title: Identification of Predictive Immune Biomarkers Based on the Understanding of COVID-19 Pathogenesis to Influence Therapeutic Management

acronym: IMMUNOMARKCOV

summary:
Persons infected with Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2 vary in severity from being asymptomatic to having fever, cough, sore throat, general weakness and fatigue and muscular pain and in the most severe cases, severe pneumonia, acute respiratory distress syndrome and sepsis potentially leading to death. Predictive markers of clinical worsening after admission are lacking. COVID-19 immunopathogenesis and relevant therapeutic strategies are still under investigation.

Although viral shedding peaks during the first week of symptoms, reports show that clinical deterioration often coincides with the development of host antiviral immune responses. The inflammatory response to SARS-CoV-2 infection may underpin COVID-19 pathogenesis leading to aberrant and excessive immune responses that may enter the pulmonary circulation in large numbers and play an immune damaging role causing lung functional disability resulting in clinical worsening. Therapeutic strategies using corticosteroids or biotherapies targeting IL-6 may be valuable in some patients. Based on a better understanding of COVID-19 immunopathogenesis, the identification of predictive biomarkers early in the disease process would be of outstanding interest to tailor prompt therapeutic interventions.

On these bases, the present project aims to unravel, using innovative integrated multimodal immunological approaches, immunologic predictive markers by finely characterizing from their admission innate and adaptive immune responses in two well described cohorts of COVID-19 patients that are being collected in Toulouse (COVID-BioToul) and Bordeaux (COLCOV-19 BX).Those two biological cohorts are connected with two clinical cohorts in Toulouse and Bordeaux in order to have a very well defined population of COVID-19 patients and their clinical outcome. In both cohorts, investigators harvest and cryopreserve biological samples, including plasma and peripheral blood mononuclear cells (PBMCs), on admission and longitudinally from patients evolving or not toward severe forms of the disease in Bordeaux and Toulouse University Hospitals and will allow to investigate primary and secondary objectives. Moreover in the two centers, there are also two clinical outpatients cohorts of healthcare workers attending dedicated clinics in the frame of their surveillance medical program, which constitute groups of patients with benign forms of COVID-19.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital Bordeaux
University Hospital Toulouse


title: Risk Factors for Early Remodelling in Severe Asthma in Children

acronym: P'tit-ASTHME

summary:
Background: Asthma is a frequent disease characterized by bronchial hyperresponsiveness, inflammation and remodeling. Consistent epidemiological data indicate that outcome of asthma in adults may be determined in early childhood. This may be due to bronchial remodeling, an abnormal repair process that contributes to the development of poorly reversible airway narrowing. It appears very early in the natural history of the disease and involves increased mass of bronchial smooth muscle (BSM). The mechanism of such an increase has been related with an increase in smooth muscle cell proliferation. Recently, we have demonstrated that in severe asthma, BSM increased proliferation is induced by an enhanced mitochondrial biogenesis. Moreover, we have also shown that immature human, non-asthmatic airway smooth muscle cells (ASMC) proliferate to a greater extent than normal adult ASMC, in a similar fashion to adult asthmatic ASMC. Immature ASMC may thus have great potential to stimulate airway remodeling. We thus hypothesized that remodeling is an early process and certain characteristics of ASMC in severe preschool asthma may predispose such children to persistent remodeling with airway obstruction later in life.
Purpose: To investigate prognostic factors of airway remodeling in preschool children, with special attention to ASMC proliferation (mitochondrial mass & biogenesis).
Methods: In the initial phase of the project, 75 severe asthmatic preschool children (<5 yr) will be prospectively recruited from the "CHU de Bordeaux" and the "CHU de Toulouse" according to the "Haute Autorité de Santé" criteria. Inclusion visit will include written informed consent, asthma control evaluation, clinical examination, lung function testing (exhaled NO, plethysmography), prick tests, chest X Ray and blood sample for total IgE levels. Bronchial specimens from all subjects will be obtained by fiberoptic bronchoscopy at visit 2. Airway remodeling will be evaluated by morphological analysis. After smooth muscle mitochondria will be analyzed by electronic microscopy & immunoblotting. Comparison between the 2 groups will be performed by unpaired t tests for parametric data and x2-tests for non-parametric data. In the second phase of the project, patients will then be followed-up till the age of 7-10 yrs, when another bronchoscopy with biopsies will be performed.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Bordeaux
Hôpital des Enfants

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Treg Cell Therapy in Liver and Kidney Transplantation - Preclinical Validation of Batches of Treg Cells Amplified in Vitro

acronym: PRE-TREG

summary:
Kidney and liver transplantation requires a fine tuning of immune responses in order to achieve long term operational tolerance with immunosuppressants or immune modulators. Numerous experimental findings indicate that CD4+ FOXP3 expressing regulatory T (Treg) cells play a central role in the induction of tolerance to the grafts indicating that the use of Treg cells may be an innovative therapeutic strategy in kidney transplantation that would enable the diminution of immunosuppressive drugs or even their discontinuation, thus decreasing their risk of adverse events.

As human Treg cells represent less than 10% of CD4+ T cells, and because it has been shown in mice that a dose of 2*104 polyclonal Tregs/g was necessary to induce tolerance in animal models of solid organ transplantation, it is mandatory to expand human Treg cells ex vivo, after isolating them from peripheral blood. The investigators previously defined a protocol for Treg cell isolation and expansion in clinical grade conditions (cGMP) that enabled us to obtain the expected number of expanded cells maintaining high levels of FOXP3 (3).

The investigators therefore hypothesize in humans, as it has been already shown in mice, that the infusion of autologous expanded polyclonal Treg cells would lead to the obtaining of operational tolerance in kidney and liver graft in association with classical immunosuppressants and an expectable diminution of those.

To this end, it is necessary to have pre-clinical batches of expanded Treg cells validated by the National Agency for Medicines and Health Products Safety validate (ANSM). The investigators therefore plan to have 4 batches from 2 liver transplant patients and 2 kidney transplant patients validated.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

status_simplified: Ongoing


title: Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide: Investigation of Disruptive Mood Dysregulation Disorder

acronym: ACTIHUMEUR

summary: An excess suicide-related morbidity is observed among young people in the Picardie region, as reflected by the > 100% occupation rate of the Amiens University Hospital Adolescent Medicine Unit

study_start_date_type: Actual

status: Terminated

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
AP HP
CHU Amiens

intervention_type: Device

status_simplified: Unknown


title: Recherche d'un Marqueur Pronostique de l'Atteinte rénale du Purpura Rhumatoïde de l'Enfant. Validation de la méthode de détection Des IgA1 Avec Gradient de la Glycosylation Par spectrométrie de Masse

summary: In this ancillary study on the FoxTreg cohort, the study investigators will select variables to input and thus develop two models (Linear Discriminant Analysis and Decision Tree). The aim of this study is to validate the method in terms of repeatability, reproducibility, control of pre-analytical conditions and sample conservation, to complete the screening of IgA glycosylation in individuals of the FoxTreg cohort and to refine the glycopeptide signature to predict renal involvement.

status: Active, not recruiting

study_type: Observational

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Ozen S, Pistorio A, Iusan SM, Bakkaloglu A, Herlin T, Brik R, Buoncompagni A, Lazar C, Bilge I, Uziel Y, Rigante D, Cantarini L, Hilario MO, Silva CA, Alegria M, Norambuena X, Belot A, Berkun Y, Estrella AI, Olivieri AN, Alpigiani MG, Rumba I, Sztajnbok F, Tambic-Bukovac L, Breda L, Al-Mayouf S, Mihaylova D, Chasnyk V, Sengler C, Klein-Gitelman M, Djeddi D, Nuno L, Pruunsild C, Brunner J, Kondi A, Pagava K, Pederzoli S, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). EULAR/PRINTO/PRES criteria for Henoch-Schönlein purpura, childhood polyarteritis nodosa, childhood Wegener granulomatosis and childhood Takayasu arteritis: Ankara 2008. Part II: Final classification criteria. Ann Rheum Dis. 2010 May;69(5):798-806. doi: 10.1136/ard.2009.116657.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHRU de Montpellier
CHU de Nimes


title: Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification

acronym: CALCILUP

summary:
Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of osteoporosis and cardiovascular calcification. It has also been suggested that bone remodelling and cardiovascular calcification are regulated by the same mechanisms, but inversely in terms of calcium deposition, as osteoporosis is often associated with cardiovascular calcification. Inflammatory and immune factors have been implicated in these two processes.

The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts, while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly established, its role in vascular calcification is only hypothetical at the present time.

