title: Adjuvant Radiotherapy in Breast With Intensity Modulated by Tomotherapy: Evaluation of the Toxicity and Quality of Life

acronym: TOMOBREAST

summary: Adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. The diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. The adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (Early Breast Cancer Trialists' Collaborative Group 2011). The aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.

ReferenceCitation: Pasquier D, Bataille B, Le Tinier F, Bennadji R, Langin H, Escande A, Tresch E, Darloy F, Carlier D, Crop F, Lartigau E. Correlation between toxicity and dosimetric parameters for adjuvant intensity modulated radiation therapy of breast cancer: a prospective study. Sci Rep. 2021 Feb 11;11(1):3626. doi: 10.1038/s41598-021-83159-3.

family: Pasquier

full_name: David Pasquier

given: David

family: Bataille

full_name: Benoit Bataille

given: Benoit

family: Le Tinier

full_name: Florence Le Tinier

given: Florence

family: Bennadji

full_name: Raoudha Bennadji

given: Raoudha

family: Langin

full_name: Hélène Langin

given: Hélène

family: Escande

full_name: Alexandre Escande

given: Alexandre

family: Tresch

full_name: Emmanuelle Tresch

given: Emmanuelle

family: Darloy

full_name: Franck Darloy

given: Franck

family: Carlier

full_name: Damien Carlier

given: Damien

family: Crop

full_name: Frederik Crop

given: Frederik

family: Lartigau

full_name: Eric Lartigau

given: Eric

journal_name: Scientific Reports

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Léonard de Vinci
Centre Oscar Lambret


type: Other Identifier

title: Analysis of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department: Predicting Respiratory Prognosis

acronym: EDDRAPro

summary: The main objective of this study is to show that "diaphragmatic excursion measures upon emergency admission" (CDA values) on patients with acute respiratory failure are predictive of the need to use mechanical ventilation (invasive or non-) in the first four hours.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Diagnostic and Prognostic Biomarkers for Acute Graft-versus-host Disease: a Prospective Single Centre Biological Study

acronym: PLASMA-INCA

summary: Validation of already described biomarkers on acute GVHD prediction and severity Fecal calprotectin and alpha 1 anti-trypsin, plasmatic RER3a, IL-8, Elafin, TNFaR1, IL-2R alpha, HGF

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

status_simplified: Unknown


title: Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?

acronym: MGM-PicRemi

summary:
Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a conventional MacIntosh laryngoscope.

Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that it modifies the anesthetic drugs requirement. .

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

family: Liu

full_name: Ngai Liu

given: Ngai

sequence: first

family: Chazot

full_name: Thierry Chazot

given: Thierry

sequence: additional

family: Hamada

full_name: Sophie Hamada

given: Sophie

family: Landais

full_name: Alain Landais

given: Alain

family: Boichut

full_name: Nathalie Boichut

given: Nathalie

family: Dussaussoy

full_name: Corinne Dussaussoy

given: Corinne

family: Trillat

full_name: Bernard Trillat

given: Bernard

family: Beydon

full_name: Laurent Beydon

given: Laurent

family: Samain

full_name: Emmanuel Samain

given: Emmanuel

family: Sessler

full_name: Daniel I. Sessler

given: Daniel I.

family: Fischler

full_name: Marc Fischler

given: Marc

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Closed-Loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index

ReferenceType: derived

ReferenceCitation: Ing R, Liu N, Chazot T, Fessler J, Dreyfus JF, Fischler M, Le Guen M. Nociceptive stimulation during Macintosh direct laryngoscopy compared with McGrath Mac videolaryngoscopy: A randomized trial using indirect evaluation using an automated administration of propofol and remifentanil. Medicine (Baltimore). 2017 Sep;96(38):e8087. doi: 10.1097/MD.0000000000008087.

family: Ing

full_name: Rathvirak Ing

given: Rathvirak

family: Fessler

full_name: Julien Fessler

given: Julien

family: Dreyfus

full_name: Jean François Dreyfus

given: Jean François

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

currency_apc_doaj: USD

journal_name: Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

location_facility:
Hopital Foch
Institut Hospitalier Franco-Britannique


title: Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly

summary:
The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of elderly patients, the therapeutic resources to control the passing pain require in their manipulation a certain caution and are not divested of side effects badly tolerated at this age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative of choice in the care of these pains, in particular in case of pre-existent cognitive achievement, of polypathologies or of polymédication.

The gas MEOPA administered to the mask could thus be an effective additive in the physiotherapy treatment of the elderly person.

The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Pôle de Gérontologie Hôpital de Cimiez CHU de Nice

intervention_type: Drug


title: Head-up Position, Active Compression-decompression Mechanical Cardiopulmonary Resuscitation and Impedance Threshold Device to Improve Outcomes in Out-of-hospital Cardiac Arrest. A Multicenter Prospective Controlled Quasi-experimental Trial

acronym: GRAVITY

summary:
Elevation of the head and thorax, also known as Head-up cardiopulmonary resuscitation (HUP CPR), has been studied extensively in pigs in ventricular fibrillation (VF). HUP combined with active compression decompression and impedance threshold device (ACD+ITD) CPR improves vital organ perfusion and results in a doubling of cerebral perfusion when compared with the same method of CPR in the flat or horizontal plane. HUP CPR enhances the drainage of venous blood from the brain, lowers central venous pressures, reduces intracranial pressures during the decompression phase of CPR, redistributes blood flow through the lungs during CPR, and may reduce brain edema. These mechanisms collectively contribute to improved blood flow and less injury to the brain during CPR. These benefits are due in large part to the effects of gravity on the physiology of HUP CPR. Importantly, HUP CPR is dependent upon a means of generating enough forward flow to adequately pump blood "uphill" to the brain.

In this proposed pilot study, CPR will be performed manually before the patient is placed on a controlled mechanical elevation device (Elegard, Minnesota Resuscitation Solutions LLC, USA). An ITD-16 (ResQPOD-16, Zoll, USA) will be placed on the patient's airway before the head is elevated. Automated CPR will be initiated as soon as feasible using a new automated CPR mechanical compression device that provides full active compression-decompression CPR (LUCAS-AD, Stryker, USA).

The proposed feasibility clinical study will be the first ever to test the fully integrated system of ACD+ITD HUP CPR.

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Other

ipd_sharing: Yes

ipd_sharing_description: Study protocol will be submitted for publication. IPD will be shared with other researcher

lead_sponsor: University Hospital, Grenoble

location_facility:
SAMU 54 - CHU Nancy
SAMU 38

status_simplified: Ongoing


title: Study on the Treatment of Children and Their Families in Services Related to Early Childhood Morvan Hospital Qualitative Study

acronym: PERAM-QUAL

summary:
Breastfeeding is recommended for preterm infants. Development of breastfeeding is an important issue, requiring the involvement of medical and paramedical staff in neonatal units. There are few data concerning the fathers of preterm infants. However, the role of the father is identified in the literature as a key factor in the initiation and continuation of breastfeeding. In our neonatal unit care, reasons for breastfeeding high rates are not identified but may be related to the father being in close and constant contact with the medical and paramedical staff. In fact, fathers are often first in contact with caregivers. They can be invested in the implementation of nursing care, skin to skin, as well as being asked to support the development of their child in the service and at home.

The aims of this study are to:

Analyze the beliefs, social representations and the experience of the fathers of premature infants hospitalized in intensive care unit concerning breastfeeding.
Analyze the factors facilitating and inhibiting the initiation and continuation of breastfeeding.
Consider strategies of care and support that can be used for the families of premature infants and of children born at term.
Explore the expectations of medical staff with regards to the management of children and families, their practices, identify the role attributed to the father.
Initiate and facilitate reflexivity of medical and paramedical staff about their respective practices

lead_sponsor: University Hospital, Brest

location_facility:
CH du Mans
CHRU de Brest


title: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL FOR EVALUATING THE EFFICACY OF AB-LIFE PROBIOTIC PRODUCT ON THE LDL-CHOLESTEROL REDUCTION IN THE MODERATE HYPERCHOLESTEROLEMIA

summary: This study aims to demonstrate the effect of the chronic consumption of AB-Life probiotic blend on blood LDL cholesterol level in volunteers with moderate hypercholesterolemia.

primary_purpose: Prevention

lead_sponsor: AB Biotics, SA

location_facility: Naturalpha Biofortis

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


title: Determinants of Frailty Among of Informal Caregivers of Demented Patient Evaluated in Day Care Hospital.

acronym: DELFAF

summary: Frailty, a transitional state between successful and pathological aging, may be benefit from early multi-interventional intervention. Fried's criteria are the more commonly used criteria to diagnose frailty. The caregivers' burden increases caregivers' morbidity .The main objective of the study was to assess the relationship between frailty among informal caregivers of demented patients and the caregiver's burden (Zarit scale). The Secondary objective was to assess determinants of frailty among caregivers.

ipd_sharing: No

lead_sponsor: Gérond'if

location_facility:
Paul Brousse Hospital
Broca Hospital


type: Registry Identifier

title: Ocular Blood-flow Assessment by Magnetic Resonance Angiography in Glaucoma

acronym: OBAMAg

summary:
Background : Glaucoma is a common disease, potentially blinding, characterized by progressive damage to the optic nerve. If the intraocular pressure is the most known risk factor, however, there are cases of glaucoma scalable despite well-controlled intraocular pressure, ocular hypertension without glaucoma or glaucoma without ocular hypertension (normal tension glaucoma).

