title: Prospective Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV) in Singleton Pregnancy in Breech Presentation at Term

acronym: MEOREV

summary:
The variety of breech presentation at term is about 3-4% of all births. Our study aims to assess the value of using an equimolar mixture of oxygen and nitrous oxide. Indeed, in some patients algic or relaxed, the success rate seems more important.

It's a single blind prospective randomized controlled study, comparing success rate of ECV after an equimolar mixture of oxygen and nitrous oxide or placebo (medical air).

We need to include 150 patients (75 in each arm), for a period of 2 years. After ECV, we will give the patient a satisfaction questionnaire. We compare the success rate of ECV as primary outcome.

ReferenceCitation: Dochez V, Esbelin J, Misbert E, Arthuis C, Drouard A, Badon V, Fenet O, Thubert T, Winer N. Effectiveness of nitrous oxide in external cephalic version on success rate: A randomized controlled trial. Acta Obstet Gynecol Scand. 2020 Mar;99(3):391-398. doi: 10.1111/aogs.13753. Epub 2019 Nov 18.

name: Department of Gynecology and Obstetrics University Hospital of Nantes Nantes France

name: Clinical Investigation Center (CIC) University Hospital of Nantes Nantes France

family: Dochez

full_name: Vincent Dochez

given: Vincent

family: Esbelin

full_name: Julie Esbelin

given: Julie

family: Misbert

full_name: Emilie Misbert

given: Emilie

family: Arthuis

full_name: Chloé Arthuis

given: Chloé

family: Drouard

full_name: Anne Drouard

given: Anne

family: Badon

full_name: Virginie Badon

name: Biometrics and Biostatistics Platform University Hospital of Nantes Nantes France

family: Fenet

full_name: Olivier Fenet

given: Olivier

family: Thubert

full_name: Thibault Thubert

given: Thibault

family: Winer

full_name: Norbert Winer

given: Norbert

journal_name: Acta Obstetricia et Gynecologica Scandinavica


type: EudraCT Number

title: Study of the Racecadotril Linearity After Single Administrations of 10, 30 and 60 mg of a New Racecadotril Formulation (Suspension) by Oral Route and Evaluation of the Comparative Bioavailability of This New Formulation Versus the Sachet Formulation (Granules) After a 60 mg Single Oral Administration in Healthy Male Volunteers

summary:
To investigate the Racecadotril pharmacokinetic linearity after single oral administration of 10, 30 and 60 mg as a suspension.

To evaluate the comparative bioavailability of the new Racecadotril formulation (suspension) versus the reference sachet formulation (granules)

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: Bioprojet

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents

acronym: CHIMORAL

summary: The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term of early or unforeseen recourse to the hospital for adverse events.

study_start_date_type: Actual

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

lead_sponsor_type: academique


title: OPMED STUDY: Multidisciplinary Program "Optimization of Drug Prescription" : Impact on the Quality of Drug Prescription in Hospitalized Elderly Patients

acronym: OPMED

summary:
Drug prescription is a fundamental component of care for the elderly. Even if drugs are a chance for the older patient, because of changes in pharmacological, pharmacokinetic and pharmacodynamic parameters related with age and acute/or chronic pathologies, the risks associated with drug prescription, particularly those associated with potentially inappropriate medication (PIM), are increased in the elderly.

We suppose that many of hospitalized elderly have at least one prescribed medication without valid indication. Conversely, many diseases are currently undertreated in elderly patients: e.g. medicines used to treat heart failure and osteoporosis are underused in 20 to 70% of patients. Moreover, PMI prescription is associated with an increased of morbidity, mortality, risk of drug-related adverse events, utilization of health care system, care costs and impairment of quality of life. Thus, optimization of drug prescription is a major concern for improvement of the quality and safety of care in elderly.

The investigators' hypothesis is that a multidisciplinary program entitled "Optimisation de la Prescription MEDicamenteuse" ("Optimization of drug prescribing") focused on drug prescription optimization including a physician training to the specificity of the drug prescription in the elderly and a checklist allowing an adapted and standardized pharmaceutical analysis is effective in reducing PIM in elderly patients hospitalized in short-term medical and geriatric care departments.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot

intervention_type: Other


title: Is There a Correlation Between the Pulmonary Artery Pressure and the Acceleration of the Flow in the Pulmonary Artery Evaluated by Transesophageal Echocardiography (TOE) ?

summary:
The measure of the pulmonary artery pressure (PAP) is a very useful index in intensive care to estimate right ventricular after load. The reference technique for this measure is the right catheterism which is an invasive technique. It is possible to estimate the pulmonary artery pressure by using transthoracic echocardiography (TTE) which allows, using the continuous Doppler, the measure of maximum speed of tricuspid regurgitation (TRvmax). The measure of the TRvmax can however be difficult for intensive care patients with little echogenicity or impossible for those having no tricuspid leak. The evaluation of the tricuspid regurgitation is also particularly difficult using TOE. To avoid these drawbacks, one can use the analysis of the pulmonary ejection in the pulmonary artery (PAAT) with TOE. However, the data of the literature are controversial on this method and it was not validated in mechanically ventilated intensive care patients.

The aim of this work is to compare three methods of measure of the PAP: the measure TRVMAX (by means of the tricuspid leak) by transthoracic echocardiography, the measure of the TAAP by transesophageal ultrasound and the direct measure of the pulmonary pressures by right catheterization, in ventilated patients already monitored with a catheter in the right cavities for usual indications in intensive care (ARDS, shock). We shall analyze then the correlation between the TRVmax, the TAAP and the pressures measured by the right catheterism which serves as reference technique.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

status_simplified: Unknown


title: EFFECT OF SMOKING ON MUCUS HYPERSECRETION MECHANISMS IN ASTHMA AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE

summary:
Asthma and COPD are characterized by an accelerated decline in lung function associated with incompletely reversible airflow obstruction. This could be the result of lung structural changes and inflammation. Tissue repairing mechanisms may result in a restitution ad integrum of bronchial epithelium. But in most cases, especially in COPD and severe asthma, the "remodeling" is characterized by mucus cells hyperplasia, overproduction of mucus, and physicochemical, biological and immunological changes. Clinically, this mucus overproduction is reported by patients as the clinical symptom called "chronic bronchitis". Generally, it develops at a bronchiolar level where it is responsible for the progression of these diseases. There is a paradox, because the intrinsic properties of mucus seem rather beneficial so fighting against it may not be really wise at long-term. Especially its defensive effect against microbial agents which remains poorly explained. Currently, no treatment aims to reduce the production of mucus and mechanisms leading to such an overproduction are poorly understood in severe asthma and COPD. The identification of new targets to treat this overproduction of mucus in COPD is therefore of major interest.

In view of current knowledge, inflammatory mediators and signal transduction leading to increased mucin production and increased number of goblet cells are probably IL-9, IL-13, IL -1ß and TNF-α involving calcium-sensitive chloride channels. Intracellular signaling pathways seem to be based on STAT-6, FOXA2, SPDEF, EGFR and / or COX-2

design_allocation: Non-Randomized


title: Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.

acronym: AL-EN-PHED

summary: The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.

status: Withdrawn

primary_purpose: Treatment

lead_sponsor: Lactalis

intervention_type: Dietary Supplement


summary: The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.

ReferenceType: result

ReferenceCitation: Queille-Roussel C, Bang B, Clonier F, Lacour JP. Phase I evaluation of the vasoconstrictor potential of an innovative fixed combination calcipotriene plus betamethasone dipropionate aerosol foam versus other corticosteroid psoriasis treatments. J Am Acad Dermatol. 2015:72 Suppl 1;AB243 (P915).

lead_sponsor: LEO Pharma

location_facility: CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie


title: Does Body Position Influence Pressure Recording by High-resolution Manometry ?

summary:
The anorectal manometry is the gold standard in the evaluation of anorectal function.

Several techniques are currently used (balloons, perfused catheters) and are always performed in the supine position.

Few studies have reported the evaluation of sphincter function in the upright position, whereas symptoms of fecal incontinence occur in this position.

Recently developed, high-resolution manometry, thanks to its many mechanical sensors, allows topographic analysis and evaluation of anorectal function more acurate. In addition, the rigid nature of the probe should allow stability measures / recording, which is not possible with probes perfused catheters example.

