title: Epidemiological Characteristics and Prognosis Factors of Cancer Patients Admitted at French Emergency Departments

acronym: EPICANCER

summary:
Patients with cancer or hematological malignancy are susceptible to present acute complications linked to their disease or to their specific treatments (dyspnea, sepsis, coma, hemorrhagic syndrome). Emergency physicians are in first line when these complications arise and have to face with some complex situations in which informations about patient malignancy or prognosis may be lacking. Nowadays, there is very few epidemiological data published concerning how cancer patient use Emergency Departments (EDs) and cancer patient care delivery in the EDs.

Thus, an observational multicenter prospective cross-sectional study is conducted to study the prevalence of cancer patients admitted to French EDs, and to describe the different reasons for cancer patients to seek care in EDs with their prevalence and underscore those linked to cancer or treatment complication

ReferenceCitation: Peyrony O, Fontaine JP, Trabattoni E, Nakad L, Charreyre S, Picaud A, Bosc J, Viglino D, Jacquin L, Laribi S, Pereira L, Thiriez S, Paquet AL, Tanneau A, Azoulay E, Chevret S, Initiatives de Recherche Aux Urgences Iru-Sfmu Research Group. Cancer Patients' Prehospital Emergency Care: Post Hoc Analysis from the French Prospective Multicenter Study EPICANCER. J Clin Med. 2021 Mar 9;10(5):1145. doi: 10.3390/jcm10051145.

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

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

publisher_dissemination: MDPI


title: Evaluation of Post-operative Morbidity and Mortality After Cardiac Surgery Performed in Bichat Hospital

acronym: Cardiobase

summary: The local database results from a joint initiative of anesthesic, cardiology and cardiac surgery departements.Its purpose is to record in an exhaustive fashion all the interventions of cardiac surgery performed under extracorporeal circulation in adults at Bichat hospital.This database includes the preoperative characteristics of the patients, the type of surgery, the post-operative complications and the in-hospital mortality. The purpose of this observational study is to evaluate in-hospital morbidity and mortality for all types of cardiac surgery interventions and to analyze it according to the characteristics of the patients and the type of intervention.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: with others French University Hospitals (Rennes, Nantes, Paris (PITIE SALPETRIERE) , Bordeaux)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: département de cardiologie et d'anesthésie réanimation Hôpital Bichat 46 rue Henri Huchard

lead_sponsor_type: academique

status_simplified: Ongoing


title: Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction Survey

summary:
Reusable (RU) flexible bronchoscopes (FB) require intermediate level disinfection operations to prevent transmission of infectious agents from patient to patient. These operations have a significant material and human cost and impact their availability in case of emergency. One alternative is the use of disposable FB.

The aim of the study is to evaluate the quality of FB during procedures carried out with each of the two solutions in intensive care unit (ICU), respiratory endoscopy (RE) and anesthesia (A) department.

A prospective non-interventional and non-randomized monocentric study compare the operator satisfaction of therapeutic procedures performed with RU FB (EB FujifilmTM range, FB/FI PentaxMedicalTM range, StorzTM intubation FB) versus disposable FB (aScope 3® and aScope 4® (AmbuTM), Broncoflex® (AxessvisionTM). An evaluation form is completed by the operator at the end of procedure. Judging criteria, rated from 0 to 10, concern handling, ergonomics, image and suction quality.

status: Unknown status

ipd_sharing: No

lead_sponsor: University Hospital, Limoges

status_simplified: Unknown


title: Content and Expectations of Consultations of Patients With Opioid Substitution Treatment Considered as Stabilized: Cross-Testimonials Doctors - Patients (MSOSuiStab)

acronym: MSOSuiStab

summary:
Consultations in general medical practice concerning the follow-up of the patients receiving opiate substitution treatments are not exceptional.

It is nowadays agreed that addictive pathology goes far beyond the issue of product dependence, in favor of a pathology in itself. Centered on problems of attachment, of framework, of trust. The implementation of the opiate substitution treatments and the lifting of the product dependence appears only as a preliminary to the background work with the patient ex-user of opiate.

Finally, the literature provides little information on the experience of general practitioners and their patients under opiate substitution treatments regarding follow-up consultations in the stability phase.

The objective of this work is therefore to study the feelings on follow-up consultations, general practitioners and their patients under opiate substitution treatments considered stabilized.

time_perspective: Other

lead_sponsor: University Hospital, Angers

intervention_type: Other


title: Nutritional Status Assessment in the Elderly Suffering From Cancer (NutriAgeCancer) : a National Cross-UCOG Survey

acronym: NutriAgeCancer

summary:
Protein-energy malnutrition (PEM) is a frequent condition in patients suffering from cancer, especially the elderly. According to some studies, this malnutrition has important consequences in this population, by increasing the risk of treatment toxicities, premature interruption of chemotherapy, mortality and risks of complications. Identifying cases of malnutrition is an objective pursued by the National Nutrition and Health Programme and an important task of the "Unités de Coordination en Oncogériatrie".

The main goal of this study is to assess the loss of weight over the 6 month-period preceding the cancer treatment, regardless of kind (chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiation therapy, surgery, comfort care), in the elderly suffering from cancer.

lead_sponsor: Société Francophone d'Onco-Gériatrie

lead_sponsor_type: industriel


type: Registry Identifier

title: Atropine Weight and Risk of Postoperative Confusion After Hip Fracture Surgery or Prosthetic Surgery of the Lower Limb, in the Elderly

acronym: ATROPAGE

summary:
The identification of a high atropine load of treatment received during hospitalization as a predictor of postoperative confusion could have various benefits:

Pharmacoepidemiological: identify factors associated with postoperative confusion
Clinics: by favoring treatments with a low atropine load during anesthesia, the management of patients hospitalized in orthopedics. Similarly, stopping or re-evaluating treatments with a high atropine weight for scheduled surgery is an easy step to take.
Socio-economic: by reducing the costs related to the occurrence of a confusional syndrome (over-treatment, prolonged hospital stay, loss of autonomy, institutionalization of patients...).

In total, the present study would improve the daily management of hospitalized patients and the practices of clinicians, by offering a decision-making aid.

lead_sponsor: University Hospital, Toulouse


title: Hyperglycemic Response to Steroid Administration After Noncardiac Surgery in Patients With and Without Diabetes

acronym: DexGlySurg

summary: The hyperglycemic response to surgery and the added effect of low-dose steroids (dexamethasone 4 to 8mg), and whether these differ in diabetics and nondiabetics remain unclear. Therefore, we prospectively evaluate the intraoperative and postoperative serum glucose concentrations in diabetics and nondiabetics that received intravenous steroid administration. This multicentre study include > 250 patients.Primary endpoiunt was glucose concentration at H6 after surgery. Secondary endpoints were glucose concentration at H12 and at H24 and effect of anesthesia (regional anesthesia)

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Drug

status_simplified: Completed


title: Assessement of Viral Shedding Duration After a Respiratory Tract Infection in Oncology and Hematology Patients

acronym: ONCOVIR

summary: The purpose of this study is to assess the duration of the viral shedding in hematology and oncology patients after a respiratory tract viral infection. This duration has not been much studied in that population whereas it is probably longer than that in immunocompetent patients. Thereby it may be a source of transmission amongst these immunocompromised patients.

study_type: Interventional

primary_purpose: Prevention

lead_sponsor: Poitiers University Hospital

intervention_type: Diagnostic Test


title: Characterization of the Initial Psoriatic Skin Transcriptionnl Profile Associated to a Response to Adalimumab Therapy

acronym: IMPRA

summary: The objective is to compare the initial skin inflammatory transcriptomic profile of psoriatic patient responder to Adalimumab therapy (defined as the achievement of a Psoriasis Area and Severity Index 75 response at 16 weeks) with the transcriptomic profile of patient non-responder to Adalimumab therapy (defined as the non-achievement of a Psoriasis Area and Severity Index 50 response at 16 weeks) to identify differentially expressed genes in order to define predictive markers of response to the treatment.

primary_purpose: Basic Science


title: Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry

acronym: Gr-CryoFS

summary: The aim of this study was to assess the long-term success rates of pulmonary vein isolation using first and second generation cryoballoons in patients with paroxysmal and persistent atrial fibrillation.

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, Cardin C, Combes N, Combes S, Boveda S, Albenque JP. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace. 2015 Feb;17(2):225-31. doi: 10.1093/europace/euu215. Epub 2014 Sep 3.

ReferenceCitation: Cardoso R, Mendirichaga R, Fernandes G, Healy C, Lambrakos LK, Viles-Gonzalez JF, Goldberger JJ, Mitrani RD. Cryoballoon versus Radiofrequency Catheter Ablation in Atrial Fibrillation: A Meta-Analysis. J Cardiovasc Electrophysiol. 2016 Oct;27(10):1151-1159. doi: 10.1111/jce.13047. Epub 2016 Aug 16.

ReferenceCitation: Jiang J, Li J, Zhong G, Jiang J. Efficacy and safety of the second-generation cryoballoons versus radiofrequency ablation for the treatment of paroxysmal atrial fibrillation: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2017 Jan;48(1):69-79. doi: 10.1007/s10840-016-0191-9. Epub 2016 Sep 28.

ReferenceCitation: Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

version: acceptedVersion

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

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

ReferenceCitation: Lemes C, Wissner E, Lin T, Mathew S, Deiss S, Rillig A, Heeger C, Wohlmuth P, Reissmann B, Tilz R, Ouyang F, Kuck KH, Metzner A. One-year clinical outcome after pulmonary vein isolation in persistent atrial fibrillation using the second-generation 28 mm cryoballoon: a retrospective analysis. Europace. 2016 Feb;18(2):201-5. doi: 10.1093/europace/euv092. Epub 2015 May 19.

lead_sponsor: University Hospital, Grenoble


title: Phase II Trial Evaluating Low-dose Deferasirox (DFX) in Patients With Low-risk (MDS) Myelodysplastic Syndrome Resistant or Relapsing After ESA Agents (LODEFI)

acronym: LODEFI

summary: Patients with low-risk MDS verifying the eligibility criteria may be included in the study.

primary_purpose: Treatment

ipd_sharing_description: e crf

sponsor_collaborators:
University Hospital, Grenoble
Novartis


title: Virtual Reality and Brain Stimulation, an Experiential Approach

acronym: REVISTIM-X

summary: The aim of this study is to assess feasibility, acceptability and efficacy of two VRET (Virtual Reality Exposition Therapy)session associated with either active anodal tDCS or sham tDCS on the ventromedial prefrontal cortex to decrease anxiety related to visual height intolerance

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: Nantes University Hospital

intervention_type: Device


type: Other Identifier

title: Evaluation of a Power Assistance Device for Wheelchair-DUO

acronym: EVALDUO

summary:
Power assisted wheelchairs have specific advantages compared to manual propelled or powered Wheelchair. Autonomad Mobility has developed a new device (DUO), the assistance being triggered by the motion of the wheelchair and not an push on the hand rim, people who use their foot to move or people pushing the wheelchair can be helped by the device as people propelling the wheelchair with their arms.