Purpose :Involvement of vascular factors in the development of glaucoma and scalability has been proved, associated with a possible loss of vascular autoregulation. The objective of this study is to quantify MRI flow of blood flows referred ophthalmic patients with glaucoma untreated comparison with control subjects.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Centre d'ophtalmologie Victor Pauchet
CHU Amiens


title: Identification of Biomarkers Related to Liver Fibrosis as New Therapeutic Targets

acronym: FIBROTHER

summary: Fibrosis is a dynamic process resulting from the balance of fibrogenesis and fibrolysis, mainly secondary to chronic necro-inflammation related to regular alcohol consumption, metabolic syndrome (NASH) or viral hepatitis. The liver has the property of allowing the reversion of fibrosis / cirrhosis when the necrotic-inflammatory activity is controlled. The balance between fibrosis / fibrolysis and its inhibition depends on many pathways and the hypothesis of the efficacy of a single treatment remains uncertain. Molecular factors in the progression of liver fibrosis should be determined. It is necessary to control the liver fibrosis and thus reduce the risk of carcinoma in this population. The anti-fibrotic drugs are being developed, but so far only alpha-tocopherol and obeticholic acid have been shown to have a significant anti-fibrotic effect in humans. Several new drugs are currently being evaluated in ongoing Phase 2 and 3 randomized clinical trials, but most of them have intrinsic limitations: (i) they take a long time for evaluation (> 3 years), ( ii) they generally require an histopathological evaluation by serial liver biopsies that are invasive and unpopular with patients who are aware of noninvasive tests for fibrosis assessment and (iii) treatment is often a single treatment versus a placebo group with the uncertainty that at 1 or 3 years, serial liver biopsies results are convincing.

lead_sponsor: Institut Pasteur

location_facility:
Pitie-Salpetriere Hospital
Cochin Hospital


title: Performance and Safety of the Resorbable Collagen Membrane "Ez Cure" in Guided Tissue Regeneration and Guided Bone Regeneration Procedures

summary:
The evaluation of the clinical data has demonstrated the conformity of the Resorbable Collagen Membrane (RCM), EZ CureTM, with the relevant essential requirements for its use in periodontal applications. The RCM is intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) procedures. It acts as a barrier against the migration of epithelial cells within the bone defect (performance) and thus complies with several surgical indications in the treatment of maxillofacial bone defects. It has been concluded that the risks associated with the use of this device are acceptable when weighted against the benefits to the patients.

In order to improve the clinical data on the RCM, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:

Tissue regeneration (mucosa health on the site of implantation)
Safety (report of any adverse event)
Radiographic analysis of periodontal tissues

lead_sponsor: Biomatlante

location_facility: Centre de soins dentaires - Centre Hospitalo-Universitaire de Nantes


title: Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors

acronym: BCBCOLON

summary: Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.

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

location_facility: Institut Régional du cancer de Montpellier


title: Identification and First Validation of Early Non-invasive Biomarkers of Diabetic Nephropathy in Type I Diabetic Children

summary:
About 30 to 40% of patients suffering from type I diabetes are at risk of developing a diabetic nephropathy (DN) leading more or less rapidly to an end-stage renal disease. Nowadays, the microalbuminuria is the most often used clinical parameter for possible onset of DN. However, it is a late (because it permits to detect a renal disease already present), non-specific and low sensitive biomarker.

Therefore the main objective of this study is to identify early urinary biomarkers predictive of DN in children with type I diabetes, before the appearance of a microalbuminuria.

lead_sponsor: University Hospital, Toulouse

location_facility:
Purpan Children Hospital
Rangueil Hospital


title: The Importance of the Nurse's Role in Treatment Observance and Social Autonomy in Schizophrenia Using an Innovating Tool for Daily Transports: a Pilot Study

acronym: Schizovirt

summary:
Schizophrenia is a mental health issue that affects mostly young adults. The main symptoms are hallucinations, delirium, and agitation, poor social relations, lack of motivation, thought disorganization. Also, patients suffering from schizophrenia encounter important cognitive disorders affecting memory, executive functioning and attention. These cognitive alterations are often linked to social exclusion and stigmatisation.

Antipsychotic treatments are effective mainly on the positive dimension of symptoms (hallucinations etc…); however their action is very limited on the cognitive difficulties encountered. Psychosocial techniques can be used to treat the cognitive symptoms, such as cognitive remediation or psychosocial rehabilitation .

These cognitive difficulties mainly have an impact on patients' daily life, affecting their abilities to drive, for example. Schizophrenic patients suffer more road accidents than healthy subjects .

Thus, considering this information, it appears important to us to address this driving problem for various reasons:

Firstly, knowing how to drive is often linked to daily autonomy,
Secondly, driving is also linked to keeping an active social network and to work.

Patients suffering from schizophrenia often encounter difficulties in learning how to drive which reinforces the stigmatisation and fear of failure.

Thus, a specific driving and theory training prior to driving lessons could be a way of helping patients in their cognitive difficulties and pass their driving test. Daily transports mobilize a number of cognitive functions (attentional vigilance, working memory, psychomotor coordination, divided attention, visuo-spatial abilities .

Using a driving virtual reality tool could constitute an ecological cognitive remediation tool, by simulating daily driving situations. This "serious game" approach enables us to involve virtual reality in training but also in assessments. The driving simulator allows standardized evaluations and could also become a therapeutic tool of ecological cognitive remediation.

This study thus appears interesting in order to develop road safety and daily autonomy.

lead_sponsor: Hôpital le Vinatier

location_facility:
Hopital Vinatier
Hôpital le vinatier

intervention_type: Behavioral


title: Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study

acronym: Tapas

summary:
The primary purpose of TAPAS study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (TAP block) performed at the beginning of stoma reversal, compared to standard of care.

The hypothesize is that a TAP block performed at the beginning of surgery of stoma reversal would improve patient's satisfaction (evaluated by Quo-r40 questionnaire), would reduce the incidence of post operative pain, time spent in recovery room, and reduce hospitalisation time

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU
CHU Rennes

intervention_type: Procedure


title: Prevalence of Preoperative Short-acting Mimetic beta2 Therapy by Parents of Asthmatic Children Attending Emergency Room for Asthma Attack

acronym: ASPECT

summary:
prospective multicenter observational study. Parents whose children meet the inclusion criteria complete a questionnaire assessing the child's follow-up, the management of the current asthma attack, and the treatment provided at home.

The main objective is to calculate the prevalence of placement of short-acting bronchodilators. The secondary objectives are to describe the factors associated with their implementation.

location_facility:
Ch Quimper
CHRU de Brest


title: Assessment of a Novel Method for Non-invasive Sampling of the Distal Airspace in Acute Respiratory Distress Syndrome Patients Receiving Inhaled Sedation With Sevoflurane)

acronym: ANAISS

summary:
The main objective of this study is to compare the protein composition of simultaneously collected undiluted pulmonary edema fluid and AnaConDa-S ® fluid from patients with ARDS.

In a previous pilot randomized controlled trial, in patients with moderate-severe acute respiratory distress syndrome (ARDS), the use of inhaled sevoflurane improved oxygenation and decreased levels of a marker of lung epithelial injury (soluble receptor for advanced glycation end-products, sRAGE) and of some inflammatory markers (interleukin (IL)-1β, IL-6, IL-8 and tumor necrosis factor (TNF)-α), compared to intravenous midazolam. These results reinforce those from previously published preclinical studies as they suggest a protective effect of sevoflurane from alveolar/systemic inflammation and from reduced epithelial injury and/or improved alveolar fluid clearance, as assessed by plasma soluble receptor for advanced glycation end-products (sRAGE). The results from available studies support the safe use of sevoflurane inhalation through dedicated device is well tolerated, with no major adverse effect, e.g. on renal function or respiratory mechanics, in critically ill patients admitted to the intensive care unit (ICU), including those with ARDS.

Because the investigators group frequently uses sevoflurane in patients with ARDS and are interested in developing further research on the effects of inhaled sedation in ARDS, the current study has been designed to verify whether the same concept could be applied to the filter the investigators use to vaporize sevoflurane in their ICUs.

study_start_date_type: Anticipated

status: Withdrawn

intervention_type: Biological


title: Longitudinal Exploratory Prospective Evaluation of Clinical Evolution in Patients With Motor Predominant Parkinson Disease.

summary: The objective of this study is the longitudinal prospective clinical evaluation in patients with motor predominant PD; it will assess the individual disease progression (change) of the clinical and imaging parameters measured at 6-month interval over a minimum of 12 months.

status: Suspended

lead_sponsor: BrainEver

location_facility:
Hôpital Henri Mondor
Hôpital Pitié-Salpétrière


title: Deciphering Mechanisms Underlying Cancer Immunogenicity

acronym: DECIDE

summary:
This trial is a translational, open-label, monocentric, prospective cohort study of 900 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors.

The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed for their standard of care at the IUCT-O.

Patients with any of the following tumor types may be enrolled in the trial:

Head and neck cancer,
Ovarian cancer,
Cervical cancer,
Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer),
Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer)

Each tumor type will be considered as an independent cohort.

For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected.