This study will focus on patients with SLE diagnosed and followed in the Amiens University Hospital Internal Medicine and Nephrology departments

primary_purpose: Basic Science

location_facility:
CHU Rouen
CHU Amiens


title: Tight Postoperative Control of Mean Arterial Pressure Using a Closed-loop System for Norepinephrine Administration: A Randomized Controlled Trial in Patients Admitted to the Intensive Care Unit After a Major Surgery.

acronym: COMAP-ICU

summary: The goal of this randomized controlled trial is to compare two different strategies of postoperative mean arterial pressure (MAP) management (manual versus automated) in patients who underwent a major surgery and admitted in the intensive care unit or post-anesthesia care unit for postoperative care. The investigators hypothesis is that the automated group will spend more time in a predetermined target MAP range of 80-90 mmHg compared to the manual group.

status: Recruiting

design_allocation: Randomized

primary_purpose: Treatment

location_facility:
Bicêtre Hospital
Paul Brousse Hospital


title: Performance Evaluation of Von Willebrand:Collagen-Binding Assays to Diagnose Von Willebrand Factor Deficiency in Patients With Increased Risk of Bleeding

acronym: PERICOLL

summary:
Von Willebrand Disease (VWD) is defined as an inherited bleeding disorder that is caused by deficiency or dysfunction of von Willebrand factor (VWF), a plasma protein that mediates the initial adhesion of platelets at sites of vascular injury and also binds and stabilizes blood clotting factor VIII (FVIII) in the circulation. The most severe forms of VWD are usually easy to diagnose (obvious hemorrhagic symptoms and major VWF deficiency), whereas the mild forms of the disease are still difficult to confirm. It is indeed reported that about 1% of the population carry mild biological VWF deficiency without any bleeding tendency and any "actual disease". On the contrary, some patients with severe bleeding history can carry a true VWF abnormality, well-confirmed by genetic studies, without any VWF deficiency when evaluated with standard biological methods, such as Ristocetin Cofactor activity (VWF:RCo). However, in these patients, the use of alternative methods, such as PFA-100 (Platelet Fonction Analyzer-100), the study of Factor VIII (FVIII:C) to VWF (FVIII:C/VWF) ratio or the evaluation of VWF activity using more specialized methods such as VWF:CB (VWF-Collagen Binding) assay can detect the VWF deficiency and possible hemorrhagic predisposition.

In this project, the investigators plan to assess the performance of VWF:CB in the diagnosis of VWF deficiency in patients with unexplained bleeding history.

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

location_facility:
Nantes University Hospital
Dijon University Hospital


title: Effect and Tolerability of Lactobacillus Rhamnosus GG LA801 for the Preventive Nutritional Care of Nosocomial Diarrhea in Children

acronym: EPISODE

summary:
One of the most common infections acquired in hospital, also known as nosocomial infections, is intestinal infections. These infections can lead to the development of nosocomial diarrhea which can have serious consequences in young / very young children. These infections tend to prolong the average length of hospital stay of this fragile population. Conventional treatment of these infections, in the absence of knowledge of the infectious agent, is purely symptomatic. It is therefore necessary to develop new prevention strategies for this type of disease. In this sense, the administration of probiotic strains in order to prevent the onset of nosocomial diarrhea is a promising avenue and the present study aims to validate the preventive effect of this supplement.

The objective of this study is to assess the effect of Babybiane® Imedia or the microbiotic strain Lactobacillus rhamnosus GG LA801 in the preventive nutritional management of nosocomial diarrhea in children aged 1 to 24 months. This evaluation will be made in comparison with a placebo. The tolerance of the product under study will also be assessed.

lead_sponsor: PiLeJe

location_facility:
Centre hospitalier d'Auxerre
Hopital Robert Debré

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


title: Prevalence of Chronic Pain After an Emergency Department Visit for Severe Acute Pain and Influence of the Analgesia Initially Used

acronym: CHROPAIN

summary: The main objective for investigators is to determine the prevalence of moderate to severe chronic pain in the adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission and defined as greater than or equal to 6/10 by the numerical pain scale.

lead_sponsor: University Hospital, Grenoble

location_facility:
Grenoble Alpes University Hospital
CHU Pellegrin


title: NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants

summary:
Very premature birth and the necessary hospitalization expose to a risk of morbidity and mortality which impacts the neurodevelopmental prognosis. Sleep and behavior monitoring have not been developed in the neonatal units. This has to be improved since it is known from clinical and animal studies that the quality, organization and quantity of sleep in very preterm infants impact neurological development and brain plasticity.

The collection system provide neonatal care nurse with access to motion curves (evaluated by signal processing of live video) and real-time infrared video (also available in low-light conditions).

This new non-invasive technology allows an evaluation of the activity cycles of the newborn by the caregivers which until now was only accessible occasionally by short recordings of actigraphy or polysomnography. The investigators wish to demonstrate that this can contribute to an organization of care that respects the sleep patterns of the newborn, which they know to condition the neurodevelopmental prognosis.

primary_purpose: Supportive Care

lead_sponsor: Rennes University Hospital

location_facility:
CHU Rennes Hôpital Sud
Pôle Femme Mère Enfant

intervention_type: Behavioral


title: Using Nasal Broadband Glasses HFNC (High Flow Nasal Cannula) in the Initial Management of Severe Bronchiolitis in Infants Admitted in ICU: Bicentric Observational Study on the 2013-2014 Epidemic

acronym: HFNC

summary:
The aim of this study is to evaluate the use of nasal broadband glasses HFNC (High Flow Nasal Cannula) in the initial management of severe bronchiolitis in infants admitted in ICU.

Nasal HFNC can deliver warmed humidified gas through a nasal interface, greatly improving the safety and efficacy of administering O2. This device generates a continuous positive pressure in the airways, to reduce the work of breathing. The sealing absence of the HFNC at the nasal interface improves patient comfort and avoiding nasal trauma.

lead_sponsor: Fondation Lenval

location_facility: Hôpital Arnaud de Villeneuve - CHU de Montpellier

location_facility: Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL


title: Evaluation of Diagnosis of Fever and Biologic Inflammatory Syndrome of Unknown Origin

acronym: FUO

summary:
Fever of unknown origin (FUO) and biologic inflammatory syndrome of unknown origin (SII) are two frequent causes of hospitalization or consultation in infectious disease unit and internal medicine.

There are many etiologies, in four categories: infections, auto-immune disease, cancer and miscellaneous causes. Currently there is no specifics recommendations to follow a "diagnosis way" of FUO and SII.

Purpose: Evaluation of clinical practices in the diagnosis of fever and biologic inflammatory syndrome of unknown origin, in two units of the University Grenoble Hospital.

ReferenceCitation: PETERSDORF RG, BEESON PB. Fever of unexplained origin: report on 100 cases. Medicine (Baltimore). 1961 Feb;40:1-30.

ReferenceCitation: Durack DT, Street AC. Fever of unknown origin--reexamined and redefined. Curr Clin Top Infect Dis. 1991;11:35-51. Review.

ReferenceCitation: Knockaert DC, Vanderschueren S, Blockmans D. Fever of unknown origin in adults: 40 years on. J Intern Med. 2003 Mar;253(3):263-75. Review.

ReferenceCitation: Bleeker-Rovers CP, Vos FJ, de Kleijn EMHA, Mudde AH, Dofferhoff TSM, Richter C, Smilde TJ, Krabbe PFM, Oyen WJG, van der Meer JWM. A prospective multicenter study on fever of unknown origin: the yield of a structured diagnostic protocol. Medicine (Baltimore). 2007 Jan;86(1):26-38. doi: 10.1097/MD.0b013e31802fe858.

ReferenceCitation: Kucukardali Y, Oncul O, Cavuslu S, Danaci M, Calangu S, Erdem H, Topcu AW, Adibelli Z, Akova M, Karaali EA, Ozel AM, Bolaman Z, Caka B, Cetin B, Coban E, Karabay O, Karakoc C, Karan MA, Korkmaz S, Sahin GO, Pahsa A, Sirmatel F, Solmazgul E, Ozmen N, Tokatli I, Uzun C, Yakupoglu G, Besirbellioglu BA, Gul HC; Fever of Unknown Origin Study Group. The spectrum of diseases causing fever of unknown origin in Turkey: a multicenter study. Int J Infect Dis. 2008 Jan;12(1):71-9. Epub 2007 Jul 12.

location_facility:
University Hospital
CHU Grenoble


title: Electrical Impedance Tomography: Collapse in Dependent Areas as a Predictor of Response to Prone Position Ventilation in COVID-19 Acute Respiratory Distress Syndrome

acronym: COVIDEIT

summary:
There are several clinical presentations of SARS-CoV-2 infection. Among the severe forms, pulmonary involvement with respiratory failure is common. Although severe lung involvement with SARS-CoV-2 meets the Berlin criteria for Acute Respiratory Distress Syndrome (ARDS), it differs from classic ARDS in that compliance (reflecting distensibility of the lung parenchyma) is frequently preserved.

If the interest of Electrical Impedance Tomography has been demonstrated in classical ARDS, this is not the case in ARDS with COVID-19.

However, the use of this technique in this particular patient population would make it possible to distinguish patients with severe hypoxemia linked to derecruitment from those without derecruitment, in whom hypoxemia is more likely to be linked to the loss of hypoxic vasoconstriction.

ipd_sharing: Undecided

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Medico-economic Evaluation of Complicated Obesity in Primary Care

summary:
The investigators developed the Aviitam® online platform. The purpose of the project is to test the medico-economic impact related to the utilization of the Aviitam online platform in primary care.

Primary objective: To assess the cost-effectiveness at 24 months follow-up of the utilization of the Aviitam® online software in primary care for people with obesity and at least one comorbidity compared to a usual follow-up in primary care.

Secondary objectives: Weight loss; quality of life ; blood pressure change; changes in lipid profile, blood glucose and HbA1c; physician satisfaction; patients satisfaction, profiling of patients and data mining analysis on the collected data.

