title: Comparison of Both Metabolic and Functional Effects Induced by Two Neuromuscular Electrical Stimulation Protocols: A Comprehensive Approach Using Magnetic Resonance Imaging and Spectroscopy

summary: Neuromuscular electrical stimulation (NMES) has emerged as a suitable tool for restoring, maintaining and/or enhancing muscular performance. From a practical point of view, NMES can elicit contractions either by direct activation of motor axons (i.e. peripheral mechanism) or by the recruitment of motoneurons in the spinal cord through the depolarization of sensory axons (central mechanism). It is noteworthy that NMES parameters widely affect the balance between transmission along these two pathways. Conventional NMES is usually delivered using short pulse duration (0.05-0.4 ms), low stimulation frequency (15-40 Hz) and high stimulus intensities so that the large antidromic volley in motor axons ensures that the evoked contraction will be driven largely by the direct depolarization of motor axons beneath the stimulation site with no or little involvement of central nervous system. On the contrary, when NMES is delivered using wide pulse widths (1 ms) and high frequency (up to 100 Hz) (WP-HF NMES), a portion of the evoked contraction arises from a central mechanism and the corresponding force (recently referred to as "extra force") is significantly (three times) larger than the conventional NMES-induced force. This extra force is supposed to represent the central contribution from the recruitment of spinal motoneurons by the evoked afferent volley given that no additional force was observed during a complete anesthetic block of the nerve proximal to the stimulation site. Despite the obvious differences in terms of activation of the neuromuscular system between conventional and WP-HF NMES, the functional, metabolic and cortical responses associated to both protocols remain to be determined

lead_sponsor: Assistance Publique Hopitaux De Marseille


type: Other Identifier

title: Abilities of Dynamic Preload Dependence Indicators to Predict Fluid Responsiveness During Neurosurgery in Sitting Position

summary: Intraoperative optimization of cardiac output using goal directed fluid challenge is associated with better outcome. Dynamic preload dependence indicators are well validated during surgery in supine position. Positioning from supine to sitting position under anesthesia is responsible of several hemodynamic changes. Predictability and cut-off values of dynamic preload dependence indicators during surgery in sitting position are unknown. The objective of this prospective study is to evaluate ability of three dynamic preload dependence indicators, i.e. PPV (Pulse Pressure Variation), SVV (Stroke Volume Variation) and PVI (Plethysmographic Variability Index), during neurosurgery in sitting position.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility: Fédération d'anesthésie réanimation Hôpital Pierre Wertheimer

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Interest in the Medium Term of an Infrared Reflexotherapy on Overweight or Class I Obese People

acronym: REFLEX-IR

summary:
It is known that the care that is offered to overweigh of class I obese people leads to an initial weight loss.

However, after 12 months, people start to gain their weight back. French National Authority for Health suggests that physicians warn their patients against restrictive diets that can are the origin of weight's fluctuation can be health threatening. This weight regain is linked to numerous factors, mainly dietary compensation phenomenon tied to cravings (Lecerf, 2013. Obésité : pourquoi les regimes échouent-ils ? Nutr Clin Metab (in press)).

Due to the difficulties to keep the weight loss, it seems interesting to consider alternatives like reflexotherapy. This method seems to act in reducing the dietary urges causes by stress, by cravings or by frustration.

This technique would allow to re-establish normal hormones' or neurotransmitters' concentrations mainly involved in the food intake.

This could be a complementary response to the limits of the classic treatments for weight maintenance management, but it needs to be confirmed by a specific study.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

lead_sponsor: Institut Pasteur de Lille

intervention_type: Device

status_simplified: Unknown


title: Interest of a Geriatric Intervention Plan Associated to a Comprehensive Geriatric Assessment on Autonomy, Quality of Life and Survival of Patients Aged 70 Years Old and More Surgically Treated for a Resectable Cancer (Thoracic, Digestive or Urologic). Randomized Multicentric Study

acronym: epigac

summary:
The curative treatment of thoracic (lung and oesophagus), digestive (gastric, pancreatic, hepatic, colorectal), and urologic (renal, bladder, prostatic) cancers needs a surgical resection. For patients aged of 70 years old and more, this surgery is associated to an increased morbid-mortality especially because of more frequent co-morbidities. Comprehensive geriatric assessment (CGA) allows distinguishing patients for whom a resection surgery can be complicated by high morbid-mortality or a loss of autonomy. It has been proved that for old patient population without cancer, CGA associated with a geriatric intervention plan (GIP) allows autonomy preservation, decrease of institution admission, and survival improvement. The reference study showed that a CGA associated to a GIP improves survival of old patients who had a cancer surgery. However this study included patients from 60 years old and the GIP consisted in 3 home visits and 5 phone calls during the 4 weeks following hospital discharge.

We propose to perform a prospective and randomized study to evaluate the impact of a CGA with GIP in 70 years old and more patients with a thoracic, digestive or urologic cancer resection, respectively 1, 3, 6 and 12 months after discharge. CGA and GIP will focus on 8 distinct fields: autonomy, co-morbidities, co-medication, mobility, nutritional status, depression, cognitive function and social status. The impact of such a strategy on autonomy and survival has never been studied.

primary_purpose: Supportive Care

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Other


title: Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo

summary:
Atrial fibrillation remains a major cause of morbidity following cardiac surgery with cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong endogenous vasodilating agent has been involved in cardiac surgery-induced atrial fibrillation, via A2A receptors modulation.

The effects of caffeine on the inducibility of atrial fibrillation are actually well-known, leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical study has demonstrated that coffee drinking was inversely associated with total and cause-specific mortality.

The investigators therefore examined the preventive effects of oral caffeine on valvular surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A adenosine receptors modulation.

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Lagier D, Nee L, Guieu R, Kerbaul F, Fenouillet E, Roux N, Giorgi R, Theron A, Grisoli D, Gariboldi V, Collart F, Bruder N, Velly L, Guidon C. Peri-operative oral caffeine does not prevent postoperative atrial fibrillation after heart valve surgery with cardiopulmonary bypass: A randomised controlled clinical trial. Eur J Anaesthesiol. 2018 Dec;35(12):911-918. doi: 10.1097/EJA.0000000000000824.

family: Lagier

full_name: David Lagier

given: David

sequence: first

family: Nee

full_name: Laetitia Nee

given: Laetitia

sequence: additional

family: Guieu

full_name: Régis Guieu

given: Régis

family: Kerbaul

full_name: François Kerbaul

given: François

family: Fenouillet

full_name: Emmanuel Fenouillet

given: Emmanuel

family: Roux

full_name: Nicolas Roux

given: Nicolas

family: Giorgi

full_name: Roch Giorgi

given: Roch

family: Theron

full_name: Alexis Theron

given: Alexis

family: Grisoli

full_name: Dominique Grisoli

given: Dominique

family: Gariboldi

full_name: Vlad Gariboldi

given: Vlad

family: Collart

full_name: Frederic Collart

given: Frederic

family: Bruder

full_name: Nicolas Bruder

family: Velly

full_name: Lionel Velly

given: Lionel

family: Guidon

full_name: Catherine Guidon

given: Catherine

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

intervention_type: Drug


title: Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy

acronym: MTM-COLON-II

summary: The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.

ReferenceType: background

ReferenceCitation: Solligård E, Juel IS, Spigset O, Romundstad P, Grønbech JE, Aadahl P. Gut luminal lactate measured by microdialysis mirrors permeability of the intestinal mucosa after ischemia. Shock. 2008 Feb;29(2):245-51.

ReferenceCitation: Cibicek N, Živná H, Zadák Z, Kulír J, Čermáková E, Palicka V. Colon submucosal microdialysis: a novel in vivo approach in barrier function assessment - a pilot study in rats. Physiol Res. 2007;56(5):611-617. Epub 2006 Dec 19.

ReferenceCitation: Krejci V, Hiltebrand L, Büchi C, Ali SZ, Contaldo C, Takala J, Sigurdsson GH, Jakob SM. Decreasing gut wall glucose as an early marker of impaired intestinal perfusion. Crit Care Med. 2006 Sep;34(9):2406-14.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure

acronym: CBP-DO

summary: Investigators will evaluate determinants of the patients' care type : palliative, medical or intensive care. The place of patient or family on care's decision will be noticed. Investigators will evaluate 3 month-survival and patients' feelings (visit with a psychologist) according to type of care they benefited.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Grenoble


title: Pilot Study of the Efficacy and Tolerance of the Adjunction of a Fish Oil Emulsion to Daunorubicin and Cytarabine Chemotherapy for the Treatment of Acute MYeloblastic Leukemia of Younger Patients With High-risk Cytogenetics

acronym: FAMYLY

summary: Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients (under 61 years) with high-risk cytogenetics.

