title: Validation of a Standardized Tool for Evaluation Function of Patients With Temporomandibular Disturbances (DTM) by Physiotherapists

acronym: DTM-SCORE

summary:
Temporo-Mandibular Disorders (TMD) are the reason for consultation on more common in maxillofacial. However, there is no consensus on their care. For a long time, Rehabilitative management of the TMD was content to treat only the symptoms.

No validated score does not allow to evaluate globally the malfunctions at the origin of the TDM, as well as the symptoms and functional discomfort that result. The creation of such a tool would standardize the physical examination of the physiotherapist.

This is a functional evaluation scale including 2 subparts: an examination of functional etiologies and an assessment of symptoms. At the same time, a self-questionnaire was created to gather the patient's feelings and evaluate the impact of the TMD on his life daily.

The outcome of this research would be to create a score to track the patient's progress during the reeducation, trying to rate the different factors according to their number and severity. This tool would then make it possible to objectify the impact of rehabilitation treatment on the factors etiological and verify the effectiveness of rehabilitation protocols.


type: Other Identifier

title: Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis: a Randomised Placebo-controlled Trial

summary:
Chronic Rhinosinusitis (CRS) is a chronic condition with limited therapeutic options. Moreover, the pathophysiology is poorly understood. The aim of this study is to evaluate the efficacy of osteopathic manipulative treatment (OMT) in the course of this condition by applying several techniques supposed to be related to the autonomic nervous system. Our hypothesis is that these techniques could have beneficial effects on inflammation and head symptoms in CRS.

Methods:

A sample of 90 patients diagnosed by ENT specialist will be randomly assigned to the OMT group or the placebo group. The placebo procedure will consist in using light touch around the nose, on the throat and on the thorax. Treatment and placebo protocols are composed of two visits at day 0 and day 30.

A general practitioner will determine the eligibility for the study.

The outcomes include Peak Nasal Inspiratory Flow (PNIF) measured five times: at day 0, 30 (twice each, before and after treatment) and 180 (once). The two groups will be compared regarding short and long term evolution.

The evolution of symptoms will be assessed by the Sino-nasal Outcome Test (SNOT-22) seven times: at day 0, 30, 60, 90, 120, 150 and 180. This outcome will be analyzed using mixed effect modelling

A Qualitative study will be conducted in the two groups to understand the patients' experiences during care.

This protocol has been approved by a french ethic committee (Comité de Protection des Personnes Sud Ouest et Outre-Mer II, 2020.04.09).

study_start_date_type: Anticipated

status: Withdrawn

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Institut des Hautes Etudes Osteopathiques de Nantes

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Unknown


title: Role of the Clinical Pharmacist in an Oncology Ambulatory Center to Prevent Drug Related Problems Before Antitumor Treatment Initiation

acronym: CHOPIN

summary:
The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.

The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases. The primary endpoint is the prevalence of pharmacist interventions among patients who are going to receive an oral targeted therapy or cancer chemotherapy or immunotherapy

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Thomas-Schoemann A, Blanchet B, Bardin C, Noe G, Boudou-Rouquette P, Vidal M, Goldwasser F. Drug interactions with solid tumour-targeted therapies. Crit Rev Oncol Hematol. 2014 Jan;89(1):179-96. doi: 10.1016/j.critrevonc.2013.08.007. Epub 2013 Aug 28.

ReferenceCitation: P. Boudou Rouquette, A. Thomas-Schoemann, A. Chahwakilian et al., Clinical benefit of a one-day multidisciplinary work-up for risk assessment in unfit cancer patients. ESMO congress, abstract 1558; Amsterdam 2013

ReferenceCitation: Bonnet C, Boudou-Rouquette P, Azoulay-Rutman E, Huillard O, Golmard JL, Carton E, Noe G, Vidal M, Orvoen G, Chah Wakilian A, Villeminey C, Blanchet B, Alexandre J, Goldwasser F, Thomas-Schoemann A. Potential drug-drug interactions with abiraterone in metastatic castration-resistant prostate cancer patients: a prevalence study in France. Cancer Chemother Pharmacol. 2017 May;79(5):1051-1055. doi: 10.1007/s00280-017-3291-z. Epub 2017 Mar 30.

ReferenceCitation: Lees J, Chan A. Polypharmacy in elderly patients with cancer: clinical implications and management. Lancet Oncol. 2011 Dec;12(13):1249-57. doi: 10.1016/S1470-2045(11)70040-7. Epub 2011 Jul 6.

ReferenceCitation: Riechelmann RP, Tannock IF, Wang L, Saad ED, Taback NA, Krzyzanowska MK. Potential drug interactions and duplicate prescriptions among cancer patients. J Natl Cancer Inst. 2007 Apr 18;99(8):592-600. doi: 10.1093/jnci/djk130.

ReferenceCitation: Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):56-66. doi: 10.3322/caac.20004.

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: APHP -Cochin Hospital and Georges Pompidou European Hospital

lead_sponsor_type: academique

status_simplified: Completed


title: Clinical Study of In Vivo Damage Induced bu UV in the Epidermis of the Scalp

summary:
Squamous cell carcinomas (SCC) are the second most common skin cancer in humans. The incidence of SCCs in the USA in 2012 was estimated at 700,000 casesSCCs have a metastatic course in 3% to 5% of cases that is of poor prognosis. In men, the SCCs of the scalp represent the most frequent location of the head and neck, the 3rd location of the whole body. The SCCs of the scalp are more undifferentiated than in other locations. In addition, actinic keratoses of scalp, precursors of SCC, are more resistant to treatment than in other areas. These particularities of the SCCs of the scalp suggest the existence of specific factors at the epidermis level of the scalp.

UV-induced damage to DNA is the defining event in skin photocarcinogenesis. It has already been shown that DNA damage induced by UV and the kinetics of repair of this damage may vary with age or phototype of patients, but the topographic variation of DNA damage has never been studied, although it is known that gene expression in skin cells may differ from one region of the body to another.

the hypothesis is therefore that the particular characteristics of KAs and SCCs at the scal level could be explained by an increased sensitivity to UV-induced damage. It is planned to study UV-induced damage and its repair at the scalp level in humans compared to the forearm.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Colorectal Cancer Immunomodulation Combined to Radiofrequency ablatIon

acronym: ColIBRI

summary:
The primary objective of the study aims to compare soluble CD154 (CD40L) levels before and after radiofrequency ablation (RFA) in patients with colorectal cancer (CRC) liver metastases.

The secondary objectives aims:

to compare soluble CD154 (sCD40-L) levels before and after treatment by RFA or surgery alone in patients with CRC liver metastases;
to study the feasibility and reliability of soluble CD154 (sCD40-L) levels to detect and quantify the induction of immun response in CRC liver metastases patients after RFA;
to study the impact of surgery on plasma soluble CD154 levels;
to study association between CD154 expression level before and after RFA in CRC liver metastases patients and relapses rate at 1 year.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Lemdani K, Mignet N, Boudy V, Seguin J, Oujagir E, Bawa O, Peschaud F, Emile JF, Capron C, Malafosse R. Local immunomodulation combined to radiofrequency ablation results in a complete cure of local and distant colorectal carcinoma. Oncoimmunology. 2019 Jan 10;8(3):1550342. doi: 10.1080/2162402X.2018.1550342. eCollection 2019.

ReferenceCitation: Meier S, Stark R, Frentsch M, Thiel A. The influence of different stimulation conditions on the assessment of antigen-induced CD154 expression on CD4+ T cells. Cytometry A. 2008 Nov;73(11):1035-42. doi: 10.1002/cyto.a.20640.

ReferenceCitation: Dymicka-Piekarska V, Korniluk A, Gryko M, Siergiejko E, Kemona H. Potential role of soluble CD40 ligand as inflammatory biomarker in colorectal cancer patients. Int J Biol Markers. 2014 Sep 30;29(3):e261-7. doi: 10.5301/jbm.5000083.

ReferenceCitation: Tada N, Tsuno NH, Kawai K, Murono K, Nirei T, Ishihara S, Sunami E, Kitayama J, Watanabe T. Changes in the plasma levels of cytokines/chemokines for predicting the response to chemoradiation therapy in rectal cancer patients. Oncol Rep. 2014 Jan;31(1):463-71. doi: 10.3892/or.2013.2857. Epub 2013 Nov 19.

ReferenceCitation: Zhao P, Fang WJ, Chai L, Ruan J, Zheng Y, Jiang WQ, Lin S, Zhou SH, Zhang ZL. The prognostic value of plasma soluble CD40 ligand levels in patients with nasopharyngeal carcinoma. Clin Chim Acta. 2015 Jul 20;447:66-70. doi: 10.1016/j.cca.2015.05.015. Epub 2015 May 29.

ReferenceCitation: Allard MA, Bachet JB, Beauchet A, Julie C, Malafosse R, Penna C, Nordlinger B, Emile JF. Linear quantification of lymphoid infiltration of the tumor margin: a reproducible method, developed with colorectal cancer tissues, for assessing a highly variable prognostic factor. Diagn Pathol. 2012 Nov 13;7:156. doi: 10.1186/1746-1596-7-156.

location_facility: Department of digestive surgery, Ambroise Paré Hospital, APHP


title: 12-months of Treatment With Burosumab in Children and Adolescents With X-linked Hypophosphatemia: a Prospective Longitudinal Cohort Study

summary:
In this prospective longitudinal cohort study we studied the efficacy and safety of burosumab in real-clinical practice for <13- and >13-years old children affected with X-linked hypophosphatemia.