Method : Overweight & obese patients with associated comorbidities will receive a 24 months follow-up to assess the impact of the use of the online platform Aviitam®.

Practitioners will be randomized by lot between an Aviitam® group and a control group (usual care).

A medico-economic analysis will be conducted with a cost-effectiveness analysis and a budget impact analysis.

With no hypothesis on the primary endpoint, the calculation of the required number of subjects was based on the quality of life. 150 patients will be included per group Patients of the 2 groups will be assessed at baseline and after 24 months. The first day of each month, each patient included in the study will receive a questionnaire to fill online to evaluate their health care consumption in the previous month and the EQ5D questionnaire , a standardized questionnaire validated in French to assess the effects on health and to be used to calculate cost - utility.

Expected results and perspectives Proving the effectiveness of the Aviitam® online program focused on non-drug therapies and therapeutic lifestyle changes for overweight and obesity management with reduced health costs, improvement in quality of life, reduction in weight and improvement of comorbidities.

In terms of public health, the use of the platform Aviitam® can be expect to improve management of excess body weight and reduced health costs. Furthermore, Aviitam® could be a valuable tool to support healthcare professionals in outpatient therapeutic education approaches.

status: Unknown status

lead_sponsor: University Hospital, Montpellier

location_facility: Departement Nutrition Diabète Hôpital lapeyronie 371 avenue du Doyen Gaston Giraud


title: Radiofrequency Ablation for Aldosterone-producting Adenoma in Patients With Primary Aldosteronism: Evaluation of the Blood Pressure Control and of Its Safety.

acronym: ADERADHTA

summary: The aim of the study is to evaluate the novel use of adrenal radiofrequency ablation on a prospective cohort of patients with primary aldosteronism and unilateral adrenal adenoma concerning the efficacy on blood pressure control. The safety of the procedure is one of the secondary outcomes.

location_facility:
CHU Bordeaux
CHU de Toulouse


title: Dose-escalation, Phase I Multicentric Trial, Evaluating the Combination of Ribociclib and Capecitabine in Locally Advanced or Metastatic Breast Cancer HER2 Negative in Patients Previously Treated With Anthracyclines and Taxanes

summary:
The proposed study is a multicenter, open-label phase I trial, conducted in locally advanced or metastatic breast cancer HER2 negative patients and divided into 2 parts:

STEP 1: a dose escalation part (n= up to 30) to evaluate the safety profile and pharmacokinetics and to define the MTD and RP2D to recommend in a phase II.
STEP 2: an expansion cohort part to confirm the safety and tolerability of ribociclib and capecitabine association on a longer follow-up, and to obtain preliminary evidence of anti-tumor activity on two expanded cohorts of HR positive and HR negative patients. Up to 14 patients in each cohort, taking into account patients already included in step one at this DL, may be enrolled, for a total of 28 at the RP2D.

lead_sponsor: UNICANCER

location_facility:
Centre Leon Berard
Institut de Cancérologie de l'Ouest

intervention_type: Drug


title: Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation

acronym: REVISON

summary:
Speech is a privileged means of communication for humans: its trouble can thus prove being extremely handicapping. Standard speech therapy is limited in some cases by the lack of sensory feedback available to the patient (hearing, surgery, neural damage, etc.).

The present study aims at quantify the contribution of the tongue articulatory visual feedback offered by ultrasound echography to speech trouble rehabilitation.

Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and 10 childrens with important speech troubles due to central nervous system damage.

The principle is to conduct standard speech therapy sessions, alternating series of sessions with the use of visual feedback and sessions without visual feedback.

The progress will be regularly measured by means of standard batteries of speech articulation tests.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Institut d'Education Motrice
Centre Médical Rocheplane


title: Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations and Living at Home

acronym: OPTIM

summary:
Aging is often associated with multiple chronic conditions conducting increased consumption of drugs. Drug therapy is necessary for the treatment of many diseases. However, misuse of drugs, particularly linked to the potentially inappropriate prescribing and polypharmacy, increases the iatrogenic risks and can lead to adverse events such as falls, cognitive decline, increased use to the health system: hospital admissions, emergency room visits, and institutionalization. These problems are common since about 20% of emergency room use in elderly patients due to an adverse event related to drugs. Nearly 28% of adverse events related to drug prescriptions could be avoided.

Interventions to optimize drug therapy showed a reduction in the number of potentially inappropriate medications, but their impact on health, has rarely been evaluated. If an association with death has been established, the link with the loss of functional autonomy, which leads to reduced quality of life and significant cost of care, has not been investigated. The evolution towards functional disabilities, frequent with aging has many causes, among which some could be prevented. The optimization of drug prescriptions could thereby delay or prevent the loss of functional autonomy by reducing the risk of adverse events, such as falls or cognitive decline and improving the management of chronic diseases. Our hypothesis is that an optimization program of the drug prescribing may slow progression to functional dependence. To assess the effect of the optimization program of drug prescribing on the level of functional autonomy, a multicenter Randomized Controlled Trial will be conducted in geriatric and memory consultations.

Expected results The implementation of the "OPTIM" program should enable optimization of drug prescribing in elderly patients and therefore slow or prevent progression to addiction. It should also help to develop and strengthen collaboration and communication between the team of geriatric consultation, the clinician pharmacist and referring physicians in town (private practice). In addition, pharmaceutical notice sent to referring physicians should help raise awareness of the prescription of drugs in these patients.

ReferenceType: derived

ReferenceCitation: Dauphinot V, Jean-Bart E, Krolak-Salmon P, Mouchoux C. A multi-center, randomized, controlled trial to assess the efficacy of optimization of drug prescribing in an elderly population, at 18 months of follow-up, in the evolution of functional autonomy: the OPTIM study protocol. BMC Geriatr. 2017 Aug 30;17(1):195. doi: 10.1186/s12877-017-0600-7.

family: Dauphinot

full_name: Virginie Dauphinot

given: Virginie

sequence: first

family: Jean-Bart

full_name: Elodie Jean-Bart

given: Elodie

sequence: additional

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

given: Pierre

family: Mouchoux

full_name: Christelle Mouchoux

given: Christelle

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Geriatrics

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility:
Hôpital des Charpennes
Hôpital gériatrique du Mont d'Or


title: Evaluation of the Effect of Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule: A Prospective, Bicentric, Pilot Study

acronym: INREG 1

summary: The main objective of this study is to measure changes in the thickness of the vaginal lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Neuropsychological Factors Associated With Vulnerability to Suicidal Behavior in Depressed Elderly Patients

acronym: SPAD

summary: The main objective of this study is to confirm the existence of risky decision making in a non strategic situation (Iowa Gambling Task) and a deficit of decision making in social situations, linked to greater sensitivity to injustice (Ultimatum Game) and a lower level of trust (Trust Game) in elderly depressed patients with a history of suicide attempts in comparison with older depressed patients without a history of suicidal acts and healthy subjects.

ReferenceCitation: Mann JJ. The neurobiology of suicide. Nat Med. 1998 Jan;4(1):25-30. Review.


title: Study of Modifications of the Composition and Structure in the Aseptic Osteonecrosis of the Femoral Head and Etiopathogenic MRI Correlations

acronym: ONTF

summary: In this study, the aim is to identify the modifications responsible for aseptic osteonecrosis of the femoral head and its structural evolution by the association of the micro scanner analysis and Raman spectrometry performed on the femoral heads removed during hip replacements. The study of femoral heads will allow the analysis of bone tissue at two different scales, both correlated with the biomechanical properties of the bone. Also, the association with preliminary MRI analysis will provide pathogenic explanations correlated to these modifications.

lead_sponsor: Lille Catholic University

location_facility: Hospital Group of the Catholic Institute of Lille


title: French Cohort of covid19 Patients With Post-intensive Care Syndrome : Rehabilitation From Intensive Care Unit to Home Return

acronym: COREADOM

summary: The purpose of this study is to describe post-intensive care syndrome (PICS) of patients surviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recovery process from hospital to home return

location_facility: Department of Rehabilitation, Institute of Rheumatology Cochin

location_facility: Department of Physical Medicine and Rehabilitation


title: Detection of Postoperative Complications Through Continuous Monitoring Using the Biobeat Patch

acronym: Biobeat-Postop

summary:
Brief Summary: Post-operative morbidity remains a reality as shown by the International Surgical Outcomes Study published in 2016 and 2019 and by several recent publications which focus mainly on hypotension and cardio-vascular complications. Other complications, such as respiratory depression, are less often studied. The hypothesis is that this connected patch could be used in surgical departments to detect a postoperative complication.

Biobeat Technologies Ltd has developed a sensor which continuously records the photoplethysmographic waveform and allows the calculation of several physiological parameters: heart rate (HR), oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP), stroke volume (SV), cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), respiratory rate (RR), and temperature.

The objective of this study is the quantification of hemodynamic, respiratory and temperature abnormalities detected by routine monitoring (routine nursing follow-up) and continuous monitoring by the Biobeat patch during the first 72 postoperative hours.

ReferenceCitation: Liem VGB, Hoeks SE, Mol KHJM, Potters JW, Grüne F, Stolker RJ, van Lier F. Postoperative Hypotension after Noncardiac Surgery and the Association with Myocardial Injury. Anesthesiology. 2020 Sep;133(3):510-522. doi: 10.1097/ALN.0000000000003368.

