title: Evaluation of a Serious Game for Patients With Bipolar Disorder Involved in a Psychoeducation Group

acronym: Bipolife

summary:
Bipolar disorder is a condition characterized by succession of episodes- manic, hypomanic, and depressive episodes. Major risks factors of relapses are poor compliance, sleep disorder, and toxics consumption. The aims of psychoeducation programs are to increase compliance and knowledge about bipolar disorder. Serious game are supposed, in bipolar disorder, to strengthen the efficacy of psychoeducation programs. Bipolife® is a serious game which purpose is to help bipolar patients to deal with their conditions, through 3 mains messages : to pursue the treatment, to have daily routine and to request the psychiatrist in case of relapse.

This is a multicentric randomized controlled study with two harms parallels. After a classic psychoeducation group program, patients are randomized in two groups : interventional group and control group with treatment as usual.

The main objective is to evaluate the observance in the two groups. The other objectives are to evaluate daily routine, global functioning, and access to health care. Evaluations are realized at one and four months after inclusion visit. Acceptability and satisfaction about the serious game Bipolife® will be assessed in the interventional group.


title: 4 Cities for Assessing CAlcification PRognostic Impact After TAVI

summary:
Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure. Despite a high rate of procedural success, some patients do not benefit from the procedure. The investigators hypothesis is that aortic stiffness may be of major prognostic significance after stenosis relief.

The aim of this study is to test the prognostic impact of aortic stiffness estimated by the volume of calcifications of the thoracic aorta on the CT-scan performed systematically before the procedure. This prognostic value will be assessed in 4 independent cohorts issued from 4 french cities (Lyon, Rouen, Paris, Clermont-Ferrand).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Relationship Between antimüllerian Hormone Measured by a Fully Automated Assay and the Initial Dose of HP-hMG (Menopur®) Prescribed for Infertile Women Undergoing Their First IVF/ICSI Cycle.

acronym: AME

summary: AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first IVF/ICSI cycle in the current practice.

time_perspective: Prospective

lead_sponsor: Ferring Pharmaceuticals

location_facility: Hospital FOCH (there may be other sites in this country)

intervention_type: Drug

lead_sponsor_type: industriel


title: Usefulness of built-in Non-invasive Ventilator Software to Detect the Change in the Breathing Pattern of COPD Patients Under Home Mechanical Ventilation Before an Admission for Acute Exacerbation of COPD.

summary:
Acute exacerbation of COPD (AECOPD) worsen prognosis and quality of life of COPD patients. Telemonitoring could be a useful tool for early identification of AECOPD. Parameters that have to be monitored are not well defined.

Patients with severe COPD may use home non-invasive ventilation (NIV). NIV have built-in software which are recording the breathing pattern of patients when used. The aim of this study is to identify ventilation parameters that are modified at the early stage of an AECOPD.

lead_sponsor: University Hospital, Rouen

location_facility: Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires

intervention_type: Other


type: Other Identifier

title: Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study

acronym: Nalmefene TCI

summary:
Impulse control disorders (ICDs) (such as pathological gambling, hypersexuality, compulsive shopping …) are an increasingly recognized psychiatric complications in Parkinson's disease (PD). Therapeutic management of these disorders is important since they have an impact on patient quality of life. Dopamine agonists play a key role in the emergence of ICD.

Animal models and imaging underline the implication of opioid system in the genesis of ICD.

An opioid antagonist, the naltrexone, has been studied to treat ICDs in PD. Papay and al 2014 have found that patients treated by naltrexone showed an interesting decrease of their ICDs measured by the QUIP RScale. Nevertheless, naltrexone has shown adverse effects such as increasing hepatic liver enzymes. Nalmefene has no known hepatic adverse effects. Nalmefene is an opioid antagonist that has an antagonist action on μ and δ receptors, but also an agonist action on κ receptor. Grant and al 2006 has shown significant reduction of the severity of pathological gambling in patients treated with nalmefene.

The primary purpose is to evaluate the efficacy and the safety of nalmefene in the treatment of ICDs in PD.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

status_simplified: Unknown


title: Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty

summary: This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.

status: Recruiting

ipd_sharing: No

lead_sponsor: BBraun Medical SAS

status_simplified: Ongoing


title: Establish a Quality Rating Scale for Primary Care Centers and Nursing Homes Pluri Professionals Integrating the Perspective of Patients in Complex Situations and Their Caregivers

acronym: QualSoPrim

summary: Identify and analyze in the exercise groups coordinated (GECO) the effects of coordination arrangements between professionals on the transformation of modes of exercise of professional care, and on the experience of patients / users and that of caregivers, particularly on dimensions constituted that the quality of care in order to build a coordinated exercise structures rating scale primary care on the basis of criteria suggested by patients

lead_sponsor: University Hospital, Brest

location_facility: Maison de santé de l'Aulne Maritime du Faou


title: Comparison of the Skin Conductance Values and Patient Pain Scores During Minor Procedures in the ICU

acronym: ICUPAIN

summary: Pain in hospitalized patients has received increasing attention, however due to its subjective nature, it has defied objective, quantitative measurements. If a patient is able to communicate, pain may be assessed using standardized sentences, visual analog scales (VAS) or plain numeric scales.When a patient is unable to communicate, a method that would allow the caregiver to continuously monitor patients' pain and alert the provider that the patient may be in pain would be quite useful. The Pain Monitor uses a novel measurement technique of analyzing changes in skin conductance that can be used in patients who are unable to provide a subjective pain score. This study will compare the relationship between the measurements taken by the PainMonitor and pain scores given by communicative patients to evaluate the safety and efficacy of this monitor during planned, routine procedures.

primary_purpose: Other

lead_sponsor: Hopital Foch


title: Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)

acronym: TEP-SVD

summary:
Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.