Furthermore DUO has an option with a longer assistance (AEP+) which can be preferred by some people.

To be referenced and reimbursed by the French health insurance, DUO has to be compared with an other power assistance device for wheelchairs, already referenced.

The study is a comparative study between DUO and the ALBER E Motion. Each patient is his own control and is assessed in 4 experimental conditions, with intervals of 3 or 4 days, manually propelled, with the E mtion device, with the DUO device and the single push configuration, with the DUO device and the AEP+ configuration.

The main outcome measure will be the user's satisfaction (using 8 items of the ESAT questionnaire)

lead_sponsor: University Hospital, Lille


title: Evaluation of an Ultra-speed Picosecond Laser for Treating Tattoos

acronym: PicoS

summary:
The investigators developed an ultra-speed picosecond laser (20ps) with a 20gHz repetition rate that provide very promising results in vitro and in ex vivo skin to remove skin tattoos.

The aim of this study is to evaluate the efficacy and tolerance of a new ultra-speed picosecond laser and to compare it to a nanosecond laser for treating black tattoos.

In a first phase of the study 10 patients with black tattoos will be treated with increasing fluencies of the picosecond laser to the optimal parameters in terms of efficacy and tolerance.

In a second phase, 10 additional subjects with black tattoos will be treated after central randomization on half of the tattoo with the picosecond laser (with the parameters determined in the first phase) and the other half treated with a nanosecond laser.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - Dermatologie - Hôpital Archet


title: Role of the Posterior Parietal Cortex in the Processing of Sensory Information Modulating the Excitability of the Primary Motor Cortex in Humans

acronym: CORTEX

summary: Although the primary motor cortex is considered has the common final pathway of motor commands, it is influenced by several structures as, for example, the premotor cortex and the posterior parietal cortex which are involved in motor planning and programming and which integrates movement-induced sensory impute (parieto-frontal circuits). Several studies have shown that there are some direct functional connections between the premotor cortex and the posterior parietal cortex and from these two regions to the primary motor cortex. The posterior parietal cortex can then be considered as a sensorimotor interface whose function in planification and motor control of upper limb is well demonstrated. The hypothesis is that the posterior parietal cortex could participate to the modulation of motor cortex excitability by proprioceptive sensory inputs namely long latency afferent inhibition and afferent induced facilitation.


title: Efficiency of Negative Pression Therapy With Instillation in the Debridement of Wound

acronym: TPN

summary: the aim of the study is to evaluate the efficiency of the therapy with negative pression (TPN) and instillation in the debridement of chronic wound


type: EudraCT Number

title: A Pilot Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Pulmonary Fibrosis With Anti-myeloperoxydase (MPO) Antibodies or With Anti-MPO Associated Vasculitis."

acronym: PIRFENIVAS

summary: The purpose of this study is to determine wether pirfenidone is safe and effective in the treatment of pulmonary fibrosis with anti-myeloperoxydase (MPO) antibodies or pulmonary fibrosis with anti-MPO associated vasculitis.

ReferenceCitation: Hervier B, Pagnoux C, Agard C, Haroche J, Amoura Z, Guillevin L, Hamidou MA; French Vasculitis Study Group. Pulmonary fibrosis associated with ANCA-positive vasculitides. Retrospective study of 12 cases and review of the literature. Ann Rheum Dis. 2009 Mar;68(3):404-7. doi: 10.1136/ard.2008.096131. Epub 2008 Oct 28.

ReferenceCitation: King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. doi: 10.1056/NEJMoa1402582. Epub 2014 May 18. Erratum In: N Engl J Med. 2014 Sep 18;371(12):1172.

ReferenceCitation: Lancaster L, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, King TE Jr, Lederer DJ, Lin Z, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, Noble PW. Safety of pirfenidone in patients with idiopathic pulmonary fibrosis: integrated analysis of cumulative data from 5 clinical trials. BMJ Open Respir Res. 2016 Jan 12;3(1):e000105. doi: 10.1136/bmjresp-2015-000105. eCollection 2016.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Roche Pharma AG


acronym: NPO-NIV

summary: The Nutritional Practices and Outcomes in Non-Invasive Ventilation (NPO/NIV) study is a collaboration with lead sites from pediatric critical care units within US and Canada, and participating sites from multiple international regions. The goal of NPO/NIV is to understand how non-invasive ventilation (NIV) is used to treat critically ill children and, concurrently, how these children are fed while on NIV. Designed as a period prevalence study, NPO/NIV will collect observational, cross-sectional data over the course of five study weeks. Each study week will require two days of screening for eligible patients. On Mondays, study staff will screen for patients eligible in the previous 48 hours. On Tuesdays, study staff will screen for patients eligible in the previous 24 hours. Patients meeting study inclusion will be eligible to complete V0, V1, and V2. Included patients will be followed for 7 days after the initiation of NIV or until the patient is discharged from the pediatric intensive care unit. This study was granted exempt status by the University of Arizona Human Subjects Protection Program, including a waiver of informed consent. As no personal health information is transmitted during the course of the study, the University of Arizona does not require Data Use Agreements between sites to participate.


acronym: START

lead_sponsor: UNICANCER

summary:
This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one patient randomized in Arm n°2.

The trial population is composed of women over 18 years old with triple-negative and androgen receptor positive, locally recurrent (unresectable) or metastatic breast cancer.

title: A Randomized Phase 2 Study in Patients With Triple-negative Androgen Receptor Positive Locally Recurrent (Unresectable) or Metastatic Breast Cancer Treated With Darolutamide or Capecitabine

source: euctr

ipd_sharing: Undecided


title: Prognostic Value of SPECT-CT Quantitative Indices for the Response Assessment of Bone Metastatic Prostate Carcinoma

acronym: INTEVOPROSTATE

summary: Prognostic interest of bone scintigraphy in bone metastatic prostate carcinoma (BMPC) has been shown. Recent technological advances allow to perform quantitative bone SPECT-CT in routine practice. The aim of this study is to assess the prognostic interest of quantitative bone SPECT-CT in BMPC.

lead_sponsor: University Hospital, Brest


title: Increased Resting Energy Expenditure Compared to Six Predictive Theoretical Equations in Amyotrophic Lateral Sclerosis: a Study Versus Controls

summary:
Introduction: About 50-60% of Amyotrophic Lateral Sclerosis (ALS) is characterized by hypermetabolism, defined as 10% or more excess resting energy expenditure (REE) compared to theoretical values. Harris and Benedict's (HB) formula is the equation mainly used to predict REE, but others are also applied in current practice. The present study aimed to assess REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.

Nutritional assessments were performed in ALS patients and in two control populations without hypermetabolism: healthy elderly people (control 1) and patients with non-restrictive-eating disorders (control 2). Weight, height and body composition (by bioimpedance analysis) were assessed.

EE was measured (mREE) by indirect calorimetry and calculated (cREE) using HB 1919 and 1984, World Schofield, De Lorenzo, Johnstone and Mifflin formulas. Mann-Whitney and Chi2 tests were used to compare the equations.


title: Impact of a Ciclosporin A Preconditioning for Prevention of Ischemia-reperfusion Injury After Renal Artery Stenosis Dilation

acronym: CicloSAAR

summary:
Renal artery stenosis is one the leading cause of secondary hypertension. Previous randomized controlled trials in humans have failed to demonstrate an improvement of renal function after stenosis dilation, probably because of a selection bias with more severe patients being excluded from randomization. Renal ischemia-reperfusion injuries have also not been taken into account. Indeed, reperfusion leads to a rapid renal blood flow recovery associated with renal ischemia-reperfusion injuries.

Mitochondrial permeability transition pore (mPTP) is a key player in the occurrence of ischemia reperfusion injuries because its opening leads to mitochondria leakage and cell death. However, preconditioning whether pharmacological or ischemic can prevent mPTP opening and protect cells. Ciclosporin A can prolong mPTP closing during reperfusion and reduce renal and cardiac tissular lesions. Another mPTP blocker (Bendavia) has been associated with an improvement of renal blood flow (RBF) and glomerular filtration rate (GFR) after renal artery stenosis dilation at 6 weeks in pigs. Based on a recent study, dilation overall benefit could be secondary to an improvement of the contralateral kidney GFR and tissue oxygen content, requiring a single kidney evaluation of those renal functional parameters. The investigators previously demonstrated that dose and timing of ciclosporin A preconditioning is key to protect kidneys from ischemia-reperfusion injuries. Previous controlled trials that failed to demonstrate a benefit of ciclosporin A conditioning have used post conditioning on necrotic cells. Considering kidney ischemia-reperfusion injuries, preconditioning have led to more encouraging results compared to ciclosporin A post conditioning in animals. Therefore the investigators aim to conduct the first clinical study of ciclosporin A preconditioning for prevention of kidney ischemia-reperfusion injuries after renal artery stenosis dilation.

