title: Analysis of Mandibular Kinematics of a Group of Asymptomatic Subjects Recorded With the Modjaw® Device

summary:
In oral rehabilitation, the integration into the digital flow of mandibular movements and the patient's individual reference planes optimizes the functional adaptation of prosthetic elements whose design is computer aided. The innovative Modjaw® device allows you to record and then virtually simulate mandibular movements.

This retrospective study aims to: 1) Test the reliability of the Modjaw® device; 2) Measure the condylar displacements of asymptomatic subjects for the arbitrary programming of simulators.

Kinematic recordings of 22 healthy volunteers (15F / 7H; mean age: 22.2 years) were analyzed. Two recording sessions were carried out within one month of each other, by three different operators; each subject was followed by the same operator during the first (E1) and the second (E2) recording. The values of sagittal condylar inclination (SCI) obtained in opening, protrusion, right-left mediotrusion were calculated at 3 and 5 mm of condylar displacement. The transverse condylar inclination (TCI) was calculated at 4mm.

ipd_sharing_description: No data sharing is planned

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Caring for Children in Vital Distress: Assessment of Paramedical Uses and Benefits of a Software

acronym: EasyPedia

summary:
Errors during a stressful pediatric critical situation occur more frequently than thought. The main aim of the study is to quantify the number and the type of errors made by pediatric paramedical teams during the management of vital emergencies (medication dosage calculation, compliance with algorithms for management of cardiac arrest…). Then, simulations with and without the EasyPédia software will be compared during a high-fidelity simulation of a standardized pediatric cardiac arrest scenario in order to evaluate its impact on reducing errors during the management of a resuscitation.

This study will be a single-center and observational trial in the pediatric intensive care unit of the Besançon University Hospital.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Besancon

lead_sponsor_type: academique

status_simplified: Ongoing


type: EudraCT Number

title: Dose Dense Re-challenge of High Dose Methotrexate (HD-MTX) With Glucarpidase (CPG2) for Relapsed Primary Central Nervous System Lymphoma (PCNSL): A Phase I Trial

acronym: METHOGLU

summary:
High dose intravenous Methotrexate (HD-MTX) is the key drug in the treatment of primary central nervous system lymphoma (PCNSL). HD-MTX is usually delivered with time interval ranging from 10 to 21 days. Reduction of injection time interval is limited by MTX renal excretion and systemic toxicity.

Glucarpidase (CPG2) is a recombinant bacterial rescue enzyme that cleaves circulating MTX into inactive metabolites, reducing plasma MTX concentrations within few minutes.

The research hypothesis is that CPG2 used after HD-MTX injection allows to reduce time interval between MTX injections, increase dose intensity of the chemotherapy, reduce systemic toxicity and duration of hospitalization.

study_type: Interventional

primary_purpose: Treatment

ipd_sharing: Yes

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

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
BTG International Inc.

intervention_type: Drug


type: Other Identifier

title: Study of the Evolution of Olfactory Disorders in Patients With Persistent Loss of Smell Following COVID-19

acronym: ETOC

summary:
The COVID-19 pandemic is a novel medical challenge, particularly because of the systemic nature of this disease. Indeed, COVID-19 affects several organs and systems at once. The brain is affected in several ways: direct infection of nerve cells by SARS-CoV-2, inflammation of the central nervous system, severe systemic inflammation damaging nerve cells, global cerebral ischaemia related to respiratory failure, thromboembolic events related to increased intravascular coagulation and severe psychological stress. As a result, COVID-19 sometimes manifests as neurological and neuropsychiatric symptoms such as dizziness, sleep disturbances, cognitive deficits, delirium, or severe depression.

Sudden loss of smell is a common symptom associated with COVID-19 and SARS-CoV-2 infection of neurons in the olfactory system has been reported in both hamsters and humans. The vast majority of COVID-19 patients recover their olfactory function within a few weeks. However, a significant minority of infected individuals (1 in 5 cases) still suffers from olfactory disorders (anosmia, hyposmia and/or parosmia) several months after the primary infection. These olfactory disorders are frequently associated with depressive behaviour and cognitive complaints. In PET scans, it is even possible to correlate this cognitive dysfunction with hypometabolism of certain brain regions, including the olfactory gyrus.

This project proposes, during one year, to evaluate and follow the evolution of the olfactory capacities of patients suffering from persistent smell disorder since one year (+/- 4 months) following COVID-19. The issue is to study the link between viral persistence in the olfactory sensory organ, chronic inflammation, and central damage to the olfactory system. The follow-up of the evolution of olfactory and neurocognitive capacities, in an integrative way by means of molecular, physiological and behavioural approaches, will inform us on the specificities of "COVID-long" and on the level of peripheral and/or central damage of the olfactory system.

primary_purpose: Basic Science

ipd_sharing: No

lead_sponsor: Institut Pasteur

sponsor_collaborators:
Institut Pasteur
Hopital Lariboisière

intervention_type: Other


title: Characterisation of TIM-3/Gal-9 Immune Checkpoints in Primary Central Nervous System Diffuse Large B Cell Lymphomas

summary: Primary central nervous system diffuse large B cell lymphoma is a rare and aggressive entity of diffuse large B cell lymphoma. A previous transcriptomic study showed an overexpression of TIM-3 and Gal-9 in the tumor microenvironment. The investigators aimed to characterise TIM-3/Gal-9 immune checkpoints by using immunohistochemistry in the tumor microenvironment of primary central nervous system diffuse large B cell lymphoma.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Evaluation of the Effectiveness of the Therapeutic Education Program "Living Better With ADHD" in Improving the Quality of Life of Children With ADHD and Their Parents

summary:
Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by attention deficit, impulsivity and hyperactivity. It's one of the most frequently encoutered disorder in child psychiatry. ADHD has a significant impact on the quality of life of children and their parents.

In the child psychiatry department of the MPEA Peyre Plantade, a Therapeutic Education program specific to ADHD has been set up for children and their parents. This program consists of different workshops whose aim is to reduce the ADHD repercussions on the daily life of children and their families and thus improve their quality of life.

The principal aim of our study is to evaluate the effectiveness of this program in improving the quality of life of children with ADHD and their parents.

status: Unknown status

status_simplified: Unknown


title: Assessment of the Value of Passive Leg Raising (PLR) in Predicting the Onset of Maternal Arterial Hypotension and Norepinephrine Requirements After Spinal Anesthesia for Scheduled Cesarean Section.

acronym: EDLIDL

summary:
Spinal anesthesia for cesarean section is associated with a high incidence of low blood pressure. However, the pathophysiology of this arterial hypotension is not unequivocal and could involve, in addition to drug vasoplegia, a mechanical cause linked to lower caval compression or even true or relative hypovolemia. Passive leg raise test has been proposed in an attempt to identify parturients who are more likely to develop low blood pressure after spinal anesthesia. Nevertheless, the data available on this volume expansion test to predict hemodynamic variations after performing spinal anesthesia are still limited and few objective criteria have been described to predict this arterial hypotension.

The objective of the research is to study the hypothesis according to which the presence of hypovolaemia (true or relative) objectified by a positive passive leg raise test would cause hypotension more frequent and more marked in intensity.

primary_purpose: Diagnostic


title: LIQUID BIOPSY IN Low-grade Glioma Patients

acronym: GLIOLIPSY

summary:
Diffuse low-grade gliomas (DLGG) (or WHO grade II gliomas) are rare tumors, with an incidence estimated at 1/105 person-year. DLGG are characterized by a continuous growth and an unavoidable anaplastic transformation. DLGG malignant progression is classically characterized by a continuum, from grade II to grade III or IV tumors.

To date, the histomolecular diagnosis of lower grade gliomas (that is, grade II and III gliomas) is achieved on tumor samples obtained from surgical resection or biopsy. Indeed, whereas brain MRI is often suggestive of DLGG, there is a need for a histological confirmation of diagnosis prior to any medical treatment. Moreover, MRI features to not always accurately predict the tumor grade, with grade II tumor presenting with contrast enhancement or non-enhancing authentic grade III tumors.

In this setting, the value of liquid biopsy (in blood or cerebrospinal fluid CSF) as a non-invasive, disease-associated biomarker has gained interest in the past decade, either at tumor diagnosis or to monitor tumor evolution in order to guide patient management and to detect changes of molecular features over time. While extracranial metastasis of glioma rarely occurs, recent reports suggest the possible presence of circulating tumor cells (CTCs) in blood of high-grade glioma patients. Beside CTCs, other circulating biomarkers have been recently investigated in glioma, including circulating tumor DNA, microRNA or tumor-educated platelet (TEP) RNA. Some of these techniques allow genome-wide characterization of RNA/DNA contents.

However, these studies are all small exploratory studies that have mainly included glioblastoma (grade IV glioma) patients rather than lower-grade gliomas, or glioma patients with no precision on tumor grade. Moreover, some of these studies analyzed samples performed after the patient received a medical oncological treatment (chemotherapy or radiation therapy). They advocate for the search of a circulating signature that would not be restricted to biomarkers directly derived from the tumor but include markers induced at a distance by the tumor. Indeed, slow-growing DLGG are likely to induce a systemic reaction to allow, for many years, an immuno-tolerance of the tumor. This reaction could have an impact on peripheral blood cells, including their RNA content.