This study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.

lead_sponsor: Nantes University Hospital


title: Study on Effectiveness of Flash Mediation Therapy in the Context of Acute Psychological and Behavioral Symptoms of Dementia in Nursing Homes

summary: In order to offer a non-drug intervention for caregivers in nursing home to respond promptly to a behavioral crisis with an appropriate response to each patient, a chariot has been developed by the Institute of Ageing Well Korian (Institut du Bien Vieillir Korian) to bring together eleven mediation activities. These activities lasting about 15 minutes are based on emotion (reminiscent, games) and sensory interventions (music, massage, touch) to decentralize patient stimulus that disturbs and focus on a subject not disruptive. This emergency intervention should provide a reduction in Behavioral and Psychological Symptom of Dementia (BPSD) of nursing home patients. The main objective is to measure its immediate effect on productive symptoms (agitation, aberrant motor behavior and disinhibition). The secondary objectives are to measure its immediate impact on the well-being and psychotropic treatments, and measure its effect after two months and after four months on all BPSD with a focus on agitation, the administration of psychotropic drugs, the hospitalizations and the number of falls.

design_allocation: Non-Randomized

primary_purpose: Health Services Research

location_facility: Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"

intervention_type: Behavioral


title: Acute Abdominal Pain in Emergency Department: Evaluation of Venous LACtate Value and Strong Ion GAp According to the Stewart Approach as Predictive Factors of Surgical Issue

acronym: GALAC

summary:
Abdominal pain is one of the most common reasons for consultation in Emergency Departments (ED) worldwide. The challenge for physicians is to not misdiagnose a surgical emergency. The actual gold standard for diagnosis is computed tomography (CT). However with this procedure there is high radiation exposure and a risk factor of radiation-induced cancers, therefore alternative diagnostic techniques should be considered. The aim of this study is to evaluate the performance of measuring venous lactate in patients presenting with acute abdominal pain in ED.

In this single-center, prospective, non-interventional study, the diagnostic accuracy of venous lactate in order to detect surgical emergencies is evaluated. The hypothesis made here is that venous lactatemia is a positive predictive factor of surgical emergencies in patients with acute abdominal pain.

lead_sponsor: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences


title: Post Infarction Exercise Training Effects on Systolic and Diastolic Myocardial Function Assessed by 2D Strain Ultrasound

acronym: TrainStrain

summary:
The main goal of our project is to study and describe the effect of exercise training on systolic and diastolic myocardial function assessed by 2D ultrasound strain after myocardial infarction.

Our working hypothesis is that the intrinsic myocardial contractility and relaxation assessed by global longitudinal strain in phase II (or 2D strain) during post-infarction exercise training will be improved compared to baseline values as well as compared to values in a no-training group. Should this hypothesis prove true, it would help explain the improvements in functional capacity observed during the post-infarction period and after exercise training.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Effectiveness of Osteopathic Manipulative Therapy for Managing Symptoms of Irritable Bowel Syndrome. A Prospective Randomized Study -IBSOMT

acronym: IBSOMT

summary:
The Irritable Bowel Syndrome (IBS) is defined by a combination of abdominal pain, bowel dysfunction during recurrent periods of shorter or longer duration. The absence of well-defined pathophysiological marker requires a clinical definition. The most used are the Rome criteria III whose version was published in 2006 and version IV under development.

An epidemiological study conducted in 2003 in Europe in 8 countries with over 42 000 people, found on the basis of questionnaires a prevalence of 11.5% with a diagnosis of IBS of 4.8%.in the total population; the results of this study were comparable to data obtained in the USA. A French work of our team at 35 447 healthy adults found a 6.2% frequency. In all these studies, there is a very large predominance of women (sex ratio near 2), with a preponderance of subjects of the age group 40-50 years.

IBS economic weight is high, partly due to costs directly incurred by the IBS and the costs generated by associated diseases: number of visits to the general practitioner, to the specialist, the prescription and realization of complementary examinations, hospitalization, purchase drugs and work stoppage.

From a pathophysiologic perspective, IBS is now considered as a multifactorial disease involving varying degrees, depending on the individual variables, visceral hypersensitivity, disturbances of digestive motility, impaired sensorimotor way communications between the gastrointestinal tract and the central nervous system, intestinal micro-inflammation.

Hypothesis of this search is that the osteopathic manipulative treatment (OMT) will improve the symptomatology of IBS in patients with functional gastrointestinal disorders.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Hundscheid HW, Pepels MJ, Engels LG, Loffeld RJ. Treatment of irritable bowel syndrome with osteopathy: results of a randomized controlled pilot study. J Gastroenterol Hepatol. 2007 Sep;22(9):1394-8.

ReferenceCitation: Florance BM, Frin G, Dainese R, Nébot-Vivinus MH, Marine Barjoan E, Marjoux S, Laurens JP, Payrouse JL, Hébuterne X, Piche T. Osteopathy improves the severity of irritable bowel syndrome: a pilot randomized sham-controlled study. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):944-9. doi: 10.1097/MEG.0b013e3283543eb7.

ReferenceCitation: Attali TV, Bouchoucha M, Benamouzig R. Treatment of refractory irritable bowel syndrome with visceral osteopathy: short-term and long-term results of a randomized trial. J Dig Dis. 2013 Dec;14(12):654-61. doi: 10.1111/1751-2980.12098.

ReferenceCitation: Müller A, Franke H, Resch KL, Fryer G. Effectiveness of osteopathic manipulative therapy for managing symptoms of irritable bowel syndrome: a systematic review. J Am Osteopath Assoc. 2014 Jun;114(6):470-9. doi: 10.7556/jaoa.2014.098. Review.

