acronym: CYTOPRO

title: Comparison Between 25 µg Vaginal Misoprostol Versus Slow Release Pessary Prostaglandin-E2 (PGE2) : Could we Use Low Dose Vaginal Misoprostol as a First Line Treatment for Induction of Labor ?

type: EudraCT Number

source: euctr

ReferenceCitation: Mounie M, Costa N, Gaudineau A, Molinier L, Vayssière C, Derumeaux H. Cost-effectiveness analysis of vaginal misoprostol versus dinoprostone pessary: A non-inferiority large randomized controlled trial in France. Int J Gynaecol Obstet. 2022 Aug;158(2):390-397. doi: 10.1002/ijgo.13999. Epub 2021 Nov 19.

ReferenceCitation: Gaudineau A, Senat MV, Ehlinger V, Gallini A, Morin M, Olivier P, Roth E, Orusco E, Javoise S, Fort J, Lavergne C, Arnaud C, Rozenberg P, Vayssiere C; Groupe de Recherche en Obstétrique rt Gynécologie. Induction of labor at term with vaginal misoprostol or a prostaglandin E2 pessary: a noninferiority randomized controlled trial. Am J Obstet Gynecol. 2021 Nov;225(5):542.e1-542.e8. doi: 10.1016/j.ajog.2021.04.226. Epub 2021 Apr 19.

location_facility:
Bicêtre Hospital
University Hospital Toulouse
Hospital Poissy
Hôpitaux Universitaires de Strasbourg

summary:
For about 10% of pregnancies, it is necessary to induce delivery for medical reasons. Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In France, dinoprostone is the own approved medication. It is in the form of gel or sustained release device whose effectiveness and side effects are comparable. The vaginal misoprostol has no marketing authorization in France, but is sometimes used. Some data in the scientific literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more complications, was at least as effective and seems to be cost-effective compared with dinoprostone. Misoprostol with this dose and route of administration is now recommended by the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on induction of labor). According to HAS, the investigators still lack data on large samples to confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of cesarean section, and lower cost compared to dinoprostone.

The primary objective is to demonstrate non-inferiority of vaginal misoprostol 25 mcg vs. dinoprostone in terms of cesarian section occurence with a non-inferiority margin of +5% difference.


type: Other Identifier

title: Impact of an Intervention of Screening, Treatment Initiation and Referral to Promote Smoking Cessation in Emergency Department Patients: the Pilot PROSCEED Randomized Controlled Study

acronym: PROSCEED

summary: Smoking cessation assistance is one of the major issues in prevention policies because the prevalence of smoking remains high in France. With its numerous consultations, an emergency service seems to be an interesting place for setting up and helping with weaning, despite specific working conditions. The study, which is a pilot, is interested in the feasibility and efficacy of the implementation of a STIR (Screening, Treatment Intervention and Referral) protocol, which screening, brief intervention, nicotine replacement therapy and referral to a specialist in order to help the patients in smoking cessation.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Emergency department Hospital Pitié-Salpêtrière

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Prospective French Study on ACQUIred Haemophilia Treatment With Recombinant Factor VIIa (NovoSeven®) A Prospective Observational Study on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for the Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia

summary: This study is conducted in Europe. The aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor VII (NovoSeven®) in patients with acquired haemophilia in France. The secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Novo Nordisk A/S

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Prospective National Cohort Study on Swedish Adjustable Gastric Band (SAGB) for Gastroplasty (Étude de Cohorte Nationale Prospective de l'Implant Annulaire Ajustable Pour Gastroplastie SAGB)

summary:
Longitudinal prospective cohort study of patients treated consecutively by SAGB in a sample of centers representative of this activity in France.

Verification by means of a screening log (exhaustive list of all bariatric procedures performed by participating surgeons between the beginning and end of the cohort inclusion period) requested from all centers.

No comparator group. No randomization or blinding techniques

ReferenceType: derived

ReferenceCitation: Ribaric G, Buchwald J. Gastric band is safe and effective at three years in a national study subgroup of non-morbidly obese patients. Croat Med J. 2014 Aug 28;55(4):405-15.

lead_sponsor: Ethicon Endo-Surgery (Europe) GmbH


title: Études Observationnelles Des conséquences de l'Infection à Virus Zika au Cours de la Grossesse Pendant l'épidémie Des départements français d'Amérique de l'année 2016

acronym: ZIKA-DFA-FE

summary: The Zika (ZIKV) epidemic has spread into the three French Overseas Departments in the Caribbean (DFAs). It is therefore urgent to set up tools to collect clinical and paraclinical data for the evaluation of potential complications due to having ZIKV infection during pregnancy. This study is meant to collect, within usual care practices, clinical and paraclinical information which will allow the precise description of the consequences of ZIKV infection occurring during pregnancy.

ReferenceType: result

ReferenceCitation: Funk AL, Hoen B, Vingdassalom I, Ryan C, Kadhel P, Schepers K, Gaete S, Tressières B, Fontanet A. Reassessment of the risk of birth defects due to Zika virus in Guadeloupe, 2016. PLoS Negl Trop Dis. 2021 Mar 3;15(3):e0009048. doi: 10.1371/journal.pntd.0009048. eCollection 2021 Mar.

ReferenceCitation: Hoen B, Schaub B, Funk AL, Ardillon V, Boullard M, Cabié A, Callier C, Carles G, Cassadou S, Césaire R, Douine M, Herrmann-Storck C, Kadhel P, Laouénan C, Madec Y, Monthieux A, Nacher M, Najioullah F, Rousset D, Ryan C, Schepers K, Stegmann-Planchard S, Tressières B, Voluménie JL, Yassinguezo S, Janky E, Fontanet A. Pregnancy Outcomes after ZIKV Infection in French Territories in the Americas. N Engl J Med. 2018 Mar 15;378(11):985-994. doi: 10.1056/NEJMoa1709481.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: CH de l'Ouest Guyanais Franck Joly (CHOG)


title: Oral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic Markers

summary:
Systemic sclerosis (SSc) is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. As all connective tissues can be affected, this condition has multiple effects on the orofacial region. Indeed, the latter is involved in approximately 80% of SSc patients. Oral manifestations have a major impact on quality of life and require specific treatments that should be performed as early as possible.

Widening of the periodontal ligament space, that seems to be linked to an increased collagen synthesis, is one of the most common dental radiographic finding. However, this radiologic sign has been mostly studied on two-dimensional radiographs. The investigators have recently described in a patient suffering from SSc the existence of calcifications within the periodontal ligament space using Cone Beam Computed Tomography (CBCT) approach (Jung et al., Oral Surg Oral Med Oral Pathol Oral Radiol 2013). Such calcifications, that have never been observed before, could be part of the phenotypic spectrum of the disease, in particular when dystrophic calcinosis is associated. They could furthermore constitute a specific feature of SSc. However, this radiographic sign requires to be investigated in a largest number of patients.

Several cytokines have been implicated in SSc pathogenesis. A recent study has revealed that elevated CXCL4 serum levels correlate with disease complications, suggesting that this molecule could be used as a prognostic biomarker. Increased IL-6 serum levels also correlate with SSc severity. Gingival crevicular fluid can be easily collected from the gingival crevice surrounding the teeth and constitute an indicator of local but also systemic inflammation. Analysis of gingival crevicular fluid cytokine profile could contribute to the identification of specific SSc biomarkers and allow a better comprehension of oral manifestations pathogenesis.

The aim of this case-control study is to characterize precisely the oral manifestations associated with SSc within the National Referral Center for Rare Autoimmune Diseases (Strasbourg, France) patient cohort in order to identify specific radiological, clinical and/or biological signs. Some of them could be correlated to the severity or to the prognosis of the disease. To the investigators knowledge it is the first study using tridimensional CBCT approach.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Strasbourg, France

intervention_type: Radiation

status_simplified: Unknown


title: ESSAI DE PHASE III RANDOMISE EVALUANT LE FOLFOX AVEC OU SANS DOCETAXEL (TFOX) EN 1ère LIGNE DE CHIMIOTHERAPIE DES ADENOCARCINOMES OESO-GASTRIQUES LOCALEMENT AVANCES OU METASTATIQUES

acronym: GASTFOX

summary:
Gastric cancer is the fourth commonest cancer and the second largest cause of mortality from cancer. Surgical resection of localised forms of gastric cancer offers the only chance of a cure. The vast majority of patients, however, present with advanced disease from the outset (locally advanced or metastatic) or recurrent after resection of a localised form.

For metastatic or locally advanced stages of gastric or gastro-oesophageal junction adenocarcinoma, the combination of 2 chemotherapy drugs (dual therapy) as compared with monotherapy or no chemotherapy, makes it possible to improve the tumour response and patient survival. Dual therapy comprising cisplatin + fluoropyrimidine (CF protocol) is considered as one of the first-line chemotherapy treatment standards.

The addition of docetaxel to the CF regime (referred to as the DCF protocol) has made it possible to improve the tumour response rate, the time to tumour progression and overall survival in a randomised phase III trial. This improvement in treatment efficacy was achieved, however, at the expense of a significant increase in grade 3-4 toxicity, including diarrhoea , neutropenia, and neutropenia with complications. Although DCF is considered as a therapeutic standard for advanced forms of gastric cancer, its use is limited in clinical practice due to its high toxicity.

Oxaliplatin has shown its usefulness in treatment of oesophagogastric cancer, with an efficacy at least equal to that of cisplatin. Peripheral sensory neuropathy was less common in the 5FU-cisplatin arm. In terms of treatment efficacy, 5FU-oxaliplatin versus 5FU-cisplatin was associated with a non-significant improvement in median progression free survival rates, and overall survival.

