title: Impact de la Vaccination Sur la Distribution Des génotypes de Papillomavirus (HPV) et Suivi de la Dynamique Intra-individuelle de l'Infection et Des Co-infections Dans Une Population d'étudiantes âgées de 18 à 20 Ans

acronym: DyPAVIR

summary:
Human papillomavirus (HPV) infection is the most common sexually transmitted infection. The high risk oncogenic types, HPV-16 and -18 are responsible for 70% of cervical cancers. The introduction of vaccination against two major oncogenic genotypes of HPV raises questions about genotype replacement because of the existence of other oncogenic types not targeted by the vaccine. A better understanding of natural history of HPV infection and interaction (competition, synergy) between genotypes are required in order to anticipate this phenomenon.

The aims of this study are to characterize HPV infection in young female students and to follow up HPV infection and co-infection dynamics with different genotypes, taking into account both vaccination status and immunity to HPV 16 and 18. The study also focuses on the determination of factors influencing the development of persistent cervical HPV infections.

The DyPAVIR-ISHARE study is based on the participation of 5000 young female students, from 18 to 20 years-old, all registered at the Universities of Bordeaux or Versailles Saint-Quentin (UVSQ). The 3-years follow-up includes completion of a self-administrated questionnaire regarding sexual behaviour, socio-demographic characteristics, access to health-care services and, for a sub-group of 1000 students, the taking of genital and oral self-taken samples for the detection and genotyping of HPV (every 3 months). Previously, a pilot phase study (2 visits in 3 months of interval) is set up on 50 young female students from UVSQ in order to test feasibility.

This study will provide data to gain insight into the possibility of type replacement. Moreover, this study would provide an overview of HPV vaccine coverage and effectiveness HPV incidence and factors associated with HPV infection and co-infection ; Partners recruitment would allow us to follow HPV transmission dynamics among couples, and in particular, HPV exposure in young adult women. The HPV research won't be limited to virus detection in samples but will indicate the presence or absence of HPV infection.

Finally, additional genetic studies could be conducted in order to study genetic susceptibility to HPV infection, to chronic HPV infection and to co-infection.

This research project is part of the i-Share program funded by the "Investissement d'Avenir" cohort call.

ipd_sharing: Undecided

lead_sponsor: Institut Pasteur

location_facility: Service Universitaire de Médecine Préventive et de Promotion de la Santé (SUMPPS)


title: Population Pharmacokinetics of Levofloxacin in Intensive Care Patients With Severe Community-acquired Pneumonia.

acronym: LEVO-PHARM

summary: The aim of this study is 1. to describe levofloxacin pharmacokinetics in ICU patients suffering from pneumonia with taking into account physio-pathological parameters. 2. to verify clinical and bacteriological efficiency and to know if the peak/Minimum Inhibitory Concentration (MIC) ratio > 5 and Area Under Curve (AUC) /Minimum Inhibitory Concentration(MIC) ratio > 125. No therapeutic drug monitoring will be performed in this study.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: French Digestive Polyposis Cohorte

summary: French cohorte about polyposis digestive diseases

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Hôpital Edouard Herriot

intervention_type: Other

status_simplified: Unknown


type: EudraCT Number

title: DRESS - Setting of Corticosteroid Treatment.

acronym: DRESSCODE

summary:
Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare and severe multiorgan adverse drug reaction occurring within 2 to 6-8 weeks after a new drug intake. DRESS syndrome is defined by the combination of clinical manifestations, cutaneous, visceral and biological disturbances. Its prognosis is directly linked to severity of visceral involvement, with a mortality evaluated above 10%.

Considering curative treatment, there is no consensus. Until now, no controlled trial has been performed. Systemic steroids are mainly used in first intention, in particular for management of visceral involvements, whatever their severity. From clinical practice, topical steroids are often used and could be helpful in the therapeutic management of DRESS.

We propose to evaluate systemic steroids versus very potent topical steroids in a multicentric randomized controlled trial including defined moderate DRESS, ie the non-inferiority of very potent topical steroids in terms of remission of visceral involvement at Day30 and the superiority of very potent topical steroids in terms of delay to remission of skin involvement.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Eshki M, Allanore L, Musette P, Milpied B, Grange A, Guillaume JC, Chosidow O, Guillot I, Paradis V, Joly P, Crickx B, Ranger-Rogez S, Descamps V. Twelve-year analysis of severe cases of drug reaction with eosinophilia and systemic symptoms: a cause of unpredictable multiorgan failure. Arch Dermatol. 2009 Jan;145(1):67-72. doi: 10.1001/archderm.145.1.67.

ReferenceCitation: Mardivirin L, Valeyrie-Allanore L, Branlant-Redon E, Beneton N, Jidar K, Barbaud A, Crickx B, Ranger-Rogez S, Descamps V. Amoxicillin-induced flare in patients with DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms): report of seven cases and demonstration of a direct effect of amoxicillin on Human Herpesvirus 6 replication in vitro. Eur J Dermatol. 2010 Jan-Feb;20(1):68-73. doi: 10.1684/ejd.2010.0821. Epub 2009 Oct 12.

ReferenceType: derived

ReferenceCitation: Funck-Brentano E, Duong TA, Bouvresse S, Bagot M, Wolkenstein P, Roujeau JC, Chosidow O, Valeyrie-Allanore L. Therapeutic management of DRESS: a retrospective study of 38 cases. J Am Acad Dermatol. 2015 Feb;72(2):246-52. doi: 10.1016/j.jaad.2014.10.032.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01% and Lumigan® 0.03% Unit Dose, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension, Stabilized by Lumigan® 0.01% With Ocular Surface Intolerance

lead_sponsor: Laboratoires Thea

source: euctr

summary:
Primary objective:

The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84.

The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).

lead_sponsor_type: industriel


title: REGENERATING AGENT (OTR4120) AND BACTERIAL KERATITIS : A RANDOMISED TRIAL

acronym: CACICOL

summary: The purpose of this study is to evaluate efficiency of CACICOL20 for bacterial keratitis. It is a double blinded comparison of epithelial defect in two groups of patients randomized between CACICOL20 and physiological salt solution.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Device


title: Thrombectomy Under Reopro Versus Alteplase and Neurologic Deficit Outcome Trial

acronym: TURANDOT

summary: Intravenous (IV) Alteplase (rt-PA) is the gold standard for brain infarction within 4 h 30 of symptoms onset. Efficacy of this therapy is limited in the setting of large artery occlusions. For middle cerebral artery occlusions (MCA)or internal carotid artery occlusions (ICA), recanalization rates will drop as low as 10%. This element is critical as prognosis is linked to recanalization. Arterial re-occlusions are frequent and may reach 30%, which limits IV thrombolysis efficacy.With the endovascular approach, recanalization rates may reach 90% with last generation devices. A recent meta-analysis has shown that the best candidates for thrombectomy are MCA occlusions. In the coronary literature, endovascular therapy efficacy is increased in association with antiplatelets such as abciximab. The aim of the study was to assess the feasibility of thrombectomy associated with abciximab on revascularisation (TICI score), as well as safety (symptomatic intracranial bleeding), in order to design a clinical trial versus the gold standard for acute ischemic stroke revascularization strategies using IV rt-PA.This is a controlled, pilot study, evaluating feasibility and safety of thrombectomy with abciximab versus IV rt-PA in acute ischemic stroke patients within 4h30 of symptoms onset.

status: Terminated

lead_sponsor: SOS Attaque Cérébrale

intervention_type: Procedure


title: One Year Change in Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children

summary:
Objectives: The aims were to measure one year change in caloric compensation (CC) and eating in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating context and to link these change with individual characteristics (adiposity, age, gender) and maternal feeding practices.

Three series of measurements of caloric compensation (CC) and eating in the absence of hunger (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of measurement was composed of three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.

time_perspective: Cross-Sectional

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation


title: Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor in Patients With or Without Epidural Anesthesia

acronym: Pain Drain

summary:
Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance.

Withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.

time_perspective: Prospective

lead_sponsor: Hopital Foch


title: Evaluation of Accuvein in Obese Patients

acronym: AVO

summary: The objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.


title: Evaluation du Niveau d'activité Physique Quotidien, Chez Des Patientes Porteuses d'un Cancer du Sein en période Post thérapeutique

acronym: APQ

summary:
Many studies have demonstrated the beneficial effects of Adapted Physical Activity (APA) in different cancer types.

It therefore seems necessary to assess spontaneous Physical Activity in order to integrate it to the overall calculation of physical activity in clinical practice.

To assess the AP, two types of methods are validated : the subjective method using a questionnaries and objective method using a pedometer , accelerometer or measures calorimetry .

Subjective method shows , good acceptability by patients and low cost but can sometimes lead to poor estimation of the level of activity.

Objective methods obviously increase the accuracy of assessments but are more difficult to use for epidemiological studies , less accepted by the patient and more expensive.

In this study the investigators will measure the spontaneous Daily Physical Activity by both methods andd evaluate the correclation.

lead_sponsor: University Hospital, Limoges


title: Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function

acronym: FFSI

summary: Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.

ReferenceCitation: Quero G, Fiorillo C, Dallemagne B, Mascagni P, Curcic J, Fox M, Perretta S. The Causes of Gastroesophageal Reflux after Laparoscopic Sleeve Gastrectomy: Quantitative Assessment of the Structure and Function of the Esophagogastric Junction by Magnetic Resonance Imaging and High-Resolution Manometry. Obes Surg. 2020 Jun;30(6):2108-2117. doi: 10.1007/s11695-020-04438-y.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil


title: Evaluation of Therapeutic Management in ESBL-infected Patients or Carriers by Providing and Sharing a Free Tool - the "ESBL toolKIT" and Interventional Study of a Prospective Cohort of HIV+ Patients Searching for Possible Sexual Transmission Factors in ESBL (Extended-spectrum ß-lacatamase-producing Bacteria) Carriers

acronym: Calires

summary:
Bacterial resistance to antibiotics is a major public health problem. The epidemiology of enteric bacteria including E. coli is changing rapidly with the global spread of a resistance mechanism type beta-lactamase extended spectrum (ESBL), responsible for resistance to almost all penicillins and cephalosporins. The resistance is up to 75% for Quinolones, 67% for Cotrimoxazole and 30-50% for Aminoglycosides.