ReferenceCitation: Piche T, Pishvaie D, Tirouvaziam D, Filippi J, Dainese R, Tonohouhan M, DeGalleani L, Nébot-Vivinus MH, Payrouse JL, Hébuterne X. Osteopathy decreases the severity of IBS-like symptoms associated with Crohn's disease in patients in remission. Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1392-8. doi: 10.1097/MEG.0000000000000219.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: Evaluation of Metamemory Using a Semantic Construction Strategy in Patients With Schizophrenia

acronym: Metamemory 2

summary:
The purpose of this study is to determine the respective roles of aging and schizophrenia in the regulation of metamemory using a sentence construction strategy. 4 groups will be necessary to comparison:

Adult patients (18-45 years) Adult controls (18-45 years) Aged patients (≥ 55 years) Aged controls (≥ 55 years)

The effects of age and the disease could lead to interaction in regulating metamemory. The effect of age would be aggravated by the disease.


title: Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation

acronym: GREFFE

summary: This study evaluates the influence of the taste sensitivity, of food preferences and of the reward system on the energetic balance before and after liver transplantation in cirrhotic patients and after kidney transplantation in renal failure patients

lead_sponsor: University of Burgundy


title: Influence of Sex Hormones Variation During Third Trimester of Pregnancy and Post-partum on QT Interval Duration

acronym: QuTe

summary:
QT interval prolongation, corrected for heart rate (QTc), either spontaneous or drug-induced, is associated with an increased risk of torsades de pointes and sudden death. Women are at higher risk of torsades de pointes, particularly during post-partum and the follicular phase.

The aim of this study is to explore if QTc duration is prolonged during post-partum as compared to the 3rd trimester of pregnancy

primary_purpose: Screening

lead_sponsor: French Cardiology Society

location_facility: Centre d'investigation Clinique - Paris est


title: Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®

summary:
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.

The inclusion period will be 12 months and the follow-up 24 months

lead_sponsor: Medicrea International


title: Evaluation of the Efficacy and Safety of the PASS MIS® System in the Treatment of Spinal Thoracolumbar Fractures

summary: Prospective, multicenter non comparative and observational study (post-market clinical follow-up).


acronym: TempCore

summary:
Temperature is one of the vital signs usually monitored in patients of ICUs. Indeed, fever occurs frequently in ICU especially in brain injured patients and may require targeted temperature management (TTM) in special case as intracranial hypertension or post cardiac arrest. In ICU, non invasive device to monitor temperature are not recommended and only invasive ones are accurate enough for TTM. Arterial pulmonary temperature is still the gold standard, but esophageal device is currently used in ICU patients.

The goal of this study is to compare accuracy of a continuous noninvasive cutaneous temperature using zero-heat-flux (ZHF) method to esophageal temperature, arterial temperature and intracerebral temperature if present for clinical monitoring.

All adults patients admitted in the neurosurgical or surgical ICU are eligible for inclusion into this study.

Assessment of temperature will be continuously monitored by esophageal probe (MON-A-THERM, 12Fr, COVIDIEN, Dublin, Ireland) (Teso), ZHF sensor (SpotOn, 3M, St Paul, MN, USA) (TZHF) and, in patients requiring cardiac output monitoring, by femoral arterial catheter (Pulsiocath PICCO, PULSION, Munich, Germany) (Tart). The correct positioning of the esophageal probe will be controlled by chest X-ray. The ZHF temperature sensor (TZHF) will be placed on the forehead as recommend by the manufacturer and connected to the SpotOn monitor. Intra cerebral temperature (Tbrain) will be obtained with an intracranial probe used as calibrator for partial pressure of O2 in brain (PbO2, Licox®Combined Oxygen and Temperature Probe 462 mm device necessary for monitoring severe brain injured patients. The ZHF sensor will be changed every 24 hours according to the manufacturer's directions for use. Temperatures will be recorded automatically at a 5-minutes interval via the patient's monitor with an electronic data acquisition system (Data Collect, Phillips) for a maximum of 5 days.

For each patient included, data recorded will be: demographic and clinical particulars for each patient; information on hemodynamics, sedative, analgesic and inotropic agents, use of neuromuscular blockades and their indication, reason of hypo or hyperthermia (spontaneous or therapeutic), indication and the means used (neuromuscular blockades, external or internal cooling) in case of Targeted Temperature Management; complications related to the ZHF sensor application.

lead_sponsor: Poitiers University Hospital


title: Study of Factors Associated With the Volumetric and Areal Bone Mineral Density and Bone Strength in Parkinson's Disease

acronym: PAFOS

summary:
Studies show that patients with idiopathic Parkinson's disease (IPD) have an increased risk of fracture, particularly hip fracture whose complications and postoperative mortality appear to be higher than in the general population.

This increased risk of fracture is due partly to an increased risk of falling, and secondly to an impairment of bone tissue with lower bone mineral density (BMD). A meta-analysis concluded that patients with IPD have lower BMD than healthy controls. Prospective studies also showed rapid bone loss in these patients compared with controls. The association between low BMD and IPD seems dependent on the severity and duration of the disease even if some data are contradictory. Various mechanisms may explain this bone loss including weight loss, malnutrition and a low level of physical activity. However, enrollments in these studies are often weak and it is difficult to conclude on the real impact of these factors on bone loss in the IPD. The main objective of our study is to assess and prioritize from these various bone loss mechanisms. Bone assessment by "peripheral quantitative computed tomography" (pQCT) will also assess the impact of various risk factors on bone strength parameters. The prevalence of vertebral compression fractures in the IPD, at this day unknown can be evaluated. This study will also estimate the prevalence of vertebral compression fractures in the IPD.

time_perspective: Cross-Sectional


title: Blood Biomarkers for the Management of Concussion in Professional Rugby Players

summary: In the past 20 years, the incidence of concussion in direct contact sports has significantly increased. The incidence of concussion in rugby players ranges between 8 to 17 episodes / 1000 playing hours. A recent study published by the French Rugby Federation (FFR) and the National Rugby League (LNR) showed similar results. The latter study was performed analyzing the French "TOP14", which includes 14 teams participating in professional rugby championships. At least two concussions were diagnosed each week. Despite the recent evidence, cognitive assessment remains the only means to determine whether or not players experiencing concussions can return to the game or not.


acronym: BARODEF

summary:
We must implement 8 implantable cardioverter defibrillators (ICDs) to save a life in 3 years after myocardial infarction (MI) in primary prevention.