ReferenceCitation: Picou F, Debeissat C, Bourgeais J, Gallay N, Ferrié E, Foucault A, Ravalet N, Maciejewski A, Vallet N, Ducrocq E, Haddaoui L, Domenech J, Hérault O, Gyan E. n-3 Polyunsaturated fatty acids induce acute myeloid leukemia cell death associated with mitochondrial glycolytic switch and Nrf2 pathway activation. Pharmacol Res. 2018 Oct;136:45-55. doi: 10.1016/j.phrs.2018.08.015. Epub 2018 Aug 22.

family: Picou

full_name: Frédéric Picou

given: Frédéric

family: Debeissat

full_name: Christelle Debeissat

given: Christelle

family: Bourgeais

full_name: Jérôme Bourgeais

given: Jérôme

family: Gallay

full_name: Nathalie Gallay

given: Nathalie

family: Ferrié

full_name: Elise Ferrié

given: Elise

family: Foucault

full_name: Amélie Foucault

given: Amélie

family: Ravalet

full_name: Noémie Ravalet

given: Noémie

family: Maciejewski

full_name: Aurore Maciejewski

given: Aurore

family: Vallet

full_name: Nicolas Vallet

family: Ducrocq

full_name: Elfi Ducrocq

given: Elfi

family: Haddaoui

full_name: Lamya Haddaoui

given: Lamya

family: Domenech

full_name: Jorge Domenech

given: Jorge

family: Hérault

full_name: Olivier Hérault

given: Olivier

family: Gyan

full_name: Emmanuel Gyan

journal_name: Pharmacological Research

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Gyan E, Raynard B, Durand JP, Lacau Saint Guily J, Gouy S, Movschin ML, Khemissa F, Flori N, Oziel-Taieb S, Bannier Braticevic C, Zeanandin G, Hebert C, Savinelli F, Goldwasser F, Hébuterne X; NutriCancer2012 Investigator Group. Malnutrition in Patients With Cancer: Comparison of Perceptions by Patients, Relatives, and Physicians-Results of the NutriCancer2012 Study. JPEN J Parenter Enteral Nutr. 2018 Jan;42(1):255-260. doi: 10.1177/0148607116688881. Epub 2017 Dec 11.

name: Hematology and Cell Therapy, Tours Teaching Hospital (CHRU), Tours, France and Faculty of Medicine of Tours, University François Rabelais, Tours, France

name: Dietetic and Nutrition Unit, Gustave Roussy, Cancer Campus, Grand Paris, France

family: Raynard

full_name: Bruno Raynard

given: Bruno

name: Medical Oncology, Cochin Teaching Hospital, AP-HP, Paris, France and University Paris Descartes, Paris, France

family: Durand

full_name: Jean-Philippe Durand

given: Jean-Philippe

name: Otolaryngology Head and Neck Surgery, Tenon Teaching Hospital, AP-HP, Paris, France and University Pierre et Marie Curie, Paris VI, France

family: Lacau Saint Guily

full_name: Jean Lacau Saint Guily

given: Jean

name: Gynecological Surgery, Gustave Roussy, Cancer Campus, Grand Paris, France

family: Gouy

full_name: Sébastien Gouy

given: Sébastien

name: Digestive and Hepatobiliary Surgery, Pitié-Salpêtrière Teaching Hospital, AP-HP, Paris, France and University Pierre et Marie Curie, Paris VI, France

family: Movschin

full_name: Marie Lespiau Movschin

given: Marie Lespiau

name: Gastroenterology, Perpignan Hospital, Perpignan, France

family: Khemissa

full_name: Faiza Khemissa

given: Faiza

name: Clinical Nutrition and Gastroenterology, Cancer Institute (ICM Val d’Aurelle), Montpellier, France

name: Medical Oncology, Paoli-Calmettes Institute, Marseille, France

name: Oncology and Geriatrics, Paoli-Calmettes Institute, Marseille, France

name: Gastroenterology and Clinical Nutrition, Nice Teaching Hospital (CHU) and University of Nice Sophia-Antipolis Nice, France

name: Oncology, Antoine Lacassagne Institute, Nice, France

name: Medical Oncology, Saint-Joseph Hospital, Paris, France. A complete list of collaborators is presented in the acknowledgment section.

journal_name: Journal of Parenteral and Enteral Nutrition

title: Malnutrition in Patients With Cancer


title: Phenotype/Genotype Correlation in a Family With Early Onset Osteoarthritis: Contribution of Genetic in the Diagnosis and Early Management of Patients.

acronym: Exorhum

summary:
This study will investigate the genes responsible for osteoarthritis. Individuals with osteoarthritis known or suspected to be caused by a gene mutation (change) may be eligible for this study. Family members may also participate.

Patients will talk with investigators who will explain the study and its possible implications for the patient and family and answer questions. The patient's medical records will be reviewed, a personal and family history will be taken, and a physical examination will be done. Two procedures may be done including blood sampling (which will be used for DNA (genetic) studies) and X-rays (to define osteoarthritis grade).

If no known mutations responsible for osteoarthritis will be detected, participating family members will be interviewed by telephone about their personal and family health history and will have a blood sample drawn for DNA testing, and X-rays.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Caen

intervention_type: Radiation


title: Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site

acronym: ROPI

summary:
The aim of the study is to Evaluate of the analgesic effect of ropivacaine in topical use at the thin skin graft donor site.

For Patient needing a thin skin graft < 320 cm2, randomization will be done in 2 groups, one receiving the standard treatment (20 mL of physiologic serum) during the surgical intervention in topical use to recover an alginate dressing (Algosteril)and the other receive 20 mL of Naropein during the surgical intervention on alginate dressing.

The hypothesis of the study is the administration of ropivacaine will decrease the post-operative pain compared to physiologic serum

lead_sponsor: University Hospital, Rouen


title: Hypertension of Our Patients: Knowledge, Control, Comorbidity

summary:
Numerous studies highlight the insufficiency of blood pressure control in treated hypertensive population [1].

As shown in the MONICA study, increased cardiovascular mortality is found in Alsace compared to other french regions. The incidence and prevalence of diabetes and obesity are likely explanatory factors leading to this excess mortality [2].

Furthermore, the incidence and prevalence of alsacian patients with end-stage renal failure (ESRD) is also higher than the national average. The high prevalence of diabetes, hypertension and obesity in this population is also probably responsible for the high prevalence of ESRD [3].

Opportunities to prevent the progression of kidney disease involve an optimal control of treatable evolutionary factors.

Beyond control of diabetes and obesity, optimization of blood pressure control are an important factor to consider, as national and international guidelines recommend lower blood pressure targets in this population [4]. Knowledge of the disease and treatment goals are a key component of hypertensive patient management. Studies have shown that the knowledge of hypertensive disease and therapeutic targets were correlated with treatment compliance and with the rate of blood pressure control [5]. Patient education and participation of non-medical actors (nurses, pharmacists, …) are likely to improve the management and treatment compliance of these patients [6]. To our knowledge, no investigation has been performed in our region to determine the epidemiological characteristics, the knowledge level and blood pressure control in the population of hypertensive patients. The main objectives of this observational study are to evaluate, in a treated hypertensive population:

the knowledge level of the blood pressure treatment goals, the impact of patient knowledge on this blood pressure control, the potential impact of the patient's comorbidities on his blood pressure control.

Such a study should provide the basis for the feasibility of a large survey.

ReferenceCitation: Mancia G, Sega R, Milesi C, Cesana G, Zanchetti A. Blood-pressure control in the hypertensive population. Lancet. 1997 Feb 15;349(9050):454-7.

ReferenceCitation: Bérard E, Bongard V, Arveiler D, Amouyel P, Wagner A, Dallongeville J, Haas B, Cottel D, Ruidavets JB, Ferrières J. Ten-year risk of all-cause mortality: assessment of a risk prediction algorithm in a French general population. Eur J Epidemiol. 2011 May;26(5):359-68. doi: 10.1007/s10654-010-9541-6. Epub 2010 Dec 28.

ReferenceCitation: Registre REIN Rapport annuel 2010

ReferenceCitation: Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, Cifkova R, Clément D, Coca A, Dominiczak A, Erdine S, Fagard R, Farsang C, Grassi G, Haller H, Heagerty A, Kjeldsen SE, Kiowski W, Mallion JM, Manolis A, Narkiewicz K, Nilsson P, Olsen MH, Rahn KH, Redon J, Rodicio J, Ruilope L, Schmieder RE, Struijker-Boudier HA, Van Zwieten PA, Viigimaa M, Zanchetti A. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. Blood Press. 2009;18(6):308-47. doi: 10.3109/08037050903450468.

ReferenceCitation: Atallah A, Papouin G, Mimran C, Braunstein C, Ganty J, Larifla L, Djaballah K, Inamo J. [Knowledge of hypertension among hypertensive patients in general practice, and its relation to achieving therapeutic goals: The Co-HACT study, French West Indies]. Ann Cardiol Angeiol (Paris). 2011 Feb;60(1):21-6. doi: 10.1016/j.ancard.2010.06.001. Epub 2010 Jul 16. French.