We therefore propose to compare anal sphincter pressure in supine and standing, measured in high-resolution manometry.

primary_purpose: Diagnostic

intervention_type: Device


title: Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis

summary: Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care is also more and more used in infants with severe acute bronchiolitis. There is no evidence that nCPAP improves outcome, but several studies showed that it reduces work of breathing (WOB), improves gas exchange and decreases intubation rate. High flow nasal prong (HFNP) therapy, also used in neonatal units, has recently been suggested for bronchiolitis management. This technique allows warmed and moist gas administration protecting nasal mucosa, and preventing variations of inspired gas FiO2. HFNP also creates a continuous positive pressure, reducing WOB, and seems much more comfortable and better tolerated by babies than nCPAP. There are no studies comparing both techniques for bronchiolitis management. The main objective of this study is to compare WOB with nCPAP and HFNP therapy in infants with severe bronchiolitis in pediatric intensive care unit. Secondary purpose is to compare efficacy and tolerance of both techniques. We propose to lead an open, single center, crossover randomized study. Each patient will receive the two treatments. Three consecutive periods will be studied: first one (minimum 2 hours), with the first technique CPAP or HFNP according to randomization (treatment 1); second period (2 hours) with the second technique (treatment 2); Third period (6 hours) with the second technique. The primary endpoint will be the comparison of WOB (estimated by the calculation of the transdiaphragmatic pressure-time product) at the end of the two firsts periods. Efficacy and tolerance of each technique will be evaluated and compared by compared measuring respiratory rate, heart rate, FiO2, SpO2, transcutaneous PCO2, modified Wood score, and EDIN score during the third period. Nine subjects by groups are required.


title: A Prospective Study on the Feasibility of Pedicle Screw Placement in the Lumbar Level With a New Robotic-assisted System

acronym: ARASS

summary: The main objective of the study is to evaluate the feasibility of using the robotic assisted device ROSA™ for pedicle screws placement. This device is currently used in cranial neurosurgery but its applications can be extended to other fields, such as spinal surgery. In the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and safety of surgery for the patient.

lead_sponsor: University Hospital, Montpellier


title: Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents

summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence.

This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the liver transplanted patients with recurrent HCV infection and treated with direct-acting anti-HCV agents.

ReferenceType: derived

ReferenceCitation: Barrail-Tran A, Goldwirt L, Gelé T, Laforest C, Lavenu A, Danjou H, Radenne S, Leroy V, Houssel-Debry P, Duvoux C, Kamar N, De Ledinghen V, Canva V, Conti F, Durand F, D'Alteroche L, Botta-Fridlund D, Moreno C, Cagnot C, Samuel D, Fougerou-Leurent C, Pageaux GP, Duclos-Vallée JC, Taburet AM, Coilly A. Comparison of the effect of direct-acting antiviral with and without ribavirin on cyclosporine and tacrolimus clearance values: results from the ANRS CO23 CUPILT cohort. Eur J Clin Pharmacol. 2019 Nov;75(11):1555-1563. doi: 10.1007/s00228-019-02725-x. Epub 2019 Aug 5.

family: Barrail-Tran

full_name: Aurélie Barrail-Tran

given: Aurélie

sequence: first

family: Goldwirt

full_name: Lauriane Goldwirt

given: Lauriane

sequence: additional

family: Gelé

full_name: Thibaut Gelé

given: Thibaut

family: Laforest

full_name: Claire Laforest

given: Claire

family: Lavenu

full_name: Audrey Lavenu

given: Audrey

family: Danjou

full_name: Hélène Danjou

given: Hélène

family: Radenne

full_name: Sylvie Radenne

given: Sylvie

family: Leroy

full_name: Vincent Leroy

family: Houssel-Debry

full_name: Pauline Houssel-Debry

given: Pauline

family: Duvoux

full_name: Christophe Duvoux

given: Christophe

family: Kamar

full_name: Nassim Kamar

given: Nassim

family: De Ledinghen

full_name: Victor De Ledinghen

given: Victor

family: Canva

full_name: Valérie Canva

given: Valérie

family: Conti

full_name: Filomena Conti

given: Filomena

family: Durand

full_name: François Durand

given: François

family: D’Alteroche

full_name: Louis D’Alteroche

given: Louis

family: Botta-Fridlund

full_name: Danielle Botta-Fridlund

given: Danielle

family: Moreno

full_name: Christophe Moreno

family: Cagnot

full_name: Carole Cagnot

given: Carole

family: Samuel

full_name: Didier Samuel

given: Didier

family: Fougerou-Leurent

full_name: Claire Fougerou-Leurent

family: Pageaux

full_name: Georges-Philippe Pageaux

given: Georges-Philippe

family: Duclos-Vallée

full_name: Jean-Charles Duclos-Vallée

given: Jean-Charles

family: Taburet

full_name: Anne-Marie Taburet

given: Anne-Marie

journal_name: European Journal of Clinical Pharmacology

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

ReferenceCitation: Antonini TM, Coilly A, Rossignol E, Fougerou-Leurent C, Dumortier J, Leroy V, Veislinger A, Radenne S, Botta-Fridlund D, Durand F, Houssel-Debry P, Kamar N, Canva V, Perré P, De Ledinghen V, Rohel A, Diallo A, Taburet AM, Samuel D, Pageaux GP, Duclos-Vallée JC; ANRS C023 CUPILT study group. Sofosbuvir-Based Regimens in HIV/HCV Coinfected Patients After Liver Transplantation: Results From the ANRS CO23 CUPILT Study. Transplantation. 2018 Jan;102(1):119-126. doi: 10.1097/TP.0000000000001928.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Leroy V, Dumortier J, Coilly A, Sebagh M, Fougerou-Leurent C, Radenne S, Botta D, Durand F, Silvain C, Lebray P, Houssel-Debry P, Kamar N, D'Alteroche L, Petrov-Sanchez V, Diallo A, Pageaux GP, Duclos-Vallee JC; Agence Nationale de Recherches sur le SIDA et les Hépatites Virales CO23 Compassionate Use of Protease Inhibitors in Viral C in Liver Transplantation Study Group. Efficacy of Sofosbuvir and Daclatasvir in Patients With Fibrosing Cholestatic Hepatitis C After Liver Transplantation. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1993-2001.e1-2. doi: 10.1016/j.cgh.2015.05.030. Epub 2015 Jun 1.

journal_name: Clinical Gastroenterology and Hepatology


title: Interest of the Association of Two Complementary Techniques, Hypnosis and Transcutaneous Electrical Nerve Stimulation in the Treatment of Chronic Non-cancer Pain, Nociceptive and / or Neuropathic Pain: Randomized Trial

acronym: HYPTENS

summary: At Saint-Antoine's hospital, in CETD a multidisciplinary team takes care of patients with chronic pain. Free-drug techniques are available to reduce their consumption of analgesics. This study is to assess the relief obtained by the simultaneous combination of these two techniques: transcutaneous electrical nerve stimulation and hypnosis.

primary_purpose: Supportive Care

ReferenceCitation: Tonye-Geoffroy L, Mauboussin Carlos S, Tuffet S, Fromentin H, Berard L, Leblanc J, Laroche F. Efficacy of a combination of hypnosis and transcutaneous electrical nerve stimulation for chronic non-cancer pain: A randomized controlled trial. J Adv Nurs. 2021 Jun;77(6):2875-2886. doi: 10.1111/jan.14833. Epub 2021 Mar 30.

name: Assistance Publique ‐ Hôpitaux de Paris (AP‐HP)Pain Department of Saint‐Antoine University Hospital and Medical University SorbonneHôpital Saint‐Antoine Paris France

family: Tonye‐Geoffroy

full_name: Louise Tonye‐Geoffroy

given: Louise

family: Mauboussin Carlos

full_name: Stéphanie Mauboussin Carlos

given: Stéphanie

name: Assistance Publique ‐ Hôpitaux de Paris (AP‐HP)AP‐HP.Sorbonne UniversitéClinical Research Unit of East of Paris (URC‐Est) Paris France

family: Tuffet

full_name: Sophie Tuffet

given: Sophie

name: Assistance Publique ‐ Hôpitaux de Paris (AP‐HP)AP‐HP.Sorbonne UniversitéClinical Research Center of East of Paris (CRC‐Est) Paris France

family: Fromentin

full_name: Hélène Fromentin

name: Assistance Publique ‐ Hôpitaux de Paris (AP‐HP)AP‐HP.Sorbonne UniversitéClinical Research Platform of East of Paris (URC‐Est/CRC‐Est) Paris France

family: Berard

full_name: Laurence Berard

given: Laurence

family: Leblanc

full_name: Judith Leblanc

given: Judith

name: Musculoskeletal Pain Group ‐ INSERM U987 ‐ Ambroise Paré Hospital Boulogne Billancourt France

family: Laroche

full_name: Françoise Laroche

given: Françoise

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Advanced Nursing

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Efficacy of a combination of hypnosis and transcutaneous electrical nerve stimulation for chronic non‐cancer pain: A randomized controlled trial

intervention_type: Behavioral


title: A Phase 1, Open-label, One-sequence Study to Assess the Effect of Verapamil on the Steady State Pharmacokinetics of Solifenacin and Tamsulosin Administered as a Combination Tablet EC905 in Healthy Male Subjects.

summary: This study investigates the effect of the co-administration of verapamil on the steady-state pharmacokinetics (PK) of solifenacin succinate and tamsulosin given as a combination tablet, EC905.

lead_sponsor: Astellas Pharma Europe B.V.


title: Double-blind Randomized Multicenter Phase III Study Evaluation of the Efficacy of Hippocampal Avoidance on the Cognitive Toxicity of Whole-brain Radiation Therapy After Surgical Resection of Single Brain Metastasis of Breast Cancer.

summary:
The incidence of brain metastases (BM) in metastatic breast cancer is increasing, due to the improvement in the control of systemic disease, and due to an improved detection through imagery.

