title: Determinants of the Recovery of Diaphragm Dysfunction in Patients With Prolonged Mechanical Ventilation

acronym: DD-SRPR

summary: The transition to unassisted breathing after invasive ventilation often proves challenging. Persistent ventilator dependence predisposes patients to nosocomial complications and death and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. At the same time, many ventilator-dependent patients exhibit striking loss of respiratory pump capacity due to diaphragm dysfunction which predisposes to prolonged ventilator dependence. Diaphragm dysfunction is common in ventilated patients. By prolonging ventilator dependence it may be an important contributor to the poor long-term clinical and functional outcomes of survivors of critical illness. While some main risk factors for diaphragm dysfunction have been already described (diaphragm disuse induced by mechanical ventilation, sepsis, initial severity upon admission), the determinants of recovery of diaphragm dysfunction are unknown, as well it has not been elucidated whether diaphragm function can simply improve after the acute phase of ICU admission. Therefore, the goal of this study is to investigate the time course evolution of diaphragm function in patients exposed to prolonged duration of mechanical ventilation (i.e. in a weaning center) and to determine which factors are associated with an improvement of the diaphragm function leading to a safe mechanical ventilation discontinuation.


title: Biology of Cerebral Arteriovenous Malformations : Study of the Link Between Blood Biomarkers and the Haemorrhagic Prognosis of Cerebral Arteriovenous Malformations

acronym: BioMAV

summary:
The cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation.

The cerebral arteriovenous malformations are an important cause of hemorrhagic stroke.

The hypothesis is that cerebral haemorrhage associated with a cerebral arteriovenous malformations would come from peri-nidal micro-vessels, in connection with infiltration of leucocytes and / or defective maintenance of microvascular integrity by platelets.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Mutual Interactions Between Absence Epilepsy Seizures and the Integration of Sensory Stimuli

acronym: Absence SLI

summary: Epileptic seizures arise from neuronal defects that often alter the capacity of the brain to process sensory information. During absence seizures, a frequent epileptic syndrome in children, the normal conscious and perceptual processes are temporarily interrupted. This is the result of abnormal synchronized neural activities in the thalamo-cortical loops, leading to bilateral spike-and-wave discharges (SWDs) in the cortical electroencephalograms (EEGs). The brain mechanisms underlying the lack of sensory experience during absence seizures are disputed. Based on preliminary data, the investigators hypothesize that the alternation of 'spike' and 'wave' patterns during seizure could cause a time-to-time inconstancy in cortical responsiveness, preventing conscious perception. Using a real-time closed-loop stimulation system, the investigators will research how the S- and W-patterns specifically alter the sensory-evoked responses in the EEG. During a standard EEG, visual stimulations will be applied between and during absence seizures to test the hypothesis that repeated sensory stimuli, applied with an appropriate timing relative to the seizure-related oscillatory cycle, could negatively interfere with the regenerative network mechanisms involved in the occurrence of SWDs. The completion of this project should permit to unveil a new neuronal mechanism supporting the lack of conscious experience during absences and pave the way for new clinical non-invasive strategies to interrupt ongoing seizure activity.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

intervention_type: Procedure

status_simplified: Unknown


acronym: Phase 1

summary: Overview of response rate published in recent oncology phase I trials

status: Completed

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Chakiba C, Grellety T, Bellera C, Italiano A. Encouraging Trends in Modern Phase 1 Oncology Trials. N Engl J Med. 2018 Jun 7;378(23):2242-2243. doi: 10.1056/NEJMc1803837.

ipd_sharing: No

lead_sponsor: Institut Bergonié

intervention_type: Other

status_simplified: Completed


title: International Consensus Process to Provide Guidelines for the Definition of Efficacy Endpoints to Assess Treatment Efficacy in Randomized Controlled Trials in Elderly Cancer Patients

acronym: DATECANelderly

summary:
Context and hypothesis: In cancer randomized controlled trials (RCT), the validated and most objective criterion to assess treatment efficacy is overall survival (OS). In the elderly population, OS presents limitations as it can be affected by factors other than treatment such as comorbidity or severe toxicity. Although mortality reduction is important for patients of all ages, alternative outcomes such as the ability to live independently or with a better quality of life, may be more important for older patients.

Reviews of RCT have highlighted (i) the heterogeneity of such alternative efficacy outcomes and (ii) an absence of standardized definitions for these endpoints. As a result, this may limit the quality of RCT as well as the comparison of results across trials. Our objective is to provide guidelines for standardized definitions of such alternative endpoints to assess treatment efficacy in cancer RCT in elderly populations.

The development of guidelines will follow a formal consensus method (questionnaires + in-person meetings). A large panel of international experts will participate.

Guidelines are awaited due to the heterogeneity of endpoints and absence of standardized definitions. Standardizing definitions will improve the quality and design of future trials and enhance comparison between trials.

status: Active, not recruiting


type: Other Identifier

title: GRAFted Patients' anxieTY Report (GRAFTY)

acronym: GRAFTY

summary: Autograft is a technique requiring several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. In this study, level of anxiety will be reported weekly throughout hospitalizations for autologous transplant, to detect the most stressful period.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Exercise and Baseline Respiratory Functional Tests Among Obese Teenagers

acronym: EFRADO

summary:
In obese adolescents, the severity of obesity should not influence the outcome of resting PFT. The amplitudes of the rest PFT should make it possible to predict the performance achieved while exercising on a cycloergometer.

We wish to highlight the presence of a significant correlation, probably low, between some respiratory parameters at rest, and cardio-vascular parameters at the exercise.

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire de Besancon

lead_sponsor_type: academique


title: Midline Catheter and Its Impact on Central Lines Removal in ICU

acronym: MIDREA

summary: The study will evaluate 2 strategies to remove central venous catheter (CVC): in one part, the insertion of a midline catheter and in the other part, the conventional insertion of peripheral venous catheter (PVC)

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Departemental Vendee

intervention_type: Device


title: Status of Superficial Esophageal Cancers Treated by Endoscopy

acronym: OESOFARE

summary:
In 2013, esophageal cancer was the 9th cause of cancer in the world and the 6th in terms of cancer mortality. The prognosis of this cancer varies according to geographical areas, but in Europe and the USA, the 5-year survival rate has risen from less than 5% in the 1960s to around 20% in the 2000s. In the United States, however, the survival rate has risen from 5% in the 1960s to around 20% in the 2000s.

Increased the detection of premalignant lesions and early stages may improve prognosis. The presence of esophageal cancer is determined by endoscopy, biopsy and histological confirmation. However, endoscopic techniques (mucosectomy and sub mucosal dissection) are also used as curative treatment for early esophageal lesions.

Now, due to the low number of diagnoses of esophageal tumours at the superficial stage, few studies are available in Europe on the efficacy of these endoscopic techniques and on the complications resulting from their use. Similarly, little is known about the complications of endoscopic techniques and about therapeutic strategies for managing these superficial lesions. In particular, no data are available concerning the adequacy between the treatment proposed in multidisciplinary consultation meetings and the actual management of patients.

Our study is therefore fundamental to make an inventory of superficial esophageal cancers treated by endoscopy, and their management

lead_sponsor: Nantes University Hospital


title: Test and Optimization of New Specific MRI Sequences on an Imager Dedicated to Research

acronym: SEQ-IRM

summary: Magnetic Resonance Imaging (MRI) performance depends on equipment performance, equipment maintenance and relevance of MRI sequence used. To optimize MRI performance, it's necessary to develop, optimize, test and validate new acquisition sequences for enhanced diagnosis and therapy monitoring. These new sequences will allow better spatial resolution and specificity while reducing acquisition time.

primary_purpose: Other

lead_sponsor: University Hospital, Bordeaux


title: Impairment of the Cognitive Flow in the Development of a Depressive Disorder and Suicidal Ideas

acronym: AQUARIUM

summary: The study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients.

lead_sponsor: Centre Hospitalier René Dubos

intervention_type: Behavioral


title: Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology

acronym: HYP-ANGE

summary:
This study highlights the global management of the various components of outpatient pain by hypnoanalgesia (pain management by hypnosis) in radiopediatrics.

Indeed, pain is induced by sclerosis of cutaneous angiomas in interventional radiology. It is managed by MEOPA (an equimolar mixture of oxygen nitrous oxide) or by general anesthesia.

For four years, the medical electroradiology technologist of the Mother and Child Hospital (HFME) of the Hospices Civils de Lyon offer patients in addition a pain management by hypnoanalgesia.

The investigator propose a multicenter open randomized study comparing two pain management strategies, in children aged 7 to 18 years treated for cutaneous angioma by sclerosis in interventional radiology at the HFME. The two strategies studied are: Hypnoanalgesia and MEOPA (the reference strategy).

The main objective is to evaluate the efficacy of hypnoanalgesia compared to the standard of care of pain, which is the use of MEOPA, in the treatment of sclerosis of cutaneous angioma in pediatric interventional radiology.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon


title: Study on the Prevalence of a Localized or Diffuse Pruritus in a Population With One or Several, Primitive or Secondary, Brain Tumor(s)

acronym: PRURI-C

summary: The association between the presence of pruritus, especially centrofacial, and the presence of a brain tumor is a widespread notion in the medical community but based on a single publication by Andreev et al. in the British Journal of Dermatology published in 1975. No other study has studied this association with a rigorous methodology. The aim of this study is to evaluate the prevalence of pruritus in patients with one or more primary or secondary brain tumor(s), benign(s) or malignant(s).

lead_sponsor: University Hospital, Brest


title: Cognitive Control Training in Online Problem Gambling: an Online Randomized Controlled Trial Among Non-treatment Seeking Problem Gamblers

acronym: TRAIN-ONLINE

summary: An online single blinding, randomized, comparative therapeutic web-based, controlled trial. The main objective of the study is to assess the clinical efficacy of an online computerized cognitive training program targeted on cognitive control, namely on inhibition, measured with the PGSI-recent, a modified version of Problem Gambling Severity Index (PGSI) with a 30 days recall period in patients with problem gambling, at 6 weeks, as compared to a control program with a similar setting.

