title: Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy

acronym: ETRICAPT

summary:
Lung cancers treated by Tomotherapy represent between 60 and 100 patients per year at the CHR of Metz-Thionville. Some patients were observed to present acute toxicities during treatment such as dysphagia or esophagitis of CTCAE grade > 2. Beyond well known therapeutic and comorbidities factors, the pathophysiology of these events is largely ruled by a constitutional factor - the enzymatic equipment allowing more or less good repair of the DNA lesions induced by radiotherapy (RT). This equipment is characteristic of each individual, hence the term individual radiosensitivity (IR).The scientific literature is rather poor in data describing the frequency of these toxicities in patients receiving RT for lung cancer.

The objective of this study is to describe the frequency of acute and late toxicities after normofractionated radiotherapy of 66 Gy in 33 fractions in patients with small cell or non-small cell lung cancer, stage 2 or 3.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Clinical Validation of the Wrist Blood Pressure Measuring Device Combei BP 880 W for Home Use According to "the Universal" Standard (AAMI/ESH/ISO)" in the General Population

summary: Clinical validation of the wrist blood pressure measuring device Combei BP 880 W for home use according to "the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO)" in the general population.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

lead_sponsor: International Society for Vascular Health

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Early Outcomes of Natives and Graft-related Femoral Reconstruction Managed With Orthotopic Xenopericardial Patchs

summary:
Groin wound infection after arterial femoral prosthetic reconstruction or percutaneous access and drug abusers are frequent and increase largely the post operative morbi-mortality.

There is no perfect substitute to replace infected graft or to restaure femoral artery in septic condition moreover when all the femoral bifurcation is involved with a femoro-femoral bypass mandatory.

Seeing the encouraging results of rolled pericardium patch to treat native and prosthetics aortic infections in term of patency and infection resistance, the investigators propose to evaluate the outcomes of this subsitute rolled with samples in case of femoro-femoral repair in septic condition.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Alonso W, Ozdemir B, Chassin-Trubert L, Ziza V, Alric P, Canaud L. Early outcomes of native and graft-related abdominal aortic infection managed with orthotopic xenopericardial grafts. J Vasc Surg. 2021 Jan;73(1):222-231. doi: 10.1016/j.jvs.2020.04.513. Epub 2020 May 20.

ReferenceCitation: McMillan WD, Leville CD, Hile CN. Bovine pericardial patch repair in infected fields. J Vasc Surg. 2012 Jun;55(6):1712-5. doi: 10.1016/j.jvs.2011.11.139. Epub 2012 Mar 28.

lead_sponsor: University Paul Sabatier of Toulouse

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Prevalence of Venous conGestion and Its Association With Renal Injuries Evaluated by the VExUS Score On Admission With UltraSound in Patients With Cardiogenic Pulmonary Edema

acronym: GRIEVOUS

summary:
Acute respiratory distress (ARD) is a frequent reason for seeking care in emergency medicine and represents an important cause of morbidity and mortality. Among the various etiologies, Acute Cardiogenic Pulmonary Edema (C APE) currently represents one of the main causes of ARD, particularly in the elderly, with a prevalence of 43% and an estimated mortality of 21%. According to the recommendations issued in 2021 by the European Society of Cardiology (ESC), the treatment of cardiogenic APE is currently based on a triptych combining:

Oxygen therapy with an Saturation of Hemoglobin with Oxygen (SpO2) target > 94% and the use of non-invasive ventilation (NIV),
A vasodilator administered intravenously (IV),
A loop diuretic by IV route. Although most C APE are today considered to occur in a context of hypervolaemia and are uniformly treated by the administration of diuretics according to the recommendations in force, several works underline the fact that a non-negligible part of these clinical pictures would occur in patients with no water and sodium overload but with "relative" hypervolaemia masking euvolaemia or even hypovolaemia.

At present, no additional examination is recommended to determine the patient's volume status. However, it has been shown more recently that some patients who do not have absolute hypervolaemia could develop acute renal complications during treatment for C APE. In addition, systematic treatment with loop diuretics in patients without absolute hypervolaemia could be harmful by inducing post-treatment hypovolaemia.

At the present time, there are no data from the literature having been interested in the possible association existing between the state of blood volume of the patient on admission and the occurrence of renal complications in the aftermath of the treatment. initial. The prevalence of renal complications was nevertheless evaluated at 9% in this category of patients. The estimated prevalence of this complication and its particular seriousness, particularly in the case of chronic acute kidney injury, as well as its cost to society, justify carrying out a study aimed at evaluating the prevalence of venous congestion in the acute phase and of its possible association with the occurrence of renal complications in the course of this.

Among the various methods for assessing blood volume status, there is a growing literature regarding the use of clinical ultrasound in emergency medicine (ECMU). More recently, an ultrasound score called "VExUS score" (Venous Excess Ultrasound Score) has been developed. This offers the possibility of evaluating and classifying in 4 grades of increasing severity, simply and quickly, the state of venous congestion of patients. This score is based on the presence or absence of venous Doppler ultrasound abnormalities assessed at the level of the inferior vena cava, at the level of the supra-hepatic veins, of the portal and renal venous flow. This score, adapted to the practice of ECMU and making it possible to distinguish patients with or without venous congestion criteria, could provide arguments to guide diuretic treatment by offering personalized care. This evaluation would ultimately make it possible to offer diuretic treatment only in the event of signs suggestive of absolute hypervolaemia and thus avoid the occurrence of complications related to inappropriate therapy.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

intervention_type: Other


title: Carbon " Super Spikes " Performances on Sprint Acceleration : Just Use it? A Multiple N-of-1 Trial. A Multiple N-of-1 Trial in Healthy Athletes

summary:
Objectives :

To determine intra and inter-subject sprinting performance modifications with trademarked Carbon-made spiked-Shoes (CS) compared to usual carbon-free ones (Standard spiked-Shoes-SS).

Methods :

Design. Multiple N-of-1 trial (Alternating Treatments Design), with block randomisation and double blind procedure. For each participants, sixteen repetitions of 30m-sprint are applied either with CS or SS, in random order for each repetition, during a 3h session a day. Blind procedures are reached by applying a dark sleeve cover on each shoes, and by separating raters from investigators.

Patients. Regional to National healthy sprinting athletes (750 IAAF/WA points), affiliated to the French Athletics Federation among the South Regional Athletic League (Comité du Var-FFA), are recruited as volunteers, with their own CS (from the same brand for homogeneity and generalisation concerns) and SS.

Main criteria. Time on a 30-meters sprint, with Force-Velocity Profiling (FVP) procedure, using Stalker Sport radar.

Secondary outcome measures. F0, V0, Vmax, Pmax , DRP and other standard FVP parameters, also measured with MySprint software; morphometric and cinematic data ; mean price difference between the two models.

Statistical analyses. A block randomisation model will be applied to check for the randoms size; variance analysis with a mixt linear model will be applied for group and confounding factors analysis. Student-T test and NAP will be applied for intra-individuals analysis.

design_allocation: Randomized

ReferenceCitation: Samozino P, Rabita G, Dorel S, Slawinski J, Peyrot N, Saez de Villarreal E, Morin JB. A simple method for measuring power, force, velocity properties, and mechanical effectiveness in sprint running. Scand J Med Sci Sports. 2016 Jun;26(6):648-58. doi: 10.1111/sms.12490. Epub 2015 May 21.

ReferenceCitation: Edouard P, Lahti J, Nagahara R, Samozino P, Navarro L, Guex K, Rossi J, Brughelli M, Mendiguchia J, Morin JB. Low Horizontal Force Production Capacity during Sprinting as a Potential Risk Factor of Hamstring Injury in Football. Int J Environ Res Public Health. 2021 Jul 23;18(15):7827. doi: 10.3390/ijerph18157827.

ReferenceCitation: Nagahara R, Kanehisa H, Fukunaga T. Influence of shoe sole bending stiffness on sprinting performance. J Sports Med Phys Fitness. 2018 Dec;58(12):1735-1740. doi: 10.23736/S0022-4707.17.07834-3. Epub 2017 Oct 27.

ipd_sharing: Yes

ipd_sharing_description:
Data will be available upon reasonable request. For the Editorial office of the corresponding relevant editor; for meta-analyses needs, or for other detailed requests.

From all types, with de-identified files (Morphometric, cinematic and FVP data, Statistical Analysis, etc..).

Via a controlled access repositories, such as clinicalstudydatarequest.com, the YODA project, or Vivli.

lead_sponsor: Hôpital Léon Bérard


title: Pilot and Descriptive Study of the Effects of the Implementation of Computer Assisted Music Remediation Groups on the Cognitive Functioning of Young Patients Presenting a First Episode Psychosis

acronym: MAOPEP

summary:
The use of music in the field of cognitive remediation is growing and much research has focused on the relevance and effectiveness of its use in care. Studies have therefore made it possible to show the relevance of the use of musical material in the remediation of patients with various pathologies with cognitive disorders (head trauma, stroke, Alzheimer's disease). Although cognitive remediation has been widely studied in patients with schizophrenia, few studies suggest the effects of remediation in patients with a first psychotic episode. No study currently demonstrates the relevance of this material in the remediation of young people presenting a first psychotic episode.

The Mobile Intensive Care Team of the Adult Psychiatry Service of the CHU de Caen (EMSI) takes care of patients who have presented with a first psychotic episode. Young people entering an emerging psychosis frequently exhibit cognitive impairment. These attacks are variable and can concern memory, attentional and executive functioning. The most frequent disorders concern memory functioning and it is important to deal with them early in order to improve the functional prognosis of the young person.