Left ventricular ejection fraction (LVEF) is proposed as the one tool predicting sudden cardiac death after MI.

Several studies have shown that impairment of spontaneous baroreflex sensitivity (BRS) after MI was predictor of sudden death.

primary_purpose: Diagnostic


acronym: D-Velocity

summary: To evaluate the pulsatility index changes after setting supine position in non brain- injured patient under general anesthesia.


title: Prospective, Randomized Study Comparing Conventional, Burst And High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation

acronym: MULTIWAVE

summary:
Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a spine surgery. Treatment of this chronic condition by further operation or medical management has a heavy financial impact on health care systems.

Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS to be a clinically effective adjunct to medical management. SCS has the advantages of being reversible and less invasive than surgery and may cause fewer issues over time than long-term pharmacological treatments.

Despite variable levels of success in the literature, approximately 30-55% of the patients treated with traditional SCS for neuropathic pain disorders will not receive adequate long term pain relief. Therefore, technical SCS system refinements, as well as new techniques have emerged.

Two new stimulation waveforms based on traditional SCS technology have appeared to further optimize the outcome for specific painful conditions;

Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500 Hz per burst and pulse width and interspike intervals of 1 ms.
High-frequency stimulation (from 1 to 10 kHz) mode.

Several studies have demonstrated the potential interest of these 2 new waveforms to treat FBSS patients compared to traditional SCS.

The Precision Spectra™ system allows MultiWave Technology by offering a broad spectrum of waveform options (from Tonic Conventional Stimulation (TCS), BURST stimulation to High Frequency stimulation (HF)).

To date, literature data comparing these 3 stimulation patterns is lacking but it is suggested the pain relief in some of non-responsive patients can be "recaptured" by increasing the SCS frequency to 500 Hz by BURST stimulation or beyond by HF stimulation. It seems important to conduct RCT in crossover, thanks to the new Precision SCS Stimulator, to compare the effects of these 3 different SCS modalities in FBSS patients and to determine which concept is the most effective in terms of pain reduction and energy consumption.

ReferenceType: derived

ReferenceCitation: Billot M, Naiditch N, Brandet C, Lorgeoux B, Baron S, Ounajim A, Roulaud M, Roy-Moreau A, de Montgazon G, Charrier E, Misbert L, Maillard B, Vendeuvre T, Rigoard P. Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study). Trials. 2020 Aug 3;21(1):696. doi: 10.1186/s13063-020-04587-6.

family: Billot

full_name: Maxime Billot

given: Maxime

sequence: first

family: Naiditch

full_name: Nicolas Naiditch

given: Nicolas

sequence: additional

family: Brandet

full_name: Claire Brandet

given: Claire

family: Lorgeoux

full_name: Bertille Lorgeoux

given: Bertille

family: Baron

full_name: Sandrine Baron

given: Sandrine

family: Ounajim

full_name: Amine Ounajim

given: Amine

family: Roulaud

full_name: Manuel Roulaud

given: Manuel

family: Roy-Moreau

full_name: Aline Roy-Moreau

given: Aline

family: de Montgazon

full_name: Géraldine de Montgazon

given: Géraldine

family: Charrier

full_name: Elodie Charrier

given: Elodie

family: Misbert

full_name: Lorraine Misbert

given: Lorraine

family: Maillard

full_name: Benjamin Maillard

given: Benjamin

family: Vendeuvre

full_name: Tanguy Vendeuvre

given: Tanguy

family: Rigoard

full_name: Philippe Rigoard

given: Philippe

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Trials

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions

summary:
Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are required to receive triple antithrombotic therapy . This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).

Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 . Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA. Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents.

Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated. However they are based on an expert consensus because of the scarce data available.

These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study . In the recently published ESC guidelines on the management of atrial fibrillation, despite the lack of new data, the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months.

The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy .

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation

acronym: FILYTHO

summary:
During liver transplantation (LT), hyperfibrinolysis is one of the most important modification of haemostasis. It is associated with t-PA and protein C increased activity. Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA, PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the clinical practice in the operating room.

The "Lysis Timer" is a device developed by Hyphen-Sysmex in collaboration with SD Innovation and Charleroi University Hospital (Belgium). It allows the implementation of the "Global Fibrinolytic Capacity", or GFC test, in a complete system associating i) the reagents for in vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal of the absorbance modifications related to clot formation into a numeric signal) and iii) a dedicated software treating the numeric signal to define clot lysis time.

The GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.

lead_sponsor: University Hospital, Bordeaux

location_facility: BORDEAUX UNIVERSITY HOSPITAL Haut Lévêque


title: Comparison of Methods to Collect Healthcare Consumption Data of Patients in Clinical Trials With an Economic Evaluation

acronym: COMERE

summary:
Pragmatic study comparing historical data from usual collection tools to medical administrative databases (local / national PMSI and CRF / SNIIRAM). There are 3 phases to the data collection:

Collection of hospitalization data from the local PMSI and outpatient data from CRF
Collection of hospitalization data in the national PMSI with a probabilistic matching between local and national PMSI data
Collection of outpatient consumption data from SNIIRAM after matching of data from the national PMSI to the SNIIRAM.

ipd_sharing: Undecided


title: Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance

summary: Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.

primary_purpose: Supportive Care

ReferenceType: result

ReferenceCitation: Mazerand E, Le Renard M, Hue S, Lemée JM, Klinger E, Menei P. Intraoperative Subcortical Electrical Mapping of the Optic Tract in Awake Surgery Using a Virtual Reality Headset. World Neurosurg. 2017 Jan;97:424-430. doi: 10.1016/j.wneu.2016.10.031. Epub 2016 Oct 15.