ReferenceType: derived

ReferenceCitation: Santiago A, Carré A, Miranda R, Lemogne C, LeStrat Y, Benyamina A, Perney P, Luquiens A. Study protocol for an online randomised controlled trial among non-treatment seeking problem gamblers: training inhibition in online problem gambling (TRAIN-online) trial. BMJ Open. 2021 Nov 30;11(11):e051641. doi: 10.1136/bmjopen-2021-051641.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Prognostic Value of Cardiac Output Measured by Impedancemetry in Patients Monitored for Pulmonary Hypertension

acronym: HPepic

summary: Monocentric cohort study, prospective, evaluating the variability of cardiac output measurement by resting and stress impedancemetry as a prognostic factor for Pulmonary Hypertension

primary_purpose: Prevention

lead_sponsor: University Hospital, Toulouse


title: Evaluation of Oxygenation Methods and Non-invasive Ventilatory Support in Patients With Acute Respiratory Failure for Whom a Do-not Intubate Order Was Taken: Prospective Observational Study

acronym: OXYPAL

summary: ICU care of patients considered "palliative" but without contraindications to admission to intensive care, for whom a do-not intubate order decision was made upon admission represents a particular target for non-invasive oxygenation techniques. The benefits of non invasive ventilation (NIV) in this population are debated especially in cancer patients. The more recently used nasal humidified high flux canula oxygenation (HFNC) therapy may have benefits over NIV in these patients. It is supposed to have better tolerance and could allow better compliance and thus higher efficiency. These potential benefits are major for such a population for which tolerance and symptomatic relief are priority goals

ReferenceCitation: Robert R, Frasca D, Badin J, Girault C, Guitton C, Djibre M, Beuret P, Reignier J, Benzekri-Llefevre D, Demiri S, Rahmani H, Argaud LA, I'her E, Ehrmann S, Lesieur O, Kuteifan K, Thouy F, Federici L, Thevenin D, Contou D, Terzi N, Nseir S, Thyrault M, Vinsonneau C, Audibert J, Masse J, Boyer A, Guidet B, Chelha R, Quenot JP, Piton G, Aissaoui N, Thille AW, Frat JP. Comparison of high-flow nasal oxygen therapy and non-invasive ventilation in ICU patients with acute respiratory failure and a do-not-intubate orders: a multicentre prospective study OXYPAL. BMJ Open. 2021 Feb 12;11(2):e045659. doi: 10.1136/bmjopen-2020-045659.

lead_sponsor: Poitiers University Hospital


title: Sensors for HEalth Recording and Physical Activity Monitoring

acronym: SHERPAM

summary: The SHERPAM project is part of a scientific and technological context which aim is to record, transmit, analyse the physiological parameters of a patient, as well as to record the feedback to the patient and health professional to suggest the best individualised attitude. The questions of SHERPAM are generic. However, two specific applications will be addressed, in which the partners have already acquired some expertise: the recognition and quantification of physical activity with energy expenditure estimation, and the assessment of walking ability in patients with obliterative vascular disease in the lower limbs. Another application concerns the monitoring of the practice of physical activity and some biological signs in subjects with cardiovascular risk and in cardiac patients (arrhythmogenic diseases). Despite various clinical contexts and health goals, a common approach will be developed.

design_allocation: Non-Randomized

primary_purpose: Device Feasibility

lead_sponsor: Rennes University Hospital


title: Peri-gravidic Exposure to Endocrine Disrupting Persistent Organic Pollutants Dioxins and Dioxin-like Dioxins and the Development of Breast Cancer Within 15 Years: Prospective Longitudinal Case-control Study

acronym: SEINPOL

summary:
Breast cancer, the first female cancer, affects one in eight women in her lifetime. The increase and unequal distribution of its prevalence throughout the world, regardless of age and genetic factors (< 10% of cases), observations in migrant women and the increased risk in women who have been exposed in utero to diethylstilbestrol, suggest the involvement of environmental factors that can act very early in development, such as persistent chemical pollutants (POPs) that are endocrine disrupting (EP) acting via nuclear receptors. But the demonstration of the deleterious role of such exposure to chemical pollutants is confronted epidemiologically with methodological difficulties: the correlation is most often sought at the time of cancer discovery when the critical windows of exposure are for the breast, fetus, perinatal, peri-advertising or pregnant and a single pollutant is usually measured, whereas they can be potentiated ("cocktail effect").

The objective of this project is therefore to assess the risk related to pre- and per-gravidic exposure to a range of POPs families (dioxins, dioxin-like, PolyChlorinated Bysphenyls PCBs, flame-retardant polybrominated compounds, waterproofing perfluorinated compounds and several organochlorine pesticides), to develop breast cancer within 15 years of delivery, taking into account the conventional risk factors for breast cancer.

This project benefits from a historical bio-bank of 6242 cord blood, an indirect reflection of the pre and per-gravidic maternal exposure, a bank set up between 2002 and 2005, during a PHRC at the Nice University Hospital, frozen and stored under strict and regulatory conditions, declared to the CNIL, and the Cancer Observatory / CRISAP of the PACA-Corsica region, with an exhaustive register of over 92% since 2005, and containing the main characteristics of cancer. The cross-referencing of these two registers (biobanks and CRISAP), supported by the preliminary feasibility study (155 cases of cancer expected, 35% of controls lost to follow-up or opposed to participation), makes it possible to consider a prospective case-control study nested in the cohort of mothers included in the bio-bank.

It will therefore be investigated whether women parturient women of this period who had the highest levels of POPs cord blood between 2002 and 2005 had a higher risk of developing breast cancer than those who had the lowest levels, taking into account other known risk factors.

The assays will be carried out by LABERCA in Nantes, the national reference laboratory, using gas chromatography/high-resolution mass spectrometry coupling. Blood lipid concentrations will be described in quartile and analyzed in continuous values, alone or in combination with a cumulative score, in N=140 cases and 2N=280 controls, matched for age and parity at birth by random drawing, sample required for 80% power, risk 5% OR at 2, frequency of exposure>70%.

The investigators propose to develop a predictive model of breast cancer occurrence based on exposure to endocrine disrupters measured during pregnancy by adjusting for known breast cancer risk factors.

These conditions should provide information on the possible association of exposure to POPs present in the domestic environment during critical pre- and per-gravidic periods and the risk of breast cancer and reinforce the relevance of preventive measures recently recommended during pre-conceptional and/or pre-natal consultations.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: SMOLY : Phenotype and Functions of Monocyte Subtypes in High Grade B Lymphoma: Towards New Biomarkers?

acronym: SMOLY

summary:
Large-cell B-cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma and accounts for about 40% of new cases. Although the DLBCL is a single entity in the WHO classification, several subgroups with different prognoses are recognized. These subgroups take into account the tumor localization (primitive cerebral lymphoma, serous lymphoma, intravascular or exclusive lymph node) or a particular molecular signature (GCB profile, germline center B cell or ABC, activated B cell). Despite the introduction of immunotherapy, treatment failures are common. Overall survival at 5 years is estimated to be between 26 and 73%. This highlights the important heterogeneity of this pathology and therefore the need for biomarkers prognosis. Recently, an increase in monocytes in the blood of DLBCL patients has been proposed as a prognostic factor for independent survival. This marker of poor prognosis is also found in many solid.

Monocytes are effectors of the inflammatory response. They have different functional profiles depending on the level of expression of CD14 and CD16. Four subtypes of monocytes are distinguished: classical (CD14posCD16neg), intermediate (CD14posCD16pos) and non-classical (CD14lowCD16pos); the latter population is divided into two sub-groups depending on the expression of the SLAN protein. The different monocytic subpopulations have very diverse functions ranging from an immunosuppressive profile to an activation of the immune system. CD14posCD16neg monocytes are specialized in phagocytosis, production of oxygen derivatives (ROS) and pro-inflammatory cytokine secretion in response to microbial infection. CD14dimCD16pos monocytes are specialized in immune surveillance and produce proinflammatory cytokines such as TNFα and IL-1β in response to LPS stimulation.7 The Slanpos subpopulation produces IL-12 and thus has pro-inflammatory properties. Finally, CD14posCD16pos monocytes have controversial functions. For some authors, they produce the immunomodulatory cytokine IL-10, inhibit the proliferation of CD4 T lymphocytes and induce the recruitment of regulatory T lymphocytes, while for others they produce TNF-α, a pro- inflammatory.From a practical point of view CD14 and CD16 expression forms a continuum, which translates into complexity in the phenotypic definition of these cells and explains the contradictory data on their functionalities. Interestingly, in a laboratory work and in the course of publication, this fraction is increased in the blood of DLBCL patients compared to healthy donors (manuscript in preparation), on the contrary the monocytic fraction CD14dimCD16 pos is decreased in these patients.