57 children with XLH were switched from conventional treatment to burosumab. After 12 months we assessed the efficacy and safety of treatment with burosumab on the whole cohort and separately on the cohort of >13-years old adolescents.

lead_sponsor: Bicetre Hospital

intervention_type: Drug


title: Design of a Mobility Protocol to Assess the Impact of Visual Pathologies in Daily Life Activities for Subjects With Advanced Visual Deficits

acronym: PROMA

summary:
Retinitis Pigmentosa is characterized by a progressive disappearance of photoreceptors, responsible for a progressive and severe loss of vision.

People Retinitis Pigmentosa therefore encounter a large number of difficulties in daily life, specifically for:

Visual research
Visuo-motor coordination in tasks requiring fine motor control
Visuo-motor coordination in mobility tasks

This study aims to assess the difficulties in the daily life of subjects with Retinitis Pigmentosa at a very advanced stage unsing, quaify of life questionnaires, simplified locomotion tasks in real situation and a posture task.

They are proposing a new test adapted and carried out in real situations, in binocular and monocular vision, making it possible to finely assess locomotion especially for "very low vision" patients.

This test will also ultimately make it possible to better evaluate the effectivements, that is to say to observe and quantify objectively by a score the performance progression obtained for locomotion tasks related to the visual recovery generated by the treatment.

status: Recruiting

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

intervention_type: Behavioral

status_simplified: Ongoing


title: Feasibility of Isoflurane Sedation Using an Anesthetic-conserving Device in Prehospital Emergency Medicine: A Retrospective Study

acronym: ANACONDA

summary:
Achieving the optimal sedation level for patient management is not always possible using our standard intravenous medications in Pre-hospital Emergency medicine. Inhaled sedation is possible with the Anesthetic-conserving device with a standard respirator.

The pharmacodynamics and pharmacokinetics of halogenated agents allow deep sedation quickly after absorption.

The feasibility of inhaled sedation has never been studied in hospital.

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie result in a publication

lead_sponsor: University Hospital, Brest


title: Allogeneic Bone Paste Versus Allogeneic Bone Powder in Pre-implant Guided Bone Regeneration in Oral Surgery: a Randomized Non-inferiority Clinical Trial

summary: Autogenous bone graft has been considered the gold standard in Guided Bone Regeneration (GBR) technique used for bone augmentation. However, there are disadvantages associated with autograft use such as limited amount of available bone and increased morbidity for the patient at the sampling site. Several biomaterials have been used as a replacement of the autogenous bone. Viral-inactivated bone allograft powder is an alternative that has proven efficacy and tolerance. This study aims to assess the non-inferiority of viral-inactivated allogeneic bone paste compared to a viral-inactivated cortico-cancellous allogenic bone powder in achieving the ideal bone volume.

lead_sponsor: Biobank

sponsor_collaborators: Biobank EVAMED

intervention_type: Biological


title: Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject, by a Threshold Inspiratory Load and During a Maximal Breath Holding.

acronym: Volatopnee

summary:
The dyspnea is a common symptom in patients with many respiratory diseases particularly chronic obstructive airway diseases, but also cardiovascular pathologies, obesity, or also in the deconditioned healthy subjects.

Called volatolom corresponds to the set of volatile organic compounds (VOCs) contained in exhaled air.

The analysis of volatolom can be done either by the methods based on mass spectrometry which allows the identification of each VOC in the exhaled air or by the use of electronic noses which are more simple to use, less specific and produce a quantitive signal change based on pattern recognition algorithms providing a global profile of the VOC without identifying them.

The aim of the study is to determine whether the analysis of VOCs in exhaled air would identify biomarkers related to the intensity and type of experimental dyspnea.

lead_sponsor: Hopital Foch


title: Nasal Carrying by Staphylococcus Aureus ST398 Strains in Community and Hospital Settings

acronym: CONASA 398

summary: The aim of this study was to compare the prevalence of nasal carrying of SA ST398 strains in community and hospital settings, identify the factors associated with colonization of SA ST398, determine the distribution of imported and acquired cases among SA ST398 hospital cases and characterize the genetic structure of the ST398 SA population involved in colonization.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Procedure


title: Clinical Efficacy of Fosfomycin Trometamol Per os in the Treatment of Documented Male Urinary Tract Infections With ESBL-producing Enterobacteriaceae With ESBL Producing Enterobacteriaceae and Resistance Associated With Fluoroquinolones and Cotrimoxazole (FOSF'HOM)

acronym: FOSF'HOM

summary: The aim of the study was to evaluate the clinical and microbiological efficacy of fosfomycin trometamol (FT) per os in the treatment of documented male urinary tract infections with ESBL-producing enterobacteriaceae

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: The ARCAN Database is Used for Retrospective Non-interventional Research Projects. The Database Collects Clinical and Laboratory Data From Patients With Lymphoid Malignancies. The Database Doesn't Require Biological Sample of Patients, it Records Only Information Based on the Patients' Medical File.

acronym: Arcan database

summary: To identify the diagnostic and therapeutic approach (efficacy and toxicity) of patients with lymphoid malignant hemopathy who are managed in the hematology department.

lead_sponsor: Hospices Civils de Lyon


title: Prosthetic Arthroplasties in Weight-bearing Shoulders in Individuals With Long-term Wheelchair Use

summary: Repeated transfers and wheelchair propulsion in patients with neurological deficit of the lower limbs leads to a major mechanical overload of the upper limbs, especially on shoulders, the "weight-bearing" shoulder. Under these conditions, arthroplasty is subject to significant constraints; such an indication in this condition is always discussed. The objective of this study was to evaluate the medium-term clinical and functional outcomes of anatomical and reverse arthroplasty on the weight-bearing shoulder in individuals with long-term wheelchair use.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Interest of Individual Biomarkers From the Identification of Tumor Genotype in Plasma (ctDNA: Circulating Tumor DNA) by High-throughput Molecular Next Generation Techniques(CAPP Seq, PhAsE Seq, VIRCAPP-seq) in the Diagnosis and Personalized Management of Lymphomas in a Prospective Monocentric Cohort

summary:
Lymphomas are the most common haemopathic malignancy. The 3 most common types are diffuse large B-cell lymphoma (DLBCL), Hodgkin's lymphoma (HL) and follicular lymphoma (FL). In these three subtypes, the treatment strategy is most often curative. The therapeutic strategy is guided by PET (positron emission tomography), which optimises the risk-benefit balance between the efficacy and toxicity of the treatment and makes it possible to limit the intensity of treatment for good responders and to intensify the treatment of poor responders with a worse prognosis. PET therefore plays a central role in the pre-therapeutic evaluation of the disease and in the assessment of response to treatment. However, other complementary approaches could improve characterization prior to initiating lymphoma t-treatment and individual patient management during treatment and beyond. In DLBCL, it has been shown that the risk of relapse of good and bad responders is decreased by combining the PET response with a reduction in the amount of tumor DNA (ctDNA) in the blood, i.e. the genetic program of lymphoma cells that circulates freely in the blood. This evaluation of ctDNA has been made possible by the development of innovative techniques such as Next Generation Sequencing (NGS). In lymphomas, several approaches have been developed, the most sensitive and promising being CAPP-Seq (CAncer Personalized Profiling by deep Sequencing) developed at Stanford University.

It is therefore useful to study the description of ctDNA in the 3 types of lymphomas and to analyse the progression profiles under treatment by trying to establish the major potential usefulness of these techniques: modifying treatment in case of poor response based on ctDNA +/- and PET, detecting relapses earlier than at present in patients without any other sign of relapse (clinical, blood or PET).

The project presented here aims to build a collection of plasma samples taken before treatment, during treatment and during the first 2 years of follow-up in patients with one of the 3 most frequent types of lymphoma and undergoing curative treatment. The hypothesis is that sequential evaluation of ctDNA could improve the individualized management of future patients based on the results generated by the analyses of patients in this cohort.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY: A FEASIBILITY STUDY (KNEE EMBOLISATION)

summary: Recent works in interventional radiology have shown interesting results in the treatment of musculoskeletal inflammatory sites by arterial embolization. Supra-selective arterial embolization has been successfully developed by Dr. Okuno (Japan) to manage moderate to severe knee osteoarthritis. Also, inflammation of the surgical site mediated via geniculate arteries is a major cause for persistent chronic post-operative gonalgia.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Caracteristics of the Patients Hospitalized With Unvonluntary Commitment Procedure, in Pandemic and Confinement Context

acronym: HoCoPsy

summary:
The actual worldwide context (disease outbreak, confinements instaured in many countries) is a stressful factor for many people. It can have consequences on mental health : separation from loved ones, loss of freedom, uncertainty about infection status, boredom. Patients with mental disorders are especially vulnerable.

On march 17th, the french government ordonned a national confinement to slow the progression of the COVID-19 outbreak, for 15 days at first then renewed several times. This situation has led to a reorganization of care as requested on March 22nd, 2020 in the recommendations applicable to the organization of care in psychiatric services : priority to telephone contacts and teleconsultation by multiplying contacts and assessments.

By the time the reorganization of care became operational, the most vulnerable patients may have experienced a decompensation of their disease.

It is important to know if the COVID-19 outbreak combined with the confinement increased the number of unvoluntary commitment the month after the announce of the confinement.