ReferenceCitation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13.

ReferenceCitation: International Surgical Outcomes Study (ISOS) group. Prospective observational cohort study on grading the severity of postoperative complications in global surgery research. Br J Surg. 2019 Jan;106(2):e73-e80. doi: 10.1002/bjs.11025.

ReferenceCitation: Turan A, Chang C, Cohen B, Saasouh W, Essber H, Yang D, Ma C, Hovsepyan K, Khanna AK, Vitale J, Shah A, Ruetzler K, Maheshwari K, Sessler DI. Incidence, Severity, and Detection of Blood Pressure Perturbations after Abdominal Surgery: A Prospective Blinded Observational Study. Anesthesiology. 2019 Apr;130(4):550-559. doi: 10.1097/ALN.0000000000002626.

ReferenceCitation: Paternot A, Aegerter P, Martin A, Ouattara J, Ma S, Adjavon S, Trillat B, Alfonsi P, Fischler M, Le Guen M. Screening for postoperative complications by continuous monitoring: protocol for the Biobeat-Postop cohort study. F1000Res. 2021 Jul 21;10:622. doi: 10.12688/f1000research.54781.1. eCollection 2021.

family: Paternot

full_name: Alexis Paternot

given: Alexis

family: Aegerter

full_name: Philippe Aegerter

given: Philippe

family: Martin

full_name: Aurélie Martin

given: Aurélie

family: Ouattara

full_name: Jonathan Ouattara

given: Jonathan

family: Ma

full_name: Sabrina Ma

given: Sabrina

family: Adjavon

full_name: Sherifa Adjavon

given: Sherifa

family: Trillat

full_name: Bernard Trillat

given: Bernard

family: Alfonsi

full_name: Pascal Alfonsi

given: Pascal

family: Fischler

full_name: Marc Fischler

given: Marc

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

bso_classification: Biology (fond.)

currency_apc_doaj: USD

oa_host_type: publisher

publisher: F1000 Research Ltd

publisher_dissemination: Informa

publisher_group: Informa

ipd_sharing: Yes

ipd_sharing_description: Dryad Repository

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
Groupe hospitalier Paris Saint-Joseph


title: Early Biomarkers of Sepsis Identification in the Emergency Department

acronym: BIPS

summary: Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis.

lead_sponsor: Pitié-Salpêtrière Hospital

location_facility:
Institut Pasteur
Hôpital Pitié Salpêtrière

intervention_type: Biological


title: Study of Balance Reactions in a Virtual Environment Compared to a Real Environment

acronym: EQUIVIRT

summary: Validate a virtual environment by demonstrating a non modification of the characteristics of postural reaction and displacement of the body's center of pressure between a real environment and the same environment in immersive virtual reality.

primary_purpose: Screening

lead_sponsor: Pôle Saint Hélier

location_facility:
Pole Saint-Hélier
Hôpital la Musse


title: Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)

summary:
Tobacco use is one of the world's leading preventable causes of disease and premature death, and the physician has a central role in detecting smokers and helping them to quit.

Tobacco use in the military undermines fitness, readiness and performance, and increases health care costs.

A study conducted on a French Army contingent on external operations in Afghanistan have shown an increase in tobacco use in situation of operational constraints (stress, shift work, etc.). However, another study conducted in Ivory Coast on a mobile gendarmerie squadron showed no significant difference.

Among the American firefighters who have been exposed to the 9/11 World Trade Center attacks, smoking have been shown to play an aggravating role in the recovery of lung function.

This study is aimed at assessing smoking prevalence in the Paris Fire Brigade, which is composed of young and healthy sportsmen and women who are exposed to strong operational constraints.

location_facility:
Antenne médicale de Ménilmontant
Centre Médical de Champerret


title: Cerebral NIRS Profiles During Premedication for Neonatal Intubation

summary:
Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate.

Primary outcome:

Cerebral desaturation defined by a rScO2 delta >20% from the baseline value (before premedication).
Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 .

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.

ReferenceType: result

ReferenceCitation: Vedrenne-Cloquet M, Breinig S, Dechartres A, Jung C, Renolleau S, Marchand-Martin L, Durrmeyer X. Cerebral Oxygenation During Neonatal Intubation-Ancillary Study of the Prettineo-Study. Front Pediatr. 2019 Mar 1;7:40. doi: 10.3389/fped.2019.00040. eCollection 2019.

family: Vedrenne-Cloquet

full_name: Meryl Vedrenne-Cloquet

given: Meryl

family: Breinig

full_name: Sophie Breinig

given: Sophie

family: Dechartres

full_name: Agnes Dechartres

given: Agnes

family: Jung

full_name: Camille Jung

given: Camille

family: Renolleau

full_name: Sylvain Renolleau

given: Sylvain

family: Marchand-Martin

full_name: Laetitia Marchand-Martin

given: Laetitia

family: Durrmeyer

full_name: Xavier Durrmeyer

given: Xavier

journal_name: Frontiers in Pediatrics

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

title: Cerebral Oxygenation During Neonatal Intubation–Ancillary Study of the Prettineo–Study

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Hôpital intercommunal de Créteil
Hôpital des enfants


title: Descriptive Study on the Evolution of Intestinal Microbiota Profiles in Patients With Juvenile Spondylarthropathy According to the Typology of Treatment and Response to it: A Descriptive, Prospective Pilot Study

acronym: MESAJ

summary: Idiopathic juvenile arthritis includes 20% of patients with arthritis with enthesitis or juvenile spondyloarthropathy. This is treated with anti-inflammatory drugs and then followed by biotherapy with DMARDs (Drugs Modifying the Activity of Rheumatic Disease) if the former are insufficient. Methotrexate (MTX) may also be used before these biotherapies. Recently, in adults, a particular profile of intestinal microbiota has been shown to alter the availability of MTX making it in efficient. Knowing that pediatric patients with juvenile spondyloarthropathy have an imbalance of their intestinal flora (dysbiosis) the investigators wanted to explore whether DMARDs could have a similar impact on the microbiota of these young patients and alter the response to treatment.

location_facility: Montpellier University Hospital, Arnaud de Villeneuve Hospital


title: Radiation Therapy and Venous Thromboembolic Events

acronym: RIT

summary: The aim of the present study is to determine the frequency and to identify main risk factors for venous thromboembolism of venous thromboembolic complications in a population of cancer patients treated with a curative intent by ionizing radiation.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de cancérologie Lucien Neuwirth


title: Non-invasive Neurological Evaluation During Cardiopulmonary Resuscitation for Out of Hospital Cardiac Arrest Patients Neuro-E-CPR Study

acronym: Neuro-E-CPR

summary:
Cardiac arrest remains a leading cause of death, currently affecting >250,000 Europeans outside the hospital each year. Manual cardiopulmonary resuscitation (CPR) provides between 15 to 30 % of normal blood flow to the heart and brain. For out-of-hospital cardiac arrest, the return of spontaneous circulation (ROSC) is possible only for 20-40% of patients with trained resuscitation teams. However, only 5-10% of patients will survive with good neurological status. A good quality CPR, a short time before initiation of the resuscitation and a short delay before the first defibrillation have been associated with improved neurological outcome. Unfortunately it is currently impossible to obtain reliable information on the quality of the perfusion and oxygenation of organs during CPR. The current monitoring during CPR is limited to heart rhythm analysis, pulse rate evaluation and end tidal CO2 (EtCO2). The last one is the only parameter which have been linked with probability of ROSC and its value gives no indication of the long-term prognosis nor the neurological status.

Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting the balance between need and supply of brain oxygenation. This technique has been recently used in cardiac arrest showing a possible association between rSO2 measured during CPR and the occurrence of ROSC or survival. The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome in the hospital for patient successfully reanimated after out-of-hospital cardiac arrest (OHCA). Recently, a feasibility study has shown that its use was also possible during CPR in the pre-hospital setting.

The investigators aim to study a composite prognostic factor combining quantitative rSO2 and automated pupillometry measured during CPR. The investigators hypothesized that the rate of survival with good neurologic outcome at 30 days will be lower in patients with rSO2 <30% for more than 5 min and an absent pupillary reflex more than 5 min or decreasing during CPR .

ReferenceCitation: Levine RL, Wayne MA, Miller CC. End-tidal carbon dioxide and outcome of out-of-hospital cardiac arrest. N Engl J Med. 1997 Jul 31;337(5):301-6.

