title: Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.

acronym: CIRCUP

summary: Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary tract infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs in healthy children. The effect of circumcision on the number of UTIs in boys with PUV has not yet been studied. Through a prospective randomised trial of children with posterior urethral valves the investigators wish to determine the effect of circumcision on the risk of presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other will be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. Both groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24 months. A DMSA scan will be performed at 1-2 and 24 months and biological renal function will also be monitored. The relative risk of presenting a febrile UTI in each group will be determined. Clinical, radiological and antenatal data concerning each child will be analysed. At 24 months follow-up, an "impact on family scale" survey (IOFS) will be proposed parents.

ReferenceCitation: Woolf AS, Thiruchelvam N. Congenital obstructive uropathy: its origin and contribution to end-stage renal disease in children. Adv Ren Replace Ther. 2001 Jul;8(3):157-63. doi: 10.1053/jarr.2001.26348.

ReferenceCitation: Parkhouse HF, Barratt TM, Dillon MJ, Duffy PG, Fay J, Ransley PG, Woodhouse CR, Williams DI. Long-term outcome of boys with posterior urethral valves. Br J Urol. 1988 Jul;62(1):59-62. doi: 10.1111/j.1464-410x.1988.tb04267.x.

ReferenceCitation: Singh-Grewal D, Macdessi J, Craig J. Circumcision for the prevention of urinary tract infection in boys: a systematic review of randomised trials and observational studies. Arch Dis Child. 2005 Aug;90(8):853-8. doi: 10.1136/adc.2004.049353. Epub 2005 May 12.

ReferenceCitation: Simforoosh N, Tabibi A, Khalili SA, Soltani MH, Afjehi A, Aalami F, Bodoohi H. Neonatal circumcision reduces the incidence of asymptomatic urinary tract infection: a large prospective study with long-term follow up using Plastibell. J Pediatr Urol. 2012 Jun;8(3):320-3. doi: 10.1016/j.jpurol.2010.10.008. Epub 2010 Nov 5.

ReferenceCitation: Mukherjee S, Joshi A, Carroll D, Chandran H, Parashar K, McCarthy L. What is the effect of circumcision on risk of urinary tract infection in boys with posterior urethral valves? J Pediatr Surg. 2009 Feb;44(2):417-21. doi: 10.1016/j.jpedsurg.2008.10.102.

ReferenceCitation: Harper L, Blanc T, Peycelon M, Michel JL, Leclair MD, Garnier S, Flaum V, Arnaud AP, Merrot T, Dobremez E, Faure A, Fourcade L, Poli-Merol ML, Chaussy Y, Dunand O, Collin F, Huiart L, Ferdynus C, Sauvat F. Circumcision and Risk of Febrile Urinary Tract Infection in Boys with Posterior Urethral Valves: Result of the CIRCUP Randomized Trial. Eur Urol. 2022 Jan;81(1):64-72. doi: 10.1016/j.eururo.2021.08.024. Epub 2021 Sep 22.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility: Department of pediatric surgery, Bordeaux hospital


title: Study of the Electrophysiological Activity of the Subthalamic Nucleus During the Processing of Emotional and Motivational Information in Patients With Parkinson's Disease

acronym: EMOPHYSIO

summary: The role of the basal ganglia in the processing of information with emotional or motivational content has been demonstrated by several lesion and functional imaging studies in humans and animals. Deep brain stimulation surgery provides an opportunity to study these structures in humans in electrophysiological terms. The aim of this study is to investigate modifications in the electrophysiological activity of the subthalamic nucleus (STN) during the perception of auditory and visual stimuli with emotional or motivational connotations in patients with Parkinson's disease who have just undergone implantation of a deep brain stimulator in the STN.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Rennes University Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Premature Aging and Type 2 Diabetes Mellitus: an Increased Risk of Cardiomyopathy?

summary:
The potential clinical implications of this study are to optimise the selection of a population at risk for developing a diabetic cardiomyopathy among diabetic patients in order to develop early therapeutic strategies to prevent the left ventricular remodelling.

Therefore, the originality of this project is to hypothesize that :

Diabetes mellitus is often associated with a premature aging syndrome
Cellular senescence may potentiate the mechanisms that are involved in decreasing myocardial contractility in DM and,
DM associated to premature aging may increase the risk of developing a cardiomyopathy Thus, the modulation of telomerase activity and the control of telomere length, together with the attenuation of the formation of reactive oxygen species, might represent important new targets in order to develop therapeutic tools in prevention of diabetic cardiomyopathy.

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

status_simplified: Completed


title: Effects of Recto-colic Enemas of Butyrate on the Digestive Disorders of Very Low Birth Weight Preterms <1250 Grams. Clinical Trial Prospective, Monocentric, Randomized in Double-blinded.

acronym: NEOTRANS

summary:
Clinical management of very low birth weight newborns (VLBW <1250g) consists in several challenges to adapt immature physiological systems to extrauterine life. Advances in neonatal medicine for pulmonary and/or neurological and/or cardiovascular diseases have significantly improved outcomes of these children. However, the gastro-intestinal (GI) tract remains a major cause of morbidity due to

the immaturity of GI functions (prolonged ileus, bacterial overgrowth and translocation),
the complication of GI tract immaturity: intestinal perforation and enterocolitis necrotizing)
the need of a prolonged parenteral nutrition and its complications (central venous catheter infections, sepsis, electrolyte disturbances) but without generate a high proof level on this targeted population (<1250g).

The GI functions are progressively acquired during development and are largely sensitive to the environment, especially the intestinal luminal content. Indeed, probiotics and prebiotics have shown beneficial effects upon GI functions of newborns. One of the metabolite of the gut flora potentially involved is the butyrate. Butyrate is a short chain fatty acid produced in the colon by the microbiota (carbo-hydrates degradation). The colonic amount of butyrate increases gradually after birth. The beneficial effects of butyrate are related to its properties upon the epithelial barrier (anti-inflammatory, antioxidant, barrier repair) and upon the enteric nervous system (network of neurons and glial cells) that regulate GI functions and in particular colonic motility.

To date, there is no clinical consensus to manage digestive disorders of VLBW. Several clinical studies have assessed the effects of prokinetic drugs, dietary supplements (probiotics, prebiotics) but without generate a high proof level on this targeted population. In this context, a recent study of our Research Unit (INSERM-CIC Mère-Enfant 004) has shown benefit effects of oral probiotics supplementation in children with birth weight greater than 1000g but not in extreme preterms with birth weight less than 1000g.

The main hypothesis to explain theses results lies in the intensive use of antibiotic and feeding interruption frequency in this targeted population which induce disturbances in the composition of the gut lumen (in particular the flora).

Colonic enemas assessed in various observational studies concerning VLBW seem to demonstrate a clinical efficiency upon the colonic transit, underlying by mechanical and osmotic mechanisms.

Here, the investigators propose to evaluate the clinical efficiency of butyrate enemas by a prospective randomized clinical trial blinded design.

The purpose of NEOTRANS study is to demonstrate that butyrate enemas may improve the nutritional management of extreme preterm less than 1250 grams, by facilitating the development of colic motility and clinical nutrition tolerance.

status: Terminated

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Nantes University Hospital

intervention_type: Drug


type: Other Identifier

summary:
Context: Sport and physical activity during and after cancer treatment can improve fitness and social inclusion in adults. In children, although early studies show interesting results, conclusive data are lacking. A preliminary evaluation conducted in a dozen children following a physical training program showed a significant improvement in endurance, muscle tone, overall self-esteem, sports skills and self-perceived strength. The investigators then want to evaluate the health of a group of children during treat cancer that physical activities adapted compared to children who did not practice.

Objective: Measuring the impact of physical activity program on health of children and adolescents with cancer with improved physical, psychological health, social reintegration and reduced time hospitalization.

Method and Design: The study plans to include 90 children from the pediatric hematology - oncology department of the La Timone CHU, aged 5-19 years with cancer, over a period of 18 months.

This is a randomized controlled open trial open with a stratified distribution. Children will be randomized between two arms - Arm A (Experimental - Immediate Program): the child follows the physical activity program for a period of 18 months, as soon as his medical condition permits. - Arm B (Control - Delayed Program): the child does not participate to the program during the first 6 months, and he joins the delayed program late after 6 months. Each child integrates the physical program for a period of one year.

Regardless of the randomization arm, the child performs the initial tests, the intermediate tests at 6 and 12 months and final tests at 18 months. Follow-up physical testing will be performed at 3 and 9 months.

The physical activity program includes a minimum of 30 days of activities per 6 months (4days/month and a long stay). The child practice between 2 to 4 hours of activity per day.

The investigators aim at demonstrating a difference of 50 meters on the total walked distance during the endurance test in the experimental group as compared to the control group after 6 months of program.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance publique hopitaux de marseille


title: Protocole de Validation Clinique du Logiciel d'Interface Cerveau-Ordinateur RoBIK Pour la Communication Des Patients Atteints de Maladie Neuromusculaires (MNM)

acronym: PVCAFM

summary: the objective of this protocol is evaluate the safety and tolerance of a communication system for severely disable patients with myopathies. The system analyses the brain electric activity in real time and converts it into digital commands for a spelling device, which is refered to as the P300 speller in the scientific literature. The secondary objective is to compare the performance of such tool with a more traditional assistive technology for the communication of severely disabled patients : scanner systems.

