-risk patients to develop necrotic cholecystitis during this pandemic and their management.

ReferenceCitation: Eldar S, Eitan A, Bickel A, Sabo E, Cohen A, Abrahamson J, Matter I. The impact of patient delay and physician delay on the outcome of laparoscopic cholecystectomy for acute cholecystitis. Am J Surg. 1999 Oct;178(4):303-7.

ReferenceCitation: Ying M, Lu B, Pan J, Lu G, Zhou S, Wang D, Li L, Shen J, Shu J; From the COVID-19 Investigating and Research Team. COVID-19 with acute cholecystitis: a case report. BMC Infect Dis. 2020 Jun 22;20(1):437. doi: 10.1186/s12879-020-05164-7.

ReferenceCitation: Bruni A, Garofalo E, Zuccalà V, Currò G, Torti C, Navarra G, De Sarro G, Navalesi P, Longhini F, Ammendola M. Histopathological findings in a COVID-19 patient affected by ischemic gangrenous cholecystitis. World J Emerg Surg. 2020 Jul 2;15(1):43. doi: 10.1186/s13017-020-00320-5.

ReferenceCitation: Campanile FC, Podda M, Arezzo A, Botteri E, Sartori A, Guerrieri M, Cassinotti E, Muttillo I, Pisano M, Brachet Contul R, D'Ambrosio G, Cuccurullo D, Bergamini C, Allaix ME, Caracino V, Petz WL, Milone M, Silecchia G, Anania G, Agrusa A, Di Saverio S, Casarano S, Cicala C, Narilli P, Federici S, Carlini M, Paganini A, Bianchi PP, Salaj A, Mazzari A, Meniconi RL, Puzziello A, Terrosu G, De Simone B, Coccolini F, Catena F, Agresta F. Acute cholecystitis during COVID-19 pandemic: a multisocietary position statement. World J Emerg Surg. 2020 Jun 8;15(1):38. doi: 10.1186/s13017-020-00317-0.

ReferenceCitation: Bourikian S, Anand RJ, Aboutanos M, Wolfe LG, Ferrada P. Risk factors for acute gangrenous cholecystitis in emergency general surgery patients. Am J Surg. 2015 Oct;210(4):730-3. doi: 10.1016/j.amjsurg.2015.05.003. Epub 2015 Jun 27.

family: Bourikian

full_name: Seda Bourikian

given: Seda

family: Anand

full_name: Rahul J. Anand

given: Rahul J.

family: Aboutanos

full_name: Michel Aboutanos

given: Michel

family: Wolfe

full_name: Luke G. Wolfe

given: Luke G.

family: Ferrada

full_name: Paula Ferrada

given: Paula

journal_name: The American Journal of Surgery

ReferenceCitation: Önder A, Kapan M, Ülger BV, Oğuz A, Türkoğlu A, Uslukaya Ö. Gangrenous cholecystitis: mortality and risk factors. Int Surg. 2015 Feb;100(2):254-60. doi: 10.9738/INTSURG-D-13-00222.1.

name: Department of General Surgery, Faculty of Medicine, Dicle University, Diyarbakır, Turkey

family: Önder

full_name: Akın Önder

given: Akın

family: Kapan

full_name: Murat Kapan

given: Murat

family: Ülger

full_name: Burak Veli Ülger

given: Burak Veli

family: Oğuz

full_name: Abdullah Oğuz

given: Abdullah

family: Türkoğlu

full_name: Ahmet Türkoğlu

given: Ahmet

family: Uslukaya

full_name: Ömer Uslukaya

given: Ömer

journal_name: International Surgery

oa_host_type: repository

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

repository_institution: PubMed Central - Europe PMC

publisher: International College of Surgeons

publisher_dissemination: International College of Surgeons

publisher_group: International College of Surgeons

publisher_normalized: International College of Surgeons

title: Gangrenous Cholecystitis: Mortality and Risk Factors

ReferenceCitation: Gomes CA, Soares C, Di Saverio S, Sartelli M, de Souza Silva PG, Orlandi AS, Heringer TL, Gomes FC, Catena F. Gangrenous cholecystitis in male patients: A study of prevalence and predictive risk factors. Ann Hepatobiliary Pancreat Surg. 2019 Feb;23(1):34-40. doi: 10.14701/ahbps.2019.23.1.34. Epub 2019 Feb 28.

name: Surgery Department, Hospital Universitário Therezinha de Jesus, Faculdade de Ciências Médicas e da Saúde Juiz de Fora (SUPREMA), Hospital Universitário da Universidade Federal de Juiz de Fora (ufjf), Juiz de Fora, Brazil.

family: Gomes

full_name: Carlos Augusto Gomes

given: Carlos Augusto

family: Soares

full_name: Cleber Soares

given: Cleber

suffix: Junior

name: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, England.

family: Di Saverio

full_name: Salomone Di Saverio

given: Salomone

name: Department of Surgery, Macerata University Hospital, Macerata, Italy.

name: Internal Medicine Unit, Hospital Universitário da Universidade Federal de Juiz de Fora (ufjf), Juiz de Fora, Brazil.

name: Internal Medicine Unit, Hospital Universitário Therezinha de Jesus, Faculdade de Ciências Médicas e da Saúde Juiz de Fora (SUPREMA), Juiz de Fora, Brazil.

name: Department of General Surgery, Maggiore Hospital, Parma, Italy and Department of Surgery, “Infermi” Hospital, Rimini, Italy.

journal_name: Annals of Hepato-Biliary-Pancreatic Surgery

publisher: The Korean Association of Hepato-Biliary-Pancreatic Surgery

ReferenceCitation: Contini S, Corradi D, Busi N, Alessandri L, Pezzarossa A, Scarpignato C. Can gangrenous cholecystitis be prevented?: a plea against a "wait and see" attitude. J Clin Gastroenterol. 2004 Sep;38(8):710-6.

ReferenceCitation: Pisano M, Ceresoli M, Cimbanassi S, Gurusamy K, Coccolini F, Borzellino G, Costa G, Allievi N, Amato B, Boerma D, Calcagno P, Campanati L, Campanile FC, Casati A, Chiara O, Crucitti A, di Saverio S, Filauro M, Gabrielli F, Guttadauro A, Kluger Y, Magnone S, Merli C, Poiasina E, Puzziello A, Sartelli M, Catena F, Ansaloni L. 2017 WSES and SICG guidelines on acute calcolous cholecystitis in elderly population. World J Emerg Surg. 2019 Mar 4;14:10. doi: 10.1186/s13017-019-0224-7. eCollection 2019. Review.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Università degli Studi di Milano - Institutional Research Information System

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

ReferenceCitation: Hunt DR, Chu FC. Gangrenous cholecystitis in the laparoscopic era. Aust N Z J Surg. 2000 Jun;70(6):428-30.

location_facility: Centre Hospitalier Intercommunal Poissy-Saint Germain en Laye