ReferenceCitation: M Ashok Kumar. Improving medication adherence and clinical outcomes of hypertensive patients through patient counseling. Research Journal of Pharmaceutical, Biological and Chemical Sciences 2011; 2: 232-241

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: Predictive Factors of the Reduction of Emotional Eating After a Behavior Change Program Among Individuals With Obesity of Class II and Class III.

summary: Recent studies show that overweight people have a greater sensitivity to the rewarding aspect of food due to the disturbance of the dopaminergic system. These perturbations lead to a greater amount of food to satisfy this rewarding aspect. Then, this rewarding aspect to food would also facilitate food intake related to emotions, whether they are positive or negative. However, the food intake in response to emotions can be modulated by physical activity. But, there are no interventional studies in the literature examining the behavioral and biological factors related to emotional eating together with the fact, there are few data on the explanatory mechanisms. The purpose of the study is to evaluate the predictive factors of emotional eating 6 months after a behavior change program adapted to the motivational state and to identify the its underlying mechanisms

primary_purpose: Basic Science

lead_sponsor: University Hospital, Montpellier

location_facility: University Hospital of Montpellier-Hopital La colombière


title: Immunologic Profile of Children and Teenagers With Severe Allergy to Peanuts and Nuts After Induction of Tolerance: a Pilot Project

acronym: TOY

summary:
Many authors propose the strict avoidance of allergenic food as the only treatment for children known to be allergic to certain food. However, it has been observed an increase of the frequency and severity of the allergic accidents in these children in the long term. Other teams have suggested treating these allergies (in particular peanut allergies) by controlled and progressive reintroduction of the allergenic food. A good tolerance and a prevention of allergic reactions consecutive to the ingestion of the same allergenic food were observed. The immunological mechanisms of this type of treatment are not well known.

A decrease of specific IgE and an increase of IgG4 have been observed in the case of egg allergies after this kind of treatment. Certain experiments realized in mice models testing the allergenic stimulation challenge showed an increase of lymphocytes T regulators (foxp3+ , CD4+, CD25+), stimulated by dendritic cells, and also an increase of interleukin 10, leading to the modification of the balance between Th1 and Th2.Our hypothesis is that after treating allergies by the reintroduction of the allergenic food, the immunological mechanism of acquisition of tolerance is associated to variations in populations of lymphocytes and in the activation or decrease of pro and anti-inflammatory cytokines. This reaction will be studied in two groups: 1. Children with a confirmed allergy to peanuts or nuts and 2. Children without antecedents of allergy or familiar atopy.

lead_sponsor: Lille Catholic University

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


title: The Proposed Study is to Validate a New Non-invasive Imaging Technique for Evaluation of Cardiac Microciculation in Coronary Artery Disease With a Comparison With Validated Technique Invasive, Which is Measure of Index of Myocardial Resistance

acronym: EVACORY

summary: The proposed study is to validate a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease with a comparison with validated technique invasive, which is measure of index of myocardial resistance.


title: Effects of Physical Activity Program on the Emotional and Cognitive Dynamics in Major Depressive Disorder Patients

summary: The main objective of this study is to evaluate the effect of a 12 weeks adapted physical activity program (active walking) on depression by analyzing the dynamics of emotional and cognitive functioning. The secondary objectives are to test the effects of a physical activity on functional performance and to highlight psychological mechanisms.

primary_purpose: Health Services Research

ReferenceCitation: Deschamps T, Thomas-Ollivier V, Sauvaget A, Bulteau S, Fortes-Bourbousson M, Vachon H. Balance characteristics in patients with major depression after a two-month walking exercise program: A pilot study. Gait Posture. 2015 Oct;42(4):590-3. doi: 10.1016/j.gaitpost.2015.07.057. Epub 2015 Jul 31.

family: Deschamps

full_name: Thibault Deschamps

given: Thibault

family: Thomas-Ollivier

full_name: Véronique Thomas-Ollivier

given: Véronique

family: Sauvaget

full_name: Anne Sauvaget

given: Anne

family: Bulteau

full_name: Samuel Bulteau

given: Samuel

family: Fortes-Bourbousson

full_name: Marina Fortes-Bourbousson

given: Marina

family: Vachon

full_name: Hugo Vachon

given: Hugo

journal_name: Gait & Posture

lead_sponsor: Laboratory Motricité, Interactions, Performance

lead_sponsor_type: industriel


title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities

summary: The aim of this study was to find functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.

primary_purpose: Prevention

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche en Nutrition Humaine Auvergne


title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities in Free-living Conditions (eMouve 2)

summary: The aim of this study was to validate functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.


title: A Cohort to Quantify and to Predict Treatment Related Chronic Toxicities in Patients With Non-metastatic Breast Cancer

acronym: CANTO

summary:
The aims of the cohort will be to quantify impact of cancer treatments toxicities , and to generate predictors of chronic toxicity in patients with non-metastatic breast cancer.

The project will include four specific aims :

To develop a database of chronic treatment related toxicity in a cohort of 13250 women with stage I-III breast cancer (= non metastatic), whatever these treatments are (surgery; radiation therapy; chemotherapy …)
To describe incidence, clinical presentation, and outcome of chronic toxicities over a maximum of 8 years.
To describe the psychological, the social and the economic impacts of chronic toxicities.
To generate predictors for chronic toxicities in order to prevent them, based upon biological criteria.

The expected impact of these toxicities, when identified, will be to improve quality of life and to decrease health cost, by the early identification of patients at high risk of toxicity. Such early identification could lead to prevent toxic effect by: a. developing prevention strategies, b. substituting toxic treatment by a non (less) toxic one.

Also, such cohort will offer a quantification of the impact of treatment toxicity, that could be further used to quantify medical usefulness of strategies that aim at decreasing treatment toxicities (implementation of predictive biomarker for resistance, cytotoxic-free regimen etc…)

status: Recruiting

primary_purpose: Other

ReferenceCitation: Caumette E, Vaz-Luis I, Pinto S, Havas J, Bovagnet T, Ruiz de Azua G, Di Meglio A, Martin AL, Everhard S, Cottu P, Vanlemmens L, Jouannaud C, Lerebours F, Dumas A, Menvielle G. The Challenge of Return to Work after Breast Cancer: The Role of Family Situation, CANTO Cohort. Curr Oncol. 2021 Oct 1;28(5):3866-3875. doi: 10.3390/curroncol28050330.

family: Caumette

full_name: Elsa Caumette

given: Elsa

family: Vaz-Luis

full_name: Inès Vaz-Luis

given: Inès

family: Pinto

full_name: Sandrine Pinto

given: Sandrine

family: Havas

full_name: Julie Havas

given: Julie

family: Bovagnet

full_name: Thomas Bovagnet

given: Thomas

family: Ruiz de Azua

full_name: Garazi Ruiz de Azua

given: Garazi

family: Di Meglio

full_name: Antonio Di Meglio

given: Antonio

family: Martin

full_name: Anne-Laure Martin

given: Anne-Laure

family: Everhard

full_name: Sibille Everhard

given: Sibille

family: Cottu

full_name: Paul Cottu

given: Paul

family: Vanlemmens

full_name: Laurence Vanlemmens

given: Laurence

family: Jouannaud

full_name: Christelle Jouannaud

given: Christelle

family: Lerebours

full_name: Florence Lerebours

given: Florence

family: Dumas

full_name: Agnès Dumas

given: Agnès

family: Menvielle

full_name: Gwenn Menvielle

given: Gwenn

currency_apc_doaj: CHF

journal_name: Current Oncology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: MDPI AG

ReferenceCitation: Di Meglio A, Menvielle G, Dumas A, Gbenou A, Pinto S, Bovagnet T, Martin E, Ferreira AR, Vanlemmens L, Arsene O, Ibrahim M, Wassermann J, Martin AL, Lemonnier J, Del Mastro L, Jones LW, Partridge AH, Ligibel JA, Andre F, Michiels S, Vaz Luis I. Body weight and return to work among survivors of early-stage breast cancer. ESMO Open. 2020 Nov;5(6):e000908. doi: 10.1136/esmoopen-2020-000908.

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

ReferenceCitation: Pistilli B, Paci A, Ferreira AR, Di Meglio A, Poinsignon V, Bardet A, Menvielle G, Dumas A, Pinto S, Dauchy S, Fasse L, Cottu PH, Lerebours F, Coutant C, Lesur A, Tredan O, Soulie P, Vanlemmens L, Jouannaud C, Levy C, Everhard S, Arveux P, Martin AL, Dima A, Lin NU, Partridge AH, Delaloge S, Michiels S, André F, Vaz-Luis I. Serum Detection of Nonadherence to Adjuvant Tamoxifen and Breast Cancer Recurrence Risk. J Clin Oncol. 2020 Aug 20;38(24):2762-2772. doi: 10.1200/JCO.19.01758. Epub 2020 Jun 22.

name: Institut Gustave Roussy, Villejuif, France

name: Université Paris-Saclay, Faculté de Pharmacie, Saint-Aubin, France

name: Institut Pierre Louis d’Epidemiologie et de Santé Publique, Paris, France

name: Université Paris Diderot UFR de Médecine, Paris, France

name: Université Paris Decartes, Paris, France

name: Georges-Francois Leclerc Centre, Dijon, France

name: Institut de Cancerologie de Lorraine, Nancy, France

name: Institut de Cancerologie de L’Ouest, Saint Herblain, France

name: Centre Francois Baclesse Centre Lutte Contre le Cancer, Caen, France

name: Université Claude Bernard, Villeurbanne, France

name: Dana-Farber Cancer Institute, Boston, MA

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

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

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Kaboré EG, Guenancia C, Vaz-Luis I, Di Meglio A, Pistilli B, Coutant C, Cottu P, Lesur A, Petit T, Dalenc F, Rouanet P, Arnaud A, Arsene O, Ibrahim M, Wassermann J, Boileau-Jolimoy G, Martin AL, Lemonnier J, André F, Arveux P. Association of body mass index and cardiotoxicity related to anthracyclines and trastuzumab in early breast cancer: French CANTO cohort study. PLoS Med. 2019 Dec 23;16(12):e1002989. doi: 10.1371/journal.pmed.1002989. eCollection 2019 Dec.