In this study, the investigators aim at conducting an exploratory study in DLGG patients to explore the value of several blood-based biomarkers for the disease diagnosis and/or monitoring.

design_allocation: Non-Randomized

primary_purpose: Other

intervention_type: Biological


title: Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients Using 8 Sites Score

summary: Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess of mortality. The diagnosis of fluid overload in haemodialysis patient is routinely based on clinical examination which consists of cardiopulmonary auscultation and edema palpation of limb member. Clinical examination can be completed by paraclinical examinations, and bioimpedance is an objective tool that assess fluid overload state. This test provides an individualized hydration status and fluid overload based on normal extracellular volume considering body composition. Echocardiography allows an accurate assessment of blood volume status by simultaneous studying left ventricular filling pressures, systolic pulmonary artery pressure and the diameter of the inferior vena cava. Lung ultrasound analyses the B-lines defined as artefactual images resulting from contact between air in "alveoli" and water in "septa". It can estimate pulmonary congestion. The aim of the study is to evaluate the lung ultrasound using "8 sites" score accuracy for estimating fluid overload of patients before hemodialysis session.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Nasality Evolution in a Nasal Polyposis Context: Multiparametric Evaluation: Articulatory (Imaging), Aerodynamics, Acoustics and Perception

acronym: MultiNas

summary:
"Nasal polyposis is a chronic inflammation of the sinonasal mucosa which is characterized by the development of polyps in the sinonasal cavities. In the general population, its prevalence is 4% with a clear increase from the age of 50 years.

When drug treatment is not effective, and the patient's quality of life is impaired, surgery is proposed. It allows to widen the nasal cavities with aerodynamic and acoustics effects on speech. There are few studies, that have focused on the impact of NP and its treatment on speech. Yet there is a real demand from patients to obtain answers related to the impact of this surgery on their voice.

Preoperatively and postoperatively, the resonance will be disturbed: polyps will impacted the quality of the nasal sounds. And after surgery, the new anatomical shape can create an excessive resonance in the nasal cavities.

Indeed, there is a diversity of acoustic effects that differ according to the sinuses involved, the nature and type of surgery and the anatomical and physiological specificities of the patient.

The impairment of acoustic properties after surgery is diverse and little known.

The surgery improves the communication between sinuses and nasal cavities but the real impact on nasal resonance still unknown.

The particularity of this pathology stands in the obstruction of the sinonasal cavity by polyps. On this study, it represents a model of nasality disturbance/impairment ? Indeed, all aspects of nasality will be altered : the articulation by the obstruction of the sino-nasal cavities, the aerodynamic by a disturbance of the circulation of the airflow within the nasal cavity, acoustics by an alteration of the resonance of this flow, and finally the perception of speech by others where the comprehension of speech is difficult. Thus, the investigators wish to observe this dysfunction in a multipara metric way in order to have an accurate approach.

This population is therefore ideal. In preoperative, it will allow to measure by aerodynamic, articulatory, acoustic, and perceptive data taking this dysfunction, to give precise answers. Then, postoperatively, these measurements will be repeated to observe a return to the expected functioning of the nasal cavity. Indeed, the cavities being no longer congested, a greater flow of nasal air would be expected, which would have acoustic consequences on the resonance of nasal sounds. This could be accentuated because of the new anatomical configuration due to the surgery. Perceptually, the voice after surgery should no longer be considered as pathological.

In addition to the linguistics aspect, this population has the particularity of having a strongly impacted quality of life. The investigators would therefore like to measure this impact on quality of life before and after surgery.

For this study, the main objective is to measure the articulatory, aerodynamics, acoustics and perceptive impact of the nasal polyposis on speech before and after surgery.

the secondaries objectives are to:

Compare the differences in aerodynamic, acoustic, articulatory and perceptual changes between the ""presence of polyps in the nasal and sinus cavities"" group and the ""presence of polyps in the sinus cavities"" group
Compare the modifications on the speech of the pathology before and after surgical treatment
Identify the elements related to the quality of life impacted by this pathology.
Identify the glottic compensation strategies induced by the pathology
Compare preoperative and postoperative nasal resonance and the relationship between nasal and sinus cavities using 3D models
Validate the adequacy of the nasality-speech questionnaire for patients with sinonasal polyposis"

study_start_date_type: Anticipated

time_perspective: Prospective

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Sorbonne University


title: Study "HEMORROIDAL SURGERY AND Chronic Inflammatory Bowel Disease"

acronym: CHRMICI

summary:
Hemorrhoidal surgery is considered potentially harmful in patients with chronic inflammatory bowel disease (IBD). Patients with Crohn's disease may have ano-perineal involvement during the course of the disease or even before diagnosis. In addition, patients with IBD (Crohn's or RectoColitis Haemorrhagic, UC) may have rectal involvement. In both cases, hemorrhoidal surgery can be harmful to the anorectal level. However, recent data from the literature has proven to be reassuring. Indeed, the latest studies published on this subject have shown that hemorrhoidal surgery can be performed in a large majority of patients with IBD, especially when the disease is quiescent.

The main objective is to assess the morbidity of hemorrhoidal surgery in IBD patients who have been operated on at our center. Postoperative complications will be the main elements sought in the study.

The secondary objective is to search for predictive factors of complications from hemorrhoidal surgery in patients with IBD. This requires an exhaustive collection of clinical data.

ReferenceType: result

ReferenceCitation: Cracco N, Zinicola R. Is haemorrhoidectomy in inflammatory bowel disease harmful? An old dogma re-examined. Colorectal Dis. 2014 Jul;16(7):516-9. doi: 10.1111/codi.12555.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Jeffery PJ, Parks AG, Ritchie JK. Treatment of haemorrhoids in patients with inflammatory bowel disease. Lancet. 1977 May 21;1(8021):1084-5. doi: 10.1016/s0140-6736(77)92337-6.

ReferenceCitation: McKenna NP, Lightner AL, Habermann EB, Mathis KL. Hemorrhoidectomy and Excision of Skin Tags in IBD: Harbinger of Doom or Simply a Disease Running Its Course? Dis Colon Rectum. 2019 Dec;62(12):1505-1511. doi: 10.1097/DCR.0000000000001524.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Lightner AL, Kearney D, Giugliano D, Hull T, Holubar SD, Koh S, Zaghiyan K, Fleshner PR. Excisional Hemorrhoidectomy: Safe in Patients With Crohn's Disease? Inflamm Bowel Dis. 2020 Aug 20;26(9):1390-1393. doi: 10.1093/ibd/izz255.

publisher_dissemination: Oxford University Press

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Observational Study Evaluating Safety and Performance of Dental Implant Systems (5 Implant Ranges: IDAll, IDBio, IDCam, IDMax, ID3; 3 Types of Prosthetic Parts: Sealed, Screw-retained and Removable) in Subjects Followed During 18 Month

summary: Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery).

lead_sponsor: Implants Diffusion International

intervention_type: Device

lead_sponsor_type: industriel


title: Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia: PHARM-LMC Study

acronym: PHARM-LMC

summary:
The aim of this trial is therefore to identify concomitant treatments with taking Tyrosine Kinase Inhibitor (=TKI) in the indication of Chronic Myeloid Leukemia (CML), whatever the stage of the disease, via pharmaceutical conciliation. These concomitant treatments as well as their dosages will be correlated with the TKI dosage since patients must have a sufficient residual concentration to be considered effective and to confirm adherence to treatment, the leading cause of treatment failure.

In the event of unsatisfactory results, pharmaceutical interventions may take place: changes in treatments (TKI and not TKI) and / or dosages. In case of modification, a new dosage of TKI should be carried out.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: The E-consult Application for Patients With Breast Cancer: Interest in Empathy and Empowerment of Patients.

acronym: e-CONSULT

summary: Demonstrate that the use of this application in consultation could improve the empathy perceived of the doctors by the patients after the consultation.

lead_sponsor: Centre Francois Baclesse


title: Biological Material Bank for Studies Related to Organ Transplantation

summary:
This study aims to constitute a collection of biological materials from in transplant patients and to provide biological materials from transplanted patients in order :

i) validate new theory on the cause of allograft loss, ii) develop innovative biomarker for rejection and other transplantation-related conditions (such as BK virus nephropathy, Post-transplant lymphoproliferative disorder ( PTLD) ...)

lead_sponsor: Hospices Civils de Lyon


title: Effect of Neurodynamic Mobilization Techniques on Knee Extension Range of Motion of Asymptomatic Young Students: a Prospective, Comparative Study.

acronym: SPEAKER

summary:
Background: The neurodynamics technique seems interesting for increased lower limb flexibility of the lower limbs in healthy subjects. The objective of this study is to assess the physiological effects of the SLUMP sliding technique on the range of knee extension during the SLUMP test.

Methods: 60 physiotherapy students perform measurements during three tutorials. The first involves training in evaluation techniques. The second involves mobilizing the knee, out of the SLUMP position. The third tutorial includes neuronal mobilization in SLUMP.

Knee extension in SLUMP position is measured immediately after completing techniques. The mobilization amplitudes (degrees) will be compared between the techniques by a Student test on paired series, each subject being his own control.

Discussion: The results of this study will provide evidence for the physiological effect of SLUMP sliding techniques performed by physiotherapy students on the range of knee extension during the SLUMP test in asymptomatic subjects.

lead_sponsor: University Hospital, Rouen


title: Interest of Adding Neuromuscular Electrical Stimulation for Quadriceps Femoris and Triceps Surae Muscles to Pulmonary Rehabilitation in COPD : Randomized Clinical Trial

acronym: COMBIELEC

summary:
Patients with COPD frequently have muscle disorders. Pathogenic mechanisms generate significant pathophysiological changes in the locomotor muscles structure, leading to decreased strength, decreased endurance and limited exercise capacity.

Pulmonary rehabilitation is the first choice therapy and training overall lower limb endurance is a priority. Even if the effects of pulmonary rehabilitation are no longer to be demonstrated, it is still necessary to optimize the modalities of muscular strengthening. In fact, it is recommended to associate to this global endurance training a specific strengthening of the muscles of the lower limbs. Neuromuscular electrostimulation (NMES) is a muscular strengthening technique, but this method is not used in usual practice in pulmonary rehabilitation and often only the quadriceps are concerned. In a pulmonary rehabilitation program, including sessions of NMES of the quadriceps femoris and triceps surae could increase its effectiveness.

Recent studies suggest that NMES can improve muscle function, exercise tolerance, dyspnea and quality of life in COPD patients.

