title: Study of the Determinants of Dream Recall and Content in Patients With Epilepsy

acronym: EPIDREAM 1

summary:
Dreaming is a sleep-associated cognitive process whose neural substrates and functions remain poorly understood. In healthy subjects, the frequency of dream recall is influenced by several factors such as age, gender, interest in dreams and sleep quality. The content of dreams mainly depends on waking life experiences, especially when they are recent and have a strong emotional content. The function of dreams remains debated but it is widely accepted that dreams play a role in emotional regulation.

Modifications in dreams are observed in several neurological diseases and sleep disorders, due to the modifications of sleep related to these diseases, as well as to associated disturbances in cognitive functioning and to the impact on such diseases on waking life. Epilepsy is a neurological condition characterized by a predisposition to seizures resulting from excessive and synchronized abnormal brain activity; it is associated with numerous co-morbidities including sleep and cognitive disorders, which are present in nearly one in two patients. However, the influence of epilepsy on sleep-related cognitive processes is poorly understood. It is suspected that nocturnal epileptic activity disturbs sleep-related memory consolidation processes, but the consequences of epilepsy on dreams have been little investigated.

The study of the determinants (epilepsy syndrome, location of the epileptic focus, presence of sleep-related seizures, certain anti-epileptic treatments, alteration of the quality of sleep) of dream characteristics in this context could lead to a better understanding of the dreams physiology, the interactions between epilepsy and sleep, as well as the cognitive and emotional functioning related to sleep in epilepsy. It could also determine whether dream characteristics can provide information on the epilepsy syndrome and on the presence of nocturnal seizures, and thus constitute a diagnostic tool.

In this cross-sectional observational study, we aim to identify determinants of dream recall in relation to epilepsy by administering a simple and brief questionnaire on sleep and dreams, to all consecutive patients seen in epileptology consultation during 12 months. Our objectives are

To determine whether the presence of sleep-related seizures influences the frequency of dream recall in patients with epilepsy
To describe the characteristics of dreams in epilepsy, the influence of epilepsy on dreams and to characterize the determinants of dream recall frequency in patients with epilepsy We hypothesize that the presence of seizures during sleep will be associated with poorer sleep quality, increased frequency of dream recall, and that we will observe the inclusion of epilepsy symptoms in dream content, particularly in subjects who are aware of their nocturnal seizures and are awakened by them.

lead_sponsor: Hospices Civils de Lyon


title: Effects of Optimizing Nocturnal Glycemic Control on Sleep Parameters in Type 1 Diabetes

acronym: DIABNIGHT

summary:
Sleep is crucial for physical and mental health. Environmental, social, or professional pressures can cause sleep duration to fall below the recommended 7-9 hours of sleep per night. Young adults with type 1 diabetes, have additional interference with fear, control and management of hypo/hyperglycemia management, alarms from their devices, which delay bedtime, disrupt sleep and generate multiple awakenings and difficulty returning to sleep. Sleep disturbance is correlated with blood glucose variability as recently demonstrated by a coupled analysis of sleep and glucose level collected by Continuous Glucose Monitoring (CGM). In this study, higher glucose variability predicted impaired sleep at the individual level.

Automated insulin infusion has shown impressive results in clinical and real-life studies, with more than 90% of patients achieving good glycemic control. Il seems to improve sleep quality in subjects after 4 weeks in hybrid closed-loop, self-administered studies compared to a control group.

The main objective of our study is to measure the positive influence of a better glycemic control on the different sleep parameters in subjects with type 1 diabetes at the time of the passage in hybrid closed-loop and in comparison to an identical period in open-loop.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty

summary: The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .

status: Active, not recruiting

enrollment_type: Actual

lead_sponsor: Societe dEtude, de Recherche et de Fabrication

lead_sponsor_type: industriel


title: Study of Management and Prognosis of Patients With Acute Myeloblastic Leukemia in Saint-Antoine Hospital

acronym: LAMSA

summary:
AML in adults represents a group of heterogeneous diseases; the prognosis remains poor despite significant therapeutic advances in recent years. In order to optimize patient care, it is necessary to have "real life" data that exhaustively reports on the patients treated in our department. The objective of this study is:

To describe the AML treated within the hematology department
To optimize the management of patients with AML.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Other

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of Hematology, Hospital Saint Antoine


type: Other Identifier

title: Prospective Cardiac Magnetic Resonance Imaging Study in Duchenne Muscular Dystrophy (DMD-CMP)

acronym: DMD-CMP

summary: The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.

study_type: Interventional

primary_purpose: Diagnostic

intervention_type: Diagnostic Test


title: Monocentric Descriptive Study Regarding the Impact of Severe Dysmenorrhea on Teenagers, Their Parents and Caregivers Receiving Those Patients

acronym: DEMETER

summary: Teenagers experimenting severe dysmenorrhea also face age-specific challenges, particularly impacting their self-confidence, self-esteem, and relations. On one hand, the study team will conduct focus group interviews to better understand the experience of teenagers and their parents consulting pediatric services for severe dysmenorrhea. On the other hand, they will conduct focus group interviews with caregivers from services that usually encounter such patients (gastrologic, gynecologic and pain services). This, allowing to later propose specific tools and healthcare organization to evaluate and accompany teenagers suffering from severe dysmenorrhea.

status: Completed

study_completion_date_type: Actual

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Fondation pour la Recherche Médicale

status_simplified: Completed


title: Intérêt de l'échoguidage Dans Les Ponctions de Fistule artério-veineuse en hémodialyse pédiatrique

acronym: PafusGuC

summary: The arteriovenous fistula (AVF) is the reference hemodialysis vascular access for both adult and pediatric patients. The cannulation quality is decisive for the quality of the dialysis. Difficult AVF cannulations are more frequent in pediatrics than in adults. Recent studies in adults have shown that ultrasound-guided AVF cannulation improves the cannulation quality and therefore the quality of dialysis. This study aims to prove that ultrasound-guided AVF cannulation in children will improve the quality of dialysis overall.

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: University Hospital, Montpellier


title: Functional Evaluation of the Recovery of Prehension in Persons With Tetraplegia by Implanted Neural Stimulation

acronym: AGILIS

summary:
A selective neural stimulation as the investigators propose allows to stimulate several muscles via a single electrode. Neural stimulation requires less energy for muscle activation. In our approach, 2 electrodes will be implanted above the elbow on the median, the ulnar and the radial nerves. This considerably reduces the number of implanted elements and therefore i) the risk of infection, ii) the risk of failure, iii) the surgical risk through minimally invasive surgery.

Our main hypothesis is that multipolar neural electrical stimulation of the median and the ulnar nerve (flexion) and the radial nerve (extension) allows:

on the one hand, a selective, individualized motor activation (muscle by muscle)
on the other hand, a synergistic motor activation (association of several muscles) for the purpose of production of functional movements.

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Fattal C, Teissier J, Geffrier A, Fonseca L, William L, Andreu D, Guiraud D, Azevedo-Coste C. Restoring Hand Functions in People with Tetraplegia through Multi-Contact, Fascicular, and Auto-Pilot Stimulation: A Proof-of-Concept Demonstration. J Neurotrauma. 2022 May;39(9-10):627-638. doi: 10.1089/neu.2021.0381. Epub 2022 Feb 2.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Mary Ann Liebert Inc

lead_sponsor: Centre Bouffard Vercelli - USSAP

collaborators: Institut National de Recherche en Informatique et en Automatique

location_facility: Rehabilitation Center Bouffard-Vercelli USSAP


title: Study of the Interest of Serum Calprotectin Determination in the Diagnosis of Spondyloarthritis and to Diferenciate With Fibromyalgia

acronym: Calprotectine

summary: To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Development of an EORTC Immune Checkpoint Inhibitor-specific Quality of Life Item List: Phase 1 & 2

acronym: EORTC ICI

summary:
Over the past 20 years, the views and experiences of patients in the field of oncology (through patient-reported outcomes, PROMs) have become increasingly important. When used in clinical trials, PROMs contribute to better detection and are used in clinical trials to improve the detection and management of treatment side effects. The Health-related quality of life assessments are widely used in oncology research, and the development of reliable and valid measurement instruments has become a major challenge.

In this context, health-related quality of life in cancer patients covers various aspects (functional status, physical or psychological symptoms) and several cancer-specific measurement instruments have been developed, including the EORTC QLQ-C30 quality of life questionnaire.

Among the different therapies used to treat cancers, immunotherapy with immune checkpoint inhibitors has been gaining momentum in recent years. Commonly used to treat a wide variety of cancers, it also has a wide range of known side effects.

However, little is known about the health-related quality of life of patients patients who receive this therapy: specific self-questionnaires are almost non-existent or inadequate, not covering all the effects related to immune checkpoint inhibitor toxicity. As for the data currently collected, they suffer from methodological problems.

In view of the increasing use of immune checkpoint inhibitors in cancer treatment, their known side effects and the lack of valid questionnaires specific to these treatments, it appears important to provide a valid questionnaire to take into account these impacts on the quality of life of patients.

lead_sponsor: Institut Curie


title: Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures.

acronym: AXAES

summary:
Activated clotting time (ACT) is currently recommended to monitor high concentrations heparin anticoagulation. ACT-LR was specifically designed to measure the activity of low dose of heparin used during endovascular surgery. The correlation between ACT-LR and Anti Xa activity which is considered as the gold standard seems to be debated.

Few studies in literature had shown controversial results. These studies were conducted in patients who underwent open as endovascular surgery. However, the ACT monitoring is not recommended in open surgery. In addition, heparin administration protocols are not described and specific to each centre.