The treatment management of single BM remains controversial. Indeed, even though it is widely accepted that local treatment increases the median survival time in patients having a good prognostic status, the adding of "adjuvant" whole-brain radiation therapy (WBRT) is currently subject to controversy, due to its potential toxicity. Yet, two randomized trials have demonstrated a clear increase in intra-cerebral recurrence and in death from neurologic origin in case of absence of "adjuvant" WBRT, without change in overall survival (but overall survival was not a primary endpoint in any of these studies).

The data from literature on cognitive toxicity (CT) of WBRT on BM are scarce and sometimes controversial. CT of WBRT affects the subcortical frontal functions. It is postulated that the alteration of hippocampal neurogenesis (mainly due to inflammation process), situated in the subgranular zone of the dentate gyrus, has an essential role in the development of these brain dysfunctions.

It has been shown that the incidence of BM in the hippocampal region (hippocampus + 5mm expansion) is low, in the range of 8,6%.

New irradiation techniques, in particular intensity-modulated radiotherapy associated with rotational radiotherapy, allow to modulate the dose on an intra-cerebral structure, all the while distributing an adapted dose to the remaining brain.

This prospective, randomized study, will compare, through a battery of neuropsychological tests, the cognitive impact of WBRT of 40 Gy in 20 fractions with or without hippocampal avoidance by intensity modulated radiotherapy, in patients presenting with a single operated brain metastasis of breast cancer. If the hippocampal avoidance leads to a significant improvement in cognitive function, this radiotherapy scheme could become the standard postoperative treatment to be proposed to patients presenting the best prognostic factors. This would allow to prevent long-term cognitive deficit, while preserving WBRT benefit on intra-cerebral control.

Justification of evaluation criteria :

Principal criteria :

Evaluation criteria to assess cognitive toxicity have been selected on the basis of the recommendations from C. Meyers and P. Brown, who propose an adapted test battery to evaluate memory, verbal function, visual and motor coordination, and executive function. The selected tests have been validated, also in French. They comprise HVLT-R (Hopkins Verbal Learning Test Revised), COWAT (Controlled Oral Word Association Test), Grooved Pegboard test, TMT A and B (Trailmaking tests A and B), and MMSE. The calculation of patient numbers was based on the HVLT-R test, as memory is thought to be the most frequently affected domain.

The tests will be performed before treatment ("baseline" cognitive function), at 4 months and at 12 months. In case of a missing answer to the evaluation tests, the reason(s) for not answering will be noted.

Secondary criteria :

Quality of life : QLQ-C30, QLQ-BN20, ADL, IADL Intra-cerebral Progression-free survival (PFS) Overall survival.

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Radiation


title: ANRS RF002 Intestipax : Interleukin-23 (IL-23)/Interleukin-12 (IL-12) Imbalance and T Lymphocyte Polarization in HIV Infection

acronym: INTESTIPAX

summary: Progressive HIV or HIV infection seems to be related to a preferential loss of CD4+ T lymphocytes, especially Th17+, within the mucosal intestinal lymphoid tissue, and with intestinal mucosal damage and bacterial product translocation, which correlates with the hyperactivation of the immune system, therefore with CD4+ T cell loss and prognosis. The objectives of this project are to investigate the correlation between the IL12/IL-23 imbalance and bacterial product translocation, and to study the polarization, infection or depletion of intestinal Th17 ex vivo. The investigators will test the effect of neutralizing anti-IL23 antibodies directed against p40, or less classically, anti- IL-23 p19.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Centre d'Investigation Clinique BT505, Hôpital Cochin


title: Real-time Continuous Glucose Monitoring Reduces Duration of Hypoglycemia Episodes in Very Low Birth Weight Neonates

summary: Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose testing in detecting and managing hypoglycemia. The investigators calculated a number of 48 neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will be lower.

lead_sponsor: University Hospital, Tours


title: A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates

summary: The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;

ReferenceCitation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10:CD012273. doi: 10.1002/14651858.CD012273.pub2.

name: Neonatology; National Center for Child Health and Development; Tokyo Japan

family: Amari

full_name: Shoichiro Amari

given: Shoichiro

name: Hamilton Health Sciences; Hamilton Canada

family: Shahrook

full_name: Sadequa Shahrook

given: Sadequa

name: Department of Pediatrics; Saitama Medical Center, Saitama Medical University; Kawagoe Japan

family: Namba

full_name: Fumihiko Namba

given: Fumihiko

name: Global Health Nursing, Graduate School of Nursing Science; St. Luke's International University; Tokyo Japan

family: Ota

full_name: Erika Ota

given: Erika

name: Graduate School of Medicine; Kyoto University; Kyoto Japan

family: Mori

full_name: Rintaro Mori

given: Rintaro

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

ReferenceCitation: Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, De Blay F, Guénard-Bilbault L, Hatahet R, Mulier S, Kapel N, Waligora-Dupriet AJ, Butel MJ. Safety of a New Amino Acid Formula in Infants Allergic to Cow's Milk and Intolerant to Hydrolysates. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):456-63. doi: 10.1097/MPG.0000000000000803.

family: Dupont

full_name: Christophe Dupont

given: Christophe

family: Kalach

full_name: Nicolas Kalach

given: Nicolas

family: Soulaines

full_name: Pascale Soulaines

given: Pascale

family: Bradatan

full_name: Elena Bradatan

given: Elena

family: Lachaux

full_name: Alain Lachaux

given: Alain

family: Payot

full_name: François Payot

family: De Blay

full_name: Frédéric De Blay

given: Frédéric

family: Guénard-Bilbault

full_name: Lydie Guénard-Bilbault

given: Lydie

family: Hatahet

full_name: Riad Hatahet

given: Riad

family: Mulier

full_name: Sandra Mulier

given: Sandra

family: Kapel

full_name: Nathalie Kapel

given: Nathalie

family: Waligora-Dupriet

full_name: Anne-Judith Waligora-Dupriet

given: Anne-Judith

family: Butel

full_name: Marie-José Butel

given: Marie-José

journal_name: Journal of Pediatric Gastroenterology & Nutrition

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Dupont C, Kalach N, Soulaines P, Bradatan E, Lachaux A, Payot F, de Blay F, Guénard-Bilbault L, Hatahet R, Mulier S. A thickened amino-acid formula in infants with cow's milk allergy failing to respond to protein hydrolysate formulas: a randomized double-blind trial. Paediatr Drugs. 2014 Dec;16(6):513-22. doi: 10.1007/s40272-014-0097-x.

title: A Thickened Amino-Acid Formula in Infants with Cow’s Milk Allergy Failing to Respond to Protein Hydrolysate Formulas: A Randomized Double-Blind Trial


title: GRAND BLEU Study: Does the Colonoscopy With Instillation of Blue Water (Indigo Carmin® Dilute) Enable an Improved Rate of Adenoma Detection for Colonoscopy With Insufflation of Air?

acronym: GRAND BLEU

summary:
The colonoscopy is the reference examination for the diagnosis of neoplastic lesions in the colon and rectum. Mass screening assessment studies have shown that colonoscopic detection and removal of adenomas in patients selected through fecal occult blood test reduces colorectal cancer incidence and mortality. However, the literature has reported interval cancer cases or adenomas, probably "missed" by the colonoscopy. In theory, using coloured warm water could improve colon preparation by mobilizing the residual faeces, decreasing the colic spasm and increasing the visualization of the pit pattern. Preliminary American studies, led by Leung et al, have shown a very clear increase in the adenoma detection rate.

The investigators' study involves 1 000 patients, treated in the Rhône-Alpes / Auvergne region. The patients present an indication for colonoscopy following a positive fecal occult blood test or symptoms or personal and family histories of pre-cancerous colonic lesions. They will be randomized into two study groups:one of both groups of study: Group 1: patients undergoing a colonoscopy wtih instillation of tepid water tinged with blue (Indigo Carmin®) Group 2: patients undergoing a standard colonoscopy with insufflation of air. The main objective is to show that the colonoscopy with blue water (Indigo Carmin®) enable detection of more lesions than standard colonoscopy with insufflation of air. The two techniques will be also compared in terms of tolerance, of duration of colonoscopy and type of detected lesions.

In case of improved detection of colorectal lesions, the blue water instillation technique of could dramatically change gastroenterologists' practice by becoming the reference method. The expected clinical benefits are potential revealing of more neoplastic lesions and improvement in abdominal discomfort after colonoscopy.