In the end, if the increase in monocytes is known to be poor prognosis in patients with DLBCL, the monocyte fraction involved and the monocytic functions involved in this phenomenon are not known.

Since 2011, the Clinical and Biological Hematology Services have a database from a research protocol (BMS_LyTrans). This protocol includes patients with DLBCL as well as healthy patients, in order to allow the biological characterization of biomarkers in this pathology. Thus, we have blood samples and analysis of certain monocyte subtypes by flow cytometry at diagnosis, in more than 100 patients with DLBCL.


title: Use of Compuflo in Pediatric Anesthesia: Monitoring of Injection Pressure of Local Anesthetics in Children

acronym: COMPUFLO

summary: A low injection pressure is one of the safety elements to check the correct position of the needle during regional anesthesia. Subjective assessment of pressure during manual injection of local anesthetic is most commonly used. In adults, the monitoring of the injection pressure has already been evaluated and makes it possible to objectify the pressure of the injection pressure. This is possible thanks to a device named Compuflo. No study has measured injection pressures during a regional anesthesia in children. The main objective is to control the injection pressures exercised in daily clinical practice during pediatric regional anesthesia with the Compuflo. Regional anesthesia will be proposed and explained during the anesthesia consultation. The procedure will be performed according to the habits of the anesthesiologist in charge of the patient. Only the addition of the Local Anesthetic Injection Pressure monitoring (Compuflo) to the needle changes the usual setup.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier


title: Pilot Study Evaluating the Safety and Efficacy of a Photobiomodulation Prototype, REGEnLIFE RGn530 Device, on Cognitive Performances Evolution From Mild-to-moderate Alzheimer's Disease Patients

summary:
REGEnLIFE RGn530 is a photobiomodulation medical device, consisting in a modular helmet and abdominal panel, composed of near-infrared low-level lasers (LLLT), near-infrared and red LEDs as well as a static magnetic field. RGn device application on both head and abdomen have demonstrated striking efficacy in preclinical studies. The investigator's results clearly indicated that RGn treatment produces a normalization of all parameters that are strongly modified in the model, including memory performances associated to oxidative stress, neuroinflammation or apoptosis markers, microbiota composition and specific markers related to the amyloid or tau processes (Blivet et al., Alzheimers Dement (NY), 2018).

Following such promising results, this pilot clinical study will evaluate the safety and efficacy of REGEnLIFE RGn530 device on cognitive performances evolution from mild-to-moderate Alzheimer's disease patients. The double-blind, randomized, monocentric sham-controlled clinical trial will be performed at the CHU de Montpellier. 64 patients will be enrolled: 32 in photobiomodulation group and 32 in sham group. Each patient will follow 8 weeks of treatment with 5 sessions of 25min per week (total of 40 sessions) and will undergo, for a total period of three months, series of clinical examinations including cognitive evaluation, biological and electrophysiological analyses, sleep recordings, and imaging assessments.

REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective. In the light of anti-amyloid therapeutic approaches lack of success, RGn530 dual treatment is hoped to be particularly valuable as an innovative and extensive treatment strategy for AD.

location_facility: Montpellier University Hospital, Gui de Chauliac


title: Study of Circulating Glicentin Levels in Patients With Intestinal Ischemia

acronym: GLICENTINEDIGE

summary:
Hormones derived from proglucagon represent a family of peptides produced by the alpha cells of the pancreas and by the intestinal L cells. In the pancreas, the maturation of proglucagon mainly leads to the synthesis of glucagon, while in the intestine, the cleavage of proglucagon allows the synthesis of different peptides including glicentine, oxyntomodulin, Glucagon Like Peptide-1 (GLP-1) and Glucagon Like Peptide-2 (GLP-2).

Glicentin is produced by L cells throughout the digestive tract, from the small intestine to the rectum, with a majority secretion in the colon. Studies in humans and animals have shown its role in the intestinal mucosa. It has a stimulating effect on the proliferation of the intestinal mucosa as well as an effect on smooth muscle cells and regulates trophicity and intestinal motility. Its circulating rate could be modified in case of intestinal ischemia. Mesenteric ischemia is a major diagnostic problem with high morbidity and mortality, particularly in the event of delayed treatment.

The sensitivity and specificity of current markers are low. The identification of new biomarkers of the disease would improve the diagnosis and management of patients with the disease.

The objective of the project is to determine a difference in circulating glicentin levels in patients with intestinal ischemia versus a control group.

On this prospective monocentric study, 40 patients with digestive ischemia will be included in the Emergency Department of the University Hospital of Nice. A control group of 40 patients with abdominal pain will be formed. The circulating glicentin levels will be measured on serum by Elisa technique at the Biochemistry Laboratory of the University Hospital of Nice, work that has been published in 3 scientific journals allowing us to develop and validate the technique.The staff will determine whether patients with digestive ischemia have impaired serum glicentin levels.

The evaluation of the interest of new biological markers of mesenteric ischemia such as glicentine would constitute a definite diagnostic advance. This project could eventually offer new diagnostic and/or therapeutic perspectives in the management of these patients.

primary_purpose: Basic Science


title: Children Born With Club Feet: Ultrasound Diagnosis and Antenatal Assessment

acronym: CBCF

summary:
Clubfoot is one of the most common birth defects, with a prevalence in Europe estimated between 1 and 4.5 for 1000 live birth.

It is useful to distinguish the forms of isolated clubfoot, and the forms related to others morphological abnormalities (complex clubfoot). For the complex forms, the clubfoot can be integrated in a syndromic association, be the consequence of a serious harm of the central nervous system, be associate to a genetic musculo-skeletal disease or wether be associated to a karyotype abnormality.

In those cases, the prognosis depends more about the associated morphological abnormalities that can be the beginning of a severe disability or incompatible with life or any anomaly of the karyotype that clubfoot itself.

In case of several morphological abnormalities, to propose invasive samples with realization of a karyotype and chromosome analysis with CGH array is a consensual attitude.

What the investigators should recommended to the parents in case of isolated form is less obvious and the question of antenatal investigations can not be answered clearly in the literature. Thus, the management of these patients may vary from one CPDP to another.

This study project will make it possible to analyze the management offered to patients whose fetuses have club feet and to study the results of the various examinations carried out in order to adapt the prenatal counselling and to define the best diagnostic strategy to propose to the future parents.

ipd_sharing_description: NC


title: Combination of Flash Glucose Measure System and Continuous Subcutaneous Insulin Infusion Therapy in Patients With Type 1 Diabetes and Poor Glycemic Control Related to Very Few Self-blood Glucose Measurements

acronym: FREESTYLE

summary: Patients with diabetes type 1 with poor glycemic control will be switched to insulin pump and FGM system (Flash Glucose Monitoring) during 6 months, correlated to the hypothesis that they could benefit from this intervention by being reengaged in diabetes self-management.

ReferenceCitation: Halbron M, Bourron O, Andreelli F, Ciangura C, Jacqueminet S, Popelier M, Bosquet F, Rouanet S, Amouyal C, Hartemann A. Insulin Pump Combined with Flash Glucose Monitoring: A Therapeutic Option to Improve Glycemic Control in Severely Nonadherent Patients with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jul;21(7):409-412. doi: 10.1089/dia.2019.0041.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Evaluation of the Efficiency of Lina LibrataTM System in the Treatment of Functional Idiopathic Menometrorrhagia

acronym: THERMOLIB

summary:
Menometrorrhagia is the first cause of consultation in gynecology. Etiology of menometrorrhagia is varied, but in majority of cases no underlying pathology is found, they are said functional idiopathic menometrorrhagia .

In case of failure of medical treatment, for women who do not wish to preserve reproduction possibilities, a surgical treatment by endometrectomy (destruction of the uterine endometrial epithelial) can be proposed. Currently, a new system, Lina LibrataTM is available on the market. This system allows destructing endometrial membrane with a balloon which offer several advantages compared to present used system. Specially, it does not require dilatation of uterus's cervix and it reduces the pain. The investigator make hypothesis that the use of the system Lina LibrataTM does not cause pain and can be thus used under local anesthetic in ambulatory surgery. With the aim of developing ambulatory care, the main objective of this prospective monocentric study is to estimate the efficiency of Lina LibrataTM system in the treatment of functional idiopathic menometrorrhagia. Secondary objectives are to estimate the pain during the procedure, the rate of per and post-complications and quality of life.


title: Vestibular Evaluation Before and After Treatment of Vestibular Schwannoma. Comparison of Gamma Knife Radiosurgery and Microsurgical Resection

acronym: EVTSVCGEC

summary:
Vestibular schwannoma is a benign tumor located on the vestibular nerve. Patient could present dizziness symptoms cause to the tumor, and at least after the treatment by gamaknife radiosurgery or microsurgery resection.

Only few studies keep the interest about dizziness symptoms and treatment modality in vestibular schwannoma.

In the study dizziness symptoms were compared before and after the treatment of vestibular schwannoma by radiosurgery gammaknife or microsurgery resection. 2 scales were used : dizziness handicap inventory (DHI) and dizziness functionnal scale (AAO).

ReferenceType: background

ReferenceCitation: Carlson ML, Tveiten ØV, Driscoll CL, Neff BA, Shepard NT, Eggers SD, Staab JP, Tombers NM, Goplen FK, Lund-Johansen M, Link MJ. Long-term dizziness handicap in patients with vestibular schwannoma: a multicenter cross-sectional study. Otolaryngol Head Neck Surg. 2014 Dec;151(6):1028-37. doi: 10.1177/0194599814551132. Epub 2014 Oct 1.