We therefore propose the establishment of cognitive remediation groups through the MAO with patients treated by EMSI. These groups would aim to heal memory, attention and executive functions through exercises and musical practice through the Ableton © software. We therefore propose a study that would assess the effects of these workshops on the cognitive functioning of patients with memory difficulties. Attentional and executive functioning as well as self-esteem and negative symptoms will also be assessed.

This remedy will be offered in groups of 4. In this feasibility study, 30 patients will be included depending on the inclusion and monitoring capacities of the center. Ten weekly sessions of one hour per group over a period of 3 months will be applied. To assess the beneficial effects of this group remediation, assessments will be carried out at the start of the study and at the end of the 10 sessions.

The aim of this study is to assess the effects of an CAM remediation group on cognitive functioning, mood and self-esteem in patients who presented with a first psychotic episode.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Caen


title: Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts

summary: There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol.

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections

acronym: DALBASAT

summary:
The aim of this retrospective observational study is to evaluate the efficacy of antibiotic therapy with dalbavancin in patients presenting with infection on prosthetic devices. The main questions the study aims to answer are:

What is the proportion of patients with early discontinuation of dalbavancin therapy? What are the reasons for early discontinuation of antibiotic treatment? What adverse events do patients report? The study is based on data collected as part of routine care practices.

Translated with www.DeepL.com/Translator (free version)

lead_sponsor: Tourcoing Hospital

intervention_type: Drug


title: Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Kidney Transplant Recipients -ChronoVAX

acronym: CHRONOVAX

summary: Immune response to influenza vaccine in kidney transplant patients

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Real-life Assessment of the Safety and Performance of the SYNOVIUM HCS Device

acronym: YNOVIUM

summary: Patients who are to benefit from an injection of SYNOVIUM HCS as part of their care will be offered to participate in this study. Patients will need to sign a consent form to participate. Prior to SYNOVIUM HCS injection, patients will be asked a series of questions regarding their pain and disability. Data collected during follow-up visits can be compared to pre-injection data.

lead_sponsor: LCA Pharmaceutical

sponsor_collaborators:
LCA Pharmaceutical
EVAMED


title: Urinary Markers by SpectrosCopy: Diagnostic Aid in oncologY - Application to Urological Cancer

acronym: MUSCADE

summary: This study aims to evaluate the performance of vibrational spectroscopy (Infrared and Raman spectroscopy techniques) in bladder cancer diagnosis using urine samples.

lead_sponsor: CHU de Reims


title: Predictive Factors of Hearing Rehabilitation After Cochlear Implant Surgery in Deaf Patients

summary: The aim of this study is to display the predictive factors of hearing rehabilitation after cochlear implant surgery in severely to profoundly deaf adults.

ReferenceCitation: Blamey P, Artieres F, Baskent D, Bergeron F, Beynon A, Burke E, Dillier N, Dowell R, Fraysse B, Gallego S, Govaerts PJ, Green K, Huber AM, Kleine-Punte A, Maat B, Marx M, Mawman D, Mosnier I, O'Connor AF, O'Leary S, Rousset A, Schauwers K, Skarzynski H, Skarzynski PH, Sterkers O, Terranti A, Truy E, Van de Heyning P, Venail F, Vincent C, Lazard DS. Factors affecting auditory performance of postlinguistically deaf adults using cochlear implants: an update with 2251 patients. Audiol Neurootol. 2013;18(1):36-47. doi: 10.1159/000343189. Epub 2012 Oct 19.

ReferenceCitation: Attye A, Renard F, Baciu M, Roger E, Lamalle L, Dehail P, Cassoudesalle H, Calamante F. TractLearn: A geodesic learning framework for quantitative analysis of brain bundles. Neuroimage. 2021 Jun;233:117927. doi: 10.1016/j.neuroimage.2021.117927. Epub 2021 Mar 6.

ReferenceCitation: Blamey PJ, Pyman BC, Gordon M, Clark GM, Brown AM, Dowell RC, Hollow RD. Factors predicting postoperative sentence scores in postlinguistically deaf adult cochlear implant patients. Ann Otol Rhinol Laryngol. 1992 Apr;101(4):342-8. doi: 10.1177/000348949210100410.

lead_sponsor: University Hospital, Grenoble


title: Transcranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial

acronym: StimulUS

summary: The primary objective of this study is to optimize the protocol for the TUS administration in patients with TRD while gaining an initial impression of treatment efficacy.

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier St Anne


title: Prospective National Observatory for Cow's Milk Protein Allergy.

acronym: OLAF

summary:
The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the Pepticate® Syneo® replacement formula as soon as they were diagnosed.

The Pepticate® Syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. This is a product already available on the market.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Nutricia Nutrition Clinique


title: Adaptations métaboliques, énergétiques et Nutritionnelles à la Perte de Poids Chez l'Adolescent Avec obésité : rôle du degré de Perte de Poids. Etude POWELL-2

summary:
Although multidisciplinary treatment of pediatric obesity has shown its effectiveness in leading to weight loss and improvement in the physical, mental and social health of children and adolescents; maintaining these benefits remains a real challenge. Indeed, the literature clearly shows a short- to medium-term increase in weight, the mechanisms of which have yet to be identified in order to prevent it. Although cognitive, behavioral and nutritional adaptations have been highlighted to explain this weight regain, metabolic and energetic adaptations also seem to contribute. Indeed, a reduction in resting and total energy expenditure has been shown (in connection with changes in body composition and in particular lean mass), but also of the energy cost during locomotion and mobility, thus altering the daily energy balance. These energy adaptations are also accompanied by a modification in the use of energy substrates due to a modification of muscular metabolic flexibility in particular, leading to a reduction in lipid oxidation in favor of carbohydrates. Importantly, if this reduction in the use of lipids generates a counterproductive sparing of adipose tissue, thus slowing down weight loss, the increase in carbohydrate oxidation leads to an intensification of orexigenic signals at the central level, promoting nutritional compensations and positive energy balance and therefore contributing to weight regain.

Thus, these adaptations of energy metabolism and their interactions with dietary control seem to be at the heart of the mechanisms limiting the success of obesity treatment, favoring weight gain. If these observations were made at the end of treatment programs lasting several weeks to months, a recent clinical work highlights the need to consider the kinetics and temporality of weight loss (weight loss variability and rate of weight loss), so as to identify the crucial stages where these adaptations take place and thus prevent their energy consequences.

Thus, the main objective of this project is to study total energy adaptations (energy and nutritional metabolism) at rest but also during locomotion, during the central phase of weight loss of adolescents with obesity, as well as during phases of weight regain. Ultimately, the objective of this study is to better understand energetic adaptations to weight loss and the implication of the degree of weight loss in order to study the role of the interaction between these adaptations and the degree of weight loss on the success of programs and on the profiles of "weight maintainers" or "weight regainers".

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: " Effects of Continuous Anterior Chest Compression (CACC) & Comparision With Prone Position in ARDS Patients " The StrapVent Study "

acronym: StrapVent

summary: The aim is to test the physiological effects of continuous anterior chest compression in patients with severe to moderate ARDS.

primary_purpose: Basic Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants

summary: This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage).The main objective of this study is to collect short- and medium-term clinical data on the unicondylar knee prosthesis U-Knee / Uni-Kroma, in order to evaluate the performance of these implants.

lead_sponsor: Societe dEtude, de Recherche et de Fabrication


title: Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data

acronym: ECoG

summary: This study proposes to analyze data from intraoperative ECoG recordings acquired during wakefulness interventions in order to identify the connection networks involved in cognitive functions. This study also proposes to correlate the ECoG data with the imaging data and to analyze the disturbances of the electrophysiological signals induced by the cortical and subcortical brain lesions: this will make it possible to establish a more detailed mapping of the tumor areas and to compare disturbances recorded to those recorded in healthy areas. Thus, this approach should make it possible to improve the quality of excision of glial lesions located in eloquent areas, while reducing the risk of neurological sequelae and thus improve the survival and quality of life of patients.

status: Terminated

primary_purpose: Screening

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
European Clinical Trial Experts Network

status_simplified: Unknown


title: Evaluation of Osteopathic Care After Rupture of the Antero-external Cruciate Ligament of the Knee

acronym: DIDT OSTEO

summary:
The antero-external cruciate ligament (ACL) is the ligament located inside the knee, which allows the rotation of the knee by stabilizing the femur and the tibia. Rupture of the ACL is common during the practice of certain so-called "pivot" sports, whether contact or not. It is manifested by acute pain or instability of the knee, following a crack during a twist and/or a blockage of the joint. The diagnosis will be confirmed by a clinical examination and X-rays to eliminate any fracture or tearing and by MRI to visualize the ligament rupture and the associated lesions, in particular a lesion of the meniscus.

Treatment is required because the ruptured ligament does not heal on its own and the rupture of the ligament may eventually promote the appearance of osteoarthritis. Two types of treatment can be considered, rehabilitation or surgery, depending on the patient's age and motivation to resume sports. There are several surgical techniques, the most common is to reconstruct the ruptured ligament by arthroscopy using a graft taken from the tendons of the Internal Rectus and Demi muscles tendinous (DIDT). Rehabilitation by physiotherapy is often started preoperatively and immediately after the operation, as soon as you wake up, to find a functional and painless knee. Functional recovery often depends on patient motivation.