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

collaborators: Association Française contre les Myopathies (AFM), Paris

intervention_type: Device

lead_sponsor_type: industriel


title: Preventing the Development of Neuropathic Pain Post-mastectomy/Tumorectomy by Pre-emptive or Post-operative Memantine Administration

acronym: MEMANTINE

summary: The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.

ReferenceType: derived

ReferenceCitation: Morel V, Joly D, Villatte C, Dubray C, Durando X, Daulhac L, Coudert C, Roux D, Pereira B, Pickering G. Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients. PLoS One. 2016 Apr 6;11(4):e0152741. doi: 10.1371/journal.pone.0152741. eCollection 2016.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Pickering G, Morel V, Joly D, Villatte C, Roux D, Dubray C, Pereira B. Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial. Trials. 2014 Aug 20;15:331. doi: 10.1186/1745-6215-15-331.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Springer

lead_sponsor: University Hospital, Clermont-Ferrand


title: Does Goal-directed Hemodynamic Therapy Driven by Endotracheal Cardiac Output Monitoring System During Surgical Intervention Reduce Hospital Stay and Major Adverse Cardiac Events Following Cardiac Surgery?

acronym: ECOMIII

summary:
Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic optimizations are more efficient when based on the dynamic parameters than when based on the statics ones, and the major dynamic criteria is the cardiac output. Unfortunately, transpulmonary thermodilution, the device considered as "The gold standard" to evaluate cardiac output is associated with many complications.Furthermore, devices commercialized in the past decade were not able to replace the transpulmonary thermodilution.

As all monitoring devices aren't reliable enough to be widely used in practice they are left aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on the analysis of several clinical parameters seems to guarantee good cares thanks to a favorable benefits/risks balance, it could be improved by new plug and play mini-invasive systems.

In the investigators opinion, the ECOM system seems able to provide a monitoring tool which responds to all the expectations of a modern hemodynamic monitoring device. It uses a well known technique, the bioimpedance. The investigators suppose this device should be more efficient than the one that has been used before. Indeed, as the system is build on the endotracheal tube, it comes closer to the aorta, where all the measures are made, and the recorded signal should be less affected by the passage through the surrounding tissues.

This randomized and controlled trial will study Patients scheduled for elective coronary surgery with cardiopulmonary bypass.

The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed hemodynamic therapy based on the ECOM cardiac output measure on mortality and major postoperative cardiac morbidity after coronary surgery, when compared with a standard management strategy.

Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard management strategy, applied to the control group, will be set and led by the attending anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and stroke volume variation.

The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure will reduce mortality and morbidity after cardiac surgery.

lead_sponsor: University Hospital, Caen

sponsor_collaborators:
University Hospital, Caen
CONMED Corporation

intervention_type: Behavioral


title: Comparison of Cardiac Output Measurement Between Invasive Method (Transpulmonary Thermodilution) and Non Invasive Method (Photoplethysmography) : an Observational Study

acronym: PANEX

summary: Monitoring could secure management for patient but stay invasive. The purpose of this study was to compare,after cardiac surgery, the cardiac output measurement between transpulmonary thermodilution(reference method) and digital photoplethysmography (non invasive) for absolute value and dynamics changes before and after fluid expansion for patients with indication of fluid challenge.


title: Interest of Behavioural Reeducation in Dysfunctions of Masticatory Apparatus. Relations Between Parafunctions and Dysfunctions of Mastixatory Apparatus

acronym: PARADYSAM

summary: If etiologies of temporomandibular disorders (TMD) are various, parafunctions become more and more important. Treatment of patients presenting TMD is based on conservative and reversible therapeutics. The behavioural reeducation of these patients which aims at decreasing their parafunctions is a treatment often performed.


title: Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

summary: This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.

ReferenceCitation: van Duynhoven J, van der Hooft JJ, van Dorsten FA, Peters S, Foltz M, Gomez-Roldan V, Vervoort J, de Vos RC, Jacobs DM. Rapid and sustained systemic circulation of conjugated gut microbial catabolites after single-dose black tea extract consumption. J Proteome Res. 2014 May 2;13(5):2668-78. doi: 10.1021/pr5001253. Epub 2014 Apr 10.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Chemical Society

lead_sponsor: Unilever R&D

intervention_type: Dietary Supplement


title: Phase 2 Study Evaluating the Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Lower Limb Orthopedic Surgery in the Elderly Patients

acronym: PPSA

summary: Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation resulting in hypotension. A severe and prolonged hypotension can compromise regional perfusion and worse outcome especially in very elderly patients. Moreover the venous vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a cardiac output decrease. Several authors had identified the prevention of hypotension as a key role during spinal anesthesia although none prophylactic treatment has been identified. Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension. Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic agonist and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine infusion for preventing hypotension has been demonstrated during spinal anesthesia for cesarean delivery. The investigators want to assess for the first time the prophylactic phenylephrine infusion for preventing hypotension in elderly patients undergoing orthopedic lower limb surgery under spinal anesthesia single injection.

lead_sponsor: University Hospital, Toulouse


title: Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus

acronym: Multimod'HCA

summary:
Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled cavities in the brain. The clinical symptoms are gait disturbance, mental decline and incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be able to induce regression of the symptoms in many cases meaning that ICAH is a classic, curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is complicated: improvement is often incomplete and there is no consensus on either how to assess the symptoms or how they change after CSF depletion. In consequence, the decision whether not to undertake surgery often depends on the neurosurgeon's clinical impression.

Over recent years, the cognitive profile of patients with ICAH has become better characterised and reproducible, objective techniques have been developed to assess motor function and CSF flow in the brain.

The investigators project aims to define the value of these new investigative techniques in the positive diagnosis of ICAH, in comparison to current decision-making tools.

primary_purpose: Other

lead_sponsor: University Hospital, Tours


title: Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement

acronym: PTGMass

summary:
During fthe first postoperative days, physiotherapists supported patients with knee replacement in orthopaedics of Saint-Junien's and Limoges' hospitals. This support includes movements of the leg in active and non active motions, without any help and with an arthromotor, and involves walking rehabilitation.

The investigators would like to complete the physiotherapist's support with manual lymphatic drainage (MLD) using a specific method based on pressure of finger splayed (PFS). This might have a positive impact on time recovery of joint range, on postoperative oedema resorbtion and on patient's pain during rehabilitation classes.

French National Authority for Health specifies there is not a single study assessing massage effects on knee replacement, according to current bibliography.

The investigators purpose is the establishment of a prospective, controlled, randomised trial referred as a "superiority" trial. A total of 98 patients divided in 2 parallel groups will be created.

The study will be in an open-label manner for both patient and physiotherapist involved in walk rehabilitation but will be conducted as a blinded study for the investigating physiotherapist.

Inclusion period will be 17 months and the following period will be 6 weeks.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Limoges


type: EudraCT Number

title: A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer

acronym: BEVATOMOX

summary: This phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus FOLFOX6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: Perception Ortho-nasale du Gras Chez l'Homme Sain : Relations Entre Typages olfactométriques, Sensoriels et Composition de la Salive.

acronym: SensInFat

summary: The perception of fat represents major scientific and nutritional issues. This research aims to identify salivary markers that could predict and possibly explain this perception in healthy human being. This would help to develop nutritional strategies for a more rational consumption of fat.

ipd_sharing: No

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


title: Simplification of the Test of Sensibility in the Salt: Preliminary Study at the Child and the Adult

acronym: PLADSEL

summary:
The primary objective of this study is to analyze the sensitivity of blood pressure to oral salt intake. Matched male and female participants will be selected as normal weight, overweight, and obese.

Participating subjects will have a first visit with blood pressure measurement and a blood sample. In two consecutive phases of one week, subjects will receive 12 pills of sodium (6 grams) or corresponding placebo. Blood pressure will be measured at the end of each phase.

lead_sponsor: Poitiers University Hospital


title: Diagnostic Relevance of Laser Confocal Microscopy During Reno-ureteroscopy in the Context of the Screening and Follow-up of Upper Urinary Tract Tumors

acronym: UROVISIO

summary: Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year. The standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment techniques through natural routes opens the possibility to use conservative treatments. The investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will allow the discrimination between normal and pathologic urothelium by microscopic analysis. This will prevent the systematic use of biopsies which are often difficult and iatrogenic.

primary_purpose: Diagnostic

lead_sponsor: Lille Catholic University

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: Study of Inflammatory Role of Epstein-Barr Virus (EBV) in Atrophic and Erosive Forms of Oral Lichen Planus

acronym: LICHENVIR

summary:
Oral lichen planus (OLP) is a chronic inflammatory and relapsing. The average prevalence is 1 to 4%. The clinics forms are many and symptoms are varied. The erosive form, painful and debilitating is characterized by erosive areas, ulcerated on an erythematous base with or without a keratinocyte lichenien network.

The literature data moving towards an autoimmune origin, but the pathophysiological mechanisms of OLP remain unknown.

This project represents the first part of a comprehensive project to examine the oral pathogenesis of different viruses (Herpes and papillomavirus HPV) and centered on Epstein-Barr Virus (EBV).