Using renal functional imaging and the new PET-MRI (Positron Emission Tomography-Magnetic Resonance Imaging) combined device, the investigators will evaluate kidney perfusion, oxidative metabolism, glomerular filtration rate and oxygen content before and 3 months after renal artery stenosis dilation with or without a ciclosporin A preconditioning.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Exploration Fonctionnelle Rénale, Hôpital Edouard Herriot, Hospices Civils de Lyon


title: Development of Child With Equinus Deformity Idiopathic

summary: Identification and characterization of the link between psychomotor development and the appearance of associated signs in children with "Equinus Deformity " considered isolated at birth.

lead_sponsor: Rennes University Hospital


title: Impact of the Pre-phonatory Inspiratory Volume on the Speech Quality of Neuromuscular Patients Dependent on Non-invasive Ventilation

acronym: PREPHONO

summary: We want to demonstrate that modifications of the ventilation parameters are liable to improve the different characteristics of phonation (duration, intensity, prosody..) in neuromuscular patients who are dependent on non invasive ventilation.

primary_purpose: Supportive Care

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Ectosomes, New Biomarkers of Tau Pathology?

acronym: ECTAUSOME

summary: In Alzheimer's disease (AD), neurofibrillary degeneration (NFD) is characterized by the intraneuronal aggregation of Tau proteins. The pathology progresses through a hierarchical pathway that may be associated with the intercellular transmission of pathology as demonstrated in our rat models. This transmission implies that Tau is actively secreted and may participate to the first steps of Tau pathology spreading. It is demonstrated in cell lines and animal models (rodents and non-human primates) that Tau is secreted not only in free forms but also in extracellular vesicles. If Tau is found in biological fluids before neuronal death it may represent an early marker of the NFD and will also define therapeutically targets. In this context, the aim is now to transfer this knowledge in humans and to decipher the nature of Tau secreted in plasma and cerebrospinal fluids collected from healthy controls to AD patients, and to decipher if the presence of tau inside vesicles is influenced by the pathology.


title: Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia

acronym: LICIdystonie

summary: Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with LICI strength being dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures. the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of LICI efficiency.

design_allocation: Non-Randomized


title: Study of Speech Disorders , Voice and Swallowing in Primary Dystonia Oromandibular

acronym: DOM

summary: To better define the clinical characteristics of oromandibular dystonia, we aimed to study voice, speech and swallowing disorders in idiopathic oromandibular We planned to include consecutive patients followed in Lille Movement disorders department for idiopathic oromandibular dystonia and matched, healthy control subjects. Voice and speech disorders had to be assessed with the phonetic analysis, perceptive analysis and motor examination modules of the "Batterie d'Evaluation Clinique de la Dysarthrie" (Clinical Evaluation of Dysarthria), the Grade, Rough, Breathy, Asthenic, Strained scale, and a computer recording. Activities of daily living had to be assessed with the Oromandibular Dystonia Questionnaire, the Voice Handicap Index and the Deglutition Handicap Index.


acronym: EPITOX

summary:
The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months.

As secondary objectives, the study aims to

demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities.
evaluate tolerance of treatment by grip strength measurement and adverse event collection.

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré

title: A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis


title: Non-inferiority Between Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. ACARB-GDM Study.

acronym: ACARB-GDM

summary:
Caring for women with gestational diabetes mellitus (GDM) is very time-consuming. Therapeutic strategy includes dietary and lifestyle measures and additional insulin therapy for 15 to 40% of the women with GDM if the glycemic targets are not achieved after a period of 1 to 2 weeks of diet. Insulin therapy is imperfect for the following main reasons: need for education (i.e. subcutaneous administration, dose titration), hypoglycemia and weight gain, limited acceptance and high cost. Psychosocial deprivation is associated with more cases of GDM and health accessibility may be unequal.

Glucosidase inhibitors (acarbose) reduce intestinal absorption of starch and reduce the rate of complex carbohydrate digestion. It mainly lowers postprandial glucose values and is used in type 2 diabetes for a long time. Less than 2% of a dose is absorbed as active drug in adults, with 34% of the metabolites found in the systemic circulation. Doses of up to 9 and 32 times the human dose were not teratogenic in pregnant rats or rabbits. Limited but reassuring data during pregnancy are available. Acarbose was well tolerated (little gestational weight gain, no hypoglycemia) with digestive discomfort in some women, balanced by treatment satisfaction as compared with insulin injections. Our hypothesis is that treatment aiming to control postprandial glucose values with acarbose as compared with prandial insulin injection will be as efficient and safe, but more convenient and less expensive.

status: Active, not recruiting

ReferenceCitation: Rowan JA, Hague WM, Gao W, Battin MR, Moore MP; MiG Trial Investigators. Metformin versus insulin for the treatment of gestational diabetes. N Engl J Med. 2008 May 8;358(19):2003-15. doi: 10.1056/NEJMoa0707193. Erratum In: N Engl J Med. 2008 Jul 3;359(1):106.

ReferenceCitation: Langer O, Conway DL, Berkus MD, Xenakis EM, Gonzales O. A comparison of glyburide and insulin in women with gestational diabetes mellitus. N Engl J Med. 2000 Oct 19;343(16):1134-8. doi: 10.1056/NEJM200010193431601.

ReferenceCitation: Holt RI, Lambert KD. The use of oral hypoglycaemic agents in pregnancy. Diabet Med. 2014 Mar;31(3):282-91. doi: 10.1111/dme.12376.

ReferenceCitation: Zarate A, Ochoa R, Hernandez M, Basurto L. [Effectiveness of acarbose in the control of glucose tolerance worsening in pregnancy]. Ginecol Obstet Mex. 2000 Jan;68:42-5. Spanish.

ReferenceCitation: Platt J, O'Brien W. Title Acarbose therapy for gestational diabetes: a retrospective cohort study (abstract). Review AJOG 2003;189:S107

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: ACARB GDM

titre: Non infériorité du traitement par Acarbose versus insulinothérapie prandiale dans le diabète gestationnel: une étude randomisée multicentrique prospective.

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: COSSON

prenom_porteur: Emmanuel


title: Multimodal Oral Analgesia for Trauma in the Emergency Department: a Prospective Observational Study of a Nurse-directed Protocol

summary: The prevalence of pain in the emergency department is estimated between 60% and 78%. However, many studies reported oligo analgesia in about half of patient admitted to the emergency department. The delay before effective analgesia is one of the main causes of oligoanalgesia. The use of nurse-directed protocol allows the administration of analgesic upon admission to the emergency department. Nevertheless the need of intravenous access may delay analgesia. The use of oral form analgesics even with immediate release does not allow effective analgesia before 20 min. Pain management protocol in the emergency reception desk of CHU Grenoble Alpes (CHUGA) includes paracetamol that can be combined with oxycodone tablets depending on the pain intensity. For any mono traumatized it is possible to associate self-administer methoxyflurane inhaler. The pain management protocol is already used in the emergency reception desk of CHU Grenoble Alpes.The different analgesics( paracetamol,oral oxycodone, methoxyflurane) are already administered as part of routine care.The use of these different analgesics means would allow a rapid and adapted effectiveness to the pain intensity. However, there are no data on the efficacy and acceptability of such an early multimodal analgesia protocol in the emergency department.

ReferenceType: derived

ReferenceCitation: Viglino D, Termoz Masson N, Verdetti A, Champel F, Falcon C, Mouthon A, Mabiala Makele P, Collomb Muret R, Maindet Dominici C, Maignan M. Multimodal oral analgesia for non-severe trauma patients: evaluation of a triage-nurse directed protocol combining methoxyflurane, paracetamol and oxycodone. Intern Emerg Med. 2019 Oct;14(7):1139-1145. doi: 10.1007/s11739-019-02147-8. Epub 2019 Jul 9.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

sponsor_collaborators:
University Hospital, Grenoble
Mundipharma Pte Ltd.

location_facility: Emergency Department of University Hospital Grenoble


title: An Observational, Cross-sectional, Multicenter Study Evaluating the Correlation Between Quality of Life and Aerobic Physical Fitness of Patients With a Systemic Right Ventricle.

summary:
Congenital heart disease (CHD) is the most common congenital malformations. The right ventricle in the sub-aortic position, or "systemic right ventricle" is one of these complex cardiac diseases. Several studies show that adults with CHD and especially systemic right ventricle have reduced exercise capacity. In addition, studies have shown that there is a correlation between alteration of aerobic physical capacity and alteration of right ventricular systolic function.

Understanding and assessing the determinants of the physical capacity of patients with systemic right ventricles and evaluating their quality of life could allows us to improve their therapeutic management and also to expand patient indications to a program cardiac rehabilitation. This can benefit them on their exercise capacity, their tolerance to exercise and their quality of life.

The aim is to study the correlation between the quality of life and the aerobic physical fitness of patients with a systemic right ventricle and to determine the clinical and paraclinical parameters that have an impact on the aerobic physical fitness of these patients. The quality of life of patients with a systemic right ventricle will be compared to that of the general population.

ReferenceCitation: Gavotto A, Abassi H, Rola M, Serrand C, Picot MC, Iriart X, Thambo JB, Iserin L, Ladouceur M, Bredy C, Amedro P. Factors associated with exercise capacity in patients with a systemic right ventricle. Int J Cardiol. 2019 Oct 1;292:230-235. doi: 10.1016/j.ijcard.2019.06.030. Epub 2019 Jun 13.

lead_sponsor: University Hospital, Montpellier

location_facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital


title: Risk Factors for Further Bleeding in Patients Admitted to Intensive Care for Gastro Intestinal Bleeding

acronym: HDréa

summary:
Gastro intestinal (GI) bleeding is relatively frequent and may lead to intensive care unit admission. Although a restrictive strategy for red blood cell transfusion is supported by a large randomized controlled trial literature, less is known about the impact of transfusion strategy of other blood components and administration of anti fibrinolytic on clinical outcomes.

This study aims to identify parameters that may be associated with the risk of further bleeding in patients admitted to ICU for GI bleeding.


title: EBV-associated Diffuse Large B Cell Lymphoma NOS in Non Immunocompromised Patients : a French Retrospective Case Study

summary: The aim of this study is to characterize and compare clinical, pathological (histology, immunophenotype) and molecular features of EBV-related GZL and DLBCL: do they belong to the same entity or to two different subtypes of EBV-related lymphoma ?


title: Narcolepsy Protect Against Alzheimer's Disease? Protective Role of Low Rates of Orexin on the Occurrence of Intracerebral Amyloid Deposits Characteristic of the Alzheimer's Disease: A Pilot Study

acronym: PROTECMAN

summary: Links between orexin and amyloid processes have been underlined recently. During the Alzheimer's process an upregulation of the orexin mechanism has been observed. The pathophysiological mechanism of narcolepsy type 1 is linked to orexin deficiency. Thus, the investigators hypothesized that patients with narcolepsy may be protected from amyloid brain lesions, hallmarks of the Alzheimer's process. To test this hypothesis, the investigators analyzed the brain amyloid load measured by PET-scan amyloid brain imaging in patients with narcolepsy type 1 compared to controls without cognitive deficits.