ReferenceCitation: Ferreira AR, Di Meglio A, Pistilli B, Gbenou AS, El-Mouhebb M, Dauchy S, Charles C, Joly F, Everhard S, Lambertini M, Coutant C, Cottu P, Lerebours F, Petit T, Dalenc F, Rouanet P, Arnaud A, Martin A, Berille J, Ganz PA, Partridge AH, Delaloge S, Michiels S, Andre F, Vaz-Luis I. Differential impact of endocrine therapy and chemotherapy on quality of life of breast cancer survivors: a prospective patient-reported outcomes analysis. Ann Oncol. 2019 Nov 1;30(11):1784-1795. doi: 10.1093/annonc/mdz298.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.


title: Analysis of Osteoimmune Interactions Linking Inflammation and Bone Destruction in Aggressive Periodontitis

acronym: PAG

summary: Periodontitis are inflammatory diseases characterized by the destruction of the tooth-supporting bone due to increased bone resorption by osteoclasts (OCLs). Two forms are described: chronic periodontitis (CP) and aggressive periodontitis (AP) that differ by the severity and rapidity of bone loss, much more important for AP than CP. In both forms, the link with uncontrolled activation of the immune system is largely admitted. Despite the physiopathology of CP is fairly well studied, very few data are available regarding AP. The investigators aim is to understand the severity of AP by analyzing the proportion and action of immune and mesnchymal cells potentially involved in bone destruction, on biopsies of periodontal granulation tissue (surgical waste) and blood. Three groups of 20 patients will be included: affected with AP, CP or controls (necessitating an extraction of wisdom teeth).

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Odontology Department, Nice Unversity Hospital


title: Experimental Pain Sensitivity of Subjects With Fibromyalgia Before and After rTMS Treatment in Relation to the Clinical Improvement

summary: The principal study aims at evaluating the efficiency of rTMS maintenance sessions on the clinical effect of a rTMS cure in fibromyalgic subjects. This complementary study consists in the evaluation of the experimental sensitivity to mechanical pain (pressure application on the forearm) of subjects presenting fibromyalgia before and after rTMS treatment (21 days), and to put the results in relation to the clinical improvement and the psychometric evaluations (depression,fibromyalgia impact questionnaire, catastrophism).

lead_sponsor: Centre Hospitalier Esquirol


title: Evaluation of Cardiac Arrest Recognition by Non-physicians Dispatchers in the Paris Fire Brigade Emergency Call Dispatch Center

acronym: OCAR

summary: The purpose of this study is to measure an improvement in the detection rate of cardiac arrest (CA) in the Dispatch Center as a result of debriefings and repeated trainings for non-medical operators who receive emergency calls.

lead_sponsor: Fire Brigade Of Paris Emergency Medicine Dept


title: Etude de l'Expression Des Micro-RNA Comme Biomarqueur Diagnostic et Pronostic Dans la Sclérose Latérale Amyotrophique

acronym: MIRSLA

summary: The principal goal is to demonstrate that a specific pattern of microRNA (miRNA) expression can be correlated with the definite diagnostic of Amyotrophic Lateral Sclerosis (ALS). The investigators will use biological sample (from muscle biopsy, Cerebrospinal Fluid (CSF) and blood sample) collected in three control populations: definite ALS patients according to El Escorial diagnostic criterion, control patients without any neurological disease having an orthopedic surgery for shoulder disease, and control patient explored for peripheral neuropathy and myopathy. A second goal will correlate the miRNA pattern to the severity and/or progression rate of the motor neurons define as the progression rate of the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) score/year.

lead_sponsor: University Hospital, Bordeaux


title: Targeted High Throughput Sequencing in the Diagnosis of Pediatric Acute Leukemia

summary:
Acute leukemias are a heterogeneous group of hematologic malignancies. They result from clonal expansion of immature cells whose number is greater than 20% in bone marrow. Childhood acute leukemias are the most common pediatric malignancies. In Europe and the United states, they represent about 35% of childhood cancers. 80% of them are acute lymphoblastic leukemia (ALL) and 15-20% of acute myeloid leukemia (AML). Current treatments allow a cure in about 80% of ALL, while this level is only 50% in AML.Acute leukemia diagnosis is based on the multidisciplinary exploration of leukemia cells by different techniques:

Cellular: cytology, immunophenotyping and cytochemistry
Cytogenetic: conventional (karyotype) and molecular (FISH) cytogenetic
Molecular: RT-PCR and RQ-PCR

Cytogenetic studies are performed at time of acute leukemia diagnosis. Indeed, the WHO 2008 classification of acute leukemia is based largely on the presence of recurrent cytogenetic and molecular abnormalities. The most frequent chromosomal aberrations have been associated with specific clinical and biological characteristics and are now used as diagnosis and prognostic markers. These chromosomal abnormalities affect genes involving in the leukemogenesis process. These rearrangements are of several types:

Fusion genes causing :

Repression of transcriptional activity of genes involved in differentiation of hematopoietic cells (AML1-ETO, PML-RARA…)
Deregulation of signal transduction pathway (eg BCR-ABL chimeric protein with constitutive tyrosine kinase activity)
Changing in the state of chromatin condensation resulting changes of transcription (MLL gene rearrangements in 11q23, MOZ en 8p11…)
Deregulation of genes expression: chromosomal rearrangements can sometimes induce deregulation of adjacent genes to the breakpoint. For example, inv(3)(q21q26) or t(3;3)(q21;q26) induce over expression of transcriptional factor EVI-1.
Loss of function due to deletion of variable size in genomic regions containing genes with a role in the differentiation, apoptosis, or cell proliferation (eg IKZF1, PAX5…)

In addition to the karyotype, which allows to have a global view of the genome; FISH, a targeted technique, is used to highlight invisible abnormalities on karyotype (cryptic abnormalities) or the time of karyotype failure. However, conventional and molecular cytogenetic techniques do not highlight any abnormalities (eg different partners involved in the formation of fusion genes in particular for MLL gene rearrangement, mutations) hence our interest in next generation sequencing.Indeed, the high throughput targeted sequencing messenger RNAs (RNA-seq) has the avantage of allow identification of different types of mutations in a single test, with exception of epigenetic mutations. The importance of RNAs sequencing rather than DNA genomic is the one hand, a very significant decrease in the volume of sequences to analyze because transcribed mRNA genes represent about 5% of the genome size and secondly, a better identification of chimeric genes. The RNA-seq has used as a research tool in hematologic malignancies. The purpose of this project is to use innovative technology to develop a new diagnostic and prognostic new tool in hematological malignancies. 50 acute leukemias will be tested and results will be analyzed according to three criteria:

Quantity, quality and relevance of information provided for the diagnosis, monitoring and therapeutic management compared to a conventional strategy
Period required to obtain results and methods to decrease the analysis time so that results can be integrated into therapeutic decisions.
Economic evaluation, which will calculate the cost of this diagnosis option and assess the cost/benefit ratio In future, other innovative approaches will be implemented (study of imbalances genomic abnormalities by array-CGH, transcriptome analysis with micro-array, and study of methylome) to identify the "molecular signature" of each leukemia and set of informative abnormalities for diagnosis, prognosis and treatment of disease and monitoring of residual disease.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Effect of Sleep Restriction on Decision Making and Inflammation

summary:
hypothesis: sleep restriction in healthy subject trigger alteration of decision making associated with immuno-inflammatory changes
inclusion criterias: healthy subjects, men, under 35 years, BMI<26, no sleep troubles, intermediate chronotype
design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).
parameters: decision making tests, reaction time, wakefulness test, biological parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure
control of sleep restriction: continuous polysomnographic survey

ReferenceCitation: Rabat A, Gomez-Merino D, Roca-Paixao L, Bougard C, Van Beers P, Dispersyn G, Guillard M, Bourrilhon C, Drogou C, Arnal PJ, Sauvet F, Leger D, Chennaoui M. Differential Kinetics in Alteration and Recovery of Cognitive Processes from a Chronic Sleep Restriction in Young Healthy Men. Front Behav Neurosci. 2016 May 23;10:95. doi: 10.3389/fnbeh.2016.00095. eCollection 2016.