ReferenceCitation: Raybaud H, Olivieri CV, Lupi-Pegurier L, Pagnotta S, Marsault R, Cardot-Leccia N, Doglio A. Epstein-Barr Virus-Infected Plasma Cells Infiltrate Erosive Oral Lichen Planus. J Dent Res. 2018 Dec;97(13):1494-1500. doi: 10.1177/0022034518788282. Epub 2018 Jul 13.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: SAGE Publications

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Biological


title: Effect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy Subjects

summary: The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline pharmacokinetics in healthy subjects.

lead_sponsor: Bial - Portela C S.A.


title: Etude Des Troubles métaboliques Induits Par Une Course à Pied très Longue Distance, " La Diagonale Des Fous " de La Réunion / Metabolic Disorders in Ultramarathon Runners of the Madmen's Diagonal Race on Reunion Island

acronym: METARUN

summary: Acute consequences of ultramarathon running are still unknown as very little research has been done on the matter. The investigators will assess the consequences on the metabolism of runners in the ultramarathon Madmen's Diagonal on Reunion Island. Data from the literature suggest that runners undergo loss of zinc, copper, iron, magnesium not unlike the loss of metabolites in systemic inflammatory response syndrome. The purpose of this study is to assess the metabolic disorders (selenium, zinc, vitamins B9 and B12) in ultramarathon runners, during and up to 28 days after the Madmen's Diagonal which takes place on Reunion Island every year in October.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

intervention_type: Procedure


title: Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

acronym: CAMPYTEST

summary: For a long time, culture was the only way to detect Campylobacter. It appears that rapid immunochromatographic tests (ICT) have detected more positive cases compared to culture, ELISA and molecular tests. The aim of our study is to evaluate the specificity of the ICT which are really interesting tools to use since they allow a diagnosis in about 15 min, in comparison to different methods of detection even serology.

lead_sponsor: University Hospital, Bordeaux


title: Study of the Immunogenicity of a Prime Boost Vaccination Strategy Combining Conjugated Anti-pneumococcal and Polysaccharide Anti-pneumococcal Vaccine Compared to Polysaccharide Anti -Pneumococcal Vaccine Alone in Patients With Sickle Cells Disease

acronym: DREVAC

summary:
Streptococcus pneumoniae is the major cause of bacterial infection in patients with sickle cells disease.

The 23-valent pneumococcal polysaccharide vaccine (PSV) is supposed to be poorly immunogenic in these patients. We want to evaluate whether a prime with a 13-valent pneumococcal conjugate vaccine (PCV), able to induce immunologic memory, would improve the immune response against SP polysaccharides (SPP).

Primary objective: To evaluate and compare the specific antibody response to a prime-boost vaccine strategy combining PCV prime at W0 followed by the administration of PSV boost at W4, to the administration of PSV alone at W4 in patients with sickle cells disease.

Secondary objectives: Evaluation and comparison of the specific antibody response to the thirteen pneumococcal serotypes shared by the PCV and PSV vaccines, 4 weeks after the single PSV vaccination for patients from Group 1 or 4 weeks after the boost PSV vaccination for patients from group 2. Evaluation of the duration of the specific antibody response at W24 and 96. Evaluation of the T CD4 lymphocyte response to the CRM 197 protein. Safety of the vaccines.

Study Design: Randomised, monocentric, controlled phase II study of the immunological efficacy of a prime boost strategy combining the sequential administration of the PCV and PSV, compared to the administration of the PSV alone. 180 adults patients with sickle cells disease will be included. The primary endpoint : proportion of responders at W8 to at least 10 of thirteen serotypes. Secondary endpoints : Proportion of responders at W8 according to 4 categories of responders: 5-7; 3-4; 2-1 and 0. Evaluation of the pneumococcal opsonophagocytic activity (OPA) at baseline and W8 for each serotype, defined as the proportion of patients with OPA > 1:8 geometric mean of the specific antibody titers proportion of patients who experienced an increase of specific antibody levels 1 g/ml. Evaluation of the priming effect of the PCV vaccine in the group 1. Duration of the specific antibody responses at week 24 and W96. CD4 T lymphocyte responses to the CRM 197 protein (proliferative and cytokine production) at weeks 0, 8 and 12. Safety of the vaccines frequency of Streptococcus pneumoniae infections.

Statistical Considerations: With a sample size of 180 patients, and a randomization ration of 1:1, the study will have a power of at least 90% to show a difference of 25% category between the group receiving PCV and PSV vs the group receiving PSV alone (two-sided type I error = 5%). The primary comparison between both groups will be performed using a Chi2 test for independent groups or a Fisher exact test where appropriate.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Effect of Glycabiane, a Dietary Supplement, on Glycemic Control of Prediabetic Subjects

summary: The purpose of this study is to examine the effects of supplementation Glycabiane, a dietary supplement, on glycemic control of overweight prediabetic subjects.

ReferenceCitation: Liu Y, Cotillard A, Vatier C, Bastard JP, Fellahi S, Stevant M, Allatif O, Langlois C, Bieuvelet S, Brochot A, Guilbot A, Clement K, Rizkalla SW. A Dietary Supplement Containing Cinnamon, Chromium and Carnosine Decreases Fasting Plasma Glucose and Increases Lean Mass in Overweight or Obese Pre-Diabetic Subjects: A Randomized, Placebo-Controlled Trial. PLoS One. 2015 Sep 25;10(9):e0138646. doi: 10.1371/journal.pone.0138646. eCollection 2015. Erratum In: PLoS One. 2015;10(12):e0145315.

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

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

lead_sponsor: PiLeJe


title: Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome

summary: The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).


title: Evaluation of Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention in Patients With Atrial Fibrillation

summary: The main objective of this pilot study is to investigate the protein / peptide plasma profiles before and after treatment with a direct anti-Xa (activated Factor 10) in patients with non-valvular atrial fibrillation to better understand the mechanisms of action of these molecules and perform exploratory analyses concerning proteins whose concentrations change after starting treatment.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)

acronym: NEBULAMB

summary: Compare the incidence of severe clinical exacerbations in the treatment of ABPA, between a strategy with a maintenance treatment and a conventional strategy without antifungal maintenance therapy.

ReferenceCitation: Godet C, Couturaud F, Marchand-Adam S, Pison C, Gagnadoux F, Blanchard E, Taille C, Philippe B, Hirschi S, Andrejak C, Bourdin A, Chenivesse C, Dominique S, Bassinet L, Murris-Espin M, Riviere F, Garcia G, Caillaud D, Blanc FX, Goupil F, Bergeron A, Gondouin A, Frat JP, Flament T, Camara B, Priou P, Brun AL, Laurent F, Ragot S, Cadranel J; NebuLamB study group and GREPI network; Godet C, Couturaud F, Cadranel J, Frat JP, Brun AL, Laurent F, Marchand-Adam S, Pison C, Gagnadoux F, Blanchard E, Taille C, Philippe B, Hirschi S, Andrejak C, Chenivesse C, Dominique S, Bassinet L, Murris-Espin M, Riviere F, Garcia G, Caillaud D, Blanc FX, Goupil F, Gondouin A, Flament T, Camara B, Priou P, Ragot S. Nebulised liposomal amphotericin-B as maintenance therapy in allergic bronchopulmonary aspergillosis: a randomised, multicentre trial. Eur Respir J. 2022 Jun 16;59(6):2102218. doi: 10.1183/13993003.02218-2021. Print 2022 Jun.

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: European Respiratory Society

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: CENTRE HOSP. UNIVERSITAIRE DE POITIERS

type_etablissement: CHUR

acronyme: NEBULAMB

titre: Evaluation d'une stratégie thérapeutique comprenant de l'Ambisome® nébulisé en traitement d'entretien dans l'aspergillose bronchopulmonaire allergique (mucoviscidose exclue)

discipline_principale: infectieux

nom_porteur: GODET

prenom_porteur: Cendrine


title: Effects of Propofol on Early Recovery of Hunger After Ambulatory Surgery Compared With Sevoflurane

acronym: Propo-Faim

summary:
Recovery of hunger is a source of comfort for patients after general anesthesia. Moreover, this aspect of post-operative period is often required for discharging patients from hospital after ambulatory surgery. Indeed, this item is part of a multi-parameter score (Chung score) whose validation evaluates patient's ability to return home.

The impact of anesthetics on hunger is largely unknown but few studies suggest an orexigenic effect of propofol compared to halogenated gases. These studies had neither the power nor the methodology to answer the question. The aim of our study is to evaluate the impact of propofol versus sevoflurane on early recovery of hunger after ambulatory surgery.

ReferenceCitation: Besnier E, Perdrix A, Gillibert A, Selim J, Froemer B, Ghemired A, Berby B, Rives N, Dureuil B, Clavier T, Compere V. Postoperative hunger after outpatient surgery in patients anesthetized with propofol vs sevoflurane: a randomized-controlled trial. Can J Anaesth. 2020 May;67(5):550-559. doi: 10.1007/s12630-020-01584-w. Epub 2020 Jan 29.

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Rouen

sponsor_collaborators:
University Hospital, Rouen
Centre Henri Becquerel


title: Dextromethorphan in Chemotherapy-induced Peripheral Neuropathy Management

acronym: CHEMODEX

summary: The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.

ReferenceCitation: Martin E, Morel V, Joly D, Villatte C, Delage N, Dubray C, Pereira B, Pickering G. Rationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy. Contemp Clin Trials. 2015 Mar;41:146-51. doi: 10.1016/j.cct.2015.01.012. Epub 2015 Jan 28.

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Dr Dominique JOLY / Dr Christine VILLATTE

collaborators: Dr Noémie DELAGE / Dr Fabienne MARCAILLOU / Dr Pascale PICARD


title: C Terminal Peptide Variants of the Fsh Receptor in Women Involved in an Assisted Reproduction Programm : Mechanistic Approach

summary:
Follicle-stimulating hormone (FSH) is used in medically assisted procreation, to induce an ovarian stimulation in women. However, the FSH dose that has to be injected is quite hard to adjust, because an excess of exogenous hormone could lead to very severe complications for patient. This hormone acts on its cognate receptor, the FSHR, present on the granulosa cells surface, and which regulation involve the intra-cytoplasmic carboxy-terminus domain.