The main phenomena causing this problem are:

The selection pressure by antibiotics, in their use in humans or animals
The hand transmission via the digestive reservoir (faeces)
Easy spread of resistance mechanism in Enterobacteriaceae due to transferable genetic support (plasmid)

In this context, we decided to implement a cross-border study to improve and accelerate the management, diagnosis and treatment of patients with ESBL in close collaboration between medical and paramedical staff in hospitals, laboratories and private medical offices.

The objective of this study is to standardize diagnostic and therapeutic measures allowing a better and rapid treatment of patients and thus prevent the appearence of ESBL bacteria in the PACA region and Liguria by providing a tool : The "Kit ESBL".

The " ESBL ToolKIT" (also translated into Italian) includes:

Information on epidemiological data
A checklist edited for extra-hospital use (private practitioners, health care units other than hospitals)
A checklist edited for hospital use
A leaflet BMR for the patient explaining the problematic as well as hygiene measures
Therapeutical protocols for hospital use and extra hospital use
An sample letter for the attending physician

The objective of this prospective multicenter cohort study is to evaluate the use of this kit, and to measure its impact on:

The prescription of appropriate antibiotics
The measures taken to prevent man to man transmission
The quality of information provided to the patient

In this context we are also performing a multicentre prospective interventional cohort of HIV+ patients searching for possible sexual transmission factors in ESBL (extended-spectrum ß-lacatamase-producing bacteria) carriers.

We will also try to determine if other sexually transmitted infections associated (syphilis, gonorrhea and chlamydia) are contributing factors to ESBL carriage.

So far there is no data documented on ESBL-carriage in a population of HIV-positive patients.

study_start_date_type: Actual

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Procalcitonin and Threatened Premature Delivery

acronym: MAPPRO

summary:
Among all patients hospitalized for Threatened Premature Delivery (TPD), the rate of premature birth (PB) before 37 weeks is about 42%, which reflects the inability to accurately identify patients at high risk of PB. Currently, no clinical or biological marker is recognized as the most reliable in predicting the real risk of AP in case of MAP.

The purpose of this study is to improve the knowledge of predictors of preterm delivery compared with conventional blood markers by estimating serum procalcitonin according to premature delivery or not in patients hospitalized for preterm labor .

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Ducarme G, Desroys du Roure F, Le Thuaut A, Grange J, Vital M, Dimet J. Efficacy of serum procalcitonin to predict spontaneous preterm birth in women with threatened preterm labour: a prospective observational study. BMC Pregnancy Childbirth. 2018 Mar 7;18(1):65. doi: 10.1186/s12884-018-1696-2.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Evaluation of a Clinico-biological Predictive Score of Enterocolitis and Enteropathy of the Preterm Neonates. Usefulness of the Rapid Assay of the Faecal Calprotectin.

acronym: CALPROPREMA

summary: This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.

ReferenceCitation: Campeotto F, Elie C, Rousseau C, Giuseppi A, Hachem T, Gobalakichenane P, Le Touzey M, de Stefano M, Butel MJ, Kapel N. Faecal calprotectin and gut microbiota do not predict enteropathy in very preterm infants. Acta Paediatr. 2021 Jan;110(1):109-116. doi: 10.1111/apa.15354. Epub 2020 Sep 1.


title: Randomized Short-term Pre-surgical Study to Assess the Effects of PD 0332991 in Early Breast Cancer Patients

acronym: POP

summary: This is a Phase II study trying to identify whether short term treatment with PD0332991 yields anti-proliferative response -defined by a low level of Ki67 expression (IHC) at surgery- or induces senescence as determined by SABG expression (IHC) in tumors from patients with early breast cancer non-candidates for neoadjuvant hormonotherapy or chemotherapy, as compared to no treatment.

ReferenceCitation: Turner NC, Liu Y, Zhu Z, Loi S, Colleoni M, Loibl S, DeMichele A, Harbeck N, André F, Bayar MA, Michiels S, Zhang Z, Giorgetti C, Arnedos M, Huang Bartlett C, Cristofanilli M. Cyclin E1 Expression and Palbociclib Efficacy in Previously Treated Hormone Receptor-Positive Metastatic Breast Cancer. J Clin Oncol. 2019 May 10;37(14):1169-1178. doi: 10.1200/JCO.18.00925. Epub 2019 Feb 26. Erratum in: J Clin Oncol. 2019 Nov 1;37(31):2956.

ReferenceCitation: Arnedos M, Bayar MA, Cheaib B, Scott V, Bouakka I, Valent A, Adam J, Leroux-Kozal V, Marty V, Rapinat A, Mazouni C, Sarfati B, Bieche I, Balleyguier C, Gentien D, Delaloge S, Lacroix-Triki M, Michiels S, Andre F. Modulation of Rb phosphorylation and antiproliferative response to palbociclib: the preoperative-palbociclib (POP) randomized clinical trial. Ann Oncol. 2018 Aug 1;29(8):1755-1762. doi: 10.1093/annonc/mdy202.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Health Related Quality of Life in Children With Food Allergy: Comparison to Healthy Children and Children With Other Chronic Diseases

summary:
The number of studies concerning health related quality of life (HRQL) in children with food allergy is very limited.

Only one study to date has compared HRQL of a group of children with food allergy to data published on general population and other chronic diseases. This study concluded to lowest HRQL scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.


title: Relationship Between Sperm Parameters and Metabolic Syndrome in a Infertile Couple Partner Man

acronym: Metasperme

summary: Multidisciplinary, multicentric, cross-sectional study on men in infertile couples who conduct their sperm test through their diagnosis of infertility

ReferenceCitation: Sermondade N, Faure C, Fezeu L, Shayeb AG, Bonde JP, Jensen TK, Van Wely M, Cao J, Martini AC, Eskandar M, Chavarro JE, Koloszar S, Twigt JM, Ramlau-Hansen CH, Borges E Jr, Lotti F, Steegers-Theunissen RP, Zorn B, Polotsky AJ, La Vignera S, Eskenazi B, Tremellen K, Magnusdottir EV, Fejes I, Hercberg S, Lévy R, Czernichow S. BMI in relation to sperm count: an updated systematic review and collaborative meta-analysis. Hum Reprod Update. 2013 May-Jun;19(3):221-31. doi: 10.1093/humupd/dms050. Epub 2012 Dec 12. Review.

ReferenceCitation: Hammoud AO, Gibson M, Peterson CM, Meikle AW, Carrell DT. Impact of male obesity on infertility: a critical review of the current literature. Fertil Steril. 2008 Oct;90(4):897-904. doi: 10.1016/j.fertnstert.2008.08.026. Review.

ReferenceCitation: Sermondade N, Faure C, Fezeu L, Lévy R, Czernichow S; Obesity-Fertility Collaborative Group. Obesity and increased risk for oligozoospermia and azoospermia. Arch Intern Med. 2012 Mar 12;172(5):440-442. doi: 10.1001/archinternmed.2011.1382. Review.

ReferenceCitation: Michalakis K, Mintziori G, Kaprara A, Tarlatzis BC, Goulis DG. The complex interaction between obesity, metabolic syndrome and reproductive axis: a narrative review. Metabolism. 2013 Apr;62(4):457-78. doi: 10.1016/j.metabol.2012.08.012. Epub 2012 Sep 20. Review.

ReferenceCitation: Saget S, Kappeler L, Grandjean V, Leneuve P, Berthaut I, Faure C, Czernichow S, Racine C, Lévy R, Dupont C; Metasperme Collaboratif group. Association between metabolic disorders and seminal plasma miRNA levels: a pilot study. Basic Clin Androl. 2022 Jun 7;32(1):9. doi: 10.1186/s12610-022-00159-7.


title: Development of Endothelial Biomarkers for Use in Cohort Studies. Comparison With Reference Biomarkers.

acronym: NUTREND

summary: The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.

intervention_type: Behavioral


title: Non Invasive Ventilation After Abdominal Surgery in Postoperative Acute Respiratory Failure: a Multicenter Randomized Controlled Trial.

acronym: NIVAS

summary: Acute respiratory failure may occur early in the postoperative course, requiring endotracheal intubation and mechanical ventilation in selected patients, thus increasing morbidity and mortality and prolonging intensive care unit (ICU) and hospital stay.We will perform a multicenter, prospective, randomized clinical trial to compare the efficacy of non invasive ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in the treatment of postoperative acute respiratory failure. We also set out to examine the hypothesis that early application of NIV may prevent intubation and mechanical ventilation in patients who develop acute respiratory failure after abdominal surgery.

ReferenceCitation: Jaber S, Lescot T, Futier E, Paugam-Burtz C, Seguin P, Ferrandiere M, Lasocki S, Mimoz O, Hengy B, Sannini A, Pottecher J, Abback PS, Riu B, Belafia F, Constantin JM, Masseret E, Beaussier M, Verzilli D, De Jong A, Chanques G, Brochard L, Molinari N; NIVAS Study Group. Effect of Noninvasive Ventilation on Tracheal Reintubation Among Patients With Hypoxemic Respiratory Failure Following Abdominal Surgery: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1345-53. doi: 10.1001/jama.2016.2706.

lead_sponsor: University Hospital, Montpellier

location_facility: Department of Anesthesiology & Critical Care, St Eloi University Hospital


title: Protection of Arteritic Patients by Remote Preconditioning

acronym: PARADIS

summary: Prospective, monocentric, randomised, double-blind study with 20 patients enrolled to be explored twice through a Cross-over strategy to determine whether remote preconditioning improves arteritic patients' ability to walk.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Angers

location_facility: Service de Médecine du Sport, CHU d'Angers


title: Clinical, Genetic and Epigenetic Characterization of Patients With FSHD Type 1 and FSHD Type 2

summary:
The aim of the study was to compare the severity of illness between groups of patients (Facio-Scapulo-Humeral Dystrophy = FHSD1, FSHD2 and patients both FSHD1 and FSHD2).