The main objective is to show that osteopathic care in addition to physiotherapy rehabilitation improves knee functionality in patients 6 months after reconstruction of the ACL by DIDT.


title: Prospective, Monocentric Study of the Interchangeability of Arterial Coagulation and Venous Coagulation, in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass, Using the DMDiv Hemochron Signature Elite

acronym: COAGAV

summary: Adequate coagulation measured using activated clotting (ACT) is important during vascular and cardiac surgeries. Unfractionated heparin is the most common anticoagulant used. For point of care testing, under supervision of biology department, the investigators use Hemochron Signature Elite®(HSE) (Werfen®-Barcelona Spain) to determine coagulation during cardiac surgery under Cardiopulmonary Bypass (CPB), with arterial or venous blood. The dosage of heparin varies according to this result, throughout the CPB. On the Connect Manager® software (Livanova®, Italy) which records all the data of a CPB, it is mandatory to inform, during an ACT, the sampling site in arterial or venous. The chemical compositions of arterial blood and venous blood are different (O2, Co2…) Even if the qualities of coagulation in vivo are identical, what happens when they are chemically analyzed using the medical device HSE ? Can we trust the results of this device to secure anticoagulation under CPB? Are the results affected by the sampling site? The objective of this study is to compare the reliability of hemostasis control , during cardiac surgery under cardiopulmonary bypass, for both venous and arterial blood. Effective and controllable anticoagulation is mandatory during cardiac surgeries under extracorporeal circulation. The monitoring of the effectiveness of heparin is carried out, in our center, using the Hemochron Signature Elite® (HSE) medical device, which measures the ACT (Activated Clotting Time). There is no comparative study between hemostasis of venous blood, versus arterial blood, with this point of care device.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: The Links Between Executive and Linguistic Processes and Their Lesional Determinants From a Verbal Fluency Task

acronym: FluLEx

summary:
Verbal fluency test require to produce as much words as possible in one or two minutes. This test is highly sensitive to main brain diseases and are therefore widely used in clinical routine for diagnostic purpose. The verbal fluency task requires several cognitive processes including executive and linguistic processes for which it is difficult to extract the origin of the deficit. For this reason, fluency tests are variably interpreted in terms of executive or language. The implementation of an experimental protocol exploring each of these processes separately and studying the links between the verbal fluency task and each of these processes should allow a better understanding of the origin of the verbal fluency deficit after brain injury and improve the identification of key brain structures.

Indeed, the lesion determinants of this task remain to be clarified despite remarkable advances due to the evolution of imaging techniques (voxel-based lesion-symptom mapping (VLSM); voxel-based morphometry (VBM)).

Furthermore, while the direct assessment of linguistic process, semantic memory, and processing speed is well defined, the examination of the executive component (i.e., strategic search process) remains unsettled and will be undertaken in this study.

This work will take advantage of data from previous multicenter work, validated methodologies for both analysis and interpretation of cognitive performance as well as anatomic-clinical correlations at the voxel level and will be performed in cognitive neurodegenerative and cerebrovascular disease.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

intervention_type: Diagnostic Test


title: Interest of Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival

acronym: MIPTHYS

summary:
This is a study assessing the interest of post-operative follow-up of asymptomatic papillary microcarcinomas. Today, this post-operative follow-up represents an economic cost and is a source of anxiety for patients.

The aim of this study is to determine the global survival of patients with asymptomatic papillary microcarcinoma to assess the interest of a post-operative ultrasound and/or biological follow-up.

status: Active, not recruiting

lead_sponsor: University Hospital, Toulouse


title: Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas. Prospective Monocentric Interventional Study With Blinded Evaluation

acronym: PREVENT

summary: Medical approaches remain the gold standard treatment for non-segmental forms of vitiligo. Topical ruxolitinib cream has demonstrated its efficacy and good tolerance for treating vitiligo. While about 30% of patients will achieve at least 90% of repigmentation on the face after 1 year of treatment, some locations on the body, such as hands, feet, bony prominences remain highly challenging, and most patients won't get satisfactory repigmentation on those areas despite months of application of topical treatments, even when combined with UV. The poor rate of repigmentation in these locations are probably explained by the difficulty to stimulate the differentiation and proliferation of melanocytes stem cells in those areas. To study the efficacy at 3 months of epidermal cell suspension grafting followed by twice daily applications topical 1.5% ruxolitinib cream compared to epidermal cell suspension grafting followed by placebo in vitiligo resistant areas.There will be 2 arms with intra individual comparison. Both groups will receive epidermal cell suspension (provided by Cutiss®). After 7 days the dressing will be removed. Each grafted side of the body will be randomly assigned to receive twice daily application of topical 1.5% ruxolitinib cream (Group A) or twice daily application of placebo cream (Group B). After 3 months, both sides will be treated by twice daily applications of topical ruxolitinib for 3 additional months.There will be 8 visits in total during the 7 months duration for each subject.

ipd_sharing: Undecided

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Validation of Visual Analog Scales to Measure SatisfactiOn and WELL-being at Work (SoWell-VAS)

acronym: SoWell-VAS

summary: We spend a third of our life at work. Psychosocial risks (PSR) are a major issue in occupational health 1. Approaching the different dimensions of PSR calls on a dozen essential components: workload, autonomy, social support, burnout, anxiety, efforts made, rewards, work addiction, investment, etc. a specific questionnaire which usually contains 20 to 30 questions, so that having an overall view of PSR using the current reference questionnaires (Karasek, Siegrist, etc.) represents a total of more than 300 questions. The response time is thus incompatible with current medical practice (passage in the waiting room before the occupational health medical examination) and leads to a majority of non-responses during anonymous questionnaires on the Internet. On the other hand, these validated questionnaires were carried out by different people and are very heterogeneous between them, including in their formulation, so that the respondents have the impression of disorganization and anarchy. There is therefore a need for short, quick and uniform questionnaires. EVAs offer the incredible advantage of meeting these criteria: speed, uniformity, precision. From a data analysis point of view, EVAs also have the advantage of offering a continuous quantitative response, allowing the use of all statistical approaches. If some questionnaires have already been validated in the form of EVA, such as the EVA stress versus the " Perceived Stress Scale " questionnaire (PSS), the EVA workload and EVA autonomy at work versus the Karasek questionnaire, the other reference questionnaires are not yet validated in EVA (burnout, anxiety, efforts / rewards, work addiction, etc.).


title: Longitudinal, Prospective, French, Multicenter Cohort Study on Pancreatic Radiofrequency

summary: The purpose of the study is to evaluate the oncological efficacy of pancreatic radiofrequency by the objective response rate (complete and partial responses according to RECIST 1.1.), 5 years after the end of treatment.

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


title: Non-invasive Evaluation of Muscle Oxidative Capacity. Study of Its Relationship With Muscular Endurance and Fatigue in Patients With Multiple Sclerosis

acronym: OXYSEP

summary:
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system. It is characterized by different progressive forms with periods of flare-ups interspersed with phases of remission. MS manifests clinically with signs of multiple neurological dysfunctions as well as less specific symptoms such as fatigue, the prevalence of which is found to be high in these patients and is independently associated with an alteration in their quality of life.

Recently, a non-invasive method for assessing maximal muscle oxidative capacity (mVO2) using optical measurement of muscle oxygenation (near-infrared spectroscopy, NIRS) has been described. Measuring tissue light absorption from a skin sensor facing a muscle, makes it possible to distinguish tissue concentrations of oxyhemoglobin (HbO2) and hemoglobin (Hb). The difference in absorbance of Hb and HbO2 corresponds to the balance of O2 supply and consumption in tissue capillaries, allowing calculation of a time constant (kNIRS, min-1) reflecting mitochondrial function.

Current literature provides reference values in young healthy subjects and MS patients. This index could therefore constitute a particularly interesting non-invasive indicator of mitochondrial functioning, usable in the clinic.

ReferenceCitation: Adami A, Rossiter HB. Principles, insights, and potential pitfalls of the noninvasive determination of muscle oxidative capacity by near-infrared spectroscopy. J Appl Physiol (1985). 2018 Jan 1;124(1):245-248. doi: 10.1152/japplphysiol.00445.2017. Epub 2017 Jul 6. No abstract available.

ReferenceCitation: Boushel R, Piantadosi CA. Near-infrared spectroscopy for monitoring muscle oxygenation. Acta Physiol Scand. 2000 Apr;168(4):615-22. doi: 10.1046/j.1365-201x.2000.00713.x.

ReferenceCitation: Edwards T, Pilutti LA. The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. Mult Scler Relat Disord. 2017 Aug;16:31-39. doi: 10.1016/j.msard.2017.06.003. Epub 2017 Jun 12.

ReferenceCitation: Fromont A, Binquet C, Sauleau EA, Fournel I, Bellisario A, Adnet J, Weill A, Vukusic S, Confavreux C, Debouverie M, Clerc L, Bonithon-Kopp C, Moreau T. Geographic variations of multiple sclerosis in France. Brain. 2010 Jul;133(Pt 7):1889-99. doi: 10.1093/brain/awq134. Epub 2010 Jun 15.

ReferenceCitation: Gelfand JM. Multiple sclerosis: diagnosis, differential diagnosis, and clinical presentation. Handb Clin Neurol. 2014;122:269-90. doi: 10.1016/B978-0-444-52001-2.00011-X.