The investigators first aimed to research in the c-terminus part of the receptor the presence of allelic variants that could explain the variations of response to FSH stimulation.

The investigators also would want to complete the data already known on a functionally determinant single nucleotide polymorphism on 680 position in the c-terminus part of the hFSHR.

Then, the investigators would analyze the entire sequence of the hFSHR of patients presenting an unusual phenotype in response to FSH treatment, in order to detect a potential mutation involved in the receptor functionality.

The results of this study could allow us to increase our knowledge on the hFSHR physiology and functionality, in order to adjust treatment to the genetic profile of patients.


type: Other Grant/Funding Number

title: Impact on Morbidity and Mortality of Prophylactic Dosing of Low Molecular Weight Heparin in Child-Pugh B Cirrhotic Patients: a Randomized Controlled Study

acronym: Childbenox

summary: Thrombosis occurring in the small intrahepatic, as well as in the large vessels is involved in the progression of cirrhosis. Anticoagulation could reduce morbidity and mortality in cirrhotic patients

status: Suspended

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: CHILBENOX

titre: Impact de l'anticoagulation à dose préventive par héparine de bas poids moléculaire sur la morbimortalité chez les patients cirrhotiques Child B : Essai randomisé multicentrique

discipline_principale: hépatologie

nom_porteur: POUJOL ROBERT

prenom_porteur: Armelle


title: Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach in Patients With Squamous Cell Carcinoma of the Epi-larynx: the First Three Patients

acronym: RoboCurage ORL

summary:
The main hypothesis of this study is that it is possible to make a unilateral selective dissection of ganglion levels IIa, III and IV using an endoscopic transaxillary approach via the da Vinci robotic system to reduce scarring, while respecting patient safety.

Feasibility will be assessed by two combinded criteria: 1) performance of the surgical procedure respecting the different stages of visualization and dissection of key anatomical elements; 2) obtain a minimum of 9 lymph nodes when analyzing pathological evidence of the dissection.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Outcome of Infants With Prenatal Corpus Callosum Agenesis

acronym: Dacci

summary: The purpose of this study is to assess the neurological development at three years of age of children born after prenatal diagnosis of "isolated" agenesis of the corpus callosum.

primary_purpose: Screening

ReferenceType: background

ReferenceCitation: Sotiriadis A, Makrydimas G. Neurodevelopment after prenatal diagnosis of isolated agenesis of the corpus callosum: an integrative review. Am J Obstet Gynecol. 2012 Apr;206(4):337.e1-5. doi: 10.1016/j.ajog.2011.12.024. Epub 2011 Dec 27.

ReferenceCitation: Moutard ML, Kieffer V, Feingold J, Lewin F, Baron JM, Adamsbaum C, Gelot A, Isapof A, Kieffer F, de Villemeur TB. Isolated corpus callosum agenesis: a ten-year follow-up after prenatal diagnosis (how are the children without corpus callosum at 10 years of age?). Prenat Diagn. 2012 Mar;32(3):277-83. doi: 10.1002/pd.3824.

ReferenceCitation: Moutard ML, Kieffer V, Feingold J, Kieffer F, Lewin F, Adamsbaum C, Gelot A, Campistol I Plana J, van Bogaert P, Andre M, Ponsot G. Agenesis of corpus callosum: prenatal diagnosis and prognosis. Childs Nerv Syst. 2003 Aug;19(7-8):471-6. doi: 10.1007/s00381-003-0781-6. Epub 2003 Jul 4.


title: Evaluation of the Efficiency of Nemost Growing Spine Device Associated With Physiotherapy in the Surgical Treatment of Progressive Scoliosis of the Child

acronym: NEMOST

summary:
The purpose of this study is to evaluate the performance of the device "NEMOST" on maintaining of the correction of the scoliosis with growth preservation and avoiding iterative surgeries.

Objective of this study is to evaluate the performance of the growing device "NEMOST" associated to physiotherapy at 12 months postoperatively in patients treated for progressive scoliosis and to evaluate its safety.

design_allocation: Non-Randomized

ReferenceCitation: Miladi L, Khouri N, Pradon J, Elie C, Treluyer JM. One-way self-expanding rod for early-onset scoliosis: early results of a clinical trial of 20 patients. Eur Spine J. 2021 Mar;30(3):749-758. doi: 10.1007/s00586-021-06732-4. Epub 2021 Jan 24.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Company EUROS


title: Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®

summary: This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.

status: Active, not recruiting

lead_sponsor: W.L.Gore & Associates

status_simplified: Ongoing


type: Registry Identifier

title: Determinants of Nocturnal Respiratory Disorders of Obese Patients Referred to in a Specialized Center.

acronym: SOON

summary:
The main objective of the study is to identify the determinant of sleep characteristics of obese patients attempting a tertiary clinical center for obesity management, including bariatric surgery.

More accurately the questions addressed are:

What are the determinants of the sleep habits (sleep duration, chronotype) and of their evolution
What are the determinants of sleep breathing disorders (sleep apnea, obesity hypoventilation syndrome) and of their evolution

ReferenceCitation: Guggino J, Coumes S, Wion N, Reche F, Arvieux C, Borel AL. Effectiveness and Safety of Bariatric Surgery in Patients with End-Stage Chronic Kidney Disease or Kidney Transplant. Obesity (Silver Spring). 2020 Dec;28(12):2290-2304. doi: 10.1002/oby.23001.

publisher_dissemination: Wiley

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Act For Chronic Diseases
HP2 laboratory INSERM U1042
University Grenoble Alps


title: Multicentric Cohort of HIV Patient With Extrem Profil

acronym: CODEX

summary:
A consortium of research teams has studied the immunovirological characteristics of these patients:

The ANRS CO15 ALT cohort The ANRS CO18 HIV Controller cohort the ANRS EP47 VISCONTI study

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study

acronym: EchoComp TVP

summary: The main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed by a vascular exploration expert.


title: A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects

summary: The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.


title: Genetic Polymorphisms in Catecholamine Pathway Responsible for the Tako-TSUBO Cardiomyopathy Susceptibly (TAKO-GENE)

summary:
This is a case-control association study with multicentric prospective recruitment.

Tako-TSUBO cardiomyopathy is a new clinical entity mimicking an acute coronary syndrome. It is characterized by reversible left ventricular dysfunction that is frequently precipitated by a stressful event and most of patients are postmenopausal women.

Several hypotheses concerning pathogenesis of Tako-TSUBO cardiomyopathy have been proposed, but at present, exaggerated sympathetic stimulation is the main hypothesis. However, the investigators don't know why some patients with stressful event may present Tako-TSUBO cardiomyopathy whereas most of them don't.

The investigators hypothesize that polymorphisms in the genes involved in the adrenergic pathway resulting in greater catecholamine sensitivity would be associated with an increased risk of Tako-TSUBO cardiomyopathy.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fédération Française de Cardiologie

location_facility: Name: Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré. Université de Versailles-Saint Quentin en Yvelines


title: Identify Bacteria Associated With Metabolic Diseases That Reside Both in Intestinal Crypts and in Blood.

acronym: MICIMAB

summary: The investigators will compare 16sRDNA profile in cases and controls in order to identify bacteria associated with metabolic diseases that reside both in intestinal crypts and in blood.

lead_sponsor: University Hospital, Toulouse


title: Parallel Randomised Open Blind Evaluation Study of the Efficacy of 20° Trendelenburg Position During 24 Hours After Epidural Blood Patch in the Treatment of Spontaneous Intracranial Hypotension

acronym: SIHT

summary: Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of cerebrospinal fluid. There are not controlled studies for this treatment.The main of this study is to demonstrate the superiority of the Trendelenburg position compared to supine position during 24 hours after an epidural blood patch for a spontaneous intracranial hypotension

ReferenceCitation: Ferrante E, Arpino I, Citterio A, Wetzl R, Savino A. Epidural blood patch in Trendelenburg position pre-medicated with acetazolamide to treat spontaneous intracranial hypotension. Eur J Neurol. 2010 May;17(5):715-9. doi: 10.1111/j.1468-1331.2009.02913.x. Epub 2009 Dec 29.

ReferenceCitation: Sencakova D, Mokri B, McClelland RL. The efficacy of epidural blood patch in spontaneous CSF leaks. Neurology. 2001 Nov 27;57(10):1921-3. doi: 10.1212/wnl.57.10.1921.

location_facility: Lariboisiere Hospital - Centre Urgences Céphalées (CUC)


title: Multicentric Observational NAtional Study on LISteriosis and ListeriA

acronym: MONALISA

summary:
Listeriosis is a foodborne infection responsible for severe disease. Three main forms are described: septicaemia, central nervous system infections and maternal-fetal infections. Available data on the disease, are mostly retrospective and do not provide an accurate picture of the clinical / biological / genetic risk factors for the disease, nor identify any element to determine which patients are at higher risk of death, severe neurological impairment or fetal loss.

The primary purpose of the study is to identify clinical, biological and genetic risk factors for systemic listeriosis and the determinants of listeriosis-associated mortality in the setting of a large prospective nation-wide study.

status: Recruiting

ReferenceCitation: Mylonakis E, Hohmann EL, Calderwood SB. Central nervous system infection with Listeria monocytogenes. 33 years' experience at a general hospital and review of 776 episodes from the literature. Medicine (Baltimore). 1998 Sep;77(5):313-36. doi: 10.1097/00005792-199809000-00002.