This could help us understand which patients are more vulnerable is this context, and improve our organization (ambulatory and hospitalization care) if this situation occurs again.


title: Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients

acronym: EPREX

summary: The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Umbilical Cord Arterial Eucapnic pH Compared With Arterial pH and Base Deficit as Predictor of Severe Adverse Outcomes Among Term Neonates

acronym: PHE

summary:
Neonatal asphyxia per partum can be complicated by severe neurologic sequelae and can lead to neonatal death. Of the 0.2% of live births to cerebral palsy, 10 to 28% would be secondary to neonatal acidosis. Only metabolic acidosis plays a neurotoxic role, explaining the recent interest of Racinet et al. in the development of a new biochemical marker, more specific than pH or base deficit, of neonatal asphyxia per partum at risk of anoxo-ischemic encephalopathy. This eucapnic neonatal pH raises the hope of a biochemical marker of situations at risk of poor prognosis, with high diagnostic value, prognostic and forensic.

Our hypothesis is that eucapnic pH is more efficient than cord blood arterial pH and base deficit in the prediction of adverse neurologic outcomes.


title: Intra Uterine Growth Restriction. Minimum Required Evidence-based Care and Neonatal Prognosis: Impact of Healthcare Pathways

acronym: IUGR

summary: Intrauterine growth restriction (IUGR) is associated with an increase in perinatal mortality and morbidity, as well as longer-term neurological, cognitive, cardiovascular and endocrine complications. In Europe, about 400,000 pregnancies per year are complicated by IUGR. However, antenatal diagnosis seems insufficient in clinical practice, making it impossible to recognize up to 75% of foetuses with IUGR. At a time when the use of good clinical practice has demonstrated a significant improvement in neonatal survival without severe morbidity, foetuses with IUGR are less likely to receive optimal care. Our hypothesis is that the rate of IUGR diagnosed underestimates the rate of actual IUGR.


title: Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin

summary:
Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.

Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide.

The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future


title: Immunomodulatory Profile of Dexmedetomidine Sedation in Patients Recovering After ARDS Covid-19

acronym: DEXDO-COVID

summary:
Covid-19 infection is due to SARS-CoV-2 member of the Coronavirus family represented by SARS- and MERS-CoVwith neuronal tropism capacity for the brainstem and thalami. Dexmedetomidine has(i) central antihypertensive (ii) sedative and (iii) neuroprotective properties and is often used during patient recovering after mechanical ventilation withdrawal.

Dexmedetomidine administration could change the immunomodulatory profile of Covid-19 patients and reduce inflammatory response.CAM-ICU scores and Blood samples from Covid-19 ICU patients will be collected at 4 different timepoints (before Dexmedetomidine administration, at D2, D7 and M6) to analyse the inflammatory profile with different approaches:i) chromatin accessibility, ii) transcriptome analysis, iii) inflammatory cytokines and chemokines levels.

location_facility: Intensive Care Unit and Respiratory division ; Groupe hospitalier Pitie-Salpetriere and Universite Pierre et Marie Curie Paris 6


title: Study of the Efficiency and Security of NIVOLUMAB Therapy, Used in Immuno-stimulation, in Hospitalized Obese Individuals at Risk to Evolve Towards Severe Forms of COVID-19 Infection. Multicentric, Paralleled, Randomized, Controlled Trial

acronym: NIVISCO

summary:
Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus).

Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19.

In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production.

This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15

location_facility: Hôpital Lyon Sud Service Endocrinologie, Diabète et Nutrition


title: Dental Plaque and Infectious Agents Story)

acronym: DIAS

summary: We are studying the possibility of using dental calculus as a reservoir for the genes of an infectious agent that has infected the patient in previous months; as it is done to highlight climate change in ice samples.

time_perspective: Cross-Sectional


title: Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort

acronym: MARETINE

summary:
The cardiovascular parameters of prolonged physical exercice have been studied, but very little data is available about the retinal vascularization.

The eye allows in vivo visualization of micro-vascularisation and is considered as an excellent marker of general vascular condition.

The marathon is an intense and prolonged exercise (running 42.195 km) in aerobic environment. Thus the investigators propose to study the vascular parameters of the retina, before and after this physical exercise.

This will allow : 1) to collect information on the physiology of the retinal vascularization to prolonged effort, 2) to detect any retinal damage (haemorrhages, edema, occlusion ...), not known to date.

The results may highlight vascular effects related to retinal hypoxia (venous tortuosity, haemorrhage, venous occlusion, hypoxic edema). Furthermore the results may urge prevention in this sport more and more democratized.

the investigators hypothesized that prolonged physical exercice causes a change in retinal vascularization.

ReferenceType: derived

ReferenceCitation: Mauget-Faysse M, Arej N, Paternoster M, Zuber K, Derrien S, Thevenin S, Alonso AS, Salviat F, Lafolie J, Vasseur V. Retinal and choroidal blood flow variations after an endurance exercise: A real-life pilot study at the Paris Marathon. J Sci Med Sport. 2021 Nov;24(11):1100-1104. doi: 10.1016/j.jsams.2021.03.013. Epub 2021 Mar 30.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Diagnostic Test


title: Impact of Social Marketing in Collective Prevention Actions : Case of Fall Prevention Workshop Among Elderly Living in Three French Departments.

summary: Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation and attendance resulting in Physical Activity (PA) approaches designed to prevent falls actually only benefiting a limited number of elderly subjects. Social marketing has already shown its utility in the construction of prevention programs.

ReferenceCitation: Goethals L, Barth N, Hupin D, Chapoton B, Guyot J, Celarier T, Roche F, Gallopel-Morvan K, Bongue B. Social Marketing Intervention to Engage Older Adults in Balance Workshops for Fall Prevention: A Multicenter Quasi-Experimental Protocol Study. Front Public Health. 2021 Jul 14;9:614119. doi: 10.3389/fpubh.2021.614119. eCollection 2021.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators:
Crédit Agricole Loire / Haute-Loire
Jean Monnet University


title: Evaluation of the Preparation of Runners and the Impact of an Ultra-trail Event in a Hot and Humid Environment (Ultra Trail Adaptation Environment)

summary:
Human beings are characterized by their extraordinary ability to thermoregulate. During a physical exercise, only 25% of the energy provided by the substrates is converted into muscular mechanical work. The remaining 75% is released as heat.

In fact, thermoregulation has always been an integral part of exercise's physiology.

Due to current climate change, study and understand the mechanisms of thermoregulation and the practices of runners to cope with these constraints becomes increasingly necessary in order to optimize the sports performance and protect the health of athletes of all levels.

Heat stroke is responsible for more deaths than any other environmental disaster and is the second leading cause of sport mortality after heart problems.

The exercise-related hyperthermia and malignant hyperthermia, dehydration and hyponatremia problems have been relatively well studied in several sports. For ultra endurance disciplines, the data remains very fragmentary.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Burn Out and Quality of Life at French General Practioners: is There a Link

summary: The suffering of caregivers is constantly increasing. General medicine, because of its primary role in primary care, is particularly exposed to the risk of burn-out and must protect itself. The aim of this study was to find an inverse relationship between health-related quality of life and being severely burned by French general practitioners.

lead_sponsor: Albert TRINH-DUC


title: The Lyon Real World Evidence in Metastatic NeuroEndocrine Tumours

acronym: LyREMeNet

summary:
Neuroendocrine tumours (NETs) are rare and include a heterogeneous group of neoplasms derived from the endocrine system found in the gastrointestinal tract, pancreas and lung. Gastroenteropancreatic (GEP) NETs represent the majority of neuroendocrine neoplasms (NEN) and the annual incidence of all GEP-NETs has been estimated to 6.98 per 100,000 person-years in 2012 and is steadily rising. While data on the incidence of metastatic GEP-NET is limited, more than 50% of patients with GEP-NET have metastatic disease at the time of diagnosis. Incorrect and delayed diagnoses are still common. Treatment options include surgery, locoregional interventions, and systemic treatment.

The Lyon Real world Evidence in Metastatic NeuroEndocrine Tumours study (LyREMeNET) is a descriptive observational cohort study. The main objective is to assess the healthcare resources use and the corresponding costs for management of patients with metastatic GEP and lung NETs. The secondary objective is to describe the clinical characteristics, prognostic factors, treatment patterns, and the overall survival among patients with metastatic GEP and lung NETs.

ReferenceCitation: Lemelin A, Maucort-Boulch D, Castel-Kremer E, Forestier J, Hervieu V, Lorcet M, Boutitie F, Theillaumas A, Robinson P, Duclos A, Lombard-Bohas C, Walter T. Elderly Patients with Metastatic Neuroendocrine Tumors Are Undertreated and Have Shorter Survival: The LyREMeNET Study. Neuroendocrinology. 2020;110(7-8):653-661. doi: 10.1159/000503901. Epub 2019 Oct 7.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: S. Karger AG


title: Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.

summary:
Alzheimer disease is a frequent disease in the late ages that results in global alteration of cognitive functions. In which memory complaint can be isolated in the early stages.

Physiopathology of neuronal degenerescence in Alzheimer disease is complex, two main histological lesions are known, amyloid plaques and neurofibrillar tangles. Beyond the histological knowledge, alterations of neuronal metabolism are described such as oxydative phosphorylation and glycolytic pathway. These metabolism alterations are involved in neuronal death.

Multi-nucleus magnetic resonance spectroscopy is a non-invasive non-irradiant imagery technique already used in routine. This technic allows the phosphoenergetic pool assessment, that inform about cellular metabolism.

The aim of the study is to explore the phosphorylated metabolism patterns as predictive biomarkers of cognitive decline in patients with a memory complaint diagnosed.

primary_purpose: Diagnostic

lead_sponsor: Poitiers University Hospital


title: Phase 1 Dose Escalation of Early Infusion of Zoledronic Acid in Combination With Increasing Low-dose of Interleukin-2 in Order to Expand Vγ9Vδ2 T Cells After T-replete Haplo-identical Allogeneic Stem Cell Transplantation (SCT)

acronym: HILDEGAZ

summary:
Patients receiving haplo-SCT are at high-risk of relapse. Vγ9Vδ2 T cells exhibit is a well-known population able to exert cytotoxicity toward a large range of tumor in vitro or in vivo. Activating and expanding Vγ9Vδ2 T cells early after haplo-SCT by using a combination of Zoledronic acid and low-dose interleukine (IL) -2 may be of benefit for patients by reducing incidence of relapse. The optimal dose of IL-2 to use remains to be determined.