ReferenceCitation: Hansen D, Feys P, Wens I, Eijnde BO. Is walking capacity in subjects with multiple sclerosis primarily related to muscle oxidative capacity or maximal muscle strength? A pilot study. Mult Scler Int. 2014;2014:759030. doi: 10.1155/2014/759030. Epub 2014 Jan 29.

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title: Contribution of PET/MRI in Locally Advanced Cervical Cancer

acronym: ATICC

summary:
[18 F]fluorodeoxyglucose (18F-FDG) positron emission tomography-magnetic resonance imaging (PET/MRI) is a new hybrid imaging tool that has recently arrived in oncology, and is particularly promising. Its usefulness seems obvious in certain tumor types, but its place in the staging of cervical cancers has never been explored in a prospective trial to our knowledge.

Previously, a comparative retrospective study from 2009 found a better sensitivity of PET fused to diagnostic MRI images compared to PET/CT (positron emission tomography/computed tomography) in the detection of metastatic lymph nodes (54 and 44% respectively). It was an a posteriori fusion of images, from images acquired by PET-CT.

ReferenceCitation: Picardi M, Cavaliere C, Della Pepa R, Nicolai E, Soricelli A, Giordano C, Pugliese N, Rascato MG, Cappuccio I, Campagna G, Cerchione C, Vigliar E, Troncone G, Mascolo M, Franzese M, Castaldo R, Salvatore M, Pane F. PET/MRI for staging patients with Hodgkin lymphoma: equivalent results with PET/CT in a prospective trial. Ann Hematol. 2021 Jun;100(6):1525-1535. doi: 10.1007/s00277-021-04537-5. Epub 2021 Apr 28.

ReferenceCitation: Lu XR, Qu MM, Zhai YN, Feng W, Gao Y, Lei JQ. Diagnostic role of 18F-FDG PET/MRI in the TNM staging of breast cancer: a systematic review and meta-analysis. Ann Palliat Med. 2021 Apr;10(4):4328-4337. doi: 10.21037/apm-20-2555. Epub 2021 Apr 12.

ReferenceCitation: Crimi F, Spolverato G, Lacognata C, Garieri M, Cecchin D, Urso ED, Zucchetta P, Pucciarelli S, Pomerri F. 18F-FDG PET/MRI for Rectal Cancer TNM Restaging After Preoperative Chemoradiotherapy: Initial Experience. Dis Colon Rectum. 2020 Mar;63(3):310-318. doi: 10.1097/DCR.0000000000001568.

ReferenceCitation: Kim SK, Choi HJ, Park SY, Lee HY, Seo SS, Yoo CW, Jung DC, Kang S, Cho KS. Additional value of MR/PET fusion compared with PET/CT in the detection of lymph node metastases in cervical cancer patients. Eur J Cancer. 2009 Aug;45(12):2103-9. doi: 10.1016/j.ejca.2009.04.006. Epub 2009 May 4.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Effect of Chest and Abdominal Wall Strapping on Ventilation and Work of Breathing in Infants With Severe Bronchiolitis: a Physiological Study

acronym: WRAPITIS

summary:
Bronchiolitis is the most common cause of admission to the Paediatric Intensive Care Unit (PICU) for respiratory distress.

The care of an infant with severe bronchiolitis is mainly based on symptomatic treatment (nutritional and respiratory support). The lower part of an infant's chest is larger than that of an older child, which can flatten the diaphragm, especially in obstructive disease with air trapping. Strapping the lower part (at the junction of the chest and abdomen) may provide a better condition for diaphragmatic contraction. Based on respiratory mechanics in infants and physiological studies in adults, investigators hypothesise that chest wall strapping may improve the ventilation and the diaphragmatic contraction.

Infant < 6 month with severe bronchiolitis admitted to the PICU will be recorded in 4 conditions with or without chest wall strapping and with a Continuous Positive Airway Pressure (CPAP) at 7 cmH2O or without CPAP. Physiological parameters (including work of breathing, respiratory parameters, distribution of ventilation) will be recorded and analysed.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of the Hemodynamic Effect of Dexmedetomidine in Scheduled Outpatient Surgery: Single-center Prospective Randomized Double-blind Non-inferiority Study.

acronym: DEXCOEUR

summary:
Ambulatory surgery is increasingly used in anesthesia. In case of general anesthesia, it is recommended to use anesthesia molecules with a short half-life and low doses of opiates to ensure a rapid awakening and to prevent nausea and vomiting by systematic administration of anti-emetics during the operation.

Opiates (including sufentanil) have recently been called into question because of the nausea and vomiting and the delay in waking up induced by these molecules. To combat these side effects, the authors have proposed either to reduce the doses or to substitute them with dexmedetomidine, a sedative antihypertensive drug. Recent studies have demonstrated that opiates used in general anesthesia can be replaced by dexmedetomidine. However, literature data are controversial concerning the hemodynamic impact. No study has compared the hemodynamic profile of opioid-free anesthesia with dexmedetomidine versus conventional anesthesia with opioids.

The ambulatory context lends itself to the use of dexmedetomidine because it is aimed at a population without strong cardiac pathology, concerns non-major interventions, with the need to optimize pain and side effects.

The study authors therefore wish to compare the effects of induction of general anesthesia with low-dose Dexmedetomidine versus sufentanil, on post-induction hemodynamic stability in scheduled outpatient surgeries. The investigators hypothesize that hemodynamic stability at induction of general anesthesia with low-dose dexmedetomidine is not inferior to that obtained with sufentanil in scheduled ambulatory surgeries.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C

acronym: MAGICIEN

summary:
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV antibodies (HIV-Ab), anti-HCV antibodies (HCV-Ab), and HBs antigens (HBs-Ag) in serum, plasma, venous blood and capillary blood. If not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study.

The Study includes a Technical Adjustment Phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a Validation Phase (to validate the concordance between the matrices and to evaluate the Specificity and the Sensibility of the diagnostics)

primary_purpose: Diagnostic

lead_sponsor: MagIA Diagnostics


title: Biking vs. Running HIIT in Men With Overweight/Obesity: Impact on Oxygen Consumption, Substrate Utilization and Appetite

acronym: BIKERUN

summary: The management of obesity involves hygienic and dietary measures that include appropriate nutrition and an increase in physical activity (PA). Among the various PA modalities that can be recommended, High-Intensity Interval Training (HIIT) is now recognized as a fun and effective program for promoting fat loss. A meta-analysis conducted by our team suggests a potential influence of the mode of HIIT practice (cycling vs. running) on fat mass (FM) loss. In order to better understand the metabolic adaptations following this type of practice, the investigators propose to compare two isoenergetic HIIT sessions (cycling vs. running) in overweight or obese subjects. The objective is to compare post-recovery (+2h) oxygen consumption, substrate utilization, concurrent energy expenditure and post 24h energy intakes.

lead_sponsor: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques


title: Effects of Awake Prone Positioning on Long-term Quality of Life in Patients Managed in the ICU Under Nasal High Flow for SARS-CoV2 Pneumonia, a Cohort Study Nested Within a Randomized Trial

acronym: Long-termAPP

summary: Long term follow up of patients included in a randomized controlled trial evaluating awake prone positioning among patients suffering SARS-CoV2 pneumonia (NCT04358939)

lead_sponsor: University Hospital, Tours


title: Network-based biOmarker Discovery of Neurodegenerative Diseases Using Multimodal Connectivity

acronym: NODAL

summary: The aim of the NODAL clinical trial is to demonstrate the feasibility of new, low-cost, non-invasive biomarkers of neurodegenerative pathologies as early Alzheimer and Parkinson, based on the estimation of the multimodal connectome.

design_allocation: Non-Randomized

lead_sponsor: Rennes University Hospital


title: UDFF Performance Evaluation ((Ultrason Derived Fat Fraction)

acronym: UDFF

summary: The purpose of this study is to assess UDFF performance (compared to MRI)

lead_sponsor: University Hospital, Angers


title: Evaluation of Radiofrequency Efficiency in the Treatment of Hemorrhoid Pathology

acronym: RFH

summary:
Triapedicular haemorroidectomy is currently the gold standard in haemorrhoidal pathology. Minimally invasive surgical techniques now play an important role in the haemorrhoidal management algorithm, particularly for less advanced stages of the disease. Among these techniques, radiofrequency is one of the most recent and is gradually gaining ground. It involves applying a radiofrequency current to the internal haemorrhoidal tissue in order to induce its involution.

The literature has shown that this technique leads to symptomatic improvement in over 60% of cases and a high satisfaction rate, even though some patients still seem to have haemorrhoidal symptoms postoperatively.

The aim of this study is to evaluate the efficacy of this technique in patients with haemorrhoidal pathology operated on at our centre, using "hard" criteria which are thought to be more rigorous ("cure" rather than "improvement").

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Comparison of Dermatoscopy X400 Interpreted by 6 Non-dermatologists (3 Gynecologists, 3 General Practitioners) and an Artificial Intelligence Software Skin Artificial Intelligence Versus Dermatoscopy x 20 Interpreted by 3 Expert Dermatologists, for the Identification of 150 Genital Pigmented Tumors: Towards a New Medical Organization of the Dermatologist, Non-dermatologist Articulation?

summary:
Pigmented lesions of the genital mucosa are common, affecting between 10% and 20% of the population. The clinical appearance is sometimes confusing. They are often extensive, irregular, and inhomogeneous in color, which can make them look suspicious. Moreover, dermatoscopic imaging is often complex to interpret, as shown by the many different patterns reported in the literature.