All these data thus suggest that 5FU-oxaliplatin is at least as efficacious and is better tolerated than 5FU-cisplatin, and also that docetaxel-5FU-cisplatin is more efficacious than 5FU-cisplatin, with limited use due to its high toxicity. In the logical continuation of development of chemotherapy protocols for metastatic gastric cancer, the question therefore arises of the usefulness of adding docetaxel to 5FU-oxaliplatin, in terms of efficacy and also tolerance.

In France, chemotherapy with FOLFOX is used extensively as a first line of treatment in advanced gastric cancer, but with progression-free survival and median survival rates that are still too low, and a poor response rate. The use of docetaxel at a dose of 50 mg/m2 every 2 weeks in combination with FOLFOX (TFOX protocol) has shown very interesting results in phase II studies in terms of efficacy and tolerability, and these are worth confirming through a phase III randomised trial. In fact, if these results are confirmed in phase III, TFOX could become the new first-line therapeutic standard for advanced gastric cancer, while limiting toxicity and preserving patients' quality of life, and could become the reference treatment to accompany the targeted therapies currently being developed for this disease.

The primary objective of this randomised phase III trial is to compare the progression-free survival on dual therapy with 5FU-oxaliplatin (FOLFOX protocol) with triple therapy with 5FU-oxaliplatin-docetaxel (TFOX protocol) in treatment of advanced forms of gastric or oesophagogastric junction adenocarcinoma. The secondary objectives are overall survival, the tumour response rate, toxicity, quality of life and the therapeutic index, defined as the ratio between the median progression-free survival and the febrile neutropenia rate.

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Zaanan A, Samalin E, Aparicio T, Bouche O, Laurent-Puig P, Manfredi S, Michel P, Monterymard C, Moreau M, Rougier P, Tougeron D, Taieb J, Louvet C. Phase III randomized trial comparing 5-fluorouracil and oxaliplatin with or without docetaxel in first-line advanced gastric cancer chemotherapy (GASTFOX study). Dig Liver Dis. 2018 Apr;50(4):408-410. doi: 10.1016/j.dld.2018.01.119. Epub 2018 Mar 1.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country: France Martinique

location_facility: Institut de Cancérologie de Bourgogne - GRRECC


title: A Randomized and Controlled Phase II National Protocol in Non NF1 Pediatric and AYA (Adolescent and Young Adults) Patients Bearing a Wild Type BRAF Gene Newly Diagnosed Comparing a Daily Oral MEK Inhibitor (Trametinib) Versus Weekly Vinblastine During 18 Months

acronym: PLGG - MEKTRIC

summary:
Pediatric low-grade glioma (PLGG) is a heterogeneous group of WHO grade I and II brain tumors, associated with a 10-year overall survival of 90%. It is the most common form of primary central nervous system (CNS) tumor arising during childhood, adolescence and young adulthood, accounting for over 30% of CNS tumors in this age group. A large group of PLGG patients will benefit from a complete resection of their tumor. Nevertheless, PLGG can occur anywhere and can be in some locations associated with neurological symptoms, unresectable or radiological progressive tumors that need medical treatments rapidly to avoid long-term sequelae. The current problem during this first line therapy is to improve tumor response, overall survival rate, as well as progression free survival. In our study, we will focus on a specific group of PLGGs without any congenital NF1 mutation and with a wild-type BRAF gene in the tumor. In this subgroup, for instance, the PFS is not increasing anymore above 50% at 3 years independently from the chemotherapeutic scheme. The two current standard therapies are carboplatin plus vincristine during 81 weeks or a weekly IV administration of vinblastine during 70 weeks. The most recent Canadian approach with vinblastine seems to have the same PFS rate, but with a better daily tolerance and less toxicities than the carboplatin/vincristine combination. Therefore, it is becoming the new standard approach in those patients. Nevertheless, we need to improve more their outcome with less recurs and a better first-line tumor response. The recent molecular discoveries involving the Ras/mitogen-activated protein kinase pathway in those PLGG is opening a new era with specific targeted therapies that might be the key to improve their survivals and giving hope to less treatment lines and a better tumor response. Therefore, we designed a prospective open randomized phase II study, named PLGG-MEKTRIC, comparing the experimental arm (a daily MEK inhibitor, Trametinib, Mekinist©) to a standard arm comprising weekly vinblastine during 18 courses of 4 weeks each. The study will enroll 134 patients with a PLGG during childhood, adolescence or young adulthood with no NF1-related disease and without any BRAFv600 mutation located in brain or spine. 67 patients, in each treatment arm, are planned to be enrolled to answer our primary objective. This primary objective will be to determine in the experimental arm a 20% superiority of the 3-year PFS rate in comparison with the standard treatment administered during 18 courses (e.g. 72 weeks). A stratification of the patients will be done in both arms based on molecular tumor results and brain/spine locations to obtain two equivalent arms to be analyzed.

The recruitment time will be 36 months and the complete follow-up of each patient will last 3 years. The secondary objectives will be in both arms: the tumor response rate at 24 and 72 weeks of treatment, the 3-year PFS and OS rates and the frequency of AE/SAE/SUSAR (Adverse Event/Serious Adverse Event) based on CTCAE criteria during the 3 years after the first administration. A Quality of Life (QoL) assessment, based on PEDsQL questionnaires, at 24 weeks, at the end of treatment and 3 years after 1st treatment administration in both arms will be part of this study. Finally, 3-year PFS and OS will be analyzed according to molecular biomarkers and visual assessment (LogMar scale) in each arm. An economic analysis is also planned as an ancillary study to determine a cost effectiveness of the best arm and complementary ancillary molecular studies are already organized. In the future, we hope to push forward this new-targeted therapy as a referenced first line treatment of pediatric PLGG to obtain the best tolerance and positive long-term impact and to extend our knowledge of MEK inhibitor impact in molecular subgroups and in optical pathway locations. We also plan to do a "switch" strategy in patients relapsing in standard arm and we will propose systematically to those patients the experimental treatment (MEK inhibitor ).


title: Translation, Cross-cultural Adaptation and Validation of the MGQOL-15-F

summary: The purpose of this study is to translate and culturally adapt the MGQOL-15 (health-related quality of life scale for myasthenia gravis) for use with French-speaking patients in France and to evaluate its psychometric properties to ensure reliability and validity.

location_facility: Institute of Myology, La Pitié-Salpêtrière Hospital


title: Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients

acronym: AsthmaTrain

summary:
The onset of smartphone usage has provided new opportunities for managing patients outside the walls of healthcare facilities. The development of asthma-specific smartphone applications represents an excellent area for partnership between developers and medical teams for delivering therapeutic education at the required time and in a personalised way. Within this context, the overall goal of the AsthmaTrain study is to perform a first, small pilot study comparing a new French-language chat-bot guided asthma patient education programme (the 'Vik' application) with the classic, authority-approved patient education program at the University Hospitals of Montpellier, Montpellier, France.

The primary objective is to compare a population of adult patients with asthma and participating in a standard patient education programme with a similar population participating in Vik-guided education programme in terms of change in overall scores on the Asthma Quality of Life Questionnaire (AQLQ).

ipd_sharing: Yes

ipd_sharing_description:
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study.

Data will be made available to persons who address a reasonable request to the study director.

Individual participant data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.

The study protocol, participant information materials, and paper case report form will also be made available to the public.

lead_sponsor: University Hospital, Montpellier

location_facility: Centre Hospitalier Universitaire de Montpellier


title: Analysis of Blood Cells Innate Immune Response in Patients With Lobar Pneumonia

acronym: ASTRAL

summary:
Pulmonary bacterial infections such as exacerbations of chronic bronchitis, nosocomial and community-acquired pneumonia represent a major public health issue. Antibiotics have shown their efficacy by direct antimicrobial activity and their limit particularly in case of multidrug-resistant microorganisms or in treating patients with aggravating pathologies. Innate immunity could be an alternative or complementary therapeutic pathway. Innate immunity receptors bind universal and invariant microbial molecular patterns present in bacteria, virus, fungus or parasite. Toll-like Receptors (TLR) activation by microbial agonist stimulates the innate immunity response which results in the production of chemokines, cytokines, antimicrobial molecules and the recruitment of innate cells.

The " Pulmonary Infection and Innate Immunity " team of the Immunity and Infection Center in Lille (Group of Dr. Sirard and Carnoy) has a long expertise in the study of TLR5 and its agonist, the flagellin, a structural protein of bacterial flagella. TLR5 is expressed on the cell surface of macrophages, monocytes, dendritic and epithelial cells. Several studies in mice have shown the flagellin prophylactic potential during bacterial infections through a TLR5 dependent stimulation of innate immunity. Recently, the group of Dr. Sirard and Carnoy has shown that flagellin can be used in association with antibiotics to treat Streptococcus pneumoniae respiratory infections in mice. The results demonstrate that an agonist of TLR can increase the therapeutic index of an antibiotic and improve the pulmonary anti-infectious reaction. This innovative approach allows us to consider new antibacterial strategies where antibiotics have reached their limit (nosocomial infection, multidrug-resistant bacteria…). TLR agonists can activate multiple human cell type. Indeed, blood cells activation by TLR agonists have been recently characterized in healthy volunteers.

However, there is no available data on the ability of TLR agonists to activate cells from patients with infectious pneumopathies. A study in these patients is inevitable if one is to consider the therapeutic use of agonists in respiratory pathologies.

status: Unknown status

lead_sponsor: Lille Catholic University

intervention_type: Procedure


title: Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment, a French Cohort

acronym: PsyCovART

summary:
In France, one couple in eight encounters difficulties to conceive. The diagnosis of infertility frequently leads to symptoms of anxiety and depression. These symptoms appear to be higher than in the general population.

Some recent studies have looked at the relationship between anxiety and depression in ART cares.

Results are controversial, but it appears that patients with lower levels of anxiety and depression have higher pregnancy rates. Moreover, in couple, women seem to have more symptoms of anxiety and depression than men.