family: Mazerand

full_name: Edouard Mazerand

given: Edouard

family: Le Renard

full_name: Marc Le Renard

given: Marc

family: Hue

full_name: Sophie Hue

given: Sophie

family: Lemée

full_name: Jean-Michel Lemée

given: Jean-Michel

family: Klinger

full_name: Evelyne Klinger

given: Evelyne

family: Menei

full_name: Philippe Menei

journal_name: World Neurosurgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Casanova M, Clavreul A, Soulard G, Delion M, Aubin G, Ter Minassian A, Seguier R, Menei P. Immersive Virtual Reality and Ocular Tracking for Brain Mapping During Awake Surgery: Prospective Evaluation Study. J Med Internet Res. 2021 Mar 24;23(3):e24373. doi: 10.2196/24373.

family: Casanova

full_name: Morgane Casanova

given: Morgane

family: Clavreul

full_name: Anne Clavreul

given: Anne

family: Soulard

full_name: Gwénaëlle Soulard

given: Gwénaëlle

family: Delion

full_name: Matthieu Delion

given: Matthieu

family: Aubin

full_name: Ghislaine Aubin

given: Ghislaine

family: Ter Minassian

full_name: Aram Ter Minassian

given: Aram

family: Seguier

full_name: Renaud Seguier

given: Renaud

currency_apc_doaj: USD

journal_name: Journal of Medical Internet Research

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

version: submittedVersion

ReferenceCitation: Bernard F, Lemée JM, Aubin G, Ter Minassian A, Menei P. Using a Virtual Reality Social Network During Awake Craniotomy to Map Social Cognition: Prospective Trial. J Med Internet Res. 2018 Jun 26;20(6):e10332. doi: 10.2196/10332.

repository_institution: University of Geneva - Archive ouverte UNIGE


title: Follow-up of the Patients Included in the EXESAS Study : Analysis of the Profit of the Physical Activity for the Control Group and of the Preservation of a Regular Physical Activity for the Group Initially Trained

summary: Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Pressure Ulcer-associated Osteomyelitis: Retrospective Evaluation of a Two-stage Surgical Strategy (Debridement With Vacuum-assisted Closure Therapy and Reconstruction) With Prolonged Antimicrobial Therapy

summary: Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe complication with a poorly known management, and is associated with a high rate of relapse, leading to a high-burden in hospital bed-days, financial cost, surgical intervention, antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone and joint infection management, the medical and surgical strategies are systematically discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to evaluate this complex approach and to determine risk factors of treatment failure in order to improve patient management, focusing on optimization of empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, and duration of antimicrobial therapy.

ReferenceCitation: Triffault-Fillit C, Valour F, Guillo R, Tod M, Goutelle S, Lustig S, Fessy MH, Chidiac C, Ferry T; Lyon BJI Study Group. Prospective Cohort Study of the Tolerability of Prosthetic Joint Infection Empirical Antimicrobial Therapy. Antimicrob Agents Chemother. 2018 Sep 24;62(10). pii: e00163-18. doi: 10.1128/AAC.00163-18. Print 2018 Oct.

name: Centre de Référence Interrégional pour la Prise en Charge des Infections Ostéo-articulaires Complexes (CRIOAc Lyon), Hospices Civils de Lyon, Lyon, France

name: Service des Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France

family: Triffault-Fillit

full_name: Claire Triffault-Fillit

given: Claire

name: INSERM U1111, Centre International de Recherche en Infectiologie, Université Claude Bernard Lyon 1, Lyon, France

family: Valour

full_name: Florent Valour

given: Florent

family: Guillo

full_name: Ronan Guillo

given: Ronan

name: Service de Pharmaceutique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France

name: ISPB, UMR CNRS 5558, Laboratoire de Biométrie et Biologie Évolutive, Faculté de Pharmacie de Lyon, Université Claude Bernard Lyon 1, Lyon, France

family: Tod

full_name: Michel Tod

given: Michel

family: Goutelle

full_name: Sylvain Goutelle

given: Sylvain

name: Service de Chirurgie Orthopédique, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France

family: Lustig

full_name: Sébastien Lustig

given: Sébastien

name: Service de Chirurgie Orthopédique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Lyon, France

family: Fessy

full_name: Michel-Henry Fessy

given: Michel-Henry

family: Chidiac

full_name: Christian Chidiac

given: Christian

family: Ferry

full_name: Tristan Ferry

given: Tristan

name: on behalf of the Lyon BJI Study Group Tristan Ferry Florent Valour Thomas Perpoint André Boibieux François Biron Patrick Miailhes Florence Ader Agathe Becker Sandrine Roux Claire Triffault-Fillit Fatiha Daoud Johanna Lippman Evelyne Braun Christian Chidiac Yves Gillet Laure Hees Sébastien Lustig Elvire Servien Yannick Herry Romain Gaillard Antoine Schneider Michel-Henry Fessy Anthony Viste Philippe Chaudier Romain Desmarchelier Tanguy Mouton Cyril Courtin Lucie Louboutin Sébastien Martres Franck Trouillet

journal_name: Antimicrobial Agents and Chemotherapy

oa_colors: green hybrid

evidence: open (via free pdf)

repository_institution: PubMed Central - Europe PMC

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

ReferenceCitation: Andrianasolo J, Ferry T, Boucher F, Chateau J, Shipkov H, Daoud F, Braun E, Triffault-Fillit C, Perpoint T, Laurent F, Mojallal AA, Chidiac C, Valour F; Lyon BJI study group. Pressure ulcer-related pelvic osteomyelitis: evaluation of a two-stage surgical strategy (debridement, negative pressure therapy and flap coverage) with prolonged antimicrobial therapy. BMC Infect Dis. 2018 Apr 10;18(1):166. doi: 10.1186/s12879-018-3076-y.