Thus, preliminary work in confocal microscopy has shown that it is possible to simplify diagnosis by using microscopic, in vivo, non-invasive imaging. However, CIM cameras are rare, very expensive and difficult to access.

Conversely, digital dermatoscopes with 400x magnification are much less expensive and can also allow, in a certain number of cases, an examination at the cellular level of tumors, with, in our opinion, the advantage of being easy to learn. In the context of the pooling of resources within medical centers in particular, their dissemination should accelerate. Furthermore, x400 dermatoscopy can provide similar information to IVCM for the most frequent black genital tumors.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep, Circadian Rhythms and Psychiatric Disorders

acronym: SoPsy-SoSad

summary: Despite international efforts to identify biomarkers of depression, none has been transferred to clinical practice, neither for diagnosis, evolution, nor therapeutic response. This led us to build a French national cohort (through the clinical and research network named SoPsy within the French biological psychiatry society (AFPBN) and sleep society (SFRMS)), to better identify markers of sleep and biological rhythms and validate more homogeneous subgroups of patients, but also to specify the manifestations and pathogeneses of depressive disorders.


title: Influence of Students Behaviors on Thier Performance and Quality of Life on the OSCE

acronym: ECOPERF

summary: The students behave differentially before an exam. This study aims at determining the influence of all these behaviors on the perceived quality of life of students and their performance during their OSCE.

lead_sponsor: Claude Bernard University


title: An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients With Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis

summary: This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.

lead_sponsor: Celltrion


title: Evaluation of Membrane Phospholipid Metabolism and Cellular Energy Metabolism in Subjects at High Risk of Psychotic Transition

summary:
The management of schizophrenia is a major public health issue, due to its particularly disabling psychotic symptoms and their onset at an early age, typically in adolescents or young adults.

The physiopathological hypothesis of an anomaly relating to the renewal of cell membranes and energy metabolism in schizophrenia was proposed as early as the 1930s. This is based on anomalies at certain times in the development of the balance between phosphomonesters, precursors of membrane phospholipids, and phosphodiesters, catabolites of membrane phospholipids. Alterations of these different balances sign neurodevelopmental disorders, and can be objectified by specific techniques such as phosphorus-31 magnetic resonance spectroscopy (SMR-31P). This is used in particular to characterize the energy metabolism of the brain and allows in vivo quantification of phosphorus metabolites.

The application of SMR-31P techniques to assess the metabolism of membrane phospholipids and cellular energy metabolism in subjects at high risk of psychotic transition could make it possible to objectify a difference between subjects subsequently suffering from a psychotic transition compared to those who do not suffer from it. Alterations in the metabolism of membrane phospholipids could thus represent a biomarker of psychotic transition. Secondarily, this approach would make it possible to provide elements as to the validity as a diagnosis of this category, which is very heterogeneous in its future.

Among the Ultra High Risk (UHR) group, subjects with a psychotic transition (UHR-T) are compared to subjects without this transition (UHR-NT) during the two years of follow-up.

The UHR group is compared to the control group.

At T0, UHR patients and healthy volunteers will perform brain MRI with Phosphorus 31 magnetic resonance spectroscopy.

UHR patients will then be reviewed:

at T+1 year for a clinical assessment medical interview to assess the patient's functioning and the appearance of symptoms;
at T+2 years for the realization of a follow-up interview with passing of the scales CAARMS (Comprehensive Assessment of At Risk Mental State) and SOFAS (scale of evaluation of the social and professional functioning) in order to determine if the subject belongs to the UHR-T or UHR-NT group.

lead_sponsor: Centre Hospitalier Henri Laborit


type: EudraCT Number

title: Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study.

acronym: OT-DEFI

summary: The investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.


title: Resilience,Performance and Stress in Anaesthesia Professionals: a Simulation-based Observational Study

summary: The aim of this study was to determine whether there was an association between resilience and the performance of student nurse anaesthetists in simulated critical situations.

lead_sponsor: University Hospital, Grenoble


title: Impact of Air Pollution on the Course of Inflammatory Rheumatism: a Prospective, Single-center Study

summary:
The objective of this study is to see if there is a link between air pollution and inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis)

To do this, the investigators are going to follow a cohort of about 200-400 patients for 6 months by means of a self-questionnaire, which the investigators ask the patient to fill in once a week on a fixed day, and opposite the corresponding week to put the letter corresponding to the question concerning the activity of your disease: 3 possible answers: A: no flare-up, B: short flare-up of 1 to 3 days, C: persistent flare-up of more than 3 days

Then the investigators will collect the questionnaire at the end of these 6 months and at each visit to the consultation or day hospital (on average every 4 to 6 weeks), and they will look to see if any relapses have occurred. At the same time the investigators will calculate the disease activity score (DAS or BASDAI) to have an objective score. Then in parallel they will look at the level of exposure to air pollution according to the place of residence and work of each patient.

The hypothesis is that air pollution has an influence on the activity of inflammatory rheumatism.

lead_sponsor: Centre Hospitalier Universitaire de Nice


type: Registry Identifier

title: Video-Assisted Thoracoscopy for Idiopathic Pneumothorax in Children: a Retrospective Monocentric Study

acronym: PNOPED

summary:
The goal of this retrospective study is to describe the outcomes of spontaneous idiopathic pneumothorax treated by thoracoscopy with pleural abrasion and blebectomy.

The main questions it aims to answer are:

are there risk factors leading to pneumothorax recurrence?
are pleural abrasion and blebectomy really diminishing the recurrence of pneumothorax?

ReferenceCitation: Pogorelic Z, Gudelj R, Bjelanovic D, Jukic M, Elezovic Baloevic S, Glumac S, Furlan D. Management of the Pediatric Spontaneous Pneumothorax: The Role of Video-Assisted Thoracoscopic Surgery. J Laparoendosc Adv Surg Tech A. 2020 May;30(5):569-575. doi: 10.1089/lap.2019.0742. Epub 2020 Mar 11.

ReferenceCitation: Demir M, Akin M, Kaba M, Filiz S, Sever N, Karadag CA, Dokucu AI. Thoracoscopic Resection in the Treatment of Spontaneous Pneumothorax. Sisli Etfal Hastan Tip Bul. 2020 Mar 25;54(1):94-97. doi: 10.14744/SEMB.2018.88310. eCollection 2020.

ipd_sharing_description: In the name of anonymization the investigators won't share individual participant data

lead_sponsor: University of Lorraine


title: Management of Urinary Calculi After Bladder Augmentation in Children

acronym: LITAVPED

summary:
The goal of this observational study is to analyse the occurence of urinary calculi after bladder augmentation in children:

location of the calculi (kidney or bladder)
type of bladder augmentation with higher rate of urinary calculi and why
Find risk factors of urinary calculi in bladder augmentation (age, sex, other bladder procedures..)

ReferenceCitation: Salama AK, Misseri R, Hollowell N, Hahney B, Whittam B, Kaefer M, Cain MP, Rink RC, Szymanski KM. Incidence of nephrolithiasis after bladder augmentation in people with spina bifida. J Pediatr Urol. 2021 Aug;17(4):521.e1-521.e7. doi: 10.1016/j.jpurol.2021.03.012. Epub 2021 Mar 19.

ReferenceCitation: Mathoera RB, Kok DJ, Nijman RJ. Bladder calculi in augmentation cystoplasty in children. Urology. 2000 Sep 1;56(3):482-7. doi: 10.1016/s0090-4295(00)00663-4.

ReferenceCitation: Szymanski KM, Misseri R, Whittam B, Lingeman JE, Amstutz S, Ring JD, Kaefer M, Rink RC, Cain MP. Bladder stones after bladder augmentation are not what they seem. J Pediatr Urol. 2016 Apr;12(2):98.e1-6. doi: 10.1016/j.jpurol.2015.06.021. Epub 2015 Sep 25.


title: Surgical Outcomes of Bladder Neck Procedures in Children With Neurogenic Bladder: a Retrospective Monocentric Study

acronym: CERPED

summary:
Surgical outcomes of bladder neck surgery in children with neurogenic bladder.

Consequences on bladder voiding.

ReferenceCitation: Stein R, Bogaert G, Dogan HS, Hoen L, Kocvara R, Nijman RJM, Quaedackers J, Rawashdeh YF, Silay MS, Tekgul S, Radmayr C. EAU/ESPU guidelines on the management of neurogenic bladder in children and adolescent part II operative management. Neurourol Urodyn. 2020 Feb;39(2):498-506. doi: 10.1002/nau.24248. Epub 2019 Dec 3.

ipd_sharing_description: In the name of anonymization, the investigators won't share individual participant data


title: Post Intensive Care Unit Atrial Fibrillation

acronym: PIAF

summary: Atrial fibrillation (AF) is a common heart rhythm disorder in the intensive care unit (ICU). It can be precipitated by multiple factors but it is unclear whether AF persists after discharge from the ICU, and long term. This study will investigate whether AF recurs up to one year after ICU discharge.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Cannabidiol as an add-on Treatment During Inpatient Alcohol Cessation in Patients With Severe Alcohol Use Disorder: A Phase II Trial

acronym: CBD-OH

summary: Randomized clinical trial of 10 days Cannabidiol versus placebo as an adjunctive treatment during inpatient alcohol detoxification to improve abstinence in patients with severe alcohol use disorder.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients

acronym: WALKALS

summary: Preclinical and clinical data strongly suggest that administration of salbutamol in ALS patients may improve walking capacity related to motor fatigue by enhancing neuromuscular transmission. Salbutamol may exert a neuroprotective effect and slow down the progression of clinical signs and symptoms. The main objective of the study is to test the efficacy of salbutamol on walking capacity in ALS patients and the secondary objective is to measure the target engagement of salbutamol on the neuromuscular junction (NMJ) at EMG (decrement of repetitive nerve stimulation in three nerves/muscle couples), as well as safety and tolerability. The exploratory objectives are to study the effect of salbutamol on fatigue scales, muscle strength, respiratory function, motor unit count, muscle and spinal MRI parameters and blood biomarkers


title: Study of Neonatal Immunoglobulin G (IgG) Fc Receptor (FcRn) Expression in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT): Implication in the Pathophysiology of Systemic Lupus

acronym: FiNKLUPUS

summary: This study evaluates the variation of expression of the neonatal Fc receptor (FcRn) in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT) and monocytes along with the surface expression of Fc gamma type II receptor (RII) and RIII in active or newly diagnosed lupus patients compared to inactive lupus patients.

collaborators: Research Center for Respiratory Diseases, Inserm U1100

intervention_type: Biological


title: Place of Urinary Artificial Sphincter in Children With Neurogenic Bladder

acronym: SUA

summary:
Retrospective monocentric study of the outcomes of patients with neurogenic bladder, who had a urinary artificial sphincter before the age of 18 years old.