This will be a Phase 1 3+3 escalation study. Three to 15 patients are planned. It will be proposed to Patients who refuse to participate to have samples collected until day +70 to study immune and gamma/delta T cells reconstitutions after haplo-transplant.

lead_sponsor: Nantes University Hospital


title: Attentional and Emotional Processing of Complex Visual Scenes in Children With Attention Deficit Disorder With or Without Hyperactivity

acronym: TIVE-TDA

summary: The aim of this study is to analyse explicit and implicit emotional information processing abilities in children with attention deficit disorder with or without hyperactivity

primary_purpose: Basic Science

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: Evaluation of the Tolerance of Anti-MRSA Betalactamines (Ceftaroline / Ceftobiprole) in the Management of BJI / PJI: a Retrospective Study in a Reference Center

summary:
Staphyloccous aureus and coagulase negative staphylocci are responsible of a large marjority of PJI. Regarding the high rate of methicillin resistance, current guidelines recommend the use of a glycopeptide, and most frequently vancomycin, as the anti-gram positive agent in empirical therapy, while awaiting the microbiological results. Vancomycin is not considered as a safe antibiotic, and daptomycin is frequently an alternative option.

Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. As some data report a synergistic activity with daptomycin, they could be an option in pandrug-resistant staphylococci BJI, but their use if off label in this indication.


title: Effects of an Adapted Physical Activity With an Interactive Gaming Platform on Fall Apprehension and Risk: A Randomized Controlled Trial

summary: This study evaluates the effects of an adapted physical activity with an interactive gaming platform on fall apprehension and risks. Half of the participants will receive a rehabilitation program using the Medimoov gaming program, the other half will receive the standard rehabilitation program.

ReferenceCitation: Dargent-Molina P, Cassou B. Prévention des chutes chez les personnes âgées de plus de 75 ans vivant à leur domicile: analyse des interventions efficaces et perspectives de santé publique. Bull Épidémiologique Hebd. 2017;16-17:336-43.

ReferenceCitation: Tallon G, Seilles A, Melia G, et al. Intérêt du serious game Medimoov pour améliorer l'autonomie fonctionnelle chez la personne âgée institutionnalisée. Montpellier, 2015.

ReferenceCitation: Lister C, West JH, Cannon B, Sax T, Brodegard D. Just a fad? Gamification in health and fitness apps. JMIR Serious Games. 2014 Aug 4;2(2):e9. doi: 10.2196/games.3413.

ReferenceCitation: Skjaeret N, Nawaz A, Morat T, Schoene D, Helbostad JL, Vereijken B. Exercise and rehabilitation delivered through exergames in older adults: An integrative review of technologies, safety and efficacy. Int J Med Inform. 2016 Jan;85(1):1-16. doi: 10.1016/j.ijmedinf.2015.10.008. Epub 2015 Oct 28.

ReferenceCitation: Melia G, Seilles A, Tallon G. Évaluation d'un jeu sérieux thérapeutique. 2025; 4.

ReferenceCitation: Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

ReferenceCitation: Siegrist M. Test-Retest Reliability of Different Versions of the Stroop Test. J Psychol. 1997; 131: 299-306.

ReferenceCitation: Hauer KA, Kempen GI, Schwenk M, Yardley L, Beyer N, Todd C, Oster P, Zijlstra GA. Validity and sensitivity to change of the falls efficacy scales international to assess fear of falling in older adults with and without cognitive impairment. Gerontology. 2011;57(5):462-72. doi: 10.1159/000320054. Epub 2010 Oct 22.

ReferenceCitation: Freire AN, Guerra RO, Alvarado B, Guralnik JM, Zunzunegui MV. Validity and reliability of the short physical performance battery in two diverse older adult populations in Quebec and Brazil. J Aging Health. 2012 Aug;24(5):863-78. doi: 10.1177/0898264312438551. Epub 2012 Mar 15.

ReferenceCitation: Wagner S, Helmreich I, Dahmen N, Lieb K, Tadic A. Reliability of three alternate forms of the trail making tests a and B. Arch Clin Neuropsychol. 2011 Jun;26(4):314-21. doi: 10.1093/arclin/acr024. Epub 2011 May 15.

ReferenceCitation: Lapierre N, Um Din N, Igout M, Chevrier J, Belmin J. Effects of a Rehabilitation Program Using a Patient-Personalized Exergame on Fear of Falling and Risk of Falls in Vulnerable Older Adults: Protocol for a Randomized Controlled Group Study. JMIR Res Protoc. 2021 Aug 26;10(8):e24665. doi: 10.2196/24665.

repository_institution: PubMed Central - Europe PMC

version: submittedVersion

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

publisher_dissemination: JMIR Publications

lead_sponsor: Joel Belmin

location_facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université


title: Factors Influencing Perioperative Mortality in Type A Acute Aortic Dissections Operated at Dijon University Hospital

summary: Type A acute aortic dissections are a rare condition whose natural evolution is catastrophic. Global mortality remains high even if it decreased last years. This is probably due to improvement of diagnostic techniques and the evolution of surgical practices. It is however important to have medical data and statistics obtained in past years in order to better understand the factors influencing peroperative mortality and thereby to continue this improvement.

ipd_sharing_description: All patients are informed before surgery that all the medical data included in the medical record could be used in cardiovascular monocentric retrospective study. No data shared.

lead_sponsor: Centre Hospitalier La Chartreuse

location_facility: Cardiovascular and thoracic surgery Unit - Dijon University Hopital


title: Nutritional and Psychocomportemental Reeducation, Sleep Apnea and Comorbidities in Overweight and Obese Subjects

acronym: DIETSLEEP

summary: In obese patients, the prevalence of obstructive sleep apnea (OSA) is around 40% in men and 30% in women. Weight loss after bariatric surgery significantly improves OSA, with 75% of patients having a reduction in OSA severity or becoming non-apneic. We hypothesize a similar effect on OSA of nutritional and psychocomportemental rehabilitation for obese patients. However, we expect weight loss and blood pressure reduction to probably be lower in obese patients who have OSA and nutritional rehabilitation alone than in those who are treated for their OSA or are without OSA. To address this question, we will conduct an observational study on obese patients, treated or not for OSA, following nutritional and psychocomportemental rehabilitation.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Groupe Éthique et Santé

intervention_type: Dietary Supplement


title: Study of Retinal Vascular Parameters in Patients With Wilson's Disease

acronym: WILLY

summary:
The rare disease reference center " Wilson disease and other rare copper-related diseases" of the Rothschild Foundation follows a large number of patients with Wilson's with varying degrees of impairment and located at different times of their care.

Many people with Wilson's disease have a characteristic greenish-brown ring, known as Kayser-Fleischer, appearing at the periphery of the cornea due to a deposit of copper at the Descemet membrane. As a general rule, if the patient is compliant with his treatment, the ring usually disappears within a few years, although it may persist in some patients. However, apart from the stage of diagnosis, and the evolution of the ring, ophthalmological examinations are little used for the follow-up of these patients.

The objective of this study is to describe the retinal parameters, in particular vascular with two new retinal imaging technologies (OCT-A :Optical Coherence Tomography-Angiography , Adaptive optics) in patients with Wilson's disease and to correlate them with the parameters of the usual follow-up of these patients (hepatic assessment, exchangeable plasma copper, neurological scores, compliance, etc.).

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild


title: Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study

acronym: COVIDHomeless

summary:
COVID/Homeless is a prospective observational cohort study of homeless people to determine the impact of the SARS-CoV-2 epidemic on this population.

The cohort aims for exhaustiveness for the city of Marseille, being based on the active files of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams (including one specialized in psychiatry, three specialized in addictions, and three working in squats and shantytowns).

Aims of this cohort include to identify of the prognostic factors of morbi-mortality of homeless people by COVID-19, and therefore to propose appropriate management strategies.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Evaluating Effectiveness of a Communication Facilitator to Reduce Distress and Improve Goal Concordant Care for Critically Ill Patients and Their Families: A Randomized Trial. Famiréa - FCS

acronym: Famirea - FCS

summary: This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: FCS

titre: Impacts d'un facilitateur de la communication chez les patients de réanimation et leurs proches : une étude randomisée contrôlée

discipline_principale: anesthesiology / resuscitation

nom_porteur: KENTISH-BARNES

prenom_porteur: Nancy


title: A Mobile App for the Self Quantification of Sleep and Behaviors : a Pilot Study With Teenagers and Young Adults

acronym: ASC-Val

summary: The sleep and behavior agendas are today very largely underused while they can be of a considerable contribution in the follow-up of the patients and the reinforcement of the therapeutic alliance. In the management of addictions, sleep disorders are a major comorbidity, these two components maintain indeed complex links: it was highlighted a bidirectional relationship between the effect of the consumption of addictive substances on sleep and conversely, the effect of sleep disorders on the consumption of products, the same is true for overexposure to screens.

intervention_type: Device


title: Association of Lung Microbiota With Intensive Care Unit Mortality in ARDS Patients: MicrA Study

acronym: MicrA

summary: Acute respiratory distress syndrome (ARDS) is due to diffuse and severe lung inflammation. Despite intensive research, few therapeutics have emerged and treatment is still mostly symptomatic. As lung microbiota seems to be associated with lung inflammation in numerous chronic respiratory diseases, this study aims to analyse the correlation between lung microbiota and mortality.

lead_sponsor: University of Bordeaux

location_facility: Medical intensive care unit, Pellegrin hospital


title: Cardio-Oncologie: étude Pilote évaluant la faisabilité, Utilité Concrète, Interdisciplinaire d'Une Unité Spécialisée

acronym: CONFUCIUS

summary:
Cardio-oncology is an emerging field. Most of the data available have been issued from either retrospective analysis, industry data or pharmacovigilance data. These data sources include a number of bias.