ReferenceCitation: Lesne A, Rouquette O, Touzet S, Petit-Laurent F, Tourlonias G, Pasquion A, Rivory J, Aguero Garcete G, Scanzi J, Chalumeau S, Chambon-Augoyard C, Moussata D, Leger-Nguyen F, Degeorges S, Chauvenet M, Fontanges T, Baubet S, Brulet P, Billioud C, Thimonier E, Stroeymeyt-Martin K, Hamel B, Graillot E, Cruiziat C, Scalone O, O'Brien M, Péré-Vergé D, Souquet JC, Phelip JM, Poincloux L, Poupon-Bourdy S, Denis A, Magaud L, Ponchon T, Pioche M. Adenoma detection with blue-water infusion colonoscopy: a randomized trial. Endoscopy. 2017 Aug;49(8):765-775. doi: 10.1055/s-0043-105073. Epub 2017 Apr 11.

name: Hepatogastroenterology Department, Hôpital Edouard Herriot, Hospices Civils de Lyon, France

name: Lyon 1 University Claude Bernard, Lyon, France

family: Lesne

full_name: Adriane Lesne

given: Adriane

name: Hepatogastroenterology Department, University Hospital d’Estaing, Clermont-Ferrand, France

family: Rouquette

full_name: Olivier Rouquette

given: Olivier

name: Hospices Civils de Lyon, pôle Information médicale Evaluation Recherche, and Université de Lyon, EA 7425 Health Services and Performance Research (HESPER), Lyon, France

family: Touzet

full_name: Sandrine Touzet

given: Sandrine

name: Hepatogastroenterology Department, Nord Ouest Hospital, Villefranche-sur-Saône, France

family: Petit-Laurent

full_name: Fabien Petit-Laurent

given: Fabien

name: Hepatogastroenterology Department, University Hospital Croix Rousse, Lyon, France

family: Tourlonias

full_name: Gwenaelle Tourlonias

given: Gwenaelle

name: Hepatogastroenterology Department, University Hospital Saint-Etienne, Saint-Priest en Jarez, France

name: Hepatogastroenterology Department, St Joseph St Luc Hospital, Lyon, France

family: Pasquion

full_name: Audrey Pasquion

given: Audrey

family: Rivory

full_name: Jérôme Rivory

given: Jérôme

family: Aguero Garcete

full_name: Guillermo Aguero Garcete

given: Guillermo

family: Scanzi

full_name: Julien Scanzi

given: Julien

family: Chalumeau

full_name: Sylvaine Chalumeau

given: Sylvaine

family: Chambon-Augoyard

full_name: Christine Chambon-Augoyard

given: Christine

name: Hepatogastroenterology Department, University Hospital Lyon Sud, Pierre-Bénite, France

family: Moussata

full_name: Driffa Moussata

given: Driffa

family: Leger-Nguyen

full_name: Florence Leger-Nguyen

given: Florence

name: Hepatogastroenterology Department, Public Hospital Bourgoin-Jallieu, France

family: Degeorges

full_name: Stéphane Degeorges

given: Stéphane

family: Chauvenet

full_name: Marion Chauvenet

given: Marion

family: Fontanges

full_name: Thierry Fontanges

given: Thierry

family: Baubet

full_name: Sandrine Baubet

family: Brulet

full_name: Philippe Brulet

given: Philippe

family: Billioud

full_name: Claire Billioud

given: Claire

family: Thimonier

full_name: Elsa Thimonier

given: Elsa

family: Stroeymeyt-Martin

full_name: Karine Stroeymeyt-Martin

given: Karine

family: Hamel

full_name: Benjamin Hamel

given: Benjamin

family: Graillot

full_name: Emmanuelle Graillot

given: Emmanuelle


title: Prospective Study of 3 Phone Assistance Strategies to Achieve a Continuous Cardiac Massage During Training in Non-hospital Cardiac Cases.

acronym: TeleMacc

summary:
This study must evaluate the benefit of a continuous audio guidance on the effectiveness of MCE directed by a volunteer.

The evaluation of the MCE for this study is based on both quantitative criteria (based on the recommendations ERC 2010)

frequency
depth of chest compressions.

This study compares two methods of continuous audio guide (one arm with an audio continuous guidance method by the regulator and second arm with an audio continuous guidance method by the controller relayed by an audio) to a method of incentive MCE based on a unique set made by the regulator(control arm).

lead_sponsor: University Hospital, Rouen

location_facility: CHU - Hôptaux de Rouen (Hôpital Charles Nicolle)


title: Combined Cumulative Irritation Potential and Repeat Insult Patch Test of LEO 90100

summary: The purpose of this study is to determine the skin irritation potential and sensitisation potential of LEO 90100 and the vehicle after repeated applications on the skin of healthy subjects.

primary_purpose: Other

ReferenceCitation: Queille-Roussel C, Liljedahl M, Clonier F, Lacour JP. Phase I evaluation of the dermal safety of the fixed combination calcipotriene plus betamethasone dipropionate aerosol foam and foam vehicle. J Am Acad Dermatol. 2015:72 Suppl 1;AB211 (P844).

location_facility: CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital de l'Archet 2


title: Comparative Study of the Bioavailability of Magnesium Administrated by Two ChronoMag Smart Tablet® 50 mg Versus Three Mag2® Tablets 100mg.

acronym: BioChronoMag

summary:
This clinical study is composed of two steps. The first step aims at validating the pharmacokinetic approach based on the magnesium concentration in erythrocyte and plasma.

According to these results and if this pharmacokinetic approach is validated, the second step will set up. The second phase aims at comparing the relative bioavailability of magnesium administrated by two different drug formulations: ChronoMag Smart Tablet® (two tablets50mg) versus Mag2® (three tablets100mg).

lead_sponsor: University Hospital, Clermont-Ferrand


title: Effectiveness of Two Techniques in Injection Site Spotting for Botulinum Toxin Injections: Echography or Electro Stimulation.

summary:
Botulinum toxin injections are an effective treatment of limb spasticity after stroke. Different tracking techniques are used to locate a proper injection spot. Palpatory technique is barely effective and induces a high risk of error. Localization by electro stimulation is frequently used in adults, but often requires multiple painful repositioning of the needle. Ultrasound tracking is sometimes used in children but not much in adults.

The advantages of ultrasound-guided botulinum toxin injections are a painless localization and greater injection accuracy. Safety is therefore enhanced since intravascular injection is easily avoided.

The few existing publications on the subject are essentially case reports. Few studies have focused on comparing different injection techniques and so far, no well-conducted study has highlighted superior efficiency of ultrasound-guided injections.

ReferenceCitation: Morel C, Hauret I, Andant N, Bonnin A, Pereira B, Coudeyre E. Efficacy of two injection-site localisation techniques for botulinum toxin injections: a single-blind, crossover, randomised trial protocol among adults with hemiplegia due to stroke. BMJ Open. 2016 Nov 15;6(11):e011751. doi: 10.1136/bmjopen-2016-011751.

family: Morel

full_name: Claire Morel

family: Hauret

full_name: Isabelle Hauret

given: Isabelle

family: Andant

full_name: Nicolas Andant

given: Nicolas

family: Bonnin

full_name: Armand Bonnin

given: Armand

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

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

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

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


title: Retrospective Analysis of Aminoglycoside-associated Acute Renal Injury in Septic Critically Ill Patients

acronym: REAMICHOC

summary: The purpose of the present study is to determine whether administration of aminoglycosides in septic critically ill patient is a risk factor for acute kidney injury

time_perspective: Retrospective

ReferenceCitation: Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. Epub 2004 May 24. Review.

ReferenceCitation: Boucher BA, Coffey BC, Kuhl DA, Tolley EA, Fabian TC. Algorithm for assessing renal dysfunction risk in critically ill trauma patients receiving aminoglycosides. Am J Surg. 1990 Nov;160(5):473-80.

ReferenceCitation: Boyer A, Gruson D, Bouchet S, Clouzeau B, Hoang-Nam B, Vargas F, Gilles H, Molimard M, Rogues AM, Moore N. Aminoglycosides in septic shock: an overview, with specific consideration given to their nephrotoxic risk. Drug Saf. 2013 Apr;36(4):217-30. doi: 10.1007/s40264-013-0031-0. Review.

family: Boyer

full_name: Alexandre Boyer

given: Alexandre

family: Gruson

full_name: Didier Gruson

given: Didier

family: Bouchet

full_name: Stéphane Bouchet

family: Clouzeau

full_name: Benjamin Clouzeau

family: Hoang-Nam

full_name: Bui Hoang-Nam

given: Bui

family: Vargas

full_name: Frédéric Vargas

given: Frédéric

family: Gilles

full_name: Hilbert Gilles

given: Hilbert

family: Molimard

full_name: Mathieu Molimard

given: Mathieu

family: Rogues

full_name: Anne-Marie Rogues

given: Anne-Marie

family: Moore

full_name: Nicholas Moore

given: Nicholas

journal_name: Drug Safety

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Aminoglycosides in Septic Shock

ReferenceCitation: Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. Erratum in: Crit Care Med. 2008 Apr;36(4):1394-6.

ReferenceCitation: Kollef MH, Sherman G, Ward S, Fraser VJ. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999 Feb;115(2):462-74.