Despite advances in research on the subject, answers are still needed on these diseases.

We also aim to determine whether the chromosomal genetic abnormality is involved in other diseases and the frequency of this mutation in the population of patients FSHD.

This study will increase our knowledge of the two forms of FSHD who present a common pathophysiological mechanism and may occur together in the same family with a worsening of the clinical phenotype worsening . In addition, epigenetic differences between FSHD type 1 and type 2 seems to have clinical consequences requiring appropriate management

primary_purpose: Basic Science

ReferenceCitation: Sacconi S, Briand-Suleau A, Gros M, Baudoin C, Lemmers RJLF, Rondeau S, Lagha N, Nigumann P, Cambieri C, Puma A, Chapon F, Stojkovic T, Vial C, Bouhour F, Cao M, Pegoraro E, Petiot P, Behin A, Marc B, Eymard B, Echaniz-Laguna A, Laforet P, Salviati L, Jeanpierre M, Cristofari G, van der Maarel SM. FSHD1 and FSHD2 form a disease continuum. Neurology. 2019 May 7;92(19):e2273-e2285. doi: 10.1212/WNL.0000000000007456. Epub 2019 Apr 12.

intervention_type: Biological


title: Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.

acronym: CURARES

summary:
Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction.

Primary End Point: proportion of patients with a score of motion = 0

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)

acronym: IBIS-VIRUS

summary: Morbidity and mortality of ICU patients is increased by the development of a "immunosuppression" systemic (IS). This IS develops in the early hours of hospitalization and is responsible for severe infections, including viral reactivations (Cytomegalovirus or Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and mortality in intensive care units. In clinical practice, they are searched at the onset of organ failure or unexplained fever. The investigators wish to conduct this research in the stroke patients to assess the predictive power of these viral reactivations on the duration of mechanical ventilation.

lead_sponsor: Nantes University Hospital


title: Intravenous Exenatide (Byetta®) Versus Insulin for Perioperative Glycemic Control in Cardiac Surgery: the Open-labeled Randomized Phase II/III ExStress Study

acronym: ExSTRESS

summary:
Stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non diabetic patients.

It has been shown that perioperative hyperglycemia is an independent risk factor of postoperative mortality and morbidity.

The Leuven et al.'s study suggested that strict glycemic perioperative control using an intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's patients. This study included a majority of cardiac surgery patients. Others studies have suggested that the beneficial effect of insulin-based tight perioperative glycemic control might be hampered by iatrogenic hypoglycemia. Moreover, insulin therapy failed to obtain perioperative glycemic stability in most patients.

Exenatide (Byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level.

We hypothesize that continuous intravenous infusion of exenatide could improve perioperative glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared to a conventional insulin therapy during the perioperative period of cardiac surgery.

ReferenceCitation: Goldberg PA, Sakharova OV, Barrett PW, Falko LN, Roussel MG, Bak L, Blake-Holmes D, Marieb NJ, Inzucchi SE. Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings. J Cardiothorac Vasc Anesth. 2004 Dec;18(6):690-7.

ReferenceCitation: Studer C, Sankou W, Penfornis A, Pili-Floury S, Puyraveau M, Cordier A, Etievent JP, Samain E. Efficacy and safety of an insulin infusion protocol during and after cardiac surgery. Diabetes Metab. 2010 Feb;36(1):71-8. doi: 10.1016/j.diabet.2009.05.008. Epub 2010 Jan 25.

ReferenceCitation: Galiatsatos P, Gibson BR, Rabiee A, Carlson O, Egan JM, Shannon RP, Andersen DK, Elahi D. The glucoregulatory benefits of glucagon-like peptide-1 (7-36) amide infusion during intensive insulin therapy in critically ill surgical patients: a pilot study. Crit Care Med. 2014 Mar;42(3):638-45. doi: 10.1097/CCM.0000000000000035.

ReferenceCitation: Besch G, Perrotti A, Salomon du Mont L, Puyraveau M, Ben-Said X, Baltres M, Barrucand B, Flicoteaux G, Vettoretti L, Samain E, Chocron S, Pili-Floury S. Impact of intravenous exenatide infusion for perioperative blood glucose control on myocardial ischemia-reperfusion injuries after coronary artery bypass graft surgery: sub study of the phase II/III ExSTRESS randomized trial. Cardiovasc Diabetol. 2018 Nov 1;17(1):140. doi: 10.1186/s12933-018-0784-y.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Post operative intensive care unit of the cardiac surgery department


title: Targeted Nurse-driven HIV Screening Using Rapid Tests in Emergency Departments in the Metropolitan Paris Region

acronym: DICI-VIH

summary:
To reduce late HIV diagnosis that remains common in France, the national health agency has promoted non-targeted HIV screening in health care settings, including emergency departments (EDs). In our previous survey, non-targeted nurse-driven HIV screening by rapid tests was feasible, well-accepted but identified only a few new HIV diagnoses mostly among patients at high-risk. Our findings, consistent with results from other international groups, suggest that a targeted strategy could be feasible, efficient and cost-effective with fewer tests required. However, the feasibility and the efficacy of this strategy remain unknown in France.

The main aim of the present study is to compare the efficacy of 2 strategies: 1) the combination of the nurse-driven HIV targeted screening and the current practice (physician-directed HIV diagnostic testing) versus 2) the current practice alone.

The strategies will be compared during 2 randomly assigned periods (cluster randomization and cross-over) in 8 EDs of metropolitan Paris.

During targeted period, nurses will offer screening to all patients at EDs, aged 18-64 years old, identified as high-risk by a self-administered questionnaire, not know to be HIV positive, not being seen for post-exposure prophylaxis or unstable medical illness, and accepting to participate by providing an informed consent.

In case of confirmed reactive rapid test result, a follow-up visit with an on-site infectious disease specialist will be arranged within the following 48 hours.

primary_purpose: Screening

ReferenceCitation: Leblanc J, Hejblum G, Costagliola D, Durand-Zaleski I, Lert F, de Truchis P, Verbeke G, Rousseau A, Piquet H, Simon F, Pateron D, Simon T, Crémieux AC; DICI-VIH (Dépistage Infirmier CIblé du VIH) Group. Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial. Ann Emerg Med. 2018 Jul;72(1):41-53.e9. doi: 10.1016/j.annemergmed.2017.09.011. Epub 2017 Oct 31.

ReferenceCitation: Leblanc J, Rousseau A, Hejblum G, Durand-Zaleski I, de Truchis P, Lert F, Costagliola D, Simon T, Crémieux AC. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial. BMC Infect Dis. 2016 Feb 1;16:51. doi: 10.1186/s12879-016-1377-6.

location_facility: Clinical Research Center (Centre de Recherche Clinique de l'Est Parisien, CRC-Est), Groupe Hospitalier des Hôpitaux Universitaires Est Parisien, Assistance Publique - Hôpitaux de Paris (AP-HP)


title: French National Observatory of Percutaneous Mitral Commissurotomy (PMC) Immediate Score, Scanner, Late Results

acronym: CALCIMIT

summary: The aim of this study is to validate prospectively the predictive score of late results about a diverse population recruited in France and to evaluate the contribution in predicting the outcome of the PMC scanner to study the mitral calcium score and the location of the calcifications.

ReferenceCitation: Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Iung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). [Guidelines on the management of valvular heart disease (version 2012). The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)]. G Ital Cardiol (Rome). 2013 Mar;14(3):167-214. doi: 10.1714/1234.13659. Italian.

ReferenceCitation: Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; ACC/AHA Task Force Members. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 10;129(23):e521-643. doi: 10.1161/CIR.0000000000000031. Epub 2014 Mar 3. Erratum in: Circulation. 2014 Jun 10;129(23):e651. Circulation. 2014 Sep 23;130(13):e120. Dosage error in article text.

ReferenceCitation: Wilkins GT, Weyman AE, Abascal VM, Block PC, Palacios IF. Percutaneous balloon dilatation of the mitral valve: an analysis of echocardiographic variables related to outcome and the mechanism of dilatation. Br Heart J. 1988 Oct;60(4):299-308.

ReferenceCitation: Abascal VM, Wilkins GT, Choong CY, Thomas JD, Palacios IF, Block PC, Weyman AE. Echocardiographic evaluation of mitral valve structure and function in patients followed for at least 6 months after percutaneous balloon mitral valvuloplasty. J Am Coll Cardiol. 1988 Sep;12(3):606-15.

ReferenceCitation: Palacios IF. Percutaneous mitral balloon valvuloplasty. Does it really last as long and do as well as surgery? Adv Cardiol. 2002;39:100-13. Review.

ReferenceCitation: Iung B, Cormier B, Ducimetière P, Porte JM, Nallet O, Michel PL, Acar J, Vahanian A. Immediate results of percutaneous mitral commissurotomy. A predictive model on a series of 1514 patients. Circulation. 1996 Nov 1;94(9):2124-30.

ReferenceCitation: Dreyfus J, Cimadevilla C, Nguyen V, Brochet E, Lepage L, Himbert D, Iung B, Vahanian A, Messika-Zeitoun D. Feasibility of percutaneous mitral commissurotomy in patients with commissural mitral valve calcification. Eur Heart J. 2014 Jun 21;35(24):1617-23. doi: 10.1093/eurheartj/eht561. Epub 2014 Jan 6.

ReferenceCitation: Bouleti C, Iung B, Himbert D, Messika-Zeitoun D, Brochet E, Garbarz E, Cormier B, Vahanian A. Relationship between valve calcification and long-term results of percutaneous mitral commissurotomy for rheumatic mitral stenosis. Circ Cardiovasc Interv. 2014 Jun;7(3):381-9. doi: 10.1161/CIRCINTERVENTIONS.113.000858. Epub 2014 Apr 29.