ReferenceCitation: Bateman RJ, Munsell LY, Morris JC, Swarm R, Yarasheski KE, Holtzman DM. Human amyloid-beta synthesis and clearance rates as measured in cerebrospinal fluid in vivo. Nat Med. 2006 Jul;12(7):856-61. doi: 10.1038/nm1438. Epub 2006 Jun 25.

ReferenceCitation: Bateman RJ, Wen G, Morris JC, Holtzman DM. Fluctuations of CSF amyloid-beta levels: implications for a diagnostic and therapeutic biomarker. Neurology. 2007 Feb 27;68(9):666-9. doi: 10.1212/01.wnl.0000256043.50901.e3.

ReferenceCitation: Mawuenyega KG, Sigurdson W, Ovod V, Munsell L, Kasten T, Morris JC, Yarasheski KE, Bateman RJ. Decreased clearance of CNS beta-amyloid in Alzheimer's disease. Science. 2010 Dec 24;330(6012):1774. doi: 10.1126/science.1197623. Epub 2010 Dec 9.

ReferenceCitation: Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224.

ReferenceCitation: Mendelsohn AR, Larrick JW. Sleep facilitates clearance of metabolites from the brain: glymphatic function in aging and neurodegenerative diseases. Rejuvenation Res. 2013 Dec;16(6):518-23. doi: 10.1089/rej.2013.1530.

ReferenceCitation: Kang JE, Lim MM, Bateman RJ, Lee JJ, Smyth LP, Cirrito JR, Fujiki N, Nishino S, Holtzman DM. Amyloid-beta dynamics are regulated by orexin and the sleep-wake cycle. Science. 2009 Nov 13;326(5955):1005-7. doi: 10.1126/science.1180962. Epub 2009 Sep 24.

ReferenceCitation: Coogan AN, Schutova B, Husung S, Furczyk K, Baune BT, Kropp P, Hassler F, Thome J. The circadian system in Alzheimer's disease: disturbances, mechanisms, and opportunities. Biol Psychiatry. 2013 Sep 1;74(5):333-9. doi: 10.1016/j.biopsych.2012.11.021. Epub 2012 Dec 28.

ReferenceCitation: Wu YH, Zhou JN, Van Heerikhuize J, Jockers R, Swaab DF. Decreased MT1 melatonin receptor expression in the suprachiasmatic nucleus in aging and Alzheimer's disease. Neurobiol Aging. 2007 Aug;28(8):1239-47. doi: 10.1016/j.neurobiolaging.2006.06.002. Epub 2006 Jul 11.

ReferenceCitation: Mirmiran M, Swaab DF, Kok JH, Hofman MA, Witting W, Van Gool WA. Circadian rhythms and the suprachiasmatic nucleus in perinatal development, aging and Alzheimer's disease. Prog Brain Res. 1992;93:151-62; discussion 162-3. doi: 10.1016/s0079-6123(08)64570-7.

ReferenceCitation: Hoogendijk WJ, van Someren EJ, Mirmiran M, Hofman MA, Lucassen PJ, Zhou JN, Swaab DF. Circadian rhythm-related behavioral disturbances and structural hypothalamic changes in Alzheimer's disease. Int Psychogeriatr. 1996;8 Suppl 3:245-52; discussion 269-72. doi: 10.1017/s1041610297003426. No abstract available.

ReferenceCitation: Dauvilliers YA, Lehmann S, Jaussent I, Gabelle A. Hypocretin and brain beta-amyloid peptide interactions in cognitive disorders and narcolepsy. Front Aging Neurosci. 2014 Jun 11;6:119. doi: 10.3389/fnagi.2014.00119. eCollection 2014.

ReferenceCitation: Liguori C, Romigi A, Nuccetelli M, Zannino S, Sancesario G, Martorana A, Albanese M, Mercuri NB, Izzi F, Bernardini S, Nitti A, Sancesario GM, Sica F, Marciani MG, Placidi F. Orexinergic system dysregulation, sleep impairment, and cognitive decline in Alzheimer disease. JAMA Neurol. 2014 Dec;71(12):1498-505. doi: 10.1001/jamaneurol.2014.2510.

ReferenceCitation: Slats D, Claassen JA, Verbeek MM, Overeem S. Reciprocal interactions between sleep, circadian rhythms and Alzheimer's disease: focus on the role of hypocretin and melatonin. Ageing Res Rev. 2013 Jan;12(1):188-200. doi: 10.1016/j.arr.2012.04.003. Epub 2012 Apr 30.

ReferenceCitation: Yoshida Y, Fujiki N, Nakajima T, Ripley B, Matsumura H, Yoneda H, Mignot E, Nishino S. Fluctuation of extracellular hypocretin-1 (orexin A) levels in the rat in relation to the light-dark cycle and sleep-wake activities. Eur J Neurosci. 2001 Oct;14(7):1075-81. doi: 10.1046/j.0953-816x.2001.01725.x.

ReferenceCitation: Roh JH, Jiang H, Finn MB, Stewart FR, Mahan TE, Cirrito JR, Heda A, Snider BJ, Li M, Yanagisawa M, de Lecea L, Holtzman DM. Potential role of orexin and sleep modulation in the pathogenesis of Alzheimer's disease. J Exp Med. 2014 Dec 15;211(13):2487-96. doi: 10.1084/jem.20141788. Epub 2014 Nov 24. Erratum In: J Exp Med. 2015 Jan 12;212(1):121.

ReferenceCitation: Wennstrom M, Londos E, Minthon L, Nielsen HM. Altered CSF orexin and alpha-synuclein levels in dementia patients. J Alzheimers Dis. 2012;29(1):125-32. doi: 10.3233/JAD-2012-111655.

ReferenceCitation: Gabelle A, Jaussent I, Bouallegue FB, Lehmann S, Lopez R, Barateau L, Grasselli C, Pesenti C, de Verbizier D, Beziat S, Mariano-Goulart D, Carlander B, Dauvilliers Y; Alzheimer's Disease Neuroimaging Initiative; Multi-Domain Intervention Alzheimer's Prevention Trial study groups. Reduced brain amyloid burden in elderly patients with narcolepsy type 1. Ann Neurol. 2019 Jan;85(1):74-83. doi: 10.1002/ana.25373. Epub 2018 Dec 19.

oa_host_type: repository

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

repository_normalized: HAL

version: submittedVersion

repositories_concat: HAL

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

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_facility: Montpellier University Hospital, Gui de Chauliac


title: Resting Energy Expenditure Equations in Amyotrophic Lateral Sclerosis, Creation of a ALS-specific Equation

summary:
Introduction: Resting energy expenditure (REE) formulas for healthy people (HP) are used to calculate REE (cREE) in amyotrophic lateral sclerosis (ALS) patients. In ALS an increase of measured REE (mREE) in indirect calometry (IC) compared to cREE is found in 50-60%. The aims were (i) to assess accuracy of cREE assessed using eleven formulas as compared to mREE and (ii) to create if needed a specific cREE formula for ALS patients.

Method: ALS patients followed in the ALS expert center of Limoges between 1996 and 2014 and with a nutritional evaluation were included. mREE assessed with IC and cREE calculated with eleven predictive formulas (Harris Benedict (HB) 1919, HB 1984, WSchofield, De Lorenzo, Johnstone, Mifflin, WHO/FAO, Owen, Fleisch, Wang and Rosenbaum) were collected at time of diagnosis. Fat free mass (FFM) and fat mass (FM) were measured with impedancemetry. A Bland and Altman analysis was carried out. The percentage of accurate prediction ± 10%of mREE, and intraclass correlation coefficients (ICC) were calculated. Using a derivation sample, a new REE formula was created using multiple linear regression according to sex, age, FFM and FM. Accuracy of this formula was assessed in a validation sample.


title: Prognostic Value of Textural Indices Extracted From Pre-therapeutic 18-F FDG PET/CT in Head and Neck Squamous Cell Carcinoma.

acronym: ImpactTextureO

summary:
Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800,000 new cases and 320,000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concerned squamous cell carcinomas (SCC) 90% of the time.

Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade especially because of a high rate (up to 40%) of loco-regional recurrence. Moreover, two-third of local relapse and lymph node metastases occur in the first 2 years after treatment. Hence, predicting tumor response to therapy remains a real challenge in head and neck cancers.

Usual prognostic factors include the tumor size, the lymph node involvement, the presence of distant metastasis, the anatomic subsite, and the human papilloma virus (HPV 16, 18) infection status. However, pre-treatment selection of patients with poor prognosis or who require intensified therapy remains difficult despite their careful evaluation.

HNSCC also present a high biologic heterogeneity with hypoxic area, necrotic regions, zones of high cellular proliferation and intra-tumoral angiogenic heterogeneity. A better characterization of tumor heterogeneity could help classify patients in different risk subgroups in order to improve their therapeutic management.

Pre-therapeutic 18F-fluorodeoxyglucose positron-emission tomography (FDG PET/CT) is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer. Its prognostic significance has already been suggested and a selection of patients at risk of recurrence appears possible using different quantitative parameters. Indeed, static (SUV = Standardized Uptake Value), volumetric (MTV = Metabolic Tumor Volume, TLG = Total Lesion Glycolysis) and kinetic (RI = Retention Index) parameters were demonstrated to be independent prognostic factors in several studies.

Texture analysis is currently highly studied in order to characterize tumor heterogeneity, and consists in extracting texture indices from different imaging modalities such as FDG PET/CT. Calculating texture indices relies on choosing a contouring method to delineate a tumor volume of interest and selecting several parameters such as the resampling method, matrix definitions and indices formula. Several studies conducted on small series of patients with HNSCC have showed promising results to predict survival, analyzing various cancer anatomic subsites, tumor segmentation methods and texture indices.

The objective of this study is to assess the prognostic value of texture indices in a large cohort of patients with HSNCC, including any anatomic subtype and staging.


title: Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer: Preliminary Results Concerning the Length of the Acquisition

acronym: QUIP

summary:
Prostate cancer is the most common cancer in men over 50 years old and the third leading cause of cancer death. Because of the variety of prostate cancers, different treatments exist.