A pilot study compared the effects of the combined quadriceps femoris and triceps surae versus quadriceps alone. The final evaluation showed a greater improvement in exercise capacity in favour of the combined NMES group. Only two studies with small numbers of patients evaluated the effect of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation, with encouraging results in terms of functional gain. Further larger studies seem necessary to evaluate the effects of combined quadriceps femoris and triceps surae NMES in pulmonary rehabilitation. The objective of the study is to show that combined quadriceps femoris and triceps surae NMES during a pulmonary rehabilitation program provides a more significant improvement in exercise capacity compared to a standard pulmonary rehabilitation program.

design_allocation: Randomized

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Brest

appel_a_projets: PHRIP

region: Bretagne

nom_etablissement: CHRU BREST

type_etablissement: CHUR

acronyme: COMBIELEC

titre: Intérêt de l'électrostimulation neuromusculaire combinée des quadriceps et des triceps suraux lors d'un programme de réhabilitation respiratoire dans la BPCO.

discipline_principale: pneumologie

nom_porteur: Peran

prenom_porteur: Loic


title: Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes

acronym: IODIAB

summary: Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Spinal Cord Stimulation for Gait Disorders in Parkinson's Disease: a Pilot Study

acronym: SCM-PARK

summary:
Our project is based on the fundamental hypothesis that epidural spinal cord stimulation (SCS) improves Freezing of gait (FOG) in patients with Parkinson's disease. In eight patients implantation of electrodes for SCS at the epidural thoracic level will be performed under general anaesthesia.

Evaluation of gait and motor symptoms will be performed with and without stimulation, after a 3-month period for each of the stimulation conditions.This is a pilot, single centre, prospective, randomized, double blinded, cross-over study.

lead_sponsor: University Hospital, Grenoble

intervention_type: Procedure


title: Venous Congestion and Organ Dysfunction in Intensive Care: a Prospective, Multicenter, Observational Study to Evaluate Prevalence and Risk Factors.

acronym: CoDoRéa

summary:
Venous congestion, which is a phenomenon described in cardiology and post-operative cardiac surgery, is responsible for an increase in morbidity and mortality.

Indeed, it can lead to kidney failure, liver failure, prolonged ileus, scarring complications, and neurological disorders. Clinical and ultrasound indications have been described to diagnose this condition.

To date, this phenomenon is poorly known and not described in intensive care patients outside the cardiac context. However, intensive care patients can present the risk factors associated with the occurrence of congestion: acute cardiac failure, significant water-salt overload, and/or fluid distribution anomalies. Thus, observational studies have found an association between the input-output balance, the quantity of salt-water intake, the presence of right heart dysfunction and the occurrence of acute kidney failure, digestive disorders, hypoxemia and a prolonged stay in intensive care. The presence of a congestive condition is medically treatable since diuretic decongestion is associated with improved cardiac outcomes.

It is therefore necessary, in an intensive care context, to be able to define and diagnose this state of venous congestion, to study its prevalence, and to confirm the existence of a link with organ failure in order to pave the way to known adapted treatment options.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Defining the Severe Paediatric Asthma Endotype: an Integrated Approach Combining Phenotypic Analyses Related to Immune, Metabolomics and Microbial Features

acronym: SevAsthma

summary: The primary objective of this project is to extensively characterize the endotypes of pre-schoolers (0 to 6 years) and school-age children (6 to 12 years) with SA using an integrated approach, combining a description of their phenotype (asthma symptoms, atopy, and lung function) associated with histological (airway inflammation and remodelling), immune (innate and adaptive immunity), metabolomics, and microbiota analyses. This goal shall be achieved by an unsupervised in-depth analysis of patients requiring bronchial endoscopy, with bronchial alveolar lavage (BAL) and bronchial biopsy, as part of their clinical assessment.


title: Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients : ProCOVRA

acronym: ProCOVRA

summary: COVID-19 is an infectious disease caused by SARS-CoV2 virus. The objective of our study is to analyze the progression and the severity of COVID-19 in patients with RA. Indeed, few data are available on this subject, and this would allow us to improve management of COVID-19 in these potential at-risk patients.


title: Validation Study of the ALYATEC Allergen Exposure Chamber (EEC) by Determining the Concentration of Cat Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Cat

summary:
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the Alyatec environmental exposure chamber (EEC).

The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in Alyatec EEC.

lead_sponsor: Alyatec


title: Prevention of ICU-Related Anxiety in Lung Transplantation by Virtual Reality Therapy - PIRAT Study

acronym: PIRAT

summary: ICU patients frequently face complicated recovery processes, including long-term anxiety disorders. Lung transplantation (LTx) offers people with terminal respiratory conditions both the hope of prolonged survival and a better quality of life related to health. Among the disorders usually encountered in the postoperative period of LTx are anxio-depressive disorders. These anxiety disorders affect the quality of life related to health and compromise the follow-up of the patient by phenomenon of psychological disinvestment. Other psychological disorders are also anchored in the patient's experience of this post-surgical ICU period (ie, depressive episodes and/or, at a distance, post-traumatic stress disorder (PTSD). Various models of management of anxio-depressive disorders and PTSD are proposed in the literature. To our knowledge, while many of them have shown their efficiency in the curative management of disorders, few have demonstrated their effectiveness in preventing them. Exposure therapies using virtual reality (ETVR) have in the past demonstrated their effectiveness in many areas of psychiatry. In our study, experimental arm patients will be offered ETRV support with a virtual reality headset. A scenario with progressively increasing stress levels linked to the ICU environment and different situational contexts (alarms, etc.) will be presented to patients. This habituation to the potentially anxiety context of ICU will reduce the occurrence of psycho-cognitive disorders by progressive extinction phenomenon.

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hôpitaux de Marseille

intervention_type: Behavioral


title: Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care

acronym: ASPIC

summary:
Increasing emergence of multidrug resistant (MDR) bacteria worldwide is now considered one of the most urgent threats to global health. The association between increase of antibiotics consumption and resistance emergence has been well documented for all patients admitted to the Intensive care unit (ICU) who received antibiotic treatment and for patients treated for ventilator associated pneumonia (VAP).

Reduction of use of antibiotics is a major point in the war against antimicrobial resistance. VAP is the first cause of healthcare-associated infections in ICU and more than half of antibiotics prescriptions in ICU are due to VAP.

Once the diagnosis of pneumonia under MV has been made, initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration. In the case of a good clinical response to treatment, it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia (CAP).

The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.

The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia.

This study will be a prospective, national multicenter (31 centers), phase III, comparative randomized (1:1), single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms:

Experimental group: Antimicrobial stewardship based on daily clinical assessment of clinical cure.

Control group: standard management: duration of appropriate antibiotic therapy for confirmed VAP according to guidelines.

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: ASPIC

titre: optimisation de l'antibiothérapie pour les pneumonies précoces survenant chez les patients ventilés en réanimation

discipline_principale: anesthésiologie / réanimation

nom_porteur: FOUCRIER

prenom_porteur: Arnaud


title: Impact of Echo-endoscopy Biopsy on the Circulating Tumor Cell Level in the Portal System in Pancreatic Adenocarcinoma Management Care

acronym: EUS-CTC

summary: The aim of this work is to evaluate the impact of endoscopic procedures on the circulating tumoral cells level in order to evaluate the potential effects of an endoscopic procedure in the management of pancreatic tumors.

lead_sponsor: Institut Paoli-Calmettes


title: Risk Benefit Ratio of Hirudotherapy: Retrospective Single-center Study of 37 Cases Over a Period of 9 Years

acronym: AMLEE

summary:
Venous congestion in transplanted or re-implanted tissues remains a common and chal-lenging complication in plastic and reconstructive surgery. Local application of medicinal leeches is effective to reduce postoperative venous congestion of the flap and to restore normal blood flow. However, leech therapy is associated with a number of risks, including infections. Indeed, leeches maintain a symbiotic relationship with Aeromonas species in order to digest blood in their gut. Aeromonas spp. infections can occur 1 to 30 days post-application of leeches and are associated with a dramatic decrease in flap salvage rates (88 to 30%). For these reasons, prophylactic antibiotics and, external decontamination are widely recommended throughout the course of leech therapy.

The aim of this study is to investigate the prevalence of side effects (anemia and infection) from patients treated with leeches in French Hospital.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Prospective Evaluation of Transplacental Transmission of SARS-COV-2 (COVID-19) in a Cohort of 10 Mother/Child Dyads

summary:
SARS-CoV-2, the agent responsible for pandemic COVID-19 infection, is transmitted mainly by respiratory droplets. Regarding maternal-fetal transmission, even if the mode of transmission from mother to fetus is not clear, some cases of perinatal transmission have been described, but without certainty on the routes of placental contamination, trans-cervical or by environmental exposure. .

The case described by J. Vivanti of a newborn with neonatal neurological involvement and whose mother had been infected during the last trimester of pregnancy reports possible transplacental transmission in a context of positive and elevated viremia in the mother and positive viremia in the newborn.

status: Terminated

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Safety and Efficacy of a Strategy Extending Duration of Prone Position in COVID-19-related ARDS Patients. a Retrospective Monocentric Observational Study

summary: Prone position (PP) is standard of care for mechanically ventilated patients with severe acute respiratory distress syndrome in the intensive care unit (ICU). Recommendations suggest PP durations of at least 16 hours. In 2020, COVID-19 pandemic led to a great number of patients requiring mechanical ventilation and PP in the ICU. Risk of ICU staff viral contamination and work overload led to prolongation of PP duration up to 48 hours. Here investigators report outcomes of prolonged PP sessions in terms of skin complications (pression injuries) and ventilatory improvement.

ReferenceType: background

ReferenceCitation: Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Papazian L, Aubron C, Brochard L, Chiche JD, Combes A, Dreyfuss D, Forel JM, Guerin C, Jaber S, Mekontso-Dessap A, Mercat A, Richard JC, Roux D, Vieillard-Baron A, Faure H. Formal guidelines: management of acute respiratory distress syndrome. Ann Intensive Care. 2019 Jun 13;9(1):69. doi: 10.1186/s13613-019-0540-9.