First epidemiological studies related to the COVID 19 pandemic have shown strong psychological impact on the general population with an anxiety rate estimated at more than 30%.

With COVID 19 pandemic and cessation of ART, it is highly likely that psychic symptoms of anxiety or even depression may have appeared or worsened in women undergoing infertility treatment.

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon


title: Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia

acronym: SCHIZO-CV

summary: Schizophrenia is a psychiatric disorder, affecting 600,000 patients in France. Patients with schizophrenia have life expectancy decrease from 10 to 20 years because of cardiovascular death. Cardiovascular risk factors are numerous: inadequate diet, smoking, alcohol consumption, diabetes, obesity. Primary prevention of cardiovascular risk in patients suffering from schizophrenia is difficult because of understaff in general practitioners and psychiatrists.

lead_sponsor: Université de Reims Champagne-Ardenne


title: Predictive Value of Biomarkers on Volemia, Extra and Intra Vascular Varation and Hydroelectrolytic Disorders in Different ICU Patients

acronym: ENVOL

summary: The purpose of this study is to determine whether the Biomarkers (pro adrenomedullin (MR proADM), pro arginin vasopressin (CT proAVP), pro atrial natriuretic peptid (MR proANP), Pro Endothelin) changes at Day 2, Day 5 and Day 7 of ICU admission are correlated with Intravascular volume assessed by Cr 51 on red blood cells (Day 2 and Day 7) and by I 125 on albumine Day 7. The correlation of these Biomarkers are also evaluted with other markers such as erythropoietin and catecholamines. 80 ICU patients are included.

ReferenceCitation: Vigué B, Leblanc PE, Moati F, Pussard E, Foufa H, Rodrigues A, Figueiredo S, Harrois A, Mazoit JX, Rafi H, Duranteau J. Mid-regional pro-adrenomedullin (MR-proADM), a marker of positive fluid balance in critically ill patients: results of the ENVOL study. Crit Care. 2016 Nov 9;20(1):363.

lead_sponsor: ThermoFisher Scientific Brahms Biomarkers France


title: Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline

summary:
Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients.

Design: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center.

Setting: 27 Intensive Care Units (ICU) in France

Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris

Patients: 800 patients could be included during the first 6 hours of their septic shock.

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies


title: Interoception in Anorexia Nervosa

acronym: INT-AN

summary: Anorexia nervosa is a serious psychiatric illness whose causes remain poorly understood, and which remains difficult to treat to this day. Many clinical manifestations of this disease can have their origin in abnormalities in the perception of signals coming from inside the body, but this remains to be demonstrated. In recent years, research in healthy subjects has shown how the brain constantly perceives the viscera (heart, lungs, stomach). The examiners will use these new, objective and validated methods to explore how the brain processes information from the viscera (interoception) in anorexic patients. In practice, they will quantify the coupling between the cardiac cycle and involuntary eye movements, as well as between the respiratory cycle and voluntary actions such as pressing a button. Finally, by simultaneously recording the electrical activity of the brain, and that of the stomach, the examiners will measure the coupling between the brain and the stomach. All these measurements, which will be compared between a population of patients and healthy subjects, will make it possible to determine whether anorexic patients have an alteration in the perception of their internal body signals and whether this damage affects several organs.

lead_sponsor: Fondation Santé des Étudiants de France


title: A Cohort Study to Assess the Impact of Paediatric Use of Proton Pump Inhibitors on the Risk of Community Acquired Infections

acronym: UTOPIE

summary:
Pharmacological treatment of physiologic Gastro-esophageal Reflux disease (GERD) is excessive in France, as 65%-85% of children below 11 years are being treated, frequently with Proton Pump Inhibitors (PPIs) PPI have been associated, in adults, with an increase of infection rate but data in pediatry are scarce, especially in community medecine. Recently a study conducted in England brought up controversial results suggesting that the use of PPIs can be associated with a reduced risk of community acquired pneumonia.

Our study was aimed to assess, on a population-based database, the association between PPI prescription and community infections in children of 11 years or under.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy

summary:
Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible.

The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after thyroidectomy.

lead_sponsor: Poitiers University Hospital


title: Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant

acronym: CoQualSEP

summary: Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

ReferenceCitation: Planche V, Moisset X, Morello R, Dumont E, Gibelin M, Charré-Morin J, Saubusse A, Mondou A, Reuter F, Defer G, Pelletier J, Brochet B, Clavelou P. Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study. J Neurol Sci. 2017 Nov 15;382:148-154. doi: 10.1016/j.jns.2017.10.008. Epub 2017 Oct 6.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Short Telomere in Patients at High Cardiovascular Risk: a Simple Marker or a Major Determinant of Accelerated Arterial Aging

acronym: TELARTA

summary:
The prevailing view in telomere epidemiology is that leukocyte telomere length (LTL) is associated with atherosclerosis and accelerated aging since it serves as a biomarker of the cumulative burden of inflammation and oxidative stress during adult life. Our recent results however, indicate that telomere length (TL) is mainly determined at birth and childhood. Since short telomeres ante cede atherosclerosis, the investigators hypothesize that TL is not just a simple marker, but a real determinant of arterial aging. That is because TL reflects cellular repair capacity and a short LTL denotes diminished repair reserves. This hypothesis cannot be tested by measurements of LTL alone, since this parameter reflects TL at birth and its age-dependent attrition thereafter. The investigators propose, therefore, a model that makes it possible to examine different elements of TL dynamics in different tissues: leukocytes, skeletal muscle, endothelial progenitor cells (EPCs), skin or subcutaneous fat in patients with or without atherosclerosis.

Our model is based on the following premises, which are derived from observations that TL is synchronized (equivalent) across somatic tissues/cells of the newborn:

TL in skeletal muscle mainly reflects TL at birth
The difference in TL between muscle and leukocytes in adults (approximately 1.5 Kbp) mainly reflects LTL attrition during the growth period, i.e., childhood/adolescence
TL in EPCs determines the cell proliferative ability and therefore capacity for vessels repair during aging.

The general aim of the present project is to examine the links of arterial aging with TL, as expressed in different tissues, and LTL dynamics, as expressed in the difference between TLs of muscle and leukocytes.

time_perspective: Cross-Sectional

ReferenceCitation: Toupance S, Simonici S, Labat C, Dumoulin C, Lai TP, Lakomy C, Regnault V, Lacolley P, Dignat George F, Sabatier F, Aviv A, Benetos A; TELARTA consortium †. Number and Replating Capacity of Endothelial Colony-Forming Cells are Telomere Length Dependent: Implication for Human Atherogenesis. J Am Heart Assoc. 2021 May 18;10(10):e020606. doi: 10.1161/JAHA.120.020606. Epub 2021 May 6.

ReferenceCitation: Benetos A, Toupance S, Gautier S, Labat C, Kimura M, Rossi PM, Settembre N, Hubert J, Frimat L, Bertrand B, Boufi M, Flecher X, Sadoul N, Eschwege P, Kessler M, Tzanetakou IP, Doulamis IP, Konstantopoulos P, Tzani A, Korou M, Gkogkos A, Perreas K, Menenakos E, Samanidis G, Vasiloglou-Gkanis M, Kark JD, Malikov S, Verhulst S, Aviv A. Short Leukocyte Telomere Length Precedes Clinical Expression of Atherosclerosis: The Blood-and-Muscle Model. Circ Res. 2018 Feb 16;122(4):616-623. doi: 10.1161/CIRCRESAHA.117.311751. Epub 2017 Dec 14.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
AP Hôpitaux de Marseille
Chu Nancy


title: Ibuprofen and Renal Function in Premature Infants

summary:
Purpose of the study:

To evaluate renal function maturation within the first month of life in very premature infants.
To determine whether a treatment with Ibuprofen for patent ductus arteriosus would alter renal function maturation at short term and up to 28 days of life.

ReferenceCitation: Gournay V, Roze JC, Kuster A, Daoud P, Cambonie G, Hascoet JM, Chamboux C, Blanc T, Fichtner C, Savagner C, Gouyon JB, Flurin V, Thiriez G. Prophylactic ibuprofen versus placebo in very premature infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2004 Nov 27-Dec 3;364(9449):1939-44.

ReferenceCitation: Desandes R, Jellimann JM, Rouabah M, Haddad F, Desandes E, Boubred F, Semama DS, Vieux R, Hascoët JM. Echocardiography as a guide for patent ductus arteriosus ibuprofen treatment and efficacy prediction. Pediatr Crit Care Med. 2012 May;13(3):324-7. doi: 10.1097/PCC.0b013e31822882b5.

ReferenceCitation: Vieux R, Hascoet JM, Merdariu D, Fresson J, Guillemin F. Glomerular filtration rate reference values in very preterm infants. Pediatrics. 2010 May;125(5):e1186-92. doi: 10.1542/peds.2009-1426. Epub 2010 Apr 5.

ReferenceCitation: Vieux R, Desandes R, Boubred F, Semama D, Guillemin F, Buchweiller MC, Fresson J, Hascoet JM. Ibuprofen in very preterm infants impairs renal function for the first month of life. Pediatr Nephrol. 2010 Feb;25(2):267-74. doi: 10.1007/s00467-009-1349-9. Epub 2009 Nov 10.

lead_sponsor: Maternite Regionale Universitaire

location_facility:
CHU
Maternite Regionale Universitaire
AP-HM (Néonatologie)


title: Prospective, Multicentric, Randomized on Two Arms, Controlled, by Cross-over, Pilot Study, in Order to Evaluate Disconfort Among Outpatients Using actiTENS for Neuropathic Pain vs TENS ECO 2.

acronym: QolTENS

summary:
Non-pharmacological treatments for pain relief are more and more used in clinical care although any scientific validation. Among the non-pharmacological treatments of neuropathic pain relief, TENS (Electrical Nerve Stimulation Therapy) is the major treatment with the best benefit. Unfortunately, the use of TENS by patients appears very difficult. Because of this inconvenience, more than 40% of TENS users interrupt the treatment despite treatment benefit. A new TENS device: actiTENS that seems to be less constraining than TENS is now available in France. ActiTENS efficacy and safety compared to TENS need to be investigated.