ReferenceCitation: Mylonakis E, Paliou M, Hohmann EL, Calderwood SB, Wing EJ. Listeriosis during pregnancy: a case series and review of 222 cases. Medicine (Baltimore). 2002 Jul;81(4):260-9. doi: 10.1097/00005792-200207000-00002. No abstract available.

ReferenceCitation: Lecuit M, Vandormael-Pournin S, Lefort J, Huerre M, Gounon P, Dupuy C, Babinet C, Cossart P. A transgenic model for listeriosis: role of internalin in crossing the intestinal barrier. Science. 2001 Jun 1;292(5522):1722-5. doi: 10.1126/science.1059852.

ReferenceCitation: Disson O, Grayo S, Huillet E, Nikitas G, Langa-Vives F, Dussurget O, Ragon M, Le Monnier A, Babinet C, Cossart P, Lecuit M. Conjugated action of two species-specific invasion proteins for fetoplacental listeriosis. Nature. 2008 Oct 23;455(7216):1114-8. doi: 10.1038/nature07303. Epub 2008 Sep 17.

ReferenceCitation: Charlier C, Leclercq A, Cazenave B, Desplaces N, Travier L, Cantinelli T, Lortholary O, Goulet V, Le Monnier A, Lecuit M; L monocytogenes Joint and Bone Infections Study Group. Listeria monocytogenes-associated joint and bone infections: a study of 43 consecutive cases. Clin Infect Dis. 2012 Jan 15;54(2):240-8. doi: 10.1093/cid/cir803. Epub 2011 Nov 18.

ReferenceCitation: Charlier C, Kermorvant-Duchemin E, Perrodeau E, Moura A, Maury MM, Bracq-Dieye H, Thouvenot P, Vales G, Leclercq A, Ravaud P, Lecuit M. Neonatal Listeriosis Presentation and Outcome: A Prospective Study of 189 Cases. Clin Infect Dis. 2022 Jan 7;74(1):8-16. doi: 10.1093/cid/ciab337.

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

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

publisher_dissemination: Oxford University Press

ReferenceCitation: Charlier C, Poiree S, Delavaud C, Khoury G, Richaud C, Leclercq A, Helenon O, Lecuit M; MONALISA Study Group. Imaging of Human Neurolisteriosis: A Prospective Study of 71 Cases. Clin Infect Dis. 2018 Oct 15;67(9):1419-1426. doi: 10.1093/cid/ciy449.

oa_colors: green other

evidence: open (via free article)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

ReferenceCitation: Charlier C, Perrodeau E, Leclercq A, Cazenave B, Pilmis B, Henry B, Lopes A, Maury MM, Moura A, Goffinet F, Dieye HB, Thouvenot P, Ungeheuer MN, Tourdjman M, Goulet V, de Valk H, Lortholary O, Ravaud P, Lecuit M; MONALISA study group. Clinical features and prognostic factors of listeriosis: the MONALISA national prospective cohort study. Lancet Infect Dis. 2017 May;17(5):510-519. doi: 10.1016/S1473-3099(16)30521-7. Epub 2017 Jan 28. Erratum In: Lancet Infect Dis. 2017 Sep;17(9):897.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Institut Pasteur
French National sanitory

location_facility: Centre National de Reference et Centre Collaborateur OMS Listeria, Institut Pasteur


acronym: ANASILPRA

summary: There is currently no drug with pediatric marketing authorization capable of limiting the advance in bone maturation of children with aggressive adrenarche. Estrogens are the principal actors involved in bone maturation and premature epiphyseal fusion. Aromatase inhibitors, used for the treatment of hormone-dependent cancers, block the transformation of androgens into estrogens. Third generation inhibitors, of which Anastrozole is one, appear to be well tolerated in children and are sometimes used within the framework of clinical trials to limit bone maturation and improve prognosis with respect to final size, notably in children treated with growth hormone (GH) due to a GH deficit. Nevertheless, the data reported are based on small sample sizes and do not include children with pathological adrenarche.

location_facility: Explorations Fonctionnelles d'Endocrinologie - Centre de Référence des Maladies Endocriniennes Rares de la Croissance Hôpital Armand Trousseau

title: Efficacy and Tolerance of Treatment With an Aromatase Inhibitor (Anastrozole) to Limit the Progression of Bone Maturation Related to Pathological Adrenarche in Children With Silver-Russell or Prader-Willi Syndrome

source: euctr


title: Study of the Antro-pyloro-duodenal Motor Dysfunction in Idiopathic Gastroparesis

summary: Impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even nutritionnal impairment. Delay in gastric emptying may result from antro-pyloro-duodenal motility impairement.


title: Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients

acronym: eCOPD

summary:
Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.

Multicentric Randomized Controlled Trial

Primary Objective:

To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term treatment efficacy and patient compliance

Secondary Objectives:

To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with NIV

lead_sponsor: ResMed


acronym: INTUITION

lead_sponsor: Hospices Civils de Lyon

summary:
After myopia, the second etiology of choroidal neovascularization (CNV) in young adults (<50 years old) is idiopathic choroidal neovascularization (ICNV) whose etiology remains unknown. This is a rare and severe disease, which can lead to blindness.

ICNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently indicated in Age-related Macular Degeneration (AMD). Case reports suggest that such patients would not need as many injections as in AMD.

INTUITION is an open-label, single arm, prospective, multicenter, phase II study. The main objective is to demonstrate the effectiveness in clinical terms after 52 weeks of treatment with aflibercept on the visual acuity of patients affected by ICNV. A specific dosage regimen is designed to achieve maximum efficiency. The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept are initiated with a Treat & Extend (TAE) regimen until 20 weeks (3 mandatory injections with reinjection only in case of CNV activity). Then, a pro re nata (PRN) regimen is considered until 52 weeks (reinjection in case of CNV activity).

location_facility: Hospices Civils de Lyon - Hôpital de la Croix-Rousse

title: Phase II Study Evaluating the Efficacy of Aflibercept for the Treatment of Iodiopathic Choroidal Neovascularization in Young Patients


title: Measurement of Low-energy Stimulation in Patients With Atrial Fibrillation

summary: Multistage low-energy pulses are being evaluated for their effect on atrial fibrillation during an acute testing procedure.

ReferenceCitation: Janardhan AH, Gutbrod SR, Li W, Lang D, Schuessler RB, Efimov IR. Multistage electrotherapy delivered through chronically-implanted leads terminates atrial fibrillation with lower energy than a single biphasic shock. J Am Coll Cardiol. 2014 Jan 7-14;63(1):40-8. doi: 10.1016/j.jacc.2013.07.098. Epub 2013 Sep 26.

ipd_sharing_description: No plan to share data. Data has been published in a peer reviewed journal

lead_sponsor: Cardialen, Inc.


title: Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study

acronym: PSYCNEP

summary: A randomized double-blind controlled two centers study. The primary objective of this study will be to show a superiority of hypnosis over relaxation on pain intensity in patients with neuropathic pain.

location_facility: Centre d'évaluation et de traitement de la douleur, Hôpital Ambroise Paré


title: Are Estradiol and Testosterone Levels in Seminal Plasma Predictive for Efficient Spermatogenesis in Men With Non- Obstructive Azoospermia

summary: Estradiol and Testosterone are two important hormones for the regulation of an effective spermatogenesis in human testis. The evaluation of levels of estradiol and testosterone in seminal plasma of men with non-obstructive azoospermia may be a predictive test before surgical testicular biopsy to determine the chance of a positive sperm extraction to use for ICSI.

time_perspective: Cross-Sectional


acronym: POPCUR

summary:
Curcumin, the active ingredient of turmeric, has been used for long term in the treatment of inflammatory conditions. Inhibition of NF-κB is postulated as the main mechanism responsible for the anti-inflammatory effect of curcumin

Aim : to study the effect of curcumin, 3g per day, as compared to placebo, combined with thiopurines in the prevention of Crohn's disease post-operative recurrence.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
3i nature
Naturopôle Nutrition santé

title: Controlled, Randomized, Double Blind Study, Comparing Curcumin to Thiopurines in the Prevention of Post-op Recurrence in Crohn Disease

collaborators:
3i nature
Naturopôle Nutrition santé

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

type_etablissement: CH

acronyme: POPCUR

titre: Etude controlée, randomisée, en double aveugle, comparant la curcumine au placebo, associés aux thuiopurines, dans la prévention de la récidive post-opératoire de la maladie de Crohn

discipline_principale: digestif

nom_porteur: BOMMELAER

prenom_porteur: Gilles


title: Cohort of Therapeutic Failure and Resistances in Patients Treated With a Protease Inhibitor (Telaprevir or Boceprevir), Pegylated Interferon (PEG-IFN) and Ribavirin (RBV) Included in the French Early Access Program for the Use of Protease Inhibitors in Genotype 1 Patients Who Failed to Eradicate HCV With a Previous Standard PEG-IFN and RBV Combination.

acronym: CUPIC

summary: The purpose fo the study is to evaluate the efficacy defined by the sustained virological response (SVR), in patients with compensated cirrhosis treated with PEG-IFN, RBV and telaprevir or boceprevir in the French Early Access Program for the use of protease inhibitors or after the approval of these drugs through the the marketing authorization.

time_perspective: Other

ReferenceCitation: Sultanik P, Mallet V, Lagaye S, Casrouge A, Dorival C, Barthe Y, Fontaine H, Hezode C, Mottez E, Bronowicki JP, Carrat F, Theodorou I, Abel L, Gayat E, Fontanet A, Pol S, Albert ML; ANRS CO20-CUPIC. Plasma apolipoprotein H limits HCV replication and associates with response to NS3 protease inhibitors-based therapy. Liver Int. 2015 Jul;35(7):1833-44. doi: 10.1111/liv.12759. Epub 2015 Jan 23.