ReferenceCitation: Nasa P, Azoulay E, Khanna AK, Jain R, Gupta S, Javeri Y, Juneja D, Rangappa P, Sundararajan K, Alhazzani W, Antonelli M, Arabi YM, Bakker J, Brochard LJ, Deane AM, Du B, Einav S, Esteban A, Gajic O, Galvagno SM Jr, Guerin C, Jaber S, Khilnani GC, Koh Y, Lascarrou JB, Machado FR, Malbrain MLNG, Mancebo J, McCurdy MT, McGrath BA, Mehta S, Mekontso-Dessap A, Mer M, Nurok M, Park PK, Pelosi P, Peter JV, Phua J, Pilcher DV, Piquilloud L, Schellongowski P, Schultz MJ, Shankar-Hari M, Singh S, Sorbello M, Tiruvoipati R, Udy AA, Welte T, Myatra SN. Expert consensus statements for the management of COVID-19-related acute respiratory failure using a Delphi method. Crit Care. 2021 Mar 16;25(1):106. doi: 10.1186/s13054-021-03491-y.

ReferenceCitation: Sud S, Friedrich JO, Adhikari NK, Taccone P, Mancebo J, Polli F, Latini R, Pesenti A, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L, Guerin C. Effect of prone positioning during mechanical ventilation on mortality among patients with acute respiratory distress syndrome: a systematic review and meta-analysis. CMAJ. 2014 Jul 8;186(10):E381-90. doi: 10.1503/cmaj.140081. Epub 2014 May 26.

ReferenceCitation: Labeau SO, Afonso E, Benbenishty J, Blackwood B, Boulanger C, Brett SJ, Calvino-Gunther S, Chaboyer W, Coyer F, Deschepper M, Francois G, Honore PM, Jankovic R, Khanna AK, Llaurado-Serra M, Lin F, Rose L, Rubulotta F, Saager L, Williams G, Blot SI; DecubICUs Study Team; European Society of Intensive Care Medicine (ESICM) Trials Group Collaborators. Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study. Intensive Care Med. 2021 Feb;47(2):160-169. doi: 10.1007/s00134-020-06234-9. Epub 2020 Oct 9. Erratum In: Intensive Care Med. 2021 Apr;47(4):503-520.

ReferenceCitation: Gaudry S, Tuffet S, Lukaszewicz AC, Laplace C, Zucman N, Pocard M, Costaglioli B, Msika S, Duranteau J, Payen D, Dreyfuss D, Hajage D, Ricard JD. Prone positioning in acute respiratory distress syndrome after abdominal surgery: a multicenter retrospective study : SAPRONADONF (Study of Ards and PRONe position After abDOmiNal surgery in France). Ann Intensive Care. 2017 Dec;7(1):21. doi: 10.1186/s13613-017-0235-z. Epub 2017 Feb 24.

ReferenceType: derived

ReferenceCitation: Walter T, Zucman N, Mullaert J, Thiry I, Gernez C, Roux D, Ricard JD. Extended prone positioning duration for COVID-19-related ARDS: benefits and detriments. Crit Care. 2022 Jul 8;26(1):208. doi: 10.1186/s13054-022-04081-2.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

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

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Hôpital Louis Mourier

location_facility: Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris


title: Primary Care in AURA for Covid-19: Implementation of a Regional Practice-based Surveillance Network

acronym: SOPRAC

summary: As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.

lead_sponsor: Research on Healthcare Performance Lab U1290


title: Cost-utility Analysis of Fenestrated Aortic Stents Versus Open Surgery for the Treatment of Complex Abdominal Aortic Aneurysms: a Prospective Multicenter Comparative Cohort Study

acronym: ORFEVAR

summary:
Introduction: Complex abdominal aortic aneurysms (CAA) are defined as abdominal aneurysms that are anatomically unsuitable for a standard endovascular repair because of a short infrarenal neck or no infrarenal neck. These CAAA are usually treated either by fenestrated endovascular aortic repair (FEVAR) or open repair (OR). Data comparing these thechniques remain scarce, mainly consisting of systematic reviews based on retrospective studies. Although mid-term and long-term results remain uncertain, FEVAR has gained widespread acceptance in the vascular community. However, this practice is not evidence base. Beyond clinical results, whether FEVAR is cost-effective or not is not demonstrated. A randomized controlled trial comparing FEVAR and OR is unlikely to be conducted since centers have developed specific expertise and practice, and most of surgeons are not keen to randomize patients. Thus, we believe that a prospective comparative multicentric cohort, with a propensity score and minimization of selection, classification and confusion bias is the most realistic way to provide reliable comparative data on cost effectiveness of FEVAR and OR. Overall, 382 patients are expected to be included (159 in each group).

Objective: The objective of this prospective non-randomized comparative multicenter cohort study is to compare the cost effectiveness incremental ratio at 36 months of FEVAR and OR for CAAA.

Method: Patients with CAAA discussed for FEVAR or OR in 37 french vascular centers in during a two years inclusion period constitute the population study. Preoperative and postoperative clinical and imaging data will are collected prospectively in eCRF forms. QOL before and after treatment is assessed by the E5D5L. The follow-up period is three years. The primary outcome is the Incremental cost-utility ratio (cost/QALY) at 36 months. We plan to minimize indication biases by using a proposensity score (proposnsity score maching and Inverse probablility of treatment weighting) based on clinical and anatomic characteristics. Patient at prohibitive risk for OR are excluded. Patient anatomically unsuitable for FEVAR are also excluded .

Conclusion: This study should provided valuable data on cost effectiveness of FEVAR for CAAA. Sub-goup analysis will be also conducted.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

appel_a_projets: PRME

acronyme: ORFEVAR

titre: Analyse coût / utilité des endoprothèses aortiques fenêtrées versus chirurgie ouverte pour le traitement des anévrysmes aortiques para-rénaux: une étude de cohorte prospective comparative multicentrique

discipline_principale: chirurgie viscérale et digestive

nom_porteur: Cochennec

prenom_porteur: Frédéric


type: Registry Identifier

title: Study of Complications Related to Treatments in Adults Aged 18 to 65 Years Old Responding to a First Treatment in Oncology or Onco-hematology and Participating in the PASCA (PArcours de Santé au Cours du CAncer) Post-treatment Program.

acronym: PASCA

summary:
INTRODUCTION: Approximately 44% of cancer survivors experience a deteriorated quality of life 5 years after diagnosis due to late onset of complications related to cancer treatments. The objective of the study is to evaluate the incidence rates of treatment-related complications, identify sub-clinical abnormalities and risk factors in patients participating in the PASCA post-treatment program.

METHOD: PASCA is a single-center, interventional cohort study of adult patients who received at least chemotherapy and with a complete remission to a testicular germ cell tumor, primary non-metastatic invasive breast carcinoma, high-grade soft tissue sarcoma, osteosarcoma, Ewing's sarcoma, acute myeloid leukemia, Hodgkin's or aggressive non-Hodgkin's lymphoma. Four assessment visits will be scheduled at 1 month (T1), 6 months (T2), 24 months (T3) and 60 months (T4) after completion of treatment. During these visits, 22 complications will be screened and follow-up care will be systematically offered to the health professional concerned by the complication in case of a positive result. The screening will contain the following elements: screening self-questionnaires, quality of life questionnaire, 12 biological parameters, a urinalysis evaluating hematuria, proteinuria, and leukocyturia, a spirometry, an electrocardiogram, 5 tests evaluating physical condition, vital signs and the perimetric measurement between both arms.

DISCUSSION: This systematic screening could highlight a number of complications occurring after cancer treatments. Sub-clinical abnormalities and new risk factors could also be identified. This new organization of care could improve the quality of life of adult cancer survivors.

primary_purpose: Prevention

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
Malakoff-Humanis
Fondation Apicil
Fédération Leucémie Espoir
Biogaran
Le défi Anthony
Novartis
Roche Pharma AG


title: Evaluation of the ExacTrac® Imaging Device for the Repositioning Quality of Patients Undergoing an External ENT Radiotherapy

acronym: ST-IGRT-ORL

summary:
Monocentric, category 2 study according to Jardé Law (minimal risks and constraints) of three prospective cohorts: Tumors located at the oropharynx, the oral cavity and the larynx-hypopharynx.

The main objective is to evaluate the 3D vector of the absolute residual positioning error observed with the CBCT reference imaging, after repositioning performed with ExacTrac®.

The secondary objectives are to evaluate: 1) the rate of residual errors ≥2mm (translations in all directions) and ≥2 ° (rotations in all directions) on CBCT imaging after repositionning with the ExacTrac® system; 2) the Evaluation of intrafraction movements amplitude by analyzing the ExacTrac® images taken during the irradiation; 3) the evolution of the relative position of the volume of the tumor at high risk of recurrence (CTVTHR) in relation to the spine over the entire duration of the treatment; 4) the impact of patient's weight loss, the advancement of RT and the realization of a chemotherapy / targeted therapy concomitant with RT, on the evolution of the relative position of the CTVTHR in relation to the column vertebral; 5) the dosimetric consequence of a strict bone registration on the CTVTHR coverage by calculating the post-treatment dose on the CBCT imaging.

intervention_type: Radiation

region: Auvergne-Rhône-Alpes

nom_etablissement: CENTRE LEON BERARD

type_etablissement: CLCC

acronyme: ST-IGRT-ORL

titre: Evaluation du dispositif d'imagerie ExacTrac® pour la qualité du repositionnement des patients bénéficiant d'une radiothérapie externe ORL

discipline_principale: radiothérapie

nom_porteur: BOISBOUVIER

prenom_porteur: Sophie


title: Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery

acronym: QLB

summary:
Abdominoplasty is a common surgical procedure in plastic surgery which causes postoperative pain and may delay patients' recovery. Surgery is potentially associated with a number of postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or digestive … Although they do not inevitably lead to a life-threatening prognosis, in many cases these complications delay post-operative recovery. Defined in the 1990s by Professor Henry Kehlet's Danish team, rapid rehabilitation after planned surgery is an approach to overall patient care that aims to rapidly restore previous physical and mental capacities and thus significantly reduce mortality and morbidity. Pain management is at the heart of this program and local anesthesia techniques are at the heart of early rehabilitation programs.