CONFUCIUS is a single tertiary centre prospective registry including all patients who have been referred for cardio-oncology assessemnt.

The objectives are to provide a comprehensive vue of cardoi-oncology, enable to detect early signals of cardiotoxicity and enhance ancillary projetcts aiming at specific populations (e.g., type of cancer) and/or drugs.

lead_sponsor: European Georges Pompidou Hospital

location_facility: Assistance Publique Hôpitaux de Paris - Centre Université de Paris


title: Impact of the Rheumatoid Factor on Serological Testing Performance for Covid-19 in Rheumatoid Arthritis Patients

acronym: COVID-SERA

summary: Due to the Covid-19 worldwide outbreak, fragile patients with immune diseases, notably rheumatoid arthritis (RA), have to be even more specifically and carefully followed-up. However, it has been shown that false postive serological results often occured while detecting antibodies directed against SARS-CoV-2 in patients with positive rheumatodoid factor (RF). The investigators propose here to investigated this issue. Therefore, the investigators will test three different immunoassays on this specific population. The investigators aim to establish these assays specificity and the levels of RF for which there is a risk of anti-SARS-CoV-2 false positivity and thus ensure a better follow-up of RA patients. The RF isotype will be analysed to determine whether there is a correlation and the impact of the presence of anti-CCP (citrullinated cyclic antipeptide antibodies) will be studied and assessed.

lead_sponsor: University Hospital, Montpellier


type: Registry Identifier

title: Assessment of Feeding and Eating Disorders of Young Children : Standardisation of a New Tool, the Hetero-questionnaire Named ORALQUEST

acronym: ORALQUEST

summary:
Feeding and eating disorders are frequent in children of the general population. They are much more frequent in children with congenital chronic diseases. The analysis of feeding and eating disorders in children is difficult since their causes are complex and multiple. In addition to the clinical examination and the instrumental investigation, a parental questionnaire is very useful in assessing these disorders. The questionnaire (testing the right period of age, evaluating the 4 aspects involved in the disorders, translated in French) does not exist. Consequently, the Necker team of the reference center, has built a hetero-questionnaire named ORALQUEST, which analyses 4 dimensions of the feeding and eating disorders of young children from 9 months to 6 years: behaviour, oral motor skills, sensory sensitivity and familial environment.

The objective of the study is to test the metrological qualities of Oralquest in children with congenital chronic diseases including feeding and eating disorders.

The questionnaire will be proposed to 7 cohorts of children who are followed in Necker for :

oesophageal atresia,
cardiac malformations,
Pierre Robin sequence,
cleft lip and palate,
autism spectrum disorders,
ex-prematurity < 32 AG,
chromosomal anomalies, and proposed to children consulting in the expert center for phobic and selective eating behaviour.

The analysis of the metrological qualities of the questionnaire include several calculation and specialized methods: inter-rate concordance; test-retest; intrinsic validity, concurrent validity, sensitivity/specificity.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Filiere de Sante Maladies Rares TETECOU
URC-CIC Paris Descartes Necker Cochin

location_facility: Department of Pediatry, Necker-Enfants Malades Hospital


title: Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide MR 60mg in Patients With Type 2 Diabetes Fasting During RAMADAN

acronym: DIA-RAMADAN

summary: The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa

ReferenceType: result

ReferenceCitation: Hassanein M, Al Sifri S, Shaikh S, Abbas Raza S, Akram J, Pranoto A, Rudijanto A, Shaltout I, Fariduddin M, Mohd Izani Wan Mohamed W, Al Awadi F, Alessa T; DIA-RAMADAN study investigators. A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN. Diabetes Res Clin Pract. 2020 May;163:108154. doi: 10.1016/j.diabres.2020.108154. Epub 2020 Apr 21.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

ReferenceCitation: Hassanein M, Al Sifri S, Shaikh S, Raza SA, Akram J, Rudijanto A, Shaltout I, Fariduddin M, Mohamed WMIBW, Al Awadi F, Durocher A, Cortese V, Alessa T. Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN. Diabetes Ther. 2021 Jun;12(6):1703-1719. doi: 10.1007/s13300-021-01067-1. Epub 2021 May 11.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

lead_sponsor: Servier Affaires Médicales


title: "Clinical and Epidemiological Characteristics of Inflammatory Rhinitis in Patients on Biotherapies"

summary: Inflammatory rhinitis is a side effect observed in patients treated with biotherapies in the context of chronic bowel disease (IBD) or spondylartrhopathy (SPA). This damage is still poorly described in the literature. I The objective of this study is to study the associated characteristics of crustal rhinitis in a cohort of patients treated with biotherapy for chronic inflammatory disease (IBD, SPA, psoriasis).


title: Polymorphisms, Caffeine and Sleep Disorders

acronym: SOCAF

summary:
Screening of a population of volunteer workers recruited on the occasion of their occupational health visit, within the Ministry of Defense and civil enterprises.

The voluntary subjects included will, after signing a consent, take a saliva sample (Kit Oragen DNA OG500) and fill out a computerized questionnaire.

A posteriori, the genotyping polymorphisms may be associated with variations in the pharmacokinetics or pharmacodynamics of caffeine will be achieved.

The primary objective is to determine whether polymorphisms (alone or in combination) of genes associated with the pharmacokinetics or pharmacodynamics of caffeine are independent risk factors for sleep disorders.

The secondary objectives are to determine the frequency of these polymorphisms and to evaluate the consequences of these associations on sleep habits (sleep time, chronotype, quality of sleep), daytime sleepiness, caffeine consumption, antecedents of accidents at work or traffic, drug consumption ...

primary_purpose: Screening

lead_sponsor: Institut de Recherche Biomedicale des Armees

intervention_type: Genetic


title: An Observational Study on Intermittent Self Catheterisation Discontinuation Factors in Multiple Sclerosis Patients

acronym: SEPAS

summary: Urinary disorders (UD) are common in Multiple Sclerosis (MS) and can necessitate using Intermittent Self Catheterisation (ISC). It is well experienced by patients, has little impact on daily life and improves quality of life. However, studies are lacking on long-term adherence to this treatment as well as on discontinuation factors. Our main objective is to prospectively assessed factors associated with ISC discontinuation 2 years after having introduced this technique.

lead_sponsor: University Hospital, Toulouse

collaborators: French Association for Research on Multiple Sclerosis


title: Association of Gut Microbiota Diversity With Extended-spectrum Beta-lactamase Producing Enterobacteriales Fecal Carriage and Subsequent Infection in Intensive Care Unit: Microbe Study

acronym: Microbe

summary: Antimicrobial resistance is a major threat worldwide and extended-spectrum beta-lactamase producing Enterobacteriales (ESBL-E) are a leading cause because of their wide dissemination. Gut microbiota seems to be correlated with multi-drug resistant organism carriage. This study thus aims to analyse the correlation between gut microbiota, ESBL-E fecal carriage and subsequent infection.

location_facility: Medical intensive care unit, Pelelgrin hospital


title: "Follow-up of Midlines Placed Outside the Intensive Care Unit: What Happens Next, What Side Effects? A Multicenter Observational Study"

acronym: MidDATA

summary: Midline catheter is a peripherally-inserted catheter, with the distal tip being placed into the axillary vein. For some indications, it's an alternative to the peripheral insert central catheters in case of limited venous access and infusions less than one month. The Midline catheter is poorly described in scientific literature; therefore, the aim of the study is to determinate the incidence of adverse events (Infections and thrombosis) and risk factors for patients with this device.

appel_a_projets: PHRIP

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: MidDATA

titre: Midlines posés hors unité de soins intensifs et réanimation : épidémiologie, incidence et facteurs associés aux effets secondaires

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: DEROUIN

prenom_porteur: Yvan


title: Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)

acronym: AURIX

summary:
While invasive vagal stimulation has proven its therapeutic effectiveness over the past 20 years, particularly in the treatment of epilepsy or depression, its implementation is hampered by the high cost, high technicality and sometimes significant side effects. Non-invasive vagal stimulation, most often electric, is a less expensive therapeutic alternative and easier to implement, although the level of evidence is lower than that of invasive stimulation.

Some so-called traditional therapies, such as acupuncture, also stimulate certain parts of the ear by mechanical means, most often by puncturing the ear or the concha. In these traditional therapies, more than one hundred stimulation points have been described, each precisely positioned according to an empirical topography.

However, electrical non-invasive stimulation recognizes only three areas of interest on the ear, which are the areas of sensitive innervation, namely the afferences of the vagus nerve in the concha, which is the only one used in practice, the large occipital nerve on the lobe and part of the helix, and the auriculotemporal nerve on the rest of the auricular flag.