family: Andrianasolo

full_name: Johan Andrianasolo

given: Johan

family: Boucher

full_name: Fabien Boucher

given: Fabien

family: Chateau

full_name: Joseph Chateau

given: Joseph

family: Shipkov

full_name: Hristo Shipkov

given: Hristo

location_facility: Centre de référence des Infections Ostéo-articulaires-Hôpital de la Croix Rousse


acronym: WEAN SLEEP 1

summary: The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients

ReferenceCitation: Thille AW, Reynaud F, Marie D, Barrau S, Rousseau L, Rault C, Diaz V, Meurice JC, Coudroy R, Frat JP, Robert R, Drouot X. Impact of sleep alterations on weaning duration in mechanically ventilated patients: a prospective study. Eur Respir J. 2018 Apr 19;51(4). pii: 1702465. doi: 10.1183/13993003.02465-2017. Print 2018 Apr.

family: Thille

full_name: Arnaud W. Thille

given: Arnaud W.

family: Reynaud

full_name: Faustine Reynaud

given: Faustine

family: Marie

full_name: Damien Marie

given: Damien

family: Barrau

full_name: Stéphanie Barrau

given: Stéphanie

family: Rousseau

full_name: Ludivine Rousseau

given: Ludivine

family: Rault

full_name: Christophe Rault

given: Christophe

family: Diaz

full_name: Véronique Diaz

given: Véronique

family: Meurice

full_name: Jean-Claude Meurice

given: Jean-Claude

family: Coudroy

full_name: Rémi Coudroy

given: Rémi

family: Frat

full_name: Jean-Pierre Frat

given: Jean-Pierre

family: Robert

full_name: René Robert

given: René

family: Drouot

full_name: Xavier Drouot

given: Xavier

journal_name: European Respiratory Journal

oa_host_type: publisher

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society


title: Pulmonary Microbiota in COPD Patients Colonized With P. Aeruginosa OprD Mutant Resistant to Imipenem

acronym: MiPAD

summary: Pseudomonas aeruginosa (PA ) is associated with chronic lung infections in patients with chronic obstructive pulmonary disease (COPD). Commensal flora (microbiota) in lung was recently described using high-throughput sequencing techniques (NGS). PA strains isolated during lung infection episodes of severe COPD patients often show resistance to antibiotics including imipenem that is mainly due to mutation in oprD. In collaboration with Harvard Medical School, the investigators have recently demonstrated that PA OprD mutant shows increased survival (fitness) and its virulence. This bacterium could be more likely to colonize. Colonization by PA OprD mutant could influence the pulmonary microbiota and may worsen disease evolution, particularly in terms of frequency of exacerbations. Our objective is to describe modification of pulmonary microbiota associated with PA colonization, including OprD PA mutant, in severe COPD patients. The investigators will correlate the microbiota modification to medical history. Stable severe COPD patients will be included. Three groups of patients will be sampled: 1) not PA colonized, 2) PA colonized and 3) PA OprD mutant colonized. Medical history will be recorded by the physician as usual and three samples will be performed: 1) sputum, 2) oral wash and 3) water used for oral wash. Regular bacterial culture will be performed and NGS will be performed also to characterize the microbiota.

primary_purpose: Basic Science

ReferenceCitation: Audebert C, Even G, Cian A; Blastocystis Investigation Group, Loywick A, Merlin S, Viscogliosi E, Chabé M. Colonization with the enteric protozoa Blastocystis is associated with increased diversity of human gut bacterial microbiota. Sci Rep. 2016 May 5;6:25255. doi: 10.1038/srep25255.

ReferenceCitation: Wang Z, Bafadhel M, Haldar K, Spivak A, Mayhew D, Miller BE, Tal-Singer R, Johnston SL, Ramsheh MY, Barer MR, Brightling CE, Brown JR. Lung microbiome dynamics in COPD exacerbations. Eur Respir J. 2016 Apr;47(4):1082-92. doi: 10.1183/13993003.01406-2015. Epub 2016 Feb 25.

lead_sponsor: CHU de Reims


title: Genetic Autopsy and Sudden Death of Young Subject

acronym: AGEMOS

summary: The purpose of the study is to better identify hereditary cardiac causes of sudden unexpected death in young subjects through Next-Generation Sequencing of autopsy tissue

intervention_type: Genetic


acronym: VITADOSE

summary:
Vitamin D (VD) is a pleiotropic hormone, involved in many physiological processes including calcium and phosphorus absorption. The VD metabolism begin to be well-known and involves a hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome P450 family) leading to the production of the 25(OH)D, which corresponds to the circulating form of the VD. After circulation in blood, the 25(OH)D is submitted to a second hydroxylation in the kidney resulting to the generation of 1,25(OH)2D, the active metabolite of VD. Numerous epidemiological studies reported an inverse relationship between obesity and circulation level of 25(OH)D. Several mechanisms could explain the low level of 25(OH)D observed in obese subjects, the more classical evoked being based on sequestration and/or dilution of VD in adipose tissue (AT), the main VD storage site. However, this mechanism has never been demonstrated. In order to confirm this hypothesis, the concentration of VD and its metabolites in adipose tissue need to be quantified.

The objective of this study is to determine the concentration of VD and its metabolites in adipose tissue as well as adipose tissue mass quantification and distribution (visceral or subcutaneous) to highlight putative difference of VD and its metabolites quantities between obese and non-obese patients. A quantification of VD metabolism, inflammation and lipid metabolism gene expression will be realized on biopsies. Correlations between gene expression and quantity of VD in tissue will be carrying out.

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Biological


acronym: EC-MOTION

summary:
The objective of the study is to investigate the exposure difference between antibiotic studied patients in intensive care with Extracorporeal Membrane Oxygenation and patients without Extracorporeal Membrane Oxygenation.

The exhibition is evaluated by population pharmacokinetic modeling.

lead_sponsor: Rennes University Hospital


acronym: STIMCOM

summary:
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However the optimal intensity of electrical current stimulation remains unknown.