In this study investigators want to study the correlation between LR-ACT and anti Xa after introducing a heparin protocol during complex endovascular procedures.

location_facility: Service de chirurgie vasculaire (U50) Hôpital Louis Pradel - HCL

intervention_type: Biological


title: BD Evolve On-body Injector: Clinical Feasibility and Performance in the Abdomen and Arm

summary: The purpose of this study is to evaluate the clinical feasibility, performance, safety and acceptability of the On-body Injector (OBI) when applied to the arm or abdomen of healthy volunteers to inject placebo under the skin.

lead_sponsor: Becton, Dickinson and Company

intervention_type: Device


title: Prospective Monocentric Randomized Study Comparing Arthrodesis Technique of Thoracic and/or Lumbar Spine by Posterior Approach Performed by Robot-assisted Surgery (Robot Mazor X Stealth ™) Versus Conventional Surgery

acronym: ROBARTHRODESE

summary:
Osteosynthesis by pedicle screwing is the reference technique since the 1980s, due to the quality of the mechanical grip of the screw in the pedicle, despite difficulties of placing the implant in this narrow tunnel.

This precision was improved by fluoroscopy, then by navigation, which made it possible to reduce the extra-pedicular placement of the screws and consequently the complications.

Since the 2000s, robotic has been developed in all areas, including medicine and surgery, (Da Vinci robot in urology) and several robots are currently marketed for spinal surgery, Medtronic's Mazor X Stealth ™ robot being the most successful.

The aim of this study is to evaluate on a prospective randomized comparative study the quality of the placement of the screws as well as the occurrence of complications, the clinical results and the medico-economic interest that robotic surgery can bring.

lead_sponsor: Elsan

intervention_type: Procedure


title: Identification of Factors That Predict Early Haemodialysis Arteriovenous Fistula Failure

acronym: eAVFF-RF

summary: Arteriovenous fisutla (AVF) is the vascular access of choice for hemodialysis but has a high early failure (eAVFF) rate. eAVFF can be defined as thrombosis/stenosis and Doppler ultrasound (DUS)-based failure-to-mature parameters such as postoperative blood flow (PostQa) < 500 ml/min, AVF-vein diameter (PostVD) < 5 mm, and AVF-vein depth (PostVDepth) ≥ 6 mm. We explored whether common risk factors for eAVFF could predict these eAVFF parameters and venous distensibility: the latter is largely overlooked as a potential eAVFF parameter.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: The Oxylipin Response as a New PrEdictive Biomarker of Patient Responsiveness to Biotherapy in Rheumatoid Arthritis.

acronym: OPERA

summary:
OPERA aims to better understand and predict the responsiveness of rheumatoid arthrits (RA) patients to biological disease modifying anti-rheumatic drugs (bDMARDs).

Our objectives will be (i) to determine, at baseline, the differences of oxylipin response between responders vs non-responders to Anti-Tumor necrosis factor (Anti TNF) and (ii) to investigate the relationships between the oxylipin response, the polyunsatured fatty acid (PUFA) content of immune cells and the cytokine response.

primary_purpose: Screening

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement


title: ISIdE: Open Label, Multicentric, Single-arm Phase IIIB Trial to Evaluate the Safety and Efficacy of Sacituzumab Govitecan in Triple Negative Metastatic Breast Cancer Patients With a Biomarker Analysis

acronym: ISIdE

summary:
ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or within 6 months after the end of curative treatments in order to:

evaluate the treatment efficacy in less pretreated patients.
identify biomarkers that could predict response or resistance to the drug.

100 patients will be included in this trial.

lead_sponsor: UNICANCER

sponsor_collaborators:
UNICANCER
Gilead Sciences

intervention_type: Drug


title: Physiopathology of Prosthetic Joint Infections : a Pilot Study

acronym: PROTHEE-PILOTE

summary: This study aim to explore cellular responses of bone and immune cells to bacterial infections observed in patients with prosthetic joint infections. The investigators will analyze clinical data and tissue samples collected from patients undergoing surgery as part of their usual care for prosthetic joint infections. These research will be conducted on three different hospitals in Paris: Lariboisière (AP-HP), Cochin (AP-HP) and Croix Saint-Simon.

ipd_sharing: Undecided


title: Assessing Moral Cognitive Skills in Adults With Autism Spectrum Disorders

acronym: CoMorA

summary:
In the international literature, it is currently accepted that, relative to neurotypicals, people with Autism Spectrum Disorder (ASD) present patterns of moral judgments marked by a minimization of intentionality and a strong condemnation of agents responsible for accidents. However, until now, all studies are based on declarative paradigms, and no one has proposed to examine the relationship of people with ASD to moral transgressions (i.e. to a bad action done deliberately or to a good deed deliberately omitted) in an implicit paradigm, that is, when the answer is made on the assignment of an expressive face to these moral offenses. Furthermore, no study has investigated whether diminished sensitivity to intention and intransigence of incidental judgment occur in both automatic (implicit) and deliberative (explicit) settings.

Investigators planned to study how people with ASD without intellectual disability process emotions expressed by others in response to different forms of moral offense and to examine whether patterns potentially contrast in degree and/or kind with those of neurotypicals.

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: Hôpital le Vinatier

location_facility: centre de réhabilitation - Hôpital le Vinatier


title: Reciprocal Benefit by Intergenerational Meetings Between 2 Fragile Populations

acronym: Part'Ages

summary: The investigators want to set up an experiment that allows a reciprocal benefit to 2 fragile populations: isolated seniors and disadvantaged children. The main hypothesis is that regular exchanges between these two populations reduce the feeling of social isolation of seniors and improve the school behavior of childrens. Therefore the investigators propose the following study design. The seniors and childrens will meet once a week, for 7 months, in a defined location in the city of Vallauris, over a period of one and a half hours, outside school hours (4:30 p.m. to 6:00 p.m.) and school holidays. During the school holidays the group will meet 3 times for day-long activities in the presence of at least one of the parents and possibly brothers and sisters. At the end of the project, a convivial evening will be organized in the presence of the families. The group will meet in a room in the city center and in the presence of a facilitator so that an adult will never be alone with a child. The formed pair will follow a defined schedule where will alternate activities proposed by the senior, sessions proposed by the facilitator and convivial moments in the presence of families . During the sessions proposed by the senior, he will offered the child a leisure activity that he likes and masters (eg gardening, DIY, sewing, etc.). All the proposed activities will be validated upstream by the project managers. The sessions proposed by the facilitator (e.g. games, walks) could be done with the participation of an outside speaker (e.g. for writing a gazette). A new evaluation session will be offered to all participants at the end of the meeting period, then at the end of the project, 1 month after the end of the meeting period.

ipd_sharing_description: IPD sharing is not planed

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients: a Prospective Observational Study

acronym: MUSCA

summary:
Cardiac and thoracic surgery are major procedures. In order to estimate the operative risk, many scores have been developed, including the Euroscore 2 in cardiac surgery. However, the Euroscore has limitations since it does not assess all the parameters that may influence postoperative complications, such as the patient's general condition or the status of his or her functional reserves.

However, it has been shown that the preoperative functional reserves have a significant impact on the patient's risk of developing postoperative complications following major surgery. In addition, there is a strong association between cardiac failure and a well-described decrease in peripheral muscle lean mass (sarcopenia) in patients older than 65 years.

Usually, a nutritional assessment is performed during the pre-anesthesia consultation. This assessment is based on clinical and biological criteria that are not totally predictive of the patient's functional reserve status.

Lean body mass (muscle) is a well-validated marker for the assessment of patients' functional reserves. However, the techniques used to date are complex and require radiation.

This study aims to use ultrasound of muscle groups (respiratory muscles - Quadriceps muscle - Diaphragm) to study the relationship between preoperative muscle mass and postoperative complications in patients over 65 years of age undergoing cardiac or thoracic surgery.

This is a prospective observational study to be conducted at the Dijon University Hospital by the cardiovascular anesthesia-intensive care department. A total of 300 patients will participate in this study, and we have planned to complete the project over a 2-year period. The participating patients (if they do not present any exclusion criteria and are not opposed to inclusion) will be included and undergo a muscle ultrasound in the cardiovascular surgery department or the thoracic and pulmonary surgery department the day before their intervention.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Basal Plasma Lithium Levels and Suicidal Events (LIPS)

acronym: LIPS

summary:
Suicidal behavior is a major public health issue and there are currently no specific treatments for it.

However, lithium, the reference treatment for bipolar disorder, have been shown to be effective in preventing suicidal risk.

Apart from drug treatments, lithium is present in our environment and its levels varies from one individual to another, depending, especially, on diet.

Knowing that patients with a mood disorder generally have a poor lifestyle and a less rich and varied diet than the general population, variations in basal lithium levels can be expected in these patients.

time_perspective: Cross-Sectional


title: Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients With Exudative AMD (SINE)

acronym: SINE

summary:
An inflammatory component associated with AMD has been highlighted by genetic associations of predisposition to AMD, as well as by the recently demonstrated link between AMD and periodontitis.

Some patients followed at the Fondation Adolphe de Rothschild Hospital for wet AMD seemed to show an improvement of neovascular activity (less need for intravitreal injections of anti-VEGF) after treatment of their sinusitis.