In this study, we would like to explore the justification for the topographic precision, adopted by traditional therapies, for non-invasive vagal stimulation on the concha.

status: Terminated

lead_sponsor: Hôpital Européen Marseille

sponsor_collaborators:
Hôpital Européen Marseille
Aix Marseille Université


title: Osteoarticular Infections With Pneumococcal

summary: Osteoarticular infections at pneumococcal are rare, potentially serious and remain under diagnosed. They represent 3 at 10% of the arthritis septic in the literature. 190 cases have been published of 1965 at 2003. They represent 0.3% at 0.6% of the bacteraemia at Streptococcus peumoniae.

lead_sponsor: Hospices Civils de Lyon


title: Endovascular Thrombectomy in COVID-19 Infected Patients: Intrahospital and Peri-operative Outcomes

summary:
About 5% of COVID-19 patients may present symptoms related to acute ischemic stroke (AIS). Treatment-management and outcomes related to mechanical thrombectomy (MT) for COVID-19 infected patients harboring large vessel occlusion is largely unknown.

This multicentric study aims to investigate morbidity, mortality and neurological outcomes after MT performed in patients with COVID-19 infection.

ReferenceCitation: Cagnazzo F, Piotin M, Escalard S, Maier B, Ribo M, Requena M, Pop R, Hasiu A, Gasparotti R, Mardighian D, Piano M, Cervo A, Eker OF, Durous V, Sourour NA, Elhorany M, Zini A, Simonetti L, Marcheselli S, Paolo NN, Houdart E, Guedon A, Ligot N, Mine B, Consoli A, Lapergue B, Cordona Portela P, Urra X, Rodriguez A, Bolognini F, Lebedinsky PA, Pasco-Papon A, Godard S, Marnat G, Sibon I, Limbucci N, Nencini P, Nappini S, Saia V, Caldiera V, Romano D, Frauenfelder G, Gallesio I, Gola G, Menozzi R, Genovese A, Terrana A, Giorgianni A, Cappellari M, Augelli R, Invernizzi P, Pavia M, Lafe E, Cavallini A, Giossi A, Besana M, Valvassori L, Macera A, Castellan L, Salsano G, Di Caterino F, Biondi A, Arquizan C, Lebreuche J, Galvano G, Cannella A, Cosottini M, Lazzarotti G, Guizzardi G, Stecco A, Tassi R, Bracco S, Bianchini E, Micieli C, Pascarella R, Napoli M, Causin F, Desal H, Cotton F, Costalat V; ET-COVID-19 Study Group*. European Multicenter Study of ET-COVID-19. Stroke. 2021 Jan;52(1):31-39. doi: 10.1161/STROKEAHA.120.031514. Epub 2020 Nov 23.

publisher_dissemination: Wolters Kluwer Health


title: Individualized Hemodynamic Optimization by Indirect Measurement of the Respiratory Quotient in Major Surgery: Prospective Randomized Multicentre Open-Label Study (OPHIQUE) Individualized Optimization by Indirect Measurement of the Respiratory Quotient

acronym: OPHIQUE

summary: The measurement of the inspired / expired fractions in O2 and CO2 is part of the daily monitoring of the intubated-ventilated patient in the operating theater. The ratio of VCO2 to VO2 (respiratory quotient (RQ)) is a non-invasive indirect measure of anaerobic metabolism of the patient, and an indirect reflection of tissue perfusion. We hypothesize that a hemodynamic optimization in major surgery individualized by non-invasive continuous measurement of the RQ would optimize TaO2 more specifically by informing us about the installation of a VO2 dependence, and therefore of an anaerobic metabolism. Patients are randomized in 2 groups : Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of Systolic Voume (SV) by vascular filling and use of dobutamine if necessary. Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine. Primary and secondary outcomes are recorded 1,2,7 and 30 days after the surgery.

ReferenceCitation: Bar S, Boivin P, El Amine Y, Descamps R, Moussa M, Abou Arab O, Fischer MO, Dupont H, Lorne E, Guinot PG. Individualized hemodynamic optimization guided by indirect measurement of the respiratory exchange ratio in major surgery: study protocol for a randomized controlled trial (the OPHIQUE study). Trials. 2020 Nov 23;21(1):958. doi: 10.1186/s13063-020-04879-x.

evidence: oa repository (via free pdf)

repository_normalized: Research Square

evidence: oa repository (via page says license)

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators: Centre Hospitalier Universitaire de Caen

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

acronyme: OPHIQUE

titre: Optimisation hémodynamique individualisée par la mesure indirecte du quotient respiratoire en chirurgie majeure non cardiaque : étude prospective randomisée multicentrique (OPHIQUE)

discipline_principale: optimisation hémodynamique, oxygénation tissulaire, chirurgie non cardiaque, complications

nom_porteur: BAR

prenom_porteur: Stéphane


title: Impact of a Procedure With Socio-aesthetic Care on Anxiety and Pain Scale in the Early Rest of Pulmonary Transplant.

summary:
Pulmonary transplant is a valid therapy and now accept in some case of respiratory disease at final state of their evolution in selected patients according to morbidity associated. This exceptionnal procedure (+/- 350 patients per year) brings benefits in terms of survival and quality of life but stay nevertheless, an experience very gruelling, anxiogenic and painful with sometimes extend hospitalizations in intensive care and then in pneumology unit.

Transplant can generate several complications like infection or rejection which can be fatal. The rate of death a year after the transplant is around 27% and whom 5 years after is around 48% according Biomedicine Agency, 2016) It's also mar of physical consequences (pain, scrars) specific to this act and expose the patient to several psychologic disruptions (decrease of body reflect, difficulty to accept organ of an other person...) So post transplant period is a painful and frightening moment. However, fear is not only sensory, it's also an affective side involving unpleasant feelings, fear and anxiety. It's a subjective and personnal experience influenced by the culture, context and other psychologic variables.

The collateral effects of transplantation could be controlled through additionnal diverse comfort cares but no care protocoles can be validated, especially because of multiple confounding individuals factors.

Recent studies showed that socio-aesthetic care allow an improvment of pain perception after cardiac surgery or oncology treatment.

The investigators propose to evaluate by a randomized controlled study the effect of comfort care of socio-aesthetic type on anxiety and pain in the aftermath of a pulmonary transplant.

In their hypothese, comfort care as socio-aethetic (body care, massage, manicure, corrective make up) could bring a personnalized answer to these patients, adapting to their complaint and waiting. It could ease the pain, anxiety, decrease level of corrective care and their side effects.

In their study, socio-aesthetic care will be done by therapist with 15 years of experience and working since 2003 in the oncology unit at la Timone Hospital and since 2009 to psychiatry unit to la Conception Hospital

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique des Hôpitaux de Marseille


title: Single Time Management for Seven Common Disease in Pediatric Traumatology. A Monocentric Prospective Study

summary: A recent internal study evaluating the relevance of the visit to traumatology consultation in our establishment highlight that 49.3% of consultations were not relevant passages. The project consists of individualizing 5 to 6 pathologies and to create care sheets and patient sheets to be given to the care teams and patients when the pathology lends itself to it. The aim is to reduce the irrelevant passage rate during these consultations, which is the source of absence from iterative work for parents, collateral expenses (toll, parking), absence from school for the children, unjustified expenses and X-ray examination unnecessary most often.

location_facility: Fondation Lenval Hopitaux Pediatriques de Nice Chu Lenval


title: Comparison of the Tolerance of Vancomycin in Combination With Piperacillin/Tazobactam or Cefepim as Empirical Antimicrobial Therapy of Prosthetic Joint Infection

summary: The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. T


title: Chronic Infections on Articular Prostheses With C. Acnes Diagnosed by Specific PCR : Descriptive Study of 6 Patients

summary: Osteaoarticular infection due to C. acnes are known to be of late onset, causing chronic infection possibly pauci-symptomatic. Osteaoarticular infection due to C. acnes represents a diagnostic challenge, since C. acnes is slow and difficult to grow, and can also be considered a contaminant.A 16S universal PCR bacteriological diagnosis has been proposed but is lacking of sensitivity. A specific C. acnes PCR was developed in 2010, but is not used routinely.


acronym: LOVIT ARDS

summary:
The primary objective of the study aims to compare the effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 28 days on intensive care unit (ICU) patients.

As secondary objectives, the study aims:

To compare the effect of high-dose intravenous vitamin C vs. placebo on:

6-month mortality;
6-month HRQoL;
organ function (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU);
global tissue dysoxia (at baseline);
oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU, and if still intubated);
occurrence of stage 3 acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global Outcomes) criteria20;

acute hemolysis as defined by:

clinician judgment of hemolysis, as recorded in the chart, or

hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following:

reticulocyte count >2 times upper limit of normal at clinical site lab;
haptoglobin < lower limit of normal at clinical site lab;
indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab;
lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab.

Severe hemolysis:

- hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells;

hypoglycemia as defined as core lab-validated glucose levels of less than < 3.8 mmol/L.
To assess baseline vitamin C levels in study participants (before the first dose of investigational product).

location_facility: Department Intensive Care Unit, Hospital Raymond Poincaré - APHP

title: A Multicentre Concealed-Allocation Parallel-Group Blinded Randomized Controlled Trial to Ascertain the Effect of High-Dose Intravenous Vitamin C Compared to Placebo on Mortality or Persistent Organ Dysfunction at 28 Days in Septic Intensive Care Unit Patients

type: EudraCT Number

source: euctr

acronyme: LOVIT

titre: Etude multicentrique, randomisée en double insu des effets de fortes doses de vitamine C versus placebo sur la mortalité et les défaillances d'organes à 28 jours chez les patients de réanimation avec un sepsis compliqué de SDRA

discipline_principale: anesthésiologie / réanimation

nom_porteur: ANNANE

prenom_porteur: Djillali


title: Frequency of Correct Response and Factors Associated in the Medium Term With a Multimodal Rehabilitation Program for Chronic Low Back Pain

acronym: FRELOMB

summary:
Non-specific chronic low back pain is defined as pain that originates in the lumbar spine, is persistent, lasts more than 3 months, and is unrelated to an inflammatory, traumatic, tumour, malformation, or infectious cause. Chronic low back pain is one of the most frequent reasons for consulting a physician, and one of the most common sources of disability, particularly as a result of socio-professional withdrawl. It is a major consumer of health resources (diagnostic investigations, multiple treatments) and involves heavy expenses for the investigator's health insurance system. In view of this major public health issue, in November 2017, the Health Insurance and several specialized health organizations launched a "general public" campaign to raise awareness of low back pain. This campaign, entitled "Back pain? The right treatment is movement" was designed to encourage appropriate physical activity in patients with low back pain.