ReferenceCitation: Kumar A, Safdar N, Kethireddy S, Chateau D. A survival benefit of combination antibiotic therapy for serious infections associated with sepsis and septic shock is contingent only on the risk of death: a meta-analytic/meta-regression study. Crit Care Med. 2010 Aug;38(8):1651-64. doi: 10.1097/CCM.0b013e3181e96b91. Review.

family: Kumar

full_name: Anand Kumar

given: Anand

family: Safdar

full_name: Nasia Safdar

given: Nasia

family: Kethireddy

full_name: Shravan Kethireddy

given: Shravan

family: Chateau

full_name: Dan Chateau

given: Dan

journal_name: Critical Care Medicine

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: A survival benefit of combination antibiotic therapy for serious infections associated with sepsis and septic shock is contingent only on the risk of death: A meta-analytic/meta-regression study

lead_sponsor: Université Victor Segalen Bordeaux 2

location_facility: Service de Réanimation médicale, Hôpital Pellegrin


title: Artificial Kidney Initiation in Kidney Injury, a Multicenter Randomised Trial

acronym: AKIKI

summary:
The best timing for renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) is unknown. The investigators will conduct a multicenter prospective randomized open-label trial to compare two strategies in ICU patients (mechanically ventilated and/or receiving catecholamine infusion) with severe AKI defined as RIFLE F classification. These patients will be randomly allocated to one of the following strategies:

an "early" strategy where RRT is started immediately when a RIFLE F status is documented
a "delayed" strategy where RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the following events ("Alert Criteria"): oliguria or anuria lasting for more than 72 hours after randomization, serum urea concentration > 40 mmol /L, serum potassium concentration > 6 mmol /L, serum potassium concentration > 5.5 mmol /L that persists despite well-conducted medical treatment with at least sodium bicarbonate and / or glucose-insulin infusion, arterial pH < 7.15 in the context of pure metabolic acidosis (PaCO2 <35 mmHg) or in the context of mixed acidosis with PaCO2> 50 mmHg without possibility of lowering this PaCO2 value, acute overload pulmonary edema generating severe hypoxemia requiring oxygen flow> 5L/min in spontaneously breathing patients or FiO2> 50% in mechanically (invasive or noninvasive) ventilated to maintain SpO2> 95%, despite diuretic therapy.

The primary endpoint is overall survival, measured from the date of randomization to the date of death, regardless of the cause. The minimum duration of each patient's follow-up will be 60 days.

ReferenceCitation: Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Verney C, Pons B, Boulet E, Boyer A, Chevrel G, Lerolle N, Carpentier D, de Prost N, Lautrette A, Bretagnol A, Mayaux J, Nseir S, Megarbane B, Thirion M, Forel JM, Maizel J, Yonis H, Markowicz P, Thiery G, Tubach F, Ricard JD, Dreyfuss D. Timing of Renal Support and Outcome of Septic Shock and Acute Respiratory Distress Syndrome. A Post Hoc Analysis of the AKIKI Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):58-66. doi: 10.1164/rccm.201706-1255OC.

name: Service de Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, Assistance Publique–Hôpitaux de Paris (AP-HP), Colombes, France

name: Unité Mixte de Recherche (UMR) S1155, Remodeling and Repair of Renal Tissue, Hôpital Tenon, French National Institute of Health and Medical Research (INSERM), Paris, France

family: Gaudry

full_name: Stéphane Gaudry

given: Stéphane

name: Epidémiologie Clinique et Évaluation Économique Appliquées aux Populations Vulnérables (ECEVE), U1123, Centre d’Investigation Clinique 1421, INSERM, Paris, France

name: Université Paris Diderot, Sorbonne Paris Cité, ECEVE, UMRS 1123, Paris, France

name: Département de Biostatistiques, Santé Publique, et Information Médicale, Hôpital Pitié-Salpêtrière, AP-HP, Paris, France

family: Hajage

full_name: David Hajage

given: David

name: Service de Réanimation Polyvalente Adulte, Centre Hospitalier Inter-communal, Créteil, France

family: Schortgen

full_name: Frédérique Schortgen

given: Frédérique

name: Réanimation Médico-Chirurgicale, Centre Hospitalier Général, La Roche-sur-Yon, France

family: Martin-Lefevre

full_name: Laurent Martin-Lefevre

given: Laurent

family: Verney

full_name: Charles Verney

given: Charles

name: Service de Réanimation, Centre Hospitalier Universitaire (CHU) de Pointe à Pitre–Abymes, Pointe à Pitre–Abymes, France

name: CHU de la Guadeloupe, Pointe-à-Pitre, France

family: Pons

full_name: Bertrand Pons

given: Bertrand

name: Réanimation Polyvalente, Centre Hospitalier René Dubos, Pontoise, France

family: Boulet

full_name: Eric Boulet

given: Eric

name: Réanimation Médicale, CHU Bordeaux, Hôpital Pellegrin, Bordeaux, France

name: Service de Réanimation, Centre Hospitalier Sud Francilien, Corbeil Essonne, France

family: Chevrel

full_name: Guillaume Chevrel

given: Guillaume

name: Département de Réanimation Médicale et Médecine Hyperbare, CHU Angers, Université d’Angers, Angers, France

family: Lerolle

full_name: Nicolas Lerolle

name: Réanimation Médicale, CHU Rouen, Rouen, France

family: Carpentier

full_name: Dorothée Carpentier

given: Dorothée

name: Service de Réanimation Médicale, Hôpitaux Universitaires Henri Mondor, Département Hospitalo-Universitaire Ageing Thorax-Vessels-Blood, AP-HP, Créteil, France

name: Cardiovascular and Respiratory Manifestations of Acute Lung Injury and Sepsis (CARMAS) Research Group and Université Paris-Est Créteil Val de Marne, Créteil, France

family: de Prost

full_name: Nicolas de Prost

name: Réanimation Médicale, Hôpital Gabriel Montpied, CHU de Clermont-Ferrand, Clermont-Ferrand, France

family: Lautrette

full_name: Alexandre Lautrette

name: Réanimation Médico-Chirurgicale, Hôpital de La Source, Centre Hospitalier Régional d’Orléans, BP 6709, Orléans, France

family: Bretagnol

full_name: Anne Bretagnol

given: Anne

name: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié-Salpêtrière, AP-HP, Paris France

family: Mayaux

full_name: Julien Mayaux

given: Julien

name: Centre de Réanimation, CHU de Lille, Lille, France

name: Faculté de Médecine, Université de Lille, Lille, France

family: Nseir

full_name: Saad Nseir

given: Saad

name: Réanimation Médicale et Toxicologique, Hôpital Lariboisière, Université Paris-Diderot, INSERM U1144, Paris, France

family: Megarbane

full_name: Bruno Megarbane

name: Réanimation Polyvalente, CH Victor Dupouy, Argenteuil, France

family: Thirion

full_name: Marina Thirion

given: Marina

name: Service de Réanimation des Détresses Respiratoires Aiguës et Infections Sévères, Hôpital Nord Marseille, Marseille, France

family: Forel

full_name: Jean-Marie Forel

given: Jean-Marie

name: Service de Réanimation Médicale CHU de Picardie, INSERM U1088, Amiens, France

family: Maizel

full_name: Julien Maizel

name: Réanimation Médicale, Hôpital de la Croix Rousse, Lyon, France

family: Yonis

full_name: Hodane Yonis

given: Hodane

name: Réanimation, Centre Hospitalier Cholet, Cholet, France

family: Markowicz

full_name: Philippe Markowicz

given: Philippe

family: Thiery

full_name: Guillaume Thiery

name: Université Pierre et Marie Curie, Sorbonne Universités, Paris, France

name: Université Paris Diderot, Sorbonne Paris Cité, Infection, Antimicrobials, Modelling, Evolution (IAME), UMRS 1137, Paris, France; and

journal_name: American Journal of Respiratory and Critical Care Medicine

ReferenceCitation: Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Pons B, Boulet E, Boyer A, Chevrel G, Lerolle N, Carpentier D, de Prost N, Lautrette A, Bretagnol A, Mayaux J, Nseir S, Megarbane B, Thirion M, Forel JM, Maizel J, Yonis H, Markowicz P, Thiery G, Tubach F, Ricard JD, Dreyfuss D; AKIKI Study Group. Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit. N Engl J Med. 2016 Jul 14;375(2):122-33. doi: 10.1056/NEJMoa1603017. Epub 2016 May 15.

ReferenceCitation: Gaudry S, Hajage D, Schortgen F, Martin-Lefevre L, Tubach F, Pons B, Boulet E, Boyer A, Lerolle N, Chevrel G, Carpentier D, Lautrette A, Bretagnol A, Mayaux J, Thirion M, Markowicz P, Thomas G, Dellamonica J, Richecoeur J, Darmon M, de Prost N, Yonis H, Megarbane B, Loubières Y, Blayau C, Maizel J, Zuber B, Nseir S, Bigé N, Hoffmann I, Ricard JD, Dreyfuss D. Comparison of two strategies for initiating renal replacement therapy in the intensive care unit: study protocol for a randomized controlled trial (AKIKI). Trials. 2015 Apr 17;16:170. doi: 10.1186/s13063-015-0718-x.