ReferenceCitation: Park CE, Park BJ, Lim YJ, Yeo SG. Functional outcomes in retrosigmoid approach microsurgery and gamma knife stereotactic radiosurgery in vestibular schwannoma. Eur Arch Otorhinolaryngol. 2011 Jul;268(7):955-9. doi: 10.1007/s00405-011-1596-9. Epub 2011 Apr 11. Review.

ReferenceCitation: Pollock BE, Driscoll CL, Foote RL, Link MJ, Gorman DA, Bauch CD, Mandrekar JN, Krecke KN, Johnson CH. Patient outcomes after vestibular schwannoma management: a prospective comparison of microsurgical resection and stereotactic radiosurgery. Neurosurgery. 2006 Jul;59(1):77-85; discussion 77-85.

ReferenceCitation: Coelho DH, Roland JT Jr, Rush SA, Narayana A, St Clair E, Chung W, Golfinos JG. Small vestibular schwannomas with no hearing: comparison of functional outcomes in stereotactic radiosurgery and microsurgery. Laryngoscope. 2008 Nov;118(11):1909-16. doi: 10.1097/MLG.0b013e31818226cb.

lead_sponsor: University Hospital, Grenoble

intervention_type: Radiation


title: Medication Reconciliation for Patients Over 65 Years Old : Cost Analysis of the Process Implemented in the Polyvalent Internal Medical Unit of Rennes University Hospital

acronym: CONTEMPS

summary: Among the strategies to secure the patient's care path, medication reconciliation is a powerful approach for the prevention and interception of medication errors.


title: Impact of Personalized SMS in Relay of Therapeutic Education Programs to Improve the Physical Activity of Patients in Rheumatology

summary: Therapeutic patient education is an approach that has shown its usefulness in rheumatology, but the duration of its impact is limited, and therapeutic revisions are regularly necessary. The practice of physical activity is one of the goals of TPE in rheumatology and new technologies, such as SMS messages represent a possible complementary tool to amplify behavioral changes The study primary objective is to evaluate the impact of individualized SMS compared to standard SMS messages on the physical activity of patients with chronic inflammatory rheumatism or osteoporosis, included in a therapeutic education program. Our hypothesis is that individualized SMS has a higher efficiency compared to standard SMS messages to increase the practice of physical activity in these patients.

lead_sponsor: Hôpital Cochin


title: Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.

acronym: PANORAMIC

summary: Pilot study to assess the feasibility of creation of a bone and arterial panorama by 2D-2D registration technique during endovascular femoro-popliteal procedures with a mobile C-arm X-ray system using EndoNaut® software.


title: Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?

acronym: COVAP

summary:
Suspicions of carbon monoxide poisoning that lead to the treatment of victims are numerous. Measurement of transcutaneous carbon monoxide saturation (SpCO) is a useful diagnostic and triage tool for victims and the toxic threshold is clearly defined for both non-smokers (SpCO> 5%) and smokers ( SpCO> 10%).

Currently, the use of e-cigarettes is democratizing. Unfortunately, the threshold for toxic SpCO is not defined for this patient profile.

The risk is treating in excess or worse than underestimating carbon monoxide poisoning in e-cigarette users who would be exposed to carbon monoxide exposure.

lead_sponsor: University Hospital, Tours

location_facility: Adult Emergency Department, University Hospital, Tours


title: Feasibility Study - The Place of Surgical Management by Fatty Autograft in Patients With Healed Pelvic Eschar. Interest in Secondary Prevention.

acronym: FATSCAR

summary:
Autografting of fat cells is widely used in plastic surgery in breast reconstruction, burn scars, unsightly scars etc. It is known that the autografting of fat cells not only makes it possible to bring adipocytes, and thus to create a volume, but also promotes neo-angiogenesis by providing the growth factors which allows an improvement of the local cutaneous tissue.

Currently the investigators perform this action in their service on healed eschars, by analogy with burn scars that are also dystrophic, so as to improve cutaneous trophicity, and reduce the recurrence of eschars on these scars. However, the literature on the autografting of fat cells on eschars is limited.


title: Evaluation of Pain and Postoperative Nausea Vomiting Incidence in Outpatient Surgery at IUCT-Oncopole Hospital

summary:
The effectiveness of the analgesic and anti-nausea prevention techniques of the investigators justifies being evaluated regularly in order to adapt the management strategy to the specificities of each surgical act.

A first evaluation took place in June 2016 and allowed to identify a category of patients (partial breast surgery with or without axillary gesture) not benefiting from an ideal algological management because justifying in 30% of the cases of a level 3 analgesic remedy in the postoperative recovery room. This use of morphine results in a significant incidence of postoperative nausea and prolonged recovery time before return home harmful to the patient.

With their experience in locoregional anesthesia technique in complete breast surgery (total mastectomy) and aware of the effectiveness of this type of anesthesia on the management of immediate and chronic pain, the investigators have extended their indications of ALR to partial breast surgery in ambulatory.

ReferenceCitation: Gärtner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. Erratum in: JAMA. 2012 Nov 21;308(19):1973.

ReferenceCitation: Fuzier R, Puel F, Izard P, Sommet A, Pierre S. Prospective cohort study assessing chronic pain in patients following minor surgery for breast cancer. J Anesth. 2017 Apr;31(2):246-254. doi: 10.1007/s00540-016-2288-9. Epub 2016 Nov 24.

ReferenceCitation: Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

ReferenceCitation: Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lantéri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. Epub 2005 Jan 26.

ReferenceCitation: Kumar SP. Utilization of brief pain inventory as an assessment tool for pain in patients with cancer: a focused review. Indian J Palliat Care. 2011 May;17(2):108-15. doi: 10.4103/0973-1075.84531.

lead_sponsor: Institut Claudius Regaud


title: Radiological Study of the Hemodynamic Changes in the Aorta and Its Branches Before and After Endovascular Treatment of the Aortic Dissection

summary:
Aortic dissection (AD) is a serious pathology affecting one person for 300 000 habitants per year. In case of complicated AD on the descending aorta, it is necessary to perform an endovascular surgery in association with medical treatment. An endoprosthesis is implanted on the descending thoracic aorta in order to close the main intimal tear. This closure lead to an increase in the thoracic true lumen diameter, a decrease in the thoracic false lumen diameter, a better perfusion of the aortic branches. Furthermore, even in case of open surgical treatment of the ascending aorta it can be necessary to perform an endovascular treatment on the descending aorta, either to prevent and treat aneurysmal evolution or to treat patent malperfusion syndrome.

CT and Magnetic Resonance angiography, by the realization of an aortic morphologic evaluation, are the two key imaging exams in the DA. Nevertheless, CT can't provide aortic dynamic evaluation, contrary to MRI. This exam, thanks to the phase-contrast sequence can measure velocity and flow data in vessels, including aorta but also true and false lumen in the AD. Thus, by verifying the perfusion of the aortic true lumen and the aortic branches it is possible to perform an early evaluation of the endovascular treatment of the DA.

Actually, only one study has realized an aortic dynamic evaluation on the AD, unfortunately this study was limited to non-operated patients.

In order to assess the place of MRI in the AD, the ingestigation propose to determine if phase-contrast MRI is able to evaluate the impact of the endovascular treatment on the hemodynamic state of the aorta and its branches.

primary_purpose: Diagnostic


title: Association Between Hidradenitis Suppurativa and Spondyloarthritis

acronym: VESPA

summary:
Hidradenitis suppurativa is a chronic dermatosis, characterized by an inflammation of the follicular epithelium in the apocrine glands.

The hypothesis of a link between hidradenitis suppurativa and inflammatory rheumatism has been widely considered, with evidence in support of this theory accumulating from several case reports and small series. The most frequently cited rheumatismal disease thought to be associated with Hidradenitis suppurativa is spondyloarthritis.

Taken together, these data suggest that there may a link between hidradenitis suppurativa and spondyloarthritis, but literature data are sparse, and to date, no study has investigated or demonstrated such a relation. Indeed, existing studies to date were observational, descriptive, and retrospective, and did not use modern diagnostic approaches for documenting spondyloarthritis, such as magnetic resonance imaging (MRI) or the recent classification of spondyloarthritis.

ReferenceCitation: Fauconier M, Reguiai Z, Barbe C, Colosio A, Eschard JP, Salmon JH, Direz G. Association between hidradenitis suppurativa and spondyloarthritis. Joint Bone Spine. 2018 Oct;85(5):593-597. doi: 10.1016/j.jbspin.2017.09.005. Epub 2017 Sep 28.

lead_sponsor: CHU de Reims


title: Feasibility and Security of a Rapid Rule-out and rule-in Troponin Protocol in the Management of NSTEMI in an Emergency Departement.

acronym: ICTUS

summary: Management of NSTEMI in emergency departements represent 10% of the global activity. Since the the last European Society of Cardiology recommendation the use of an 1 hour rule-in and rule-out protocol is recommended combined with high-sensitivity troponin. But studies show 3% of the patients are false negative using this protocol. This study aims at analysing the feasibility of this protocol in an Emergency Departement and the security of this protocol if combined with a pre-troponin probability score.

lead_sponsor: Nantes University Hospital


title: Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus

acronym: CALIGALOC

summary: To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.

lead_sponsor: University Hospital, Lille


title: Children Peritonitis Ecology at CHU de Rennes - (IIAPEDIA)

acronym: IIAPEDIA

summary: The main objectif is assess the germs (species + antibiograms) implicated in children intra-abdominal infections (community acquired or nosocomial ) at CHU de Rennes.

intervention_type: Biological


title: Prevention Study, on Loss of Autonomy and Physical Dependence, Based on Physical Exercises and Nutrition Counseling Applied to 70 Years Old and More People.

acronym: PREPA

summary:
According to several reports, the percentage of persons aged of more than 80 years is going to be doubled for the 25 years, to reach 10 % of the population. This implies an adaptation of practices of taken care for elderly people. Furthermore, the expectancy of life without any disability at 65 years old is 10.4 years and remains much lower than the general expectancy of life, which is of 24.4 years for women and 19.1 years for men.