ReferenceCitation: Palacios IF, Block PC, Wilkins GT, Weyman AE. Follow-up of patients undergoing percutaneous mitral balloon valvotomy. Analysis of factors determining restenosis. Circulation. 1989 Mar;79(3):573-9.

ReferenceCitation: Ben-Farhat M, Betbout F, Gamra H, Maatouk F, Ben-Hamda K, Abdellaoui M, Hammami S, Jarrar M, Addad F, Dridi Z. Predictors of long-term event-free survival and of freedom from restenosis after percutaneous balloon mitral commissurotomy. Am Heart J. 2001 Dec;142(6):1072-9.

ReferenceCitation: Bouleti C, Iung B, Laouénan C, Himbert D, Brochet E, Messika-Zeitoun D, Détaint D, Garbarz E, Cormier B, Michel PL, Mentré F, Vahanian A. Late results of percutaneous mitral commissurotomy up to 20 years: development and validation of a risk score predicting late functional results from a series of 912 patients. Circulation. 2012 May 1;125(17):2119-27. doi: 10.1161/CIRCULATIONAHA.111.055905. Epub 2012 Mar 28.

ipd_sharing: No

lead_sponsor: French Cardiology Society


title: Evaluation of Impact of Disease on Quality of Life, Education and Socio-professional Integration of Adults and Parents of Children Living With Sickle- Cell Disease in France

acronym: DREPAtient

summary:
Sickle cell disease (SCD) is the most common genetic disease in France. Its consequences on patient's life-course and quality of life need to be precisely identified among French patients and their family to be able to improve patients care according to their specific needs.

The aim of the study is to accurately describe the impact of SCD on quality of life of patients living in France, or their family (for minor patients). The consequences of the disease on professional life, education and material condition of patients or their parents will be described by the patients themselves.

ReferenceCitation: Crosby LE, Joffe NE, Irwin MK, Strong H, Peugh J, Shook L, Kalinyak KA, Mitchell MJ. School Performance and Disease Interference in Adolescents with Sickle Cell Disease. Phys Disabil. 2015;34(1):14-30.

ReferenceCitation: Dos Santos JP, Gomes Neto M. Sociodemographic aspects and quality of life of patients with sickle cell anemia. Rev Bras Hematol Hemoter. 2013;35(4):242-5. doi: 10.5581/1516-8484.20130093.

ReferenceCitation: Gardner K, Douiri A, Drasar E, Allman M, Mwirigi A, Awogbade M, Thein SL. Survival in adults with sickle cell disease in a high-income setting. Blood. 2016 Sep 8;128(10):1436-8. doi: 10.1182/blood-2016-05-716910. Epub 2016 Jul 20.

ReferenceCitation: Habibi A, Arlet JB, Stankovic K, Gellen-Dautremer J, Ribeil JA, Bartolucci P, Lionnet F; centre de référence maladies rares " syndromes drépanocytaires majeurs ". [French guidelines for the management of adult sickle cell disease: 2015 update]. Rev Med Interne. 2015 May 11;36(5 Suppl 1):5S3-84. doi: 10.1016/S0248-8663(15)60002-9. French.

ReferenceCitation: Chapelon E, Garabedian M, Brousse V, Souberbielle JC, Bresson JL, de Montalembert M. Osteopenia and vitamin D deficiency in children with sickle cell disease. Eur J Haematol. 2009 Dec 1;83(6):572-8. doi: 10.1111/j.1600-0609.2009.01333.x. Epub 2009 Aug 13.

ReferenceCitation: Godeau B, Noël V, Habibi A, Schaeffer A, Bachir D, Galactéros F. [Sickle cell disease in adults: which emergency care by the internists?]. Rev Med Interne. 2001 May;22(5):440-51. Review. French.

ReferenceCitation: LINDENBAUM J, KLIPSTEIN FA. FOLIC ACID DEFICIENCY IN SICKLE-CELL ANEMIA. N Engl J Med. 1963 Oct 24;269:875-82.

ReferenceCitation: Noll RB, Vannatta K, Koontz K, Kalinyak K, Bukowski WM, Davies WH. Peer relationships and emotional well-being of youngsters with sickle cell disease. Child Dev. 1996 Apr;67(2):423-36.

ReferenceCitation: Rees DC, Williams TN, Gladwin MT. Sickle-cell disease. Lancet. 2010 Dec 11;376(9757):2018-31. doi: 10.1016/S0140-6736(10)61029-X. Epub 2010 Dec 3. Review.

ReferenceCitation: Salih KMA. The impact of sickle cell anemia on the quality of life of sicklers at school age. J Family Med Prim Care. 2019 Feb;8(2):468-471. doi: 10.4103/jfmpc.jfmpc_444_18.

ReferenceCitation: Sehlo MG, Kamfar HZ. Depression and quality of life in children with sickle cell disease: the effect of social support. BMC Psychiatry. 2015 Apr 11;15:78. doi: 10.1186/s12888-015-0461-6.

lead_sponsor: Argo Sante

location_facility: Centre de références syndromes drépanocytaires majeurs thalassémie et autres maladies rares du globule rouge et de l'érythropoïése


title: Construction of New Predictive Mathematical Models of Mortality in Decompensated Cirrhotic Patients Who Are Candidates for Liver Transplantation

acronym: SUPERMELD

summary:
The MELD score is a predictive model of cirrhosis mortality used in France since 2007 to prioritize access to liver transplantation for patients enrolled in the national waiting list. The predictive value of this score was recently revised downward with a C index of the order of 0.65-0.67 and 20% of the patients enrolled for decompensated cirrhosis have access to liver transplantation by a subjective system of "expert component" independent of the MELD because of this lack of precision. The use of the MELD score to individually define access to the transplant should so be reconsidered. Recently new predictive models of cirrhosis mortality better than MELD have been developed and new mortality predictors independent of MELD have been published.

The goal of this study is to design prognostic predictive models of mortality for decompensated cirrhotic patients enrolled on the national liver transplant waiting list including known (MELD, MELD Na) as more recent (CLIF-C AD, CLIF - CACLF) predictive models and new objective predictors studied in combination in order to optimize the system of allocation of hepatic allografts in France.

The expected benefits of this search are twofold:

At the individual level: The possibility for patients at high risk of death but with intermediate MELD score to be transplanted.

Public health plan:

Improving the equity of graft allocation system.
Decreased mortality in the waiting list by improving the fairness and efficiency of the graft allocation system, a major public health issue

status: Recruiting

primary_purpose: Other

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Ongoing


title: Validation of the Hospital Frailty Risk Score in Combination With Charlson/Elixhauser Comorbidity Coding Algorithms on French Hospital Databases

acronym: HFRS France

summary: Older people are increasing users of health care globally. Constraints in bed capacity and resources raise important challenges with regards to management of older people with complex needs, which usually require assertive and holistic assessment. It is important, therefore, to identify aged patients most likely to benefit from such frailty-attuned approaches of care. A previous study using national Hospital Episodes Statistics conducted in the United Kingdom (UK) showed that patients aged over 75 years with characteristics of frailty and at risk of adverse health-care outcomes can be identified using routinely collected data (Gilbert T et al., Lancet 2018). This study lead to the development of the Hospital Frailty Risk Score (HFRS), which is based on International Statistical Classification of Diseases and Related Health Problems 10 (ICD-10) diagnosis codes and has the potential to be used in other countries worldwide, using the ICD-10 coding framework, to identify patients at risk of frailty at the hospital and commissioners levels, as well as for database research purposes. This score has successfully been validated in Canada, Australia and Switzerland. The aim of the present study is to evaluate the ability of the HFRS to predict 30-day in-patient mortality of patients aged 75 years and older admitted to French hospitals as an emergency.

ReferenceCitation: Gilbert T, Cordier Q, Polazzi S, Bonnefoy M, Keeble E, Street A, Conroy S, Duclos A. External validation of the Hospital Frailty Risk Score in France. Age Ageing. 2022 Jan 6;51(1). pii: afab126. doi: 10.1093/ageing/afab126.

lead_sponsor: Hospices Civils de Lyon

location_facility: service de court séjour gériatrique, Hôpital Lyon Sud


title: Acid Sphingomyelinase Deficiency (ASMD): Data Analysis of Adult and Pediatric Patients on Early Access to Olipudase Alfa in France

acronym: OPERA

summary:
Primary Objective:

To describe the lung, spleen and liver outcomes of olipudase alfa

Secondary Objectives:

To describe the patient's characteristics
To describe conditions of olipudase alfa use
To describe safety data related to the use of olipudase alfa
To describe complementary effectiveness outcomes parameters

ipd_sharing: Yes

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

lead_sponsor: Sanofi


title: Cardiovascular Risk in General Practice in France

summary: The purpose of this study is to evaluate the proportion of patients which present a high cardiovascular risk estimated by the SCORE scale, in general practice consultations of the 7 French regions (Paris area, North-East, Paris basin, West, South-West, South- East, Mediterranean area)

lead_sponsor: AstraZeneca


type: Registry Identifier

title: L'Expectation Temporelle Dans la Maladie de Parkinson : étude Oculomotrice Psychophysique et Par électroencéphalographie

acronym: PEDUPARK

summary:
Although major progresses were realized during recent years, temporal cognition is still poorly understood. However, abnormal temporal cognition is an underestimated aspect of several neurological disorders, particularly if basal ganglia (BG) are affected. Therefore, the interest of studying temporal cognition is double: firstly, it is an essential function necessary to guide all behavior; secondly, it seems to be very sensitive to the integrity of dopaminergic pathways. It is well known that Parkinson's disease (PD) is partly due to a degeneration of neurons producing dopamine in the Substantia Nigra pars compacta (SNc). Therefore, in this project, PD patients and healthy volunteers will be used as a model to study the role of dopamine in temporal expectation.