The main objective is to evaluate and to compare the use of actiTENS, with TENS Eco 2, the classical device in patients with chronic neuropathic pain.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
APHP - Hopital Saint Antoine
CHD La Roche Sur Yon
CHU Amiens Picardie
CHU de Nantes
CHU Montpellier
CHU de Toulouse


type: Registry Identifier

title: Interest of Azithromycin With or Without Hydroxychloroquine for the Treatment of COVID-19 Pneumonia : a Retrospective Observational Study

acronym: AZITHROVID

summary:
During COVID-19 epidemic, hydroxychloroquine was proposed and authorized as a possible key agent in the treatment of COVID-19 hospitalized pneumonia, including in France. Gautret et al. proposed the combination regimen with azithromycin. However only one study reported the interest of azithromycin alone.

Retrospective study reporting the impact of the anti-infective agents used during the pandemic in a tertiary care hospital, using azithromycin with or without hydroxychloroquine.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Relating the 'Experienced Present' With the Mechanisms of Neuronal Function: A Comparative Study in Patients With Schizophrenia and Healthy Controls Using Psychophysical and Neurophysiological Methods

summary: Abnormalities in the ability to distinguish events in time may have a great impact on everyday life. The main objective of the study is to evaluate the magnitude of the temporal windows in schizophrenia, i.e. the time interval during which two events are perceived as synchronous. The investigators test the hypothesis that these temporal windows are enlarged, and check the relationship between this impairment and disorganization symptoms, in order to explore the link between this cognitive impairment and clinical symptoms. They explore also the neurobiological bases of the impairment by means of electroencephalogram (EEG) recordings. Event-related potentials (N50) will reveal whether or not the coding of the stimuli has the same temporal characteristics in patients and controls. The distribution and amplitude of oscillatory activities will be analyzed as a function of the synchronous or asynchronous response of the subject, thus allowing to explore the links between synchrony perception and neuronal synchronization phenomena.

location_facility: Service de Psychiatrie Adulte & INSERM U841, Hôpital Albert Chenevier et Henri Mondor (AP-HP)

location_facility: INSERM U666 - Département de Psychiatrie - Hôpitaux Universitaires de Strasbourg


title: Evaluation of FabLife's Personalised Support Program Effectiveness in Sperm Quality Improvement in Men Suffering From Hypofertility

acronym: FabLife

summary:
FabLife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan France.

The main objective is to evaluate the effect of FabLife personalised program over a period of 15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to general dietary recommendations.

primary_purpose: Health Services Research

lead_sponsor: FabLife

location_facility:
Tenon Hospital (AP-HP)
Drouot Laboratory

intervention_type: Device


title: Prevention of Cardio-embolic Stroke Using Anti-vitamin K and Direct Oral Anticoagulants. A Model of Action in Burgundy.

acronym: AOD

summary: Stroke is a major public health problem as it is very frequent (140,000 cases/year in France), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading cause of handicap). Ischemic cardio-embolic stroke accounts for around 25% of ischemic strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial fibrillation (CAAF) is the leading non-atheromatous cause. The aim of this study is to optimise the secondary prevention of CAAF-related stroke identified at the University Hospital of Dijon Burgundy in the framework of the recommendations of the '2010-2014 stroke plan' and the Compulsory Consultation at the 6th month (Directive DGOS//2015/262 of the 3rd August 2015)


title: EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications

summary: The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is an iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO). EASYX™ is CE-marked since December 2016 and has been used in humans a few time for type II endoleaks, portal vein and varicocele (<10 cases at the date of submission). The purpose of this study is to evaluate the safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP - Hopital Europeen Georges-Pompidou Paris, France


title: Implementation of a National Register of Children and Adults Presenting Prader-Willi Syndrome

summary:
Prader-Willi Syndrome (PWS) is a rare syndrome with a prevalence of 15 to 20 000 at birth. PWS represents a large fraction of mental retardation syndromes due to a genetic cause and the most frequent cause of genetic obesity. The majority of the patients are seen by paediatricians. This syndrome is responsible for severe physical, psychological and social impairments.

The diversity and the severity of the manifestations of this disease explain the requirement of multidisciplinary care which deserve specific evaluation. Today the follow-up and management of a great proportion of these patients are greatly insufficient if not absent.

Teams strongly lack information on the natural history of this severe disease and on the factors involved in its evolution and the outcome of these patients throughout life. The present project is to implement a register in the whole country for children and adult patients

ReferenceCitation: Pacoricona Alfaro DL, Lemoine P, Ehlinger V, Molinas C, Diene G, Valette M, Pinto G, Coupaye M, Poitou-Bernert C, Thuilleaux D, Arnaud C, Tauber M. Causes of death in Prader-Willi syndrome: lessons from 11 years' experience of a national reference center. Orphanet J Rare Dis. 2019 Nov 4;14(1):238. doi: 10.1186/s13023-019-1214-2.

lead_sponsor: University Hospital, Toulouse


title: How a Patient's Words Change the Rewarding Value of Food: Mapping the Neurocognitive Shift Generated by Motivational Interviewing During the Therapy of Food Addiction Onto the Brain - MOTIVFOOD

acronym: MOTIVFOOD

summary: Why in some situations can words soothe our cravings? This research proposal will test the power of self-generated reasons for behavioural change in food addiction, which concerns about three out of ten persons and causes major life hazards such as obesity, diabetes and cancer. While food addiction is becoming more and more frequent in western societies, not much is known about its underlying neurocognitive mechanisms and how to tackle it. This study aims to investigate if and why certain types of affirmation-based therapies such as motivational interviewing (MI) are beneficial for the treatment of food addiction. The working hypothesis proposes that cognitive regulation-based self-control underpins the neurocognitive shift of a patient's willingness to change addictive behaviour, generated by the patient during MI therapy of food addiction. To test this hypothesis this study combines functional magnetic resonance imaging with behavioural testing of dietary decision-making following a participant's change or sustain talk statements. It will compare three groups of participants with and without food addiction and obesity and lean controls. This study will contribute to the improvement of therapies based upon talking oneself in and out of addiction promoting goals. Findings will provide a better understanding of how our everyday life dietary decision-environments prompt good intentions such as improving long-term nutritional quality to actual behaviours such as forgoing immediate desire.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

intervention_type: Behavioral


title: Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".

acronym: COGIT

summary:
Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics. Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source of these troubles. Its anatomical substrates is based on connections between frontal and striatal areas.

Initially, a battery of behavioral tests measuring different types of impulsivity (motor, cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40 patients treated and 40 untreated) and 40 healthy volunteers.

Then, investigators will study the fronto-striatal connections in the TS group of 80 patients (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging techniques (3T MRI). The techniques used will be functional connectivity study of "resting state" MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging data to highlight the functional anatomical substrates of impulsivity in patients with TS.

Finally, investigators will look specifically using functional MRI activation, the anatomical and functional substrates of the three types of impulsivity (motor, cognitive and decision-making).

Through this study, investigators hope to elucidate the anatomical and functional bases of cognitive impulsivity in patients with TS and thus lay the basis for more targeted treatments.


title: Development of New Multi-contrasts Approaches by Magnetic Resonance Imaging at 3 Tesla Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients.

summary:
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a validated procedure, used in many French and international centers for the treatment of severe forms of Parkinson's disease (PD). The improvement of parkinsonian motor symptoms by stimulation of the STN is 50 to 80% on average. The main advantage of DBS is that the surgery has low morbidity and mortality, it is adaptable to the patient's symptoms and its effect is reversible. This treatment is now a routine and more than 85,000 patients worldwide have benefited from the installation of this system. Since 1997, this treatment is available to patients followed in the Pitié Salpêtrière (GHPS).

The accuracy of preoperative anatomic targeting in stereotactic neurosurgery will improve with the use of high-field MRI. However, several new issues and inherent in that high-field MRI should be evaluated before the images can be used directly.

The chosen sequences must be short to be feasible, minimizing patient discomfort, and evaluated on several patients to ensure the low interindividual variability. In addition, the quality of the display on all of the sections should provide a reliable three-dimensional information. Finally, the quality of targeting and its possible improvement should be checked.

ReferenceCitation: Benabid AL, Koudsie A, Benazzouz A, Piallat B, Krack P, Limousin-Dowsey P, Lebas JF, Pollak P. Deep brain stimulation for Parkinson's disease. Adv Neurol. 2001;86:405-12. Review.

ReferenceCitation: Bejjani BP, Dormont D, Pidoux B, Yelnik J, Damier P, Arnulf I, Bonnet AM, Marsault C, Agid Y, Philippon J, Cornu P. Bilateral subthalamic stimulation for Parkinson's disease by using three-dimensional stereotactic magnetic resonance imaging and electrophysiological guidance. J Neurosurg. 2000 Apr;92(4):615-25.

ReferenceCitation: Egidi M, Rampini P, Locatelli M, Farabola M, Priori A, Pesenti A, Tamma F, Caputo E, Chiesa V, Villani RM. Visualisation of the subthalamic nucleus: a multiple sequential image fusion (MuSIF) technique for direct stereotaxic localisation and postoperative control. Neurol Sci. 2002 Sep;23 Suppl 2:S71-2.