Several criteria guide this management in daily practice: PSA level; TNM stage (digital rectal examination, trans-rectal ultrasound and classical visual imaging) and pathological differentiation with the Gleason score, to which can be added other prognostic criteria: growth and doubling time of the serum PSA, number of positive biopsies and percentage of cancer lesions by biopsy.

Functional imaging by PET and MRI is increasingly used in daily clinical practice to characterize prostate cancer, either during initial discovery or during recurrence. In this context, it is the qualitative visual analysis that is mainly used. Quantitative image analysis could add new criteria to guide patient management.

Consequently, the objective of this study were:

Optimization of 18F-choline PET/CT Acquisition in Prostate Cancer
Comparison the quantitative parameters obtained by 18F-Choline PET / CT and both perfusion MRI and histological parameters.


title: Role of the Chemical Environment in the Pathogenesis of Inflammatory Bowel Disease

acronym: CHIMICI

summary:
Inflammatory Bowel Diseases (IBD) including Crohn's disease and ulcerative colitis are multifactorial diseases leading to chronic inflammation of intestinal mucosa. Their etiology is still unknown. Recently, major advances in the understanding of their pathophysiology have allowed to define them as heterogenic polygenic diseases, occurring in genetically susceptible patients. However, the whole genetic susceptibility does not explain the development of IBD and several data argue in favor of the involvement of environmental factors, which remain to be identified.

The aims of this clinical trial are:

As main objective: To determine the effects of environmental pollutants on intestinal homeostasis and particularly on inflammatory process and endoplasmic reticulum stress.
As secondary objective, to assess in human the genetic susceptibility of intestinal mucosa to environmental chemical compounds (I.e. xenobiotics), its interindividual variability, and its potential involvement in the pathogenesis of IBD.

status: Terminated

time_perspective: Cross-Sectional


title: Longitudinal Study of Patients Undergoing Cardiac Surgery or Implantation of a Percutaneous Valve Prosthesis

acronym: POMI-AF

summary: To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.


title: Interest of Oxygenated Hypothermic Perfusion in Preservation of Hepatic Grafts From Expanded Criteria Donors. A Prospective Monocentric Study.

acronym: PERPHO

summary: Interest of oxygenated hypothermic perfusion in preservation of hepatic grafts from expanded criteria donors.

ReferenceCitation: Rayar M, Beaurepaire JM, Bajeux E, Hamonic S, Renard T, Locher C, Desfourneaux V, Merdrignac A, Bergeat D, Lakehal M, Sulpice L, Houssel-Debry P, Jezequel C, Camus C, Bardou-Jacquet E, Meunier B. Hypothermic Oxygenated Perfusion Improves Extended Criteria Donor Liver Graft Function and Reduces Duration of Hospitalization Without Extra Cost: The PERPHO Study. Liver Transpl. 2021 Feb;27(3):349-362. doi: 10.1002/lt.25955.

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

publisher_dissemination: Wolters Kluwer Health


title: Evaluation of a Preoperative Pharmacological Protocol for Mydriasis in Femtosecond Laser-assisted Cataract Surgery

acronym: MYFLACS

summary: Laser-assisted cataract surgery is an innovative and growing procedure to improve the safety and results of modern cataract surgery. However, this technique faces to some obstacles: economics in the one hand due to the cost and time spent for the laser procedure before the conventional surgery, and technical in the other hand, especially due to some loss of pupil dilation during the surgery, which is highly important to ensure a perfect procedure. The present study aims at assessing a pharmacological protocol to maintain an accurate pupil dilation all along the surgery in order to improve the whole procedure.

lead_sponsor: CHU de Reims


title: Positive Communication Within Healthcare Team and Clinical Performance: a Prospective, Randomised and Controlled Simulation Trial.

acronym: ComPerf

summary: The emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The investigators hypothesize that positive communication during medical transmission can increase clinical performance for managing a subsequent stressful unexpected adverse event.

ReferenceCitation: Bertrand B, Evain JN, Piot J, Wolf R, Bertrand PM, Louys V, Terrisse H, Bosson JL, Albaladejo P, Picard J. Positive communication behaviour during handover and team-based clinical performance in critical situations: a simulation randomised controlled trial. Br J Anaesth. 2021 Apr;126(4):854-861. doi: 10.1016/j.bja.2020.12.011. Epub 2021 Jan 7.

oa_colors: green other

evidence: open (via free article)

license: publisher-specific-oa

license_normalized: publisher-specific

evidence: open (via crossref license, author manuscript)

repositories_concat: PubMed Central

publisher_dissemination: Elsevier

lead_sponsor: University Grenoble Alps


title: Influence of Oesophageal Contractile Reserve in High Resolution Manometry on Post Operative Dysphagia After Anti-reflux Surgery

summary: The main objective of this study is to evaluate, in a prospective cohort, the link between preoperative contractile reserve of oesophagus evaluated by high resolution manometry (HRM) and the occurrence of post operative dysphagia after anti-reflux surgery.

primary_purpose: Diagnostic

intervention_type: Procedure


title: Combined Therapy of Nivolumab and Adoptive T Cell Therapy in Metastatic Melanoma Patients: Pilot Study Phase I/II

acronym: Nivo-TIL

summary:
To improve the efficacy of immunotherapy for cancer, recent studies focused on specific targets to redirect the immune network toward eradicating a variety of tumors and ameliorating the self-destructive process.

A clinically relevant immune escape mechanism in melanoma is the activation of the Programmed cell Death-1 (PD-1) receptor on infiltrating T cells. By blocking PD-1 receptors with anti-PD-1 monoclonal antibodies (mAbs), T-cells are unaffected by the PD-L1 expressed on tumor cells and the patients T cells are free to respond to melanoma antigens and attack tumor cells. So the objective of this trial is to evaluate the safety and the efficacy of a combined therapy Nivolumab and adoptive T cell therapy in metastatic melanoma patients.

sponsor_collaborators:
Nantes University Hospital
Bristol-Myers Squibb


title: Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis

acronym: NET-SSC

summary:
Systemic sclerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve reactive oxygen species (ROS).

Neutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of neutrophil extracellular traps (NETs) in other auto-immune diseases such as systemic lupus erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called "NETosis". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE.

We hypothesis that this phenomenon could be dysregulated in SSC as in SLE and could play a prominent role in the induction of autoimmunity, as well as in the induction and perpetuation of organ damages.


title: Impact of Renin-Angiotensin System Inhibitors Continuation on Outcome After Major Surgery : a Multicenter, Prospective, Randomized and Controlled Trial

acronym: STOPORNOT

summary:
More than 200 million major surgical procedures are performed annually worldwide. Many of these patients have comorbidities including hypertension and/or heart failure. Chronic treatment of hypertension and/or heart failure very often includes a Renin-Angiotensin System (RAS) inhibitor (Angiotensin-Converting Enzyme Inhibitors (ACE-Is) or Angiotensin Receptor Blockers (ARBs). To stop or not to stop these medications before major surgery remain unknown. Data on management of RAS inhibitors before major surgery and anesthesia remain lacking and matter of debate. It is much likely that the strategy regarding management of RAS inhibitors in the peri-operative setting have important impact on peri-operative complications.

The lack of evidence leads to conflicting guidelines with respect to RAS inhibitors management before major surgery. While French guidelines are to stop RAS inhibitors patients with hypertension to avoid profound anesthestic-drugs-induced hypotension, international guidelines differ. The American heart association task force states that continuation of RAS inhibitors perioperatively is reasonable (class IIa recommendation,level of evidence: B). The purpose of this study is to determine the prognostic impact of withholding vs continuing ARBs before major non cardiac surgery.

ReferenceCitation: Legrand M, Payen D. Case scenario: Hemodynamic management of postoperative acute kidney injury. Anesthesiology. 2013 Jun;118(6):1446-54. doi: 10.1097/ALN.0b013e3182923e8a. No abstract available.

ReferenceCitation: Augoustides JG. Angiotensin blockade and general anesthesia: so little known, so far to go. J Cardiothorac Vasc Anesth. 2008 Apr;22(2):177-9. doi: 10.1053/j.jvca.2008.01.002. No abstract available.

ReferenceCitation: Mets B. To stop or not? Anesth Analg. 2015 Jun;120(6):1413-9. doi: 10.1213/ANE.0000000000000758. No abstract available.

ReferenceCitation: Mets B, Hennrikus E. Perioperative angiotensin axis blockade, to continue or discontinue, that is the question? Anesth Analg. 2014 Nov;119(5):1223-4. doi: 10.1213/ANE.0000000000000430. No abstract available.

ReferenceCitation: Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN; American College of Cardiology; American Heart Association. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014 Dec 9;64(22):e77-137. doi: 10.1016/j.jacc.2014.07.944. Epub 2014 Aug 1. No abstract available.

ReferenceCitation: Legrand M, Futier E, Leone M, Deniau B, Mebazaa A, Plaud B, Coriat P, Rossignol P, Vicaut E, Gayat E; STOP-OR-NOT study investigators. Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial). Trials. 2019 Mar 5;20(1):160. doi: 10.1186/s13063-019-3247-1.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: University of California - eScholarship University of California

repositories:
HAL
PubMed Central
escholarship.org

repositories_concat: HAL;PubMed Central;escholarship.org

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

unpaywall_oa_status: gold

lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronyme: STOPORNOT study

titre: Impact de la poursuite des inhibiteurs du système rénine angiotensine-aldostérone avant chirurgie majeure sur la morbi-mortalité péri-opératoire. Etude randomisée en simple aveugle

discipline_principale: anesthésiologie / réanimation

nom_porteur: GAYAT

prenom_porteur: Etienne


title: Hypobaric Lateral Spinal Anesthesia Versus General Anesthesia: Hemodynamic Stability and Short Term Cardiovascular Complications in Elderly Patients Undergoing Hip Fracture Surgery.

acronym: RACHYP

summary:
Hip fracture is a frequent pathology, involving elderly patients with many co-morbidities ; therefore, post-operative morbidity and mortality is high. It is reported that intra-operative hemodynamics correlate with post-operative complications such as myocardial injury after non-cardiac surgery (MINS) or acute kidney injury (AKI) ; that is why elderly patients undergoing hip fracture surgery should benefit from a better hemodynamic stability.