Among predictive factors of loss of autonomy, the loss of mobility and muscular weakness are major components (OR=3.28 up to 3 years). These two factors are the origins for disabilities being responsible of falls, fractures, which lead to quality of life diminution, and increase of mortality.

The only components easily employed in a preventive manner and which have proved their efficacy are physical exercise and nutrition. But programs nowadays are still not implemented into primary taken care.

A multimodal program including these two components for patients at risk of loss of mobility is an imperative of public health.

location_facility: Service de Médecine Gériatrique Groupement Hospitalier Sud


title: Evaluation of the Uses of a Digital-assisted Self-rehabilitation Device Coupled With a Tele-reeducative Follow-up in Patients With Parkinson's Disease on a Defined Health Area (TELE-PARK)

acronym: TELE-PARK

summary: Evaluate the use by the patient and his family and professional environment of a self-rehabilitation device with follow-up in tele-rehabilitation in people with Parkinson's disease taking into account the different actors within a health area (health professionals and paramedics in structure and in liberal).

lead_sponsor: Pôle Saint Hélier


title: Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation

acronym: GENEPSO

summary: Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

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ReferenceCitation: Andrieu N, Easton DF, Chang-Claude J, Rookus MA, Brohet R, Cardis E, Antoniou AC, Wagner T, Simard J, Evans G, Peock S, Fricker JP, Nogues C, Van't Veer L, Van Leeuwen FE, Goldgar DE. Effect of chest X-rays on the risk of breast cancer among BRCA1/2 mutation carriers in the international BRCA1/2 carrier cohort study: a report from the EMBRACE, GENEPSO, GEO-HEBON, and IBCCS Collaborators' Group. J Clin Oncol. 2006 Jul 20;24(21):3361-6. Epub 2006 Jun 26.

ReferenceCitation: Lecarpentier J, Noguès C, Mouret-Fourme E, Gauthier-Villars M, Lasset C, Fricker JP, Caron O, Stoppa-Lyonnet D, Berthet P, Faivre L, Bonadona V, Buecher B, Coupier I, Gladieff L, Gesta P, Eisinger F, Frénay M, Luporsi E, Lortholary A, Colas C, Dugast C, Longy M, Pujol P, Tinat J; GENEPSO, Lidereau R, Andrieu N. Variation in breast cancer risk associated with factors related to pregnancies according to truncating mutation location, in the French National BRCA1 and BRCA2 mutations carrier cohort (GENEPSO). Breast Cancer Res. 2012 Jul 3;14(4):R99. doi: 10.1186/bcr3218.

ReferenceCitation: GENEPSO : cohorte nationale prospective de personnes porteuses d'une mutation sur les gènes BRCA1 et BRCA2 GENEPSO: French BRCA1/2 carrier cohort study E. Fourme, C. Picard, M.L. Manche-Thévenot, C. Noguès, groupe Génétique et cancer* La Lettre du Sénologue • n° 43 - janvier-février-mars 2009

ReferenceCitation: Bonaïti B, Alarcon F, Bonadona V, Pennec S, Andrieu N, Stoppa-Lyonnet D, Perdry H, Bonaïti-Pellié C; Groupe Génétique et Cancer. [A new scoring system for the diagnosis of BRCA1/2 associated breast-ovarian cancer predisposition]. Bull Cancer. 2011 Jul;98(7):779-95. doi: 10.1684/bdc.2011.1397. French.

ReferenceCitation: Eisinger F, Bressac B, Castaigne D, Cottu PH, Lansac J, Lefranc JP, Lesur A, Noguès C, Pierret J, Puy-Pernias S, Sobol H, Tardivon A, Tristant H, Villet R. [Identification and management of hereditary predisposition to cancer of the breast and the ovary (update 2004)]. Bull Cancer. 2004 Mar;91(3):219-37. Review. French.

ReferenceCitation: Kuchenbaecker KB, Hopper JL, Barnes DR, Phillips KA, Mooij TM, Roos-Blom MJ, Jervis S, van Leeuwen FE, Milne RL, Andrieu N, Goldgar DE, Terry MB, Rookus MA, Easton DF, Antoniou AC; BRCA1 and BRCA2 Cohort Consortium, McGuffog L, Evans DG, Barrowdale D, Frost D, Adlard J, Ong KR, Izatt L, Tischkowitz M, Eeles R, Davidson R, Hodgson S, Ellis S, Nogues C, Lasset C, Stoppa-Lyonnet D, Fricker JP, Faivre L, Berthet P, Hooning MJ, van der Kolk LE, Kets CM, Adank MA, John EM, Chung WK, Andrulis IL, Southey M, Daly MB, Buys SS, Osorio A, Engel C, Kast K, Schmutzler RK, Caldes T, Jakubowska A, Simard J, Friedlander ML, McLachlan SA, Machackova E, Foretova L, Tan YY, Singer CF, Olah E, Gerdes AM, Arver B, Olsson H. Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers. JAMA. 2017 Jun 20;317(23):2402-2416. doi: 10.1001/jama.2017.7112.

ReferenceCitation: Mancini J, Le Cozannet E, Bouhnik AD, Resseguier N, Lasset C, Mouret-Fourme E, Noguès C, Julian-Reynier C. Disclosure of research results: a randomized study on GENEPSO-PS cohort participants. Health Expect. 2016 Oct;19(5):1023-35. doi: 10.1111/hex.12390. Epub 2015 Jul 23.

ReferenceCitation: Lecarpentier J, Noguès C, Mouret-Fourme E, Buecher B, Gauthier-Villars M, Stoppa-Lyonnet D, Bonadona V, Fricker JP, Berthet P, Caron O, Coupier I, Pujol P, Faivre L, Gesta P, Eisinger F, Mari V, Gladieff L, Lortholary A, Luporsi E, Leroux D, Venat-Bouvet L, Maugard CM, Colas C, Tinat J, Lasset C, Andrieu N; GENEPSO. Breast Cancer Risk Associated with Estrogen Exposure and Truncating Mutation Location in BRCA1/2 Carriers. Cancer Epidemiol Biomarkers Prev. 2015 Apr;24(4):698-707. doi: 10.1158/1055-9965.EPI-14-0884. Epub 2015 Jan 22.

ReferenceCitation: Julian-Reynier C, Resseguier N, Bouhnik AD, Eisinger F, Lasset C, Fourme E, Noguès C. Cigarette smoking in women after BRCA1/2 genetic test disclosure: a 5-year follow-up study of the GENEPSO PS cohort. Genet Med. 2015 Feb;17(2):117-24. doi: 10.1038/gim.2014.82. Epub 2014 Jul 10.

ReferenceCitation: Bureau E, Pellegrini I, Noguès C, Lasset C, Julian-Reynier C. "Maybe they have found something new" participants' views on returning cohort psychosocial survey results. Health Expect. 2015 Dec;18(6):2425-36. doi: 10.1111/hex.12211. Epub 2014 May 30.

ReferenceCitation: Lapointe J, Dorval M, Noguès C, Fabre R; GENEPSO Cohort, Julian-Reynier C. Is the psychological impact of genetic testing moderated by support and sharing of test results to family and friends? Fam Cancer. 2013 Dec;12(4):601-10. doi: 10.1007/s10689-013-9621-3.

ReferenceCitation: Pijpe A, Andrieu N, Easton DF, Kesminiene A, Cardis E, Noguès C, Gauthier-Villars M, Lasset C, Fricker JP, Peock S, Frost D, Evans DG, Eeles RA, Paterson J, Manders P, van Asperen CJ, Ausems MG, Meijers-Heijboer H, Thierry-Chef I, Hauptmann M, Goldgar D, Rookus MA, van Leeuwen FE; GENEPSO; EMBRACE; HEBON. Exposure to diagnostic radiation and risk of breast cancer among carriers of BRCA1/2 mutations: retrospective cohort study (GENE-RAD-RISK). BMJ. 2012 Sep 6;345:e5660. doi: 10.1136/bmj.e5660.

ReferenceCitation: Eisinger F, Fabre R, Lasset C, Stoppa-Lyonnet D, Julian-Reynier C, Nogues C. Spontaneous disclosure of BRCA1/2 genetic test results to employers: a French prospective study. Eur J Hum Genet. 2012 Sep;20(9):981-3. doi: 10.1038/ejhg.2012.37. Epub 2012 Feb 29.