ReferenceCitation: Storm C, Leithner C, Krannich A, Wutzler A, Ploner CJ, Trenkmann L, von Rheinbarben S, Schroeder T, Luckenbach F, Nee J. Regional cerebral oxygen saturation after cardiac arrest in 60 patients--a prospective outcome study. Resuscitation. 2014 Aug;85(8):1037-41. doi: 10.1016/j.resuscitation.2014.04.021. Epub 2014 Apr 30.

family: Storm

full_name: C. Storm

given: C.

family: Leithner

full_name: C. Leithner

family: Krannich

full_name: A. Krannich

given: A.

family: Wutzler

full_name: A. Wutzler

family: Ploner

full_name: C.J. Ploner

family: Trenkmann

full_name: L. Trenkmann

given: L.

family: von Rheinbarben

full_name: S. von Rheinbarben

given: S.

family: Schroeder

full_name: T. Schroeder

given: T.

family: Luckenbach

full_name: F. Luckenbach

given: F.

family: Nee

full_name: J. Nee

given: J.

journal_name: Resuscitation

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Regional cerebral oxygen saturation after cardiac arrest in 60 patients—A prospective outcome study

ReferenceCitation: Ito N, Nishiyama K, Callaway CW, Orita T, Hayashida K, Arimoto H, Abe M, Endo T, Murai A, Ishikura K, Yamada N, Mizobuchi M, Anan H, Okuchi K, Yasuda H, Mochizuki T, Tsujimura Y, Nakayama T, Hatanaka T, Nagao K; J-POP Registry Investigators. Noninvasive regional cerebral oxygen saturation for neurological prognostication of patients with out-of-hospital cardiac arrest: a prospective multicenter observational study. Resuscitation. 2014 Jun;85(6):778-84. doi: 10.1016/j.resuscitation.2014.02.012. Epub 2014 Mar 5.

family: Ito

full_name: Noritoshi Ito

given: Noritoshi

family: Nishiyama

full_name: Kei Nishiyama

given: Kei

family: Callaway

full_name: Clifton W. Callaway

given: Clifton W.

family: Orita

full_name: Tomohiko Orita

given: Tomohiko

family: Hayashida

full_name: Kei Hayashida

family: Arimoto

full_name: Hideki Arimoto

given: Hideki

family: Abe

full_name: Mitsuru Abe

given: Mitsuru

family: Endo

full_name: Tomoyuki Endo

given: Tomoyuki

family: Murai

full_name: Akira Murai

given: Akira

family: Ishikura

full_name: Ken Ishikura

given: Ken

family: Yamada

full_name: Noriaki Yamada

given: Noriaki

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

repository_institution: Kyoto University - Kyoto University Research Information Repository

title: Noninvasive regional cerebral oxygen saturation for neurological prognostication of patients with out-of-hospital cardiac arrest: A prospective multicenter observational study

ReferenceCitation: Singer AJ, Ahn A, Inigo-Santiago LA, Thode HC Jr, Henry MC, Parnia S. Cerebral oximetry levels during CPR are associated with return of spontaneous circulation following cardiac arrest: an observational study. Emerg Med J. 2015 May;32(5):353-6. doi: 10.1136/emermed-2013-203467. Epub 2014 Mar 24.

ReferenceCitation: Schewe JC, Thudium MO, Kappler J, Steinhagen F, Eichhorn L, Erdfelder F, Heister U, Ellerkmann R. Monitoring of cerebral oxygen saturation during resuscitation in out-of-hospital cardiac arrest: a feasibility study in a physician staffed emergency medical system. Scand J Trauma Resusc Emerg Med. 2014 Oct 5;22:58. doi: 10.1186/s13049-014-0058-y.

journal_name: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

ReferenceCitation: Suys T, Bouzat P, Marques-Vidal P, Sala N, Payen JF, Rossetti AO, Oddo M. Automated quantitative pupillometry for the prognostication of coma after cardiac arrest. Neurocrit Care. 2014 Oct;21(2):300-8. doi: 10.1007/s12028-014-9981-z.

repositories_institution:
Université de Lausanne - SERVAL
reroDoc Digital Library

title: Automated Quantitative Pupillometry for the Prognostication of Coma After Cardiac Arrest

ReferenceCitation: Behrends M, Niemann CU, Larson MD. Infrared pupillometry to detect the light reflex during cardiopulmonary resuscitation: a case series. Resuscitation. 2012 Oct;83(10):1223-8. doi: 10.1016/j.resuscitation.2012.05.013. Epub 2012 May 30.

title: Infrared pupillometry to detect the light reflex during cardiopulmonary resuscitation: A case series


title: Exploratory Study. Endothelium-dependent Vasodilatation and Other Biomarkers: Predictive Indicators of the Progression From Gestational Hypertension to Preeclampsia?

acronym: BIOVASC-PreHTA

summary:
Hypertension during pregnancy remains a leading cause of maternal and foetal morbidity and mortality. The frequency (5 to 10% of pregnancies) and potential severity of these diseases, both for the mother and the child, are reasons for standardizing and optimizing medical practices.

The cause of hypertension during pregnancy and in particular the pathophysiology of preeclampsia remains poorly understood. Guidelines distinguish these two entities by the existence of proteinuria from and after the 20th week of amenorrhea and by maternal-foetal complications, more serious in pre-eclampsia than in gestational hypertension.

During gestational hypertension and preeclampsia acute placental vasculature and blood flow abnormalities were observed, maybe due to generalized vascular endothelial activation and vasospasm resulting in systemic hypertension and organ hypoperfusion. Endothelial dysfunction and abnormal expression of several specific blood biomarkers are now well accepted as characteristics of preeclampsia.

However, the progression of gestational hypertension to preeclampsia is difficult to predict; between 15 and 40 % of gestational hypertension cases progress to preeclampsia, suggesting that it is the same worsening disease.

Endothelial dysfunction could be at the origin of gestational hypertension, and subsequent development of preeclampsia through an imbalance between pro- and anti-angiogenic factors.

The main objective of this research is to assess whether the alteration of endothelium-dependent vasodilatation in pregnant women with stable hypertension is correlated with the occurrence of preeclampsia later during pregnancy.

ReferenceCitation: Report of the National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy. Am J Obstet Gynecol. 2000 Jul;183(1):S1-S22.

ReferenceCitation: Wu P, Haththotuwa R, Kwok CS, Babu A, Kotronias RA, Rushton C, Zaman A, Fryer AA, Kadam U, Chew-Graham CA, Mamas MA. Preeclampsia and Future Cardiovascular Health: A Systematic Review and Meta-Analysis. Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2). pii: e003497. doi: 10.1161/CIRCOUTCOMES.116.003497. Epub 2017 Feb 22. Review.

ReferenceCitation: Myatt L, Roberts JM. Preeclampsia: Syndrome or Disease? Curr Hypertens Rep. 2015 Nov;17(11):83. doi: 10.1007/s11906-015-0595-4. Review.

ReferenceCitation: Hod T, Cerdeira AS, Karumanchi SA. Molecular Mechanisms of Preeclampsia. Cold Spring Harb Perspect Med. 2015 Aug 20;5(10). pii: a023473. doi: 10.1101/cshperspect.a023473. Review.

ReferenceCitation: Cain MA, Salemi JL, Tanner JP, Kirby RS, Salihu HM, Louis JM. Pregnancy as a window to future health: maternal placental syndromes and short-term cardiovascular outcomes. Am J Obstet Gynecol. 2016 Oct;215(4):484.e1-484.e14. doi: 10.1016/j.ajog.2016.05.047. Epub 2016 Jun 2.

ReferenceCitation: Buchbinder A, Sibai BM, Caritis S, Macpherson C, Hauth J, Lindheimer MD, Klebanoff M, Vandorsten P, Landon M, Paul R, Miodovnik M, Meis P, Thurnau G; National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units. Adverse perinatal outcomes are significantly higher in severe gestational hypertension than in mild preeclampsia. Am J Obstet Gynecol. 2002 Jan;186(1):66-71.

ReferenceCitation: Antonios TF, Nama V, Wang D, Manyonda IT. Microvascular remodelling in preeclampsia: quantifying capillary rarefaction accurately and independently predicts preeclampsia. Am J Hypertens. 2013 Sep;26(9):1162-9. doi: 10.1093/ajh/hpt087. Epub 2013 Jun 11.

ReferenceCitation: Debbabi H, Bonnin P, Ducluzeau PH, Lefthériotis G, Levy BI. Noninvasive assessment of endothelial function in the skin microcirculation. Am J Hypertens. 2010 May;23(5):541-6. doi: 10.1038/ajh.2010.10. Epub 2010 Feb 18.

ReferenceCitation: Debbabi H, Bonnin P, Levy BI. Effects of blood pressure control with perindopril/indapamide on the microcirculation in hypertensive patients. Am J Hypertens. 2010 Oct;23(10):1136-43. doi: 10.1038/ajh.2010.115. Epub 2010 May 27.

ReferenceCitation: Davis KR, Ponnampalam J, Hayman R, Baker PN, Arulkumaran S, Donnelly R. Microvascular vasodilator response to acetylcholine is increased in women with pre-eclampsia. BJOG. 2001 Jun;108(6):610-4.

ReferenceCitation: Ramsay JE, Stewart F, Greer IA, Sattar N. Microvascular dysfunction: a link between pre-eclampsia and maternal coronary heart disease. BJOG. 2003 Nov;110(11):1029-31.

ReferenceCitation: Agatisa PK, Ness RB, Roberts JM, Costantino JP, Kuller LH, McLaughlin MK. Impairment of endothelial function in women with a history of preeclampsia: an indicator of cardiovascular risk. Am J Physiol Heart Circ Physiol. 2004 Apr;286(4):H1389-93.

ReferenceCitation: Khan F, Belch JJ, MacLeod M, Mires G. Changes in endothelial function precede the clinical disease in women in whom preeclampsia develops. Hypertension. 2005 Nov;46(5):1123-8. Epub 2005 Oct 17.