ReferenceCitation: Longhi M, Ricciardi G, Tommasi G, Nicolato A, Foroni R, Bertolasi L, Beltramello A, Moretto G, Tinazzi M, Gerosa M. The Role of 3T Magnetic Resonance Imaging for Targeting the Human Subthalamic Nucleus in Deep Brain Stimulation for Parkinson Disease. J Neurol Surg A Cent Eur Neurosurg. 2015 May;76(3):181-9. doi: 10.1055/s-0033-1354749. Epub 2015 Mar 12.

ReferenceCitation: Lefranc M, Derrey S, Merle P, Tir M, Constans JM, Montpellier D, Macron JM, Le Gars D, Peltier J, Baledentt O, Krystkowiak P. High-resolution 3-dimensional T2*-weighted angiography (HR 3-D SWAN): an optimized 3-T magnetic resonance imaging sequence for targeting the subthalamic nucleus. Neurosurgery. 2014 Jun;74(6):615-26; discussion 627. doi: 10.1227/NEU.0000000000000319.

ReferenceCitation: Yelnik J, Bardinet E, Dormont D, Malandain G, Ourselin S, Tandé D, Karachi C, Ayache N, Cornu P, Agid Y. A three-dimensional, histological and deformable atlas of the human basal ganglia. I. Atlas construction based on immunohistochemical and MRI data. Neuroimage. 2007 Jan 15;34(2):618-38. Epub 2006 Nov 15.

ReferenceCitation: Breit S, LeBas JF, Koudsie A, Schulz J, Benazzouz A, Pollak P, Benabid AL. Pretargeting for the implantation of stimulation electrodes into the subthalamic nucleus: a comparative study of magnetic resonance imaging and ventriculography. Neurosurgery. 2006 Feb;58(1 Suppl):ONS83-95.

ReferenceCitation: Cheng CH, Huang HM, Lin HL, Chiou SM. 1.5T versus 3T MRI for targeting subthalamic nucleus for deep brain stimulation. Br J Neurosurg. 2014 Aug;28(4):467-70. doi: 10.3109/02688697.2013.854312. Epub 2013 Nov 5.

ReferenceCitation: Patil PG, Conrad EC, Aldridge JW, Chenevert TL, Chou KL. The anatomical and electrophysiological subthalamic nucleus visualized by 3-T magnetic resonance imaging. Neurosurgery. 2012 Dec;71(6):1089-95; discussion 1095. doi: 10.1227/NEU.0b013e318270611f.

ReferenceCitation: Marques JP, Kober T, Krueger G, van der Zwaag W, Van de Moortele PF, Gruetter R. MP2RAGE, a self bias-field corrected sequence for improved segmentation and T1-mapping at high field. Neuroimage. 2010 Jan 15;49(2):1271-81. doi: 10.1016/j.neuroimage.2009.10.002. Epub 2009 Oct 9.

ReferenceCitation: Liu T, Eskreis-Winkler S, Schweitzer AD, Chen W, Kaplitt MG, Tsiouris AJ, Wang Y. Improved subthalamic nucleus depiction with quantitative susceptibility mapping. Radiology. 2013 Oct;269(1):216-23. doi: 10.1148/radiol.13121991. Epub 2013 May 14.

ReferenceCitation: Xiao Y, Fonov VS, Beriault S, Gerard I, Sadikot AF, Pike GB, Collins DL. Patch-based label fusion segmentation of brainstem structures with dual-contrast MRI for Parkinson's disease. Int J Comput Assist Radiol Surg. 2015 Jul;10(7):1029-41. doi: 10.1007/s11548-014-1119-4. Epub 2014 Sep 24.

ReferenceCitation: Starr PA, Martin AJ, Ostrem JL, Talke P, Levesque N, Larson PS. Subthalamic nucleus deep brain stimulator placement using high-field interventional magnetic resonance imaging and a skull-mounted aiming device: technique and application accuracy. J Neurosurg. 2010 Mar;112(3):479-90. doi: 10.3171/2009.6.JNS081161.

ReferenceCitation: Bardinet E, Belaid H, Grabli D, Welter ML, Vidal SF, Galanaud D, Derrey S, Dormont D, Cornu P, Yelnik J, Karachi C. Thalamic stimulation for tremor: can target determination be improved? Mov Disord. 2011 Feb 1;26(2):307-12. doi: 10.1002/mds.23448. Epub 2010 Dec 13.


title: Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting

acronym: NEPAL

summary:
The frequency of neurological and psychiatric complaints for participants taking rilpivirine, elvitegravir, or dolutegravir reaches on average 20-30% during clinical trials. The inclusion and exclusion criteria for enrolling people living with HIV are at times so selective and the subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and ambiguous that one cannot extrapolate these particular research results to practicing medicine. These adverse events negatively affect the patient's quality of life and ultimately his or her good adherence to treatments.

This study aims at assessing the prevalence and at describing the neurological and psychiatric adverse events related to these drugs.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Pilot Study to Assess Efficacy and Safety of a Triple Therapy With Asunaprevir, Daclatasvir and BMS-791325 in HCV Genotype 4-infected Patients After Failure of Pegylated Interferon-Ribavirin Regimen

acronym: QUATTROTURBO

summary:
ANRS HC 33 is a pilot study to assess efficacy and safety of a DCV 3DAA therapy with Asunaprevir, Daclatasvir and BMS-791325 in HCV genotype 4-infected patients after failure of pegylated Interferon-Ribavirin regimen.

Proportion of patients with cirrhosis will be limited to 50% of all patients included, cirrhosis being defined as a METAVIR score of F4 on the liver biopsy or an hepatic impulse elastometry ≥ 14 kPa or a Fibrotest® result > 0,75.

status: Withdrawn

lead_sponsor: ANRS, Emerging Infectious Diseases


title: A FRENCH SURVEY OF THE DIAGNOSTIC AND THERAPEUTIC MANAGEMENT OF ELDERLY PEOPLE WITH HISTOLOGICALLY/CYTOLOGICALLY CONFIRMED LUNG CANCER.

summary: Management of lung cancer remains very controversial for elderly patients (pts) and they are often excluded from clinical trials. We present here a survey performed about the management of lung cancer pts aged 70 or more in France. All pts aged 70 or more with histo/cytologically proved lung cancer diagnosed between sept 02 and oct 03 in participating centers were recorded and their characteristics, the diagnostic procedures, therapeutic management and survival were analysed.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique


title: A Comparative Phase 2 Study Assessing the Efficacy of Triheptanoin, an Anaplerotic Therapy in Huntington's Disease

summary: In the study the investigators plan to include 100 early affected HD patients (5 ≤ UHDRS ≤ 40) in a randomized, double-blind, controlled study in 2 centers (France and the Netherlands). Patients will receive either triheptanoin at 1g/kg of body weight per day (n = 50), or a control oil (n = 50) at 1g/kg of body weight per day for 6 months followed by an open label phase using triheptanoin for another 6 months. Efficacy of triheptanoin will be evaluated by measurements of caudate volume using volumetric magnetic resonance imaging and brain energy metabolism as evaluated by the ratio of inorganic phosphate/phosphocreatine, during visual stimulation, using 31P-MRS. Clinical improvement will be evaluated by UHDRS, TFC, and PBA-S scores as well as performance on the neuropsychological battery; patient quality of life will be evaluated with qualitative research methods after 6 months and with the SF-36 questionnaire before and after treatment; biological tolerance and compliance will be evaluated by routine biochemical blood tests, plasma and urine measurements of triheptanoin oil derivatives and patient report.

ReferenceCitation: Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.

location_country: Netherlands France

location_facility:
Department of Neurology
Département de Génétique


title: Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers to the Optimal Care Pathway for Parkinson Disease Patients

acronym: ECOSO-ICAREPD

summary:
According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients.

It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.


title: Performances of Immunoassays Based on the Detection of Antibodies Directed Against Mycobacterium Tuberculosis Antigen for the Diagnosis of Active Tuberculosis in Adults

acronym: MycoTB

summary: TB remains a health problem in France with about 5,000 new cases per year. Development of new screening tests is a priority for TB. The main objective of the study is to evaluate performances of innovative blood tests to identify active tuberculosis in adults patients living in low-prevalence country. Adult patients with possible TB from will be tested for the presence of antibodies directed against M. tuberculosis selected antigens. Positive and negative predictive values will be established based on TB culture results.

lead_sponsor: University Hospital, Montpellier

location_facility: University Hospital Montpellier Department of microbiology


title: Epidemiological Study of Seroprevalence Against the SARS-CoV-2 Virus (COVID-19) in the Population of the Grand Nancy Metropolitan Area

acronym: COVAL-NANCY

summary:
In order to inform the public decision on the containment strategy and knowledge of the intensity of the epidemic during post-containment, estimates of the share of the population infected with the SARS-CoV-2 virus responsible for COVID-19 disease at the territorial level are needed as soon as possible. The aim of the study is to estimate the prevalence of positive anti-SARS-CoV-2 serologies by detection of IgT-total antibodies (IgM/IgA/IgG) in the general population of the Grand Nancy Metropolitan area.

A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected will be conducted.

The target population consists of all the inhabitants of the Grand Nancy Metropolitan area, from which a sample is drawn from the electoral lists (households) in a random manner to ensure representativeness. In order to ultimately include 2000 people in the study

primary_purpose: Screening

intervention_type: Biological


title: Effects of a Multidisciplinary Outpatient Rehabilitation Program on Physical Capacity and Quality of Life in Patients With Ehlers-Danlos Syndrome.

summary: The management of patients with Ehlers-Danlos syndrome (EDS) is still underdeveloped in healthcare institutions in France. Although multidisciplinary management through exercise rehabilitation has demonstrated its benefits in many chronic pathologies, it has not been evaluated for EDS. As a result, to date there is no evidence of its effectiveness in patients with EDS. The objective of this study is therefore to objectively evaluate the effectiveness of such a treatment on the different dimensions of these patients' health.