Study participation of each patient will be 5 years.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


title: Utilisation du Dispositif BBloo® Pour le Traitement de l'ictère néonatal : Satisfaction Des Parents et Des Personnels Soignants

summary:
Jaundice occurs in most newborn infants. Most jaundice is benign, but because of the potential toxicity of bilirubin, newborn infants must be monitored to identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or kernicterus. Jaundice is a commonly observed, usually harmless condition in newborn infants during the first week after birth. However, in some babies the amount of bilirubin pigment can increase to dangerous levels and require treatment. Treatment of jaundice in newborn infants is done by placing them under phototherapy, a process of exposing their skin to light of a specific wavelength band. Fluorescent tubes or halogen lamps have been used as light sources for phototherapy for many years. A light-emitting diode (LED) is a newer type of light source which is power efficient, has a longer life and is portable with low heat production. Several technologies and devices are developed around this LED and specially a compact system.

The purpose of this study is to evaluate efficacity of LED phototherapy by comparing with conventional phototherapy (non-LED) and satisfaction of the parents and the professional staff about comfort of this new technology. The newborn infant is placed in a sleeper with the device B' bloo ® which maintains him in position (lap or dorsal) allowing to pass the blue light. This one is generated by the module LED and transmitted in the braid of optical fibers which takes place directly on the mattress of the cradle in which is placed the patient usually.

The device is endowed with an hour counter to schedule the time of treatment. The energy illumination varies between 3 and 4 mW / cm ² for an average 3,6 mW / cm ².

lead_sponsor: Association Pédiatrique des Groupes d'Acuueil et de Recherche

location_facility:
hopital Antoine Béclère
Bicetre Hospital


title: Titration Morphinique autocontrôlée Par le Patient Par un Dispositif mécanique à Usage Unique Versus Administration Par l'infirmière Chez Les Patients Ayant Une Douleur aiguë sévère Aux Urgences.

acronym: TACIDOU

summary:
Intense acute pain is a common reason for Emergency admittance and its management is one of the major public health goals.

In the recommendations formalized experts, it is recommended to use a protocol titration with morphine bolus of 2 mg (for patients less than 60 kg) or 3 mg (for patients over 60 kg) repeated every 5 minutes with a target of the Visual Analog Scale less than or equal to 30.

Despite these specific recommendations and a broad awareness of the teams, management of pain remains to be improved, the major difficulty of morphine titration at the emergency department being the availability of paramedical personnel to perform revaluations and reinjection. Thus, effective analgesia would be obtained in 50% of cases to 30 minutes.

The investigators want to study the self-controlled morphine titration by the patient by a mechanical device for single use (efficacy/safety).

lead_sponsor: University Hospital, Angers

location_facility:
SCHOTTE Thibault
CHOUKROUN Jacques


title: Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica - Controlled Randomized Trial With Double Blind Evaluation

acronym: EPI-AMELIE

summary: In discal sciatica, after failure of medical treatment, the investigators propose frequently a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently, some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of indications of this type of infiltration. An alternative would be to propose a lateral epidural infiltration on contact with conflict.The objective of this study is to compare, in 112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control versus an epidural infiltration of the same corticoid done in lateral on contact of disco radicular conflict on scan control.

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU de Montpellier - Hôpital Lapeyronie
CHU Carémeau


type: EudraCT Number

title: A Phase I, First in Human, Open-label Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

summary:
This Phase 1 Study is an open-label, non-randomized, dose escalation, safety, efficacy, pharmacokinetic, and pharmacodynamic evaluation study of INA03 administered as a single agent IV infusion every 2 weeks to patients ≥18 years of age with R/R AML, MLL, or ALL.

The study will be performed in 2 parts: a Dose Titration for Day 1 study (Part 1) followed by a Dose Escalation Part (Part 2) of INA03 used as monotherapy.

ReferenceCitation: Kell J. Considerations and challenges for patients with refractory and relapsed acute myeloid leukaemia. Leuk Res. 2016 Aug;47:149-60. doi: 10.1016/j.leukres.2016.05.025. Epub 2016 Jun 11. Review.

ReferenceCitation: Döhner H, Dolnik A, Tang L, Seymour JF, Minden MD, Stone RM, Del Castillo TB, Al-Ali HK, Santini V, Vyas P, Beach CL, MacBeth KJ, Skikne BS, Songer S, Tu N, Bullinger L, Dombret H. Cytogenetics and gene mutations influence survival in older patients with acute myeloid leukemia treated with azacitidine or conventional care. Leukemia. 2018 Dec;32(12):2546-2557. doi: 10.1038/s41375-018-0257-z. Epub 2018 Oct 1.

ReferenceCitation: Eleni LD, Nicholas ZC, Alexandros S. Challenges in treating older patients with acute myeloid leukemia. J Oncol. 2010;2010:943823. doi: 10.1155/2010/943823. Epub 2010 Jun 10.

ReferenceCitation: Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Récher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Döhner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.

name: Hôpital Saint Louis, Institut Universitaire d’Hématologie, University Paris Diderot, Paris, France;

family: Dombret

full_name: Hervé Dombret

given: Hervé

name: Peter MacCallum Cancer Centre, East Melbourne, Australia, and University of Melbourne, Parkville, Australia;

family: Seymour

full_name: John F. Seymour

given: John F.

name: Wroclaw Medical University, Wroclaw, Poland;

family: Butrym

full_name: Aleksandra Butrym

given: Aleksandra

name: Medical University of Lodz, Lodz, Poland;

family: Wierzbowska

full_name: Agnieszka Wierzbowska

given: Agnieszka

name: Algemeen Ziekenhuis Sint-Jan, Brugge, Belgium;

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

name: Samsung Medical Center, Seoul, Republic of Korea;

family: Jang

full_name: Jun Ho Jang

given: Jun Ho

family: Kumar

full_name: Rajat Kumar

given: Rajat

name: Barts Health National Health Service Trust, London, United Kingdom;

family: Cavenagh

full_name: James Cavenagh

given: James

name: Princess Margaret Cancer Centre, Toronto, Canada;

family: Schuh

full_name: Andre C. Schuh

given: Andre C.

name: Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine, Italy;

family: Candoni

full_name: Anna Candoni

given: Anna

name: Centre Hospitalier Universitaire de Toulouse, Toulouse, France;

family: Récher

full_name: Christian Récher

given: Christian

name: University of Alberta Hospital, Edmonton, Canada;

family: Sandhu

full_name: Irwindeep Sandhu

given: Irwindeep

name: Hospital Central de Asturias, Oviedo, Spain;

family: Bernal del Castillo

full_name: Teresa Bernal del Castillo

given: Teresa

name: Universitätsklinikum Leipzig, Leipzig, Germany;

family: Al-Ali

full_name: Haifa Kathrin Al-Ali

given: Haifa Kathrin

name: Institute of Hematology and Medical Oncology “L. e A. Seràgnoli,” Bologna, Italy;

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

name: Hospital Universitario Virgen del Rocio/Instituto de BioMedicinia de Sevilla, Sevilla, Spain;

family: Falantes

full_name: Jose Falantes

given: Jose

name: Universitätsklinikum Essen Klinik für Hämatologie, Essen, Germany;

family: Noppeney

full_name: Richard Noppeney

given: Richard

name: Dana-Farber Cancer Institute, Boston, MA;

family: Stone

full_name: Richard M. Stone

given: Richard M.

family: Minden

full_name: Mark D. Minden

given: Mark D.

family: McIntyre

full_name: Heidi McIntyre

given: Heidi

family: Songer

full_name: Steve Songer

given: Steve

family: Lucy

full_name: Lela M. Lucy

given: Lela M.

family: Beach

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

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ReferenceCitation: DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. doi: 10.1056/NEJMoa1716984. Epub 2018 Jun 2.

name: From the University of Texas M.D. Anderson Cancer Center, Houston (C.D.D., H.M.K.); Memorial Sloan Kettering Cancer Center (E.M.S., M.S.T.) and Weill Cornell Medical College (G.J.R.), New York; Institut Gustave Roussy, Villejuif (S.B., C.W.), and Centre Hospitalier Universitaire Bordeaux, Bordeaux (A.P.) — both in France; Northwestern University, Chicago (J.K.A.); Ohio State University Wexner Medical Center, Columbus (A.S.M.); Sylvester Comprehensive Cancer Center, University of Miami, Miami (R.S.);...

title: Durable Remissions with Ivosidenib inIDH1-Mutated Relapsed or Refractory AML

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ReferenceCitation: Kolb HJ, Simoes B, Schmid C. Stem cell transplants for patients with relapsed/refractory leukaemia. Curr Opin Hematol. 2009 Nov;16(6):444-52. doi: 10.1097/MOH.0b013e3283309647. Review.

ReferenceCitation: Wolach O, Stone RM. How I treat mixed-phenotype acute leukemia. Blood. 2015 Apr 16;125(16):2477-85. doi: 10.1182/blood-2014-10-551465. Epub 2015 Jan 20.

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ReferenceCitation: Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010 Nov 4;363(19):1812-21. doi: 10.1056/NEJMoa1002965.