The investigators would therefore like to assess the link between AMD and sinusitis, an infection close to the site of AMD.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring? A Cohort Retrospective Study.

summary: In this study, the investigators tend to highlight pre and peroperative factors that predict major postoperative complication after a surgery for resection of peritoneal carcinomatosis. Factors associated with major postoperative complications were used to elaborate un predictive nomogram model. A score was assigned for each factor of the nomogram which correspond to the weight of the association of the factor with the occurrence of the major postoperative complication. The nomogram assessed the probability of major postoperative complication after surgery by adding up the scores identified on the "Points" scale for each factor. The total score projected from the "Total points" axis to the "Risk of major postoperative complication" axis, indicated the probability of major postoperative complication occurrence. A cut-off of total score was calculated to identify patients at low or high risk for major postoperative complications. The developed nomogram may be a helpful tool to adapt postoperative monitoring of patients after surgery of peritoneal carcinomatosis resection according to the risk of occurrence of a major postoperative complication.

lead_sponsor: CHU de Reims


title: Evaluation of the Impact of a Digital Tool MEDIASCREEN of Preventive Information for Patients on the Knowledge of the Risk of Pressure Sores Acquired During a Hospitalization, a Randomized Controlled Pilot Interventional Study in Single Blind

acronym: EDUCESCARRES

summary: The study focuses on the impact of a digital MEDIASCREEN tool on the knowledge, technical know-how and behavioural skills in terms of pressure sores of patients. In addition, the cognitive impact of this type of tool will also be studied in our study population (self-esteem and feeling of personal effectiveness). The objective is to compare the impact of a digital MEDIASCREEN information tool with information tool compared to the usual paper-based prevention materials on knowledge of the risk of hospital-acquired pressure sores.

lead_sponsor: Pôle Saint Hélier


title: Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis

acronym: RéMiFaSy

summary: Peripheral facial palsy affects 15 to 40 people per 100,000 inhabitants and induces important functional and social repercussions. Synkinesis is a frequent after-effect of facial palsy recovery, consisting of involuntary facial spasms that disturb the gestural harmony and can go as far as a painful hypertonic spasm. More than 55% of patients recovering from facial palsy will develop transient or permanent synkinesis. These facial hypertonias have two main causes: imperfect axonal regeneration, which is all the more important as the damage is proximal, and hyperexcitability of the facial nerve nucleus due to a lack of central control. Management is therefore essential for the functional restoration of the face, especially since synkinesis do not evolve spontaneously. The main treatments are currently botulinum toxin injection, acting on the motor plate, and functional rehabilitation, consisting on local muscle relaxation and central motor control work. In recent years, therapies based on biofeedback and acting on central motor control have shown interesting results, and technological advances in virtual reality have made it possible to deepen this treatment in patients suffering from stroke, limb trauma or Parkinson's disease. In this project, the investigators evaluate the contribution of virtual reality to the management of facial palsy, and hypothesize that self-rehabilitation using this technology will improve motor control of the skin muscles and reduce complications related to their hypertonia such as synkinesis.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Therapeutic Recommendations for Children Registered in the RFAOP Register and With a Hodgkin Lymphoma

summary:
The GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.

Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unites who will adapt these recommendations.

lead_sponsor: French Africa Pediatric Oncology Group

collaborators: Gustave Roussy, Cancer Campus, Grand Paris


title: Prevalence of Cannabidiol (CBD) Consumption and Cancer Patients' Expectations in One Oncology Day-Hospital: A Cross-sectional Study and Questionnaire Validation

acronym: CANPADIOL

summary: Alternative and complementary medicines (MAC) are commonly used by cancer patients to help them to face with anticancer treatment, reduce oncology symptoms and/or anticancer treatment adverse effects, detoxifying the body. In consistence with guidelines from the French Society for Oncology Pharmacy (SFPO), the pharmaceutical consultation includes a discussion and collection of herbs, botanical and other natural products consumed by cancer patients. This aim to prevent and manage herb-drug interaction as well as other drug-related problems (DRP). The recent French experimentation dedicated to cannabidiol for medical use could enhance interest of cancer patients in the field of MAC. However, cannabidiol have shown inhibitory effect on different cytochromes with a risk of HDI as other MAC. While the prevalence of MAC consumption is already known in some type of cancer, the consumption of CBD is less known and should be explored. Through this study we wish to know the prevalence of cannabidiol consumption in cancer patients and to establish a typical profile as well as to know the modalities of use. We also want to validate a questionnaire through a literacy scale.


title: Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS

summary:
Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%). Approximately 30% of ARDS patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ARDS prognostic. To date, reliable bedside tools to adjust tidal volume are lacking. Excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility.

Mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. Pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. Increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions.

The investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation


title: Randomized, Single-blind Study Evaluating the Interest of Prior Relaxation on the Quality of the Recordings of the SomatoSensory Evoked Potentials

acronym: RELAXPE

summary:
Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation.

The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination.

The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Evaluation of Thoracic Ultrasound in Monitoring Pleural Drainage in Postoperative Thoracic Surgery

acronym: EchTHor

summary: The investigator would like to conduct a study in patients undergoing thoracic surgery to evaluate the effectiveness of thoracic ultrasound in the decision to discharge the patient after pleural drain removal.

lead_sponsor: University Hospital, Limoges


title: Impact of a Strategy Based on the PCR Testing System on Appropriate and Targeted Antimicrobial Treatment in Immunocompromised Patients With Suspected Ventilator-associated Pneumonia or Hospital-acquired Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial

acronym: RESPIRE

summary: RESPIRE is a randomized, unblinded, controlled study to measure the impact of a strategy based on a PCR test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or hospital-acquired pneumonia (VAP/HAP) requiring mechanical ventilation (MV) in Intensive Care Unit (ICU). The gold-standard microbiological diagnostic method for pneumonia in the ICU is based on culture identification and antimicrobial susceptibility testing. Results are obtained in several days after the initiation of empiric antimicrobial therapy, exposing patients to a potential inappropriate broad-spectrum antimicrobial treatment. We aim to measure the impact of a PCR-based strategy to improve the percentage of patients with VAP or HAP receiving targeted antimicrobial therapy 24 hours after diagnosis compared to standard care

lead_sponsor: University Hospital, Lille

appel_a_projets: PRTS

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

type_etablissement: CH

acronyme: RESPIRE

titre: Effets du sévoflurane inhalé sur la perméabilité épithéliale pulmonaire liés à la voie RAGE et identification d'un marqueur de réponse thérapeutique dans le syndrome de détresse respiratoire aiguë

discipline_principale: ophtalmologie

nom_porteur: FUTIER

prenom_porteur: Emmanuel

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: CHR LILLE

titre: Intérêt de la PCR pour l'antibiothérapie ciblée des patients immunodéprimés suspects de pneumonie acquise sous ventilation mécanique (PAVM) ou de pneumonie acquise à l'hôpital nécessitant une ventilation mécanique (PAH-VM): essai randomisé contrôlé


title: Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively

acronym: PHEDOPO

summary: This project aims to study various predictive factors of postoperative pain after oral surgery among different parameters accessible preoperatively, in order to build a predictive model. It also aims to validate the external consistency of the Pain Sensitivity Questionnaire in an odontological context.


title: Awareness of Emotional Feelings and Management of Risky Situations

acronym: COSMOS

summary: The goal of this project is to help individuals better self-assess by taking advantage of their emotional feelings.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: CHU Besancon - Clinical Psychiatric Department

intervention_type: Behavioral


title: Recurrent Collection By Medical Student From Sorbonne-Université in General Medicine

acronym: RCIMG

summary: The project for the recurrent collection of data from interns in general medicine is a formalized description of the consultations attended by medical students during their outpatient training. This formalization uses the International Classification of Primary Care. This project aims to create a research network between general medical interns, mainly for their thesis, which pools their observations in a database accessible to all participants.

lead_sponsor: Sorbonne University

appel_a_projets: RESPIR

region: Île-de-France

nom_etablissement: HOPITAL FONDATION A DE ROTHSCHILD

type_etablissement: EBNL

titre: Recueil récurrent de données de consultation par les internes en médecine générale en stage ambulatoire

discipline_principale: autre

nom_porteur: AVENIN

prenom_porteur: Guillaume


title: Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis

acronym: BHAPE

summary: The recording or bowels is easy and cheap. The investigators wonder if these sounds are modified in babies with high risk of necrotizing enterocolitis. In this study, the investigators suggest to record and do a spectral analysis of 30 seconds of bowel sounds in preterm babies of less than 32WA before and after enteral nutrition, every day until the end of hospitalization. A spectral analysis will be made for each record to determine frequencies of the signal. The investigators will try to determine physiological frequencies and look for modifications in pathological situations.


title: Impact of Simulation-Based Training on the Safety of Medication Administration

acronym: SIM-SAM

summary:
Task interruption is part of professional life. The healthcare world is not exempt from this phenomenon. Task interruptions lead to errors and increase the risks in managing patients.

Medication administration is the critical step, in that it is the final step to stop medication errors produced upstream. It therefore requires the full attention of any healthcare professional.

In the field of health, simulation has become an innovative educational tool allowing experiential learning and reflective practice.

The general aim of this study is to objectivize the value of simulation-based training as regards medication administration when task interruptions occur.

lead_sponsor: University Hospital, Angers

location_facility: Simulation center All'Sims; University Hospital of Angers


title: Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer

acronym: AIDORL

summary:
Head and Neck invasive cancer usually requires surgery that is associated with modifications of the body structure of patient regarding breathing, eating and communication. These modifications are correlated with an important loss of autonomy in patients. During the study, while the patient is hospitalised after the surgery, the paramedical team will train the caregiver of the patient from experimental group a new dimension of autonomy in order to assure a safe return home. The level of learning depends on each caregiver and patient; therefore, an adapted training is provided.