An expectation is an internal representation of an event that is likely to occur in the future. Temporal expectation builds-up as time elapses before the upcoming event. The role of temporal expectation in the oculomotor domain has often been studied using anticipatory eye movements as a tool. Indeed, expectation evokes anticipatory eye movements. However, to the knowledge of the investigators, expectation and anticipation have so far been studied in experimental tasks where temporal information is essential but not voluntarily controlled. This is usually referred to as 'automatic' or 'emergent' timing: the timing of the eye movement adapts to the timing of the target, implicitly and without voluntary control of the subject. However, anticipatory movements can also be based on an explicit estimation of time, e.g. during music playing. In summary, timing can be based on cognitive (explicit) or automatic (implicit) processing. The originality of the behavioral task the investigators will use in this study is that it will require an explicit comparison of a memorized duration with elapsing time in order to anticipate target appearance. In this task, expectation of the upcoming event will build up on explicit temporal information.

Same PD patients will be tested under treatment ("ON") and without treatment ("OFF") to determine the effect of dopamine in time expectation . Only levodopa responsive Parkinson patients will be included and among them only those receiving levodopa and/or dopa agonists three times daily at a stable dosis since 30 days.

the investigators hypothesize that eye movements latency will not linearly covary with objective time in "OFF" PD patients. In treated PD patients, a recovery of the linear relationship between subjective and objective time is expected. This would clearly demonstrate the role of dopamine in temporal expectation in humans.

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

location_facility: ICM-IHU ICM


title: Registre Wilson France

acronym: WIL-FR

summary: This registry concerns adults and children with Wilson's disease. The collection of a large amount of data will allow a better understanding of the epidemiology of this rare disease, in particular the age of onset according to the hepatic or hepato-neurological forms, but also the geographical distribution of patients consulting in France. This database will also make it possible to know all the therapies prescribed to "Wilsonian" patients. The genetic study of these patients will make it possible to specify the various genetic mutations involved in Wilson's disease. The information (clinical, biological, radiological and genetic) relating to the disease will be entered by a doctor or a professional specialising in Wilson's disease.


title: Epi-Hypo: Survey on Epidemiology of Hypoparathyroidism in France

acronym: Epi-Hypo

summary: Very few data has been published on the epidemiology of hypoparathyroidism worldwide: none exists specifically for France. Hypoparathyroidism could led to complications. Here, the investigators plan to collect data about both epidemiology, medication and complication of hypoparathyroidism in France.

lead_sponsor: European Georges Pompidou Hospital

location_facility: European Georges Pompidou Hospital, APHP


title: Perceptions, Representations and Experiences of Malaria Prophylaxis in Patients Born in Endemic Areas and Living in France.

acronym: PREPAP

summary:
The aim of this study is to analyze the perceptions, representations and expe-riences of malaria prophylaxis in patients born in endemic areas and living in France.

This analysis could lead to better understanding and communication between the medical profession and patients in malaria. It would also provide patient-specific responses to their expectations, as to their families.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Villeneuve St Georges


title: Desensitization With Bortezomib Before a Living Kidney Donation

acronym: VELDON

summary: The investigators plan to study the role of bortezomib for desensitizing patients awaiting a living kidney donation who have a titer of Donor Specific anti human leucocyte antigen (HLA) Antibody (DSA) between 1000 and 3000 MFI with a pilot study of 10 patients recruited in 4 hospital in FRANCE.

location_facility: Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital


title: Epidemiology and Clinical Presentation of Human Anaplasmosis in Eastern France

summary: Anaplasmosis is a tick-borne transmitted infection. Its clinical expression include fever, cytopenia and hepatitis.This infection was initially described in United States. In Europe, its epidemiology is not well known. Some isolated cases have been diagnosed in several country, were the tick Ixodes ricinus is known to transmitted another infection :the Lyme borreliosis.The purpose of our study is to look systematically for Anaplasmosis, in patient living in Eastern France, and presenting with compatible clinical symptoms using a new diagnosis tool : PCR in blood samples. So we will have new data about epidemiology in our country and the clinical symptoms that are associated with Anaplasmosis.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service des Maladies Infectieuses et Tropicales Hôpitaux Universitaires de Strasbourg

location_facility: Service des Maladies Infectieuses et Tropicales - CHU de Besançon

location_facility: Service des Maladies Infectieuses et Tropicales - CHU de Nancy

location_facility: Service de Médecine Interne et Maladies Infectieuses - CHU de Reims

location_facility: Département d'Infectiologie CHU de Dijon


title: Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France

acronym: MEDVETFQ

summary:
Diseases naturally transmitted between animals and humans (zoonoses) are one of the leading causes of emergence or re-emergence of human infectious diseases. Non-foodborne zoonoses are commonly transmitted to human directly by contact with infected animals or contaminated environment. People working with animals such as farmers and veterinarians are particularly at risk of infection. Some zoonoses can also be transmitted indirectly thought the air and therefore can affect the general population. Example is Q fever, a disease caused by Coxiella burnetii, a bacterium highly resistant in the environment.

In Western France, Q fever is endemic in cattle herds. To improve human zoonotic disease surveillance, the investigators will conduct a population based study in this area.

The aims of the study are:

To assess seroprevalence of Coxiella burnetii infection among general population, farmers and veterinarians in Western France
To identify risk factors for Coxiella burnetii seropositivity in these populations


title: Prospective Observational Study to Describe Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France and Its Use in Routine Clinical Practice

acronym: PILOTE

summary: The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen


title: Population Genomic Diversity of France

acronym: POPGEN

summary:
Having access to DNA sequences from individuals that share common ancestry with patients is of interest when analysing individual genomes for diagnoses. Information regarding allele frequency distribution in the same geographic areas where patients have ancestry will be necessary to help select the variants that are the most likely involved in disease and should hence be tested in functional assays.

To provide such a general population panel for France, the POPGEN project will select 10,000 individuals from CONSTANCES cohort with ancestry in different regions of France outside western part. These participants will have their DNA extracted from salivary kits and genotyped using SNP-chip. Among these 10,000 individuals, 4,000 individuals will have their whole genome sequenced. This study is one of the four pilot projects of the France Genomic Medicine plan (FMG 2025). The FMG2025 plan aims at introducing genome sequencing in the routine clinical practice to accelerate and improve diagnoses. The POPGEN project will provide the required references from the general French population to help filter out common variants from the genomes of patients.

status: Active, not recruiting

intervention_type: Genetic


title: Phase Ia/Ib, Randomized, Double Blinded, Dose Escalation Trial to Evaluate the Safety and Immunogenicity in Healthy European and Burkinabe Adults of a Placental Malaria Vaccine Candidate (PRIMVAC) Formulated With Alhydrogel ® or GLA-SE

acronym: PRIMALVAC

summary:
The primary objective of the study is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and Burkinabe adults.

The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions The safety profile will included local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria

ReferenceCitation: Gamain B, Chêne A, Viebig NK, Tuikue Ndam N, Nielsen MA. Progress and Insights Toward an Effective Placental Malaria Vaccine. Front Immunol. 2021 Feb 25;12:634508. doi: 10.3389/fimmu.2021.634508. eCollection 2021. Review.

ReferenceCitation: Sirima SB, Richert L, Chêne A, Konate AT, Campion C, Dechavanne S, Semblat JP, Benhamouda N, Bahuaud M, Loulergue P, Ouédraogo A, Nébié I, Kabore M, Kargougou D, Barry A, Ouattara SM, Boilet V, Allais F, Roguet G, Havelange N, Lopez-Perez E, Kuppers A, Konaté E, Roussillon C, Kanté M, Belarbi L, Diarra A, Henry N, Soulama I, Ouédraogo A, Esperou H, Leroy O, Batteux F, Tartour E, Viebig NK, Thiebaut R, Launay O, Gamain B. PRIMVAC vaccine adjuvanted with Alhydrogel or GLA-SE to prevent placental malaria: a first-in-human, randomised, double-blind, placebo-controlled study. Lancet Infect Dis. 2020 May;20(5):585-597. doi: 10.1016/S1473-3099(19)30739-X. Epub 2020 Feb 4.

location_country:
Burkina Faso
France

location_facility:
CIC 1417
CNRFP


title: Immune Response Under Immunotherapy in Metastatic Non-Small Cell Lung Cancer: Sputum, Blood Samples and Microbiota Study

acronym: RICEPS

summary: Prospective pathophysiological exploratory monocentric study, focusing on adult patients with non-small cell lung cancer (NSCLC) : non-squamous type without oncogenic addiction, metastatic, treated with immune checkpoint inhibitors alone or in combination with chemotherapy in front line at the CHRU de Tours, France.

lead_sponsor: University Hospital, Tours


title: TIBOLA : Multicenter Descriptive Study in Eastern France

summary:
TIBOLA (TIck-BOrne LymphAdenopathy) is a tick-borne disease. The pathogen is most often rickettsia (R. slovaca or R. raoultii), but other strict intracellular bacteria have been described (Francisella tularensis, Coxiella burnetii, Bartonella hensenlae).

Transmitted by ticks (Dermacentor), it is characterized by an inoculation eschar at the tick bite site, accompanied by painful loco-regional lymphadenopathy. It is most often a benign pathology, which can nevertheless leave sequellar alopecia or persistent asthenia.

In spring 2021, an impression of increased cases was reported by clinicians in Eastern France. The study aims to clarify the clinical-biological presentation and the evolution of the number of cases of TIBOLA in this region between 2016 and 2021.

At the same time, entomologists have noted an upsurge in this tick in certain biotopes in recent years.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
Elisabeth Baux
Yves Hansmann


title: Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France

acronym: SALTO

summary:
Childhood cancers are rare, and today 75% of patients survive them. An estimated one out of 850 French persons has survived childhood cancer. However, the complications of chemotherapy, radiotherapy or surgery can lead to a higher risk of secondary mortality, which the literature estimates is at 14%. Regular care has a positive impact on the quality of life and health of adults who survived cancer during their childhoods. It aims to detect the potential long-lasting effects of cancer and to provide therapeutic education and psychological care. Thanks to cancer registries, several countries (USA, Canada, UK, Germany, the Netherlands) have developed long-term care structures which function with specially trained adult medicine practitioners. There are only two structures in France: the Long-Term Oncology/Hematology Follow-Up Clinic, headed by Dr François Pein, in Nantes (France), and the LEA program for the follow-up of children treated for leukemia in the PACA-Corse and Lorraine regions of France, which began in 2003 and has since been extended to other centers.