Low-dose hypobaric lateral spinal anesthesia with a reduced dose of local anesthetic has been shown to have better hemodynamic stability than conventional spinal anesthesia. It has also been reported that general anesthesia and conventional spinal anesthesia in elderly patients undergoing hip fracture surgery have the same hemodynamic effect. However, no published study has compared low-dose hypobaric lateral spinal anesthesia to general anesthesia with regards to hemodynamic effects.

The aim of the present study is to compare the intra-operative hemodynamics of low-dose hypobaric lateral spinal anesthesia with that of general anesthesia in elderly patients undergoing hip fracture surgery.

ReferenceCitation: Simonin M, Delsuc C, Meuret P, Caruso L, Deleat-Besson R, Lamblin A, Huriaux L, Abraham P, Bidon C, Giai J, Riche B, Rimmele T. Hypobaric Unilateral Spinal Anesthesia Versus General Anesthesia for Hip Fracture Surgery in the Elderly: A Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1262-1270. doi: 10.1213/ANE.0000000000006208. Epub 2022 Sep 22.

location_facility: Hôpital Edouard Herriot - Service d'Anesthésie-Réanimation


title: Usability and Satisfaction Evaluation of Sufentanil Sublingual Patient-Controlled Analgesia After Elective Surgery With Moderate-to-Severe Postoperative Pain

acronym: USE-SSPC

summary: Intravenous patient-controlled analgesia (iv-PCA) is the gold standard for the treatment of moderate to severe postoperative pain. It is used in more than 20% of cases after major surgery. Well known disadvantages of this method include the need of intravenous line (invasive, infection risk), the risk of pump programming error, possible delay for ambulation/barrier for enhanced rehabilitation programmes, and time/resource demanding (the need of preparation and installation). Sublingual sufentanil based PCA (Zalviso®) addresses cited issues. The safety and analgesia efficiency of this system is well described. However, the usability and satisfaction of Zalviso® varies depending on clinical settings. The goal of this study is to evaluate the usability and satisfaction of patients, nurses, and physical therapists using Zalviso® System during the first 72 hours in the settings of Enhanced Recovery After Surgery protocol after major interventions associated with moderate to severe postoperative pain.

ReferenceCitation: Amson H, Lasselin P, Naegels B, Pardey Bracho GF, Aubrun F, Dziadzko M. Usability evaluation of sufentanil sublingual tablet analgesia in patients following Enhanced Recovery After Surgery. J Comp Eff Res. 2021 Jun;10(9):743-750. doi: 10.2217/cer-2020-0239. Epub 2021 Apr 21.

publisher_dissemination: Becaris Publishing Limited

location_facility: Hôpital de la Croix Rousse - Service d'Anesthésie-Réanimation


title: Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient on Geriatrics Department.

acronym: OPTAH

summary: The main object is to identify and understand why some hospitalized aged patients oppose himself to treatment or diagnosis procedure. This mixed study will used a census in a geriatrics department and a qualitative research.

ReferenceCitation: Tannou T, Trimaille H, Mathieu-Nicot F, Koeberle S, Aubry R, Godard-Marceau A. Investigation of opposition to diagnostic or therapeutic procedures in older people hospitalized in acute geriatric services: the OPTAH pilot study protocol. Pilot Feasibility Stud. 2020 Dec 14;6(1):194. doi: 10.1186/s40814-020-00742-7.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Association Between Obstructive Sleep Apnea and Non-alcoholic Fatty Liver Disease Investigated by Liver Biopsy

acronym: NASHSAS

summary:
Obstructive sleep apnea (OSA) and nonalcoholic fatty liver disease (NAFLD) are frequently encountered in patients with metabolic syndrome (MS). Several data suggest that OSA per se could be a risk factor of liver injury. Most previous studies evaluating the association between OSA severity and the severity of NAFLD used indirect markers of NAFLD including liver imaging or liver injury blood markers or have been performed in morbidly obese patients undergoing intraoperative needle liver biopsy during bariatric surgery.

The current study propose to investigate with a full night polysomnography consecutive patients undergoing percutaneous liver biopsy for suspected NAFLD.

primary_purpose: Screening

lead_sponsor: University Hospital, Angers


title: Prospective Analysis of Incidence and Risk Factors of Infection of Midline Catheter

acronym: TIM-GHM

summary:
The Midline catheter is a peripherally-inserted catheter, with the distal tip being placed at or below the level of the axilla. It is a relevant alternative to other catheters in case of limited venous access and long-run perfusions. Moreover, another significant advantage may be the reduction of the risk of infection.

However, the Midline catheter is poorly described in scientific literature, essentially through retrospective and meta analyses including multiple types of catheters (Piccline, CVC, PAC). Therefore, the TIM-GHM study aims to prospectively assess the rate of infections in case of the Midline catheter.

The results of this study could bring a collective benefit in terms of knowledge and reliability of these intravascular devices.

Depending on these results, a randomized, controlled study will be considered, in order to compare the Midline catheter to its main alternative : the Piccline.

ReferenceCitation: Goetz AM, Miller J, Wagener MM, Muder RR. Complications related to intravenous midline catheter usage. A 2-year study. J Intraven Nurs. 1998 Mar-Apr;21(2):76-80.

ReferenceCitation: Chopra V, Ratz D, Kuhn L, Lopus T, Chenoweth C, Krein S. PICC-associated bloodstream infections: prevalence, patterns, and predictors. Am J Med. 2014 Apr;127(4):319-28. doi: 10.1016/j.amjmed.2014.01.001. Epub 2014 Jan 17.

ReferenceCitation: Timsit JF, Dubois Y, Minet C, Bonadona A, Lugosi M, Ara-Somohano C, Hamidfar-Roy R, Schwebel C. New materials and devices for preventing catheter-related infections. Ann Intensive Care. 2011 Aug 18;1:34. doi: 10.1186/2110-5820-1-34.

ReferenceCitation: Ugas MA, Cho H, Trilling GM, Tahir Z, Raja HF, Ramadan S, Jerjes W, Giannoudis PV. Central and peripheral venous lines-associated blood stream infections in the critically ill surgical patients. Ann Surg Innov Res. 2012 Sep 4;6(1):8. doi: 10.1186/1750-1164-6-8.

ReferenceCitation: Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. doi: 10.1007/s15010-014-0689-y. Epub 2014 Oct 21.

ReferenceCitation: Zochios V, Umar I, Simpson N, Jones N. Peripherally inserted central catheter (PICC)-related thrombosis in critically ill patients. J Vasc Access. 2014 Sep-Oct;15(5):329-37. doi: 10.5301/jva.5000239. Epub 2014 Apr 25.

ReferenceCitation: Mermel LA, Parenteau S, Tow SM. The risk of midline catheterization in hospitalized patients. A prospective study. Ann Intern Med. 1995 Dec 1;123(11):841-4. doi: 10.7326/0003-4819-123-11-199512010-00005.

ReferenceCitation: Pongruangporn M, Ajenjo MC, Russo AJ, McMullen KM, Robinson C, Williams RC, Warren DK. Patient- and device-specific risk factors for peripherally inserted central venous catheter-related bloodstream infections. Infect Control Hosp Epidemiol. 2013 Feb;34(2):184-9. doi: 10.1086/669083. Epub 2012 Dec 14.

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble

collaborators:
TIMC-IMAG
Vygon GmbH & Co. KG


title: Imaging Location of Hamstring Muscle Lesions in Sport and Relationships With Injury Mechanism.

acronym: HAMMER

summary: Hamstring muscle injuries are a common pathology in sports mainly present in sprint and acceleration sports, accounting for about 12% of all football injuries. Because of their frequency, risk of reinjury and financial cost, they can be considered as a public health problem. Improving knowledge of the pathophysiology of hamstring muscle injury appears to be a relevant research focus for prevention purposes.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Impact of the Inspiratory Cortical Control on the Outcome of the Ventilatory Weaning Test in Patients Intubated in Resuscitation

summary:
In case of respiratory distress, patients are intubated to be connected to an artificial respirator to ensure gas exchanges. Before any ventilatory weaning, a breathing test in spontaneous ventilation under artificial nose is practiced. The patient keeps the endotracheal tube but is no longer assisted by the ventilator. Mortality is markedly increased with the prolongation of the weaning period. Despite the presence of all weaning criteria and the success of a breathing test in spontaneous ventilation under artificial nose, failure of extubation occurs in 20% of patients.

Experimental application of an additional inspiratory load in awake healthy subjects causes a compensatory increase in respiratory work to maintain effective ventilation, and the subject does not develop hypoventilation. This respiratory drive to breathe has been demonstrated by quantified electroencephalography in inspiratory load tests in the form of pre-inspiratory negative deflections of low amplitude similar to the potential described during the preparation of the voluntary movement of a limb. These inspiratory pre-motor potentials begin about 2.5 seconds before the start of a movement in the additional motor area.

Does the simple and noninvasive analysis of inspiratory cortical control during the spontaneous ventilation breath test under artificial nose predict the outcome of this test as well as weaning at 7 days?

lead_sponsor: Poitiers University Hospital


title: A Multi-center Randomized in Double-blinded Phase III Study Comparing Standard Care Therapy Alone Versus Corticosteroids and Low-dose Methotrexate (MTX) for the First-line Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

acronym: MTX-aGVHD

summary:
Phase III randomized double-blinded trial designed to compare the efficacy of the addition of MTX to current standard acute GVHD first-line treatment with corticosteroids. The protocol will use a novel endpoint for benchmarking interventions based on a composite primary endpoint of GVHD-free and corticosteroids-free survival.

The primary endpoint of the trial will be the assessment of a composite endpoint of graft-versus-host disease-free and corticosteroids-free survival at 12 months after randomization

location_facility: Saint Antoine Hospital - Hematology Department


title: In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions

acronym: ALCOBRAIN

summary: This study aims to validate that PLGF is a biomarker of cerebral lesions and therefore of secondary developmental disorders and disabilities that will be best diagnosed at 2 and 6 years of age.

lead_sponsor: University Hospital, Rouen


title: Study of the Combined Influence of Sepsis and Mechanical Ventilation on the Human Diaphragm

acronym: SEPTIC

summary: The aim of this study is to study the combined impact of mechanical ventilation and sepsis on the human diaphragm in order to establish the neutral, protective or destructive character of mechanical ventilation by studying the diameter of the fibers, activation of proteolytic systems, inhibition of protein synthesis, tissue inflammation as well as contractile function.


title: Study of Hemodynamic Conditions Measured During Hepatectomy

acronym: DEBIFOIE

summary:
Hepatocellular insufficiency is a dreaded complication after hepatectomy, since, if it is persistent, it leads to the death of the patient in the absence of liver transplantation.