Described for just over a decade, Quadratus Lumborum Block (QLB) have shown their effectiveness for analgesia in abdominal, or orthopedic, or obstetrical surgery. Considering the anatomical territory concerned, this locoregional anesthesia technique seems to be very interesting in abdominoplasty to allow early rehabilitation of the patient.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Role of the Microbiota in the Evolution of the SARS-CoV-2 Disease in Hospitalized Patients

acronym: MicrobioCOVID

summary:
Patients hospitalized for COVID-19 may need intensive care (e.g. mechanical ventilation) during hospitalization. Some risk factors are already known but better targeting of such patients is still needed, at least because existing risk factors are not strong enough to provide an accurate prediction. Care organization would benefit for such a predictive tool.

Oropharyngeal and gut microbiota could potentially fill a significant gap in predictive performances. The investigators therefore propose to sample 200 patients (oropharyngeal and rectal swab) admitted in infectious disease department at Bichat Hospital and at high risk of needing intensive care during hospitalization. The investigators plan to perform metagenomic sequencing and bioinformatic analysis of these samples to characterize the diversity of bacterial species present in the oropharynx and the gut and to identify new factors associated with the need for intensive care. Aside metagenomic analyses, The investigators will perform semi-quantitative cultures of the oropharyngeal and gut microbiota to identify and quantify pathogens in order to predict the risk of bacterial infections in COVD-19 patients.

For patients transferred in intensive care unit, The investigators will to perform another series of samples to better characterize the evolution of microbiota during mechanical ventilation and identify factors associated with the risk of developing a ventilator-associated pneumonia.

Microbiota data will be considered together with the host genotype, the viral sequence and a deep immunological profiling to identify the main determinants of the evolution toward severity of COVID-19.


title: Observational Study of Glycemic Control and Self-management of Young People (Aged 13 to 25 Years ) With Type 1 Diabetes During COVID-19 Lockdown.

acronym: COVIDIABADO

summary:
Lockdown resulting from the COVID-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (T1D) whose lifestyle is known to strongly impact disease management. The investigators aimed to assess changes in self-monitoring and glycemic control in this population before, during, and after the two-month French lockdown. Te investigators hypothesized an improvement in glucose control and glucose sensor usage.

The protocol will include all patients with T1D from 13 to 25 years old using a flash glucose monitoring related to the LibreView cloud platform.

The primary outcome, evolution of percentage of glucose time in range 70-180 mg/dL (TIR), and secondary outcomes (glucose management indicator GMI, time spent below range TBR, and sensor usage) will be analyzed with a linear mixed-effects regression model.


title: Hospital Interns Psychological State During the COVID-19 Pandemic

acronym: RESICOV

summary:
The mental health of the French population in response to covid-19 pandemic is of concern.

Health professionals are prone to more mental disorders due to their direct exposure to the pandemic consequences. Indeed, compared to general population, health care workers face enormous in the current health situation, especially those who may be in contact with suspected or confirmed cases (risk of infection, inadequate protection, loss of control, lack of experience in managing the diseases, overwork, stigma, lack of support). Thus, it seems interesting to describe the psychological state of hospital interns during this pandemic.

lead_sponsor: University Hospital, Montpellier


title: Return to Work and Functional Results of French Soldiers After Anterior Cruciate Ligament Reconstruction

summary:
The return to work in the military population after surgical reconstruction of the anterior cruciate ligament (ACL) has been poorly investigated within the French armed forces. Only American studies are available and show that this surgery has a significant impact on the operational capacity of soldiers.

ACL rupture is extremely frequent in active populations. This pathology has already been extensively explored in at-risk populations, particularly in sports. Most studies show that the resumption of sport is greatly affected by this pathology.

Furthermore, an over-risk (10 times greater incidence of ACL rupture) in the military has been demonstrated.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Impact of Respiratory Rehabilitation on Quality of Life, Measures by the SF-36 Score, in Patients With Hyperventilation Syndrome: Crossover, Prospective and Randomized Study

acronym: RESPIR-HVS

summary: The hyperventilation syndrome is a quite frequent pathology, affecting up to 10% of the general population and 40% of the asthmatic population. Its physiopathology is still badly known and even if it is a benign affection, its associated comorbidities and symptomatology greatly decrease the patients' quality of life. Yet, no medicinal treatments have been proved useful, but prescribers noticed improvements after physiotherapy. Given that the physiotherapy impact on hyperventilation syndrome is not well described in the literature, this study aims to scientifically ascertain physiotherapy benefits on quality of life and symptomatology in hyperventilation syndrome-suffering patients.

ReferenceCitation: Gardner WN. The pathophysiology of hyperventilation disorders. Chest. 1996 Feb;109(2):516-34. doi: 10.1378/chest.109.2.516. No abstract available.

ReferenceCitation: Lewis RA, Howell JB. Definition of the hyperventilation syndrome. Bull Eur Physiopathol Respir. 1986 Mar-Apr;22(2):201-5.

ReferenceCitation: Thomas M, McKinley RK, Freeman E, Foy C. Prevalence of dysfunctional breathing in patients treated for asthma in primary care: cross sectional survey. BMJ. 2001 May 5;322(7294):1098-100. doi: 10.1136/bmj.322.7294.1098.

ReferenceCitation: Lewis T, Cotton, Barcroft J, Dufton D, Milroy TR, Parsons TR. BREATHLESSNESS IN SOLDIERS SUFFERING FROM IRRITABLE HEART. Br Med J. 1916 Oct 14;2(2911):517-9. doi: 10.1136/bmj.2.2911.517. No abstract available.

ReferenceCitation: van Dixhoorn J, Duivenvoorden HJ. Efficacy of Nijmegen Questionnaire in recognition of the hyperventilation syndrome. J Psychosom Res. 1985;29(2):199-206. doi: 10.1016/0022-3999(85)90042-x.

ReferenceCitation: Vansteenkiste J, Rochette F, Demedts M. Diagnostic tests of hyperventilation syndrome. Eur Respir J. 1991 Apr;4(4):393-9.

ReferenceCitation: Nixon PG. Effort syndrome: hyperventilation and reduction of anaerobic threshold. Biofeedback Self Regul. 1994 Jun;19(2):155-69. doi: 10.1007/BF01776488.

ReferenceCitation: Chenivesse C, Similowski T, Bautin N, Fournier C, Robin S, Wallaert B, Perez T. Severely impaired health-related quality of life in chronic hyperventilation patients: exploratory data. Respir Med. 2014 Mar;108(3):517-23. doi: 10.1016/j.rmed.2013.10.024. Epub 2013 Nov 7.

ReferenceCitation: Kraft AR, Hoogduin CA. The hyperventilation syndrome. A pilot study on the effectiveness of treatment. Br J Psychiatry. 1984 Nov;145:538-42. doi: 10.1192/bjp.145.5.538.

ReferenceCitation: Van De Ven LL, Mouthaan BJ, Hoes MJ. Treatment of the hyperventilation syndrome with bisoprolol: a placebo-controlled clinical trial. J Psychosom Res. 1995 Nov;39(8):1007-13. doi: 10.1016/0022-3999(95)00508-0.

ReferenceCitation: Hoes MJ, Colla P, Folgering H. Clomipramine treatment of hyperventilation syndrome. Pharmakopsychiatr Neuropsychopharmakol. 1980 Jan;13(1):25-8. doi: 10.1055/s-2007-1019606.

ReferenceCitation: Jones M, Harvey A, Marston L, O'Connell NE. Breathing exercises for dysfunctional breathing/hyperventilation syndrome in adults. Cochrane Database Syst Rev. 2013 May 31;(5):CD009041. doi: 10.1002/14651858.CD009041.pub2.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Use of Nomogram for Predictions of Ocular Mysathenia Gravis Generalization

acronym: MYASTEN

summary: Secondary ocular myasthenia gravis (OMG) generalization represents a pejorative evolution and no validated generalization prevention strategy exists. The aim of this observational study was to determine the percentage of patients with OMG generalization and identify factors predictive of that pejorative evolution. Data from patients with OMG registered in the Fondation Hospital A. de Rothschild database between January 1990 and January 2017 were collected. Among the 183 patients registered in this database, 151 patients with available informations were analyzed.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle: A Cross-sectional Observational Multicenter Prospective Study

summary:
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex. As a result of the improved patient care over the last decades, the number of children and adults with single ventricle is increasing significantly. Today, the main challenge is to ensure an optimal follow-up of these new patients in order to improve their life expenctancy as well as their quality of life (QoL). Currently, echocardiography and cardiopulmonary exercice test (CPET) are central in management of patients with single ventricle as part of good clinical practice guidelines.

Single ventricle volumes and function are very difficult to asses with conventional echocardiography because of their complex geometry. Indeed, single ventricle size and morphology vary depending on the patient characteristics and on the initial CHD (before surgical repair). That's why conventional 2D echocardiographic parameters are not reliable for single ventricle assessment.

Magnetic resonance imaging (MRI) is more effective in assessing single ventricle volumes and function. Nevertheless, MRI is not universally available, is not practical in many situations, is expensive, and is a relative contraindication in patients with pacemakers.

Over the past decade, the use of the 3D echocardiography has increased. This is an available tool that can assess ventricular function and volumes in few seconds. Recent studies shown a good correlation between 3D echocardiography and MRI for assessment of ventricular volumes and function in patient with CHD and especially in those with single ventricle.