The Rhône-Alpes and Auvergne regions have had childhood cancer registries since 1987; they compile about 200 new cases a year. The Rhône-Alpes registry has conducted a preliminary trial on children (0-15 years old) diagnosed with cancer between 1987 and 1992. They analyzed the correlation between patients' quality of life and the long-term medical effect of cancer and treatment, both recorded in patients' medical files and declared by patients. These young adults who survived pediatric cancer appear to suffer from and declare many complications, although this does not impact their global quality of life much. There is a negative correlation between the number of complications (observed or declared) and the global quality of life score, but only three types of complications play a significant role (motor function complications, auditory complications, and alopecia.) In addition, there is a significant mismatch between patients's perceived health (what they say they experience), and the information contained in their medical files. These young adults expressed the need for their impressions to be better taken into account by health care professionals. This study does not assess patients' psychopathological characteristics.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Clermont-Ferrand
CHU de Saint-Etienne
IHOP
CHU de Grenoble


title: Medically Assisted Procreation and Choice of the Embryo: How Far Would French People Like to go - An Opinion Survey Among Patients Resorting to in Vitro Fertilization (IVF) in France.

summary:
In today's context of bioethics laws revision concerning Medically Assisted Procreation, the investigators focus on the opinion of couples resorting to In Vitro Fertilization on a fundamental, much debated issue ; the choice of the embryo.

French lawmakers fear the investigators might be drifting towards embryo selection procedures, but no study allows us to state this is what patients request. This study aims at determining, among the population of patients who resort to Medically Assisted Procreation in France, the ratio of patients who are willing to select the embryo due to its genetic characteristics.

status: Enrolling by invitation

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

acronym: SISTOLA

summary: The purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution


title: Impact of E-reporting by Patients With Relapsing-remitting Multiple Sclerosis on the Reporting of Adverse Drug Reactions in France: a Randomized Controlled Trial.

acronym: VigiP-SEP

summary:
Adverse drug reactions are collected exhaustively during the experimental development phase of the drug, but the trial population is not representative. In post-marketing authorization, the use in the real life of medicines requires to specify the profile of adverse effects through pharmacovigilance. However, in clinical practice, under-reporting of adverse drug reactions prevents a satisfactory knowledge of the risks. For example, in the multiple sclerosis (MS) patients population in 2015, only 1 case of congestive flushing was reported by physicians, none by patients, for approximately 7,800 patients treated with Tecfidera® dimethyl-fumarate, while trials reported 39% of flush.

The investigators propose a study measuring the impact of the deployment of e-reporting to patients in a population suffering from multiple sclerosis in initiation of first line drug therapy. The study design will be a randomized controlled trial. Twenty-four direct or indirect partner centers of the OFSEP will be randomized in 2 arms (1 standard arm without intervention, and one interventional arm), Each arm including 6 CHU, 3 CHG and 3 liberal neurologists. CHUs will include 10 patients in 6 months, and CHGs and liberal neurologists 5 patients, a total of 180 patients will be included. The expected duration of this study is 12 months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient. At 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be made by telephone call to each patient.

The study is part of the pharmacovigilance system in place in France and aims to improve its efficiency by increasing declarations and therefore earlier detection of signals in order to prevent and minimize risks.

The comparison of the two arms should make it possible to decide on the usefulness of national support for e-reporting, while respecting a good integration with the French pharmacovigilance system.

ReferenceCitation: Defer G, Fedrizzi S, Chevanne D, Montastruc F, Briant AR, Parienti JJ, Peyro-Saint-Paul L; French VigipSEP Study Group; Société Francophone de la Sclérose en Plaques (SFSEP). Adverse Drug Reaction Reporting Using a Mobile Device Application by Persons with Multiple Sclerosis: A Cluster Randomized Controlled Trial. Drug Saf. 2021 Feb;44(2):223-233. doi: 10.1007/s40264-020-01009-z. Epub 2020 Oct 13.

lead_sponsor: University Hospital, Caen


title: Assessment of ECMO in Acute Myocardial Infarction With Non-reversible Cardiogenic Shock to Halt Organ Failure and Reduce Mortality (ANCHOR)

acronym: ANCHOR

summary:
Data from case series and large retrospective trials suggest that the early treatment of cardiogenic shock AMI patients with the association of VA-ECMO and IABP may significantly decrease mortality, which is still unacceptably high nowadays (40-50% at 30 days).

An important benefit for the patients randomized to the ECMO arm is expected and the risk-to-benefit ratio is expected to be in favor of the experimental treatment arm.

ReferenceCitation: Thiele H, Akin I, Sandri M, Fuernau G, de Waha S, Meyer-Saraei R, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Savonitto S, Torremante P, Vrints C, Schneider S, Desch S, Zeymer U; CULPRIT-SHOCK Investigators. PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock. N Engl J Med. 2017 Dec 21;377(25):2419-2432. doi: 10.1056/NEJMoa1710261. Epub 2017 Oct 30.

ReferenceCitation: Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29.

ReferenceCitation: Thiele H, Akin I, Sandri M, de Waha-Thiele S, Meyer-Saraei R, Fuernau G, Eitel I, Nordbeck P, Geisler T, Landmesser U, Skurk C, Fach A, Jobs A, Lapp H, Piek JJ, Noc M, Goslar T, Felix SB, Maier LS, Stepinska J, Oldroyd K, Serpytis P, Montalescot G, Barthelemy O, Huber K, Windecker S, Hunziker L, Savonitto S, Torremante P, Vrints C, Schneider S, Zeymer U, Desch S; CULPRIT-SHOCK Investigators. One-Year Outcomes after PCI Strategies in Cardiogenic Shock. N Engl J Med. 2018 Nov 1;379(18):1699-1710. doi: 10.1056/NEJMoa1808788. Epub 2018 Aug 25.

ReferenceCitation: Overtchouk P, Pascal J, Lebreton G, Hulot JS, Luyt CE, Combes A, Kerneis M, Silvain J, Barthelemy O, Leprince P, Brechot N, Montalescot G, Collet JP. Outcome after revascularisation of acute myocardial infarction with cardiogenic shock on extracorporeal life support. EuroIntervention. 2018 Apr 6;13(18):e2160-e2168. doi: 10.4244/EIJ-D-17-01014.

ReferenceCitation: Muller G, Flecher E, Lebreton G, Luyt CE, Trouillet JL, Bréchot N, Schmidt M, Mastroianni C, Chastre J, Leprince P, Anselmi A, Combes A. The ENCOURAGE mortality risk score and analysis of long-term outcomes after VA-ECMO for acute myocardial infarction with cardiogenic shock. Intensive Care Med. 2016 Mar;42(3):370-378. doi: 10.1007/s00134-016-4223-9. Epub 2016 Jan 29.


title: Descriptive Pharmacoepidemiological Study on the Use of Symbicort Turbuhaler in the Treatment of Asthma in France and Impact of a New Therapeutic Strategy on the Compliance and Control of Asthma

acronym: SYMBIOSE

summary: Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment of asthma in France and impact of a new therapeutic strategy on the compliance and control of asthma


title: Prevalence of Geophagy and Knowledge About Its Health Effects Among Native Sub-Saharan Africa, Caribbean and South America Healthy Adults Living in France

acronym: Prevalgeophagy

summary: Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.

ReferenceCitation: Decaudin P, Kanagaratnam L, Kmiec I, Nguyen Y, Migault C, Lebrun D, Hentzien M, Bertin E, Drame M, Bani-Sadr F. Prevalence of geophagy and knowledge about its health effects among native Sub-Saharan Africa, Caribbean and South America healthy adults living in France. Eat Weight Disord. 2020 Apr;25(2):465-469. doi: 10.1007/s40519-018-0624-9. Epub 2018 Dec 13.

lead_sponsor: CHU de Reims


title: Multicentric Cohort of Melanoma Patients in Ile de France Area

acronym: Melan-Cohort

summary: This is a multicentric prospective cohort of all stage melanoma patients from AP-HP ,the largest consortium of University hospitals over Europe. 7 investigation sites (7 dermatological services of AP-HP) in Ile de France region are involved. 1300 patients will be enrolled and be followed during 10 years.


title: Overdiagnosis of Thyroid Cancer in the Marne and Ardennes Departments of France From 1975 to 2014

acronym: OTCancer

summary:
Introduction - Incidence of thyroid cancer has increased considerably in France in recent years, but the mortality rate has declined only slightly. Part of this increased incidence could be attributable to overdiagnosis. We aimed to estimate the contribution of overdiagnosis to the incidence of papillary thyroid cancer.

Material and methods. - Incidence rates were calculated based on data from the specialised Marnes-Ardennes thyroid cancer registry, for cancers diagnosed between 1975 and 2014, by age category and by five-year period. The population was divided into two groups according to pTNM classification at diagnosis (i.e. localised or invasive). Overdiagnosis was defined as the difference in incidence rates between the invasive cancer and localised cancer groups. This rate was then divided by the incidence rate in the localised cancer group for the most recent period (2010-2014) to obtain the proportion of cancers attributable to overdiagnosis.