ReferenceCitation: Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11. Review.

name: Department of Pathology, Stanford University, Stanford, CA;

name: Department of Pathology, Weill Cornell Medical College, New York, NY;

name: Department of Pathology, Massachusetts General Hospital, Boston, MA;

name: Institute of Pathology, University of Cologne, Cologne, Germany;

name: Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD;

name: Section of Hematology/Oncology, University of Chicago, Chicago, IL;

name: Comprehensive Cancer Center, James Cancer Hospital and Solove Research Institute, The Ohio State University, Columbus, OH;

name: Department of Molecular Medicine, University of Pavia, and Department of Hematology Oncology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; and

name: Department of Pathology, University of Chicago, Chicago, IL

ReferenceCitation: Han TH, Gopal AK, Ramchandren R, Goy A, Chen R, Matous JV, Cooper M, Grove LE, Alley SC, Lynch CM, O'Connor OA. CYP3A-mediated drug-drug interaction potential and excretion of brentuximab vedotin, an antibody-drug conjugate, in patients with CD30-positive hematologic malignancies. J Clin Pharmacol. 2013 Aug;53(8):866-77. doi: 10.1002/jcph.116. Epub 2013 Jun 10.


title: Randomised Double-blind Evaluation of the Prophylactic Efficacy of Transcranial Direct Current Stimulation (tDCS) in Chronic Migraine

acronym: Medis

summary: The purpose of this study is to determine whether TDCS is an effective prophylactic therapy of chronic migraine.

location_facility:
Hospital of Voiron
Grenoble University Hospital


title: Impact of Multidisciplinary Review of Drug Prescriptions on Patient Safety in a Residence for Dependent Elderly

acronym: Rev-EHPAD

summary: The main objective of the study is to show that the multidisciplinary review of drug prescriptions changes the adverse drug event (ADE) geriatric risk score (according to Trivalle and Ducimetière 2013) for patients living in the Nîmes University Hospital Residence for Dependent Elderly.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier


acronym: TOUPIE

summary:
Idiopathic pulmonary fibrosis (IPF) is one of the most common chronic idiopathic fibrotic interstitial lung disease (ILD). IPF is an evolving disease that requires regular follow-up through clinical examination, respiratory functional investigations and thoracic CT. Thoracic CT is necessary for the follow-up, usually performed yearly, and in case of deterioration of respiratory function. The disadvantages to its realization are the repeated irradiation, the cost, the accessibility, and sometimes the difficulties of realization related to the supine position.

Several signs of thoracic ultrasound have been described in ILD, including the number of B lines, the irregularity of the pleural line, and the thickening of the pleural line. Cross-sectional studies have correlated the intensity of these signs with the severity of fibrosis lesions on chest CT in patients with ILD, including IPF. However, no studies have prospectively described the evolution of ultrasound signs in the same IPF patient, or their correlation to clinical, functional and CT scan evolution.

The hypothesis is that thoracic ultrasound is a relevant tool to highlight the evolution of pulmonary lesions in IPF.

The main objective is to show with thoracic ultrasound an increase in one or more of the ultrasound signs: line B score, pleural line irregularity score, and pleural line thickness during the follow-up of patient with IPF.

The study will enroll patients with a validated diagnosis of IPF in a multidisciplinary staff. At each follow-up visit, patients will have a clinical examination, pulmonary functional test and thoracic ultrasound. The CT data collected will include the last thoracic CT performed in the 3 months before the inclusion and those performed during the patient's participation. The presence, location and severity of ultrasound signs, will be recorded for each patient during successive reassessments and correlation to clinical, functional and CT scan evolution will be made.

This study will add significant knowledge in the study of ultrasound signs evolution in patients with IPF. If there is a correlation with the clinical or CT scores, it will be possible to carry over the realization of the CTs to limit the irradiation of the patients. Conversely, early detection of worsening ultrasound signs may lead to faster therapeutic adjustments to limit the extent of irreversible fibrotic lesions.

ReferenceCitation: Legué S, Marchand-Adam S, Plantier L, Bayeh BA, Morel H, Mangiapan G, Flament T. ThOracic Ultrasound in Idiopathic Pulmonary Fibrosis Evolution (TOUPIE): research protocol of a multicentric prospective study. BMJ Open. 2021 Mar 25;11(3):e039078. doi: 10.1136/bmjopen-2020-039078.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Tours

location_facility: Pulmonology Department, University Hospital, Tours


title: Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women

acronym: VALOBAB-C

summary:
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism.

Polar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids.

The purpose of this research is to study plasma cholesterol variation after daily intake of milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of cheese product during four weeks instead of their usual cheese products.

It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).

ReferenceCitation: Le Barz M, Vors C, Combe E, Joumard-Cubizolles L, Lecomte M, Joffre F, Trauchessec M, Pesenti S, Loizon E, Breyton AE, Meugnier E, Bertrand K, Drai J, Robert C, Durand A, Cuerq C, Gaborit P, Leconte N, Bernalier-Donadille A, Cotte E, Laville M, Lambert-Porcheron S, Ouchchane L, Vidal H, Malpuech-Brugère C, Cheillan D, Michalski MC. Milk polar lipids favorably alter circulating and intestinal ceramide and sphingomyelin species in postmenopausal women. JCI Insight. 2021 May 24;6(10). pii: 146161. doi: 10.1172/jci.insight.146161.

family: Le Barz

full_name: Mélanie Le Barz

given: Mélanie

family: Vors

full_name: Cécile Vors

given: Cécile

family: Combe

full_name: Emmanuel Combe

given: Emmanuel

family: Joumard-Cubizolles

full_name: Laurie Joumard-Cubizolles

given: Laurie

family: Lecomte

full_name: Manon Lecomte

given: Manon

family: Joffre

full_name: Florent Joffre

given: Florent

family: Trauchessec

full_name: Michèle Trauchessec

given: Michèle

family: Pesenti

full_name: Sandra Pesenti

given: Sandra

family: Loizon

full_name: Emmanuelle Loizon

given: Emmanuelle

family: Breyton

full_name: Anne-Esther Breyton

given: Anne-Esther

family: Meugnier

full_name: Emmanuelle Meugnier

family: Bertrand

full_name: Karène Bertrand

given: Karène

family: Drai

full_name: Jocelyne Drai

given: Jocelyne

family: Robert

full_name: Chloé Robert

given: Chloé

family: Durand

full_name: Annie Durand

given: Annie

family: Cuerq

full_name: Charlotte Cuerq

given: Charlotte

family: Gaborit

full_name: Patrice Gaborit

given: Patrice

family: Leconte

full_name: Nadine Leconte

given: Nadine

family: Bernalier-Donadille

full_name: Annick Bernalier-Donadille

given: Annick

family: Cotte

full_name: Eddy Cotte

given: Eddy

family: Laville

full_name: Martine Laville

given: Martine

family: Lambert-Porcheron

full_name: Stéphanie Lambert-Porcheron

given: Stéphanie

family: Ouchchane

full_name: Lemlih Ouchchane

given: Lemlih

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

publisher: American Society for Clinical Investigation

ReferenceCitation: Vors C, Joumard-Cubizolles L, Lecomte M, Combe E, Ouchchane L, Drai J, Raynal K, Joffre F, Meiller L, Le Barz M, Gaborit P, Caille A, Sothier M, Domingues-Faria C, Blot A, Wauquier A, Blond E, Sauvinet V, Gésan-Guiziou G, Bodin JP, Moulin P, Cheillan D, Vidal H, Morio B, Cotte E, Morel-Laporte F, Laville M, Bernalier-Donadille A, Lambert-Porcheron S, Malpuech-Brugère C, Michalski MC. Milk polar lipids reduce lipid cardiovascular risk factors in overweight postmenopausal women: towards a gut sphingomyelin-cholesterol interplay. Gut. 2020 Mar;69(3):487-501. doi: 10.1136/gutjnl-2018-318155. Epub 2019 Jun 12.

location_facility: Université d'Auvergne-Laboratoire de Nutrition Humaine


title: Prospective Evaluation of Bulbar Function in Neuromuscular Patients

acronym: ORDEG

summary: The main objective is prospectively study the upper airways function in an adult population of neuromuscular patients. The main measurement will be the evolution of tongue strength recorded each year during annual clinical evaluation on a 5 years period.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility: Non invasive ventilation Unit - Necker Hospital

location_facility: Home Ventilation Unit, Raymond Poincare Hospital


title: Evaluation of the Impact of Adding Remifentanil to Propofol on the Conditions of the Diagnostic Panendoscopy of the Upper Airway Under General Anesthesia With Tubeless Spontaneous Ventilation.

acronym: ENDOTANIL

summary:
The most important considerations for the general anesthesia in diagnostic panendoscopy of the upper airway is the maintenance of a patient's airway for optimal surgical exposure, adequate ventilation and sufficient depth of anesthesia. Tubeless anesthestic techniques with preserved spontaneous ventilation and total intravenous administration of anesthetic drugs are widely use. Due to its pharmacological profile, propofol anesthesia is often considered as the gold standard for the anesthesia in the diagnostic panendoscopy. Previous studies suggested that adding remifentanil to propofol could improve the conditions for laryngoscopy and tracheal intubation.

The aim of this study is to assess the impact of propofol remifentanil general anesthesia compared to propofol general anesthesia on the conditions of the diagnostic panendoscopy of the upper airway.

ReferenceCitation: Schnider TW, Minto CF, Gambus PL, Andresen C, Goodale DB, Shafer SL, Youngs EJ. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998 May;88(5):1170-82.

ReferenceCitation: Minto CF, Schnider TW, Egan TD, Youngs E, Lemmens HJ, Gambus PL, Billard V, Hoke JF, Moore KH, Hermann DJ, Muir KT, Mandema JW, Shafer SL. Influence of age and gender on the pharmacokinetics and pharmacodynamics of remifentanil. I. Model development. Anesthesiology. 1997 Jan;86(1):10-23.