Moreover, according to some authors, CPET parameters are strongly correlated with risk of hospitalization, risk of death, physical activity and quality of life, especially in patients with single ventricle.

To date, there is no study performed about the relationship between 3D echocardiography and CPET parameters in patients with single ventricle.

time_perspective: Cross-Sectional

ReferenceCitation: Femenia V, Pommier V, Huguet H, Iriart X, Picot MC, Bredy C, Lorca L, De La Villeon G, Guillaumont S, Pasquie JL, Matecki S, Roubertie F, Leobon B, Thambo JB, Jalal Z, Thomas J, Mouton JB, Avesani M, Amedro P. Correlation between three-dimensional echocardiography and cardiopulmonary fitness in patients with univentricular heart: A cross-sectional multicentre prospective study. Arch Cardiovasc Dis. 2023 Apr;116(4):202-209. doi: 10.1016/j.acvd.2023.02.002. Epub 2023 Mar 9.

sponsor_collaborators:
University Hospital, Montpellier
University Hospital, Bordeaux


title: Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors

summary: The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.

lead_sponsor: Smart Immune SAS

location_facility: CIC Paris Est, Hôpital Pitié Salpêtrière


title: Evaluation of Pétale® (Small Hearing Test Equipment for Children) for the Screening of Hearing Disorders in Children From 9 Months to 3 Years Old by the General Practitioner or Pediatrician

acronym: PETALE

summary: The aim of this study is to confirm the value of this new version of Pétale® ((small equipment for testing the child's hearing) in the daily practice of general practitioners or pediatricians for the screening of hearing disorders in very young children.

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
European Clinical Trial Experts Network


title: Monocentric Single-blind Randomized Controlled Trial Evaluating the Impact of the Addition of a Specific and Personalized Body Approach by Osteopathic Treatment in the Care of Adolescents With Anorexia Nervosa

acronym: ACAMTO

summary:
Abstract:

Background: Anorexia nervosa (AN) is a common pathology affecting mainly women (sex ratio 1/10), which starts most often during adolescence. The prognosis of the AN remains poor (10% of deaths and high risk of chronicity). Body dissatisfaction, disturbances in recognition and identification of body sensations are some of the key symptoms of AN. There is, however, a contrast between this consensual observation of the importance of troubles in body image in AN, and the relative deficit of specifically targeted body treatments. Our proposal for a body approach specifically dedicated to AN is based on the understanding that posture, breathing, muscle tension and body perception are closely linked to our psychological and emotional state, and are therefore disturbed in patients with AN.

The purpose of this monocentric randomized controlled trial is to evaluate if a targeted osteopathic protocol treatment for AN in addition to as-usual care is significantly more effective compared to as-usual care.

Methods: Seventy-two female patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups : one receiving the specific osteopathic treatment targeted for AN in addition to the as-usual care (group A) and the other one, the as-usual care (group B). The patients of group A will receive 5 sessions of osteopathic treatment for 25 minutes. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be realized. The as-usual care is defined by the multidisciplinary approach recommended by the high authority of health. The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms and assessment of somatic dysfonctions' evolution. A qualitative study will also be carried out, applying the Interpretative Phenomenological Analysis method. Patients will be included for a maximum of 14 weeks between the inclusion time and the last evaluation.

Discussion:

If the results of the study are positive (statistically significant effectiveness of this body approach in addition to as-usual care compared to as-usual treatment), patients with anorexia will be benefit from the possibility of additional treatment that is effective, relatively inexpensive, non-invasive and non-pharmacological.

ReferenceCitation: Letranchant A, Montebello YK, Bigre CD, Wagner A, Curt F, Silva J, Nicolas I, Votadoro P, Kalindjian N, Korchonnoff A, Gutierre A, Novelli AB, Pham-Scottez A, Corcos M. The ACAMTO study-impact of add-on osteopathic treatment on adolescent patients with anorexia nervosa: study protocol for a randomized controlled trial. Trials. 2021 Nov 24;22(1):839. doi: 10.1186/s13063-021-05810-8.

repositories_concat: PubMed Central

lead_sponsor: Institut Mutualiste Montsouris

sponsor_collaborators:
Institut Mutualiste Montsouris
Fondation de l'Avenir


title: Validation of COVILUS Score in Patients Suspected of COVID-19 Infection in the Emergency Room

summary: Covid-19 (English acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called SARS-CoV-2. The current pandemic has resulted in a significant number of admissions in the emergency room (ER) due to suspicion of COVID-19 infection. Use of lung ultrasound is standard practice to diagnose acute respiratory failure in ER. Recently, typical lung ultrasonographic characteristics of COVID-19 disease has been described. The investigators demonstrated that the association of 4 signs in pulmonary ultrasound associated with a clinical sign (COVILUS score) could predict the occurrence of a positive RT-PCR in patients suspected of COVID-19 infection admitted to the emergency room. The investigators are going to conduct a new study to validate this COVILUS score in this type of patient. The main objective will be to validate the diagnostic performance of lung ultrasound in patients admitted to the emergency room with suspected COVID19 infection.

intervention_type: Diagnostic Test


title: SKin and Soft Tissue Necrotizing INfections in the Intensive Care Unit: a Prospective Multi-national Cohort Study

acronym: SKIN-ICU

summary:
Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few prospective studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. The "SKin and soft tissue necrotizing INfections in the ICU" (SKIN-ICU) study is a multinational prospective non-interventional cohort study that will include patients admitted to the ICU/intermediate care unit for NSTI or not.

The objectives of the study are :

To assess hospital (i.e., ICU and hospital mortality) and medium-term (day-90 mortality, functional outcomes and health-related quality of life scores, HR-QoL) outcomes
To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life

ReferenceCitation: Stevens DL, Bryant AE. Necrotizing Soft-Tissue Infections. N Engl J Med. 2017 Dec 7;377(23):2253-2265. doi: 10.1056/NEJMra1600673. No abstract available.

ReferenceCitation: Urbina T, Canoui-Poitrine F, Hua C, Layese R, Alves A, Ouedraogo R, Bosc R, Sbidian E, Chosidow O, Dessap AM, de Prost N; Henri Mondor Hospital Necrotizing Fasciitis Group. Long-term quality of life in necrotizing soft-tissue infection survivors: a monocentric prospective cohort study. Ann Intensive Care. 2021 Jul 2;11(1):102. doi: 10.1186/s13613-021-00891-9.

ReferenceCitation: Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America. Clin Infect Dis. 2014 Jul 15;59(2):147-59. doi: 10.1093/cid/ciu296. Epub 2014 Jun 18.

ReferenceCitation: Peetermans M, de Prost N, Eckmann C, Norrby-Teglund A, Skrede S, De Waele JJ. Necrotizing skin and soft-tissue infections in the intensive care unit. Clin Microbiol Infect. 2020 Jan;26(1):8-17. doi: 10.1016/j.cmi.2019.06.031. Epub 2019 Jul 5.

ReferenceCitation: Madsen MB, Skrede S, Bruun T, Arnell P, Rosen A, Nekludov M, Karlsson Y, Bergey F, Saccenti E, Martins Dos Santos VAP, Perner A, Norrby-Teglund A, Hyldegaard O. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT): protocol and statistical analysis plan. Acta Anaesthesiol Scand. 2018 Feb;62(2):272-279. doi: 10.1111/aas.13024. Epub 2017 Oct 29.

lead_sponsor: Henri Mondor University Hospital

collaborators: European Society of Intensive Care Medicine


title: Epidemiology of CoV-2 SARS Infections: Dynamics of Community Contamination in Children and Adults

summary: Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (RSV) where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.

lead_sponsor: Hospices Civils de Lyon


title: Description of Immunologic, Enzymatic and Metabolic Biomarkers Associated to the Severity of COVID-19 and Its Resolution

acronym: BIOMARK-COVID

summary: Prospective study to describe the immunological, metabolic and serologic profile in the acute and post acute phases of Coronavirus disease (COVID-19)

lead_sponsor: Poitiers University Hospital


title: Comparison of Changes in the Quality of Life of Patients Operated on Breast Cancer at the Drôme Ardèche Breast Institute According to Access to Supportive Oncological Care

acronym: IDSein

summary: The aim of this study is to explore the quality of life of cancer patients, in particular women operated on breast cancer, throughout their care journey, taking into account their access to supportive oncological care within and outside the establishment care.


title: IMMunological resPonse Assessment afteR Acute iSchemic Stroke Treated With Endovascular Therapy

acronym: IMPRESS

summary: IMPRESS study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the first 24/36 hours of treatment of patients suffering from AIC treated with TM, and to study the possible impact of these profiles on the functional prognosis at 3 months of AIC treatment.

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild


title: Change in Coronary Microcirculation and Fractional Flow Reserve After Transcatheter Aortic Valve Implantation in Patients With Concomitant Coronary Artery Disease and Severe Aortic Stenosis.

summary:
Change in coronary microcirculation and Fractional Flow Reserve after Transcatheter Aortic Valve Implantation in patients with concomitant coronary artery disease and severe aortic stenosis.

Severe aortic stenosis is the most common indication of valvular replacement in developed countries. Stable coronary artery disease (CAD) is frequently associated with severe aortic stenosis in patients treated by Transcatheter Aortic Valvular Implantation (TAVI). Its prognostic impact is not clearly established, and available studies uncommonly used functional assessment of severity from a coronary stenosis to stratify the risk in this situation.

Fractional Flow Reserve (FFR) is recommended to guide revascularization by percutaneous coronary intervention (PCI) in clinical practice. Its use is not validated in patients with severe aortic stenosis. Left ventricular hypertrophy induced by aortic obstruction leading to microvascular disorders, and can alter coronary reserve, possibly biasing FFR values. After aortic valvular replacement, a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment.