family: Rabat

full_name: Arnaud Rabat

given: Arnaud

family: Gomez-Merino

full_name: Danielle Gomez-Merino

given: Danielle

family: Roca-Paixao

full_name: Laura Roca-Paixao

given: Laura

family: Bougard

full_name: Clément Bougard

given: Clément

family: Van Beers

full_name: Pascal Van Beers

given: Pascal

family: Dispersyn

full_name: Garance Dispersyn

given: Garance

family: Guillard

full_name: Mathias Guillard

given: Mathias

family: Bourrilhon

full_name: Cyprien Bourrilhon

given: Cyprien

family: Drogou

full_name: Catherine Drogou

given: Catherine

family: Arnal

full_name: Pierrick J. Arnal

given: Pierrick J.

family: Sauvet

full_name: Fabien Sauvet

given: Fabien

family: Leger

full_name: Damien Leger

given: Damien

family: Chennaoui

full_name: Mounir Chennaoui

given: Mounir

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Frontiers in Behavioral Neuroscience

repository_institution: PubMed Central - Europe PMC

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Sauvet F, Drogou C, Bougard C, Arnal PJ, Dispersyn G, Bourrilhon C, Rabat A, Van Beers P, Gomez-Merino D, Faraut B, Leger D, Chennaoui M. Vascular response to 1 week of sleep restriction in healthy subjects. A metabolic response? Int J Cardiol. 2015;190:246-55. doi: 10.1016/j.ijcard.2015.04.119. Epub 2015 Apr 16.

title: Vascular response to 1week of sleep restriction in healthy subjects. A metabolic response?

lead_sponsor: Institut de Recherche Biomedicale des Armees

location_facility: Institut de recherche biomédicale des armées


title: Body Posture Assessment Considering Jaws Position Before and After Orthognathic Surgery on Adult Patient.

summary:
Postural balance on both feet, characteristic of the human species, is possible by the tension of muscle of the whole body from toes to head.

Body position depends on many inputs such as vision, vestibule, skin receptors, states of muscle tension receptors. Information is integrated in a complex nervous system via the ascending and descending pathways. The information is then analyzed to provide feedback on body position. Any variation of body position, induces a variation of the center of pressure. Impaired body positioncan cause pain (back pain, neck pain) or long-term deformation (including scoliosis or kyphosis).

Maxillas position, via the activity of masseter and temporal muscles, acts on the muscle chain that controls posture. Incorrect positioning of the jaw in the three directions of space seems to create an asymmetric masticatory muscles activity and thus destabilize the muscle chain responsible for body position. Repositioning maxillas by orthognathic surgery could alter the body posture via changing the activity of the masticatory muscles.

However, nowadays no clear link has been demonstrated between maxillas repositioning and body posture modification.

The purpose of this study is to highlight the link between posture and jaws position, by analyzing the variation of the masticatory muscles activity and, the changes in body center of pressure before and after orthognathic surgery of jaws standardization.

In this study each patient will be evaluated in terms of occlusion and body posture before surgery and after surgery (2 months) by the same protocol. The surgery will be performed in the Maxillofacial Surgery service - Pr BLANC and assessment will take place in the dentistry department - Prof. Salvadori La Timone Hospital, Marseille.

The assessment includes the body posture study with a stabilometric platform (eyes open / eyes closed and with / without tooth contact), and analysis of the head orientation relative to the vertical. Electromyographic muscle masseter assessment (jaw with/without contact ) are devoted to check the evolution of the developed forces, and hand strength will be recorded using a dynamometer.

All these data will be recorded for all the patients. Patients will be divided into four subgroups: (1) maxillary endognathia, (2) mandibular prognathism , (3) mandibular retrognathia and (4 mandible repositioning.

Statistical analysis is aimed at validating or not the hypothesis of changes in body posture caused by surgical maxillas repositioning.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Prospective Non-randomized Comparative Study Evaluating the Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement in Osteoarthritis Indication

summary: Osteopathy is an alternative healthcare that seems effective in relieving the pain of patients. The main purpose of this study is to evaluate the efficacy of preoperative osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The secondary objectives are to assess pain during the first postoperative month on a VAS and knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy will decrease postoperative pain and increase knee function.

lead_sponsor: Hospital Ambroise Paré Paris


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

acronym: DyPAVIR

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

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

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

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

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

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

ipd_sharing: Undecided

lead_sponsor: Institut Pasteur

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


title: Clinical Assessment of Innovative Procedure Using Image-guided Surgery to Avoid Sinus Lift

acronym: SINIMAGE

summary: The objective of this study is to compare two surgical procedure to place implant in severely resorbed posterioir part of the maxilla.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Service de Consultations et Traitements Dentaires


title: French Digestive Polyposis Cohorte

summary: French cohorte about polyposis digestive diseases

time_perspective: Retrospective

lead_sponsor: Hôpital Edouard Herriot


type: EudraCT Number

title: DRESS - Setting of Corticosteroid Treatment.

acronym: DRESSCODE

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

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

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

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

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

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

family: Funck-Brentano

full_name: Elisa Funck-Brentano

given: Elisa

family: Duong

full_name: Tu-Anh Duong

given: Tu-Anh

family: Bouvresse

full_name: Sophie Bouvresse

given: Sophie

family: Bagot

full_name: Martine Bagot

given: Martine

family: Wolkenstein

full_name: Pierre Wolkenstein

given: Pierre

family: Roujeau

full_name: Jean-Claude Roujeau

given: Jean-Claude

family: Chosidow

full_name: Olivier Chosidow

given: Olivier

family: Valeyrie-Allanore

full_name: Laurence Valeyrie-Allanore

given: Laurence

journal_name: Journal of the American Academy of Dermatology

title: Therapeutic management of DRESS: A retrospective study of 38 cases

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Advantage of Detection of phIGFBP-1 to Reduce Hospitalization Time for Stable Patients With a Risk of Preterm Labour.

summary:
It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.

Methods Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/- described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to our gold standard protocol. After 48 hours, they will be assessed by examination, external tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be included and randomized into 2 groups of 210 patients each. The first group "A" will benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical and ultrasound assessment); whereas the second group, "B", will have the benefit of the detection of phIGFBP-1.If the result proves negative, patients could be discharged early at day 2. In the case of a positive result, patients will follow the standard procedure because of the low positive predictive value of the test. The main outcome is the total duration of hospitalization.

Study duration The trial period will be 36 months.

Expected results The use of detection of IGFBP-1 would enable us to select patients at risk and to decrease the duration of hospitalization in the case of a negative result.

Perspectives The negative predictive value of phIGFBP-1 test could be useful to select patients with stabilized risk of preterm labor, who could be discharged early. Moreover it could be used, in the Perinat Sud network, to decide if patients with a risk of preterm labor would benefit from hospitalization in a level II or III maternity ward.


title: Prevalence of Digestive Carriage of Integrons to Resistance in Two Populations in Limousin

acronym: APIHA

summary: Bacterial resistance to antimicrobials is an increasing problem. Doctors occasionally face genuine therapeutic dead-ends, when attempting to cure nosocomial infections and, more and more frequently, community-acquired infections. Mastering antimicrobial resistance diffusion is nowadays a major Public Health issue.

lead_sponsor: University Hospital, Limoges


title: Prospective and Multicentre Evaluation of 3 Different Doses of IV Busulfan Associated With Fludarabine and Thymoglobuline in the Conditioning of Allogeneic Stem Cell Transplantation (SCT) From a Matched Related or Unrelated Donor in Patients With Poor Prognosis Myeloid Malignancies

acronym: AAA

summary:
Albeit the safety of the stem cell transplantation procedure has been greatly improved, further refining the intensity of the conditioning is an important issue to explore, especially in patients with poor prognosis, the goal being to maintain the very favorable safety profile and improve the disease control. This is the goal our prospective trial; we aim to prospectively evaluate in a prospective multicenter trial the efficacy of different conditioning regimens in patients with high-risk myeloid malignancies.

The study is a phase II trial randomizing patients between a prospective active control arm (BX2) and two experimental arms (BX3 and BX4). A standard group was kept in this clinical trial in order to avoid the limitations induced by the comparison with historical controls in the context of continuously improving practice. Each experimental arm will be conducted in parallel according to a standard phase II trial design.