This study evaluates the impact of paramedical care in accompanying caregivers of patients that had surgery for an ENT invasive cancer, by comparing the experimental group (paramedical care) to the standard group (standard care).

The hypothesis of the study is that a benefit will be seen in the experimental group, by reducing the caregiver burden, improving the quality of life of patients and lowering the rate of hospitalisations and prolonged hospitalisations in these patients.

lead_sponsor: Centre Henri Becquerel


title: Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT

acronym: TIMAGING

summary: Cochlear fibrosis development can compromise the success and the outcomes of the cochlear implantation (CI) thus affecting the quality of life of the implanted patient. Correlating the results of the Transimpedance Matrix (TIM) measurements to the implant electrode location determined by the Cone Beam Computer Tomography (CBCT), this study aims to identify a range of TIM profiles within the implanted population, certain profiles suggesting the growth of the fibrosis tissue in cochlea

lead_sponsor: University Hospital, Montpellier


title: Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood

summary:
Abionic society has developed a novel point-of-care (POC) platform, the abioSCOPE, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (PSP) to be analyzed specifically with the abioSCOPE® device. The PSP is a host protein biomarker produced by the pancreas in response to a sepsis-related organ dysfunction and has shown a great potential in the early identification of septic patients This test is intended to be used to aid in the early recognition of sepsis. The test is extremely easy to use and has a total turnaround time of approximately 8 minutes. This test uses only 50 microliters of K2/K3-EDTA venous anticoagulated whole blood. Results are quantitative (ng/ml). The product is for Investigational Use Only in the US and bears CE-marking. It is commercially available in selected European and non-European countries. The test has also been clinically validated in a multicentric, prospective, observational study performed (AB-PSP-001, clinicaltrials.gov identifier NCT03474809).

The main goal of this study is to evaluate the analytical performances components of this product in a point-of-care environment, in particular the sample type comparability between arterial and venous whole blood.


title: Prospective Evaluation of the Quality of Life of Elderly Patients Undergoing Transfemoral Percutanous Aortic Valve Replacement (TAVI) for the Treatment of Severe Aortic Stenosis. (TAVI QdV)

acronym: TAVI QdV

summary:
In order to overcome the shortcomings of the assessment questionnaires currently available on the assessment of overall quality of life, the "Toronto Aortic Stenosis Quality of Life Questionnaire" (TASQ) was developed as a specific assessment tool for the impact of severe aortic stenosis in elderly patients, through 16 questions covering 5 domains: symptoms and physical limitations, emotional impact and expectations following TAVI, as well as social limitations incurred.

A better knowledge and understanding of the clinical outcomes and quality of life of elderly patients with severe symptomatic aortic stenosis at 12 months of follow-up of a TAVI procedure would further optimize the clinical decision-making process and patient selection who will benefit the most from this intervention in the long term.

lead_sponsor: Elsan

sponsor_collaborators:
Elsan
Belledonne clinic
European Clinical Trial Experts Network


title: Effectiveness of an Optimisation Strategy for Emergency Tracheal Intubation on Postintubation Morbidity: A Cluster Randomized Controlled Trial

acronym: OSETIM

summary: This study has to objective to assess, in adults' patients needing tracheal intubation because of vital distress, the effect of a combined strategy to reduce intubation-related morbidity. This strategy will associate systematic use of rocuronium as paralyzing agent to facilitate tracheal intubation, bag face-mask ventilation before intubation and Gum Elastic Bougie (GEB) use.

lead_sponsor: University Hospital, Bordeaux


title: Kinetics of the Determinants of Performance During an Ultra-trail

summary:
The Scientific Trail Protocol of Clécy - Suisse Normande (TCS) is exploratory study including several specific protocols, on a real event of 156 km on hilly terrain (6000 m of difference in level), allowing to evaluate the constraints and immediate (6000 m of difference in altitude), allowing to evaluate the constraints and the immediate physiological adaptations under race conditions.

The evaluations will be performed by collecting biological and neurobiological variables before, during and after the race (inflammation, hydro-electrolytic, cardiac, renal and muscular balance), physiological parameters whose thermoregulatory processes (core temperature, skin temperature, hydration), neuromuscular fatigue, cognitive performances (motivation, attention, emotion) and sleep changes (before, during and after the race).

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen


title: Effects of Dihydropyridine Calcium Channel Inhibitors on Respiratory Gas Exchanges in the Intensive Care Unit: a Pharmacovigilance Study in VigiBase® and a Comparison With Urapidil

summary: Due to their effects on hypoxic pulmonary vasoconstriction (HPV), dihydropyridine calcium channel inhibitors (CCI) could lead to hypoxia in patients with a pulmonary shunt. To the present time only preclinical studies and case reports focused on this potential adverse drug reaction. We aimed to assess the reporting association between CCI and hypoxia using the World Health Organization pharmacovigilance database (VigiBase®).

location_facility: Caen University Hospital, Department of Pharmacology


title: Characterization of Anti-HLA I Antibodies Involved in Platelet Transfusion Refractoriness: Optimization of the Transfusion Management of Patients With Severe Thrombocytopenia

acronym: ACERTP

summary: Platelet Transfusion Refractoriness is one of the severe complications after multiple transfusions in patients with severe thrombopenia. Platelet Transfusion Refractoriness is characterized by inefficient transfusion and arise from allo-antibodies specific of platelets antigenes, mostly carried by HLA-I molecules.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Rôle du métabolisme du Glucose Dans la Migration Des Cellules Dendritiques cutanées Dans le Psoriasis : étude Pilote Translationnelle

summary: Dendritic cells (DC) paly a key role in the induction and chronicity of psoriasis by capturing the antigenes and activating the T cell repsonse. This activation requires their migration from the cutaneous sensitisation site to the lymph nodes. This migration requires an important intracellular metabolic activity, with a strong involvmenet of glucdic metabolism. This activity is linked with the systemic activity. This study aims to compare the migration and the phenotypic and metabolic caracteristics of blood and skin DCs in patients with or without psoriasis and with or without type 2 diabetes,

lead_sponsor: Centre Hospitalier Universitaire de Nice


type: Registry Identifier

title: Residual Insulin Secretion in Patients With Type 1 Diabetes Under a Low Carbohydrate Diet or a Ketogenic Diet

acronym: KetoDiab

summary:
Low Carbohydrate Diet (LCD) (< 130 g of carbohydrate per day) and ketogenic diet (< 50 g of carbohydrate per day) are popular among patients with type 1 diabetes (T1D). In most cases, LCD allow a better glycemic control and a important decrease of insulin requirements that cannot, however, be the sole result of low carbohydrate intake. However, due to the increase production of ketone bodies and the decrease of the insulin/glucagon rate, this diet is not without risk in T1D patients and some of them develop ketoacidosis.

Type 1 diabetes is a autoimmune disease defined by the destruction of the pancreatic beta cells by the effector T cells, in condition of low regulatory T cells (Tregs). Indeed, some nutrients could regulate the plasticity and the function of Tregs, and be involved in the control of some autoimmune diseases in animals models thanks to a direct effect on immune cells of the digestive tract or an indirect effect by microbiota modulation.

The study hypothesises that LCD may be able to restore residual insulin secretion in some patients by modulating immunity. The metabolic mechanisms leading to the effects described in patients with T1D patients under LCD have not been studied : in particular, there is no data on the evolution of the residual insulin secretion and no immunological parameter has been studied on these patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family

summary: The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.

lead_sponsor: Arthesys


title: Adaptation of the Motor System to Experimental Pain

acronym: KinesioPoint

summary: This study aims to measure the impact of an experimental pain on electromyography, kinematics of motion and motor cortical excitability.

lead_sponsor: Universite du Littoral Cote d'Opale


title: Comparison Between Respiratory and Quadriceps Muscle Fatigability During a Maximal Loading for ICU Weakness Patients

summary:
Muscle dysfunction can be lead to poor outcomes moreover ICU muscle weakness recovery are not correctly described.

The investigators aimed to assess the ability for quadriceps or respiratory muscles to repeat an effort at a maximal loading.

lead_sponsor: Groupe Hospitalier du Havre


title: Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy on 1.5T T2*-Weighted Imaging

acronym: CSS

summary: Cerebellar superficial siderosis (SS) has been recently reported to be present in about 10% of both hereditary (n=50) and sporadic (n=46) cerebral amyloid angiopathy (CAA) patients on 3T MRI using susceptibility-weighted imaging (SWI) in the majority of patients. In that study, cerebellar SS was associated with a higher number of supratentorial lobar and superficial cerebellar macrobleeds (although cerebellar SS was not directly located adjacent to these cerebellar macrobleeds). It is unclear if cerebellar SS is caused by in situ leakage of cerebellar leptomeningeal vessels or rather represents hemorrhagic diffusion from cerebellar parenchymal micro/macrobleeds or from supratentorial bleeding sources via the tentorium cerebelli (TC).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Photoplethysmographic Measurements of Pulse Wave Velocity (PWV) and Blood Pressure (BP) MEPPAVOP

acronym: MEPPAVOP

summary: Theoretically, there is a correlation between the PWV and the value of the BP, mediated by the distensibility of the segment of artery where the measurements take place. The hypothesis is therefore that the measurement of the PWV through a multisite medical device for detecting the pulse wave by photoplethysmography makes it possible to deduce the value of the BP.

primary_purpose: Device Feasibility

ReferenceType: background

ReferenceCitation: Sharman JE, O'Brien E, Alpert B, Schutte AE, Delles C, Hecht Olsen M, Asmar R, Atkins N, Barbosa E, Calhoun D, Campbell NRC, Chalmers J, Benjamin I, Jennings G, Laurent S, Boutouyrie P, Lopez-Jaramillo P, McManus RJ, Mihailidou AS, Ordunez P, Padwal R, Palatini P, Parati G, Poulter N, Rakotz MK, Rosendorff C, Saladini F, Scuteri A, Sebba Barroso W, Cho MC, Sung KC, Townsend RR, Wang JG, Willum Hansen T, Wozniak G, Stergiou G; Lancet Commission on Hypertension Group. Lancet Commission on Hypertension group position statement on the global improvement of accuracy standards for devices that measure blood pressure. J Hypertens. 2020 Jan;38(1):21-29. doi: 10.1097/HJH.0000000000002246.