Hypothesis: what was the impact of the urinary artificial sphincter on the global management of the patient.

ReferenceCitation: Delgado-Miguel C, Munoz-Serrano A, Amesty V, Rivas S, Lobato R, Martinez-Urrutia MJ, Lopez-Pereira P. Artificial urinary sphincter in congenital neuropathic bladder: Very long-term outcomes. Int J Urol. 2022 Jul;29(7):692-697. doi: 10.1111/iju.14874. Epub 2022 Mar 26.

ReferenceCitation: Sheppard KE, Roberts JL, Blum M. Adrenocorticotropin-releasing factor down-regulates glucocorticoid receptor expression in mouse corticotrope tumor cells via an adenylate cyclase-dependent mechanism. Endocrinology. 1991 Aug;129(2):663-70. doi: 10.1210/endo-129-2-663.


title: Robot-Assisted Laparoscopic Pyeloplasty in Children Younger Than 5 Years Old: a Monocentric Retrospective Study

acronym: PYEROB

summary:
The goal of this retrospective study is to analyse the outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old:

indication criteria
clinical symptoms
operating time
length of stay
complications
follow-up

ReferenceCitation: Esposito C, Cerulo M, Lepore B, Coppola V, D'Auria D, Esposito G, Carulli R, Del Conte F, Escolino M. Robotic-assisted pyeloplasty in children: a systematic review of the literature. J Robot Surg. 2023 Aug;17(4):1239-1246. doi: 10.1007/s11701-023-01559-1. Epub 2023 Mar 13.

ReferenceCitation: Trachta J, Kucerova B, Rygl M. Robotic pyeloplasty in children - a pilot study. Rozhl Chir. 2022 Winter;101(2):79-84. doi: 10.33699/PIS.2022.101.2.79-84.


title: Mitochondrial Adaptations and Oxidative Stress With High Intensity Interval Training During Pulmonary Rehabilitation

acronym: MITOXITRAIN

summary:
Pulmonary rehabilitation (PR) is a validated treatment in patients with Chronic Obstructive Pulmonary Disease (COPD), improving exercise tolerance, quality of life and dyspnea. However, 20 to 30% of patients did not respond to PR and particularly those with chronic hypoxaemia. In most disabled patients, High Intensity Interval training (HIIT) is an alternative to perform exercise training with similar gain in exercise capacity than continuous exercise training. In patients with exercise-induced oxygen desaturation, the repetitions of hypoxia/resaturation phases during intermittent exercise could result in bursts of oxidative stress and induce positive or detrimental effect on mitochondrial function according to the importance in the oxidant stimulus.

Few data have ascertained the benefit of HIIT on mitochondrial oxidative capacity (Vmax) in healthy subjects compared to continuous exercise training but no data are available in COPD patients with exercise-induced desaturation, and the change in oxidative stress in such training regimen.

The investigators hypothesize that the repetitive bursts of oxidative stress and the improved antioxidant capacity in the course of the training sessions would stimulate mitochondrial adaptations to a larger extent after HIIT than continuous exercise training in severe COPD patients with hypoxemia. Moreover, they will assess the relationship between the change in oxidative stress in blood and in muscle. The clinical relevance of this study will be to ascertain the benefit and the safety of HITT in this subgroup of COPD patients in whom benefit of PR is often weak.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Influence of Body Composition, Total Body Fat and Body Mass Index on the Pharmacokinetics of Docetaxel in Localized Breast Cancer

acronym: FATTAX

summary: The purpose of this study is to determine if pharmacokinetics of docetaxel is modified by the body composition (assessed by the BMI but also by CT-scan) in patients treated by docetaxel as adjuvant treatment of a localized breast cancer

lead_sponsor: Centre Henri Becquerel

sponsor_collaborators:
Centre Henri Becquerel
Erasmus Medical Center
Universitaire Ziekenhuizen KU Leuven


title: Study of the Improvement of Gait by Spinal Stimulation in Patients With Post-operative Chronic Lumbosciatalgia: Pilot Study

acronym: GAITSTIM

summary: The purpose of this study is to explore the changes in objective walking parameters induced by medullary stimulation in patients with Fail Back Surgery Syndrome, after chronic stimulation, in comparison with preoperative condition.


title: Detection of Local Field Potentials in the Ventral Tegmental Area of the Midbrain in Chronic Cluster Headache Patients Treated by Deep Brain Stimulation : a Feasibility Study

acronym: DETECT

summary:
The physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (CH) is still partially unknown. Three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. There are many clinical arguments in favor of the involvement of the hypothalamus in CH. In addition, several radiological studies have confirmed the involvement of the posterior hypothalamic region in cluster attacks. Thus, a positron emission tomography study showed hyperactivity of the posteroinferior nucleus of the ipsilateral hypothalamus. Voxel based MRI studies have shown a bilateral increase in the volume of the inferoposterior part of the homolateral hypothalamus. The involvement of the posterior hypothalamic region or more precisely the ventral tegmental area of the midbrain therefore seems acquired, although its real role as a generator or modulator of pain remains to be precised.

Deep brain stimulation (dBS) is used in the management of chronic drug-resistant CH with an overall efficacy in 2/3 of patients. Nevertheless, its mechanism of action remains poorly understood, thus limiting the selection of patients and the optimization of care. The lack of clear neurophysiological criteria to identify the neuronal population to be targeted is a major source of uncertainty in the positioning of dBS electrodes and parameters adjustment. In order to improve the understanding and at the same time the results of this technique, obtaining in vivo electrophysiological data seems mandatory. Local fields potentials (LFP) have been recordered by in vivo by dBS in other diseases (Parkinson's disease, tremor…) and their analysis has brought new insigights in the characterization and understanding of these pathology. New generations of neurostimulator (Percept Medtronic) enables continuous recording of LFP in implanted patients. The goal of our study is the recording of LFP at the time of CH attacks via the BrainSenseTM system. This system included in the stimulator allows in vivo collection of LFP in the absence and presence of stimulation. The pathophysiological data recordered will then be correlated with the clinical benefit of the dBS ( nulber of attacks, duration, pain intensity…). As it is a feasibility study, only 5 patients will be included.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Evaluation of the Mechanisms of Weight-bearing of the Hemiplegic Limb During Table Tennis Sessions in the Framework of Post-stroke Rehabilitation : Pilot Study

acronym: HEMITENNIS

summary:
This is an experimental, observational, prospective study designed to develop medical knowledge.

The primary objective of the study is to analyze the weight bearing of the hemiplegic side according to the different areas of interest during the practice of table tennis.

This study is part of a usual framework of management of post-stroke hemiplegic patients with an additional passage to the movement laboratory to collect additional data collection, via the use of force plateforms, considered here as non-interventional.

The passage to the movement laboratory consists in the practice of a table tennis session including three game situations. Before to the table tennis session, the subject placed on the force plateforms, performs a spontaneous bipodal station followed by a maximum voluntary support transfer on the hemiplegic limb. During the table tennis session, the subject is filmed and his load on the hemiplegic side during the game situations is evaluated using the force platforms.

In addition of the table tennis session three questionnaires are administered to the patient in order to know :

The static and dynamic balance in order to identify persons at risk of falling: Berg Balance and Evaluation Scale
The degree of autonomy of the patient: Modified Rankin Score
The Stroke severity: NIHSS score

lead_sponsor: FondationbHopale


title: Selective Reporting for Antibiotic Susceptibility Testing and GPs' Prescribing of Broad-spectrum Antibiotics in Women With E. Coli UTIs

acronym: ABC-MG

summary:
The control of antibiotic resistance requires a reduction in inappropriate prescriptions of broad-spectrum antibiotics (amoxillin-clavulanate (AMC), fluoroquinolones (FQ), third-generation cephalosporins (C3G)), particularly for urinary tract infections treated in primary care. Several studies have reported the positive impact of antibiotic susceptibility testing performed on urine cultures on the appropriate use of antibiotics.

The "selective reporting for antibiotic susceptibility testing ", defined as the restriction of the list of antibiotics mentioned in the report according to the antibiotic resistance profile, would allow, according to observational studies, a reduction of 25 to 70% of the initial prescriptions of broad-spectrum antibiotics and a 20% rate of antibiotic de-escalation (=reduction of the antibacterial spectrum of an antibiotic treatment after re-evaluation).