Among the available therapies, multimodal programs are recommended as a first line treatment. In order to incorporate physical activity into patients' daily lives, these rehabilitation programs are based on a comprehensive multidisciplinary approach (therapeutic education, muscle strengthening, reconditioning, ergonomics, psychological, social, professional and nutritional management and cardiovascular risk factors). Although such programmes have already shown short term effectiveness, few data are available on their continued effectiveness in the medium term (1 year). This project aims to identify good and bad responders to a multimodal program in the medium term, based on common clinical parameters (Quebec City questionnaire score and spontaneous walking speed), and to identify the mechanisms underlying this response.

In addition, in clinical practice, heterogeneity in maintaining the effectiveness of the program is observed but little documented. The limited data available show a heterogeneity of these programs and one of the objectives of this project will be to identify the existing barriers and levers available to improve this situation.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of the Puncture of the RP6 Point on the Ampliation and Injuries of the Perineum During Childbirth

acronym: PELVPUNCTURE

summary:
During the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present.

After signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. The acupuncturist midwife does not perform the delivery herself. At the time of the expulsive efforts, she punctures the point drawn at random. The patient's participation in the study ends when she leaves the labour room after the birth.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Sud Francilien


title: Evaluation of the Efficacy of an Educational Program Through Video Conference

acronym: Visio-Respir

summary: Educational programs are essential for cystic fibrosis patients who need to take several different drugs every day. Compliance is often klow in these patients, and clinicals and paramedics try to increase it, through educational programs. As for inhaled therapies, the CF center of Montpellier uses a video conference tool to educate patients. The program may involve either the physiotherapist or the doctor or both. Through the present study, the investigators would like to evaluate the current practice at the CF center of Montpellier and verify if patients feel that the physiotherapist could handle the program on his own, without the support of a physician.


title: Evaluation of the Impact of the Therapeutic Communication Training of the Stretcher Bearers on the Patient Anxiety in the Operating Room (STRESSCOM)

acronym: STRESSCOM

summary:
Anxiety is a form of psychic and/or physical discomfort caused by the feeling of the imminence of a danger. It is a frequent perioperative manifestation of patients. Pharmacological premedication is currently used to avoid perioperative anxiety. However, its effect is now controversial and non-drug techniques have been also studied.

The therapeutic communication aims to provide analgesia or anxiolysis to enhance the patient's well-being and to separate the patient from the surrounding reality through the suggestion of positive images with a chosen verbal and nonverbal approach. This prospective, monocentric, comparative, double-blind study aims to evaluate the impact of the training of stretcher-bearers in therapeutic communication on the anxiety of patients who go to the operating room for an endoscopic examination under general anaesthesia.Two groups of patients will be compared: In the first group patients will be accompanied to the operating room by a stretcher-bearer trained in therapeutic communication, in the second group patients will be accompanied by a stretcher bearer without this specific training.

lead_sponsor: Lille Catholic University

sponsor_collaborators:
Lille Catholic University
University Hospital, Lille


title: DERMACLIC : Study on Skin Toxicities Induced by Cancer Treatments

acronym: DERMACLIC

summary: The skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, or lung.

lead_sponsor: Institut Curie


title: Clinical Relevance of the Reverse Lipopolysaccharide Transport Pathway in Patients With Acute Peritonitis An Observational Prospective Study

acronym: LIPS

summary:
When there is infection in the intra-abdominal area, bacteria secrete toxins that are absorbed by the peritoneum. These toxins then bind to lipoproteins (which carry cholesterol in the blood) and are eliminated by the liver. Phospholipid transfer protein (PLTP) is a protein that facilitates the binding of bacterial toxins to lipoproteins and thus their elimination.

The objective of this study is to study the relationship between PLTP and the elimination of bacterial toxins in humans. A better understanding of the elimination of these toxins will lead to a better understanding of the disease. The ultimate objective is to improve the management of intra-abdominal infections.


title: Validation Study of a Rapid Screening Test of Food Addiction in Patients Suffering From Obesity and Healthy Volunteer

acronym: FAST - FR

summary: Food addiction (FA) is a behavioral addiction characterized by a high consumption of palatable foods, which markedly activate the reward system, despite adverse consequences. FA was first described in 1956 but remains controversial. The Yale Food Addiction Scale (YFAS), developed by Gearhardt et al. in 2009, is currently regarded as the "Gold Standard" for FA screening. In a previous study, we established a Food Addiction Screening Test using artificial intelligence. The main objective of the present study is to validate the sensitivity, specificity and precision for FA diagnosis in a sample of patient suffering from obesity and healthy volunteers.


title: Identification of Psychosocial Factors Associated With Diagnostic Delay in Advanced Basal Cell Carcinoma

acronym: PSYCHO-CBC

summary: The aim of this study was to identify psycho-social factors associated with diagnostic delay in advanced basal cell carcinomas. Thus, the objective is to develop recommendations to better identify CBCa populations at risk, improve earlier their diagnosis and thus their care with an adequate and targeted information.

ReferenceCitation: Garrouteigt C, Broc G, Legrand A, Quintard B, Beylot-Barry M. Facilitators of and obstacles to consultation in patients with advanced basal cell carcinoma: a French pilot study. Arch Dermatol Res. 2021 Dec;313(10):829-835. doi: 10.1007/s00403-020-02175-x. Epub 2021 Jan 12.

lead_sponsor: University Hospital, Bordeaux

collaborators: Bordeaux Population Health Research centre

location_facility: Service de Dermatologie - Hôpital Saint André


title: Place of Ultrasound Guidance of Surgery Site in Surgery for Lumbar Canal Stenosis and Lumbar Disc Herniations

summary:
The identification of the operative site of lumbar ductal stenosis and lumbar disc herniation is classically done by radioscopy, thus inducing irradiation of the patient.

The use of ultrasound in spine surgery is little studied and poorly mentioned in the scientific literature. However, it is commonly used for other types of scouting (especially anesthetics). Thus, in the absence of consensus and clear recommendations, some practitioners perform ultrasound scans . Methodological developments also validate the feasibility of the ultrasound approach.

The double benefit of an ultrasound identification is firstly a lack of exposure to X-rays for both the patient and the operating team and secondly a lower cost than a conventional radiography.

The main objective is to demonstrate the interest of the ultrasound identification of the surgical site in the intervention of lumbar ductal stenosis and lumbar disc herniations in terms of concordance of the operating site between ultrasound and fluoroscopy.

lead_sponsor: Centre Medico-Chirurgicale et Obstetrique Cote d'Opale


title: International Opinion Study on Peri-operative Cerebrospinal Fluid Leaks Management After Endoscopic Skull Base Surgery

summary:
Cerebrospinal fluid (CSF) leak is a rare condition. When it involves the ventral skull base, a surgical closure may be achieved using endoscopic skull base surgery techniques. The major principles remain in achieving a watertight closure that can also support the brain (and avoid brain sagging) in case of extensive skull base defects. Surgical techniques are well described. Many clinical factors may influence the successful rate of the reconstruction. However, there is a lack of clinical study on perioperative management of CSF leaks. The purpose of this study is to gather the opinion of skull base surgeons on the post-operative management of patients to avoid CSF leak recurrence.

•Methods: The investigators will collect data from skull base surgeons using an electronic survey questionnaire (Google Form, Google, Mountain View, California, U.S.A.) submitted by e-mail to the members of the French Association of Rhinology, to the European Rhinologic Society, to the French college of neurosurgeons, to the Italian skull base society members, and to the former students of the European endoscopic skull base diploma. This is an anonymous 60-items survey. Questions were classified in eight sections: general questions, material used at the end of the surgical procedure, post-operative resting position, drugs, CSF depletion, post-operative advices, explorations in case of early recurrence of the rhinorrhoea, and follow-up modalities.

•Discussion: The investigators aim to understand the actual practice of skull base surgeons after closure of ventral skull base CSF leaks. This can serve as a basis for conducting clinical studies in the future.


title: Observational Retrospective Study Evaluating Efficacy and Safety of Ialuset Cream or Gauzepad in Second Degree Burns Use for Children

summary:
Observational retrospective monocentric study occured in the univeristy hospital center of Bensançon the department of pediatric surgery.

Data of patients treated in the hospital between January 2016 and January 2019 have been collected.

lead_sponsor: Laboratoires Genévrier


title: Oral Health Perception and Difficulties Encountered by Parents in the Implementation of Oral Hygiene of Children Under 6, Qualitative Study.-

summary:
A qualitative analysis was carried out on 15 participants, in 3 different places: the Montpellier health center, a pediatric odontology practice in Nîmes and a dentistry practice in Marseille.

Two methods of analysis were chosen: thematic analysis and word counting.

time_perspective: Other


title: Ex Vivo Study of Drugs Transfer Across the Placenta

acronym: DRUGS-PTP

summary: Drug prescriptions are usual during pregnancy however women and their fetuses still remain an orphan population with regard to drugs efficacy and safety clinical studies. Most xenobiotics diffuse through the placenta and some of them can alter fetus development resulting in structural abnormalities, growth or functional deficiencies. The aim of the study is to study the drug transfer using human placenta after delivery.