ReferenceCitation: Pujol P, Lasset C, Berthet P, Dugast C, Delaloge S, Fricker JP, Tennevet I, Chabbert-Buffet N, This P, Baudry K, Lemonnier J, Roca L, Mijonnet S, Gesta P, Chiesa J, Dreyfus H, Vennin P, Delnatte C, Bignon YJ, Lortholary A, Prieur F, Gladieff L, Lesur A, Clough KB, Nogues C, Martin AL; French Federation of Cancer Centres (FNCLCC). Uptake of a randomized breast cancer prevention trial comparing letrozole to placebo in BRCA1/2 mutations carriers: the LIBER trial. Fam Cancer. 2012 Mar;11(1):77-84. doi: 10.1007/s10689-011-9484-4.

ReferenceCitation: Lecarpentier J, Noguès C, Mouret-Fourme E, Stoppa-Lyonnet D, Lasset C, Caron O, Fricker JP, Gladieff L, Faivre L, Sobol H, Gesta P, Frenay M, Luporsi E, Coupier I; GENEPSO, Lidereau R, Andrieu N. Variation in breast cancer risk with mutation position, smoking, alcohol, and chest X-ray history, in the French National BRCA1/2 carrier cohort (GENEPSO). Breast Cancer Res Treat. 2011 Dec;130(3):927-38. doi: 10.1007/s10549-011-1655-3. Epub 2011 Jul 15.

ReferenceCitation: Dorval M, Noguès C, Berthet P, Chiquette J, Gauthier-Villars M, Lasset C, Picard C, Plante M; INHERIT BRCAs; GENEPSO Cohort, Simard J, Julian-Reynier C. Breast and ovarian cancer screening of non-carriers from BRCA1/2 mutation-positive families: 2-year follow-up of cohorts from France and Quebec. Eur J Hum Genet. 2011 May;19(5):494-9. doi: 10.1038/ejhg.2010.227. Epub 2011 Jan 19.

ReferenceCitation: Antoniou AC, Rookus M, Andrieu N, Brohet R, Chang-Claude J, Peock S, Cook M, Evans DG, Eeles R; EMBRACE, Nogues C, Faivre L, Gesta P; GENEPSO, van Leeuwen FE, Ausems MG, Osorio A; GEO-HEBON, Caldes T, Simard J, Lubinski J, Gerdes AM, Olah E, Fürhauser C, Olsson H, Arver B, Radice P, Easton DF, Goldgar DE. Reproductive and hormonal factors, and ovarian cancer risk for BRCA1 and BRCA2 mutation carriers: results from the International BRCA1/2 Carrier Cohort Study. Cancer Epidemiol Biomarkers Prev. 2009 Feb;18(2):601-10. doi: 10.1158/1055-9965.EPI-08-0546. Epub 2009 Feb 3.

ReferenceCitation: Brohet RM, Goldgar DE, Easton DF, Antoniou AC, Andrieu N, Chang-Claude J, Peock S, Eeles RA, Cook M, Chu C, Noguès C, Lasset C, Berthet P, Meijers-Heijboer H, Gerdes AM, Olsson H, Caldes T, van Leeuwen FE, Rookus MA. Oral contraceptives and breast cancer risk in the international BRCA1/2 carrier cohort study: a report from EMBRACE, GENEPSO, GEO-HEBON, and the IBCCS Collaborating Group. J Clin Oncol. 2007 Sep 1;25(25):3831-6. Epub 2007 Jul 16.

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ReferenceCitation: Jégu M, Some Der A, Morcel K, Abadie C, Fritel X, Levêque J. [Breast and ovarian cancer due to BRCA1&2 hereditary cancer predisposition syndrome and reproduction: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2015 Jan;44(1):10-7. doi: 10.1016/j.jgyn.2014.10.011. Epub 2014 Nov 18. Review. French.

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ReferenceCitation: Suivi prospectif à 5 ans des tests de prédisposition génétique au cancer du sein et/ou de l'ovaire : comportements de prévention, attentes envers la recherche et inégalités sociales (cohorte nationale Genepso) Institut National du Cancer (INCa) dans le cadre de l'appel à projets 2011 Projets libres de recherché en sciences humaines et sociales, épidémiologie et santé publique.

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lead_sponsor: Institut Paoli-Calmettes


title: Direct Anterior Total Hip Arthroplasty (THA), in Versus Outpatients : A Prospective Monocentric Study in Rennes University Hospital.

acronym: AHVACA

summary: The main objective is to show that cumulative length of stay over the first 45 post operative days (i.e. : primary length of stay and readmission) is significantly lower in the outpatients group than in the inpatients group


title: Pilot Study for Measuring Molecular Biomarkers and Their Capacity to Characterize Radionuclide Therapy With Lu-177 DOTATATE) in Metastatic G1-G2 Neuroendocrine Midgut Tumors

acronym: GENEBIOLuNET

summary: Midgut neuroendocrine tumours present an increasing incidence and poor survival at 5 years with limited therapeutic options for metastatic, non-operable cases. Lu-177 Dotatate, targeting somatostatin receptors, is an internal vectorized radiotherapy using Lu-177, an ideal radionuclide for peptide radionuclide therapy. In NETTER-1 phase III randomized clinical trial, Lu-177 Dotatate proved its superiority in increasing progression free survival for midgut neuroendocrine tumors. This study hypothesize that finding biomarkers of individual radio sensitivity for this type of internal vectorized therapy would allow treatment personalization. The protocol aim at studying transcript variations induced by this therapy.


title: NEURANESTH General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematomas: A Prospective Randomized Trial

summary: This study compare general anesthesia versus locoregional anesthesia for evacuation of chronic subdural hematoma. Half of participant will be operated under general anesthesia, while the other half will be operated under locoregional anesthesia.

lead_sponsor: University Hospital, Caen

intervention_type: Drug


title: Comprehensive Management of Drug Prescriptions Throughout the Elderly Person's Hospital Care, From Hospital to Home: Impact on Readmission at 30 Days After Delivery

acronym: OPTISORT

summary: This study evaluates the impact of optimizing drug prescriptions on re-admissions of elderly patients within 30 days after hospital discharge. It compares a group of patients receiving comprehensive care (medication reconciliation at hospital entry, multidisciplinary medication review, and medication reconciliation at discharge), versus another group that does not benefit from the program.

lead_sponsor: Lille Catholic University


acronym: AGIR

title: Treatment With Azacitidine of Recurrent Gliomas With IDH1/2 Mutation

lead_sponsor: Assistance Publique - Hôpitaux de Paris

type: EudraCT Number

source: euctr

summary:
Glioma are the most commun frequent brain tumour. Mutation of Isocitrate DeHydrogenase IDH1 or IDH2 genes affect 40% of gliomas, mostly grade II and III gliomas. Despite IDH mutated gliomas (IDHm glioma) have a better prognosis compared to the IDH wild type counterparts, they invariably recur after standard treatment with radiotherapy and alkylating agent. IDH mutation results in the accumulation of D-2 hydroxyglutarate (D2HG) produced by the IDH mutant enzyme. D2HG acts as a competitive inhibitor of the alphaketoglutarate cofactor in a wide range of cellular reactions, including Ten-eleven translocation (TET) family enzymes and histone demethylases, resulting in DNA hypermethylation (CIMP phenotype) and histone hypermethylation. Preclinical data have shown a dramatic anti-tumor effect of hypomethylating drugs as 5-azacytidine on IDH1 mutated human gliomas. These hypomethylating drugs are routinely used in myelodysplasic syndrome (MDS) and are well tolerated.

The AGIR Trial will be a phase II, non-comparative, open label, non randomised monocentric trial evaluating efficacy of a treatment by azacitidine in recurrent IDHm gliomas. The main objective is to evaluate the efficacy of azacitidine according to the RANO criteria on progression-free survival at 6 months, evaluated according to the RANO criteria. Given the slow mode of action of treatment, it is proposed to include only patients whose life expectancy at inclusion is greater than 9 months.

A 6-month progression-free survival of less than 15% will be inefficient. The minimum efficiency must be at least 30%. An interim analysis (according to Fleming's method) will be performed when 19 patients have been included and followed up to 6 months. If the interim analysis is inconclusive, 36 additional patients will be included. The maximum number of analysable patients to include is 55.


title: Comparison of the Clinical Effectiveness of the Quadratus Lumborum Block and Femoral Block in the Analgesia of Total Posterior Hip Arthroplasty

acronym: ATHAQLuB

summary:
Patients are painful after total hip arthroplasty. These patients have significant co-morbidities. Analgesics cause significant side effects in this population. Locoregional analgesia is therefore an effective means of reducing the consumption of opioids in this surgery.

The "gold standard" of locoregional analgesia after Total Hip Arthroplasty is the femoral block. However, a new technique has recently been described: the Quadratus Lumborum Block.

The comparison of these two techniques is lacking in the literature. The comparison of the Quadratus Lumborum Block to the femoral block in Total Hip arthroplasty is important in the analgesic strategy of patients undergoing this surgery.


title: Atrial Function and Supraventricular Arrhythmia of the Veteran Athlete.

summary:
Supraventricular arrhythmias (including atrial fibrillation) are the most common arrhythmias of the veteran athlete and have a major impact in terms of morbidity and mortality. Although moderate sports practice has been shown to decrease the occurrence of these arrhythmias, it has also been shown that very intense athletic activity is associated with an increased risk of developing atrial fibrillation. The pathophysiological mechanism is not clearly understood. However, it has already been shown that intensive sports practice leads to electrical and morphological atrial remodeling, which could be the cause of the occurrence of supraventricular arrhythmias for these athletes.