ReferenceCitation: Vlachopoulos C, Aznaouridis K, O'Rourke MF, Safar ME, Baou K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with central haemodynamics: a systematic review and meta-analysis. Eur Heart J. 2010 Aug;31(15):1865-71. doi: 10.1093/eurheartj/ehq024. Epub 2010 Mar 2.

ReferenceCitation: Bramwell C, Hill and AV, The Velocity of the Pulse Wave in Man, Proc. R. Soc. Lond. B 1922 93, 298-306

ReferenceCitation: Lubin M, Vray D, Bonnet S. Blood pressure measurement by coupling an external pressure and photo-plethysmographic signals. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:4996-4999. doi: 10.1109/EMBC44109.2020.9176730.

ReferenceCitation: Block RC, Yavarimanesh M, Natarajan K, Carek A, Mousavi A, Chandrasekhar A, Kim CS, Zhu J, Schifitto G, Mestha LK, Inan OT, Hahn JO, Mukkamala R. Conventional pulse transit times as markers of blood pressure changes in humans. Sci Rep. 2020 Oct 2;10(1):16373. doi: 10.1038/s41598-020-73143-8.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Commissariat A L'energie Atomique


title: Arthrogryposis Multiplex Congenita in Pediatric Age: Correlation Between MUScular MRI and Functional Evaluation

acronym: AMUSE

summary: The aim of our study is to evaluate the correlation between quantified fibro-adipous infiltration of muscles on MRI assessed by MERCURI Score and the functional abilities (deficiencies, activity limitations and social participation of pediatric patients with arthrogryposis.

ReferenceCitation: Hall JG. Arthrogryposis multiplex congenita: etiology, genetics, classification, diagnostic approach, and general aspects. J Pediatr Orthop B. 1997 Jul;6(3):159-66.

ReferenceCitation: Mercuri E, Pichiecchio A, Counsell S, Allsop J, Cini C, Jungbluth H, Uggetti C, Bydder G. A short protocol for muscle MRI in children with muscular dystrophies. Eur J Paediatr Neurol. 2002;6(6):305-7. doi: 10.1016/s1090-3798(02)90617-3.

ReferenceCitation: Figueroa-Bonaparte S, Segovia S, Llauger J, Belmonte I, Pedrosa I, Alejaldre A, Mayos M, Suarez-Cuartin G, Gallardo E, Illa I, Diaz-Manera J; Spanish Pompe Study Group. Muscle MRI Findings in Childhood/Adult Onset Pompe Disease Correlate with Muscle Function. PLoS One. 2016 Oct 6;11(10):e0163493. doi: 10.1371/journal.pone.0163493. eCollection 2016.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Quijano-Roy S, Avila-Smirnow D, Carlier RY; WB-MRI muscle study group. Whole body muscle MRI protocol: pattern recognition in early onset NM disorders. Neuromuscul Disord. 2012 Oct 1;22 Suppl 2:S68-84. doi: 10.1016/j.nmd.2012.08.003.

ReferenceCitation: Dieterich K, Le Tanno P, Kimber E, Jouk PS, Hall J, Giampietro P. The diagnostic workup in a patient with AMC: Overview of the clinical evaluation and paraclinical analyses with review of the literature. Am J Med Genet C Semin Med Genet. 2019 Sep;181(3):337-344. doi: 10.1002/ajmg.c.31730. Epub 2019 Aug 1.

publisher_dissemination: Wiley


title: Effects of Preventive Physiological and Psychological Interventions on Performances During Objective Structured Clinical Examination (OSCE) for Medical Students: Cardiac Biofeedback, Mindfulness, or Inner Resources Mobilization

summary:
Objective Structured Clinical Examination (OSCE) is a newly implemented evaluation standard for medical students and is a determinant part of the national competition they have to undergo.

Exam periods are significantly associated with increased stress and anxiety which led to reduced performance, impaired memorization and impaired workload capacities.

Cardiac biofeedback and mindfulness techniques are efficient methods for stress reduction. Interventions that aim to mobilize competence, such as mobilization of inner strength and resources techniques, should improve the level of preparation of medical students. These three procedures could influence the stress level and improve performance during the OSCE.

There is currently no study exploring the effect of these physiological and psychological procedures on the performance during OSCE for medical students.

lead_sponsor: Claude Bernard University


title: Influence of Medical Students Coping Behaviour Types on Health Related Behaviour and Stress Level on the Day of the OSCEs

summary:
Objective structured clinical examinations (OSCEs) have recently been incorporated in the French medical studies. They will soon be an important part of the national evaluation of the students, therefore being responsible for a high level of stress.

The differents strategies of coping have never been characterized for this particular group of students. We hypothetize that different strategies of coping are associated with different level of stress, thus being an interesting insight to help students to deal with their stress and prevent disorders linked to stress.

We will be using the Brief Cope Scale to assess the different ways of coping, in addition to multiple demographic and health-related questionnaires.


title: Stress of Anesthesia Professionals in the Operating Room

acronym: StressBloc

summary: The objective of this study was to determine whether there was an association between the resilience of anesthesia professionals in the operating room of the Grenoble University Hospital and perceived work-related stress.


title: Pathophysiology of Gas Exchange and Time Course Changes in Spontaneously Breathing Patients With Acute Respiratory Failure Due to COVID-19. A Multicenter Prospective Study.

acronym: COVAQ

summary: The pathophysiology of SARS-COV-2 related respiratory disease is still poorly understood, especially in its most severe form called acute respiratory distress syndrome (ARDS). In this case, very few studies have investigated changes in gas exchange during COVID-19 progression in spontaneously breathing patients. The investigators purpose in this study to explore the pathophysiology of gas exchange and time course changes in spontaneously breathing patients with acute respiratory failure due to COVID-19. Moreover, our aim is to identify early markers associated with worsening respiratory failure and requiring endotracheal intubation.

status: Unknown status

lead_sponsor: CHU de Reims

status_simplified: Unknown


title: Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank

acronym: SCLEROBREST

summary:
This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis.

It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Overnight Rostral Fluid Shift in the Pathogenesis of Obstructive Sleep Apnea in Spinal Cord Injured Patients

acronym: OUI-SCI

summary:
Obstructive Sleep Apnea (OSA), a common disorder resulting from repetitive pharyngeal collapse during sleep, is multifactorial. Usually, OSA is considered primarily a problem of upper airway anatomy, with the craniofacial structure or neck fat decreasing the size of the pharyngeal airway lumen. Obesity, male sex and genetics are well established pathogenic factors. In the last decade rostral fluid displacement (fluid shift) to explain the pathogenesis of upper airway collapsibility has been increasingly studied.

Individuals living with spinal cord injury are at increased risk for OSA, with a prevalence that is three- to fourfold higher than the general population. Individual with acute tetraplegia and undiagnosed or untreated OSA may participate less in rehabilitation due to sleepiness and fatigue and therefore be less engaged in activities that improve quality of life and maintain functioning over time. Intermittent hypoxia, sleep fragmentation and alterations of the autonomous nervous system induced by OSA are thought to delay or limit recovery and in the long term, increase cardio- and cerebrovascular morbi-mortality.

Redolfi et al have shown that overnight change in leg fluid volume correlated strongly with the Apnea Hypopnea index (AHI) and the time spent sitting. In SCI patients two mechanisms may underline fluid shift importance in the pathogenesis of OSA: first, time spent sitting is obviously increased in patients with no walking abilities (prolonged sitting position in wheelchair). Secondly, motor deficit lead to the loss of skeletal muscle pumping activity which could promote leg fluid accumulation during the day.

In our knowledge, no study has specifically assessed the impact of rostral fluid displacement on upper airway collapsibility among patients with spinal cord injury.

Better comprehension of upper airway collapsibility determinants in patients with spinal cord injury is mandatory to identify new therapeutic targets (diuretics, contention…) especially since CPAP, the first line treatment for severe OSA, continue to pose adherence issues in SCI patients. In the future, phenotyping OSA patients, especially those with SCI, will improve personalized management.

The main objective is to find if there is a correlation between the apnea-hypopnea index (AHI) and rostral fluid shift overnight, in non-obese spinal cord injured patients. The secondary aim is to find if there is a correlation between AHI and:

Neck circumference
Neck volume
Time spent sitting down

ReferenceCitation: Redolfi S, Yumino D, Ruttanaumpawan P, Yau B, Su MC, Lam J, Bradley TD. Relationship between overnight rostral fluid shift and Obstructive Sleep Apnea in nonobese men. Am J Respir Crit Care Med. 2009 Feb 1;179(3):241-6. doi: 10.1164/rccm.200807-1076OC. Epub 2008 Nov 14.

ReferenceCitation: Sankari A, Vaughan S, Bascom A, Martin JL, Badr MS. Sleep-Disordered Breathing and Spinal Cord Injury: A State-of-the-Art Review. Chest. 2019 Feb;155(2):438-445. doi: 10.1016/j.chest.2018.10.002. Epub 2018 Oct 12.