ReferenceCitation: Saint-Martin C, Dramé M, Dabakuyo S, Kanagaratnam L, Arveux P, Schvartz C. Overdiagnosis of thyroid cancer in the Marne and Ardennes Departments of France from 1975 to 2014. Ann Endocrinol (Paris). 2017 Feb;78(1):27-32. doi: 10.1016/j.ando.2016.07.005. Epub 2016 Sep 15.


title: Phase II Trial of a Vaccination With Tumor Antigen-loaded Dendritic Cell-derived Exosomes on Patients With Unresectable Non Small Cell Lung Cancer Responding to Induction Chemotherapy

acronym: CSET 1437

summary: Lung cancer is the worldwide leading cause of cancer death. In France, with 28,000 new cases per year, lung cancer is the 4th in terms of incidence but remains the leading cause of cancer death. The 5-year survival of lung cancer, all stages and all types, is very low, estimated at 12% among men and 16% among women in France. In advanced unresectable non small cell lung cancer, standard treatment relies on platinum-based induction chemotherapy. The median progression-free survival (PFS) in patients responding or stabilized after 4 chemotherapy cycles ranges from 2 to 2.8 months. Gustave Roussy and Curie institutes have developed an immunotherapy involving metronomic cyclophosphamide (mCTX) followed by vaccinations with tumor antigen-loaded dendritic cell-derived exosomes (Dex). mCTX inhibits Treg functions restoring T and NK cell effector functions and Dex are able to activate the innate and adaptive immunity. Phase I trials showed the safety and feasibility of Dex vaccines but no induction of T cells could be monitored in patients. Since 2007, we validated a new process for isolation of second generation Dex with improved immune stimulatory capacities. We propose a maintenance immunotherapy in 47 advanced unresectable NSCLC patients responding or stabilized after induction chemotherapy with Dex-based treatment to improve PFS rate at 4 months in these patients.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Portrayal of Hospital Alcohol Detoxifications and Factors Associated With Longer or Ulterior Hospitalizations in France From 2011 to 2020

acronym: Alcostop

summary: Even if hospital alcohol detoxifications are frequent in France, their caracteristicscharacteristics remain unknown. The investigators aim to describe the clinical and paraclinical caracteristicscharacteristics of their patients, their length and geographical repartition, etc… The investigators also aim to evaluate factors associated with longer stays or ulterior re-hospitalization for the same reason. Finally, The investigators aim to compare the stays by facility type.


title: Study of the Interest of ECG Teletransmission in Retirement Home (EHPAD) In the Ile-de-France Region.

acronym: TEECAD

summary: The aim of the study is to evaluate the interest and the workability of ECG teletranmission in EHPAD in Île-de-France. ECG for the elderly is beneficial to detect or monitor cardiovascular disease.

lead_sponsor: Gérond'if

location_facility: Psychiatric Geriatric Department, Broca hospital


title: Moderators of Online Gambling, How Effective? Experimental, Controlled and Randomized Study.

acronym: MOD&JEU

summary:
Prevalence of problem gambling is estimated about 1-3% of the general adult population. This percentage increases to 5% when talking about online gambling. In France, the market for online gambling was recently opened up to competition and regulation (May 2010), including poker and sports/horse races betting, but excluding for the moment casino games. Recent international studies show that legalizing online gambling led to an increase of practices, including problem gambling.

In France, the law stipulates the establishment of moderators of online gambling, to prevent excessive gambling practices. The Regulatory Authority of Online Games (ARJEL) guarantees the implementation of these moderators. However, no evaluation of the effectiveness of these moderators is planned.

Therefore the investigators propose to conduct an experimental study about online gambling. The objective will be to evaluate the effectiveness of four kinds of moderators, some already legislated, but not evaluated, and others offered by the investigators team. Proposals for amending legislation will be made according the results of this study.

ReferenceCitation: Caillon J, Grall-Bronnec M, Saillard A, Leboucher J, Péré M, Challet-Bouju G. Impact of Warning Pop-Up Messages on the Gambling Behavior, Craving, and Cognitions of Online Gamblers: A Randomized Controlled Trial. Front Psychiatry. 2021 Jul 23;12:711431. doi: 10.3389/fpsyt.2021.711431. eCollection 2021.

ReferenceCitation: Challet-Bouju G, Grall-Bronnec M, Saillard A, Leboucher J, Donnio Y, Péré M, Caillon J. Impact of Wagering Inducements on the Gambling Behaviors, Cognitions, and Emotions of Online Gamblers: A Randomized Controlled Study. Front Psychiatry. 2020 Nov 17;11:593789. doi: 10.3389/fpsyt.2020.593789. eCollection 2020.

ReferenceCitation: Caillon J, Grall-Bronnec M, Hardouin JB, Venisse JL, Challet-Bouju G. Online gambling's moderators: how effective? Study protocol for a randomized controlled trial. BMC Public Health. 2015 May 30;15:519. doi: 10.1186/s12889-015-1846-7.

lead_sponsor: Nantes University Hospital


title: National, Multicentric, Prospective Phase II Study Estimating the Interest of a Dose Decrease for Radiation Therapy Associated With a Carboplatine and Etoposide Based Chemotherapy for the Treatment of Standard Risk Adult Medulloblastomas

summary:
Adult medulloblastoma is a rare tumour.

The "standard risk " group (complete surgery or residual tumour lower than 1,5 cm2, absence of malignant cells in the cerebrospinal fluid, absence of metastasis, absence of MYC amplification and exclusion of large cells medulloblastoma) concerns, for the adult population, a majority of patients at diagnosis (about ¾ of cases).

Conventional treatment is classically based on a 54/36 Gy cranio-spinal radiotherapy (54 Gy on the posterior fossa and 36 Gy on the nevraxis).

This treatment is associated with an acute toxicity (haematological, cutaneous, digestive and general) wich decreases gradually when patient goes away from the treatment period.

For this category of patients and this modality of treatment, The French intergroup experience, pleads in favour of a late and progressive neurotoxicity.

This neurotoxicity is associated with a clear degradation of the quality of life.

In the light of paediatric studies :

We propose a phase II study to estimate the interest of a decrease of radiation doses compensated by a chemotherapy according to the following schedule

carboplatine + etoposide based chemotherapy every 28 days x 2
followed by, less than 80 days after the surgery, radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed.

The majority of French centres concerned with the neuro-oncology are involved in this trial.

About 25 new cases by year are waited. A centralized analysis of pathological slides and of the pre and post surgery Magnetic Resonance Imaging is foreseen.

The main objective is to estimate the survival without disease at 1 year

Secondary objectives associate the evaluations of the rate of complete response at the end of procedure, the overall survival, the survival without disease, the survival without events, the neurocognitiv toxicity, the endocrine toxicity, the hearing toxicity and the time until definitive deterioration of the quality of life Associated studies

Two associated studies are besides foreseen (parallel search for co-financing):

A biologic study is planed with the aim to confirm, by morphological, genomic and transcriptomic studies, the interest, for the adult population, of the prognostic markers used in paediatric population

A radiological study is planed with the aim to estimate the interest :

of a multimodal follow-up (spectroscopy and perfusion imaging) for the premature detection of recurrences
of the study of functional connectivity in correlation with the neuropsychological follow-up for the analysis of the aetiology and premature markers of neurotoxicity.

location_facility: AP HP Groupe Hospitalier Pitié Salpétrière

intervention_type: Radiation


title: Evaluation of Covid-19 Vaccination in Elderly Subjects in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-de-France

acronym: COGEVAX

summary:
The main objective of this non-interventional, multi-center study is to compare the incidence of serious health events (death, unscheduled hospitalizations) in subjects vaccinated against Coronavirus with that of unvaccinated subjects, in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-De-France during the same observation period 12-months minimun and up to18 months according vaccinal schedule.

The primary outcome will be the incidence of serious health events (death and unscheduled hospitalizations) in subjects vaccinated against Coronavirus compared to that of unvaccinated subjects.


title: National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood

acronym: DENACAPST

summary:
The DENACAPST programme represents an important initiative to provide near nation-wide roll-out of an important cancer surveillance program for childhood cancer survivors. The program is based on internationally recognized standards in cancer surveillance, which were developed by the International Guideline Harmonization Group (IGHG) with support of all relevant stakeholders in cancer survivorship research and clinical work in Europe, Canada and the United States and recognized French recommendations about breast screening for women at high risk of cancer.

With this programme, French centers organized themselves to provide to childhood cancer survivors adequate medical attention, which includes close medical surveillance for breast/thyroid cancer where appropriate, based on adequate risk stratification.

The aim of the study is to analyze if the recommendations about breast and thyroid cancer screening are followed in this population and secondly to provide more informations about these second cancers and about the screening.

study_start_date_type: Anticipated


title: Observational Study on the Use of Xydalba: A Multicenter, Prospective Study to Characterize the Use of Xydalba in France

summary:
This observational study will collect data on the use of the drug Xydalba® in daily clinical practice in France. Such observational studies are also referred to as registries. The sponsor of the study is Correvio International Sárl, based in Switzerland.

Xydalba® contains the active substance dalbavancin, a remedy for a certain type of bacterial pathogens (so-called "gram positive bacteria") which cause the disease. Active ingredients against bacteria are also called antibiotics.

Correvio wants to know which patients received the drug and how the disease went. The treatment places where you got Xydalba, ie clinic, intensive care unit or elsewhere should be recorded. In addition, it is important in this type of medication to track whether the pathogens are changing in any way. Any safety-relevant events (such as side effects) that have occurred during treatment should be investigated by the sponsor and submitted to the competent European authorities.

lead_sponsor: Correvio International Sarl

location_facility: Centre Hospitalier Universitaire de Nîmes (CHU)

location_facility: Centre hospitalier universitaire de Nice

location_facility: Centre hospitalier universitaire de Saint-Étienne

location_facility: CHU GRENOBLE, Maladies infectieuses et tropicales

location_facility: Pontchaillou University Hospital, Infectious Diseases and Intensive Care Unit

location_facility: Centre Hospitalier de Tourcoing,Service des Maladies Infectieuses et du Voyageur

location_facility: Hôpital de la Croix-Rousse, Service des maladies infectieuses et tropicales

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Saint-André

location_facility: Centre hospitalier d'Ajaccio, Maladies infectieuses et tropicales

location_facility: Centre hospitalier régional et universitaire de Nancy


title: Multicenter, Non-interventional Study, Describing Patients With Inherited Retinal Disease (IRD) in France

acronym: EPI-genRET

summary:
Genetic diagnostic testing becomes increasingly important for enhancing our understanding of the disease notably the genetics and providing the best care to the patients, and several initiatives seek to gather more data in order to better understand and treat those diseases.