The preoperative evaluation aims in particular to estimate the risk of postoperative hepatocellular insufficiency so as to minimize or contraindicate high-risk patients.

It has been shown that the flow of the portal vein is correlated with liver function, especially in the living donor and after portal embolization. More recently, the study of flow rates in the portal vein and the hepatic artery after transplantation has shown a correlation with the recovery of graft function.

The hypothesis is that portal and arterial flow after hepatectomy can predict postoperative hepatocellular function.

lead_sponsor: University Hospital, Tours

location_facility: Service de Chirurgie Digestive, Oncologique, Endocrinienne et Transplantation Hépatique, CHRU de TOURS


title: Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome

acronym: ProCoCo

summary:
Unresolved ARDS is defined by the persistence of ARDS criteria at the end of the first week of evolution despite an appropriate treatment of the cause of ARDS. A persistent ARDS is associated with an increased mortality and prolonged lengths of mechanical ventilation, ICU stay and hospitalization. Persistent ARDS is characterized by ongoing inflammation, parenchymal-cell proliferation, and fibroproliferation leading to disordered deposition of collagen. All of these pathways may be responsive to corticosteroid therapy.

Only two randomized controlled double-blinded trials assessed the use of corticosteroids for persistent ARDS. In 24 patients, Meduri et al. reported an improvement of lung function and survival (1). In 180 patients, Steinberg et al showed no effect of corticosteroids on survival (2). A lower risk of death was observed when corticosteroids were started before 14 days after the onset of ARDS (2).

Alveolar procollagen III is validated as a biomarker of active fibroproliferation. Alveolar procollagen III > 9 µg/L is associated to fibroproliferation (3).

As mortality was lower in patients who received corticosteroids while presenting a high alveolar level of procollagen III on inclusion, Steinberg et al. showed that patients presenting with a low level of procollagen III and treated with corticosteroids had an increased risk of death (2).

Investigatores hypothesize that the use of procollagen III could improve personalized decision-making regarding steroid treatment in patients presenting with persistent ARDS. The future of anti-fibrotic treatment, including corticosteroids, in persistent ARDS might propose to individualize the therapy according to the presence of an active fibroproliferative phase (precision or personalized medicine).

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

region: Provence-Alpes-Côte d'Azur

nom_etablissement: APHM DIRECTION GENERALE

acronyme: ProCoCo

titre: Corticothérapie guidée par le dosage du procollagène 3 au cours des syndromes de détresse respiratoire aiguë persistants

nom_porteur: FOREL

prenom_porteur: Jean Marie


title: Movement Error-processes and Sensorimotor Adaptation in Parkinsonian Patient

acronym: Kinarm

summary: The aim of the present project is to document the relationship between the behavioral deficits and the electrophysiological anomalies observed in PD patients in tasks involving motor adaptation to visual or mechanical perturbations.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Service de Neurologie, Hôpital de la Timone, Assistance Publique Hôpitaux de Marseille


title: Analysis of Changes in Medication Prescriptions After Hospitalization for 4 Disciplines: Gerontology, Diabetology, Cardiology and Rheumatology: Medical, Pharmaceutical and Economic Aspects

acronym: PHMEV

summary: The modifications of the medicinal treatments secondary to the hospitalizations have multiple reasons: reassessment of the previous treatment (conciliation), new therapeutic necessities, potential risk of iatrogeny or of drug interaction, restrictions of the therapeutic booklet, classification in reserve or hospital prescription ... These modifications are potentially generating extra costs for the Health Insurance and are monitored under the terms of the Contract of Good Use. The aims of this analysis are to define the medical-pharmaceutical rationale of the treatment changes imposed by hospitalization in a university-hospital center, their influence on the security of the medical treatment of patients and their financial implications for healthcare organizations


title: Attributional Style Assessment in Patients With Parkinson's Disease Treated With Deep Brain Stimulation

acronym: ParkAIHQ

summary: Parkinson's disease (PD) is a common neurodegenerative disorder affecting 1-2% of the population over 65 years-old. In addition to the motor impairment characterized by resting tremor, bradykinesia, rigidity and postural instability, patients suffer with non-motor symptoms such as dysautonomia syndrome, sleep disturbances, depressive disorders, delusional disorders and cognitive disorders. Research and management of these non-motor symptoms is essential because these can be disabling and have a negative impact on the quality of life of patients. Among cognitive functions, social cognition is defined as the aspect that is dedicated to process social information for adaptive functioning. More specifically, it refers to an intricate set of higher-order neuropsychological domains that allow for adaptive behaviors in response to others. Four dimensions are usually included in this construct: theory of mind (ToM), emotion processing, social perception and social knowledge, and attributional style. Recently, different categories of social cognition have been studied in patients suffering from PD, such as the ToM or the recognition of facial emotions. Other aspects of social cognition that seem relevant in this population are still poorly studied; the attributional style is a cognitive bias defined as "the way we explain the causes of the positive or negative events that occur". Indeed, different causes can be attributed to an event, and this attribution is shared between oneself, others and other factors related to the situation. People with attribution bias may mistakenly attribute to one cause all the situations. For example, when an individual blame the others for an event, he may develop a feeling of hostility that may lead to maladaptive behavior such as aggression and thus affect his social functioning. The impact of PD treatments, particularly deep brain stimulation (DBS), on the ToM has been studied, showing a deficit after stimulation. No study has assessed the impact of therapeutics on the attributional style of PD patients. In this context, it seems relevant to evaluate the effect of deep brain stimulation on the attributional style in this population.


title: (18F)-Fluoroethyl-L-tyrosine Positron Emission Tomography and Multiparametric MRI for the Delination of Target Volumes in High-grade Glioma Patients Undergoing Radiotherapy

acronym: IMAGG

summary:
Glioblastoma is the most common malignant brain tumor in adults. The primary treatment consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be predominantly within or at the margin of the irradiated volume, but distant failure are not rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based on on planning CT with co-registered postoperative MRI, with the addition of a clinical target volume margin of 2-3 cm to account for infiltrative odema.

To better characterize the disease, more specific physiological and/or metabolical markers of tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion, diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine ([18F]-FET) are now available and suggest that aggressive areas, like uptake of PET tracer and vascularity are present outside areas of contrast enhancement usually irradiated. These informations could be incorporated to optimize the treatment of radiotherapy.

ReferenceCitation: Dissaux B, Mazouz Fatmi D, Ognard J, Allard B, Keromnes N, Latreche A, Lepeuve A, Schick U, Bourbonne V, Ben Salem D, Dissaux G, Querellou S. Radiotherapy Target Volume Definition in Newly Diagnosed High-Grade Glioma Using 18F-FET PET Imaging and Multiparametric MRI: An Inter Observer Agreement Study. Tomography. 2022 Aug 16;8(4):2030-2041. doi: 10.3390/tomography8040170.


title: Effect of Monoclonal Anti-cd303 on the Inhibition of Type I Interferon Secretion in the Peripheral Blood of Patients With Autoimmune Diseases

summary:
The pathogenic role of type I interferons (IFNs) in the development of different autoimmune diseases has been extensively described in the literature. Since plasmacytoid dendritic cells (pDCs) are the main source of type I IFNs, there is evidence of the involvement of pDCs in autoimmune diseases. The CD303 surface protein (also called BDCA-2) is specifically expressed by the pDCs.

The hypothesis leading to the realization of this study is to observe, in vitro, an inhibition of the secretion of the type I IFNs by pDCs in the peripheral blood in patients with autoimmune disease, thanks to the action of the anti-CD303 antibody Developed by the LFB Group, which could reduce the inflammatory response and improve patients with autoimmune disease

lead_sponsor: University Hospital, Lille

collaborators: Laboratoire français de Fractionnement et de Biotechnologies

intervention_type: Biological


title: Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies (Increasing the Infliximab Dose or Introduction of Immunosuppressive Therapy) in Patients Chronic Inflammatory Bowel Diseases in Loss of Response to Infliximab

acronym: STAMP

summary: This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.


title: Effects of Capnometry Monitoring in Post Anesthesia Care Unit

acronym: CAPNOSSPI

summary: There is few information about the best capnometry value in recovery room for intubated awakening patients. Furthermore, capnometry values could influence ventilation applied by nurses on these patients. The aim of this study is to observe the effects of capnometry monitoring on intubated awakening patients in recovery room.

ReferenceCitation: Potvin J, Etchebarne I, Soubiron L, Biais M, Roullet S, Nouette-Gaulain K. Effects of capnometry monitoring during recovery in the post-anaesthesia care unit: a randomized controlled trial in adults (CAPNOSSPI). J Clin Monit Comput. 2022 Apr;36(2):379-385. doi: 10.1007/s10877-021-00661-9. Epub 2021 Feb 7.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre hospitalier Universitaire de Bordeaux


title: Multicentric Data Collection: Virologic Effectiveness at W48 of the Dual Therapy Etravirine (400 mg) + Raltegravir (800 mg) by Once Daily in HIV-positive Patients, Previously Handled by a Dual Etravirine (200 mg x 2/Day) + Raltegravir (400 mg x 2/Day) Taken Twice a Day

acronym: ETRALQD

summary:
Efficacy of etravirin + raltegravir dual therapy was showed in the ANRS 153 ETRAL protocol, in HIV-1 seropositive patients. The use of these two drugs avoids the use of nucleoside reverse transcriptase inhibitors and protease inhibitors, with a real benefit in older patients, who increasingly present contraindications to these drugs' families. The disadvantage of this strategy is twice daily (BID). Pharmacological data suggest that etravirine once a day and raltegravir once a day may provide the same virological efficacy.

The objective of our study is to evaluate the ability of ETRAL QD (etravirine 400 mg x1/day + raltegravir 800 mg x1/day) to maintain virologic success at week 48 (W48), after switch, in HIV-patients under ETRAL BID (etravirine 200 mg x2/day + raltegravir 400 mg x2/day). Virological success is defined as absence of virological failure, and virological failure is defined as two consecutive plasma viral loads >50 cp/ml over 2-4 weeks, or one plasma viral load >400 cp/ml.