ReferenceCitation: Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire


title: A Bicentre Retrospective Study of Features and Outcomes of Patients With Reactive Arthritis

summary: The aim of this study is to assess the incidence and the clinical and therapeutic characteristics of reactive arthritis and to compare them with those of a historical cohort. We hypothesised that improved hygiene together with prevention and treatment of sexually transmitted infections may have decreased the incidence of reactive arthritis.

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon

location_facility:
Centre Hospitalier Lyon Sud
CHU de Besançon


title: Non-controlled Prospective Pilot Study Assessing Prognostic Performance of Circulating Tumour DNA Kinetic Analysis for Monitoring Response to Treatment of Metastatic Non-small Cell Lung Cancers

acronym: ELUCID

summary:
In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy.

Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response.

An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Jaafar BENNOUNA
Marie MARCQ


title: Immunoglobulin M (IgM)-Anti-myelin-associated-glycoprotein(MAG) Peripheral Neuropathy Study: From Proper Assessment to Trial Needs - IMAGiNe Study-Lyon/Bicêtre

summary:
There is no international consensus regarding how to assess and treat patients with immunoglobulin M (IgM)-anti-myelin-associated-glycoprotein (MAG) monoclonal gammopathy associated peripheral neuropathy. The purpose of the IMAGiNe study-Lyon/Bicêtre is to prospectively collect standardized clinical data of 25 patients with IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy in order to participate in the international IMAGiNe Study.

The main objective is to describe in detail the various clinical subtypes, clinical course, treatment responses, antibody titers of IgM-anti-MAG monoclonal gammopathy associated peripheral neuropathy using a variety of outcome measures. The obtained observational data will allow the construction of an IgM monoclonal gammopathy associated peripheral neuropathy-specific Rasch-built overall Disability Scale (RODS) that should fulfill all modern clinimetric requirements, including cross-cultural validity. The coordinating centers for the IgM-RODS construction will be the Maastricht University Medical Center and University Medical Center Utrecht, both in the Netherlands.

location_facility: Hospices Civils de Lyon Service Neurologie C, Pathologies Neuromusculaires, Unité 302


title: Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

acronym: MetAlloLip

summary: This study is designed to assess the hypothesis that the lipopolysaccharide (LPS) activity index can be quantified early after transplantation, as well as the the PhosphoLipid Transfer Protein (PLTP) activity and these both biological variables are independent variables for predicting the risk of severe Graft versus Host Disease (GVHD).

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Besançon


title: Monocentric, Prospective, Uncontrolled Pilot Study of Extra Cardiomyocytary Fixation Profile in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography in Patients With Dilated Cardiomyopathy.

summary:
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a promising tool for identification of myocardial inflammation in patients with dilated cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the fixation of FDG in non cardiomyocyte cells in a number of patients with DCM, to specify the frequency and describe the different binding profiles in comparison with MRI data.

Patients will perform an ethologic evaluation of a non ischemic DCM with in a cardiac MRI.

All patients will have with in 4 weeks after the MRI a 18F-fluorodeoxyglucose (FDG) PET. A high fat and low carbohydrate diet and an heparin injection will be prescribed to patients before this FDG PET.

Patients will be identified as FDG+ or FDG -. The clinical status of the patient will be completed by a 12 months evaluation.

lead_sponsor: Nantes University Hospital

location_facility: West Cancerology Institute/Nantes UH : PET plateform


title: Effects of Inspiratory Muscle Training (IMT) on Dyspnea in COPD During Pulmonary Rehabilitation: Randomized Controlled Trial

acronym: EMI II

summary: Demonstrate that IMT associated with a conventional pulmonary rehabilitation program allows a significant improvement of dyspnea in subjects with severe or very severe COPD than a conventional pulmonary rehabilitation program alone.

ReferenceCitation: Beaumont M, Mialon P, Le Ber C, Le Mevel P, Péran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1). pii: 1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.

family: Beaumont

full_name: Marc Beaumont

given: Marc

family: Mialon

full_name: Philippe Mialon

given: Philippe

family: Le Ber

full_name: Catherine Le Ber

given: Catherine

family: Le Mevel

full_name: Patricia Le Mevel

given: Patricia

family: Péran

full_name: Loïc Péran

given: Loïc

family: Meurisse

full_name: Olivier Meurisse

given: Olivier

family: Morelot-Panzini

full_name: Capucine Morelot-Panzini

given: Capucine

family: Dion

full_name: Angelina Dion

given: Angelina

family: Couturaud

full_name: Francis Couturaud

given: Francis

journal_name: European Respiratory Journal

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

version: publishedVersion

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

lead_sponsor: University Hospital, Brest

location_facility: Centre des maladies respiratoires et allergiques - Les Acacias


title: Self Assessment Vs. Expert for Fetal Ultra Sound Biometry Images

acronym: SAVE US

summary:
To improve the quality of fetal ultrasound images, self assessment is less resource consuming than assessment by an expert reviewer, and may be as effective.

To test this hypothesis, we randomize volunteer experienced ultrasonographers into two groups.

One group assess their own images (self assessment). The other group has their images assessed by an expert. Images are audited via the internet in a standardized procedure that generates feedback with recommendation for change.

Three to 6 months later, participants are audited again. If the improvement in image quality turns to be the same in both groups, it will be likely that self assessment is indeed as effective as assessment by an expert reviewer - at least for professionals experienced in fetal ultrasound.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Groupe Hospitalier Pitié Salpetrière
Collège Français d'échographie Foetale


title: Phase 2 Multicentric Open-label Study of Switch From Abacavir/Lamivudine Fixed Dose Combination Plus Nevirapine to Abacavir/Lamivudine/Dolutegravir in Virologically Suppressed HIV-1 Infected Adults

acronym: SWAD

summary: Abacavir/Lamivudine + Nevirapine (ABC/3TC + NVP) is a very effective and well tolerable regimen on the long-term. However this regimen comprises 2 pills per day. Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) offers simplification with a single pill per day with no food constraints, Dolutegravir (DTG) having the advantage over Nevirapine (NVP) of high potency, higher genetic barrier to resistance, with a very good safety profile. The objective of this study is to evaluate the virologic safety (maintenance of virologic suppression) after switching from ABC/3TC + NVP to ABC/3TC/DTG in 50 HIV-1 infected adults with prolonged HIV RNA suppression on ABC/3TC + NVP, as well as clinical and laboratory safety. Because nevirapine is a strong inducer of hepatic enzymes, pharmacocinetic (PK) assessment will be performed in all patients in the first weeks after switch and 24-hours PK in a subset of 10 patients after 5 days of DTG addition to current regimen, before switching to ABC/3TC/DTG.

ReferenceCitation: Dailly E, Allavena C, Grégoire M, Reliquet V, Bouquié R, Billaud E, Hernando H, Bouchez S, Deslandes G, Hall N, Jolliet P, Raffi F. Influence of nevirapine administration on the pharmacokinetics of dolutegravir in patients infected with HIV-1. J Antimicrob Chemother. 2015 Dec;70(12):3307-10. doi: 10.1093/jac/dkv245. Epub 2015 Aug 13.

family: Dailly

full_name: Eric Dailly

given: Eric

family: Allavena

full_name: Clotilde Allavena

given: Clotilde

family: Grégoire

full_name: Matthieu Grégoire

given: Matthieu

family: Reliquet

full_name: Véronique Reliquet

given: Véronique

family: Bouquié

full_name: Régis Bouquié

given: Régis

family: Billaud

full_name: Eric Billaud

family: Hernando

full_name: Hélène Hernando

given: Hélène

family: Bouchez

full_name: Sabelline Bouchez

given: Sabelline

family: Deslandes

full_name: Guillaume Deslandes

given: Guillaume

family: Hall

full_name: Nolwenn Hall

given: Nolwenn

family: Jolliet

full_name: Pascale Jolliet

given: Pascale

family: Raffi

full_name: François Raffi

given: François

journal_name: Journal of Antimicrobial Chemotherapy

oa_colors: green hybrid

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

host_type: repository

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_facility:
Nantes University Hospital
La Roche-sur-Yon Hospital


title: Perineal Consequences of Twin Pregnancies According to Mode of Delivery

acronym: JUMODA-CP

summary:
This is an ancillary study to the "JUMODA" (National Prospective and Comparative Study on the Mode of Delivery of Twins) study: please see NCT01987063.

The main objective of this study is to investigate the role of the mode of delivery (vaginal versus cesarean) as a risk factor for the occurrence of urinary incontinence at 3 months post-delivery in primiparous women delivering twins after 34 weeks of pregnancy.

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: Does Correction of Exercice-induced Desaturation by O2 Improve Systematically Exercise Tolerance in COPD Patients ?

summary:
In the literature, the effects of acute oxygen administration on exercise tolerance and related symptoms have often appeared to be contradictory. Some investigations have reported benefits from acute oxygen supply during exertion, including increased exercise performance, reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have reported no improvement. Recently, we advanced then the hypothesis that some patients would be non-responders and even worsen under oxygen treatment. The preliminary results confirmed our hypothesis since we demonstrated that while 56% of the patients were improved with supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased performance and increased dyspnea during endurance exercise with supplemental oxygen). However, this was a pilot study offering preliminary insights and tentative conclusions that must be confirmed in a larger case series.