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central


title: EVESOR: a Phase 1 Trial of Everolimus and Sorafenib to Assess the Impact of Doses and Administration Sequences on Pharmacokinetic and Pharmacodynamic Effects of the Combination

acronym: EVESOR

summary: EVESOR multiparameter phase I trial aims at determining the safety of different doses and dosing schedules of everolimus in combination with sorafenib as well as the recommended doses & dosing schedules for phase 2 trials in adult patients with advanced solid tumors.

ReferenceCitation: El-Madani M, Colomban O, Tod M, Maillet D, Peron J, Rodriguez-Lafrasse C, Badary OA, Valette PJ, Lefort T, Cassier P, El-Shenawy SM, El-Demerdash E, Hommel-Fontaine J, Guitton J, Gagnieu MC, Ibrahim BM, Barrois C, Freyer G, You B. EVESOR, a model-based, multiparameter, Phase I trial to optimize the benefit/toxicity ratio of everolimus and sorafenib. Future Oncol. 2017 Apr;13(8):679-693. doi: 10.2217/fon-2016-0357. Epub 2017 Jan 12.

name: Faculté de Médecine Lyon-Sud, Univ Lyon, Université de Lyon, Université Claude Bernard Lyon 1, EMR UCBL/HCL 3738, Lyon, France

name: National Research Centre, Pharmacology Department, Cairo, Egypt

family: El-Madani

full_name: Mévidette El-Madani

given: Mévidette

family: Colomban

full_name: Olivier Colomban

given: Olivier

family: Tod

full_name: Michel Tod

given: Michel

name: Medical Oncology, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), CITOHL, Centre Hospitalier Lyon-Sud, Lyon, France

family: Maillet

full_name: Denis Maillet

given: Denis

family: Peron

full_name: Julien Peron

name: Biochemistry & molecular biology department; Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Lyon, France

family: Rodriguez-Lafrasse

full_name: Claire Rodriguez-Lafrasse

given: Claire

name: Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt

family: Badary

full_name: Osama A Badary

given: Osama A

name: Radiology Department, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Lyon, France

family: Valette

full_name: Pierre-Jean Valette

given: Pierre-Jean

family: Lefort

full_name: Thibaud Lefort

given: Thibaud

name: Phase 1 trial Unit, Centre Léon Bérard, Lyon, France

family: Cassier

full_name: Philippe Cassier

family: El-Shenawy

full_name: Siham M El-Shenawy

given: Siham M

name: Department of Pharmacology & Toxicology, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt

family: EL-Demerdash

full_name: Ebtehal EL-Demerdash

given: Ebtehal

name: Pathology Department, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Lyon, France

family: Hommel-Fontaine

full_name: Juliette Hommel-Fontaine

given: Juliette

family: Guitton

full_name: Jerome Guitton

given: Jerome

family: Gagnieu

full_name: Marie-Claude Gagnieu

given: Marie-Claude

family: Ibrahim

full_name: Bassant MM Ibrahim

given: Bassant MM

family: Barrois

full_name: Catherine Barrois

given: Catherine

family: Freyer

full_name: Gilles Freyer

given: Gilles

family: You

full_name: Benoit You

given: Benoit

journal_name: Future Oncology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd


title: Treatment of Hypertensive Leg Ulcer by Adipose Tissue Grafting

acronym: Angiolipo

summary:
The hypertensive leg ulcer is a very painful leg related to acute skin microangiopathy. It occurs in patients older than 60 years followed for hypertension. Clinical diagnosis requires eliminating other causes arterial ulcers, cryoglobulinemia, thrombophilia, cholesterol crystal emboli, vasculitis associated with hepatitis C, myeloproliferative disorders and ulcers associated with the Hydrea ® outlet.

There is no treatment of the ulcer because conventional treatments are ineffective. The pain has subsided by analgesics III. Other treatments are not effective outside skin grafts to be repeated because they necrotic regularly. In a prospective uncontrolled study, 11 patients healed through autohemotherapy.

Ineffective treatment of this painful condition and efficiency of these cells to the damaged tissue, due to the secretion of many bioactive molecules, led us to propose subcutaneous injections of autologous fat to change the wound bed, promote healing and eliminate pain. This treatment should help to avoid long-term hospitalization (about 15 days) that can lead to physical and psychological degradation of these elderly patients.

The investigators propose an open clinical study of 10 patients with a single-center recruitment (CHU Caen). The study took place over a period of 18 months with a 12-month recruitment and follow-up of 6 months for each patient.

The purpose of this study was to evaluate the one hand, tolerance, in terms of pain and side effects, and, on the other hand, the effectiveness of this therapeutic approach, in terms of healing of the ulcer assuming a decrease in the size of the estimated at least 40% at 3 months wound. The measure of effectiveness will also focus on the changing appearance of the wound, including the relative areas of fibrin, necrosis and budding. These efficiency measures (area ratio) will be done through a computer program (CANVAS ®) on photographs taken at each assessment time.

Eventually, if this study was to demonstrate the effectiveness of this treatment lipofilling, it would be possible to perform a multicenter study on a large number of patients to demonstrate the effectiveness, in terms of wound healing that the pain it causes and offer a shorter hospital stay, and in parallel, this approach should improve the pathophysiology of ulceration (translational research).

lead_sponsor: University Hospital, Caen

intervention_type: Procedure


title: Identification and Quantification of Immune Response Induced by Hyaluronidase and Other Factors of Virulence of Invasive Human Infections of Streptococcus Pneumoniae

acronym: Hyalo strepto

summary:
4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the patient within 24 hours following inclusion (D0) in the department in which the patient is hospitalised
4 tubes (2 x7-ml dry tubes with yellow gelose, and 2 x 5 ml tubes with blue CTAD) will be taken from the patient every 7 days following inclusion for 5 weeks (if the patient is still in hospital at the time), in the department where he/she is hospitalised (D7, D14, D21, D28, D35). Samples will no longer be taken once the patient has left the CHU, even if all of the samples have not been taken.
For children less than 6 years old, only 2 tubes (1 x 7 ml dry tube with yellow gelose, and 1x5 ml tube with blue CTAD) will be taken following the same timetable.
For hospitalised patients, a leeway of 48 hours is authorized for the sampling procedure. Samples will be taken at the same time samples are taken for the usual care of the patient.
The tubes will be taken to the Bacteriology Laboratory using the usual collection circuit of the CHU. These tubes will then be redirected to the Infectious Diseases Laboratory to be centrifuged and then stored at -80°C. The strain of Streptococcus pneumoniae isolated in the patient will be preserved at -80°C. If strains other than Streptococcus pneumoniae are isolated, these different strains will all be preserved at -80°C under the same identification number.

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological


title: Results of Selective Prostatic Arterial Embolization in Patients With Indwelling Urinary Catheter Due to Benign Prostatic Hyperplasia Refractory to Medical Treatment.

acronym: Prost-EMBOL

summary:
Background: Patients with indwelling urinary catheter for chronic retention due to obstructive BPH refractory to medical therapy are candidates for prostatectomy still considered as the gold standard of treatment. Urinary tract infection, strictures, postoperative pain, incontinence, sexual dysfunction, anesthesiologist risk and blood loss are complications associated with surgery. Minimally invasive treatments were originally conceived as an attempt to offer equivalent efficacy without the burden and risk of operative morbidity. Recently, it was suggested that prostatic arterial embolization (PAE) to treat BPH might follow uterine artery embolization for uterine leiomyomas. Animal studies in pigs and dogs have shown that PAE is safe and can induce prostatic volume reduction. The first report of this technique in the management of BPH in humans was by DeMeritt et al, who reported a single case of BPH with obstructive symptoms and blood loss refractory to other treatments that was successfully managed by PAE with polyvinyl alcohol (PVA) particles.

Objective : We investigate whether PAE might be a feasible procedure as an alternative treatment option to treat urinary retention due to obstructive BPH. The primary objective is to evaluate the success rate of procedure defined when selective prostatic arterial catheterization and embolization were achieve and patients can be able to urinate after their urinary catheter has been removed.

Patients and methods : A monocentric prospective study is undertaken in 25 patients aged 50-85 years who present with indwelling urinary catheter due to obstructive BPH refractory to medical treatment with a clinical indication for surgery who agreed to undergo PAE. The study is approved by the hospital ethical committee and an informed consent form for PAE as an alternative treatment is signed by all participants.