ReferenceCitation: Hezode C, Fontaine H, Dorival C, Zoulim F, Larrey D, Canva V, De Ledinghen V, Poynard T, Samuel D, Bourliere M, Alric L, Raabe JJ, Zarski JP, Marcellin P, Riachi G, Bernard PH, Loustaud-Ratti V, Chazouilleres O, Abergel A, Guyader D, Metivier S, Tran A, Di Martino V, Causse X, Dao T, Lucidarme D, Portal I, Cacoub P, Gournay J, Grando-Lemaire V, Hillon P, Attali P, Fontanges T, Rosa I, Petrov-Sanchez V, Barthe Y, Pawlotsky JM, Pol S, Carrat F, Bronowicki JP; CUPIC Study Group. Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis. Gastroenterology. 2014 Jul;147(1):132-142.e4. doi: 10.1053/j.gastro.2014.03.051. Epub 2014 Apr 3.

license: cc-by-nd

license_normalized: cc-by-nd

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

ReferenceCitation: Hezode C, Fontaine H, Dorival C, Larrey D, Zoulim F, Canva V, de Ledinghen V, Poynard T, Samuel D, Bourliere M, Zarski JP, Raabe JJ, Alric L, Marcellin P, Riachi G, Bernard PH, Loustaud-Ratti V, Metivier S, Tran A, Serfaty L, Abergel A, Causse X, Di Martino V, Guyader D, Lucidarme D, Grando-Lemaire V, Hillon P, Feray C, Dao T, Cacoub P, Rosa I, Attali P, Petrov-Sanchez V, Barthe Y, Pawlotsky JM, Pol S, Carrat F, Bronowicki JP; CUPIC Study Group. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) - NCT01514890. J Hepatol. 2013 Sep;59(3):434-41. doi: 10.1016/j.jhep.2013.04.035. Epub 2013 May 10.


title: A Double Blind, Randomized, Two Period Crossover Study To Determine The Effect of Multiple Doses of 120 MG Modified Release Formulation of YM150 on the Steady State Pharmacokinetics of Digoxin in Healthy Subjects

summary: This study is to evaluate the effect of YM150 on the plasma concentration of digoxin in healthy subjects.

ReferenceCitation: Kadokura T, Groenendaal D, Heeringa M, Mol R, Verheggen F, Garcia-Hernandez A, Onkels H. Darexaban (YM150), an oral direct factor Xa inhibitor, has no effect on the pharmacokinetics of digoxin. Eur J Drug Metab Pharmacokinet. 2014 Mar;39(1):1-9. doi: 10.1007/s13318-013-0141-1. Epub 2013 Jun 11.

lead_sponsor: Astellas Pharma Inc


title: TherapyGuide : Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function

summary:
The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient. This progress led to a more and more complex programming for the physicians. To help them set optimally the pacing parameters, physicians refer to the existing recommendations of learned societies as well as to his expertise. Manufacturers developed also algorithms integrated into pacemakers with the aim of assisting physicians in their programming.

TherapyGuide is a function which proposes a programming adapted to the psychopathological state of the patient, with a justification based on experts' consensus, clinical studies as well as on published articles.

Physicians have the choice to accept or reject the programming proposed by TherapyGuide. When rejected, there is no means to analyze the modifications brought to the proposed set of parameters. The nature, the frequency and the reasons of these modifications are not thus known.

The purpose of this study is to assess the acceptance of the TherapyGuide proposals by physicians and to identify the most frequent type of programming changes they make and their rationale.

lead_sponsor: Medtronic Bakken Research Center

sponsor_collaborators:
Medtronic Bakken Research Center
Medtronic


title: Prospective Study of the Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as a New imMUne Prognostic Biomarker in Breast Cancer Treated by NEOadjuvant Chemotherapy

acronym: PRIMUNEO

summary: Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. Achieving pathological complete response (pCR) after chemotherapy is the most important prognostic factor for these patients. However, patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not achieve pCR is poorly documented, and no specific prognostic factors have been clearly identified.Preclinical and clinical studies argue for an immunogenic role of some chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence antitumour immune response, partially contributing to efficacy. Conversely, tumours can promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour immune response, and increased numbers of regulatory T-cells are associated with less favourable prognosis in breast cancer patients. We have previously shown that a high number of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry on surgical specimens, is associated with better response and better survival in breast cancer patients, independently of whether pCR was achieved, the type of chemotherapy used, and the type of breast cancer. Therefore, we propose to validate in a prospective study this immunological prognostic marker in a large cohort of patients treated with neoadjuvant chemotherapy.

lead_sponsor: Centre Georges Francois Leclerc


title: A 2-years Extension Study of MAPT Trial : Evaluation of the Long Term Effects of Interventional Strategies to Prevent the Decline in Cognitive Functioning in Frail Older Adults

acronym: MAPT-PLUS

summary: The MAPT PLUS study is a two-year extension of follow-up of the patients included in the MAPT preventive study, after completion of the interventions. Subjects in the four groups of the MAPT study will be prospectively followed. MAPT is a multicentre, randomised, placebo-controlled study, using a 4-group design with 3 treatment groups (omega 3 alone, multi-domain intervention alone, omega 3 plus multi-domain intervention, n=420 each) and a placebo group (n=420). The MAPT PLUS study will be an extension of the MAPT study and includes an annual follow-up for two years.

ReferenceCitation: Takano E, Maltais M, Kondo I, Rolland Y; MAPT/DSA group. Bidirectional relationship between depressive symptoms and physical performance in community-dwelling older people with subjective memory complaints. Eur Geriatr Med. 2021 Oct;12(5):973-980. doi: 10.1007/s41999-021-00473-9. Epub 2021 Mar 5.

ReferenceCitation: Delrieu J, Voisin T, Saint-Aubert L, Carrie I, Cantet C, Vellas B, Payoux P, Andrieu S. The impact of a multi-domain intervention on cerebral glucose metabolism: analysis from the randomized ancillary FDG PET MAPT trial. Alzheimers Res Ther. 2020 Oct 19;12(1):134. doi: 10.1186/s13195-020-00683-6.

evidence: oa repository (via page says license)

repository_normalized: Research Square

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

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

ReferenceCitation: Delrieu J, Payoux P, Carrie I, Cantet C, Weiner M, Vellas B, Andrieu S. Multidomain intervention and/or omega-3 in nondemented elderly subjects according to amyloid status. Alzheimers Dement. 2019 Nov;15(11):1392-1401. doi: 10.1016/j.jalz.2019.07.008. Epub 2019 Sep 23.

license: cc-by-nc

license_normalized: cc-by-nc

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

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

ReferenceCitation: Pothier K, de Souto Barreto P, Maltais M, Rolland Y, Vellas B. Shifting from Declines to Improvements: Associations between a Meaningful Walking Speed Change and Cognitive Evolution over Three Years in Older Adults. J Nutr Health Aging. 2018;22(10):1183-1188. doi: 10.1007/s12603-018-1059-8.

ReferenceCitation: Lilamand M, Cesari M, Cantet C, Payoux P, Andrieu S, Vellas B; the MAPT/DSA study group. Relationship Between Brain Amyloid Deposition and Instrumental Activities of Daily Living in Older Adults: A Longitudinal Study from the Multidomain Alzheimer Prevention Trial. J Am Geriatr Soc. 2018 Oct;66(10):1940-1947. doi: 10.1111/jgs.15497. Epub 2018 Sep 12.


title: Development of a New Pain Rating Scale for Children and Validation Against Criteria by Comparison With Faces Pain Scale - Revised (FPS-R) and Visual Analogue Scale (VAS)

acronym: NOUNOURS

summary:
In clinical practice with young children, gold standard rating scales used to evaluate the pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are self-assessment tools. These scales present however certain limitations: the VAS is not applicable if the child does not know how to estimate the distances, as young children, or children with mental retardation. As for FPS-R, it can be frightening for children by the aspect of faces looking like impersonal masks.

For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face Legs Activity Cry Consolability (FLACC) can be used, according to the current recommendations.

We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide sample of children. We made the hypothesis that the teddy scale would enable to evaluate the pain in the same way that the FPS-R, being better accepted and preferred by children.

The first phase of this study will be to develop the teddy scale with a sample of 30 healthy children from 4 to 11 year-old, having already experienced pain. This stage allows the validation of the images chosen for the scale, to make sure of their relevance and their optimal recognition by the children.

The scale will then be validated with a sample of 218 hospitalized children from 2 to 11 years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to determine which scale they preferred. Children from 2 to 4 years old will have the teddy scale; the FLACC will be filled in by parents.

Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that of the FPS-R scale The validation of the teddy scale will enable to objectify children's pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to check the efficiency of these decisions. This teddy scale could be used in current practice as a replacement of the FPS-R.