The objective is to assess the impact of disseminating a selective reporting for antibiotic susceptibility testing on the dispensing of broad-spectrum antibiotics prescribed by general practitioners (GPs) for E. coli positive urine cultures in adult women, compared to the dissemination of a standard antibiotic susceptibility testing.

lead_sponsor: Nantes University Hospital


title: "neoBREASTIM": A Phase 2 Study of Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer (TNBC)

acronym: neoBREASTIM

summary: Neoadjuvant treatment is an important part of the treatment strategy for locally advanced TNBC having established a positive and significant correlation of pathologic Complete Response (pCR) with long-term clinical benefit such as Event-Free Survival (EFS) and Overall Survival (OS) as shown via large meta-analysis. Much effort has been made to identify novel agents and new drug combinations that can improve pCR rates in this specific clinical setting, which is the leading rationale to evaluate RP1 oncolytic immunotherapy in combination with Atezolizumab.

ipd_sharing_description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

lead_sponsor: Institut Curie

collaborators:
Replimune Inc.
Roche Pharma AG

sponsor_collaborators:
Institut Curie
Replimune Inc.
Roche Pharma AG

intervention_type: Combination Product


title: Bedside Bone Biopsy Versus Conventional Bone Biopsy for Management of Diabetic Foot Osteomyelitis: an Open-label Controlled Randomized Non-inferiority Trial

acronym: BOLBOC

summary:
During their lifetime, 15 to 25% of patients with diabetes mellitus will develop a Diabetic Foot Ulcer (DFU) related to neuropathy and/or peripheral arterial disease. DFU is the leading cause of non-traumatic lower-extremity amputation worldwide. Diabetic foot osteomyelitis (DFO), which complicates up to 60% of DFU, is a major trigger of amputation in over 80% of persons with diabetes resulting in subsequent loss of quality of life. It has been shown that medical treatment of DFO may prevent amputations with early diagnosis of osteomyelitis and appropriate use of antibiotics. Empirical antimicrobial treatment is not recommended for DFO as for other chronic infections. Surgically or radiologically acquired bone sample for culture is the reference standard recommended by the International Working Group of Diabetic Foot (IWGDF) to diagnose DFO and to determine the causative bacteria and their susceptibility. However, defining appropriate antimicrobial therapy directed to the causative bacteria in DFO is challenging since it requires bone biopsy (BB) procedures which are underused in clinical practice for various reasons: lack of availability, cost, and delay. Some clinicians also find bone biopsy cumbersome or too invasive.

To overcome these barriers, we have set up for a few years a bedside blind BB procedure performed by diabetologists at the bedside in the clinical ward. Since then, this method has been used in more than 200 patients with DFO in the diabetology departments of Lariboisiere Hospital and Bichat Hospital (Paris). We have recently published our observational data of 79 patients showing that bedside BB is a simple, safe and efficient procedure for the diagnosis of DFO with a similar rate of complete healing at 12 months compared to conventional surgical or radiological bone biopsies. In order to extend and confirm these preliminary and observational results, the aim of this study is to compare the efficiency and safety of bedside BB versus conventional bone biopsy in a randomized controlled trial (RCT) of patients with DFO. Our hypothesis is that bedside BB is non-inferior to conventional bone biopsy in DFO and can be used as a simpler alternative procedure to document DFO


title: Monitoring of Argatroban Anticoagulant Therapy in Patients With Acute Suspected Heparin-induced Thrombocytopenia: French Multicenter Study

acronym: TIH-FM

summary:
Heparin-induced thrombocytopenia (HIT) is a rare but potentially serious complication of heparin therapy. , argatroban is the alternative anticoagulant of choice in patients with suspected HIT and renal impairment, high bleeding risk or risk of invasive surgery/gesture. Despite its increasing use in these fragile patients, methods for biological monitoring of argatroban's anticoagulant activity are heterogeneous, and neither the therapeutic zone nor the modalities for argatroban dosage adjustment are clearly defined, particularly in patients in the acute phase of thrombosis.

Soluble fibrin monomers (FM) indirectly reflect thrombin generation in vivo. This marker could thus represent a new strategy for monitoring the anticoagulant activity of argatroban. However, the effect of argatroban anticoagulation on FM levels remains unknown.

In a preliminary retrospective study carried out at Bichat hospital, we showed that FM levels could therefore be an early marker of the efficacy of argatroban treatment in patients with suspected HIT.In order to confirm these results, we will include patients with clinico-biological suspicion of HIT and receiving argatroban treatment.

Ten French laboratories will participate in this study. All plasmas collected will be from samples taken only in the context of care.

This prospective study will determine whether the daily monitoring of FM is beneficial for the management of patients treated with argatroban.


title: Risks Factors and Outcome of Recurrences in Patients With Ventilator-Associated Pneumonias (REVAP)

acronym: REVAP

summary:
Ventilator-associated pneumonia (VAP) is a frequent and serious complication in the ICU, defined by the development of a lung infection in patients ventilated for more than 48 hours. The incidence rate of this condition exceeds 18 episodes per 1000 days of mechanical ventilation in Europe. This nosocomial infection is associated with the highest mortality, ranging from 24% to 76% depending on the series. Reducing the incidence of VAP remains a challenge for clinicians, as evidenced by the many recent recommendations that have led to "bundles" to prevent the onset of this complication. Despite this, these recommendations do not propose a strategy to prevent the recurrence of PAVM, a frequent entity with a reported incidence of 25-35% and a non-consensual definition that increases antibiotic consumption, duration of mechanical ventilation and length of stay in the ICU .

In fact, these recurrences can be linked to:

Intrinsic patient risk factors (immunosuppression, severity of disease, major inflammatory response, reason for initial admission),
Inappropriate initial antibiotic therapy (type, duration and dose administered),
Characteristics specific to the pathogens encountered (virulence factors or resistance),
Intercurrent complications during management of the initial pneumonia (ARDS, abscess, pleural empyema).

Given the frequency of these recurrences, and the persistent doubts about the role of terrain and pathogen characteristics in their genesis, it seems appropriate to look at risk factors that could help anticipate these events.

The aim of our study will be to identify the risk factors and mortality associated with the occurrence of a recurrence of VAP in patients hospitalized in the intensive care unit.

An essential first step in this work will be to identify and then use the most consensual definition of recurrence of VAP, encompassing recurrence, persistence and superinfection. We will use the definitions in the protocol for the ASPIC trial, which is currently undergoing enrolment.

The second step is to identify risk factors for recurrence. By identifying these factors, it could be possible to propose a prognostic score that would enable careful monitoring (or modification of antibiotic therapy) of patients most at risk of recurrence. Such a score could then be evaluated in a prospective study.

ReferenceCitation: Combes A, Figliolini C, Trouillet JL, Kassis N, Dombret MC, Wolff M, Gibert C, Chastre J. Factors predicting ventilator-associated pneumonia recurrence. Crit Care Med. 2003 Apr;31(4):1102-7. doi: 10.1097/01.CCM.0000059313.31477.2C.

ReferenceCitation: Combes A, Luyt CE, Fagon JY, Wolff M, Trouillet JL, Chastre J. Early predictors for infection recurrence and death in patients with ventilator-associated pneumonia. Crit Care Med. 2007 Jan;35(1):146-54. doi: 10.1097/01.CCM.0000249826.81273.E4.

ReferenceCitation: Foucrier A, Roquilly A, Bachelet D, Martin-Loeches I, Bougle A, Timsit JF, Montravers P, Zahar JR, Eloy P, Weiss E; ASPIC study group. Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care (the ASPIC trial): study protocol for a randomised controlled trial. BMJ Open. 2023 Feb 21;13(2):e065293. doi: 10.1136/bmjopen-2022-065293.

ipd_sharing_description: unplanned for the moment

lead_sponsor: Société Française d'Anesthésie et de Réanimation


title: Real-world Experience of Dupilumab for the Treatment of Severe Asthma in the United Kingdom: a Retrospective Study

acronym: DUPIAZA

summary: The purpose of this retrospective medical record review is to describe the real-world clinical effectiveness of dupilumab with patients in the United Kingdom with severe asthma.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi


title: Psoas Tenotomy Under Ultrasound

acronym: TEPSe

summary:
The ilio-psoas conflict is a commonly accepted complication after total hip replacement, often linked to a mispositioning of the acetabular prosthetic component that conflicts with the ilio-psoas tendon. To correct these pains, a psoas tenotomy can be proposed. The results proven by the literature are very satisfactory. Psoas tenotomy is performed endoscopically, arthroscopically, or more rarely open.

The contribution of echo surgery allows to limit the scar ransom but also to free itself from a complex infrastructure to the operating room including an arthroscopy column and an intraoperative fluoroscopy for a conventional tenotomy, This also saves procedural and installation time.

No studies to date have described ultrasound-assisted psoas tenotomy Yhe investigators conducted a cadaveric study of the feasibility of psoas tenotomy under ultrasound that confirms the feasibility of this technique and the safety of the gesture for the surrounding anatomical structures.