Statistical analysis : The sample size has been calculated in order to have an estimated probability of success (corresponding of primary objective) of 50% (worst case) with 95% confidence intervals of 30 to 70. The two-sample t-test (and Wilcoxon rank-sum test) is used to compare the mean changes of the variables from baseline to 10, 30 and 90 days. Finally, the Chi-square test is used to test for adverse events at the end of follow-up. P ≤ 0.05 is indicative of statistically significant.

status: Terminated


title: Contribution of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure Post Extubation in Patient With Critical Care Neuromyopathy

acronym: NEUROMIE

summary:
Respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality.

the study will evaluate the contribution of Mechanical Insufflation-Exsufflation (MI-E) in Preventing Respiratory Failure After Extubation as compared manually assisted coughing

lead_sponsor: University Hospital, Bordeaux


title: Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption.

acronym: TABELEC

summary:
The primary purpose of the protocol is to evaluate the effect of repeated application for 5 consecutive days of a real tDCS compared to the application of a placebo tDCS (sham procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5.

The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on the left dorsolateral prefrontal cortex region will reduce the craving induced causing a decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final visit between Day 15 and Day 20.

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lead_sponsor: University Hospital, Toulouse


title: Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive Pressure Support Ventilation in Patients at Risk for Respiratory Distress Needed Preventive Used of Noninvasive Ventilation After Extubation.

acronym: NAVA-VNI

summary: The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in patient at risk of respiratory distress after extubation.


title: Factors Linked to Outcomes After Esophageal Cancer Surgery: a Multicenter National Study

acronym: FREGAT I

summary:
Background

Esophageal carcinoma is the sixth leading cause of cancer -related mortality and the eighth most common cancer worldwide
The incidence is increasing rapidly
The overall 5-year survival ranges from 15% to 25% in the literature and poor outcomes are related to diagnosis at advanced stages.
Surgery used to be the cornerstone of treatment of resectable esophageal cancer, but treatment of esophageal carcinoma remains challenging and need to be considered through a multimodal approach. However the modalities and the impact of this multimodal approach at a national level are unknown Primary objective: To identify predictors of recurrence after esophageal cancer surgery

Secondary objectives :

5-year recurrence free survival
5-year overall survival
Predictors of postoperative mortality and morbidity after surgery
Impact of pCR on recurrence and survival
Impact of neoadjuvant treatments on recurrence and survival
Impact of patient preconditioning (such as nutritional support, esophageal prosthesis, mini-invasive approach…) on outcomes

Methodology : European French-speaking retrospective multicentric study Inclusion criteria: All consecutive patients operated on, for a histologically proven carcinoma of the esophagus, the oesophago-gastric junction (Siewert type I and II), in surgical investigator centers between January 2000 and December 2010 Exclusion criteria: Siewert III type carcinoma of the oesophago-gastric junction , non surgical treatment of esophageal carcinoma Planned study period: The data will be collected over a 11-year period from January 2000 to December 2010. Follow up will be ascertained in May 2013.

ReferenceCitation: Markar SR, Gronnier C, Duhamel A, Pasquer A, Théreaux J, Chalret du Rieu M, Lefevre JH, Turner K, Luc G, Mariette C; FREGAT Working Group-FRENCH-AFC. Significance of Microscopically Incomplete Resection Margin After Esophagectomy for Esophageal Cancer. Ann Surg. 2016 Apr;263(4):712-8. doi: 10.1097/SLA.0000000000001325.

family: Markar

full_name: Sheraz R. Markar

given: Sheraz R.

family: Gronnier

full_name: Caroline Gronnier

given: Caroline

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Pasquer

full_name: Arnaud Pasquer

given: Arnaud

family: Théreaux

full_name: Jérémie Théreaux

given: Jérémie

family: Rieu

full_name: Mael Chalret du Rieu

given: Mael Chalret du

family: Lefevre

full_name: Jérémie H. Lefevre

given: Jérémie H.

family: Turner

full_name: Kathleen Turner

given: Kathleen

family: Luc

full_name: Guillaume Luc

given: Guillaume

family: Mariette

full_name: Christophe Mariette

given: Christophe

journal_name: Annals of Surgery

ReferenceCitation: Mariette C, Gronnier C, Duhamel A, Mabrut JY, Bail JP, Carrere N, Lefevre JH, Meunier B, Collet D, Piessen G; FREGAT Working Group-FRENCH-AFC; FREGAT Working Group-FRENCH-AFC. Self-expanding covered metallic stent as a bridge to surgery in esophageal cancer: impact on oncologic outcomes. J Am Coll Surg. 2015 Mar;220(3):287-96. doi: 10.1016/j.jamcollsurg.2014.11.028. Epub 2014 Dec 12.

family: Mabrut

full_name: Jean-Yves Mabrut

given: Jean-Yves

family: Bail

full_name: Jean-Pierre Bail

given: Jean-Pierre

family: Carrere

full_name: Nicolas Carrere

given: Nicolas

family: Meunier

full_name: Bernard Meunier

given: Bernard

family: Collet

full_name: Denis Collet

family: Piessen

full_name: Guillaume Piessen

family: Dhahri

full_name: Abdennahceur Dhahri

given: Abdennahceur

journal_name: Journal of the American College of Surgeons

title: Self-Expanding Covered Metallic Stent as a Bridge to Surgery in Esophageal Cancer: Impact on Oncologic Outcomes

ReferenceCitation: Gronnier C, Tréchot B, Duhamel A, Mabrut JY, Bail JP, Carrere N, Lefevre JH, Brigand C, Vaillant JC, Adham M, Msika S, Demartines N, El Nakadi I, Piessen G, Meunier B, Collet D, Mariette C; FREGAT Working Group-FRENCH-AFC, Luc G, Cabau M, Jougon J, Badic B, Lozach P, Cappeliez S, Lebreton G, Alves A, Flamein R, Pezet D, Pipitone F, Iuga BS, Contival N, Pappalardo E, Mantziari S, Hec F, Vanderbeken M, Tessier W, Briez N, Fredon F, Gainant A, Mathonnet M, Bigourdan JM, Mezoughi S, Ducerf C, Baulieux J, Pasquer A, Baraket O, Poncet G, Vaudoyer D, Enfer J, Villeneuve L, Glehen O, Coste T, Fabre JM, Marchal F, Frisoni R, Ayav A, Brunaud L, Bresler L, Cohen C, Aze O, Venissac N, Pop D, Mouroux J, Donici I, Prudhomme M, Felli E, Lisunfui S, Seman M, Petit GG, Karoui M, Tresallet C, Ménégaux F, Hannoun L, Malgras B, Lantuas D, Pautrat K, Pocard M, Valleur P. Impact of neoadjuvant chemoradiotherapy on postoperative outcomes after esophageal cancer resection: results of a European multicenter study. Ann Surg. 2014 Nov;260(5):764-70; discussion 770-1. doi: 10.1097/SLA.0000000000000955.

title: Impact of Neoadjuvant Chemoradiotherapy on Postoperative Outcomes After Esophageal Cancer Resection


title: Evaluation of Excessive Diurnal Sleepiness by the Expression and Activity of Salivary Amylase in Children With Hypersomnia.

acronym: Amylase

summary:
Hypersomnia is defined as a reduced ability to remain awake during the day. There are basically two types of central hypersomnia: narcolepsy and idiopathic hypersomnia. Currently, the diagnosis of these sleep disorders is based on polysomnographic recordings which is difficult to access. Tests of sleepiness (Epworth, Karolinska) are subjective.

A biological marker of sleepiness, easily accessible and measurable, would be very useful for the diagnosis and therapeutic follow up of excessive diurnal sleepiness. Salivary secretions appear as good physiological markers. Studies have shown for healthy subjects, that the expression and activity of salivary amylase are increased when subjects are deprived of sleep.

The investigators propose to explore the usefulness of salivary biomarkers (including amylase) as a new non-invasive and simple technique for the assessment of excessive daytime sleepiness.

location_facility: Hôpital Femme-Mère-Enfant, Exploration et pathologie du sommeil


title: Study of Genic Expression Profiles of the Epithelium of the Nose and Bronchi in Healthy and Allergic Subjects

acronym: GENEBRO

summary: The respiratory epithelium plays a leading role in the development of allergic respiratory disease with barrier function alteration, its repair mechanisms, of anti-viral fight and the ability to induce by itself Th2 responses. The majority of allergic asthmatic patients have reached concomitant ENT: the concept of "one airway, one disease." Access to this material of epithelial study in the different phenotypes of the disease appears to be crucial. Nasal and bronchial epithelial tissues reveal essential differences in particular related to their environment (remodeling less intense and a lower sensitivity to the virus in the nose), but they nevertheless share many common cellular characteristics.