For sedentary patients, two major tools predict the risk of the onset of supraventricular arrhythmia: the electrocardiogram (ECG) and transthoracic echocardiography (ETT), particularly with the study of atrial function by the analysis of myocardial deformities.


title: Crystalline Exposition During Pediatric Cranial CT Imaging

acronym: ECTOPIC

summary: This study focuses on reduction of X-rays dose applied to eye's lens during cranial CT in children. Principal objective is to analyse the efficiency of ocular bismuth masks, which are associated with an eye's lens dose modulation

lead_sponsor: University Hospital, Bordeaux


title: Detection of Anti-glomerular Basement Membrane Antibodies (Anti-GBM): a Promising Biomarker for Lupus Nephritis (LN) Screening in Systemic Lupus Erythematosus (SLE) Patients?

acronym: GOODLUPUS

summary:
Introduction and background :

Glomerulonephritis and auto-immune diseases are often associated. Lupus nephritis (LN) is one of the major clinical manifestations of systemic lupus erythematosus (SLE) which have a severe impact on prognosis. This complication is a real challenge for clinicians because of insidious-onset and no predictable relapses. Biomarker use is therefore essential, but conventional biomarkers such as proteinuria have poor sensivity and low specificity to predict LN occurrence, and new more reliable biomarkers (genetic, epigenetic or protein biomarkers) are difficult to use for daily medical practice.

Anti-glomerular membrane basement disease (anti-GBM disease) is a rare (0.5 to 1/millions of inhabitants) and severe illness, characterised by rapidly progressive glomerulonephritis, pulmonary haemorrhage and the presence of anti-GBM antibodies, which are highly sensible (100%) and specific (92-100%) of this condition

. Our experience and literature review

In our department of internal medicine, we report one case of anti-GBM glomerulonephritis associated to an active SLE. After literature review, we note the following studies:

some similar association cases had been reported.
In 2006, a Chinese cohort study highlighted important rates of anti-GBM antibodies, in serum samples from patients with SLE (14 positives/157patients (8.9%) using ELISA method). Moreover, every SLE patient with positive circulating anti-GMB antibodies LN and a severer SLE (with significantly more anemias, pulmonary hemorrhage). According to histological data's, they also had more important kidney damages (10/14 had necrotizing crescentic glomerulonephritis lesions and 5/14 fulfil criteria's for anti-GBM disease diagnosis).

We also note that some authors published experimental studies showing that immunological and genetic links exist between LN and anti-GBM disease, which could explain this association.

3. Main Hypothesis: Based on these findings, we suspect that detection of significant levels of circulating anti-GBM antibodies may be more frequent in SLE followed patients than in general population, and that it could be an interesting biomarker of LN in patient with SLE.

4. Objectives First objective: based on 2 SLE patient groups (one having lupus nephritis and the other without it) we would like to compare the ratio of positive anti-GBM antibodies in each group, expecting a higher rate in SLE patients with LN.

Second objective: will be to study the positive anti-GBM group patients in their clinical aspects, serological features and renal characteristics, in this SLE population.

5. Materials and methods We suggest a retrospective analytic transversal controlled study, based on serum samples from the Lupus Biobank of Upper Rhine (LBBR project), and based on serum samples from healthy voluntary blood donors (control group). We will then perform tests in each serum sample group in our immunology laboratory and compare the ratio of positive anti-GBM in each arm.

primary_purpose: Screening


title: The Opinion of Patients With Cancer on the Claeys-Leonetti Law, on Euthanasia and the Search for Determining Factors

acronym: EPAL

summary:
The law of February 2nd 2016, known as Claeys-Leonetti, reformed the legislation of the end of life. It establishes in particular a right of the patient to deep and continuous sedation, makes advance directives binding but refuses access to euthanasia. It states that artificial hydration and nutrition are treatments and not cares, which means that they can be stopped once they are deemed unnecessary, disproportionate or have no other effect than artificial maintenance of life.

While a number of personalities from all walks of life were heard during the parliamentary debate, it was found that patients were not asked about main issues under discussion. Therefore, the investigators found it useful to collect their opinions in the context of individual interviews.

A feasibility study was carried out among 40 patients, which demonstrated the feasibility of such project. This study is the subject of an article which is currently submitted to the BMC Palliative Care Journal.

The main objective is to contribute to the elaboration of the legislation on the end of life, to its adaptation to the wishes of the patients. Patients with cancer and palliative care are directly affected by the legislation on end-of-life, and it seems legitimate that these legislative provisions correspond to their expectations. The aims also to help caregivers to act in accordance with their wishes.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Pharmacogenetics of Veno-Occlusive Disease (VOD) in Children With Haematological Stem Cell Transplantation (HSCT)

acronym: MVO

summary:
This project aims to identify common pharmacogenetic biomarkers predisposing children with cancer to develop hepatic VOD during their cancer treatment including HSCT. The impact of VOD occurrence and significant biomarkers will also be evaluated on outcome at day 100 and one year after HSCT. It should help to highlight factors that can contribute to the initiation of hepatic VOD.

Understanding mechanisms of this toxicity and to know individual parameters of disease susceptibility becomes an important issue in the care of these children. The ultimate goal of research in this area would be to develop a personalized predictive medicine and, hopefully, prevent the occurrence of VOD from a therapeutic adaptation to each patient according to his pharmacogenetic profile (adapted prophylaxis, dose adjustment, drug combinations ...). A prospective identification of patients at risk of hepatic VOD will increase the safe use of anticancer.


title: Refractory Diffuse Large B-cell Lymphoma After First-line Immuno-CT: Treatment Options and Outcomes

summary: In the rituximab era, one-third of diffuse large B-cell lymphoma (DLBCL) patients experience relapse/refractory disease after first-line anthracycline-based immunochemotherapy (IChemo). Optimal management remains an unmet medical need. The aim of this study was to report the outcomes of a cohort of refractory patients according to their patterns of refractoriness and the type of salvage option. The investigators performed a retrospective analysis, which included 104 DLBCL patients treated at Lyon Sud University Hospital (2002-2017) who presented with refractory disease. The investigators retrospectively evaluated the outcomes of a cohort of 104 refractory patients according to their patterns of refractoriness and the type of salvage option.

lead_sponsor: Hospices Civils de Lyon


title: Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.

summary:
Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.

In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.


title: DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)

acronym: DIANA

summary:
Appropriate initial antibiotic therapy is crucial in the treatment of severe infections in patients with intensive care. Adequate spectrum and appropriate doses are the keys to achieving the therapeutic goal. Despite broad consensus on the spectrum and timing of antimicrobial therapy, antibiotic use varies according to various parameters including choice, dose, method of administration, duration of antibiotic therapy and de-escalation. an empirical attitude.

Therapeutic de-escalation is considered essential for the use of antibiotics and is now clearly established by different consensus. However, routine de-escalation has recently been questioned in a randomized, controlled study that did not demonstrate non-inferiority of de-escalation with an increase in the number of days of antibiotic therapy associated with an increased number of days. superinfection.

The components of the de-escalation described in the literature, are based on the reduction of the number of antibiotics, the strict observance of the spectrum of the antibiotic, the reduction of use of the antibiotic, the stopping of any inappropriate antibiotic treatment ( lack of in vitro activity).

De-escalation can be considered in different ways; there are significant variations between hospitals, countries, teams. A large European multicenter cohort is needed.

The main objective of this study is to describe empiric antibiotic therapy in intensive care and the modalities of de-escalation.


title: FALCOn (Facteur AnthropoLogique Cancer Orl) Evaluation Des Facteurs Anthropologiques, Socio-culturels et Psychologiques Des Praticiens Qui Conditionnent la Prise de décision Pour Les Patients Atteints de Cancer Des VADS

acronym: FALCOn

summary:
There are no studies on practitioner-related factors influencing decision-making in the field of carcinology of aerodigestive carcinomas. The objective of the study is to determine what are the anthropo-sociological factors in the surgeon, the oncologists and radiotherapists influencing decision making in ear, nose, and throat carcinology. Special attention will be paid to the practitioner's gender, age, geographical origin, place and institution of training, place of practice, volume of patients treated, access to or without reconstruction by microsurgery, his tendency or aversion to risk taking.

Main objectives : To determine the individual professional and non-professional characteristics influencing physicians' decision-making in oncology of aerodigestive carcinomas between choices:

Surgery
Radio and / or chemotherapy
Support care
Neo-adjuvant chemotherapy and reassessment
Secondary objectives : Identify if certain patient profiles may lead to heterogeneous treatment decisions i.e. Human Papillomavirus status, age, comorbidities, autonomy, etc.

ReferenceCitation: Krähenmann-Müller S, Virgini VS, Blum MR, da Costa BR, Collet TH, Martin Y, Cornuz J, Zimmerli L, Gaspoz JM, Bauer DC, Kerr EA, Aujesky D, Rodondi N. Patient and physician gender concordance in preventive care in university primary care settings. Prev Med. 2014 Oct;67:242-7. doi: 10.1016/j.ypmed.2014.08.004. Epub 2014 Aug 10.

ReferenceCitation: Andersen MR, Urban N. Physician gender and screening: do patient differences account for differences in mammography use? Women Health. 1997;26(1):29-39.

ReferenceCitation: Franks P, Clancy CM. Physician gender bias in clinical decisionmaking: screening for cancer in primary care. Med Care. 1993 Mar;31(3):213-8.

ReferenceCitation: Frank E, Harvey LK. Prevention advice rates of women and men physicians. Arch Fam Med. 1996 Apr;5(4):215-9.