ReferenceCitation: Hakimi A, Bergoin C, Mucci P. Evidence of ventilatory constraints during exercise in hypermobile Ehlers-Danlos syndrome. Eur J Appl Physiol. 2022 Nov;122(11):2367-2374. doi: 10.1007/s00421-022-05017-y. Epub 2022 Aug 8.

lead_sponsor: Hakimi Adrien


title: How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

acronym: Pedia-Card

summary: Congenital heart disease is a common abnormality in newborns. The marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. With the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Pédiatrie 1 - CHU de Strasbourg - France


title: Accelerometers' Validity in Counting Number of Steps in the Elderly Subjects Before Discharge From Rehabilitation Units, Having Reached Their Maximal Walking Ability After Physiotherapy. Comparison of the Accuracy of 3 Accelerometer Positions: Wrist, Ankle, Hip

acronym: VAPODAGE

summary: Accelerometers enhance physical activity. Nevertheless, their validity (ability to accurately count steps) is not known in an elderly frail population ready for discharge from a rehabilitation unit. The objective was to assess accelerometers' validity for counting steps (10 meters), in comparison with the gold standard: steps counted by 2 physicians blind to accelerometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). The second objective was to evaluate the best position of the accelerometer: wrist, ankle, hip.


title: Pediatric ANCA Associated-vasculitis : Latest Clinical Review and Therapeutic Outcomes. A Retrospective Epidemiological Study on a French Cohort

acronym: PediANCA

summary:
The incidence in pediatrics is very low (about 0.5 per million according to a French study) and therefore the data on the pathology very poor, especially on the therapeutic level.

Without appropriate treatment, the mortality rate of the pathology is very high.

Existing treatments are almost exclusively composed of immunomodulatory and/or immunosuppressive treatments.

Complications related to pathology and iatrogeny are among the first causes of mortality from this pathology and deserve to be studied in order to be known and if possible avoided. The purpose of the study is to achieve a national comparison of clinical and therapeutic practices.


title: Effect of Muscle Strengthening on the Incidence of Psychomotor Disadaptation Syndrome After a Fall in Elderly Persons

acronym: RM-SDP

summary: The post-fall syndrome or psychomotor disadaptation syndrome can be considered as a complication of a fall and can lead to a total loss of autonomy. This syndrome remains little studied, despite its important frequency in acute geriatric services or geriatric rehabilitation care, and despite its recognized seriousness. Decreased grip strength seems to be a risk factor for psychomotor disadaptation syndrome in after a fall, which is why we hypothesize that muscle strengthening adapted to the elderly subject would limit the appearance of this syndrome. By limiting this risk, it would reduce complications such as loss of functional independence, but also reduce the number and duration of hospitalization of elderly patients.

primary_purpose: Prevention

ipd_sharing: Undecided

location_facility: Service de Gériatrie aigue - CHU de Strasbourg - France

intervention_type: Dietary Supplement


title: Study of Calcium-phosphate Complications Induced by the Administration of IV Iron Supplementation in Patients With Rendu-Osler Disease

acronym: OS-LERETRO

summary:
Hypophosphatemia induced by treatments with injectable iron is a frequent side effect already reported during marketing. Situations of osteomalacia secondary to these hypophosphatemias are rarer and reported in the form of case reports in the literature. Hypophosphatemia in this context is attributed to an excess of FGF-23 (defect of degradation linked to carbohydrates in martial preparations) with renal leakage of phosphate.

Rendu-Osler disease (ROM) is an autosomal dominant genetic disease, favoring the formation of vascular malformations, including nasal and digestive telangiectasias causing repeated bleeding, even hemorrhages. Iron deficiency is frequent and profound there, and oral martial treatments are often insufficient to compensate for these losses. Regular iron infusions, to avoid transfusions, are often necessary.

location_facility: Service de Médecine interne - CHU de Strasbourg - France


title: Amélioration Des Techniques d'étude de la Micro-cirulation cutanée Chez Des Sujets Sains

acronym: MICROTEC

summary: Current stimulation induces microvascular dilation in human skin. The investigators aimed to study (1) whether the current vasodilation is amplified after two segmental current stimulation as compared to one stimulation; (2) whether this amplification relies on prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover trial is conducted in Angers, France.

primary_purpose: Basic Science

ReferenceCitation: Mahé G, Abraham P, Humeau-Heurtier A, Gascoin L, Lefthériotis G, Durand S. Evidence for a vasomotor cyclo-oxygenase dependent mechanism of sensitization at the cutaneous level. Br J Clin Pharmacol. 2015 Aug;80(2):185-92. doi: 10.1111/bcp.12623. Epub 2015 May 26.

lead_sponsor: University Hospital, Angers


title: Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.

acronym: Trauma-Head

summary:
The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments.

The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin.

The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.

location_facility: Service d'accueil des urgences - CHU de Strasbourg - France


title: Remote Evaluation of Quality of Life and Functional Capacities in Patients Hospitalised for COVID-19: a Prospective Observational Study

acronym: TELECOVID

summary:
Around 90.000 patients have been hospitalised due to COVID-19 infection in France between March 1st and June 15th; 19% of those requiring intensive care. Approximately 80% of these patients have been discharged home by September 30th. Nonetheless, COVID-19 infection along with intensive care consequences are very likely to impede those patients quality of life and functional capacities.

This study aims to describe the quality of life outcomes and functional capacities of COVID-19 survivors, at least 6 months after primary care hospital discharge.

lead_sponsor: Groupe Hospitalier du Havre


title: Stereotactic Margins in Localized Bronchial Cancer (T1/T2a, N0)

acronym: Stereotactic

summary:
Bronchopulmonary cancer is the first cause of mortality in the world. We want to update the margins used in stereotactic radiotherapy, in the context of localized lung cancer, of non-surgical management.

The investigators wish to redefine the stereotactic radiotherapy margins according to the histological type in localized non-small cell lung cancer.

Indeed, these criteria were previously defined on a smaller cohort, in the context of 3D radiotherapy (mainly T3, T4 tumors). In addition, the incidence of radiation pneumonitis is highly dependent on the irradiated lung volume, which in turn depends on the CTV margins used.

location_facility: Service de chirurgie thoracique - CHU de Strasbourg - France


title: Study of the Impact of an Intervention Performed by a Clinical Pharmacist on Patients at Risk of Pneumococcal Infection at the End of Hospitalization

acronym: IP-VAC

summary:
In France, Streptococcus pneumoniae is the leading agent involved in community-acquired bacterial pneumopathies and bacterial meningitis. The frequency of these infections is increasing in at-risk subjects. Paradoxically, pneumococcal vaccination coverage in this type of patient is limited at the national level, even though the French High Council for Public Health (HCSP) has been extending the 13-valent conjugate and 23-valent non-conjugate double vaccination in this target population since March 2017.

These patients generally benefit from regular medical follow-up involving several health professionals in hospital or outpatient clinics. In spite of this, one of the factors identified as a hindrance to pneumococcal vaccination is the absence of a proposal from the doctor.

We would like to assess compliance with the recommendations for pneumococcal vaccination according to the High Council of Public Health (HCSP) in at-risk patients leaving hospital. We also wish to measure the potential impact of an intervention by the clinical pharmacist on the application of these recommendations.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation

acronym: VAD

summary: The frailty syndrome is important to consider in perioperative cardiac assistance. One of its components is the patient's sarcopenia. This can be assessed by measuring the size of the psoas muscle. For this purpose, one of the most studied measures seems to be the measurement of the Psoas Index. This is a contouring of the psoas muscle, performed on an axial section of a CT scan, at the level of the L4 vertebra, which is then matched to the body surface. However, there is no standardization of measurements and volume acquisitions, and different image processing is also described. A radiological evaluation of the psoas could overcome this difficulty and provide a rapid and available screening tool for sarcopenia.

location_facility: Service de Réanimation Chirurgicale - CHU de Strasbourg - France


title: Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the

acronym: PALLI-ACC

summary:
The newborn feels pain and the newborn at the end of life, in the delivery room, is potentially exposed to pain and respiratory distress.

Protocols for the management of end-of-life symptoms in the delivery room are used in current practice with very few validation studies. The protocol used in delivery rooms in Alsace uses fentanyl and midazolam intranasally. It has been used for 3 years and seems to provide satisfactory relief to newborn babies. In doing so, it seems to reassure parents about the quality of support and it seems to meet the expectations of professionals in these anxiety-provoking contexts. Scientific validation of these practices would allow wider dissemination to other maternity teams.

location_facility: Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France

location_facility: Service de pédiatrie - Hôpitaux Civils de Colmar

location_facility: Service de Néonatologie- Centre Hospitalier de Mulhouse

location_facility: Service de pédiatrie - Hôpitaux Civils de Haguenau


title: Comparative Evaluation on Blood Pressure Effect of an Equivalent Sodium Intake, in the Form of Bicarbonate or Chloride, for Hypertensive Subjects.

acronym: SODIVASC-II

summary:
Numerous large-scale epidemiological studies have made it possible to establish a link between the average consumption of table salt (sodium chloride) and blood pressure figures. In France, according to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), salt intakes could be estimated from 2 national food consumption surveys INCA 1 and INCA 2. This made it possible to take a photograph of food consumption habits and to show that the average consumption of salt contained in food in France is 8.7g/day for men and 6.7g/day for women. To these contributions must also be added 1 to 2g of salt for the resalting and the cooking water. According to the food consumption survey INCA 3, french plate still contains a large part of processed foods and still a little too much salt (on average 9g/day for men and 7g/day for women at compare with the objectives of the National Health Nutrition Program of 8g/day and 6.5g/day respectively). In addition, the World Health Organization (WHO) recommends consuming less than 5g of salt per day.