ReferenceCitation: Panza GS, Sutor T, Gee CM, Graco M, McCully KK, Chiodo A, Badr MS, Nash MS; American Congress of Rehabilitation Medicine, Interdisciplinary Special Interest Group, Spinal Cord Injury Physical Function and Wellness Task Force. Is Sleep Disordered Breathing Confounding Rehabilitation Outcomes in Spinal Cord Injury Research? Arch Phys Med Rehabil. 2022 May;103(5):1034-1045. doi: 10.1016/j.apmr.2021.08.015. Epub 2021 Sep 17.

ReferenceCitation: Bailly S, Grote L, Hedner J, Schiza S, McNicholas WT, Basoglu OK, Lombardi C, Dogas Z, Roisman G, Pataka A, Bonsignore MR, Pepin JL; ESADA Study Group. Clusters of sleep apnoea phenotypes: A large pan-European study from the European Sleep Apnoea Database (ESADA). Respirology. 2021 Apr;26(4):378-387. doi: 10.1111/resp.13969. Epub 2020 Nov 2.

ReferenceCitation: Proserpio P, Lanza A, Sambusida K, Fratticci L, Frigerio P, Sommariva M, Stagni EG, Redaelli T, De Carli F, Nobili L. Sleep apnea and periodic leg movements in the first year after spinal cord injury. Sleep Med. 2015 Jan;16(1):59-66. doi: 10.1016/j.sleep.2014.07.019. Epub 2014 Oct 7.

ReferenceCitation: Popa C, Popa F, Grigorean VT, Onose G, Sandu AM, Popescu M, Burnei G, Strambu V, Sinescu C. Vascular dysfunctions following spinal cord injury. J Med Life. 2010 Jul-Sep;3(3):275-85.

ReferenceCitation: Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.

ReferenceCitation: Murata J, Murata S, Yamagata S, Ohyama M, Kogo H, Umeki N. The attenuating effect of a dynamic cushion on the development of leg edema in wheelchair users with spinal cord injuries. Technol Health Care. 2020;28(4):447-452. doi: 10.3233/THC-192045.

ReferenceCitation: Viaene A, Roggeman S, Goessaert AS, Kessler TM, Mehnert U, Besien VV, De Muynck M, Everaert K. Conservative treatment for leg oedema and the effect on nocturnal polyuria in patients with spinal cord injury. BJU Int. 2019 May;123(5A):E43-E50. doi: 10.1111/bju.14672. Epub 2019 Feb 6.

ReferenceCitation: Leotard A, Levy J, Perennou D, Pepin JL, Lofaso F, Bensmail D, Lebret M, Baillieul S. Sleep might have a pivotal role in rehabilitation medicine: A road map for care improvement and clinical research. Ann Phys Rehabil Med. 2021 Jul;64(4):101392. doi: 10.1016/j.rehab.2020.04.006. Epub 2020 Oct 14. No abstract available.

ReferenceCitation: Berry RB, Brooks R, Gamaldo C, Harding SM, Lloyd RM, Quan SF, Troester MT, Vaughn BV. AASM Scoring Manual Updates for 2017 (Version 2.4). J Clin Sleep Med. 2017 May 15;13(5):665-666. doi: 10.5664/jcsm.6576. No abstract available.

ReferenceCitation: Kaminska M, Jobin V, Mayer P, Amyot R, Perraton-Brillon M, Bellemare F. The Epworth Sleepiness Scale: self-administration versus administration by the physician, and validation of a French version. Can Respir J. 2010 Mar-Apr;17(2):e27-34. doi: 10.1155/2010/438676.

location_facility: Unité des pathologies du sommeil, Service de physiologie explorations fonctionelles, Hôpital Raymond Poincaré, APHP


title: Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls

acronym: H-Repro

summary: Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at the joint coxo-femoral associated with a triad of symptoms, clinical signs and findings imagery. It represents premature contact symptomatic between the femur and the acetabulum. Currently, there is no consensus for determine when to return to sport securely after processing arthroscopy of a emoroacetabular impingement. Various clinical tests are used to assess the mobility or pain but no test studies specifically the level of recovery functional.

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
Ramsay santé


title: Influence of Meditation on Stress and Rumination Following Objective Structured Clinical Examination (OSCE)

summary:
Stress and rumination are linked with the development of many mental disorders. The ECOSTRESS study has shown that poor OSCE performance has a positive effect on the occurence of state-rumination among 4th year medicine students in the context of mock exams.

The goal of IMSR study is to assess the effectiveness of a post-OSCE meditation intervention to decrease psychological stress and rumination.


type: EudraCT Number

title: [18F]-Fludarabine PET/MR Imaging for the Assessment of Newly-diagnosed Primary Central Nervous System (CNS) Lymphoma : a Pilot PET-MRI Study

acronym: FLUDALOC

summary:
Primary central nervous system (CNS) lymphomas represent 5% of primary brain tumors. More than 90% of them are diffuse large B-cell lymphomas.

[18F]-Fluorodeoxyglucose positron emission tomography (PET-[18F]-FDG) is the gold standard for imaging systemic lymphomas, but its application in primary CNS lymphoma is compromised by the limited specificity of brain fixations and the high uptake of [18F]-FDG in healthy brain tissue.

[18F]-Fludarabine is a new radiopharmaceutical developed for PET imaging of lymphomas. Preclinical studies indicate a restricted binding specificity to lymphoid tissue compared to [18F]-FDG and an ability to detect residual lymphoma disease after treatment. A pilot study in humans shows good agreement of its binding with tumor sites in systemic lymphoma and superior tumor contrast to [18F]-FDG. Finally, a recent preclinical study shows a binding ratio in brain lymphoma 3 times higher than that of healthy brain tissue in mouse models of primary CNS lymphoma, whereas in mouse models of high-grade glial tumors, the binding level is very low, comparable to that of healthy tissue (background). Investigators hypothesize that [18F]-Fludarabine could be the radiopharmaceutical of choice for the diagnosis and monitoring of primary CNS lymphomas in PET.

The main objective of the study is to characterize the cerebral distribution and [18F]-Fludarabine uptake in newly-diagnosed primary CNS lymphomas before surgery, chemotherapy or radiotherapy, using PET-MR imaging.

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.


title: Evaluation of the Efficacy of a Coordinated Interprofessional Care Pathway on Disability in Patients With Chronic Low Back Pain and Patients at Risk of Chronic Low Back Pain in Primary Care: a Cluster Randomized Controlled Trial

acronym: EFFIBACK

summary: Low back pain is a public health problem with major individual and socio-economic repercussions. In primary care, strong disparities are observed in the management of low back pain patients. While general practitioners (GPs) and physiotherapists appear as two essential first-line caregivers, collaboration between these professionals remains underdeveloped, most often characterized by a lack of consultation or coordination. Systematic increased interprofessional collaboration is likely to improve the results of the care pathway, by optimizing the existing care offer.

lead_sponsor: CNGE Conseil

location_facility: Maison de Santé Pluriprofessionnelle Universitaire


title: Cohort Study of Patients With Hepatocellular Carcinoma and Circulating Tumor DNA Monitoring of Chemoembolization

acronym: Mona-Lisa

summary: Cohort study to assess the impact of ctDNA detection in the follow-up and management of patients with hepatocellular carcinoma treated by TACE

lead_sponsor: University Hospital, Rouen


title: REFLEX: A Randomized Controlled Trial to Test the Efficacy of an Emotion Regulation Flexibility Program With Daily Measures

acronym: REFLEX

summary: The main objective of this RCT is to test the efficacy of an emotion regulation group program (i.e., ART program) in college students, compared to an active control group (i.e., relaxation program). Using multilevel analyses, we expect an improvement in anxious-depressive symptomatology for both groups. However, we expect the ART group to improve specifically on emotion regulation flexibility ability, and the last to be a mediative variable on mental health.

ReferenceCitation: Berking M, Eichler E, Luhmann M, Diedrich A, Hiller W, Rief W. Affect regulation training reduces symptom severity in depression - A randomized controlled trial. PLoS One. 2019 Aug 29;14(8):e0220436. doi: 10.1371/journal.pone.0220436. eCollection 2019.

ReferenceCitation: Aldao A, Nolen-Hoeksema S. The influence of context on the implementation of adaptive emotion regulation strategies. Behav Res Ther. 2012 Aug;50(7-8):493-501. doi: 10.1016/j.brat.2012.04.004. Epub 2012 May 7.

ReferenceCitation: Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.

ReferenceCitation: Csikszentmihalyi M, Larson R. Validity and reliability of the Experience-Sampling Method. J Nerv Ment Dis. 1987 Sep;175(9):526-36. doi: 10.1097/00005053-198709000-00004.

ReferenceCitation: Gross JJ. Emotion regulation: affective, cognitive, and social consequences. Psychophysiology. 2002 May;39(3):281-91. doi: 10.1017/s0048577201393198.