The aims of this retrospective study was :

To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy treatment) and non-LTOT patients who exhibit exercise desaturation.
To identify the predictive factors among the clinical data (i.e., anthropometric, spirometric and gazometric data) and/or functional data recorded during rehabilitation program

ReferenceCitation: Héraud N, Préfaut C, Durand F, Varray A. Does correction of exercise-induced desaturation by O(2) always improve exercise tolerance in COPD? A preliminary study. Respir Med. 2008 Sep;102(9):1276-86. doi: 10.1016/j.rmed.2008.04.005. Epub 2008 Jul 10.

lead_sponsor: 5 Santé

location_facility:
Clinique du Souffle La Vallonie
Clinique du Souffle La Solane


title: Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment

acronym: NEORIS

summary:
The main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care.

The study will be divided into 3 parts:

Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine cognitive test. The relationships between cognitive scores and neonatal characteristics will be determined and compared to the results of schoolmates born at term.
The quality of parent and child relationship will be evaluated by a standardized questionnaire allowing the evaluation of persistent stress trauma related to premature birth.
An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.

lead_sponsor: Jean Michel Hascoet

location_facility: M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)


title: Evaluation de l'oxymétrie cérébrale à Deux Niveaux d'Hypothermie thérapeutique après arrêt Cardiaque Extra-hospitalier

acronym: CARBOXHYD

summary:
Cardiac arrest is a major public health problem, with 700 000 cases per year , and a survival ranging from 4 to 33%. The post- anoxic encephalopathy remains the most serious complication with only a third of survivors . It is due to a series of phenomena involving microcirculation disorders . Cerebral oximetry is a new technique to evaluate the microcirculatory status . To this day it is used in cardiovascular surgery at risk of cerebral hypoperfusion where desaturation of cerebral oximetry is synonymous with ischemia and microcirculatory disorders. Therapeutic hypothermia is the only treatment improves the outcome of patients after extra- hospital cardiac arrest resuscitation . Its mechanisms of action seem to change all the phenomena responsible for microcirculatory reperfusion disorders . Currently it is recommended to practice hypothermia between 32 and 34 ° C. However, a recent study suggests a superiority of hypothermia at 32 ° C rather than 34 ° C.

The hypothesis of this study is that cerebral oximetry value will be different in patients subjected to two different levels of therapeutic hypothermia in the aftermath of an extra- hospital cardiac arrest. These data allow a better understanding of the mechanisms underlying the benefit of this technique.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice - Hôpital Saint Roch
CH de Fréjus-Saint Raphael


title: Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes: Study of Insulin Sensitivity in the 2 Types of Treatment

acronym: TRICIDIA

summary:
This is an open multicentre, randomized study to compare two treatment arms. One arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with APIDRA®.

In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU de Dijon
CHU de Besancon


title: Accuracy of Pulse Pressure Variation (Nexfin) and of Pleth Variability Index (Radical 7) to Predict the Response to a Fluid Challenge: Comparison With the Reference Method (Measurement of Stroke Volume by Esophageal Doppler)

summary: The aim of this study is to compare the accuracy of Pleth Variability Index (Radical 7 device) and of Pulse Pressure Variation (Nexfin device) with the Doppler measurement of stroke volume (esophageal Doppler) to detect the response to a fluid challenge.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
Hopital Beaujon


title: RANDOMIZED DOUBLE-BLIND STUDY MULTICENTRIQUE TESTING THE EFFICIENCY OF the METHOTREXATE AT PATIENTS AFFECTED BY GRAVE PELADE (METHOTREXATE VERSUS PLACEBO WITH SECONDARY TREATMENT BY METHOTREXATE and PREDNISONE)

summary: Alopecia areata (AA) is an auto immune disorder. Treatment of severe types remains difficult with a rate of hair regrowth which is lower than 10%. This RCT will assess the safety and efficacy of methotrexate alone or associated with low doses of prednisone versus placebo in the treatment of severe types of AA.

lead_sponsor: University Hospital, Rouen

location_facility:
Head Dermatology Department
CHU de Rouen - Hôpitaux de Rouen


title: Screening for Arteriopathy in General Medicine: a Preliminary Feasibility Study

acronym: DAG

summary: The main objective of this study is to evaluate the inter-observer concordance when measuring the maximum value of the external antero-posterior diameter of the sub-renal aorta (both cross-sectional and longitudinal ultrasound views are measured). The first measure is made by a general practitioner in private practice; second reading are made by an expert in vascular medicine.

time_perspective: Cross-Sectional

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Comparison of the Efficacy of Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation of the Motor Cortex in Patients With Neuropathic Pain Due to Chronic Radiculopathy

summary: The present study aims to compare directly the efficacy of two noninvasive neurostimulation techniques : repetitive transcranial magnetic stimulation and transcranial direct electrical current of the motor cortex in patients with chronic lumbar radiculopathy on pain intensity.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility:
Hôpital Henri Mondor, APHP
Hôpital Ambroise Paré


title: Comparability of Bispectral Index and NeuroSENSE in Aged Patients

summary:
The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA).

Use of such devices is discussed in aged patients. The purpose of this study is to compare Bispectral Index and NeuroSENSE during awake periods and during natural sleep.

location_facility:
Hopital Stell
Hopital Foch


title: Influence of Ketamine on a Closed-Loop Anesthesia System

acronym: LoopKeta

summary: The objective is to evaluate the sparing effect of ketamine on the dose of propofol.

status: Terminated

location_facility:
Clinique Fontaine les Dijons
Hopital Foch


title: Are Sperm Head Vacuoles Associated With Sperm Nuclear Alterations?

acronym: VATES

summary:
In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need to be improved in order to increase the success of assisted reproduction treatments.

The aim of this study is to determine whether the presence of sperm head vacuoles is associated with sperm DNA alterations.

ReferenceCitation: Antinori M, Licata E, Dani G, Cerusico F, Versaci C, d'Angelo D, Antinori S. Intracytoplasmic morphologically selected sperm injection: a prospective randomized trial. Reprod Biomed Online. 2008 Jun;16(6):835-41.

ReferenceCitation: Auger J, Eustache F, Andersen AG, Irvine DS, Jørgensen N, Skakkebaek NE, Suominen J, Toppari J, Vierula M, Jouannet P. Sperm morphological defects related to environment, lifestyle and medical history of 1001 male partners of pregnant women from four European cities. Hum Reprod. 2001 Dec;16(12):2710-7.

ReferenceCitation: Bartoov B, Berkovitz A, Eltes F. Selection of spermatozoa with normal nuclei to improve the pregnancy rate with intracytoplasmic sperm injection. N Engl J Med. 2001 Oct 4;345(14):1067-8.

ReferenceCitation: Bartoov B, Berkovitz A, Eltes F, Kogosovsky A, Yagoda A, Lederman H, Artzi S, Gross M, Barak Y. Pregnancy rates are higher with intracytoplasmic morphologically selected sperm injection than with conventional intracytoplasmic injection. Fertil Steril. 2003 Dec;80(6):1413-9.

ReferenceCitation: Boitrelle F, Ferfouri F, Petit JM, Segretain D, Tourain C, Bergere M, Bailly M, Vialard F, Albert M, Selva J. Large human sperm vacuoles observed in motile spermatozoa under high magnification: nuclear thumbprints linked to failure of chromatin condensation. Hum Reprod. 2011 Jul;26(7):1650-8. doi: 10.1093/humrep/der129. Epub 2011 May 2.

ReferenceCitation: Bonduelle M, Van Assche E, Joris H, Keymolen K, Devroey P, Van Steirteghem A, Liebaers I. Prenatal testing in ICSI pregnancies: incidence of chromosomal anomalies in 1586 karyotypes and relation to sperm parameters. Hum Reprod. 2002 Oct;17(10):2600-14.

ReferenceCitation: Figueira Rde C, Braga DP, Setti AS, Iaconelli A Jr, Borges E Jr. Morphological nuclear integrity of sperm cells is associated with preimplantation genetic aneuploidy screening cycle outcomes. Fertil Steril. 2011 Mar 1;95(3):990-3. doi: 10.1016/j.fertnstert.2010.11.018. Epub 2010 Dec 4.

ReferenceCitation: Foresta C, Garolla A, Bartoloni L, Bettella A, Ferlin A. Genetic abnormalities among severely oligospermic men who are candidates for intracytoplasmic sperm injection. J Clin Endocrinol Metab. 2005 Jan;90(1):152-6. Epub 2004 Oct 27.

ReferenceCitation: Franco JG Jr, Baruffi RL, Mauri AL, Petersen CG, Oliveira JB, Vagnini L. Significance of large nuclear vacuoles in human spermatozoa: implications for ICSI. Reprod Biomed Online. 2008 Jul;17(1):42-5.

ReferenceCitation: Franco JG Jr, Mauri AL, Petersen CG, Massaro FC, Silva LF, Felipe V, Cavagna M, Pontes A, Baruffi RL, Oliveira JB, Vagnini LD. Large nuclear vacuoles are indicative of abnormal chromatin packaging in human spermatozoa. Int J Androl. 2012 Feb;35(1):46-51. doi: 10.1111/j.1365-2605.2011.01154.x. Epub 2011 Apr 28.

ReferenceCitation: Garolla A, Fortini D, Menegazzo M, De Toni L, Nicoletti V, Moretti A, Selice R, Engl B, Foresta C. High-power microscopy for selecting spermatozoa for ICSI by physiological status. Reprod Biomed Online. 2008 Nov;17(5):610-6.

ReferenceCitation: Hazout A, Dumont-Hassan M, Junca AM, Cohen Bacrie P, Tesarik J. High-magnification ICSI overcomes paternal effect resistant to conventional ICSI. Reprod Biomed Online. 2006 Jan;12(1):19-25.