This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Naturalistic Clinical Studies in Several Centres of Electrodermal Hyporeactivity in Adult Patients With Primary Depression

acronym: EUDOR-A

summary: Suicide, suicide attempts and depression are major social problems. The present research program focuses on the relationship between electrodermal hyporeactivity, as measured by the ElectroDermal Orienting Reactivity (EDOR) Test, and suicide and suicide attempts with death intent in patients with a primary diagnosis of depression. Electrodermal hyporeactivity has in several publications from different laboratories repeatedly been shown to have a high sensitivity (up to 97%) and high raw specificity (up to 98%) for suicide. Such levels are unique in psychiatry. The relationship between suicidal propensity and hyporeactivity can be considered as strongly significant. Almost all evidence in the topic up today has been established in research settings with specific exclusion criteria for some secondary psychiatric and some somatic illnesses. However, it is important to study the relationship between electrodermal hyporeactivity and suicide in relatively unselected patients regarding secondary psychiatric diagnoses and somatic diagnoses in a natural clinical ward situation and milieu. A previous naturalistic study proved that a test of electrodermal hyporeactivity fits very well into the daily clinical work.

lead_sponsor: University Hospital, Montpellier


acronym: MUTAC

summary:
Social isolation and loneliness of the elderly have become major public health problems, because of the deleterious consequences if not lethal they can generate.

Because of frequent resignation to these phenomena, support must be given to all means of prevention to prevent or at least mitigate their impacts. It appears from the literature that are isolated or living as they have adjustment difficulties which are linked to fragility. If geriatric frailty have been defined to date in somatic and cognitive criteria, psychological fragility criteria have been little discussed outside of psychiatric disorders (depression, anxiety disorders in particular).

This study aims to test in the elderly in isolation psychological fragility questionnaire and to study the statistical qualities and relations with socio-demographic variables, environmental and other known vulnerabilities.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Preterm Birth and Social Cognition: of the Executive Functions and Parental Anxiety's Stakes

acronym: TERM-COG

summary: The study aims at investigating social cognition outcomes of children born prematurely. Social cognition can be briefly defined as a process which underlines people's social and emotional behaviors. There are behavioral and cognitive evidences indicating that preterm children have executive dysfunctions. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. The literature regarding development of term born children indicates that executive functions are linked to the emergence of social cognition. Then, the investigators asked if children born prematurely, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Additionally, as it has been shown that parental anxiety is a key factor of preterm children development, the investigators assumed that it should play a role in social cognition outcomes.

ReferenceCitation: Eutrope J, Novo A, Barbe C, Loron G, Rolland AC, Caillies S. Impact of Executive Functions and Parental Anxiety on the Development of Social Cognition in Premature Children: A Cross-Sectional Case-Control Protocol. Front Psychiatry. 2021 Sep 9;12:484571. doi: 10.3389/fpsyt.2021.484571. eCollection 2021.

family: Eutrope

full_name: Julien Eutrope

given: Julien

family: Novo

full_name: Alexandre Novo

given: Alexandre

family: Barbe

full_name: Coralie Barbe

given: Coralie

family: Loron

full_name: Gauthier Loron

given: Gauthier

family: Rolland

full_name: Anne-Catherine Rolland

given: Anne-Catherine

family: Caillies

full_name: Stéphanie Caillies

journal_name: Frontiers in Psychiatry

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers


title: Effect of High-flow Nasal Cannula Therapy on Exposure to Nasal Continuous Positive Airway Pressure in Very Preterm Infants

acronym: HIFLO

summary: The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.

lead_sponsor: Hôpital de la Croix-Rousse


title: Implication of a Mobile Team of Palliative Care and Reality of the Palliative Approach in the Units

acronym: EVE

summary: The aim of the study is to estimate the impact of the implication of a Mobile Team of Palliative Care (EMSP) on the palliative strategy in the units with concerned patients. The Mobile Team of Palliative of Foch hospital Care was created in March, 2011.

status: Terminated

lead_sponsor: Hopital Foch


title: An Open Prospective Randomized Controlled Study Comparing the Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis Versus a Standard Outpatient Follow-up by Physical Consultation

acronym: SATIE-PR

summary:
Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting nearly 0.4% of the general population. It is a real public health issue. International guidelines recommend strict control (remission or low disease activity) of the disease, to avoid joint destruction in order to reduce the functional impact of the disease in the long term and to improve the quality of life of the patients.

This care is based on a close follow-up requiring regular visits with the specialist which represents an additional cost (transport, visits). In this context, tele-medicine is often proposed as a complementary approach in the management of these chronic patients.

Thus, the investigators propose to study the interest of a connected device by comparing a group of patients using this Smartphone application, coupled with a hand dynamometer during the 6 months following initiation of a new DMARD.

ReferenceCitation: Pers YM, Valsecchi V, Mura T, Aouinti S, Filippi N, Marouen S, Letaief H, Le Blay P, Autuori M, Fournet D, Mercier G, Ferreira R, Jorgensen C. A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis. Rheumatology (Oxford). 2021 Apr 6;60(4):1659-1668. doi: 10.1093/rheumatology/keaa462.

name: IRMB, University of Montpellier, INSERM U1183, CHU Montpellier, Montpellier, France

family: Pers

full_name: Yves-Marie Pers

given: Yves-Marie

family: Valsecchi

full_name: Verushka Valsecchi

given: Verushka

name: Clinical Research and Epidemiology Unit (URCE), Montpellier, France

family: Mura

full_name: Thibault Mura

given: Thibault

family: Aouinti

full_name: Safa Aouinti

given: Safa

family: Filippi

full_name: Nathalie Filippi

given: Nathalie

family: Marouen

full_name: Sarah Marouen

given: Sarah

family: Letaief

full_name: Hind Letaief

given: Hind

family: Le Blay

full_name: Pierre Le Blay

given: Pierre

family: Autuori

full_name: Michel Autuori

given: Michel

family: Fournet

full_name: Dominique Fournet

given: Dominique

name: Economic Evaluation Unit (URME), CHU Montpellier, Univ Montpellier, Montpellier, France

family: Mercier

full_name: Grégoire Mercier

given: Grégoire

family: Ferreira

full_name: Rosanna Ferreira

given: Rosanna

family: Jorgensen

full_name: Christian Jorgensen

given: Christian

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


title: Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients

summary: The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental or cognitive disabilities and could have sedative premedication. The investigators performed any type of dental care With the Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after dental care.