In this context, sodium intake through mineral water was also questioned. Both in terms of basic and clinical research, the biological effects of dietary sodium chloride intake have been the subject of a great deal of work for several decades. The mechanisms of transmission in the induced or hemodynamic effects related to the absorption of Na multiple debates and their impact on cardiovascular risks remain very uncertain. Work has shown that all subjects do not react homogeneously to sodium chloride intakes, thus determining what are called "NaCl-sensitive" people who in a situation of major sodium intake will show an increase of peripheral vascular resistance and an increase in blood pressure, much more marked than in subjects called " NaCl resistant ".

"NaCl-sensitive" people represent 10 to 30% of the population, with notable differences according to ethnic origins, regions and continents. A marked overrepresentation of this phenotype is observed in patients with hypertension or with a family history of hypertension.

Furthermore, studies conducted on animals and humans show that sodium intake does not have the same impact on the parameters mentioned above, depending on whether it is in the form of chloride or bicarbonate salt.

On the basis of these elements, the investigators developed a clinical study protocol intended to demonstrate a possible differential effect in the biological effects of the same sodium orally intake (2.56g per day), depending on the salt origin.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Platform of Clinical Investigation / Clinical Investigation Center French Institute of Health and Medical Research-1405 University Hospital


title: Shifting of Intrauterine Device and Use of the Menstrual Cup: Case-control Study

acronym: CUP-DIU

summary:
In France, 26% of women of childbearing age use an intrauterine device (IUD) containing copper or levonorgestrel as a method of contraception. Failures of IUD contraception are mainly due to shifting or expulsion of the IUD. The risk factors for expulsion of IUDs most often found in the literature are young age (<25 years), the existence of menorrhagia, dysmenorrhea, being a carrier of a copper IUD rather than a levonorgestrel IUD , a history of IUD expulsion, nulliparity, and an anomaly of the uterine cavity unrecognized (fibroma, adenomyosis).

More and more women are turning to menstrual cups (MCs) as a means of periodic protection. But the use of MC has also been mentioned as a risk factor for IUD expulsion (via a suction effect). In May 2013, reports of displacement, rupture, or even expulsion of copper IUDs in CM users were reported to ANSM.

However, few studies have examined the risks associated with the concomitant use of an MC and an IUD. The data are contradictory and insufficient to provide a clear answer to women. Hence the interest in carrying out a larger prospective study to explore the relationship between IUD expulsion and the use of MC.


title: Study of the Geometry of the Immature Human Femur Before the Age of 3 Years From Data Measured on CT Scan

acronym: GFI

summary:
Childhood fractures are the second most common presentation of abuse. The target population for screening for these injuries is children under the age of three who are unable to express themselves about the circumstances of the trauma, hence the need to develop a validated model to predict the outcome of trauma as well as the origin of a fracture.

Few morphological data are available in the literature for the femur concerning the period of rapid growth between 0 and 3 years of age.

location_facility: Service de Médecine Légale et Toxicologie - CHU de Strasbourg - France


title: Validation of Specific Biomarkers for the Diagnosis of Endometriosis

summary:
EndoSearch aims to analytically validate a cluster of specific biomarkers for endometriosis diagnosis and disease recurrence. This signature will be tested on endometrium and blood from 975 patients, divided in two groups : 550 patients affected by endometriosis and 225 patients unaffected (controls).

EndoSearch is not about drug or medical device assessment but a research study for biomarker analytical validation purpose.

lead_sponsor: Dr Afchine Fazel


title: Assessment of Personalized Follow-up in Prevention of Type 2 Diabetes

acronym: Proxipart

summary:
In France, the overall prevalence of diabetes was estimated at 5% of population in 2016, type 2 diabetes (T2DM) corresponding to 90% of cases. However, this figure is greatly underestimated,since it does not take into account people who are untreated or not diagnosed. However,it is estimated that 20 to 30% of adults with diabetes do not are not diagnosed. Conclusions presented during the annual meeting of the european Association for the Study of diabetes (EASD-Berlin) from 2019 suggest that signs precursors of the disease would be present up to 20 years before the diagnosis.

The Diagnosis is usually made around 40-50 years. The main factor of risk of T2D is the lifestyle, in particular a diet too rich for a too sedentary daily life.

From a medico-economic point of view, chronic pathologies (including diabetes) account for 60% of insurance expenditure illness even though they concern 35% of insured persons, i.e. 20 million patients. The average annual repayment of a type 2 diabetic patient is 4890 euros.

This study is part of this context as the starting point a reflection on a different, coordinated management, to know a preventive rather than a curative approach.

lead_sponsor: Ramsay Générale de Santé


title: Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?

acronym: Drain-IHR

summary: Is there an indication for drainage in contact with a prosthesis placed in a retromuscular position, during a cure for abdominal wall ventration in adults? This procedure is very frequent in digestive surgery and can be associated with serious complications, notably prosthesis infection.

location_facility: Service de chirurgie générale et digestive - CHU de Strasbourg - France


title: Causes of Mortality in Kidney Transplant Recipients, a Paradigm Shift

acronym: Paradigme

summary: The causes of mortality in kidney transplant patients and the risk factors for mortality have been widely published. However, there is a high variability according to geographical areas and time. Recent studies suggest that the classical hierarchy of causes of mortality, i.e. the predominance of cardiovascular causes of death, could be overturned by the increase in infectious and cancer-related deaths. Investigators will try to highlight this paradigm shift and the related risk factors by studying two large French transplantation databases.

location_facility: Service Néphrologie-Dialyse-Transplantation - CHU de Strasbourg - France


title: Characteristics and Consequences of Coronary Angiograms Performed in Intensive Care Patients

acronym: Coro-ICU

summary: Coronary angiography is a key examination in the management of many patients hospitalized in intensive care units. The most frequent indication remains the performance of a gesture of unblocking of part of the coronary network in the context of an acute coronary syndrome (ACS) complicated by cardiogenic shock (CS) and/or cardiac arrest. cardio-respiratory (ACR). However, there are other indications in intensive care, in particular for diagnostic purposes. Given the lack of harmlessness of this procedure in itself and the consequences of intra-hospital transport outside intensive care units for patients who are sometimes very unstable, the risk-benefit balance before performing a coronary angiography requires always be properly assessed by the resuscitating physician.

location_facility: Service de Médecine Intensive - Réanimation - CHU de Strasbourg - France


title: Epidemiology of Pediatric Traumatology

acronym: ETP

summary:
Fractures have been shown to account for 10-25% of injuries in children and the consequences of pediatric fractures are significant and result in significant restriction of activity. Despite this, the epidemiology of pediatric fractures remains poorly detailed.

Investigators seek to establish the incidence of pediatric trauma and fractures and determine patient, trauma and injury characteristics.

location_facility: Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France


title: Dating of Fractures in Children : Chronological Markers From the Radiological Evolution of a Series of Femur Fractures

acronym: DFE

summary: Although several studies have studied the predictive nature of non-accidental trauma of the different types of fractures and in particular on the femur, the physiological and radiological particularities of the child make it difficult to estimate the age of a fracture and require defining a chronology specific to the specificities of the pediatric population. Some authors have carried out work for the dating of fractures, however the number of cases or the average age of the subjects does not allow a precise estimation of the chronology of evolution of the fractures.


title: Cefiderocol in the Treatment of Multidrug-resistant Gram-negative Bacilli Infections, a Retrospective Study

acronym: CefiNoFer

summary:
Cefiderocol is a new antibiotic from the siderophore cephalosporin family for which there are few real-life data on its use in the treatment of infections with multidrug-resistant Gram-negative bacilli.

The circulation of bacterial strains multi-resistant to antibiotics is important at the Strasbourg University Hospital, so the investigators wish to report their local experience of the 1st uses of Cefiderocol in the treatment of infections with multi-resistant Gram-negative bacilli to antibiotics in order to better clarify the use of this antibiotic (therapeutic indication, method of administration)

location_facility: Service des maladies infectieuses et tropicales - CHU de Strasbourg - France


title: Cefepime vs. Carbapenems for Treating AmpC β-lactamase-producing Enterobacteriaceae Bloodstream Infections

acronym: CARBAPENEM

summary: Recent international recommendations suggest the use of carbapenem rather than cefepime in this situation, but with a low level of evidence, given the few existing studies. As cefepime is a less broad-spectrum antibiotic than carbapenems, its use would limit the selection of multidrug-resistant bacteria.


title: Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt (TIPS) - Pilot Observational Cross-sectional Study

acronym: TIPS

summary:
Patient with Advanced Chronic Liver Disease often present portal hypertension which may lead to bleading or ascites.

One of the treatment of portal hypertension in these patients is the placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS).

The indications for placing TIPS take on various clinical presentations, the most classic being digestive haemorrhage by rupture of oesophageal and/or gastric varices and refractory ascites.

TIPS placement involves changes in haemodynamics and liver function that may alter the patients' condition and quality of life.

Very few articles have evaluated the quality of life of these patients and when quality of life is evaluated it is mostly with not adapted or not validated scales.

The main objective of this study is to evaluate the quality of life of patients who have undergone TIPS using a validated and standardised quality of life questionnaire (the SF-36 questionnaire).

location_facility: Service d'Imagerie Interventionnelle Vasculaire - CHU de Strasbourg - France


title: Oral Care of Patients Treated With Anti-RANK-ligand Antibodies for a Giant Cell Tumour: Retrospective Study at the University Hospitals of Strasbourg

acronym: DENO

summary:
Giant cell tumors are mostly benign tomoral processes, most often responsible for areas of osteolysis in the metaphysoepiphyseal area of long bones, representing 5-6% of primary bone tumors. The bone weakening induced by these beaches leads to pain and risk of fracture, and this is what leads the patient to consult.

These tumors are found particularly in the young adult population between 20 and 40 years old, are locally aggressive, but malignant transformations and metastases (pulmonary) are quite rare.