In addition, this trial will associate four ancillary studies to the main clinical objective: 1/ a prospective assessment of the quality of life of the patients over a period of 2 years 2/ an analysis of the cost effectiveness of the procedure, assessed over a period of 2 years 3/ an observational busulfan pharmacokinetic study 4/ a busulfan pharmacogenomic study

ReferenceCitation: Wanquet A, Crocchiolo R, Furst S, Granata A, Faucher C, Devillier R, Harbi S, Lemarie C, Calmels B, Vey N, Weiller PJ, Chabannon C, Castagna L, Blaise D, El-Cheikh J. The efficacy and safety of a new reduced-toxicity conditioning with 4 days of once-daily 100 mg/m(2) intravenous busulfan associated with fludarabine and antithymocyte globulins prior to allogeneic stem cell transplantation in patients with high-risk myelodysplastic syndrome or acute leukemia. Leuk Lymphoma. 2016 Oct;57(10):2315-20. doi: 10.3109/10428194.2016.1146948. Epub 2016 Feb 17.

family: Wanquet

full_name: Anne Wanquet

given: Anne

family: Crocchiolo

full_name: Roberto Crocchiolo

given: Roberto

family: Furst

full_name: Sabine Furst

given: Sabine

family: Granata

full_name: Angela Granata

given: Angela

family: Faucher

full_name: Catherine Faucher

family: Devillier

full_name: Raynier Devillier

given: Raynier

family: Harbi

full_name: Samia Harbi

given: Samia

family: Lemarie

full_name: Claude Lemarie

given: Claude

family: Calmels

full_name: Boris Calmels

given: Boris

family: Vey

full_name: Norbert Vey

given: Norbert

family: Weiller

full_name: Pierre Jean Weiller

given: Pierre Jean

family: Chabannon

full_name: Christian Chabannon

given: Christian

family: Castagna

full_name: Luca Castagna

given: Luca

family: Blaise

full_name: Didier Blaise

given: Didier

family: El-Cheikh

full_name: Jean El-Cheikh

given: Jean

journal_name: Leukemia & Lymphoma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: The efficacy and safety of a new reduced-toxicity conditioning with 4 days of once-daily 100 mg/m2intravenous busulfan associated with fludarabine and antithymocyte globulins prior to allogeneic stem cell transplantation in patients with high-risk myelodysplastic syndrome or acute leukemia

lead_sponsor: Institut Paoli-Calmettes


title: Characterisation of Circadian Rhythm in Autistic Spectrum Disorder : a Clinical, Biochemical and Genetic Study

summary: Autism spectrum disorders (ASDs) are complex neurodevelopmental conditions characterized by deficits in social communication, delay in language and repetitive behaviors. Results from genetic studies reveal one pathway associated with susceptibility to ASDs, which includes synaptic cell adhesion molecules. Among the factors that could modulate this pathway are the genes controlling circadian rhythms. Sleep disorders and low melatonin levels are frequently observed in ASDs. Thus investigator will characterize the circadian rhythms of patients with ASD and search for circadian rhythms genes polymorphisms.


title: Exploratory Study of Prognostic Factors in Aortic Dissection Type B: Role of Imaging (18F-FDG PET-Scan and Angioscan) and Biomarkers

acronym: TEDAC

summary:
Clinical outcomes of chronic type B aortic dissections are unknown, especially in case of false lumen expansion and risk of rupture. Data of literature give us some indications about prognosis. The 1-year survival rate is about 80%, but we deplore the 25% rate of mortality at 3 years despite follow-up.The only known predictive factors are the initial diameter of more than 4 cm and the persistence of a false lumen patent.However, actual means of follow-up do not allow to predict severe complications. The aim of the sudy is to propose a diagnostic and preventive strategy for the follow-up of chronic type B aortic dissections treated medically.

The primary objective is then to evaluate the prognostic role of 18-FDG-PET Scan in such patients in order to predict the risk of aortic diameter growth of more than 5 mm in 1 year and/or of an aortic dissections extension at 1 year. The secondary objectives are to evaluate the link between fibrosis biomarkers MMP et TIMP) and the results of imaging results (evolution of diameter and extension and results of PET-Scan imaging) Methods: 100 patients to be included in 3 years History of chronic type B aortic dissection, treated medically, evolving since more than 1 month and less than 5 years.

Expected results: Prognostic contribution of 18FDG-PET-Scan and biomarkers for the identification of patients at high risk of evolution. Elaboration of a decisional algorithm about follow-up modalities of chronic aortic dissections. Demonstration of a correlation between aortic diameter growth or aortic dissection extension and intensity of marker fixation with 18-FDG-PET-Scan.

lead_sponsor: University Hospital, Caen


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

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

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

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


title: Monocentric Prospective Pilot Study Evaluating the Value of Indocyanine Green (ICG, Indocyanine Green) During a Surgical Resection of Cancerous Lesions Peritoneal Colorectal Origin.

summary:
Between 30% and 40% of patients with colorectal cancer develop metastatic disease intraperitoneally. The optimal treatment of this disease combines surgery and chemotherapy but requires resection of all lesions larger than 2mm.

Indocyanine green has an affinity for tumor tissues and the interest of its use has been demonstrated for the detection of sentinel lymph node and some liver surgeries.

The ability of indocyanine green to detect peritoneal carcinomatosis in humans has never been evaluated.

This study aims to evaluate the diagnostic performance of fluorescence in the detection of malignant cells in peritoneal carcinomatosis of colorectal origin compared with pathological analysis.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Effects of Whole Body Vibration (WBV) on Musculoskeletal System of Aged Women

acronym: VIBROS

summary:
A controlled, non-randomized trial will be carried out in 240 postmenopausal women, aged 55-75 years, over a 18-month period. The group 1 received a physical intervention, consisting of whole body vibration (WBV) over 12 months followed by training arrest during 6 months. The group 2 served as sedentary control. WBV training is performed 2 or 3 times per week, with each session lasting 20 minutes. The training included light squats at 35-50 Hz and ended up by stretching and relaxation exercises at 50 Hz. Bone, muscle and postural evaluations will be performed at the beginning, 6, 12 and 18 months in each group with evaluation of bone micro-architectural trabecular and cortical compartments, at the weight bearing tibia and the non weight bearing radius.

The primary outcome of the project is the pre, mid, and post evaluations of bone. Bone exploration included dual x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HR-pQCT). Bone Mass Density (BMD) will be evaluated by DXA at lumbar, femoral levels and humeral, macro and micro-architectures of the cortical and trabecular compartments will be evaluated in distal radius and tibia by HR-pQCT and bone markers will be analyzed longitudinally. The secondary aim is to assess muscle performance and proprioception. Finally will be assessed markers of cartilage degradation and synthesis, no study has been published on this tissue.


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

acronym: FFSI

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

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

family: Quero

full_name: Giuseppe Quero

given: Giuseppe

family: Fiorillo

full_name: Claudio Fiorillo

given: Claudio

family: Dallemagne

full_name: Bernard Dallemagne

given: Bernard

family: Mascagni

full_name: Pietro Mascagni

given: Pietro

family: Curcic

full_name: Jelena Curcic

given: Jelena

family: Fox

full_name: Mark Fox

given: Mark

family: Perretta

full_name: Silvana Perretta

given: Silvana

journal_name: Obesity Surgery

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: IHU Strasbourg

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


title: The Cognitive and Cardiovascular Health in the Elderly Study

acronym: COACHES

summary: The main objective of this study is to look for the interest forecast of the IPS as infra-clinical cardiovascular marker in the prediction of a change of the cognitive functions (MCI) at the elderly of 70 and more years old without clinical cardiovascular pathology.


title: Predictive Clinical and Biological Parameters in Gynecological Cancer - GC-BIO-IPC 2013-010

acronym: GC-BIO

summary: Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation

status_simplified: Ongoing


title: Procalcitonin and Threatened Premature Delivery

acronym: MAPPRO

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

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

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

family: Ducarme

full_name: Guillaume Ducarme

given: Guillaume

family: Desroys du Roure

full_name: François Desroys du Roure

given: François

family: Le Thuaut

full_name: Aurélie Le Thuaut

given: Aurélie

family: Grange

full_name: Joséphine Grange

given: Joséphine

family: Vital

full_name: Mathilde Vital

given: Mathilde

family: Dimet

full_name: Jérôme Dimet

given: Jérôme

currency_apc_doaj: GBP

journal_name: BMC Pregnancy and Childbirth

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface

acronym: FlessCare

summary: The main objective of this study is to evaluate the relationship between the angle of knee flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure at the heel area (PtAl).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Glycemic Instability of Non-diabetic Patients After Spine Surgery: a Prospective Observational Cohort Study

acronym: GLYRACH

summary: Analyzing peri operative changes in blood glucose levels from non-diabetic patients undergoing spine surgery

ReferenceCitation: Pili-Floury S, Mitifiot F, Penfornis A, Boichut N, Tripart MH, Christophe JL, Garbuio P, Samain E. Glycaemic dysregulation in nondiabetic patients after major lower limb prosthetic surgery. Diabetes Metab. 2009 Feb;35(1):43-8. doi: 10.1016/j.diabet.2008.06.007. Epub 2008 Nov 26.

ReferenceCitation: Lipshutz AK, Gropper MA. Perioperative glycemic control: an evidence-based review. Anesthesiology. 2009 Feb;110(2):408-21. doi: 10.1097/ALN.0b013e3181948a80. Review.