ReferenceCitation: Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1-27. doi: 10.1146/annurev.clinpsy.3.022806.091432.

ipd_sharing_description: Theoretical background, objectives, hypothesis, expected results, methodology

sponsor_collaborators:
University Hospital, Grenoble
Université Grenoble-Alpes


title: Study of Prostate Perfusion Before Embolization in Patients With Symptomatic Prostate Adenoma. A Single-center Prospective Cohort Pilot Study to Determine the Predictive Factors of Clinical Efficacy Associated With a Prior Phantom Study.

acronym: EMBOPERF

summary: Over the last 5 years, prostate embolization has developed as a treatment for symptomatic prostate adenoma. This long, complex procedure is effective in 80% of cases. Currently there are no means of better selecting patients to avoid this long procedure in non-responders. The hypothesis is that prostate perfusion parameters are correlated with the efficacy of embolization. Studying these prostate perfusion parameters in perfusion CT and evaluating prostate Iodine load in dual energy computed tomography will make it easier to select those patients who are most likely to respond.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: The Effect of Internal Discourses on the Perception of Trail-running Effort

summary: Determination of the effect of an intervention to develop the use of internal discourses on the perception of exercise during a sub-maximum effort following a trail running


title: Pathogen Detection by Metatranscriptomic Next Generation Sequencing in the Trophoblast Collected in Women Carrying a Fetus With Increasing Nuchal Translucency in the First Trimester of Pregnancy

acronym: METAHCN

summary: The study is based on the hypothesis that increased nuchal translucency may be associated with a materno fetal infection and that the pathogen responsible for this infection could be identify with metatranscriptomic next-generation sequencing in the trophoblast tissue.

ReferenceCitation: Sebire NJ, Bianco D, Snijders RJ, Zuckerman M, Nicolaides KH. Increased fetal nuchal translucency thickness at 10-14 weeks: is screening for maternal-fetal infection necessary? Br J Obstet Gynaecol. 1997 Feb;104(2):212-5. doi: 10.1111/j.1471-0528.1997.tb11047.x.

ReferenceCitation: Faure-Bardon V, Fourgeaud J, Guilleminot T, Magny JF, Salomon LJ, Bernard JP, Leruez-Ville M, Ville Y. First-trimester diagnosis of congenital cytomegalovirus infection after maternal primary infection in early pregnancy: feasibility study of viral genome amplification by PCR on chorionic villi obtained by CVS. Ultrasound Obstet Gynecol. 2021 Apr;57(4):568-572. doi: 10.1002/uog.23608. Epub 2021 Mar 9.

ReferenceCitation: Regnault B, Bigot T, Ma L, Perot P, Temmam S, Eloit M. Deep Impact of Random Amplification and Library Construction Methods on Viral Metagenomics Results. Viruses. 2021 Feb 7;13(2):253. doi: 10.3390/v13020253.

ReferenceCitation: Bilardo CM, Timmerman E, Pajkrt E, van Maarle M. Increased nuchal translucency in euploid fetuses--what should we be telling the parents? Prenat Diagn. 2010 Feb;30(2):93-102. doi: 10.1002/pd.2396.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Pathogen Discovery Laboratory
Institut Pasteur


title: Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen

acronym: SAFE

summary: Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen

lead_sponsor: Quantum Surgical


title: Research and Quantification of Factors Influencing Endothelial Damage During Phacoemulsification

acronym: PREDICSPILOT

summary:
The aim of this study is to determine the principal factors that influence endothelial cell loss three month post cataract surgery.

Methods: Multi center observational Cohort study, inclusion period from 12/01/2022 to 10/06/2022. One hundred and seventy-five eyes of hundred and four patients who have appointment for cataract surgical indication were included. The percentage of corneal endothelial cell loss was quantified using specular microscopy before and 3 months after the surgery.

14 variables (pre-operative and intra-operative) that could be associated to endothelial cell injury were selected.

A bivariate analysis of relationship between these factors and endothelial cell loss at 3 months was performed by simple linear regression (Wilcoxon and Fischer tests). Multivariate analysis was performed by multiple linear regression in order to identify the factors independently related to endothelial cell loss.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: The Radiologically Isolated Syndrome International Cohort

summary:
The Radiologically Isolated Syndrome (RIS) corresponds to the discovery of white matter (WM) abnormalities suggestive of multiple sclerosis (MS) by their location, size, and appearance, on the brain or spinal cord Magnetic Resonance Imaging (MRI). This imaging is performed for a reason other than for suspicion of demyelinating disease in subjects without a history of neurological symptoms and a strict routine clinical neurological examination. It was defined and named in 2009 (Okuda et al.) after publishing 3 case series (French, USA, Turkey). The Radiologically Isolated Syndrome Consortium (RISC) published a cohort of subjects with an extended follow-up after the first brain MRI of MS, with 34% presenting an event (clinical conversion) at five years, 51.2 % of these subjects showed an event at ten years. The patients who offer a higher risk of developing a first clinical demyelinating event were identified such as male sex, young age, the presence of oligoclonal bands (BOCs) in the Cerebrospinal Fluid (CSF), the presence of infratentorial lesions and spinal cord lesions on the first MRI suggestive of RIS. The location and morphology of the lesions appear to be decisive for studying the risk of conversion. Our first objective is to prospectively collect data to identify the subjects who present a higher risk of developing a first clinical demyelinating event and the progression of the disease in these subjects.

Among the objectives of this worldwide cohort is the analysis of (1) environmental factors (Vit D, EBV, tobacco…), (2) MRI biomarkers, including atrophy, central veins signs, paramagnetic rings, and DTI.

(3) digital biomarkers (4) oculography (5) biological markers To summarize, this cohort will allow for analyzing features in imaging, biology and the exploration of digital and oculographic characteristics to identify predictive factors of clinical evolution of a large cohort of subjects presenting WM abnormalities suggestive of multiple sclerosis.


title: Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis

acronym: CIRCEE

summary: Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities, whose physiopathology remains largely unknown. Quantification and characterization of epithelial and endothelial circulants in Gougerot-Sjögren's syndrome could reflect the intensity of the epithelial aggression, and thus possibly constitute a biomarker.

lead_sponsor: University Hospital, Montpellier


title: Impact of COVID 19 Vaccination or Infection on Disease Activity in Radiologically Isolated Syndrome Cohort: the VaxiRIS Study

acronym: VaxiRIS

summary: The Radiologically Isolated Syndrome (RIS) is defined as incidental Magnetic Resonance Imaging (MRI) abnormalities fulfil the criteria for dissemination in space, suggestive of multiple sclerosis. Nowadays, mandatory vaccination in patients with multiple sclerosis (MS) is widely recommended. Regarding COVID19, the absence of specific warnings led to the proposal of vaccination in patients with inflammatory diseases of the central nervous system. We aimed to evaluate if COVID19 vaccination or infection increased the risk of clinical conversion to multiple sclerosis or evidence of disease activity (EDA) in a cohort of RIS subjects.


title: Pre-therapeutic Validation of the VR-based Exposure Scenario for CBT "ReVBEB" for the Induction of Food Craving in Patients With Bulimia and Binge Eating Disorder

acronym: RevBED

summary: Food craving is a major therapeutic issue in Eating Disorders with binge eating: the Bulimia Nervosa and the Binge Eating Disorder (BED). Food craving is linked to compulsive eating and its apprehension is currently based on classic Cognitive and Behavioural Therapies (CBT). However, it remains difficult to induce in therapy and a significant number of patients do not respond to classic CBTs. The development of exposure scenarios for CBT in virtual reality (VR) has allowed a gain in efficacy and in particular therapeutic effects lasting longer after treatment. Nevertheless, the stimuli used are often simple food visuals and insufficiently consider the many factors influencing food craving (physical, psychological, socio-environmental...) and VR immersion is still limited by the use of 3D laptops (fixed) rather than wireless headsets.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Evaluation de la Performance Clinique d'un Nouveau Biomarqueur Sanguin Des Phases précoces de la Maladie de Parkinson

acronym: BIOPARK

summary: The investigators have recently discovered a metabolic biomarker which predicts Parkinson's disease (PD) at the early stages in patients and in animal models. The aim of BIOPARK is to investigate how the biomarker evolves in advanced PD stage, when diagnosis confirmation is higher, an in de novo PD patients who come from a different geographical area than those of the publication (since it is known that the metabolome is largely influenced by lifestyle). They will also evaluate if the biomarker is able to distinguish patients with a parkinsonian syndrome often confused with parkinson's disease, i.e. Multiple System Atrophy (MSA).

ReferenceCitation: Mallet D, Dufourd T, Decourt M, Carcenac C, Bossu P, Verlin L, Fernagut PO, Benoit-Marand M, Spalletta G, Barbier EL, Carnicella S, Sgambato V, Fauvelle F, Boulet S. A metabolic biomarker predicts Parkinson's disease at the early stages in patients and animal models. J Clin Invest. 2022 Feb 15;132(4):e146400. doi: 10.1172/JCI146400.

sponsor_collaborators:
University Hospital, Grenoble
Grenoble Institut des Neurosciences


title: Sociological Determinants of Adherence to Continuous Positive Airway Pressure In the Management of Sleep Apnea Syndrome - A Transdisciplinary Approach.

acronym: SOCIO-SAS

summary: Monocentric, prospective, opened study to evaluate the impact of Health Literacy Levels on CPAP withdrawal in Obstructive Sleep Apnea patients within 6 months of inclusion.

ReferenceCitation: Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

oa_host_type: repository

license: public-domain

license_normalized: public-domain

repository_institution: UWA - UWA Profiles and Research Repository

repository_normalized: Pure (Denmark)

version: acceptedVersion

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

repository_normalized: HAL

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

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

repositories:
HAL
PubMed Central
Pure (Denmark)

repositories_concat: HAL;PubMed Central;Pure (Denmark)

unpaywall_oa_status: green

publisher_dissemination: Elsevier

collaborators:
ODENORE
Laboratoire HP2

sponsor_collaborators:
University Hospital, Grenoble
ODENORE
Laboratoire HP2


title: INNOVATIVE TREATMENT OF SCARRED VOCAL FOLDS BY LOCAL INJECTION OF AUTOLOGOUS ADIPOSE-DERIVED STROMAL VASCULAR FRACTION: EFFICACY VERSUS PLACEBO

summary:
Vocal Folds scarring (whether congenitally or following phonosurgery) can result in a range of symptoms depending on severity and extent, such as hoarseness, breathy voice, increased effort to speak, and voice fatigue. The inability to phonate normally causes both physical and psychological disability, especially for professional communicators (teachers, tradesmen, singers, etc.). There are several therapies currently available but these are often disappointing, as the great complexity of vocal fold microstructure hinders the development of effective therapy. Thus, identification of innovative strategies able to improve vibrational mechanical properties of vocal folds remains an important clinical challenge.