The aim of the study is to assess the effects of inverse myocardial remodeling on coronary microcirculatory function and its association with FFR values before and after TAVI.

lead_sponsor: Nantes University Hospital


title: Intraoperative Conversion During Video-assisted Thoracoscopy Resection for Lung Cancer Does Not Alter Survival

acronym: ICVATR

summary:
Anatomical resection with systematic lymph-node dissection is currently the standard of care for the treatment of early stage non-small cell lung cancer. The use of minimally invasive approaches has increased greatly over the last two decades [either video-assisted thoracoscopic surgery (VATS) or robotic-assisted thoracoscopic surgery (RATS)], as they provide the patient with better outcomes than open thoracotomy. Minimally invasive VATS lobectomy for a standard case is generally a straightforward procedure for a well-trained surgical team, although concomitant preoperative pathologies or intraoperative findings/adverse events may result in technical difficulties, leading to intraoperative conversion, commonly by thoracotomy.

The investigators aimed to assess long-term outcomes in a consecutive cohort of patients treated by anatomical pulmonary resection either using VATS, VATS requiring intraoperative conversion to thoracotomy, or upfront open thoracotomy for lung-cancer surgery.


title: Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation

acronym: PSIC-TSA

summary: An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them keep it. The aim of this study is to evaluate the causes of this disparity, which is much greater than in children with cochlear implants without associated Autism Spectrum Disorders. Our problem is as follows: do the sensory hypersensitivity and hyposensitivity of deaf children with Autism Spectrum Disorders have an effect on the expected results after a cochlear implantation from a language and auditory reaction point of view?

lead_sponsor: University Hospital, Toulouse


title: From Micro- to Macro-vessels : Water, Salt, Heart and Kidneys

acronym: ConcentRatio

summary: Hypertension is a public health concern and affects nearly a third of the French population. It can be complicated by visceral impact (including brain, heart and kidney complications) as well as on vessels especially large arteries, responsible for arterial stiffening. There are close interactions between heart and kidneys, as well as between large arteries and micro-vessels. These relationships also involve the water and salt balance and its regulatory mechanisms. Urinary concentration abilities are closely linked to the renal medullary blood flow, which in itself depends on the integrity of renal micro vessels, thus influencing the water and salt balance. Few previous studies evaluated the interconnections between renal urinary concentration abilities and blood pressure. A previous-one reported a positive relation between pulse pressure and urinary concentration in men, suggesting that subjects with higher urinary osmolarity could present a higher cardiovascular risk. Carotid-femoral pulse wave velocity represents the gold standard for non-invasive arterial stiffness assessment and constitutes an arteriosclerosis infra-clinical marker recommended by the European Society of Cardiology- European Society of Hypertension. It is considered as an independent predictor for global and cardiovascular mortality, coronary heart disease and fatal stroke among patients with hypertension, diabetes or end stage kidney disease. The purpose of this study is to evaluate the relations between fasting urinary osmolarity and arterial stiffness assessed by carotid-femoral pulse wave velocity (CF-PWV) among patients with hypertension.

location_facility: Centre Interdisciplinaire de Thérapeutique et d'Education APHP- Hôtel Dieu Hospital


title: Functional Neurological Disorders in Patients Admitted in Stroke Units: Clinical Profile et and 6 Months Follow-up

acronym: NEUROFON

summary: Functional neurological disorders are an important subgroup of patients with stroke mimics admitted to stroke unit.Their clinical profile and outcome are poorly known. The goal of this study is to describe the cognitive and behavioral profile of stroke mimics patients, without evidence of neurological disease.


title: Assessment of a Composite Prognostic Score to Predict Severe Forms of Ischemic Colitis of Montpellier

summary: Our objective is to determine a prognostic score including CT, clinical and biological criteria predicting the serious (death / surgery) or non-serious (medical treatment) evolution of ischemic colitis and therefore possibly modify the therapeutic management (propose surgical treatment for a severe form based on prognostic score).


title: Prevalence and Characteristics of Alterations in Olfactory and Taste Function in Patients With Cardiac Amyloidosis and Nutritional Impact: Multicenter Cross-sectional Study

acronym: AMYLODOR

summary:
Amyloidosis is a disease caused by the continuous accumulation of fibrillary proteins in the extracellular matrix causing the architecture of different organs to be disrupted. The prevalence of the disease increases with age. The two most common forms are light chain amyloidosis (AL) and transthyretin (TTR). TTR amyloidosis may be hereditary (m-TTR, or mutated) or age-related (WT-TTR, or wild). The latter is also called senile amyloidosis. In all these forms, cardiac impairment is common and leads the patient to consult/or be referred to a cardiological center unfortunately often too late when the prognosis is directly related to the severity of the heart attack. The description/discovery of clinical signs prior to heart disease is important to improve the detection and diagnosis of early forms of cardiac amyloidosis (CA). For example, an infiltration of the carpal tunnel synovial by amyloid deposits is observed in some patients, 5 years before the onset of signs of heart failure and is the only warning sign of the disease known to date. We also showed in a previous study that patients had more severe and earlier impairment of hearing function than expected by age and gender.

Objective The main objective is to define the prevalence and severity of smell and taste disorders in a population of patients with cardiac amyloidosis (3 types of mutated or wild AL amyloidosis and TTR).

The main endpoint is to determine the number of patients with impaired smell and taste's functions in a population of patients diagnosed with cardiac amyloidosis (3 types of mutated (hereditary) or senile wild amyloidosis (3 types of AL amyloidosis and TTR).

Method Successive monocentric cross-sectional study on the screening of smell and taste disorders carried out as part of a cardiology hospitalization programmed for the cardiology follow-up of his pathology in a population of patients diagnosed with AC.

primary_purpose: Screening

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


title: Contribution of an Educational Game for Continuous Positive Pressure/Non-invasive Ventilation Therapeutic Education in Children

acronym: YAPOUNI

summary:
A growing number of children with obstructive sleep apnea syndrome (OSAS) or nocturnal alveolar hypoventilation syndrome are treated with continuous positive airway pressure (CPAP) or nocturnal non-invasive ventilation (NIV) therapy.

The compliance of the child and his caregivers with CPAP / NIV therapy may be challenging.

The use of an educational game (Yapouni) aims at improving communication around CPAP / NIV between the child and his caregivers, and may facilitate the compliance with CPAP / NIV at home, by increasing the motivation for using CPAP / NIV at home.

The aim of the study is to assess the parents' feelings regarding the use of CPAP / NIV on day 0 (D0) and one month (D30) later in a standard group: therapeutic education (TEP) versus a group: TEP + Yapouni.

status: Withdrawn


title: Analysis of the Kinematics of the Shoulder Complex in Sports "Overhead" Gestures Such as Kayaking Polo Throwing (Overhead)

acronym: Overhead

summary: The objective of this study is to analyze the throwing gesture specific to the kayak polo. A throw in a seated position with fixation of the pelvis (by the seat) and antepulsion of the hip ipsilateral to the throwing shoulder.


title: Securing the Immediate Perioperative Walk: Creating and Validating a Score.

acronym: Déambu

summary: The aim of this study is to set up a pre and postoperative ambulation score on a population of adult patients and undergoing outpatient surgery operated under locoregional anesthesia and sedation.


title: Pilot Epidemiological Study to Determine the Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome

acronym: RESTECH

summary:
The aim of the study is to find, using validated and efficient tools, a laryngopharyngeal reflux in patients receiving polysomnography for suspected obstructive sleep apnea syndrome.

It is proposed to carry out simultaneously, at the Sleep Center of the Polyclinique of Poitiers (CSPP), a polysomnography, a 24-hour Restech pharyngeal pH-metry (day and night), a Peptest (in the evening and in the morning of the polysomnography), with the RSS-12 questionnaire and the RSA score.

lead_sponsor: Elsan

location_facility: Centre du Sommeil de la Polyclinique de Poitiers


title: New Recommendations for Robertsonian Translocation Management After Preimplantation Genetic Testing of Structural Rearrangement (PGT-SR) Attempts: What Should be Done With Mosaic Embryos?

summary: to analyze if a probe strategy choice for PGT-SR studies of Robertsonian translocations (RT) influences the fate of embryos? Few studies discussed the importance of probe choices. However, those who did, demonstrated that analysis with locus specific probes improve a diagnosis of dubious results, and addition of a centromeric probe could affect the accuracy of diagnosis


title: Monitoring of Progesterone Administered in Infertile Patients During a Cycle of Frozen Embryo Transfer: a Population Pharmacokinetic Study.

acronym: PEKAPROGE

summary: During an In Vitro Fertilization (IVF) attempt, several embryos are obtained but not all of them can be transferred to the uterus in the same cycle due to the risk of multiple pregnancies. Thus, it is very common for these couples to benefit from cryopreservation. Patients scheduled for frozen embryo transfer (TEC) receive estrogen and progesterone replacement therapy to prepare the endometrium for implantation. Data from the literature recently showed that low progesterone on the day of embryo transfer was responsible for a significantly higher rate of implantation failure and miscarriage.


title: Validation of the French Translation of a Self-questionnaire Looking for a History of Pre-eclampsia of More Than 5 Years in Women Who Have Already Had a Pregnancy of More Than 6 Months With Childbirth at Brest University Hospital.

acronym: PRERETRO

summary: PRERETRO is a study for validation of the French translation of a self-questionnaire looking for a history of pre-eclampsia of more than 5 years in women who have already had a pregnancy of more than 6 months with childbirth at Brest University Hospital.

ReferenceCitation: Societe francaise d'anesthesie et de reanimation (Sfar); College national des gynecologues et obstetriciens francais (CNGOF); Societe francaise de medecine perinatale (SFMP); Societe francaise de neonatalogie (SFNN). [Multidisciplinary management of severe pre-eclampsia (PE). Experts' guidelines 2008. Societe francaise d'anesthesie et de reanimation. College national des gynecologues et obstetriciens francais. Societe francaise de medecine perinatale. Societe francaise de neonatalogie]. Ann Fr Anesth Reanim. 2009 Mar;28(3):275-81. doi: 10.1016/j.annfar.2009.02.015. Epub 2009 Mar 24. No abstract available. French.