ReferenceCitation: Hauth JC, Ewell MG, Levine RJ, Esterlitz JR, Sibai B, Curet LB, Catalano PM, Morris CD. Pregnancy outcomes in healthy nulliparas who developed hypertension. Calcium for Preeclampsia Prevention Study Group. Obstet Gynecol. 2000 Jan;95(1):24-8.

ReferenceCitation: Hnat MD, Sibai BM, Caritis S, Hauth J, Lindheimer MD, MacPherson C, VanDorsten JP, Landon M, Miodovnik M, Paul R, Meis P, Thurnau G, Dombrowski M; National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine-Units. Perinatal outcome in women with recurrent preeclampsia compared with women who develop preeclampsia as nulliparas. Am J Obstet Gynecol. 2002 Mar;186(3):422-6. Erratum in: Am J Obstet Gynecol. 2003 Jul;189(1):244.

ReferenceCitation: Chambers JC, Fusi L, Malik IS, Haskard DO, De Swiet M, Kooner JS. Association of maternal endothelial dysfunction with preeclampsia. JAMA. 2001 Mar 28;285(12):1607-12.

ReferenceCitation: Powe CE, Levine RJ, Karumanchi SA. Preeclampsia, a disease of the maternal endothelium: the role of antiangiogenic factors and implications for later cardiovascular disease. Circulation. 2011 Jun 21;123(24):2856-69. doi: 10.1161/CIRCULATIONAHA.109.853127. Review.

ReferenceCitation: Hirashima C, Ohkuchi A, Takahashi K, Suzuki H, Yoshida M, Ohmaru T, Eguchi K, Ariga H, Matsubara S, Suzuki M. Gestational hypertension as a subclinical preeclampsia in view of serum levels of angiogenesis-related factors. Hypertens Res. 2011 Feb;34(2):212-7. doi: 10.1038/hr.2010.212. Epub 2010 Nov 4.

ReferenceCitation: Allen RE, Rogozinska E, Cleverly K, Aquilina J, Thangaratinam S. Abnormal blood biomarkers in early pregnancy are associated with preeclampsia: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2014 Nov;182:194-201. doi: 10.1016/j.ejogrb.2014.09.027. Epub 2014 Sep 22. Review.

ReferenceCitation: Lam C, Lim KH, Karumanchi SA. Circulating angiogenic factors in the pathogenesis and prediction of preeclampsia. Hypertension. 2005 Nov;46(5):1077-85. Epub 2005 Oct 17. Review.

ReferenceCitation: SFHTA, M.-V.C.e.a., HTA et Grossesse. Consensus d'Experts de la Société Françaises d'Hypertension Artérielle. Consensus d'Experts avec le partenariat du Collège National des Gynécologues et Obstétriciens Français. 2015, Decembre: p. 1-5.

ReferenceCitation: Levine RJ, Maynard SE, Qian C, Lim KH, England LJ, Yu KF, Schisterman EF, Thadhani R, Sachs BP, Epstein FH, Sibai BM, Sukhatme VP, Karumanchi SA. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83. Epub 2004 Feb 5.

ReferenceCitation: Noori M, Donald AE, Angelakopoulou A, Hingorani AD, Williams DJ. Prospective study of placental angiogenic factors and maternal vascular function before and after preeclampsia and gestational hypertension. Circulation. 2010 Aug 3;122(5):478-87. doi: 10.1161/CIRCULATIONAHA.109.895458. Epub 2010 Jul 19. Erratum in: Circulation. 2011 Sep 13;124(11):e302.

ReferenceCitation: Kleinrouweler CE, Wiegerinck MM, Ris-Stalpers C, Bossuyt PM, van der Post JA, von Dadelszen P, Mol BW, Pajkrt E; EBM CONNECT Collaboration. Accuracy of circulating placental growth factor, vascular endothelial growth factor, soluble fms-like tyrosine kinase 1 and soluble endoglin in the prediction of pre-eclampsia: a systematic review and meta-analysis. BJOG. 2012 Jun;119(7):778-87. doi: 10.1111/j.1471-0528.2012.03311.x. Epub 2012 Mar 20. Review.

ReferenceCitation: Karumanchi SA. Angiogenic Factors in Preeclampsia: From Diagnosis to Therapy. Hypertension. 2016 Jun;67(6):1072-9. doi: 10.1161/HYPERTENSIONAHA.116.06421. Epub 2016 Apr 11. Review.

ReferenceCitation: Verlohren S, Perschel FH, Thilaganathan B, Dröge LA, Henrich W, Busjahn A, Khalil A. Angiogenic Markers and Cardiovascular Indices in the Prediction of Hypertensive Disorders of Pregnancy. Hypertension. 2017 Jun;69(6):1192-1197. doi: 10.1161/HYPERTENSIONAHA.117.09256. Epub 2017 May 1.

ReferenceCitation: Bouloumié A, Schini-Kerth VB, Busse R. Vascular endothelial growth factor up-regulates nitric oxide synthase expression in endothelial cells. Cardiovasc Res. 1999 Mar;41(3):773-80.

ReferenceCitation: Dulak J, Józkowicz A, Dembinska-Kiec A, Guevara I, Zdzienicka A, Zmudzinska-Grochot D, Florek I, Wójtowicz A, Szuba A, Cooke JP. Nitric oxide induces the synthesis of vascular endothelial growth factor by rat vascular smooth muscle cells. Arterioscler Thromb Vasc Biol. 2000 Mar;20(3):659-66.

ReferenceCitation: Motta-Mejia C, Kandzija N, Zhang W, Mhlomi V, Cerdeira AS, Burdujan A, Tannetta D, Dragovic R, Sargent IL, Redman CW, Kishore U, Vatish M. Placental Vesicles Carry Active Endothelial Nitric Oxide Synthase and Their Activity is Reduced in Preeclampsia. Hypertension. 2017 Aug;70(2):372-381. doi: 10.1161/HYPERTENSIONAHA.117.09321. Epub 2017 Jun 12.

ReferenceCitation: Yang JC, Haworth L, Sherry RM, Hwu P, Schwartzentruber DJ, Topalian SL, Steinberg SM, Chen HX, Rosenberg SA. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med. 2003 Jul 31;349(5):427-34.

ReferenceCitation: Mourad JJ, des Guetz G, Debbabi H, Levy BI. Blood pressure rise following angiogenesis inhibition by bevacizumab. A crucial role for microcirculation. Ann Oncol. 2008 May;19(5):927-34. Epub 2007 Dec 4.

ReferenceCitation: Lely AT, Salahuddin S, Holwerda KM, Karumanchi SA, Rana S. Circulating lymphangiogenic factors in preeclampsia. Hypertens Pregnancy. 2013;32(1):42-9. doi: 10.3109/10641955.2012.697953. Epub 2012 Sep 7.

ReferenceCitation: Turpin CA, Sakyi SA, Owiredu WK, Ephraim RK, Anto EO. Association between adverse pregnancy outcome and imbalance in angiogenic regulators and oxidative stress biomarkers in gestational hypertension and preeclampsia. BMC Pregnancy Childbirth. 2015 Aug 25;15:189. doi: 10.1186/s12884-015-0624-y.

ReferenceCitation: Wallukat G, Homuth V, Fischer T, Lindschau C, Horstkamp B, Jüpner A, Baur E, Nissen E, Vetter K, Neichel D, Dudenhausen JW, Haller H, Luft FC. Patients with preeclampsia develop agonistic autoantibodies against the angiotensin AT1 receptor. J Clin Invest. 1999 Apr;103(7):945-52.

ReferenceCitation: Signore C, Mills JL, Qian C, Yu K, Lam C, Epstein FH, Karumanchi SA, Levine RJ. Circulating angiogenic factors and placental abruption. Obstet Gynecol. 2006 Aug;108(2):338-44. Erratum in: Obstet Gynecol. 2006 Oct;108(4):1035.

ReferenceCitation: Zhou CC, Irani RA, Zhang Y, Blackwell SC, Mi T, Wen J, Shelat H, Geng YJ, Ramin SM, Kellems RE, Xia Y. Angiotensin receptor agonistic autoantibody-mediated tumor necrosis factor-alpha induction contributes to increased soluble endoglin production in preeclampsia. Circulation. 2010 Jan 26;121(3):436-44. doi: 10.1161/CIRCULATIONAHA.109.902890. Epub 2010 Jan 11.

ReferenceCitation: Artunc-Ulkumen B, Guvenc Y, Goker A, Gozukara C. Relationship of neutrophil gelatinase-associated lipocalin (NGAL) and procalcitonin levels with the presence and severity of the preeclampsia. J Matern Fetal Neonatal Med. 2015 Nov;28(16):1895-900. doi: 10.3109/14767058.2014.972926. Epub 2014 Oct 29.

ReferenceCitation: Yeşil A, Kanawati A, Helvacıoğlu Ç, Kaya C, Özgün ÇG, Cengiz H. Identification of patients at risk for preeclampsia with the use of uterine artery Doppler velocimetry and copeptin. J Matern Fetal Neonatal Med. 2017 Nov;30(22):2763-2768. doi: 10.1080/14767058.2016.1262841. Epub 2016 Dec 7.

ReferenceCitation: Sun IO, Santelli A, Abumoawad A, Eirin A, Ferguson CM, Woollard JR, Lerman A, Textor SC, Puranik AS, Lerman LO. Loss of Renal Peritubular Capillaries in Hypertensive Patients Is Detectable by Urinary Endothelial Microparticle Levels. Hypertension. 2018 Nov;72(5):1180-1188. doi: 10.1161/HYPERTENSIONAHA.118.11766.