Following this study, we planned to set up a second project in which the teddy scale will be adapted to electronic form (touchpads), to test its adaptability with the children.

primary_purpose: Supportive Care

location_facility: Service de Médecine Physique et Réadaptation Pédiatrique - Hôpital Femme-Mère-Enfant


acronym: GASTRIM

summary:
Oral antiplatelet therapy is a key treatment of the STEMI (ST elevation myocardial infarction). Delayed action isn't suitable and has to be elucidated. If a delayed gastric emptying time is observed during STEMI, limiting the use of morphine and encourage the use of prokinetic agents can be a first answer to optimize coronary angioplasty environment.

Investigators propose a study to assess the gastric emptying times at the acute phase of myocardial infarction using a validated paracetamol absorption test. The STEMI group will be compared to in one hand, itself with measures performed 72 hours±12h after the event onset; and on the other hand, to a stable patient group referred for angioplasty for angina or non-ST-segment elevation myocardial infarction (NSTEMI). For STEMI group and stable patient group, the delay of apparition of Prasugrel or Ticagrelor efficacy will be determined by VerifyNow® test and correlated to gastric emptying times.

location_facility: CHU de Bordeaux - Hôpital du Haut Lévèque


title: Study of the Efficacy and Tolerance of Intra-vaginal Treatment With a Total Freeze-dried Culture of Lcr Regenerans® in the Prevention of Relapses of Recurrent Vulvovaginal Candidiasis. International Phase III, Randomised, Multi-centre, Parallel-group, Two Arm, Double-blind Superiority Trial Versus Placebo.

acronym: GYNOCANS

summary:
The trial medicinal product (Lcr Regenerans®) is obtained from the culture of a strain of Lactobacillus rhamnosus Lcr35®. By virtue of the freeze-drying technique, Lactobacillus rhamnosus Lcr35® is a live bacterium administered with its culture medium.

It should be noted that Lcr Regenerans® is already marketed as a medical device (EC marking: 0499). It helps to regenerate the vaginal flora thanks to its physical and chemical effects (lowering the vaginal pH).

A number of in vitro and in vivo studies have demonstrated the ability of Lactobacillus rhamnosus Lcr35®:

to establish itself in the vaginal epithelium, along with the durability of this establishment.
and to inhibit the growth of pathogenic organisms responsible for causing bacterial vaginosis (Gardnerella vaginalis and Prevotella bivia) but also for mycoses (Candida albicans), by synthesising various microbicidal substances.

This research follows on from the Candiflore observational study in which 514 patients were monitored and which demonstrated a clearly positive result in favour of the use of vaginal Lcr Regenerans® for preventing recurrences of VVC.

The purpose of this new research is thus to demonstrate the efficacy of Lcr Regenerans®, in the prevention of vulvovaginal candidiasis recurrences in patients with a history of VVC with recurrent episodes, in view of obtaining a marketing authorisation.

lead_sponsor: Probionov


title: Comparison of MRI Sequences T1 and T2 * Cerebral Perfusion to Aid in the Diagnosis and Evaluation of Brain Therapeutic Response With Chemotherapy or Targeted Therapy(s) Lesion(s) in Patients Treated and Followed for a Pulmonary Neoplasia

acronym: METAPERF

summary:
This study therefore aims to assess current treatment recommended by scientific societies [ 6-13 ] , brain MRI with injection of contrast for the diagnosis and monitoring of brain metastases . The recommended dose of this examination gadolinium is from 0.1 to 0.3 mmol / kg [ 14 ] . Sequences infusion different from one center to the other made : some use the infusion T1, other infusion T2 * . No recommendation establishes whether it is preferable to use one or the other of these sequences.

No examination is added for the purposes of protocol. Indications for MRI and the number and timing of MRI checks under this protocol are consistent with what is done in practice . The used type of gadolinium and the injected dose will be identical for both sequences infusion . The assessment shall not in any case the contrast but the interpretation of the sequence itself. Special procedures monitoring implemented embodiment correspond to the two sequences instead of infusion (one of T1-weighted and T2 * in the other ) , in the original MRI and MRI of the first control , in order to compare their effectiveness

lead_sponsor: University Hospital, Lille


title: Phase I Study to Determine the Maximum Tolerated Dose and Evaluate the Pharmacokinetics of Intrapleural Bevacizumab After Pleural Drainage in Patients With Symptomatic Malignant Pleural Effusion in the Context of Breast Cancer

acronym: BEVAP

summary:
Metastatic pleural effusion is a common complication of late-stage cancer and reduces the quality of life and survival of patients. The survival of patients with recurrent pleurisy by uncontrolled local or systemic treatment is less than 6 months. It is important to develop specific therapies to improve the quality of life and survival of patients with metastatic pleurisy.

Bevacizumab is a monoclonal anti vascular endothelial growth factor (VEGF) which has proven effective in many indications in oncology. Vascular endothelial growth factor (VEGF) is an angiogenic factor which increases endothelial permeability. It plays a central role in many tumors of epithelial origin. In this context, it is legitimate to ask whether an antiangiogenic targeting VEGF may be effective in patients with metastatic pleurisy by decreasing local blood supply and over-permeability.

No study has been interested in the intra-pleural pharmacokinetics of monoclonal antibodies and there are no predictive or prognostic biomarkers for metastatic pleural effusions.

The investigators believe that intrapleural administration of bevacizumab will reduce the pleural vasculature permeability. It will neutralize VEGF present in pleural fluid and reduce the replenishment of effusion due to its prolonged half-life of 21 days.

The investigators therefore propose a phase I study to determine the maximum tolerated dose and the recommended dose for phases II, studying the pharmacokinetics of intrapleural bevacizumab administered by an implantable device after evacuating a symptomatic metastatic pleurisy as part of a mammary carcinoma. The VEGF intrapleural levels and serum will be study and the time until a new puncture. Dyspnea will be evaluated as well as its impact on quality of life.

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
Henri Mondor University Hospital


title: Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments: a Cluster Randomized Controlled Trial

acronym: ICECUBII

summary:
Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most difficult clinical challenges in medicine. There are few data to help guide clinicians in this area: estimates of the benefits of ICU admission, especially in the very elderly, are sparse. Rates of ICU admission of very elderly thus vary widely by hospitals.

The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of patients over 80 arriving in Emergency Departments (ED) with conditions that potentially warrant ICU admission and their outcome six months after ED visit. Overall rate of patients deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged from 5% to 38% across the participating centers. This variability persisted after adjustment for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The analysis also revealed that high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and the absence of cancer were of good prognosis for outcome six months after ED visit. Only 23% of patients visiting the ED with a life-threatening condition and all positive prognostic factors mentioned above were admitted to an ICU in the ICE-CUB1 study.

Hypothesis Elderly patients visiting the ED with a life-threatening condition, high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and no cancer will potentially benefit from ICU care and should thus be admitted.

Main objective Determine whether a strategy consisting of recommendations of ICU admission of all patients over 75 visiting the ED with a life threatening condition, no cancer, good functional and nutritional status prior to ED visit decreases the mortality of these patients six months after ED visit.

Secondary objective : Assess the impact of the strategy on:

In-hospital mortality
Rate of ICU admission
Place of living and quality of life six months after ED visit

Primary outcome :Mortality six months after ED visit Secondary outcomes

In-hospital mortality
ICU admission
Change in functional status six months after ED visit
institutionalization
Quality of life six months after ED visit

ReferenceCitation: Guidet B, Leblanc G, Simon T, Woimant M, Quenot JP, Ganansia O, Maignan M, Yordanov Y, Delerme S, Doumenc B, Fartoukh M, Charestan P, Trognon P, Galichon B, Javaud N, Patzak A, Garrouste-Orgeas M, Thomas C, Azerad S, Pateron D, Boumendil A; ICE-CUB 2 Study Network. Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial. JAMA. 2017 Oct 17;318(15):1450-1459. doi: 10.1001/jama.2017.13889.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

publisher_dissemination: American Medical Association

ReferenceCitation: Boumendil A, Woimant M, Quenot JP, Rooryck FX, Makhlouf F, Yordanov Y, Delerme S, Takun K, Ray P, Kouka MC, Poly C, Garrouste-Orgeas M, Thomas C, Simon T, Azerad S, Leblanc G, Pateron D, Guidet B; ICE-CUB 2 study network. Designing and conducting a cluster-randomized trial of ICU admission for the elderly patients: the ICE-CUB 2 study. Ann Intensive Care. 2016 Dec;6(1):74. doi: 10.1186/s13613-016-0161-5. Epub 2016 Jul 29.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prospective Randomized Multicentric Open Label Study to Evaluate Rituximab Treatment for Idiopathic Membranous Nephropathy (IMN)

acronym: GEMRITUX

summary:
The Membranous Nephropathy is one of the most common cause of Nephrotic Syndrome of adults. In 2/3 of patients the cause of the disease is idiopathic. This can also be referred to as idiopathic membranous nephropathy (IMN).The most of these patients are treated by non immunosuppressive symptomatic treatment (NIST): antiproteinuric and antihypertensive blocking the rennin-angiotensine system. However, the patients resistant to antiproteinuric treatment risk to develop an end stage renal disease (ESRD).

Rituximab has been recently used in patients suffering of nephrotic syndrome related to IMN in four international studies. Rituximab appears effective and safe in reducing proteinuria in nearly 60% of patients.

The primary outcome of the investigators prospective randomized study is to determine whether or not the Rituximab associated with NIST is more effective than non immunologic symptomatic treatment alone in inducing long term remission of proteinuria.