ReferenceCitation: Giovannini-Chami L, Paquet A, Sanfiorenzo C, Pons N, Cazareth J, Magnone V, Lebrigand K, Chevalier B, Vallauri A, Julia V, Marquette CH, Marcet B, Leroy S, Barbry P. The "one airway, one disease" concept in light of Th2 inflammation. Eur Respir J. 2018 Oct 25;52(4). pii: 1800437. doi: 10.1183/13993003.00437-2018. Print 2018 Oct.

family: Giovannini-Chami

full_name: Lisa Giovannini-Chami

given: Lisa

family: Paquet

full_name: Agnès Paquet

given: Agnès

family: Sanfiorenzo

full_name: Céline Sanfiorenzo

given: Céline

family: Pons

full_name: Nicolas Pons

family: Cazareth

full_name: Julie Cazareth

given: Julie

family: Magnone

full_name: Virginie Magnone

given: Virginie

family: Lebrigand

full_name: Kévin Lebrigand

given: Kévin

family: Chevalier

full_name: Benoit Chevalier

family: Vallauri

full_name: Ambre Vallauri

given: Ambre

family: Julia

full_name: Valérie Julia

given: Valérie

family: Marquette

full_name: Charles-Hugo Marquette

given: Charles-Hugo

family: Marcet

full_name: Brice Marcet

given: Brice

family: Leroy

full_name: Sylvie Leroy

given: Sylvie

family: Barbry

full_name: Pascal Barbry

given: Pascal

journal_name: European Respiratory Journal

oa_host_type: publisher

evidence: open (via free pdf)

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

title: The “one airway, one disease” concept in light of Th2 inflammation

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Medical and Economic Evaluation of a Magnetic Anal Sphincter for Patients With Severe Anal Incontinence

acronym: MOS STIC

summary: The purpose of this study is to compare 2 surgical treatments of severe fecal incontinence (defined as more than a major leak per week). The hypothesis of this "non-inferiority" trial is that magnetic anal sphincter is clinically as effective as SNS, but more cost-effective in managing fecal incontinence

status: Suspended

ReferenceCitation: Wong MT, Meurette G, Wyart V, Lehur PA. Does the magnetic anal sphincter device compare favourably with sacral nerve stimulation in the management of faecal incontinence? Colorectal Dis. 2012 Jun;14(6):e323-9. doi: 10.1111/j.1463-1318.2012.02995.x.

lead_sponsor: Nantes University Hospital


lead_sponsor: UNICANCER

acronym: UCGI 25

source: euctr

title: A Multicentric Randomized Phase II Trial Evaluating Dual Targeting of EGFR Using the Combination of Cetuximab and Afatinib Versus Cetuximab Alone in Patients With Chemotherapy Refractory wtKRAS Metastatic Colorectal Cancer

summary: This is a multicentric, phase II and open label study.75 patients are expected to be randomized in 35 centers. The main objective is to assess the efficacy and safety of Afatinib -cetuximab combo versus cetuximab alone in treatment of patients with refractory wtKRAS metastatic colorectal cancer.


title: Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs

summary:
The Charcot syndrome Marie Tooth is the most frequent hereditary neuromuscular diseases: there is no curative treatment at present, on the other hand precautionary measures can be taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). In the literature and in our recent study (evaluation of the pain in the disease of CMT - Reference center of the neuromuscular diseases - CHU Bow) the frequency of the pain is important varying from 66 to 96 % cases, affecting especially hands and lower limbs. The care of the pain in the Charcot syndrome Marie Tooth is not codified. The transcutaneous neurostimulation(TENS) is a not medicinal and not invasive therapeutics, without any brought back collateral effect, used at the same time in the chronic pain and acute since 1960, as well for the neuropathic pains that musculo-scrawny. No study was realized this day on the use of the TENS with analgesic aim in the CMT. We suggest studying the analgesic efficiency of the TENS in the Charcot syndrome Marie Tooth on the pains of lower limbs, the most frequent painful location in our recent works.

The main objective will be to analyze the improvement of the pain of lower limbs, based on the decrease of the analogical visual scale(ladder) (EVA), at least 30 %.

The secondary objectives will be to estimate repercussions on the functional capacities ( ONLS), the quality of life (SF(sci-fi) 12), the satisfaction (EVA), the global impression(printing) of change ( PGIC), the consumption of analgesic, DN4, NPSI (Neuropathic Pain Symptom Inventory), Concise Questionnaire of the Pains ( QCD), HAD (Hospital Anxiety and Depression scale).


title: Evaluation of the Efficiency of the Ultrasound Measure of the Thickness of the Lower Segment Associated With a Rule of Decision to Reduce the Foetal and Maternal Morbidity and Mortality in the Care of the Deliveries of the Women Having a History of Caesarian: a Pragmatic Randomized Trial : Lustrial

summary:
The rate of caesarians dramatically increased for 15 years. The main indication of caesarian became the iterative caesarian of principle because of a history of caesarian. Any attempt of reduction of the rate of caesarians should thus focus on the indications of iterative principal caesarean. Nevertheless, the main reason usually evoked to justify a reduction of the attempts of low way after caesarian is the concern generated by the risk of uterine break during the trial of labor. Yet, there is no reliable method to predict this risk of uterine break. A way of interesting research consists in estimating the potential profits of the echography of the scar lower segment. Indeed, the echography can be useful to determine the specific risk of uterine break of a patient by measuring the thickness of the lower segment of the womb.

The strong negative predictive value of the echography of the lower segment on the risk of uterine break should encourage the women encircled to accept a trial of labor. That is why, this examination associated with a rule of decision could help to decrease the rate of iterative elective caesarians and especially to decrease the mortality and the foetal and maternal morbidity connected to the trial of labor among the patients having a history of caesarian.

ReferenceCitation: Rozenberg P, Deruelle P, Sénat MV, Desbrière R, Winer N, Simon E, Ville Y, Kayem G, Boutron I; Groupe de recherche en obstétrique et gynécologie. [Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial]. Gynecol Obstet Fertil Senol. 2018 Apr;46(4):427-432. doi: 10.1016/j.gofs.2018.03.005. Epub 2018 Apr 4. French.

family: Rozenberg

full_name: P. Rozenberg

given: P.

family: Deruelle

full_name: P. Deruelle

family: Sénat

full_name: M.-V. Sénat

family: Desbrière

full_name: R. Desbrière

given: R.

family: Winer

full_name: N. Winer

given: N.

family: Simon

full_name: E. Simon

given: E.

family: Ville

full_name: Y. Ville

given: Y.

family: Kayem

full_name: G. Kayem

given: G.

family: Boutron

full_name: I. Boutron

given: I.

journal_name: Gynécologie Obstétrique Fertilité & Sénologie

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Prédiction échographique du risque de rupture utérine après césarienne : LUSTrial, un essai randomisé pragmatique

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis

summary:
The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases, initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a decreased diagnostic accuracy for the modified Duke criteria.

Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.

Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou European Hospital, Paris), the investigators plan to include consecutive patients suspected of having PVE. All of the patients will be subjected to clinical, microbiological, and echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data analysis will be based on visual interpretation and quantitative measurement of FDG uptake (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological modified Duke criteria determined during a 3-month follow-up (gold standard).

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Natural Killer Cells Functions, Tumoral Escape to Immune System and Regulation of Natural Cytotoxixity Receptors in Haematological Malignancies

summary: The NK cells participate in the innate immunity against infectious agents or transformed cells that are recognized as "no self" by the absent, weak or abnormal expression of human leukocyte antigen (HLA) class I molecules. According to the "missing self hypothesis", a negative signal is delivered to NK cells when their inhibitory receptors are engaged by the specific HLA class I molecules. NK activation requires a positive signal delivered by the engagement of activating receptors, more particularly of the "Natural cytotoxicity receptors" or NCRs who are directly involved in the natural cytotoxicity of Natural Killer. The activating receptors include NKp46, NKp44 and NKp30, also called NCR 1, 2 and 3 respectively. NKp46 and NKp30 are constitutively expressed on the surface of the NK, the expression of NKp44 is observed only after activation of cells NK. NK cells from most (80%) healthy donors express a high quantity of NCR on their surface, corresponding to the NCRbright phenotype while only 20 % present the NCRdull phenotype. In sharp contrast, most patients (80%) having leukaemia have the NCRdull while only 20 % patients have the NCRbright phenotype. The culture of NK from healthy donors ( NCRbright) with leukaemic cells result in decreased expression of the NKp30 while there is no difference on expression if these same NK are cultivated with cells from healthy donors. Moreover, study of AML patients showed that the NCRdull phenotype was acquired during leukemia development because it was observed its complete (for NKp46) or partial (for NKp30) reversibility in patients achieving complete remission (CR). Reversibility of the NCRdull phenotype after CR suggested that leukemia cells might be involved in NCR down-regulation. In line with these observations, we aim to study the mechanism of NCR down-regulation by cultivating NK NCRbright from healthy donors with leukaemic cells or healthy haematopoietic cells, in order to observe the appearance of the NCRdull phenotype and verify by qPCR if this down-regulation is transcriptionnal. If this hypothesis is be verified, we will study the regulation of NCR by focusing on the implication of genes NCR transcription factors via bio-informatic analysis of putative transcription factors fixation sequences in the promoters of these genes, followed by the verification of the capacity of identified sequences to bind transcription factors. Ultimately, we will verify the real implications of these transcription factors by studying the effect of their silencing by RNA interference experiments.