Autologous Adipose-Derived Stromal Vascular Fraction (ADSVF) is recognized as an easily accessible source of cells displaying angiogenic, anti-inflammatory, immunomodulatory and regenerative properties. Recent experimental and clinical reports also supported the anti-fibrotic potential of ADVSF, mainly attributed to the mesenchymal stem/stromal cell subset.

Safety in humans has already been confirmed in several studies, including our previous clinical trial (ClinicalTrials.gov NCT0262246; EudraCT number: 2015-000238-31). The main objective of this phase I/II trial was to measure for the first time the safety and tolerability of autologous ADSVF local injections in patients with scarred vocal folds. No severe adverse events occurred: only some minor adverse events were reported. Moreover, Voice Handicap Index was improved in all patients with a mean improvement from baseline of 40.1/120 and seven patients were considered as responders, defined as an improvement ≥ 18 points.

Based on these observations, we hypothesized that the injection of autologous ADSVF could reduce the process of fibrosis, improve vibration and then dysphonia and quality of life in patients with scarred vocal folds.

In the absence of a reference treatment, the effectiveness of the ADSVF will be compared to a placebo: the local injection of excipients solution.

This study will test efficacy of the autologous ADSVF to treat vocal folds scarring. It is a randomized, double-blind, phase II clinical trial conducted according to a 2-treatment parallel design, with medico-surgical and scientific collaboration.

Recruitment and follow-up of patients will be done in 4 university hospitals by the respective ENT teams (Marseille, Toulouse, Nice and Montpellier): 36 patients will be recruited and treated on a 24 months period.

At inclusion, 36 patients will be randomized (1:1 ratio) into two groups: ADSVF group and placebo group. Adipose tissue removal, ADSVF production and injection of ADSVF or placebo will be done on the same day during a short hospital stay. Patients will be followed and evaluated at 1 and 6 months with self-evaluation (Voice Handicap Index and a 10 points scale), video-laryngo-stroboscopic examination, vocal assessment with perceptive, acoustic and aerodynamic parameters and evaluation of adverse events. At the end of this 6-month follow-up (primary endpoint), patients of each group having tolerated the first injection well but in therapeutic failure (improvement of VHI <18 as described by Jacobson in 1997 or improvement of VHI ≥ 18 but not normal which means > 20 according to Woisard, 2004) will be offered an injection of thawed and washed ADSVF. Patients will continue to be followed in open-label on the same endpoints.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Impact of Opioids on Heart Rate During Rapid Sequence Intubation: Double-blind Randomized Controlled Study

acronym: CANDY-CRASH

summary:
The patient is seen upstream by an anaesthetists resuscitator (MAR) in order to carry out his anesthesia consultation. If the patient meets the eligibility criteria he will be informed of the study and his signed consent will be obtained.

Patients will be divided into 3 parallel groups :

Group A (placebo +remifentanil)
Group B (sufentanil + placebo)
Group C (placebo + placebo)

Constants are taken at T0. A non-invasive continuous monitoring (Clearsight ©) will be used to collect data: blood pressure, heart rate, cardiac output.

To ensure double-blinding the nurse who prepares the syringes is not part of the anesthesia team. He/she numbers them in syringe n°1 and n°2 to indicate the order of injection to the MAR.

The MAR injects the drugs according to the standardized study plan (see below):

T1: the patient receives an intravenous bolus (IV) over 5 seconds of molecule n°1
3 minute delay
Patient receives Etomidate 0.3 mg/kg IV over 10 seconds
5 second delay
The patient receives an IV bolus over 30 seconds of molecule n°2
5 second delay
The patient receives Succinylcholine or Rocuronium IV over 5 seconds
T2: End of induction, oro-tracheal intubation (= T2)

The laryngoscopy is performed by an experienced MAR or nurse (IADE). The end of the intubation is defined by the fixation of the intubation tube (T3). Hemodynamic parameters are measured every minute for ten minutes after intubation (T4 to T13).

Maintenance of anesthesia is standardized with halogen gas (SEVOFLURANE) and an opioid (SUFENTANIL). Ten minutes after the patient's intubation (T13), the blind is lifted, allowing the addition of sufentanil in groups A and C before any surgical procedure.

status: Terminated

lead_sponsor: Centre Hospitalier Sud Francilien


title: Next Generation " of Liver Derived-organoïd Biobank: Case of Colorectal Cancer Metastases and Hepatocellular Carcinomas

acronym: BORG

summary:
Recently, oncology has moved to a new clinical practice, more personalized, called Predictive Oncology (PO).

PO comes from our knowledge about tumor heterogeneity that implies that each disease, thus each patient, is unique. PO's goal is to identify and administrate the right treatment to the right patient.

For this, PO requires to go through 3 majors steps:

A good characterization of the tumor to identify candidates,
A well-established panel of drugs targeting the identified candidates,
A relevant model to functionally test these candidates.

The first point could easily be addressed with recent technologies that now allow the Next Generation Sequencing (NGS) and/or the simultaneous analysis of transcriptomic profiles from thousands of patients. The last two points have not been efficiently achieved so far, which prevents PO to be really efficient.

Indeed, even if NGS allows the identification of potential targets, the presence of a molecular candidate does not necessary means obligatory functional response.

The number of drugs approved by the Food and Drug Administration remains limited and most frequent targets in solid tumors (for ex. RAS, P53, MYC, RB1 ...) still do not have specific drugs approved in clinic.

Finally, available pre-clinical models still present many major inconvenient:

Chimiogrammes on 2D cultures are not sufficiently relevant to be really predictive of the in vivo situation;
Patient derived xenograft (PDX) are not adapted for clinical use because not all tumors graft and the time to develop a PDX is too long (several months), thus incompatible with the history of the disease (especially for most severe patients). Furthermore the host (NOD-SCID mouse) is immuno-depressed, preventing to objectively test antibodies-mediated drugs.

Recently, the 3D cell culture technology has proven its superiority to predict drug response over classical 2D chimiogrammes. It consists in growing "mini-tissues", or organoid-derived from tumor/healthy tissues, thanks to the amplification of stem cells contained within the sample. The generated organoids are personalized and biologically relevant (organoids are expend form the patient's stem cells which self-organized according to the architecture of the tissue they are originating from), they are genetically stable, their growth is compatible with patient's disease history (organoids grow in few weeks), easy and convenient to achieve, even from small biological material quantities (0.5< x < 1cm3), and they can be amplified, frozen and thawed on demand. Moreover, organoids can be made more complex with the addition of other cell types (fibroblasts, immune cells …). None of the actual available pre-clinical model regroups all these characteristics.

The constitution of a "next generation" biobank of liver samples (Metastases to the liver and Hepato Cellular Adenocarcinoma) will be very useful in the context of predictive oncology.

For this, a biopsy needs to be dissociated and grown in Matrigel™, in presence of a well-defined list of growth factors. Once the culture is established, organoids can be frozen then defrost on demand.

Our main objective is to evaluate the feasibility for building a biobank of liver-derived organoids, from liver metastases of colorectal cancers, hepatocellular adenoma and adenocarcinoma (waste tissues).

Applications related to organoids derived from tumors are quasi indefinite, from drug screening assays, tests for novel therapies or original drug combinations, to patients' stratifications or fundamental research.

In our case, we are interested in building this a biobank in the prospect of using it to build the "next generation of model for predictive oncology" to study liver-related cancers and related drugs testing. Briefly, we want to implement these organoids with cells from the microenvironment in order to makes the global model more pertinent for drug testing.

If successful, the generation of such biobank, including both tumor-derived organoids and healthy counterpart, could be really helpful for the scientific and medical community.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


title: Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study

acronym: EMOREC

summary: This study aims to compare the emotional processing in sexual offenders against children versus healthy volunteers using an objective electrophysiological measurement (EEG) during a facial emotion stimuli presentation task. Secondary goal is to assess emotion recognition performances in this population and evaluate the impact of various factors on these performances (type of emotion, age and sex of person expressing the emotion, neuropsychological and cognitive abilities of the subjects).

lead_sponsor: Hôpital le Vinatier


title: Evaluation of the Optimal Time of Recognition of a Cardiac Arrest Within the EMS 95

summary:
This study aims to evaluate the average time taken by the Medical Regulation Assistants (MRA) to detect a cardiac arrest during the call to the EMS as well as the factors influencing this delay.

Its main objective is to evaluate the delay, in seconds, between the call being picked up and the recognition of a cardiac arrest by the medical regulation assistant at the EMS 95

lead_sponsor: Hôpital NOVO

location_facility: EMS department - Hospital René Dubos - Pontoise


title: Prevalence of Mast Cell Activation Syndrome in Patients With Ehlers Danlos Hypermobile Syndrome With Digestive Disorders

acronym: SAMED

summary: The aim of the study is to confirm the association between hypermobile Ehlers Danlos syndrome (hEDS) and mast cell activation syndrome (MCAS) in patients with digestive disorders managed in allergology departments.

lead_sponsor: Lille Catholic University