ReferenceCitation: von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

ReferenceCitation: Seitz-Polski B, Dahan K, Debiec H, Rousseau A, Andreani M, Zaghrini C, Ticchioni M, Rosenthal A, Benzaken S, Bernard G, Lambeau G, Ronco P, Esnault VLM. High-Dose Rituximab and Early Remission in PLA2R1-Related Membranous Nephropathy. Clin J Am Soc Nephrol. 2019 Aug 7;14(8):1173-1182. doi: 10.2215/CJN.11791018. Epub 2019 Jul 24.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Dahan K, Debiec H, Plaisier E, Cachanado M, Rousseau A, Wakselman L, Michel PA, Mihout F, Dussol B, Matignon M, Mousson C, Simon T, Ronco P; GEMRITUX Study Group. Rituximab for Severe Membranous Nephropathy: A 6-Month Trial with Extended Follow-Up. J Am Soc Nephrol. 2017 Jan;28(1):348-358. doi: 10.1681/ASN.2016040449. Epub 2016 Jun 27.

location_facility: Department of Nephrology , Tenon hospital - APHP


title: Weight Variation and Mechanisms Involved, During Chemotherapy in Breast Cancer Patients

summary:
Weight variation has been reported as a side effect of chemotherapy treatment in early breast cancer patients. To date, there is growing evidence for an increased risk of relapse and death in these patients who gain or lose weight. However, causes of weight variation during chemotherapy and mechanisms involved in the poor prognosis have been little studied.

Thus, the investigators are conducting a prospective study to characterize weight variation in terms of body composition and to identify the mechanisms involved.

lead_sponsor: Centre Jean Perrin


title: Impact of Clopidogrel Dose Adjustment According to Platelet Reactivity Monitoring in Patients With High on Treatment Platelet Reactivity Undergoing Percutaneous Coronary Intervention

summary:
Acute coronary syndromes are related to the development of a platelet derived thrombus on a ruptured coronary atheroma. Use of dual antiplatelet therapy aspirin-thienopyridine a significantly reduced the risk of major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). However despite these therapeutic innovations, the rate of MACE in patients treated using PCI and particularly in those suffering of an acute coronary syndrome is around 5% in randomized trials. Within the factors associated with MACE, high on treatment platelet reactivity following clopidogrel loading dose has been identified as a key factor. In fact it is widely recognized that there is a large inter individual variability in clopidogrel responsiveness. In addition several authors have demonstrated a strong link between high on treatment platelet reactivity following clopidogrel loading dose and the occurrence of post PCI MACE. Vasodilator Phosphoprotein index measurement (VASP index) enables a reproducible, standardized and specific assessment of clopidogrel responsiveness.

The investigators previous works have demonstrated that a VASP index ≥ 50% had a high negative predictive value for post PCI MACE in patients undergoing PCI and that tailored clopidogrel loading dose in order to obtain a VASP index < 50% before PCI resulted in a reduction in the rate of post PCI MACE.

Prasugrel is a new generation thienopyridine with a faster and more powerful anti platelet effect compared to clopidogrel. It was shown to be superior to clopidogrel to reduce post PCI MACE in acute coronary syndromes. However in this randomized trial prasugrel achieved an excessive blockade of platelet reactivity responsible for a significant increase in bleeding events in some patients and an insufficient blockade in up to 325% of the remaining patients.

Therefore the investigators hypothesized that a strategy of individually tailored loading and maintenance dose of clopidogrel may be superior to prasugrel standard therapy in achieving an optimal platelet reactivity inhibition in acute coronary syndrome patients undergoing PCI.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Predictive Study of Radiation Induced Sarcoma From the GSF-GETO Data Base.

acronym: SARI

summary: Development of sarcoma within or adjacent to radiation field is a well known event of poor prognosis and unknown risk factors. Advanced techniques of radiation therapy including intensity modulated radiation therapy, tomotherapy or Arc therapy are providing new modalities of radiation delivery that could be responsible for developing these induced tumors. There is little data on molecular biology of radiation induced sarcoma even if some tools are still available to characterize these types of tumors aiming to compare their profile to a sarcoma observed in non irradiated area. An update of the GETO-GCSF registry, currently called CONTICANET data base in the framework of EORTC, represents the backbone of the project. The next step should follow two axes, a clinical one based on the dosimetric analysis of the characteristics of delivered radiation therapy and the second one based on a molecular characterization of the sarcomas developed in irradiated field.The data base will be updated and organized through the CONTICANET network and the radiation oncologists involved in the treatment of soft tissue sarcoma. A retrospective analysis of the clinical data and the parameters describing the initial treatment will be registered using the methodology proposed by I. Diallo for radiation induced tumors developed in childhood. The most recent data will be extracted in DICOM format for intercomparison in a dedicated software.A centralized review of pathological specimens is planned to validate the correct classification of the tumors inside the current staging system developed for soft tissue sarcoma.

intervention_type: Genetic


title: Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease

acronym: DOULOX

summary:
Patients suffering from Parkinson's disease (PD) frequently experienced painful sensations that could be, in part, due to a central modification of nociception mechanisms. Previous studies have shown that pain perception was altered in Parkinson's disease (subjective and objective pain thresholds and pain-induced cerebral activity) and that administration of L-Dopa normalized this alteration. In the central nervous system, L-Dopa is converted in dopamine and in norepinephrine. Apomorphine (a dopamine agonist) has no effect on pain threshold and pain-induced cerebral activity. Therefore the noradrenergic system could be involved in pain alteration in PD.

To assess the role of noradrenergic system in pain in patients with PD, we chose duloxetine (norepinephrine and serotonin reuptake inhibitor)because a recent study had shown that duloxetine allowed an improvement of pain clinical scores (pain questionnaires) in patients with PD.

36 patients will be enrolled in this study. We supposed that a chronic intake of duloxetine increase the pain perception level compare to the placebo. This increase would be the same than those observed with L-Dopa.

sponsor_collaborators:
University Hospital, Toulouse
French Parkinson Association


title: Ultrasound Guided Percutaneous Tracheostomy in the ICU

summary: The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy.

ReferenceCitation: Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H. Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care. 2012 Dec 12;16(2):R40. doi: 10.1186/cc11233.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease With Vaso-occlusive Crisis and Morphinic Treatment

acronym: VPACS

summary:
Acute chest syndrome is a severe respiratory complication of sickle cell disease.

The standard prevention of this dangerous complication is spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.

The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than spirometry and may improve pain and quality of sleep.

Children with vaso-occlusive crisis necessitating morphinic treatment will be randomly assigned with either spirometry or ventilation and the investigators will monitor for occurrence of acute chest syndrome, pain and quality of sleep.

location_facility: Hôpital Necker - Enfants Malades Hospital


title: Phenotype of Pulmonary Fibrosis Associated With a Mutation of Telomerase

summary:
This study is an observational and retrospective study of patients with pulmonary fibrosis associated or not with telomerase mutation.

The purpose of this study is to describe in detail the cases with telomerase mutation in terms of features on CT scan, respiratory function and evolution, in comparison to control subjects with idiopathic pulmonary fibrosis and no telomerase mutation identified or family history.

time_perspective: Retrospective

ipd_sharing: Yes

ipd_sharing_description: Under analysis, publication in preparation

lead_sponsor: Groupe d'Etudes et de Recherche sur les Maladies Orphelines Pulmonaires


title: Treatment of Methicillin-sensitive Staphylococcus Aureus Orthopaedic Infections With Clindamycin in Combination With Rifampin or Levofloxacin: a Randomized Pharmacological and Clinical Study (the CLINDOS Trial)

acronym: CLINDOS

summary:
Background:

One of the leading causes of peri-operative osteoarticular infections (OAI) is Staphylococcus aureus. Treatment usually requires surgical debridement in association with appropriate antibiotic therapy. After surgery, an intravenous (IV) antibiotic therapy is routinely indicated for 10 to 15 days, followed by a minimal one-month oral treatment. In this protocol, the latter includes clindamycin in combination with rifampin or levofloxacin. Clindamycin is considered a good option in staphylococcal infections, because of its action against biofilm formation and bacterial adherence, its high level of joint and bone penetration and its good tolerance. Rifampin, a potent cytochrome P-450 inducer, enhances the elimination of a large number of drugs. Therefore, an influence of rifampin on clindamycin pharmacokinetics must be considered.

Objectives:

The primary objective is to compare the influence of rifampin and levofloxacin respectively on the pharmacokinetics of clindamycin in a randomized series of peri-operative staphylococcal OAI. The investigators then seek to determine the optimal drug association with regard to infection control and drug tolerance.

Study design:

Monocentric, randomized, open label, comparative study

Study period:

From November 2010 to October 2011.

Materials and Methods:

Following surgical debridement and after 10 to 15 days of IV antibiotherapy, patients are randomly assigned either to the "clindamycin/rifampin" arm either to the "clindamycin/levofloxacin" arm, according to the antimicrobial susceptibility testing. Peak and trough serum concentrations of clindamycin are measured at day-1, day-15 and day-30 of oral treatment. Rifampin and levofloxacin serum concentrations are measured at the same intervals to monitor patient compliance.

ReferenceCitation: Bernard A, Kermarrec G, Parize P, Caruba T, Bouvet A, Mainardi JL, Sabatier B, Nich C. Dramatic reduction of clindamycin serum concentration in staphylococcal osteoarticular infection patients treated with the oral clindamycin-rifampicin combination. J Infect. 2015 Aug;71(2):200-6. doi: 10.1016/j.jinf.2015.03.013. Epub 2015 Apr 30.