ReferenceCitation: Pull ter Gunne AF, Cohen DB. Incidence, prevalence, and analysis of risk factors for surgical site infection following adult spinal surgery. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1422-8. doi: 10.1097/BRS.0b013e3181a03013.

lead_sponsor: Beaujon Hospital


title: First Evaluation of Morphine Hydrochloride by Nebulisation Compared to Intravenous Route in Healthy Volunteers: Preliminary Study Dose

summary:
Acute pain relief in emergency setting is still a public health priority. Pain is the primary reason for emergency room use, but the situation of "oligo-analgesia" persists in all countries. Intravenous morphine titration has become the standard method for severe acute pain management in the emergency department, but it is still insufficiently implemented. Deviations from the recommended protocol are common: initial additional loading doses, unusually extended intervals between bolus, premature discontinuation. Several factors contribute to these difficulties: heaviness of its setting up, especially in overcrowding case, procedure rigidity, high consumption of nursing time. This method requires a systematic intravenously route, which has several inconvenients: algogenic procedures, coupled initial diagnostic venous sampling (delay for analgesia), excessive "medicalization" of ambulatory patients (risk of infection and less mobility in the emergency department). An alternative to reduce the analgesic latency in emergency department, without losing the benefits of tolerance and safety should be welcome. The inhaled route looks promising, but has yet not been enough evaluated in adults, and even less in the emergency room. Aerosol techniques change from one study to another (molecules, materials, doses, painful intensities included, judgment criteria and assessment times). A morphine titration by aerosol therapy could be an interesting alternative to the standard method disadvantages, using faster, painless and easier procedures, leading to "demedicalization".

To the need for stronger fundamentals, an additional study was designed in healthy volunteers. The objective is to compare the titration of intravenous morphine titration aerosol in moderate acute pain caused by electrostimulation.

To purchase this aim, we first need to determine accurately the smallest dose of effective and well tolerated inhaled morphine, to provide the "bolus" dose we have to repeat by titration, which is still currently unknown. This dose is called ED50, it's the effective dose for at least 50% of healthy volunteers relieved. ED50 for intravenous morphine is also needed to be established, unknown in this indication. The determination of these two parallel ED50 would allow a reliable conversion factor between the two routes of administration for morphine "bolus", which can then be tested in comparative titrations. To validate our induced pain model in healthy volunteers, we also have chosen to fix in these conditions the ED50 of fentanyl that the effective dose by nebulization is better known. This study would also describe the pharmacokinetics of inhaled morphine and its derivatives after a single spray.

ReferenceCitation: Lvovschi V, Aubrun F, Bonnet P, Bouchara A, Bendahou M, Humbert B, Hausfater P, Riou B. Intravenous morphine titration to treat severe pain in the ED. Am J Emerg Med. 2008 Jul;26(6):676-82. doi: 10.1016/j.ajem.2007.10.025.

lead_sponsor: University Hospital, Rouen


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

acronym: Metasperme

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

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

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

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

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


title: Improvement of Chronic Stroke Patients Gait Pattern Following Repetitive Multifocal Botulinum Toxin Injection Sessions in Paretic Lower Limb: an Observational Study.

summary:
Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.

The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients has been compared using 3D-gait analysis after at least 2 consecutive BTI sessions.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


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

acronym: NIVAS

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

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

name: Saint Eloi University Hospital and Montpellier School of Medicine, Research Unit INSERM U1046, Montpellier, France

family: Jaber

full_name: Samir Jaber

given: Samir

name: Saint Antoine Hospital, AP-HP, Paris, France

family: Lescot

full_name: Thomas Lescot

given: Thomas

name: Estaing Hospital, Clermont-Ferrand, France

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Paugam-Burtz

full_name: Catherine Paugam-Burtz

given: Catherine

name: Rennes University Hospital, Rennes, France

family: Seguin

full_name: Philippe Seguin

given: Philippe

name: Tours University Hospital, Tours, France

family: Ferrandiere

full_name: Martine Ferrandiere

given: Martine

name: Angers University Hospital, Angers, France

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

name: Poitiers University Hospital, Poitiers, France

family: Mimoz

full_name: Olivier Mimoz

given: Olivier

family: Hengy

full_name: Baptiste Hengy

given: Baptiste

name: Institut Paoli Calmettes, Marseille, France

family: Sannini

full_name: Antoine Sannini

given: Antoine

family: Pottecher

full_name: Julien Pottecher

given: Julien

family: Abback

full_name: Paër-Sélim Abback

given: Paër-Sélim

family: Riu

full_name: Beatrice Riu

given: Beatrice

family: Belafia

full_name: Fouad Belafia

given: Fouad

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Masseret

full_name: Elodie Masseret

given: Elodie

family: Beaussier

full_name: Marc Beaussier

given: Marc

family: Verzilli

full_name: Daniel Verzilli

given: Daniel

family: De Jong

full_name: Audrey De Jong

given: Audrey

family: Chanques

full_name: Gerald Chanques

given: Gerald

name: St Michael’s Hospital, Toronto, Ontario, Canada

family: Brochard

full_name: Laurent Brochard

given: Laurent

name: Lapeyronie University Hospital and Montpellier School of Pharmacy, Research Unit IMAG U5149, Montpellier, France

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

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

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


title: Protection of Arteritic Patients by Remote Preconditioning

acronym: PARADIS

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

lead_sponsor: University Hospital, Angers

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


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

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

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

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

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

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

family: Sacconi

full_name: Sabrina Sacconi

given: Sabrina

family: Briand-Suleau

full_name: Audrey Briand-Suleau

family: Gros

full_name: Marilyn Gros

given: Marilyn

family: Baudoin

full_name: Christian Baudoin

given: Christian

family: Lemmers

full_name: Richard J.L.F. Lemmers

given: Richard J.L.F.

family: Rondeau

full_name: Sophie Rondeau

given: Sophie

family: Lagha

full_name: Nadira Lagha

given: Nadira

family: Nigumann

full_name: Pilvi Nigumann

given: Pilvi

family: Cambieri

full_name: Chiara Cambieri

given: Chiara

family: Puma

full_name: Angela Puma

given: Angela

family: Chapon

full_name: Françoise Chapon

given: Françoise

family: Stojkovic

full_name: Tanya Stojkovic

given: Tanya

family: Vial

full_name: Christophe Vial

given: Christophe

family: Bouhour

full_name: Françoise Bouhour

family: Cao

full_name: Michelangelo Cao

given: Michelangelo

family: Pegoraro

full_name: Elena Pegoraro

given: Elena

family: Petiot

full_name: Philippe Petiot

given: Philippe

family: Behin

full_name: Anthony Behin

given: Anthony

family: Marc

full_name: Bras Marc

given: Bras

family: Eymard

full_name: Bruno Eymard

given: Bruno

family: Echaniz-Laguna

full_name: Andoni Echaniz-Laguna

given: Andoni

family: Laforet

full_name: Pascal Laforet

given: Pascal

family: Salviati

full_name: Leonardo Salviati

given: Leonardo

family: Jeanpierre

full_name: Marc Jeanpierre

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: An Observational, Prospective, Single-center Study of Placement and Confirmation of Peripheral Inserted Central Catheters Tip Position Using a New Electrocardiographic Method

acronym: SHERLOCK 3CG

summary:
This is a prospective, single center, observational study. Patients who require a Peripheral Inserted Central Catheters (PICC) will constitute the study population.

The purpose of the study is to determine whether Sherlock 3CG, is adequate means for the total placement of PICC and confirmation of tip of PICC placement and if this method can be conducted safely and efficiently.

Patients will be included during a 6-month period as well as they are ambulatory or hospitalized. The patient's routine care will not be modified and only PICC will be assessed in the present study.

PICC placement will be performed using the Site Rite guidance and tip position will be confirmed using the Sherlock 3CG.

The procedure is the same as the routine habits of the operator (nurse or anesthesiologist); the vascular access team already uses the previous device for CVC placement.

Patients won't be followed up in the study.

lead_sponsor: Centre Leon Berard


title: Lipophilic Organic Polluants and Morbid Obesity: Kinetic of the Release and Impact on the Metabolic Syndrome Before and After Bariatric Surgery

acronym: POLOB

summary:
To study the kinetics of release after bariatric surgery of selected polluants stored in adipose tissue, looking for clinical and/or predictive factors
To test the hypothesis of a deleterious effect of this release on the expected improvement of insulin-resistance and on the liver inflammation.
To determine the level of contamination of morbidly obese patients, with or without metabolic syndrome, compared to a control, non obese population, with special attention to clinical (age, gender, reproductive history, pregnancy, nursing) and biological parameters (insulin-resistance, inflammation).