ReferenceCitation: Schneider H, Panigel M, Dancis J. Transfer across the perfused human placenta of antipyrine, sodium and leucine. Am J Obstet Gynecol. 1972 Nov 15;114(6):822-8. doi: 10.1016/0002-9378(72)90909-x. No abstract available.

ReferenceCitation: Hutson JR, Garcia-Bournissen F, Davis A, Koren G. The human placental perfusion model: a systematic review and development of a model to predict in vivo transfer of therapeutic drugs. Clin Pharmacol Ther. 2011 Jul;90(1):67-76. doi: 10.1038/clpt.2011.66. Epub 2011 May 11. Erratum In: Clin Pharmacol Ther. 2011 Sep;90(3):479.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Feasibility Study of the ETOILE Program, a Therapeutic Education Program in Pediatric Hematology About Acute Lymphoblastic Leukemia and Allogenic Hematopoietic Steam Cells Transplantation, for Patient and Caregivers

acronym: ETOILE

summary: Feasibility study of a therapeutic education program for the patient and his carers, intended for children suffering from acute lymphoblastic leukemia or having received an allograft of hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital ( Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will be assessed.


title: Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

acronym: HYPNOICU

summary: Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia. The aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU patients.


title: Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients

acronym: NEPHRACTIVE

summary:
Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions.

Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care.

Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters.

Nevertheless, there are no data on the medico-economic impact of such a program.

Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology.

The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.

lead_sponsor: Clinique Néphrologique Saint-Exupéry

location_facility: Clinique Néphrologique Saint Saint-Exupéry


title: End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room: Prospective Randomized Clinical Trial Comparing Two Occlusion Tests (EXPIRE)

acronym: EXPIRE

summary: The purpose of the study is to evaluate the influence of different durations of the end-expiratory occlusion test to predict fluid responsiveness in mechanically ventilated patients in the operating room.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Performance and Safety of the Polylactic Interference Screw Used in Anterior Cruciate Ligament Reconstructions

summary:
The evaluation of the clinical data has demonstrated the conformity of the Polylactic Interference Screw (PIS), with the relevant essential requirements for its use in orthopaedic applications. The Polylactic Interference Screws are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the PIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:

Objective IKDC score (clinical evaluation) Subjective IKDS score (functional evaluation) Safety (report of any adverse event) Follow-up of the patient's recovery

lead_sponsor: Biomatlante

sponsor_collaborators: Biomatlante Atlanstat


title: Safety and Feasibility of a New Neuromuscular Monitoring Device

acronym: MONITOF

summary:
The aim of the study is to compare, during general anesthesia using neuromuscular blocking agent, the feasibility of a new mechanographic device (ITF handle and Visual ITF software) with a standard acceleromyographic device (TOF Watch SX) and also to assess its safety during the first 24 hours after surgery.

The two devices will be studied simultaneously in each patient.

lead_sponsor: Poitiers University Hospital


title: Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients

summary: This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammatory, cardiovascular and oxidative stress parameters in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). The hypothesis is that these differences in glycemic response and in metabolic, inflammatory, cardiovascular and oxidative stress parameters response can be observed after 3 months of diet.

lead_sponsor: Mondelēz International, Inc.

location_facility: Centre de Recherche en Nutrition Humaine Rhone-Alpes


title: Positive and Quantitative Diagnosis of Pleural Effusions by Thoracic Ultrasonography in Patients With Acute Respiratory Failure in the Emergency Department

acronym: POCUYTO

summary:
Acute respiratory failure (ARF) is a frequent reason for consulting in the Emergency Department (ED) and one of the major clinical problems prompting admission in intensive care unit. In the ED, evaluation of an ARF is mainly based on clinical examination and frontal chest x-ray performed to the patient bedside. This practice has a limited diagnostic capacity due to a lack of specificity of clinical and radiological semiology, especially in the polypathological patient. Thoracic ultrasonography provides morphological information regrouped as a syndrome (interstitial syndrome, alveolar condensation, pneumothorax) and allows the identification of pleural effusions (PE). The PE diagnosis is easy, quick, and relies on two-dimensional ultrasound imaging. Compared to CT scan, which remains the reference examination although ill-suited in the context of emergency, thoracic ultrasonography has a sensitivity and specificity greater than 90% for pleural liquid (PL) diagnosis. In addition, thoracic ultrasonography is used to assess the volume of PL, determine its nature and guide the pleural puncture with higher performance than chest x-ray. The semi-quantitative evaluation of PEs has been validated in patients with mechanical ventilation hospitalized in intensive care unit. On the other hand, few data on the prevalence and quantification of PL for hospitalized patients in ED for an ARF are currently available.

Thus, the objective of this study is to evaluate the prevalence and severity of the PL identified by thoracic ultrasonography in patients admitted to the ED for an ARF by emergency physicians with ultrasound skills recommended by the French Society of Emergency Medicine.

lead_sponsor: University Hospital, Limoges


title: Plasma Oxalate in Patient With Short Bowel

acronym: OXAGO

summary: Hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. Not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. Plasma oxalate shouldn't increase theoretically in these patients. However recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria. The aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.

lead_sponsor: Hospices Civils de Lyon

location_facility: Nephrology Department, Edouard Herriot Hospital


title: Treatment and Long-term Outcomes of Pediatric Patient With Penetrating Crohn's Disease: the Multicenter Cross-sectional Study

acronym: Pediatric B3

summary:
The incidence of Crohn's disease (CD) increased the last few years, especially in children, with 20% percent of CD patients diagnosed during childhood. The CD is a chronic disease without curative treatment, medical or surgical, and evolution is longer in children, avoid iterative digestive resections and their consequences in these patients is a major issue.

The beginning of the disease at pediatric age is considered to be a poor prognostic factor and is considered to be more aggressive than that of adults: more extensive, more active and requiring more immunosuppressive treatments, with a more frequent dependence on corticosteroids and a shorter delay between the beginning of symptoms and the first surgery. After 5 years of evolution, 13 to 50% of patients with early pediatric MC have undergone intestinal resection.

The Paris' classification defined 3 phenotypes or behaviors in pediatric Crohn's disease. Penetrating phenotype (B3) is a heterogeneous group defined by the presence of intra-abdominal perforation, fistulas or abscesses. The B3 phenotype is a risk factor for pejorative evolution in CD with a risk increased of surgical resection.

In the pediatric population, the natural history of patients with penetrating CD is unknown. Most studies focus on CD beginning at pediatric age but with penetrating complications occurring in adulthood or pediatric penetrating CD but with relatively short follow-up. The risk of recurrence of the penetrating disease after a first complication in childhood is unknown, the factors influencing this risk also. And, there is no consensus either concerning optimal B3 management in children, and the practices are variable from specialist to specialist.

After describing the pediatric population with penetrating CD, the aim of this study was to know the incidence of bowel resection for B3 episode. The secondary aims were to describe the immediate management and long-term evolution of these patients and to identify risk factors for adverse evolution.

lead_sponsor: University Hospital, Montpellier

collaborators: Pediatric gastroenterology service, Toulouse University Hospital: Dr Breton

collaborators: Adult gastroenterology service, Montpellier University Hospital: Dr Pineton de Chambrun

collaborators: Pediatric gastroenterology service, Montpellier University Hospital: Dr Kollen


title: Pronostic Value of Diaphragmatic Excursion Measurement in Patients With Acute Respiratory Failure in the ED.

acronym: PREDIRE

summary:
Acute respiratory failure is one of the most common diagnosis in patients admitted in the Emergency Department. Acute respiratory failure is associated with morbidity and mortality. Fifteen percent of patient will require ventilatory support and among them 40% will die.

Measurement of diaphragmatic motion (excursion) at ultrasonography is a noninvasive measure, allowing to assess diaphragm dysfunction. It could be useful in predicting poor prognosis in ED patients with respiratory failure .

In this study the investigators will compare the prognostic value of diaphragmatic excursion measurement at ultrasonography to that of the National Early Warning Score (NEWS) 2 in patients presenting with acute respiratory failure in the ED

The Investigators made the hypothesis that measurement of diaphragmatic excursion in ED patients with acute respiratory failure could be of value in predicting the need for ventilatory support or mortality within 28 days from ED admission

sponsor_collaborators:
University Hospital, Montpellier
Poitiers University Hospital
University Hospital, Brest
Nord-Vienne Hospital


title: International Registry of Isolated Angioedema

acronym: CloudRHAE

summary: Angioedema is a disease characterized by the appearance of self-limiting edema that last 1-5 days and affect the subcutaneous tissue and/or gastrointestinal and oropharyngeal mucosa. In this last location edema can be lethal causing asphyxia, in all other cases full recovery is complete. Attacks can appear as part of the syndrome urticaria angioedema and can be of allergic origin. But there is a group of non-allergic angioedema that occur without hives and can be either hereditary or acquired. These angioedema are identified in some cases on the basis of etiology, in others are identified by the mediator and an overall classification of these forms of angioedema was published in 2014 as a result of a consent conference organized by the proponents of this registry. Being these forms of angioedema rare, there are not significative case studies inclusive of a high number of patients. This registry aims to collect in a single place a high number of subjects with recurring angioedema and without urticaria.

lead_sponsor: University Hospital, Grenoble


title: L'évaluation de l'Attachement, de l'Auto-compassion et Des stratégies de Coping Chez Les Patients Douloureux Chroniques

acronym: attachpain

summary: Compare the self-compassionate score by type of attachment, "safe" or "insecure", in chronic pain patients.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A de Rothschild