ReferenceCitation: Saucedo M, Deneux-Tharaux C, Bouvier-Colle MH; Le Comite national d'experts sur la mortalite maternelle. [Maternal mortality in France, 2007-2009]. J Gynecol Obstet Biol Reprod (Paris). 2013 Nov;42(7):613-27. doi: 10.1016/j.jgyn.2013.06.011. Epub 2013 Sep 13. French.

publisher_dissemination: Elsevier

ReferenceCitation: Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. BMJ. 2007 Nov 10;335(7627):974. doi: 10.1136/bmj.39335.385301.BE. Epub 2007 Nov 1.

ReferenceCitation: van Wyk L, van der Marel J, Schuerwegh AJ, Schouffoer AA, Voskuyl AE, Huizinga TW, Bianchi DW, Scherjon SA. Increased incidence of pregnancy complications in women who later develop scleroderma: a case control study. Arthritis Res Ther. 2011;13(6):R183. doi: 10.1186/ar3510. Epub 2011 Nov 4.

ReferenceCitation: Kamper-Jorgensen M, Gammill HS, Nelson JL. Preeclampsia and scleroderma: a prospective nationwide analysis. Acta Obstet Gynecol Scand. 2018 May;97(5):587-590. doi: 10.1111/aogs.13296. Epub 2018 Feb 8.

oa_colors: green other

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

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

version: acceptedVersion

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

ReferenceCitation: Diehl CL, Brost BC, Hogan MC, Elesber AA, Offord KP, Turner ST, Garovic VD. Preeclampsia as a risk factor for cardiovascular disease later in life: validation of a preeclampsia questionnaire. Am J Obstet Gynecol. 2008 May;198(5):e11-3. doi: 10.1016/j.ajog.2007.09.038. Epub 2008 Feb 1.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: A Randomized Placebo-controlled Double-blind Pilot / Phase II Study to Assess the Efficacy and Safety of HOV-12020 in Patients With Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)

summary: CADASIL is a paradigmatic cerebral small vessel disease responsible for white-matter lesions, accumulation of lacunes, microbleeds and cerebral atrophy. The disease is responsible for stroke and cognitive decline associated with motor disability. The number of incident lacunes, and amount of cerebral atrophy were recently found to have a strong relationship to cognitive decline and disability progression over 3 years in a large sample of patients. Palm tocotrienols has previously shown evidence of therapeutic effect in attenuating the progression of WMH related to sporadic cerebral small vessel disease in a randomized controlled clinical trial. We hypothesize that palm tocotrienols complex (HOV-12020) can reduce the clinical progression in CADASIL.

status: Active, not recruiting

lead_sponsor: Hovid Berhad


title: Risk Assessment and Incidence of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors

acronym: VeinIPP

summary:
Intermittent or continuous proton pump inhibitor (PPI) therapy are recommended for high-risk bleeding ulcers according to the French Society of Gastroenterology. The prevalence of incidence of vein infusion phlebitis after PPI intravenous infusion is high in geriatric acute ward (about 10% of severe vein infusion phlebitis).

The primary of objective of the study is to determinate the prevalence of vein infusion phlebitis after PPI intravenous infusion in aging people.

The secondary of objective of the study if to determinate the factors of risk of vein infusion phlebitis.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Geriatric Department, Ambroise Paré Hospital, APHP


title: Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Hospitals of the Assistance Publique - Hôpitaux de Paris (APHP)

acronym: DEVINHEF

summary: The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris.


title: Genetic Analysis and Multimodal Retinal Imaging of Asymptomatic Fovea Plana Cases in the General Population

acronym: APOGEE

summary:
Albinism is a genetic condition, resulting from mutations in at least 19 known genes responsible for the production of melanin in the skin, hair and eyes.

Ophthalmological manifestations are a constant feature of this disease. Albinism is believed to be responsible for 5% of visual impairments worldwide and all albino patients have some degree of fovea plana. In the milder forms, it is a slightly less marked foveolar depression with conservation of the normal diameter of the cones and, therefore, good visual function.

In addition to its known association with various ocular pathologies such as albinism, aniridia, nanophthalmia and retinopathy of prematurity, fovea plana was found in 3% of a population of normal children (without known ocular or systemic pathology) in a study conducted in 2014 to determine a pediatric normative basis for macular volume measured by optical coherence imaging (Stratus OCT).

More recently, a study carried out at the Hospital Foundation Adolphe de Rothschild showed that at least 35% of parents of albino children, who are totally asymptomatic, present with fovea plana in OCT. This frequency is higher than the 3% prevalence of fovea plana in asymptomatic subjects without a family history of albinism, suggesting a modulation of heterozygosity for a known gene for albinism.

The aim of this study is to verify, in patients with fortuitously discovered fovea plana (preoperative OCT for cataract surgery), with conservation of visual function and without known or manifest albinism, whether they are carriers of mutation in one of the genes referenced for albinism. This will also allow us to characterize these foveolar profiles in OCT according to the classification of Thomas et al., as well as in terms of retinal capillary density in OCT-Angiography, in order to know whether it is the same type of fovea plana or if the phenotype differs depending on the genetic damage.


title: Functional Study of Intronic Variants in Inherited Cone Disorders

acronym: INTROCONE

summary: High throughput sequencing gives the opportunity to improve the genetic diagnosis for patients suffering from retinal dystrophies and specially from cone disorders. However, a large number of mutations are identified, mostly in introns of the genes, and in silico analysis are not sufficient to assign the pathogenicity of these mutations, without which the diagnosis confirmation cannot be done. For that purpose, a functional analysis of intronic variants of unknown significance detected in patients, with minigene splice assays in parallel with the analysis of the effect of the variant on splicing directly in the cells of the patient, by analyzing the RNA from leucocytes, fibroblasts, lymphoblastoïd cells or precursor of photoreceptor cells, which is the only proof of pathogenicity for variants

lead_sponsor: University Hospital, Lille

intervention_type: Genetic


title: Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

acronym: iGRAISSE

summary:
The goal is to have a small spectrometer (pocket size) , reliable and rapid tool that can be used during liver harvesting, which enables macrosteatosis to be evaluated reproducibly and selectively, at any time.

This tool must be minimally invasive, inexpensive and without significantly impacting the general organization of multi-organ harvesting.

In the operating room, the surgeon will perform an intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta. The surgeon will not be informed of the results of the spectrometer, and will carry out (or not) the biopsy. The spectrometers' results will be compared with definitive histological findings.

status: Not yet recruiting

location_facility: Centre Hépato Biliaire de l'hopital Paul Brousse


title: Intensive Gait Training Rehabilitation Protocol to Enhance Functional Parameters of Walking After Single-event Multi-level Surgery in Cerebral Palsy

acronym: ACTIV'MARCHE

summary: In the context of cerebral palsy, rehabilitation post Single-Event Multi-Level Surgery (SEMLS) is a long process. One year after surgery and rehabilitation, the functional benefits are usually less improved than the gait pattern. This may be caused by a lack of intensity in the final rehabilitation steps. Thus we created an intensive gait training rehabilitation protocole. This protocole associates 4 weeks of intensive rehabilitation in a healthcare center followed by 2 weeks of intensive rehabilitation at home. The objective of this study is to evaluate the efficiency of this protocol to improve walking speed and endurance, gross motor function et muscular strength.

lead_sponsor: Fondation Ellen Poidatz


title: Evaluation of a Free-breathing Cardiac Cine-MRI Sequence With Image Reconstructions Developed by Deep-Learning Compared to the Classic Apnea Cine-MRI Sequence in the Assessment of Ischemic Heart Disease.

acronym: CINEDL

summary:
Today, MRI is the gold standard for the precise assessment of left ventricular volume and function, but presents the drawback of having a long acquisition time and of generating motion artifacts, in particular respiratory artifacts, requiring repeated sequences in apnea to cover the whole cardiac volume. These apneas are difficult to achieve in patients with ischemic heart disease and may lead to degradation of the images, an increase in the duration of the examination by repeated acquisitions and therefore to diagnostic inaccuracies.

Artificial intelligence, already used in practice in cardiac MRI for automatic segmentation of the heart chambers, improves radiological interpretation with rapid and precise measurements. Deep-learning, which is part of artificial intelligence, would allow the reconstruction of cine-MRI sequences in free breathing, in order to overcome the artifacts from respiratory motions, and the improvement of diagnostic performance while improving examination conditions for patients.

Patients coming for a cardiac MRI for the assessment of ischemic heart disease will be eligible to the protocol. If the patient agrees to participate, a free-breathing cardiac cine-MRI sequence with Deep Learning based image reconstruction will be added to the usual protocol.

No follow-up will be required in this study.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Platelet-rich Plasma Infiltration Versus Corticosteroid Infiltration (Prednisolone) in Treatment of Lumbar Facet Joint Syndrome

acronym: IAPRP

summary:
The prevalence of low back pain is estimated at 90% . Recent studies have shown that 15% to 52% of back pain is attributable to facet joint syndrome .

Being the only vertebral joints provided with a synovial membrane, the posterior inter-apophyseal joints are subject, like all other peripheral joints, to degenerative arthritis phenomena.

These phenomena most often result in the release of pro-inflammatory cytokines resulting in cartilage degradation.

PRP or platelet rich plasma is an autologous blood product obtained after centrifugation of a peripheral blood sample. The PRP has many anti-inflammatory properties. Numerous studies have shown the interest of intra-articular infiltration of PRP in osteoarthritis of the knee but also in tendinopathies of the shoulder and a few studies also suggest the use of PRP in the spine "intra-disc, epidural and posterior joints) .

Corticosteroid infiltrations in the posterior lumbar joints constituting the standard treatment in posterior inter-apophyseal osteoarthritis.

The goal is to obtain a new therapeutic weapon in the management of this frequent and invalid disease for patients who are often elderly and with other comorbidity.

lead_sponsor: CHU de Reims