ReferenceCitation: Mannaerts D, Faes E, Goovaerts I, Stoop T, Cornette J, Gyselaers W, Spaanderman M, Van Craenenbroeck EM, Jacquemyn Y. Flow-mediated dilation and peripheral arterial tonometry are disturbed in preeclampsia and reflect different aspects of endothelial function. Am J Physiol Regul Integr Comp Physiol. 2017 Nov 1;313(5):R518-R525. doi: 10.1152/ajpregu.00514.2016. Epub 2017 Aug 9.

ReferenceCitation: Palomaki GE, Haddow JE, Haddow HR, Salahuddin S, Geahchan C, Cerdeira AS, Verlohren S, Perschel FH, Horowitz G, Thadhani R, Karumanchi SA, Rana S. Modeling risk for severe adverse outcomes using angiogenic factor measurements in women with suspected preterm preeclampsia. Prenat Diagn. 2015 Apr;35(4):386-93. doi: 10.1002/pd.4554. Epub 2015 Feb 4.

ReferenceCitation: Moore Simas TA, Crawford SL, Solitro MJ, Frost SC, Meyer BA, Maynard SE. Angiogenic factors for the prediction of preeclampsia in high-risk women. Am J Obstet Gynecol. 2007 Sep;197(3):244.e1-8.

ReferenceCitation: Rana S, Powe CE, Salahuddin S, Verlohren S, Perschel FH, Levine RJ, Lim KH, Wenger JB, Thadhani R, Karumanchi SA. Angiogenic factors and the risk of adverse outcomes in women with suspected preeclampsia. Circulation. 2012 Feb 21;125(7):911-9. doi: 10.1161/CIRCULATIONAHA.111.054361. Epub 2012 Jan 18.

ReferenceCitation: Maynard SE, Crawford SL, Bathgate S, Yan J, Robidoux L, Moore M, Moore Simas TA. Gestational angiogenic biomarker patterns in high risk preeclampsia groups. Am J Obstet Gynecol. 2013 Jul;209(1):53.e1-9. doi: 10.1016/j.ajog.2013.03.017. Epub 2013 Mar 18.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP Jean Verdier Hospital, Gynecology and obstetrics Department

location_facility: AP-HP Avicenne Hospital, Department of internal medicine


status: Withdrawn

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

acronym: FBB ACC

type: EudraCT Number

source: euctr

title: Evaluation of Florbetaben as an Amyloid Plaque Marker in Elderly Patients With Focal or Disseminated Superficial Hemosiderosis

summary: The main objective of this study is to compare the distribution of Florbetaben (NEURACEQ: FBB) in the brain in amyloid cerebral angiopathy (ACA) manifested by isolated hemosiderosis in non-demented patients with that observed in healthy subjects, patients with ACA and with lobar hematoma(s) and patients with Alzheimer's dementia without MRI signs in favor of ACA.


title: Assessment of the Prevalence and the Impact of the COVID-19 Epidemic in the French Flight Crew in 2020

acronym: Covaé

summary: The aeronautical community was also affected and greatly impacted economically and socially by the Covid-19 pandemic. Away from the acute phase, the epidemiological impact and the consequences of this disease within the French aviation flight crew population must be assessed. This study is aimed at providing original epidemiological data among civil and military aircrew, prior to possible prevention strategies or countermeasures to optimize risk management in terms of aviation safety and to promote, if necessary, future targeted studies.

location_facility: Centre d'Expertise Medicale du Personnel Navigant (CEMPN) de l'Hôpital d'Instruction des Armées Sainte-Anne

location_facility: Centre d'Expertise Medicale du Personnel Navigant (CEMPN) de l'Hôpital d'Instruction des Armées Percy


title: The Impact of Performing a Low-dose, Whole-body Angiography as the First Element of an Imaging Assessment Following Stroke or Transient Ischemic Attack in Comparison With Usual Care: a Randomized, Controlled, Open Trial

acronym: VASCU

summary: The main objective of this study is to compare two post-stroke/TIA (transient ischemic attack) imaging strategies in terms of the number of clinically important (i.e. requiring specific treatment according to current recommendations) lesions detected. The first strategy is the current/usual strategy in each participating centre and the second strategy consists in starting the post-stroke/TIA imaging assessment by a whole-body, low-dose angiography and subsequently resorting to elements of the usual strategy if required.

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac


title: Study of Minimed 640G Insulin Pump With SmartGuard in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia

acronym: ALPPHY

summary:
The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1 diabetic adults with an increased risk of hypoglycemia.

The study should show:

A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a reduction in the time spent in hypoglycemia six months in any group compared to Baseline.
A complete prevention of severe and not severe hypoglycemia in the pump group Minimed 640G + Enlite sensor with SmartGuard activation

ReferenceCitation: Bergenstal RM, Klonoff DC, Garg SK, Bode BW, Meredith M, Slover RH, Ahmann AJ, Welsh JB, Lee SW, Kaufman FR; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. 2013 Jul 18;369(3):224-32. doi: 10.1056/NEJMoa1303576. Epub 2013 Jun 22.

ReferenceCitation: European User Evaluation of the MiniMed® 640G system. Poster session at the American Diabetes Association (ADA) 75th Scientific Sessions on Sunday, June 7 2015. Boston Convention and Exhibition Center.

location_facility:
Montpellier University Hospital
Grenoble University Hospital


title: Effect of Neuromuscular Electrical Stimulation Versus Cycle Ergometer Training in a Pulmonary Rehabilitation Program

acronym: ESNM

summary: The aim of this study is to evaluate the effectiveness of quadriceps strengthening with neuromuscular electrical stimulation versus cycle ergometer as part of pulmonary rehabilitation program , in patients with severe or very severe COPD , according to GOLD with BODE index ≥ 5 .

lead_sponsor: University Hospital, Brest

location_facility: Centre des maladies respiratoires et allergiques - Les Acacias


title: Pilot Study to Evaluate the Efficacy of and the Tolerance to a Body Bandage to Maintain Fluid Balance in Patients With Severe Sepsis or in Septic Shock in an ICU

acronym: COCOON

summary:
Early and adequate fluid resuscitation (< 6 hours) in patients with circulatory failure is essential but may exacerbate oedema, which may itself: 1) aggravate pulmonary lesions and prolong mechanical ventilation, 2) aggravate organ failure and 3) increase mortality notably in patients with acute renal failure. Improving fluid balance is considered crucial in the management of patients in septic shock, but the efficacy of the measures currently proposed (diuretics associated or not with albumin and/or dialysis) is controversial. The investigators hypothesize that a whole-body compression using a body bandage could reduce capillary leakage and thus lead to faster restoration of a normal transmural pressure gradient in postcapillary venules and improve venous return.

This is the first study to evaluate mechanical compression using a body bandage to reduce oedema in septic shock.

To do this, a whole-body compression will be set up within the 12 hours following admission. Water balance will be monitored daily throughout the duration of the compression and vital status of patients will be search at 7 days, 28 days and 90 days.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CH Chalon sur Saône
CHU de DIJON


title: Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy

acronym: HPV-BIOFRO

summary: Multicentre prospective study of concordance between two tissue sampling modes (smear / biopsy), which applies the same diagnostic method (PCR).

lead_sponsor: University Hospital, Toulouse

location_facility:
Institut Claudius Regaud
CHU Toulouse


title: Feasibility Study of Perivascular Computer Tomography-guided Ethanol Sympatholysis for the Treatment of Therapy-resistant Arterial Hypertension

acronym: SCRATCH

summary:
In this study the investigators are going to assess the feasibility of this innovate technique of renal sympathetic denervation by translumbar access under ct-guidance.

To limit the potential impact on the kidney, the investigators chose a population of chronic renal failure patients on dialysis or renal transplant (with native kidneys still present) and having resistant treatment hypertension despite antihypertensive combination therapy well conducted.

The investigators expect to obtain a decrease of the blood pressure at the 24-hours ambulatory blood pressure monitoring (ABPM) one month after the sympathetic denervation.

lead_sponsor: University Hospital, Grenoble

location_facility: Grenoble Association for the Dialysis of Uremic Chronicles

intervention_type: Radiation


title: Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity in Healthy Subjects and in Patients With Heart Failure

acronym: SOMNO-BRS

summary: To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the baroreflex. A good correlation for measuring the baroreflex sensitivity between the system "SOMNOtouch" and digital photoplethysmography as a reference method is expected but should be evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects with heart failure. We will also evaluate the feasibility of measuring the baroreflex sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance test.

lead_sponsor: University Hospital, Angers

location_facility:
CHU d'Angers
CH de Cholet


title: Study of the Concentrations of Long Acting Morphine After Oral Absorption in Subjects Who Underwent Gastric Bypass (OBEMO 2)

summary: The purpose of this study is to determine whether sustained release morphine pharmacokinetics parameters in patients undergone roux-en-y gastric bypass (RYGB) differ from subjects who did not. Our hypothesis is that exposure is comparable. Indeed, in the Study OBEMO (Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass; NCT00943969) the investigators observed changes in pharmacokinetics parameters for immediate release morphine, probably due to an earlier absorption of the morphine, in agreement with the expected clinical effect of this formulation.