ReferenceCitation: Arrington AK, Jarosek SL, Virnig BA, Habermann EB, Tuttle TM. Patient and surgeon characteristics associated with increased use of contralateral prophylactic mastectomy in patients with breast cancer. Ann Surg Oncol. 2009 Oct;16(10):2697-704. doi: 10.1245/s10434-009-0641-z. Epub 2009 Aug 4.

ReferenceCitation: Tsugawa Y, Jena AB, Figueroa JF, Orav EJ, Blumenthal DM, Jha AK. Comparison of Hospital Mortality and Readmission Rates for Medicare Patients Treated by Male vs Female Physicians. JAMA Intern Med. 2017 Feb 1;177(2):206-213. doi: 10.1001/jamainternmed.2016.7875.

ReferenceCitation: Mehrotra A, Reid RO, Adams JL, Friedberg MW, McGlynn EA, Hussey PS. Physicians with the least experience have higher cost profiles than do physicians with the most experience. Health Aff (Millwood). 2012 Nov;31(11):2453-63. doi: 10.1377/hlthaff.2011.0252.

ReferenceCitation: Meier P, Duvernoy CS. Influence of gender of physicians and patients on guideline-recommended treatment of chronic heart failure in a cross-sectional study. Eur J Heart Fail. 2009 Jun;11(6):631; author reply 631-2. doi: 10.1093/eurjhf/hfp056. Epub 2009 Apr 27.

ReferenceCitation: Berthold HK, Gouni-Berthold I, Bestehorn KP, Böhm M, Krone W. Physician gender is associated with the quality of type 2 diabetes care. J Intern Med. 2008 Oct;264(4):340-50. doi: 10.1111/j.1365-2796.2008.01967.x. Epub 2008 Apr 4.

ReferenceCitation: Reid RO, Friedberg MW, Adams JL, McGlynn EA, Mehrotra A. Associations between physician characteristics and quality of care. Arch Intern Med. 2010 Sep 13;170(16):1442-9. doi: 10.1001/archinternmed.2010.307.

ReferenceCitation: Schieber AC, Delpierre C, Lepage B, Afrite A, Pascal J, Cases C, Lombrail P, Lang T, Kelly-Irving M; INTERMEDE group. Do gender differences affect the doctor-patient interaction during consultations in general practice? Results from the INTERMEDE study. Fam Pract. 2014 Dec;31(6):706-13. doi: 10.1093/fampra/cmu057. Epub 2014 Sep 11.

ReferenceCitation: Allais, M. (1953). L'extension des théories de l'équilibre économique général et du rendement social au cas du risque. Econometrica, Journal of the Econometric Society, 269-290.

ReferenceCitation: Chabrillac E, Lamy S, Grosclaude P, Cros F, Vairel B, Sarini J, Vergez S, Nebout A, Bories P, Dupret-Bories A. The impact of physician's characteristics on decision-making inhead and neck oncology: Results of a national survey. Oral Oncol. 2022 Jun;129:105895. doi: 10.1016/j.oraloncology.2022.105895. Epub 2022 Apr 29.


title: Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era

summary:
Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well known and may represent a difficult challenge.

Patients and Methods: The investigators conducted a retrospective analysis of FL patients who relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical records were reviewed for clinical characteristics and treatment strategy at relapse. The investigators aimed to identify prognostic factors related to patient's outcome.

location_facility: Centre Hospitalier Lyon Sud, Hematology department


title: Strain Echocardiography During Septic Shock : an Observational Pilot Study

acronym: Sepsistrain

summary:
The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome.

In the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Initial Nutritional Strategy and Stature-level Growth During the Neonatal Period of Children Born Moderately Premature: Cohort EPIPAGE 2

summary:
The growth and nutrition of premature infants during the neonatal period is a concern of neonatology services; it impacts the child's health in the short and long term. The weight deficit, but especially the weak growth of the cranial perimeter during the Neonatal period is associated with an increased risk of long-term neuro-cognitive impairment.

The optimal nutritional strategy, during the neonatal period, of children born moderately premature is not known.

The optimization of nutrition in premature children is therefore a topical issue in neonatology.

Our project aims to evaluate the impact of an aggressive early nutritional strategy characterized by optimized caloric and protein intakes on the stature-level growth of 2000 children born moderately premature GA from 30 WA (week of amenorrhea) to 32 WA + 6 days and included in the national cohort of follow-up of children of small gestational ages.

Nutritional intake during the first week of life will be analyzed in tertile. Children will be grouped according to their calorie and protein during the first week of life. The tertile 1 will represent the group of children with the lowest nutritional intake (called the "nutrition not aggressive "), the tertile 3 will define the group of children presenting the contributions highest nutritional levels (called the "aggressive nutrition" group).

The primary endpoint will be the z-score change in weight, height and head circumference between birth and age (36 adjusted age WA) between the "nonaggressive nutrition" group and the group. "Aggressive nutrition".

The benefits are for public health to harmonize neonatal care practices within a region and to better understand the impact of nutritional strategies on long-term neuro-cognitive development.


title: Correlation Between Clinical Signs and High-resolution Manometry Data in Children

summary:
High resolution oesophageal manometry (HRM) is the gold standard for the diagnosis of oesophageal motility disorder.

Standard esophageal manometry has been replaced since 2000 by high resolution manometry. This one allows a more precise study with a spatio-temporal representation of the esophageal pressure values as well as an easier realization with in particular a better tolerance of the examination which is important in pediatrics.

Over a period of 10 years only a dozen studies were conducted in children. No study to date has evaluated the global place of MHR in current practice in children across all indications.

The indications that lead to the realization of a manometry in children are given by some experts but there is currently no clinical study to define the sensitivities, specificity and predictive values of clinical symptoms leading to the completion of this examination and endoscopic signs found upstream.

In addition, the link between certain underlying conditions and the manometric result has never been evaluated.

II / Objective: The objective of our study is to calculate the sensitivity, the specificity and the predictive values of each clinical and endoscopic sign according to the manometric result found and this by age group. The goal is to better define the predictive signs of the selected manometric diagnoses and therefore the indications to remember in the child.

III / Methodology:

Bi-centric retrospective collection of data on patient records in Marseille and Lille. Collection dates: from 2012 (beginning of high resolution manometry in Marseille and Lille) to December 2016.

The clinical and endoscopic signs selected will be decided a priori by an expert committee consisting of 2 adult gastroenterologists specializing in manometry, 1 pediatrician specialist in manometry, and 3 gastro-pediatricians.

Inclusion Criteria: All minor patients (<18 years old) referred for 1 st high-resolution manometry (or 2 nd or more examination if performed in the presence of a new symptom).

Number of subjects planned: all the patients who had a manometry (about 300 patients) over the given period


title: Prospective Analysis of "Genotype-phenotype" Correlations Observed in a Large Cohort of Patients With Hereditary Retinal Dystrophies - GEPHIRD

acronym: GEPHIRD

summary:
This study will carry out a detailed descriptive analysis of a large population of patients with hereditary retinal dystrophies (HRD): clinical, paraclinical and genetic data.

The information drawn from these analyzes will provide a better understanding of the pathophysiology of these rare diseases and this may ultimately impact the medical management of patients (targeted therapy).

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmologique Adolphe de Rothschild


title: Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers

acronym: SDRA-OPEX

summary: The purpose of this study is to evaluate the incidence of the ARDS in the French wounded soldiers.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte Anne


title: Comprehensive Assessment of Motor Imagery Ability After Stroke

acronym: AVCIM

summary: Individuals with stroke may experience sensory-motor deficit and/or neglect, with possible reduction in motor imagery ability (MI). To our knowledge, no study completely investigated MI ability in one individual whereas MI practice can be performed using visual or kinesthetic modalities (respectively visualizing with mind's eyes or imagining movement using sensation) and internal or external perspectives (performing action as spectator or as actor). This study aims to investigate MI ability in patients with stroke as compared to aged-matched healthy individuals. The investigators will assess explicit MI ability using 3 questionnaires (Movement Imagery Questionnaire-RS - MIQ-RS, Kinesthetic and Visual Imagery Questionnaire-20 - KVIQ-20, Vividness of Movement Imagery Questionnaire-2 - VMIQ-2) and 2 tests (imagined Time Up and Go - iTUG, imagined Box and Block test - iBBT). Outcome parameters will be i) the composite score of vividness measured for all tests using Likert scales, ii) the temporal equivalence between MI and Physical practice (PP - where MI/PP ratio equal to 1 indicate good MI ability and respect of temporal equivalence between MI and PP) and iii) the amplitude of electrodermal activity. The investigators will also study implicit MI ability using a hand laterality judgment task. Outcomes parameters will be response time (i.e. the duration to identify the hand laterality) and the percentage of correct responses.


title: Better Understanding Slow Language Impairment: Cognitive and Genetic Mechanisms

summary: This study was designed to examine the development of children aged 6 to 10 with slow language impairment (SLI). The aim was threefold: (1) to investigate language skills of children with SLI at different levels - formal, semantic, pragmatic- in comparison with those of control children; (2) to test a procedural deficit hypothesis: abnormal development in the procedural memory system could account for some language deficits; (3) to make genotype-phenotype comparisons, focusing on the different levels of language development and on procedural skills. The main hypothesis is that genetic mutations, contingently epistatique, will lead to procedural learning deficit, which will have a negative impact on language skills at the formal level and consequently on semantic and pragmatic levels.