Within this context, Novartis and SENSGENE/Strasbourg University Hospitals (HUS) want to set up, through a research collaboration, a non-interventional study in France to better understand the epidemiology of IRDs, particularly the distribution of pathogenic variants in patients. This study aims to serve as a starter study to implement an IRD national registry led by SENSGENE/Strasbourg University Hospitals (HUS). The data collected might also be used to populate global European registries. The primary objective has been defined in a sufficient broad way to address this perspective of registries.

As IRDs can present from birth to late middle age, this study will include both children and adult patients regardless of age, sex, and the type of IRD.

status: Not yet recruiting


title: AVENANCE - A Non-interventional Study to Provide Real-world Data on the Use of Avelumab as a Maintenance Treatment for Patients With Advanced or Metastatic Urothelial Carcinoma

acronym: AVENANCE

summary: A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: Polyclinique de LIMOGE-Clinique François CHENIEUX

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier Regional Universitaire de Brest

location_facility: Groupe Hospitalier La Rochelle - Re - Aunis

location_facility: La Roche Sur Yon - Centre Hospitalier Departemetal Vendee

location_facility: Centre Hospitalier Universitaire Gabriel Montpied

location_facility: Centre Hospitalier Intercommunal Louviers

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Groupe Hospitalier Mutualiste de Grenoble Institut Daniel Hollard

location_facility: Centre de Lutte Contre Le Cancer - Auvergne Jean Perrin

location_facility: Groupe Hospitalier Diaconesse La Croix Saint Simon

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: ICANS - Institut de cancerologie Strasbourg Europe


title: Multicentric, National, Prospective, Comparative, Non Randomized Study, Assessing Medico-economic Impact of Three Strategies of Sentinel Lymph Node Analysis in Immediately Operable Breast Cancer

acronym: SAGE

summary:
Breast carcinoma requires frequently an adjuvant therapy after surgical excision: in this way, one of the major criteria indicating the need of adjuvant chemotherapy is the diagnosis of a metastatic lymph-node invasion, mainly in the axillary field. Axillary surgery is therefore mandatory at the diagnosis of breast carcinoma. For many years, in order to avoid unnecessary complications due to extensive axillary surgery (for instance, arm enlargement by lymphedema), a limited surgery is frequently performed on the first supposed invaded lymph-nodes (LN) called "sentinel" LN technique; if the sentinel LN are not invaded, extensive axillary surgery can be omitted. To decide it during the surgery, removed sentinel LN are cut in 3 to 4 slices which are examined immediately as smears (cytology) or frozen slices (pathology). However, due to hazard in cutting the LN, micro-metastases can be misdiagnosed. That is why a recent molecular biology method has been developed in which the total LN are crushed and blended, then analyzed by OSNA technique (One Step Nuclear Acid analysis) so as to amplify and detect the mRNA coding for cytokeratin-19 protein witnessing the LN metastatic invasion. A standardized automated technique is available with a mean time of 30 to 50 minutes according to the number of analyzed LN.

In 12 international studies (2830 cases) the consistency between OSNA technique and final pathology is of 91 to 98% and the sensitivity seems higher. Less than 5% of all breast carcinomas cells don't express CK-19 protein.

The use of OSNA technique requires a dedicated machine and a skilled pathologist, increasing slightly the operation time; however it allows to avoid the immediate and long-term complications due to the radical LN axillary surgery in case of negativity of the sentinel LN procedure. To date, the three techniques including extemporaneous examinations (OSNA or classical methods) or not (classical pathological analysis) have their own advantages and drawbacks.

"SAGE" study main objective is to compare these three techniques in terms of direct costs and Quality of Life impacts. The superiority of any of these three techniques is not the purpose of SAGE study, but the economic burden of OSNA technique in comparison with the 2 others in the standard setting in France.

Quality of Life and Pain evaluations will be performed immediately after surgery and during the 6 months after.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
ICO Paul Papin
Institut Bergonie
Institut du Sein -Clinique Saint-Amé
Eugène Marquis
Jean Perrin
Institut Paoli Calmettes
Institut de Cancérlogie de Lorraine
Jean-Marc cancérologie CLASSE
Henri BECQUEREL
CHU
Oscar Lambret
Clinique Mutualiste
IUCT-O
Institut Curie
HEGP


title: Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France Between 2006 and 2018

acronym: Encephalitis

summary:
The number of acute encephalitides diagnosed each year is gradually increasing, reaching approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown. The majority of them are acute encephalitis of infectious origin, but it is estimated that 20% of encephalitis in northern Europe is related to an autoimmune mechanism with the majority of encephalitis with anti-NMDA Ac discovered recently in 2007. The study of a large American encephalitis cohort showed a death rate of 3% to 7% in cases of autoimmune encephalitis. Furthermore, delay in the initiation of effective treatment (tumor removal or immunotherapy) beyond 4 weeks is associated with a poor prognosis at 1 year.

It is therefore necessary to better understand the signs of autoimmune encephalitis in order to recognize the disease quickly and to start a treatment quickly; in order to improve the management and the prognosis of these children.

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


summary: The aim is to document viral etiologies of isolated fevers and inlfuenza-like syndromes during summertime in South of France in order to better understand the role of known vector-borne viruses such as Toscana virus, West Nile virus during seasonal activity of the arthropod vector. In each of the four cities, a network of general practitioners will be associated in the project to recruit patients who are not hospitalized. The combined involvement of infectious disease specialists and general practitioner will augment the range of patients (mild disease and sever cases) in the study.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service des Maladies Infectieuses et Tropicales de l'Hôpital Nord, AP-HM


title: Registry of Congenital Anomalies in Nouvelle-Aquitaine, France

acronym: ATENA

summary: Regional population-based registry for the epidemiological surveillance of congenital anomalies

lead_sponsor: University Hospital, Bordeaux


title: Impact of HPV Vaccination on the Distribution of HPV in High Grade Lesions of the Cervix in France

acronym: IMPACT

summary: The objective is to estimate the prevalence of the different genotypes of human papillomaviruses (HPV) in histologically proven high-grade lesions of the cervix in patients born between 1972 and 1993. It is plan to determine if the prevalence of HPV16 and HPV18 is lower in the population born between 1983 and 1993 and potentially exposed to HPV vaccination compared to those born between 1972 and 1982 who were not exposed to vaccination. Thus the investigators should be able to determine whether the introduction of HPV vaccination in France in 2007 has had an impact on the development of high-grade lesions associated with HPV16 and HPV18.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


acronym: PROM SSCOL

title: Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

ReferenceCitation: Tran PL, Chirpaz E, Boukerrou M, Bertolotti A. Impact of a Papillomavirus Vaccination Promotion Program in Middle School: Study Protocol for a Cluster Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e35695. doi: 10.2196/35695.

summary:
Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island, CCU is the third leading cause of cancer in women (standardized incidence rate on the world population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France where it was 1.7 / 100,000 in 2018.

CCU results from infection with the human papillomavirus (HPV), which is the most common sexually transmitted viral infection.

CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV) which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted sexually, it is important to vaccinate before the start of sex.

In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by Public Health France at 8.1% among girls aged 16 years in 2018, while the already low national average was established 23.7%.

Thus, in view of the epidemiological situation in Reunion island (high incidence and mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to study the impact of a health promotion program sex and prevention of sexually transmitted infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV vaccination among young students in middle school.


title: A Multi-centre, Prospective, Noninterventional Study Investigating the Effectiveness of Once-weekly Subcutaneous Semaglutide in a Real World Adult Population With Type 2 Diabetes

acronym: SURE FRANCE

summary: The purpose of the study is to collect information on how semaglutide works in real world patients. Participants will get semaglutide prescribed by their study doctor. The study will last for about 6 to 8 months. The participants will be asked to complete some questionnaires about their health and their diabetes treatment. Participants will complete these during their normally scheduled visits with their study doctor.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S


title: Qualitative Study Evaluating Opinions Regarding HPV Vaccinnation in Boys' Parents Aged From 11 to 14 Years Old

acronym: QUALIOPIVAC

summary:
The human papilloma virus infection is the most frequent sexually transmitted infection around the world. In the vast majority of cases, these are inapparent infections that disappear spontaneously. In some cases, the HPV infection persists and can generate anogenital warts or cancer.

In France, the papillomavirus is responsible for 6000 new cases of cancer/year with several possible localizations : cervical, anal, penile, oropharyngeal, vulvar or vaginal. Among them, 4580 new cases of cancer/year occur in women, and half of them are diagnosis of cervical cancer. A quarter of cancers caused by papillomavirus occur in men.

In France, the commercialization of anti-HPV vaccine in 2007 was addressed only to girls, in order to gain a group immunity that would therefore protect the boys. This vaccination did not achieve the cover immunization target that were announced: the objective was fixed at 60% of vaccination coverage and at the end of 2018, only 24% was achieved on the complete vaccination schedule. In December 2019, the French National Authority for Health recommended the anti-HPV vaccinations in girls and boys.

lead_sponsor: Centre Hospitalier Eure-Seine


title: Prospective, Randomized, Multi-center Trial Aiming at Assessing the Effect of Humidification on the Comfort of the Patient Receiving an Oxygen Therapy.

acronym: OXYREA

summary: In France, the most used humidifying system during oxygen therapy is a non heated device with weak efficiency and non-proven clinical benefits. This study aims to assess the lack of benefits of non-heated humidification compared to no humidification, as regards to the comfort of the patient receiving oxygen therapy.

lead_sponsor: University Hospital, Angers


title: Gastroprotective Agent Utilization and Compliance in Elderly Patients Taking Non-steroidal Anti-inflammatory Drug (NSAID) in France

summary: The purpose of this study is to assess in general population NSAID and gastroprotective agent utilization and compliance in elderly people.

lead_sponsor: AstraZeneca