ReferenceCitation: Oliveira JB, Massaro FC, Baruffi RL, Mauri AL, Petersen CG, Silva LF, Vagnini LD, Franco JG Jr. Correlation between semen analysis by motile sperm organelle morphology examination and sperm DNA damage. Fertil Steril. 2010 Oct;94(5):1937-40. doi: 10.1016/j.fertnstert.2010.01.042. Epub 2010 Mar 2.

ReferenceCitation: Perdrix A, Travers A, Chelli MH, Escalier D, Do Rego JL, Milazzo JP, Mousset-Siméon N, Macé B, Rives N. Assessment of acrosome and nuclear abnormalities in human spermatozoa with large vacuoles. Hum Reprod. 2011 Jan;26(1):47-58. doi: 10.1093/humrep/deq297. Epub 2010 Nov 18.

ReferenceCitation: Van Steirteghem A, Bonduelle M, Devroey P, Liebaers I. Follow-up of children born after ICSI. Hum Reprod Update. 2002 Mar-Apr;8(2):111-6. Review.

ReferenceCitation: Vanderzwalmen P, Hiemer A, Rubner P, Bach M, Neyer A, Stecher A, Uher P, Zintz M, Lejeune B, Vanderzwalmen S, Cassuto G, Zech NH. Blastocyst development after sperm selection at high magnification is associated with size and number of nuclear vacuoles. Reprod Biomed Online. 2008 Nov;17(5):617-27.

ReferenceCitation: Watanabe S, Tanaka A, Fujii S, Mizunuma H, Fukui A, Fukuhara R, Nakamura R, Yamada K, Tanaka I, Awata S, Nagayoshi M. An investigation of the potential effect of vacuoles in human sperm on DNA damage using a chromosome assay and the TUNEL assay. Hum Reprod. 2011 May;26(5):978-86. doi: 10.1093/humrep/der047. Epub 2011 Feb 28.

ReferenceCitation: Wilding M, Coppola G, di Matteo L, Palagiano A, Fusco E, Dale B. Intracytoplasmic injection of morphologically selected spermatozoa (IMSI) improves outcome after assisted reproduction by deselecting physiologically poor quality spermatozoa. J Assist Reprod Genet. 2011 Mar;28(3):253-62. doi: 10.1007/s10815-010-9505-5. Epub 2010 Nov 12.

location_facility: Laboratoire de Biologie de la Reproduction - CECOS - EA 4308, CHU - Hôpitaux de Rouen

location_facility: Laboratoire de spermiologie, CHRU de Lille


title: Collection d'échantillons Biologiques Humains de Sujets Sains et Malades Pour la Mise au Point et la Validation de Nouvelles méthodes de Diagnostic et Pour la réalisation d'Expertises Dans le Domaine Des Maladies Infectieuses et Tropicales

acronym: Diagmicoll

summary: Direct constitution of collections from various samples taken on a prospective cohort of healthy volunteers, to prepare human biological samples of known characteristics (biochemical and serological in particular) and quality controlled.

ReferenceCitation: Pajot A, Michel ML, Mancini-Bourgine M, Ungeheuer MN, Ojcius DM, Deng Q, Lemonnier FA, Lone YC. Identification of novel HLA-DR1-restricted epitopes from the hepatitis B virus envelope protein in mice expressing HLA-DR1 and vaccinated human subjects. Microbes Infect. 2006 Oct;8(12-13):2783-90. Epub 2006 Sep 12.

ReferenceCitation: Buffet PA, Milon G, Brousse V, Correas JM, Dousset B, Couvelard A, Kianmanesh R, Farges O, Sauvanet A, Paye F, Ungeheuer MN, Ottone C, Khun H, Fiette L, Guigon G, Huerre M, Mercereau-Puijalon O, David PH. Ex vivo perfusion of human spleens maintains clearing and processing functions. Blood. 2006 May 1;107(9):3745-52. Epub 2005 Dec 29.

ReferenceCitation: Launay O, Toneatti C, Bernède C, Njamkepo E, Petitprez K, Leblond A, Larnaudie S, Goujon C, Ungeheuer MN, Ajana F, Raccurt C, Beytout J, Chidiac C, Bouhour D, Guillemot D, Guiso N. Antibodies to tetanus, diphtheria and pertussis among healthy adults vaccinated according to the French vaccination recommendations. Hum Vaccin. 2009 May;5(5):341-6. Epub 2009 May 9.

ReferenceCitation: Taneja N, Nato F, Dartevelle S, Sire JM, Garin B, Thi Phuong LN, Diep TT, Shako JC, Bimet F, Filliol I, Muyembe JJ, Ungeheuer MN, Ottone C, Sansonetti P, Germani Y. Dipstick test for rapid diagnosis of Shigella dysenteriae 1 in bacterial cultures and its potential use on stool samples. PLoS One. 2011;6(10):e24830. doi: 10.1371/journal.pone.0024830. Epub 2011 Oct 3.

ReferenceCitation: Azimi-Nezhad M, Lambert D, Ottone C, Perrin C, Chapel C, Gaillard G, Pfister M, Masson C, Tabone E, Betsou F, Meyronet D, Ungeheuer MN, Siest SV. Influence of pre-analytical variables on VEGF gene expression and circulating protein concentrations. Biopreserv Biobank. 2012 Oct;10(5):454-61. doi: 10.1089/bio.2012.0016.

ReferenceCitation: Berthet N, Paulous S, Coffey LL, Frenkiel MP, Moltini I, Tran C, Matheus S, Ottone C, Ungeheuer MN, Renaudat C, Caro V, Dussart P, Gessain A, Desprès P. Resequencing microarray method for molecular diagnosis of human arboviral diseases. J Clin Virol. 2013 Mar;56(3):238-43. doi: 10.1016/j.jcv.2012.10.022. Epub 2012 Dec 7.

ReferenceCitation: Duran C, Nato F, Dartevelle S, Thi Phuong LN, Taneja N, Ungeheuer MN, Soza G, Anderson L, Benadof D, Zamorano A, Diep TT, Nguyen TQ, Nguyen VH, Ottone C, Bégaud E, Pahil S, Prado V, Sansonetti P, Germani Y. Rapid diagnosis of diarrhea caused by Shigella sonnei using dipsticks; comparison of rectal swabs, direct stool and stool culture. PLoS One. 2013 Nov 22;8(11):e80267. doi: 10.1371/journal.pone.0080267. eCollection 2013.

ReferenceCitation: Frémond ML, Pérot P, Muth E, Cros G, Dumarest M, Mahlaoui N, Seilhean D, Desguerre I, Hébert C, Corre-Catelin N, Neven B, Lecuit M, Blanche S, Picard C, Eloit M. Next-Generation Sequencing for Diagnosis and Tailored Therapy: A Case Report of Astrovirus-Associated Progressive Encephalitis. J Pediatric Infect Dis Soc. 2015 Sep;4(3):e53-7. doi: 10.1093/jpids/piv040. Epub 2015 Jul 12.

ReferenceCitation: Vayssier-Taussat M, Cosson JF, Degeilh B, Eloit M, Fontanet A, Moutailler S, Raoult D, Sellal E, Ungeheuer MN, Zylbermann P. How a multidisciplinary 'One Health' approach can combat the tick-borne pathogen threat in Europe. Future Microbiol. 2015;10(5):809-18. doi: 10.2217/fmb.15.15. Review.

ReferenceCitation: Neven B, Pérot P, Bruneau J, Pasquet M, Ramirez M, Diana JS, Luzi S, Corre-Catelin N, Chardot C, Moshous D, Leclerc Mercier S, Mahlaoui N, Aladjidi N, Le Bail B, Lecuit M, Bodemer C, Molina TJ, Blanche S, Eloit M. Cutaneous and Visceral Chronic Granulomatous Disease Triggered by a Rubella Virus Vaccine Strain in Children With Primary Immunodeficiencies. Clin Infect Dis. 2017 Jan 1;64(1):83-86. Epub 2016 Oct 6. Erratum in: Clin Infect Dis. 2017 May 1;64(9):1297.

ReferenceCitation: Guet-Revillet H, Jais JP, Ungeheuer MN, Coignard-Biehler H, Duchatelet S, Delage M, Lam T, Hovnanian A, Lortholary O, Nassif X, Nassif A, Join-Lambert O. The Microbiological Landscape of Anaerobic Infections in Hidradenitis Suppurativa: A Prospective Metagenomic Study. Clin Infect Dis. 2017 Jul 15;65(2):282-291. doi: 10.1093/cid/cix285.