In this study, the investigators wish to retrospectively study the oral care of patients who presented with a giant cell tumor and were treated with Denosumab at the University Hospital of Strasbourg and their associated oral follow-up

location_facility: Service de Médecine et Chirurgie Bucco-Dentaires - CHU de Strasbourg - France


title: Collection and Analysis of the Clinical and Biological Characteristics of Patients Treated at Nîmes Carémeau University Hospital, for Giant Cells ARTEitis (Horton's Disease), for Diagnosis and During Long-term Follow-up

acronym: CARTECEL

summary:
Giant cell arteritis (GCA) or Horton's disease: frequent large vessel vasculitis (cephalic) (incidence estimated at 9 per 100,000 in France), potentially responsible for blindness.

Treatment: corticosteroid therapy, which is effective in the vast majority of cases.

Clinical problem: relapse; 36% to 44% of patients have a relapse that occurs in the first year for many patients, requiring a re-escalation of corticosteroid therapy, with its consequences:

Cumulative dose of corticosteroid therapy that causes cardiovascular and infectious morbidity.
Requires additional immunosuppressive treatment.


title: Tolerance and Potential Synergistic Effect of the Combination of Intranasal Esketamine and Non-selective Monoamine Oxidase Inhibitors (MAOIs)

acronym: ESKETAM

summary:
There are already recently published data on the tolerability and efficacy of the combination of ketamine and/or esketamine with MAOIs. However, these reports are few and far between, and to our knowledge, there are no data involving intranasal esketamine.

Given the numerous interactions between MAOIs and other antidepressants, and the impossibility of combination, this pharmacological class is neglected. This is despite the fact that MAOIs are the only truly tri-aminergic drugs, that they have unparalleled efficacy in certain forms of resistant apathetic depression, and that new, more dietary permissive forms have appeared on the market. The arrival of antidepressants that can be combined with MAOIs, such as ketamine and esketamine, changes the situation and could offer a new treatment opportunity to many patients in a therapeutic impasse. For these opportunities to become a reality, sharing the clinical experience gained by specialized centers is essential.

location_facility: Service de physiologie - Explorations fonctionnelles - CHU de Strasbourg - France


title: Aspects of Vulnerability of People Living With HIV in the Alpine Arc Region

acronym: ASPEGIC

summary: HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES ("Évaluation de la précarité et des inégalités de santé dans les centres d'examens de santé ", Evaluation of precariousness and health inequalities in health examination centers).

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Impact of the IL4I1 Enzyme Expression in Patients With Cutaneous Melanoma: Prognostic Value and/or Role in Resistance to Current Immunotherapy and Targeted Therapy

acronym: ENZYMELA

summary:
To characterize and quantify immune cells expressing the Interleukine 4 induced gene 1 (IL4I1) immunosuppressive enzyme in the blood and in tissue of melanoma patients (primary tumor, sentinel lymph nodes and cutaneous metastases).

Then, to compare the results obtained in different clinical settings:

in cases of progression of the disease slower or faster compared to the prognosis established by clinical and pathological data
before and after treatments with immunotherapy (anti Programmed Death ligand 1 (anti-PD1) or anti-PD1 and anti Cytotoxic T Lymphocyte associated protein 4 (anti-CTLA-4)) and / or targeted therapies (BRAF inhibitors and /or methyl ethyl ketone (MEK)).

ReferenceCitation: Ramspott JP, Bekkat F, Bod L, Favier M, Terris B, Salomon A, Djerroudi L, Zaenker KS, Richard Y, Molinier-Frenkel V, Castellano F, Avril MF, Prévost-Blondel A. Emerging Role of IL-4-Induced Gene 1 as a Prognostic Biomarker Affecting the Local T-Cell Response in Human Cutaneous Melanoma. J Invest Dermatol. 2018 Dec;138(12):2625-2634. doi: 10.1016/j.jid.2018.06.178. Epub 2018 Jul 23.

ReferenceCitation: Bod L, Lengagne R, Wrobel L, Ramspott JP, Kato M, Avril MF, Castellano F, Molinier-Frenkel V, Prévost-Blondel A. IL4-induced gene 1 promotes tumor growth by shaping the immune microenvironment in melanoma. Oncoimmunology. 2017 Jan 13;6(3):e1278331. doi: 10.1080/2162402X.2016.1278331. eCollection 2017.

ipd_sharing_description:
The clinical data at the diagnosis and the relapse/no relapse information have to be shared from the groups 1 and 2.

The clinical response to treatments will be shared.


title: Study of the Role of Anxiety-related Antecedents on the Resumption of Work and Sport in a Series of Patients Operated on for Rotator Cuff Repair

acronym: Reprise

summary:
Anxiety-depressive disorders are also very frequent, in the form of different pathologies that are often intertwined (prevalence of generalized anxiety disorders in 5% of the population, characterized depressive episodes in 5%, etc.).

And it is even more frequent in patients with a cuff tendinopathy (26% and 23% of depression and anxiety respectively). These 2 pathologies are therefore responsible for significant economic expenses.

It is in this context that the investigators' wish to carry out this study seems justified in order to better understand and therefore manage this problem, which is frequently encountered in daily practice and which would therefore allow better understanding and therefore better information for the patients concerned.

location_facility: Service de Chirurgie orthopédique de l'épaule et du coude - CHU de Strasbourg - France


title: Validation and Evaluation of the French Version of a Hearing Loss Screening Questionnaire in Adults Aged 60 Years Old and More (Hearing Handicap Inventory for the Elderly Screening Version)

acronym: VF DEPIST 60

summary:
Nowadays in France, there is no organized screening of the hearing loss in the elderly; however, it is a very common disease and simples tests to perform to detect it exist. Lots of studies use surveys to identify deaf people; but physicians often consider them too sensitive and less specific because lots of people were classified into " deaf " people meanwhile they have a subnormal tonal audiogram.

Now, it's known that it corresponds to the "Hidden Hearing Loss" concept: it's defined as an auditive disturbance in a noisy ambiance in people with a normal tonal audiometry; corresponding to infraclinical cochlear lesions. These lesions, if detected early, can be prevented to avoid an audition degradation in time.

The aim of the study is to determinate the values of sensitivity and specificity of the HHIE-S survey translated into French, so it could be used as a screening method of hearing loss in the elderly and as a prevention of cochlear damages.

lead_sponsor: University Hospital, Bordeaux

intervention_type: Diagnostic Test


title: Mucle Resilience: Muscular Markers Predictive of Functional Recovery After Femoral Neck Fracture in Orthogeriatrics

acronym: HIPRESM

summary:
The aging of the population is a major public health problem, particularly with regard to the quality of life and the maintenance of autonomy.

The fracture of the upper end of the femur (EFSF) is a pathology:

Frequent, affecting the elderly: in France, 80,000 patients / year, 83% aged ≥ 75 years (DREES, 2011),
severe, on mortality and autonomy: 40% will not recover their walking capacity earlier than 6 months, 13% of patients > 85 years old walk unaided at 4 months and 11% of patients will be newly admitted to an institution in 6 months after the fracture (UPOG / PSL data).
and costly: costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million for health insurance in France.

Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond / recover from acute stress related to the EFSF. Physical resilience is an emerging concept in medicine that defines the dynamic ability of a subject to resist or recover from functional decline as a result of stress or disruption. In this context, developing new approaches to assessing resilience is important, to take into account this resilience specific to each patient in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to be able to identify, in elderly patients after an EFSF intervention, the muscular signature associated with good functional recovery (= physical resilience). The goal of the investigators is to develop software that will provide this muscle signature by measuring and analyzing parameters from high-definition surface electromyography (HD-sEMG). This technology is innovative, non-invasive and portable, CE marked but not yet used in clinical routine.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: APHP - Pitie Salpetriere Hospital - UPOG


title: Characterization and Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

acronym: MICROBOPH

summary:
Mild to moderate pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD); such a complication is associated with increased risks of exacerbation and decreased survival. A small proportion of COPD patients may present with severe pulmonary hypertension, defined by a mean pulmonary artery pressure more than 35 mmHg (or more than 20 mmHg with a low cardiac index < 2 l/min/m2) with pulmonary vascular resistance more than 3 Wood units, measured by right heart catheterization (RHC). In these patients, pulmonary microvessels remodeling is the main cause of increase in pulmonary arterial pressure and is thought to result from the combined effects of hypoxia, inflammation, and loss of capillaries but the mechanisms are complex.

For these patients, no drugs have been approved for treatment and lung transplantation must be considered for the more severe patients who are eligible. A better characterization of these patients is needed.

We hypothesize that microvesicles generation and endothelial damage could be related to the severity of pulmonary hypertension due to COPD, assessed by pulmonary hemodynamic parameters. Circulating biomarkers of vascular damage and cell activation will be measured in blood samples from 80 COPD patients who have hemodynamic assessment by RHC. To go further, the origin of the particles will be characterized.

location_facility: Hôpitaux Universitaire de Strasbourg - Service Pneumologie - centre de compétence de l'hypertension artérielle pulmonaire - France


title: Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

summary: The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs is usually considered as a major risk factor for bacterial tracheal colonization and subsequent development of ventilator-associated pneumonia. The rate of leakage around the cuff is related to the pressure differential across the cuff, namely the difference between the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff. Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff towards fluid leakage. However, this preventive effect of PEEP is compromised during prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a high-volume low-pressure tracheal tube cuff when performed with a high level of suction pressure (- 400 mbar) and a large size of suction catheter size (16 French).

ReferenceCitation: Beuret P, Philippon B, Fabre X, Kaaki M. Effect of tracheal suctioning on aspiration past the tracheal tube cuff in mechanically ventilated patients. Ann Intensive Care. 2012 Nov 7;2(1):45. doi: 10.1186/2110-5820-2-45.

lead_sponsor: Centre Hospitalier de Roanne