The objectives of this study are to assess the feasibility, pain and functional outcomes of ultrasound-assisted psoas tenotomy in patients with ilio-psoas conflict after total hip replacement.


title: Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)

acronym: ANDROMEDA-FR

summary: Over-resuscitation including fluid overload has been associated with increased morbidity (prolonged duration of organ failure) and mortality in septic shock. "One-size-fits-all" resuscitation strategies may increase septic shock mortality. However, clinical studies on individualized resuscitation are lacking. Hemodynamic phenotyping may allow to individualize septic shock resuscitation. The ANDROMEDA-SHOCK trial found that a simple clinical and bedside CRT-targeted resuscitation reduces organ dysfunction and 28-day mortality in septic shock. The current study will examine the hypothesis that a CRT-targeted resuscitation based on hemodynamic phenotyping considering within an decision tree usual bedside clinical parameters such as pulse pressure, diastolic blood pressure, fluid responsiveness and cardiac performance can further decrease mortality in septic shock as compared to usual care.

location_facility: Hôpital Robert Debré, Université de Reims


title: Benefit of Permanent Stimulation of the Left Branch of the His Bundle Versus Right Ventricular Stimulation After Atrioventricular Node Ablation for Rapid Atrial Fibrillation

acronym: LEANA

summary: The objective of the study is to evaluate the functional benefit of left bundle branch of His pacing compared to right ventricular pacing in patients implanted with a pacemaker prior to a atrioventricular node ablation procedure for rapid atrial fibrillation

lead_sponsor: University Hospital, Rouen


title: Physiological Study of Prone Position in Acute Respiratory Failure Syndrome

summary:
ARDS is an acutely induced respiratory failure characterized by the appearance of bilateral alveolar opacities on imaging and hypoxemia Etiologies are divided into two classes: pulmonary, including all infectious pathologies, aspiration pneumonia, and drowning, and extra-pulmonary, induced by sepsis or acute pancreatitis. The mortality rate of ARDS remains high in unselected patient populations Among strategies that have proven beneficial in terms of patient outcome, prone positioning (PP) is associated with the greatest impact in terms of reduction in mortality.

PP is currently recommended in the European guidelines for ARDS associated with a PaO2/FiO2 ratio < 150 mmHg in patients in whom ventilatory settings have been optimized beforehand, The failure of early PP studies to demonstrate a survival benefit in ARDS was attributed to insufficient session duration. The PROSEVA study was the first to demonstrate that a PP duration of 17 h is associated with a reduction in mortality

During the COVID-19 pandemic, several centers have reported the implementation of longer PP sessions. Two strategies have emerged from these studies. In one case, the patient was left in the prone position until the criteria for stopping PP were met. Thus, the PP/supine position alternation was completely suppressed. In another published strategy, PP sessions were maintained for a period covering two nights. Furthermore, in a multicenter retrospective study, PP sessions were maintained until clinical improvement was associated with reduced mortality. In this study of 263 patients, the median duration of PP in the extended duration group was 40 h, and 75% of the sessions lasted 48 h or less. Using a propensity score, the authors showed that patients treated with an extended PP duration had a lower 3-month mortality rate than patients in the standard duration group . This protocol was also associated with a 29% cumulative incidence of pressure sores, similar to the 25% cumulative incidence reported in the PROSEVA study Other data published on pressure sores and PP of duration > 24 hours are also reassuring. Finally, a recent review recently reported that an extended PP session of > 24 h had also been used before the COVID-19 pandemic.

PP sessions had a median duration of 47-78 hours and were applied mainly to ARDS secondary to community-acquired pneumonia. All pre-COVID studies were retrospective, monocentric, without a control group.


title: Evaluation of the Prevalence and Evolution of Autonomic Nervous System Dysfunction for the Management of SARS-COV 2 Infection in Intensive Care Unit Patients

acronym: COVENANT-ICU

summary: Since the spread of the COVID-19 disease, several studies have reported the presence of neurological symptoms in patients infected with SARS-CoV-2 such as dysgeusia, hypo or anosmia, hypopsia, the presence of headaches or neuralgia. It has also been described an inconsistent association, in the most severe patients, neurological disorders such as labile arterial hypertension, persistent central fever, vigilance disorders as well as a poor adaptation of the cardio vascular and respiratory systems characterized by paradoxical bradycardia and the frequent absence of polypnea in response to profound hypoxemia. These different functional signs are usually described in particular in patients with impairment of the autonomic nervous system (ANS) in connection with other neuropathological processes.

lead_sponsor: Centre Hospitalier St Anne


title: Second Generation DICART Prototype Validation for Patients With Acute Circulatory Failure

acronym: DICART II

summary:
Capillary refill time (CRT) is a clinical sign for diagnosis of acute circulatory failure and response to treatment but is also associated with prognosis in patient with shock.

CRT is clinically evaluated by physician with a high risk of inter and intra evaluator variations, depending, for example, on measurement site, pressure applicated or visual evaluation.

The investigator hypothesizes that CRT measurement with second generation DICART prototype will be well correlated with clinical measurement.

lead_sponsor: Hospices Civils de Lyon


title: Study of Thermoregulation in Exercise Heat Stroke in the Military Environment

acronym: EXPLO-MITO

summary:
The EXPLO-MITO study is an ancillary study from the main EXPLO-CCE study (NCT04593316; IDRCB: 2020-A01967-32).

The Heat Tolerance Test (HTT) is a physiological exploration that has several advantages for use in research and clinical settings. Unlike the walk-run test, it is performed under controlled conditions, both environmentally (temperature control, humidity, etc.) and in terms of effort intensity. In addition, there are published interpretation criteria for this test allowing to characterize thermoregulation profiles and to distinguish between Heat Intolerant (HI) and Heat Tolerant (HT) patients.

The reproducibility of this test and its performance in a climatic chamber allows a true comparison of thermophysiological responses (heart rate, rectal and skin temperatures, skin blood flow and sweat loss), which was not possible with the run-walk test, which was more a field test validating a physical aptitude for recovery (so-called "occupational" test) than a physiological exploration evaluating a response to stress by comparing it with the expected response in a population of young, healthy, properly trained subjects. Moreover, the HTT is a much less physiologically demanding test than the 8-km run. The HTT, which corresponds to a 2-hour walk at 5 km/h with a 2% slope at 40°C and 40% relative humidity, is a so-called "compensable" thermal stress; that is, under these conditions of exercise and environment, when the individual has normal thermoregulatory capacities, a thermal equilibrium plateau is reached during the second hour, when the individual's thermolysis capacities make it possible to compensate for the production of heat by the exercise and the gain of heat related to the environment. On average, this plateau is between 38° and 39°C. This is clearly not the case with our experience of physiological monitoring of the 8-km walk-run which rarely allows a temperature plateau to be reached and is accompanied by a temperature rise constantly above 39°C. In addition to being performed in the laboratory, this test is therefore completely safe.

For all these reasons (reproducibility, relevance, predictive value of recurrence), this test has been used for more than 30 years by the Israeli army for the assessment of these cases of exercise heat stroke before their return to work. There is therefore a fair amount of published data and hindsight on the use and interest of this test. The Israeli test has the highest level of recommendation (Grade A) of all the other published heat tolerance tests. Also, the availability of a climatic chamber means that this test can now be proposed as one of the explorations available to clinicians who have to decide on the fitness of soldiers after exercise heat stroke.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Effect of Transcranial Near InfraRed Light On Cerebral Function in Young and Healthy Older Subjects: a Functional Magnetic Resonance Imaging (fMRI) Study (TIROC)

acronym: TIROC

summary:
Numerous studies have shown that the extra-cranial application of near infrared light (λ=600-1000nm) (also called transcranial photobiomodulation or tPBM), has a positive impact on brain function in both humans and experimental animal models and a neuroprotective effect in animal models. Several of these studies have reported that tPBM could impart more beneficial effects in aged or diseased brains. The primary objective of this study is to use fMRI to compare the cerebral activations in response to a finger tapping motor task, before and after 24min of tPBM versus sham stimulation, in old and young healthy human subjects.

The hypothesis of the investigators is that tPBM improves brain function in participants who will be treated using the active device in comparison with those treated with the sham device and that this effect should will be more pronounced in the older subjects.

ReferenceCitation: Dole M, Auboiroux V, Langar L, Mitrofanis J. A systematic review of the effects of transcranial photobiomodulation on brain activity in humans. Rev Neurosci. 2023 Mar 17;34(6):671-693. doi: 10.1515/revneuro-2023-0003. Print 2023 Aug 28.

ReferenceCitation: El Khoury H, Mitrofanis J, Henderson LA. Exploring the Effects of Near Infrared Light on Resting and Evoked Brain Activity in Humans Using Magnetic Resonance Imaging. Neuroscience. 2019 Dec 1;422:161-171. doi: 10.1016/j.neuroscience.2019.10.037. Epub 2019 Nov 1.

ReferenceCitation: Dmochowski GM, Shereen AD, Berisha D, Dmochowski JP. Near-Infrared Light Increases Functional Connectivity with a Non-thermal Mechanism. Cereb Cortex Commun. 2020 Mar 19;1(1):tgaa004. doi: 10.1093/texcom/tgaa004. eCollection 2020.

ReferenceCitation: Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec.

ReferenceCitation: Nizamutdinov D, Qi X, Berman MH, Dougal G, Dayawansa S, Wu E, Yi SS, Stevens AB, Huang JH. Transcranial Near Infrared Light Stimulations Improve Cognition in Patients with Dementia. Aging Dis. 2021 Jul 1;12(4):954-963. doi: 10.14336/AD.2021.0229. eCollection 2021 Jul.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Commissariat A L'energie Atomique
Fonds de Dotation Clinatec