ReferenceCitation: Charlier C, Perrodeau É, 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.

family: Charlier

full_name: Caroline Charlier

given: Caroline

family: Perrodeau

full_name: Élodie Perrodeau

given: Élodie

family: Leclercq

full_name: Alexandre Leclercq

given: Alexandre

family: Cazenave

full_name: Benoît Cazenave

given: Benoît

family: Pilmis

full_name: Benoît Pilmis

family: Henry

full_name: Benoît Henry

family: Lopes

full_name: Amanda Lopes

given: Amanda

family: Maury

full_name: Mylène M Maury

given: Mylène M

family: Moura

full_name: Alexandra Moura

given: Alexandra

family: Goffinet

full_name: François Goffinet

family: Dieye

full_name: Hélène Bracq Dieye

given: Hélène Bracq

family: Thouvenot

full_name: Pierre Thouvenot

given: Pierre

family: Ungeheuer

full_name: Marie-Noëlle Ungeheuer

given: Marie-Noëlle

family: Tourdjman

full_name: Mathieu Tourdjman

given: Mathieu

family: Goulet

full_name: Véronique Goulet

family: de Valk

full_name: Henriette de Valk

given: Henriette

family: Lortholary

full_name: Olivier Lortholary

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Lecuit

full_name: Marc Lecuit

given: Marc

family: Hausfater

full_name: Pierre Hausfater

full_name: Vincent Cailleaux Pierre-Etienne Cailleux

full_name: Christine Chandesris Joséphine Chapalain-Cagnon

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

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

ReferenceCitation: Belizna C, Stojanovich L, Cohen-Tervaert JW, Fassot C, Henrion D, Loufrani L, Nagy G, Muchardt C, Hasan M, Ungeheuer MN, Arnaud L, Alijotas-Reig J, Esteve-Valverde E, Nicoletti F, Saulnier P, Godon A, Reynier P, Chrétien JM, Damian L, Omarjee L, Mahé G, Pistorius MA, Meroni PL, Devreese K. Primary antiphospholipid syndrome and antiphospholipid syndrome associated to systemic lupus: Are they different entities? Autoimmun Rev. 2018 Aug;17(8):739-745. doi: 10.1016/j.autrev.2018.01.027. Epub 2018 Jun 6. Review.

ReferenceCitation: Belizna C, Pregnolato F, Abad S, Alijotas-Reig J, Amital H, Amoura Z, Andreoli L, Andres E, Aouba A, Apras Bilgen S, Arnaud L, Bienvenu B, Bitsadze V, Blanco P, Blank M, Borghi MO, Caligaro A, Candrea E, Canti V, Chiche L, Chretien JM, Cohen Tervaert JW, Damian L, Delross T, Dernis E, Devreese K, Djokovic A, Esteve-Valverde E, Favaro M, Fassot C, Ferrer-Oliveras R, Godon A, Hamidou M, Hasan M, Henrion D, Imbert B, Jeandel PY, Jeannin P, Jego P, Jourde-Chiche N, Khizroeva J, Lambotte O, Landron C, Latino JO, Lazaro E, de Leeuw K, Le Gallou T, Kiliç L, Limper M, Loufrani L, Lubin R, Magy-Bertrand N, Mahe G, Makatsariya A, Martin T, Muchardt C, Nagy G, Omarjee L, Van Paasen P, Pernod G, Perrinet F, Pïres Rosa G, Pistorius MA, Ruffatti A, Said F, Saulnier P, Sene D, Sentilhes L, Shovman O, Sibilia J, Sinescu C, Stanisavljevic N, Stojanovich L, Tam LS, Tincani A, Tollis F, Udry S, Ungeheuer MN, Versini M, Cervera R, Meroni PL. HIBISCUS: Hydroxychloroquine for the secondary prevention of thrombotic and obstetrical events in primary antiphospholipid syndrome. Autoimmun Rev. 2018 Dec;17(12):1153-1168. doi: 10.1016/j.autrev.2018.05.012. Epub 2018 Oct 12. Review.

location_facility:
Institut Pasteur
Centre d'infectiologie, hopitale Necker


title: Benefit of MRI and 18F-FDG PET Imaging in the Early Diagnosis of Alzheimer-like Dementia

summary:
The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. Early detection of the disease is a major challenge to hope to slow or even stop the neurodegenerative process before the stage of dementia.

In AD the investigators observe:

A reduction in the volume of brain hippocampi associated with an alteration of the diffusion of water molecules in the white matter.
A structural brain degeneration coupled with a decrease in cerebral glucose metabolism.

Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that aim,the investigators use two imaging modalities:

Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain
Positron emission tomography (PET) is used to assess glucose metabolism in grey/white matter and also in choroid plexus.

The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be altered as well as glucose metabolism dynamic in choroid plexus.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Rouen
CHU Amiens


title: Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery

acronym: ThoTem

summary: Controlling hypothermia is essential in anesthesia to limit postoperative complications. Temperature monitoring is therefore essential. However, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature.

ReferenceCitation: Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8. Review.

ReferenceCitation: Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. Review.

ReferenceCitation: Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15.

ReferenceCitation: Melling AC, Ali B, Scott EM, Leaper DJ. Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial. Lancet. 2001 Sep 15;358(9285):876-80. Erratum in: Lancet 2002 Mar 9;359(9309):896.

ReferenceCitation: Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34.

ReferenceCitation: Winkler M, Akça O, Birkenberg B, Hetz H, Scheck T, Arkiliç CF, Kabon B, Marker E, Grübl A, Czepan R, Greher M, Goll V, Gottsauner-Wolf F, Kurz A, Sessler DI. Aggressive warming reduces blood loss during hip arthroplasty. Anesth Analg. 2000 Oct;91(4):978-84.

ReferenceCitation: Scott AV, Stonemetz JL, Wasey JO, Johnson DJ, Rivers RJ, Koch CG, Frank SM. Compliance with Surgical Care Improvement Project for Body Temperature Management (SCIP Inf-10) Is Associated with Improved Clinical Outcomes. Anesthesiology. 2015 Jul;123(1):116-25. doi: 10.1097/ALN.0000000000000681.

ReferenceCitation: Niven DJ, Gaudet JE, Laupland KB, Mrklas KJ, Roberts DJ, Stelfox HT. Accuracy of peripheral thermometers for estimating temperature: a systematic review and meta-analysis. Ann Intern Med. 2015 Nov 17;163(10):768-77. doi: 10.7326/M15-1150. Review.

ReferenceCitation: Robinson J, Charlton J, Seal R, Spady D, Joffres MR. Oesophageal, rectal, axillary, tympanic and pulmonary artery temperatures during cardiac surgery. Can J Anaesth. 1998 Apr;45(4):317-23.

ReferenceCitation: Göbölös L, Philipp A, Ugocsai P, Foltan M, Thrum A, Miskolczi S, Pousios D, Khawaja S, Budra M, Ohri SK. Reliability of different body temperature measurement sites during aortic surgery. Perfusion. 2014 Jan;29(1):75-81. doi: 10.1177/0267659113497228. Epub 2013 Jul 17.

ReferenceCitation: Rau B, Hünerbein M, Barth C, Schlag PM. [Thoracoscopy is a reliable alternative to thoracotomy in peripheral lung coin lesion]. Langenbecks Arch Chir Suppl Kongressbd. 1997;114:1280-2. German.

ReferenceCitation: Mekjavić IB, Rempel ME. Determination of esophageal probe insertion length based on standing and sitting height. J Appl Physiol (1985). 1990 Jul;69(1):376-9.

location_facility: Department of Anesthesiology - Surgical Intensive Care II, University Hospital, Tours

location_facility: Department of Anesthesiology - Surgical Intensive Care, University Hospital, Nîmes


title: Feasibility Study for the Realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for Identification of Early Recurrence in Patients Treated With Radiotherapy for Glioblastoma

acronym: PAraDiGM

summary:
This study is a non-randomized, prospective, multicentric feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma.

Patients with a MRI performed since the end of the radiotherapy until 12 months of follow up after the end of radiotherapy, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT, whatever the conclusion of the MRI (post radiation modifications, relapse or doubtful MRI).

The rationale of doing 68Ga-PSMA and 18F-FDOPA brain PET-CT in each case will be discussed in detail with the referring physician and an informed consent will be taken from each patient for the study. The two imaging studies will be done at least with a gap of 6 hours, using the same PET-CT scanner.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Berard
Hôpital Pierre WERTHEIMER - HCL

intervention_type: Diagnostic Test


title: Detection of Circulating Tumor DNA by a Personalized Molecular Tool During Treatment of Locally Advanced Operable Head and Neck Squamous Cell Carcinoma

acronym: PERSO-NECK

summary:
Locally advanced head and neck squamous cell carcinoma (LAHNSCC) is a heterogeneous disease, associated with a poor prognosis and no improvement in overall survival for years. Furthermore, treatments (surgery, radiotherapy, chemotherapy) are frequently associated with acute and late toxicities. Beside p16/HPV + tumors, only TNM classification can help estimating the prognosis of the patients. A better evaluation of the prognosis and of the risk of metastatic spread would help defining the best treatment.

Circulating tumor DNA (ctDNA) has been reported as both a prognostic factor and a non-invasive way to assess tumor relapse in several cancer types. Few data are available in HNSCC, and no data among p16/HPV- cancers. Indeed, ctDNA assessment is usually based on tumor mutation monitoring. But if recurrent mutations are frequent in several cancers types (PIK3CA, KRAS, ESR1, TERT…), there is no recurrent mutation observed in HNSCC. Thus ctDNA assessment in LAHNSCC must be performed after the identification of a tumor specific mutation for each patient.

In that context, the aim of this study is to perform a molecular analysis of primary LAHNSCC, and to look for the amount of ctDNA before surgery, after surgery, and during 18 months of follow up.

lead_sponsor: Centre Henri Becquerel

location_facility:
Centre Henri Becquerel
CHU


title: Role of the Neonatal Fc Receptor for IgG in the Pathophysiology of Lupus

acronym: RFPL

summary: This study evaluates the expression of the neonatal fc receptor (FcRn) in white blood cells and antigen-presenting cells (APC) in active lupus patients compared to inactive lupus patients and control to investigate if it's upregulated or not.

lead_sponsor: University Hospital, Tours

location_facility: Internal Medicine Service, University Hospital, Tours

location_facility: Nephrology Service, University Hospital, Tours