ReferenceCitation: Finucane MM, Stevens GA, Cowan MJ, Danaei G, Lin JK, Paciorek CJ, Singh GM, Gutierrez HR, Lu Y, Bahalim AN, Farzadfar F, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Body Mass Index). National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9·1 million participants. Lancet. 2011 Feb 12;377(9765):557-67. doi: 10.1016/S0140-6736(10)62037-5. Epub 2011 Feb 3.

ReferenceCitation: Sjöström L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjöström CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93.

ReferenceCitation: Padwal RS, Gabr RQ, Sharma AM, Langkaas LA, Birch DW, Karmali S, Brocks DR. Effect of gastric bypass surgery on the absorption and bioavailability of metformin. Diabetes Care. 2011 Jun;34(6):1295-300. doi: 10.2337/dc10-2140. Epub 2011 Apr 8.

ReferenceCitation: Skottheim IB, Stormark K, Christensen H, Jakobsen GS, Hjelmesaeth J, Jenssen T, Reubsaet JL, Sandbu R, Asberg A. Significantly altered systemic exposure to atorvastatin acid following gastric bypass surgery in morbidly obese patients. Clin Pharmacol Ther. 2009 Sep;86(3):311-8. doi: 10.1038/clpt.2009.82. Epub 2009 Jun 3.

ReferenceCitation: Hamad GG, Helsel JC, Perel JM, Kozak GM, McShea MC, Hughes C, Confer AL, Sit DK, McCloskey CA, Wisner KL. The effect of gastric bypass on the pharmacokinetics of serotonin reuptake inhibitors. Am J Psychiatry. 2012 Mar;169(3):256-63. doi: 10.1176/appi.ajp.2011.11050719.

ReferenceCitation: Raebel MA, Newcomer SR, Reifler LM, Boudreau D, Elliott TE, DeBar L, Ahmed A, Pawloski PA, Fisher D, Donahoo WT, Bayliss EA. Chronic use of opioid medications before and after bariatric surgery. JAMA. 2013 Oct 2;310(13):1369-76. doi: 10.1001/jama.2013.278344.

ReferenceCitation: Hasselström J, Säwe J. Morphine pharmacokinetics and metabolism in humans. Enterohepatic cycling and relative contribution of metabolites to active opioid concentrations. Clin Pharmacokinet. 1993 Apr;24(4):344-54.

ReferenceCitation: Gourlay GK. Sustained relief of chronic pain. Pharmacokinetics of sustained release morphine. Clin Pharmacokinet. 1998 Sep;35(3):173-90. Review.

ReferenceCitation: Lloret-Linares C, Hirt D, Bardin C, Bouillot JL, Oppert JM, Poitou C, Chast F, Mouly S, Scherrmann JM, Bergmann JF, Declèves X. Effect of a Roux-en-Y gastric bypass on the pharmacokinetics of oral morphine using a population approach. Clin Pharmacokinet. 2014 Oct;53(10):919-30. doi: 10.1007/s40262-014-0163-0.

ReferenceCitation: Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0.

ReferenceCitation: Padwal R, Brocks D, Sharma AM. A systematic review of drug absorption following bariatric surgery and its theoretical implications. Obes Rev. 2010 Jan;11(1):41-50. doi: 10.1111/j.1467-789X.2009.00614.x. Epub 2009 Jun 2. Review.

ReferenceCitation: Skottheim IB, Jakobsen GS, Stormark K, Christensen H, Hjelmesaeth J, Jenssen T, Asberg A, Sandbu R. Significant increase in systemic exposure of atorvastatin after biliopancreatic diversion with duodenal switch. Clin Pharmacol Ther. 2010 Jun;87(6):699-705. doi: 10.1038/clpt.2010.32. Epub 2010 May 5.

ReferenceCitation: Roberts DL, Dive C, Renehan AG. Biological mechanisms linking obesity and cancer risk: new perspectives. Annu Rev Med. 2010;61:301-16. doi: 10.1146/annurev.med.080708.082713. Review.

ReferenceCitation: Lötsch J, Weiss M, Ahne G, Kobal G, Geisslinger G. Pharmacokinetic modeling of M6G formation after oral administration of morphine in healthy volunteers. Anesthesiology. 1999 Apr;90(4):1026-38.

ReferenceCitation: Kharasch ED, Hoffer C, Whittington D, Sheffels P. Role of P-glycoprotein in the intestinal absorption and clinical effects of morphine. Clin Pharmacol Ther. 2003 Dec;74(6):543-54.

lead_sponsor: Hopital Lariboisière

location_facility: Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboisiere


title: Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease

acronym: TEOREM

summary: The primary objective of this trial is to assess whether a 12-week treatment with Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or without involvement of the caecum or the right colon.

location_facility:
Kremlin-Bicetre hospital
Gastroenterology department


title: Effect of a Continuous Infusion of Esmolol on Stroke Volume in Patients With Hyperdynamic Vasoplegic Septic Shock: a Multicentre, Randomized, Double-blind Trial

acronym: BétaSep

summary:
The main objective of this study is to evaluate the effectiveness of the administration of a short acting beta-blocker in terms of effective increase in stroke volume (at least 15%) after 4 hours initiation of therapy in septic shock in patients with a hyperkinetic profile after 12-24 hours of care.

This research seeks to demonstrate that the proportion of patients with an increase in the systolic ejection superior or equal to 15% (relative to baseline) at four hours is different between the two arms of the study: (1) an experimental arm where patients receive an esmolol infusion according to a predetermined procedure and (2) a control arm where patients receive a saline infusion according to a predetermined procedure.

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


lead_sponsor: University Hospital, Montpellier

location_facility:
Nîmes University Hospital
Hôpital Arnaud de Villeneuve

title: Use of Ultiva ® Associated With Xylocaine ® in the Procedures of Feticide: A Phase III Randomized Trial

summary:
The feticide is a legal and ethical obligation during a termination of pregnancy after 22 weeks' gestation. This method raise concerns about the fetal pain, maternal complications and the fetopathologic analysis. There are few studies on the subject. Investigators want to evaluate a drug in order to facilitate this method technically and emotionally challenging. They want to achieve a quick fetal asystole, a fetal analgesia, a maternal security and a optimal fetopathologic analysis. A drug, remifentanil Ultiva®, seems could meet its properties, it is a powerful morphine. A phase 2 clinical trial has assessed the feasibility, efficacy and safety of Ultiva®. They had not been able to prove bradycardia or lethal effect of Ultiva injected alone but the feasibility and safety were good.

Investigators want to set up a randomized clinical trial with 2 arms : Ultiva® and lidocaine versus sufentanil and lidocaine (standard protocol), it is a bicentric study. The primary outcome is the interval between the vascular injection of lidocaine and fetal asystole. The secondary outcomes are the success rate of method, the number of puncture of the umbilical cord, the maternal side effects and the quality of fetopathologic analysis.

The previous observational study showed a median interval of 2,3 minutes and a success rate of 55% (lower interval to 2 minutes). From the results they calculate a necessary inclusions to 66 patients.

They believe that the bradycardia property of Ultiva® allow a potentiation of the efficacy of lidocaine. If the results are satisfactory, the use of Ultiva® can be generalized to other fetal medicine team.


title: MINIDOCS : Contribution of Augmented Reality to Reduce Pain During of Botulinum Toxin Injections in Cerebral-palsied Children. A Randomized Controlled Trial

acronym: MINIDOCS

summary: Children with cerebral palsy may benefit from treatment with botulinum toxin injections to decrease spasticity for improve function and quality of life. These injections cause repeated pain throughout childhood and may be the cause of post-traumatic stress despite drug and non-drug pain management. The Mini-Docs project of the French Red Cross has a module based on a digital device with augmented reality. Distracting the child, the use of this module on a tablet would reduce pain felt during botulinum toxin injections.

location_facility: Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française

location_facility: Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française


title: Tools for Therapeutic Evaluation in Charcot-Marie-Tooth Disease Type 1A: Outcome Measures and Biomarkers

acronym: CMT-TOOLS

summary: This is a 2-year follow-up study of a cohort of 60 CMT1A patients. The objective is to identify markers allowing to better understand the phenotypic variability observed on patients with CMT1A, to identify predictive markers of the disease's progression and to provide validated measurement tools that can be used as outcome measures in future clinical trials.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis

acronym: Endoth-FPI

summary: The aim of the study is to assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial function and the severity of the IPF.

location_facility: Hopital Europeen Georges Pompidou, dpt of pneumology


summary: This study concerns the prevention of dental caries by sealing pits and fissures of permanent molars with a photopolymerizable resin. It must compare these three techniques Microdentisty (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities in the enamel and / or the outer third of the dentin. These three commonly used techniques have never been compared by retaining as endpoint retention of sealant. These techniques are painless and do not require local anesthesia.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: APHP CHU


title: Assessment of a Peripheral Endothelial Dysfunction in COPD (Chronic Obstructive Pulmonary Disease)

acronym: endothBPCO

summary: The aim of the study is to assess the peripheral endothelial function in adult COPD (chronic obstructive pulmonary disease) patients and the relationship between the peripheral endothelial function and the pulmonary function.

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location_facility:
Hôpital Foch
Hôpital Saint-Antoine