This study will be a multicentric data collection. Data will be collected at W0 (patient characteristics, plasma viral load) and then at W4, W12, W24 and W48 (plasma viral load). If stopping strategy, the reason for stopping will be documented. 125 patients will be included in the six participating centers. Data will be centralized at Pitié-Salpêtrière hospital, Paris, with an anonymized e-CRF.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida


title: Etude de Cohorte Des Patients Suivis en Allergologie au CHU de Grenoble : hypersensibilité Allergique et hypersensibilité Non Allergique

acronym: BdDAllergo

summary:
The creation of a database containing the medical data of patients followed in allergology at the University Hospital of Grenoble will permit to study allergic versus non-allergic hypersensitivity drug reaction as well as the risk of cross-reactions between medicinal drugs belonging to the same pharmacological class.

The main objectives of the study are to estimate and to compare the proportion of allergic hypersensitivity drug reaction and the proportion of non allergic hypersensitivity drug reaction, and to characterize these two types of hypersensitivity drug reaction on clinical, biological and chronological aspects.

In a second time, ancillary study will be conducted in order to :

identify drugs that potentially induced histamine-liberation in patients diagnosed with non allergic hypersensitivity drug reaction
investigate the risk of cross-reactions between drugs belonging to the same pharmacotherapeutic class in patients diagnosed with allergic hypersensitivity drug reaction.

ReferenceType: result

ReferenceCitation: Cousin F, Catelain A, Philips K, Favier B, Queuille E, Nicolas JF. [Immediate hypersensitivity is rarely implicated in drug induced urticaria]. Ann Dermatol Venereol. 2003 Mar;130(3):321-4. French.

ReferenceCitation: Ponvert C, Scheinmann P. [Allergic and pseudo-allergic reactions to betalactam antibiotics]. Arch Pediatr. 2003 Jul;10(7):658-65. doi: 10.1016/s0929-693x(03)00272-0. No abstract available. French.

ReferenceCitation: Nosbaum A, Pralong P, Rozieres A, Dargaud Y, Nicolas JF, Berard F. [Delayed-type hypersensitivity to heparin: diagnosis and therapeutic management]. Ann Dermatol Venereol. 2012 May;139(5):363-8. doi: 10.1016/j.annder.2012.01.017. Epub 2012 Mar 9. French.

lead_sponsor: University Hospital, Grenoble


title: Wearable Biosensor to Track and Quantify Limb Dysfunction in Multiple Sclerosis Patients

acronym: MYO

summary:
Multiple sclerosis (MS) is a leading cause of neurological injury in young adults. Capturing the extent of multiple domains of MS-related disability is critical for effective clinical care and the development of new paradigms for patient-focused therapeutic approaches. To date outcomes research in MS has centered on clinical exams, which may be insensitive over the short term (the 1-2 years of early stage clinical trials) and only capture a single snapshot of the patient's performance.

With the mass production of sensors in the gaming and computer control industry, there is an opportunity to transform the traditional neurological exam with biosensors already in use outside the realm of health applications. The investigators herein propose to use a commercialized wearable electroMYOgraphy sensor (MYO,Thalamic Labs Inc, Kitchener, ON, Canada) for detection of upper and lower limb dysfunction in MS patients. The investigators will determine if the device can differentiate the diseased states, refine signal processing algorithms to create reliable outcomes using this device in MS patients, and determine if these outcomes are strongly associated with patients and physicians reported ambulatory and dexterity metrics. The investigators hypothesize that this digital technology may be introduced in the standard neurological exam technique in a non-disruptive manner and more accurately and potentially remotely detect both physician-reported and patient-reported disability.

In the scope of this study, the investigators will also develop signal processing methodology to comprehensively track ambulation features.

lead_sponsor: Nantes University Hospital


title: Physiopathology of Lower Cortical Activation in COPD Patients: Contribution of Cortical Neuromodulation

summary: Patients with COPD have lower cortical activation and higher cortical inhibitory levels. The purpose of this study is to test the reversibility the lower cortical activation by counterbalancing the increased cortical inhibitory levels with neuro-modulation.

lead_sponsor: 5 Santé


title: A Study to Evaluate the Performance and Safety of CBL-102 Versus Vismed® Multi Eye Drops in the Management of Dry Eye

acronym: RESTA

summary: This is a multicenter, randomized, parallel group, investigator-masked, non-inferiority study. Approximately 84 subjects will be randomized in a 1:1 ratio.The primary objectives of this investigation are to show that the performance of CBL-102 Eye Drops is non-inferior to that of Vismed® Multi eye drops in subjects with moderate to severe keratoconjunctivitis sicca after 28 days, and to assess the safety of CBL-102 Eye Drops during a 90-day period with treatment administered 3 to 6 times per day. The primary performance endpoint for this study is the mean change from baseline (CFB) in the study eye at Visit 4 (Day 28 ± 3 days) in ocular surface fluorescein staining score.

lead_sponsor: Laboratoire Chauvin


title: Driving Pressure in Trauma. Morbi-mortality and Pulmonary Mechanics in Relation to Transpulmonary Driving Pressures in Patients With Chest Trauma. A Prospective Observational Study

summary: Traumatic chest injuries are responsible for significant morbidity and the cause of trauma-related death in 20%-25% of cases. Thoracic trauma can include multiple injuries, mainly osseous (ribs, sternal fractures, flail chest), pulmonary contusions or lacerations, pneumothoraces and pleural effusions, and sometimes involve wounds to the heart and vessels (aortic dissection, cardiac contusion) or diaphragm. Following trauma, patients with thoracic injuries are at risk of developing acute respiratory distress syndrome (ARDS). This worsening of respiratory function can lead to requirement for mechanical ventilation. In addition, changes to gas exchange may also be generated or aggravated by mechanical ventilation as a result of barotrauma, biotrauma, or ventilation-associated pneumonia. Many mechanical ventilation strategies have been tried in trauma patients in the last 30 years to determine the optimal method of maximizing gas exchange with minimal lung damage. The driving pressure of the respiratory system has been shown to strongly correlate with mortality in a recent large retrospective ARDSnet study. Respiratory system driving pressure [plateau pressure-positive end-expiratory pressure (PEEP)] does not account for variable chest wall compliance especially in cases of chest trauma. Esophageal manometry can be utilized to determine transpulmonary driving pressure. A recent study suggests that utilizing PEEP titration to target positive transpulmonary pressure via esophageal manometry causes both improved elastance and driving pressures. Treatment strategies leading to decreased respiratory system and transpulmonary driving pressure at 24 h may be associated with improved 28 day mortality. However, currently no specific study with chest trauma patients exists. We propose to investigate the effect of hight transpulmonary driving pressure on duration on mechanical ventilation, length of stay and mortality in patients with sever chest trauma.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Study of Metabolites Markers in Adjuvant Breast Cancer

acronym: EMMEEA

summary:
The breast cancer is composed of multiple biological entities. Recent progress in molecular biology, DNA or RNA chip, permitted the global tumour genome or transcriptome study. Those technics, leads to an increased in the molecular biology knowledge and a better oncogenesis understanding. Breast cancer taxonomy was established following the tumor genetic profile. Moreover this classification is incomplete and didn't include the metabolic pathways other than hormonal or HER2 pathways.

The metabolomics is an expanding field of research exploring the metabolites in cells, tissues or biologics fluids. It allows assessing the variation activation of the different cellular metabolic pathways. In oncology, it could highlight the main metabolic disturbances, the interaction of tumor cells and to identify the metabolic pathways involved in oncogenesis using the tumor cells metabolites profiles.

Compared to genomic, the metabolomics integrated the impact of the cells environments on the cells biology. The cells environment plays, in fact, a key role in the oncogenesis and in the tumor cells phenotypes. The metabolomics, thus being a complementary approach of the genomic in order to assess a better knowledge of the impact of the extracellular environment on the tumor cell phenotype. In addition, the metabolomics analyses are fast and not expensive compatible with routine practice.

The main objective of this study is to highlight a metabolic alteration specific to certain tumors phenotypes in order to have better understanding of the biology of the numerous breast cancer entities and find some biomarkers which could be some possible therapeutic target. Using a high resolution mass spectrometer, the investigators will analyze 52 tumor samples from frozen breast surgical specimen preserved in the Centre Antoine lacassagne tumor bank. The tissue analysis could be associated with a serum sample analysis from the frozen serum bank of the Centre Antoine Lacassagne. With 30 patients who performed a 18 FDG-PET before the surgery, The investigators will analyzed the correlation between the tumoral activation of the glycolysis pathways, quantified with mass spectroscopy and the 18FDG uptake. Using the 17 frozen serums available, the investigators will perform a screening to identify some metabolites or metabolites profile which could be detected in the serum in order to develop a new liquid biopsy approach. This study is a retrospective study based on data and sample already available in the center and collected during the routine practice.

lead_sponsor: Centre Antoine Lacassagne


title: Comparison of the Minimally Invasive Surgery Versus Open Reduction in the Surgery of the Pilon Fractures

acronym: MICOPIL

summary:
The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation.

The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.

lead_sponsor: University Hospital, Clermont-Ferrand


acronym: PERFE-CT

summary:
This feasibility study has therefore several aims:

construct a dedicated CT perfusion protocol for GIT wall perfusion;
used a two-compartment pharmacokinetic model which is more adapted that a unique compartment model;
from the image acquired, evaluate current parameters of perfusion including the permeability ones

intervention_type: Radiation


title: Association Between Automatic Psychological Processes, Self-regulatory Capacities and Physical Activity and Sedentary Behaviors Adoption, Change and Maintenance Among Persons With Chronic Diseases

summary: The principal aim of these researches is to explored the role of motivational parameters, including: automatic and controlled psychological processes and self-regulatory capacities, in physical activity and sedentary behaviors adoption and maintenance. Precisely investigators are interested in change in motivational and self-regulatory processes during rehabilitation programs and their prospective influences on self-reported and objective behaviors among persons with chronic diseases.


title: Oral Health Knowledge and Practice Among 15-17 Year Old Adolescents.

acronym: Oral health

summary:
The aim of this study is to identify the knowledge and behavior on dental health and hygiene among adolescents. In most cases, the investigators know tooth decay can be prevented and reversed at an early stage by observing good oral hygiene. Few studies have been done among adolescents.

This study could justify the implementation of public health actions in terms of prevention.