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

acronym: ExSTRESS

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

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

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

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

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

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

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

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

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

family: Besch

full_name: Guillaume Besch

given: Guillaume

family: Perrotti

full_name: Andrea Perrotti

given: Andrea

family: Salomon du Mont

full_name: Lucie Salomon du Mont

given: Lucie

family: Puyraveau

full_name: Marc Puyraveau

given: Marc

family: Ben-Said

full_name: Xavier Ben-Said

given: Xavier

family: Baltres

full_name: Maude Baltres

given: Maude

family: Barrucand

full_name: Benoit Barrucand

given: Benoit

family: Flicoteaux

full_name: Guillaume Flicoteaux

family: Vettoretti

full_name: Lucie Vettoretti

family: Samain

full_name: Emmanuel Samain

given: Emmanuel

family: Chocron

full_name: Sidney Chocron

given: Sidney

family: Pili-Floury

full_name: Sebastien Pili-Floury

given: Sebastien

journal_name: Cardiovascular Diabetology

lead_sponsor: Centre Hospitalier Universitaire de Besancon

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


title: Diaphragm Function in Patients Acquired Weakness and Neuromyopathy in ICU: Impact on Weaning and Outcome (DIAPH-WEAK ICU)

summary:
Critical illness neuromyopathy is a common disease acquired during ICU stay leading to a deep weakness involving the respiratory muscle work which result in a delayed weaning of mechanical ventilation.

The main objective is to quantify the loss of diaphragm function by measuring the diaphragm force (using the non invasive method by phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion) in a selected population of patients with critical illness neuromyopathy (defined as a MRC score < 48).

The second end points are to evaluate its incidence, the consequences on the patients outcome (extubation success or failure; ICU stay) and to evaluate the relations between diaphragm function (twitch airway pressure during airway occlusion, maximal inspiratory pressure and diaphragm thickness evaluated by ultrasound) and peripheral limbs force (evaluated by the Medical Research Council - MRC score).

lead_sponsor: University Hospital, Montpellier

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


title: Prospective Evaluation of Iron Status in Cancer Patients Beginning Chemotherapy

acronym: CANFER

summary:
In cancerology, anemia is a frequently-found situation, with a prevalence ranging from 30% to 90%, according to the series, disease stages, primary tumor locations and age (Scotte, Launay-Vacher et al. 2012). Although very probably a major cause of anemia, iron deficiency (ID) has been seldom investigated in the field of cancer. Its prevalence and incidence have never been assessed in a prospective study. It is well-known that anemia in the cancer setting is a source of asthenia and deterioration of quality of life, and can even reduce the efficacy of anticancer treatments such as radiotherapy. Correcting anemia therefore constitutes a daily challenge. Before 2004-2005, a very large proportion of patients were treated with erythropoietin (EPO). However, prescriptions for EPO appear to have considerably declined since the warnings issued by various scientific societies and governments on account of the possible increase in death rates and a higher incidence of thromboembolic events, as reported in 8 studies published to date (NCCN 2012). Simultaneously, the transfusion rate augmented from 3.4% to 8.7% and the median hemoglobin level fell from 10.8 to 8.9 g/dL (Feinberg, Bruno et al. 2012). The use of injectable iron appears to have improved the correction of anemia by EPO, as reported in several concordant studies versus oral iron and placebo (Pedrazzoli, Rosti et al. 2009; Steensma, Sloan et al. 2011). However, no monotherapy study has been conducted to evaluate the impact of injectable iron, alone without EPO, for the correction of ID (with or without anemia) in cancer treatment. Consequently, there exists a wide variety of practices, with an injectable iron prescription rate which, a priori, does not match the number of patients with iron deficiency. There exist other iron-based parameters to characterize ID but these are not yet used routinely during chemotherapy and need to be validated in the cancer field.

These parameters include:

An assay of reticulocyte hemoglobin content (rHC)
An assay of soluble transferrin receptor (sTfR) Soluble transferrin receptors are mainly located on red blood line cells receiving iron delivered by transferrin.

In this study, we propose to make a prospective assessment of the iron status of cancer patients beginning chemotherapy. The aim is to determine the proportion of patients who might benefit from injectable iron treatment. All ID will be covered prospectively over a 2-year period.

lead_sponsor: Centre Antoine Lacassagne


title: Salvage Chemotherapy for Poor Prognosis Germ Cell Tumors - A Phase I-II Sequential Chemotherapy Protocol of Bevacizumab (Avastin) Plus High-dose ICE (Ifosfamide - Carboplatin - Etoposide) Intensification

acronym: TAXIFIII

summary:
High-dose chemotherapy with autologous hematopoietic stem-cell transplantation is a standard salvage treatment used in adults with germ cell tumors (Einhorn et al, J Clin Oncol 2007).

Disease prognosis following 1 to 2 intensified combinations of etoposide - carboplatin +/- ifosfamide depends on the patient's performance status (PS) at inclusion and the prior sensitivity of the disease to cisplatin. A poor PS and/or being refractory to cisplatin suggest a higher toxicity and a bad prognosis.

However, predictive factors of response to high-dose chemotherapy do not include a chemo-sensitivity phase with a semi-intensive chemotherapy excluding a platinum compound (epirubicin - paclitaxel), which still allows stem-cell harvest. The use of this chemotherapy combination induced a response in more than one third of the patients treated during disease progression in the TAXIF I study. The same strategy was tested in the TAXIF II study, which completed the inclusion of 45 patients and was closed in May 2008. Results of the TAXIF II study, are currently being analyzed; they support the hypothesis to prioritarily treat patients with a sensitive relapsed disease at the time of the high-dose administration.

A combination of a semi-intensive sequential ICE type chemotherapy plus bevacizumab was used on a highly refractory patient. A 5 months nearly complete response was achieved. Indeed, the overexpression of VEGF (Vascular Endothelial Growth Factor) has been identified as an independent risk factor in patients with germ cell tumor. Therefore, a treatment strategy using an inductive chemotherapy followed, in case of response, by a double intensification therapy in combination with a VEGF treatment, could be an interesting approach in patients with poor prognosis germ cell tumors.

The aim of this phase I/II trial is to assess the feasibility of a Bevacizumab - ICE (Ifosfamide-Carboplatin-Etoposide) high dose combination with the support of autologous hematopoietic stem cell for two intensive consecutive cycles ("tandem" intensification) in patients with a poor prognosis germ cell tumor non refractory to a front-line mobilization chemotherapy using two half intensified consecutive combinations of Epirubicin-Paclitaxel.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Phase 2 Study of SERCA2a Gene Transfer in Patients With Severe Heart Failure

acronym: AGENT-HF

summary: The purpose of this study is to determine the effect of intracoronary SERCA2a Gene transfer on cardiac volumes and function using multimodality cardiac imaging.

ReferenceType: result

ReferenceCitation: Hulot JS, Salem JE, Redheuil A, Collet JP, Varnous S, Jourdain P, Logeart D, Gandjbakhch E, Bernard C, Hatem SN, Isnard R, Cluzel P, Le Feuvre C, Leprince P, Hammoudi N, Lemoine FM, Klatzmann D, Vicaut E, Komajda M, Montalescot G, Lompré AM, Hajjar RJ; AGENT-HF Investigators. Effect of intracoronary administration of AAV1/SERCA2a on ventricular remodelling in patients with advanced systolic heart failure: results from the AGENT-HF randomized phase 2 trial. Eur J Heart Fail. 2017 Nov;19(11):1534-1541. doi: 10.1002/ejhf.826. Epub 2017 Apr 10.

name: Sorbonne Universités, UPMC Univ Paris 06, AP-HP, CIC Paris-Est 1421, Institute of Cardiometabolism and Nutrition (ICAN); Pitié-Salpêtrière Hospital; F-75013 Paris France

family: Hulot

full_name: Jean-Sébastien Hulot

given: Jean-Sébastien

family: Salem

full_name: Joe-Elie Salem

given: Joe-Elie

family: Redheuil

full_name: Alban Redheuil

given: Alban

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Varnous

full_name: Shaida Varnous

given: Shaida

family: Jourdain

full_name: Patrick Jourdain

given: Patrick

name: UMR-S 942, Université Paris Diderot, DHU FIRE, Department of Cardiology, Lariboisière Hospital; Assistance Publique-Hôpitaux de Paris (AP-HP); Paris France

family: Logeart

full_name: Damien Logeart

given: Damien

family: Gandjbakhch

full_name: Estelle Gandjbakhch

given: Estelle

name: Sorbonne Universités, UPMC Univ Paris 06, AP-HP; Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department; F-75013 Paris France

family: Bernard

full_name: Claude Bernard

given: Claude

family: Hatem

full_name: Stéphane N. Hatem

given: Stéphane N.

family: Isnard

full_name: Richard Isnard

given: Richard

family: Cluzel

full_name: Philippe Cluzel

given: Philippe

family: Le Feuvre

full_name: Claude Le Feuvre

family: Leprince

full_name: Pascal Leprince

family: Hammoudi

full_name: Nadjib Hammoudi

given: Nadjib

family: Lemoine

full_name: François M. Lemoine

given: François M.

family: Klatzmann

full_name: David Klatzmann

given: David

name: ACTION Study Group, Unité de Recherche Clinique, Lariboisière; Paris France

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Komajda

full_name: Michel Komajda

given: Michel

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

family: Lompré

full_name: Anne-Marie Lompré

given: Anne-Marie

name: Cardiovascular Research Center, Icahn School of Medicine at Mount Sinaï; New York NY USA

family: Hajjar

full_name: Roger J. Hajjar

given: Roger J.