title: Ionized Calcium and Behavioural Disorders in Older Adults (CALICO Study)

summary: The primary objective of this study is to determine whether geriatric inpatients with severe behavioral disorders exhibit higher serum ionized calcium concentration than geriatric inpatients without behavioral disorders, but no difference in serum calcium or corrected calcium concentrations. The secondary objective of this study is to determine whether the serum ionized calcium concentration is associated with behavioral and cognitive performance among geriatric inpatients.

lead_sponsor: University Hospital, Angers


type: EudraCT Number

title: De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study

acronym: FOREVER

summary:
Tacrolimus is a calcineurin inhibitor. This is the immunosuppression of reference for patients undergoing a first liver transplant. This treatment can prevent graft rejection, but can cause side effects including kidney failure (in 25% after the first year).

Everolimus is an immunosuppressive that effectively prevents acute rejection in heart and kidney transplant recipients. It preserves renal function when it is started soon after the transplant, i.e. before a severe dysfunction is installed.

primary_purpose: Prevention


title: Enhanced Lung Protective Ventilation for ARDS Patients With PrismaLung

acronym: PROVAP

summary:
Acute Respiratory Distress Syndrome (ARDS) still remains associated with a mortality rate of 30 - 45 % despite improvement in mechanical ventilation. Driving pressure, defined as the difference between the end-inspiratory and the end-expiratory airway pressure, appears as an important factor contributing to mortality in patients with the ARDS. In patients already receiving a conventional tidal volume of 6 ml/kg predicted body weight (PBW), a driving pressure ≥ 14 cmH2O increases the risk of death in the hospital. One mean to lower the driving pressure is to decrease the tidal volume such that from 6 to 4 ml/kg predicted body weight. However, this strategy promotes hypercarbia by reducing the alveolar ventilation, providing the respiratory rate is constant. In this setting, implementing an extracorporeal CO2 removal (ECCO2R) therapy may offset the associated hypercarbia. The investigators have previously demonstrated that combining a membrane oxygenator within an hemofiltration circuit provides efficacious low flow ECCO2R on a renal replacement therapy monitor. In this study, we thought to investigate the efficacy of the PrismaLung stand-alone therapy. Using a PrismaFlex monitor and a HP-X circuit, a neonatal membrane oxygenator (PrismaLung) is used to provide decarboxylation without renal replacement therapy. The study will consist in three periods:

The first period will address the efficacy of the PrismaLung device at tidal volume of 6 and 4 ml/kg PBW using an off-on-off design.
The second part of the study will investigate the effect of varying the sweep gas flow and the mixture of the sweep gas on the CO2 removal rate (random order).

The third part will compare three ventilatory strategies applied in a cross-over design :

Minimal distension: Tidal volume 4 ml/kg PBW and positive end-expiratory pressure (PEEP) based on the ARDSNet PEEP/FiO2 table (ARMA).
Maximal recruitment: 4 ml/kg PBW and PEEP adjusted to maintain a plateau pressure between 23 - 25 cmH2O.
Standard: Tidal volume 6 ml/kg and PEEP based on the ARDSNet PEEP/FiO2 table (ARMA).

Each strategies will be apply in a random order for a duration of 22 hours. Pulmonary inflammatory and fibrosis pathway will be assess before and after each period using bronchoalveolar lavage (BAL) samples. Systemic inflammatory cytokines will also be investigate. Main measurements will include respiratory mechanics, transpulmonary pressure, work of breathing, end-expiratory lung volume and tidal ventilation using electrical impedance tomography.

ReferenceCitation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

name: School of Medicine and Surgery, University of Milan-Bicocca, Monza, Italy2Department of Emergency and Intensive Care, San Gerardo Hospital, Monza, Italy

family: Bellani

full_name: Giacomo Bellani

given: Giacomo

name: Departments of Anesthesia and Critical Care Medicine, Keenan Research Centre for Biomedical Science, St Michael’s Hospital4Departments of Anesthesia, Physiology and Interdepartmental division of Critical Care Medicine, University of Toronto, Canada

family: Laffey

full_name: John G. Laffey

given: John G.

name: AP-HP, Hôpital Tenon, Unité de Réanimation médico-chirurgicale, Pôle Thorax Voies aériennes, Groupe hospitalier des Hôpitaux Universitaires de l’Est Parisien, Paris, France6UMR 1153, Inserm, Sorbonne Paris Cité, ECSTRA Team, Université Paris Diderot, Pari

family: Pham

full_name: Tài Pham

given: Tài

name: Department of Medicine, University Health Network and Mount Sinai Hospital9Interdepartmental Division of Critical Care Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada

family: Fan

full_name: Eddy Fan

given: Eddy

name: Keenan Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Canada11Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada

family: Brochard

full_name: Laurent Brochard

given: Laurent

name: Hospital Universitario de Getafe, CIBER de Enfermedades Respiratorias, Madrid, Spain

family: Esteban

full_name: Andres Esteban

given: Andres

name: Istituto di Anestesia e Rianimazione, Università degli Studi di Milano, Ospedale Maggiore, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy

family: Gattinoni

full_name: Luciano Gattinoni

given: Luciano

name: Intensive Care Unit, Canberra Hospital, and Australian National University, Canberra, Australia

family: van Haren

full_name: Frank van Haren

given: Frank

name: Section of Anesthesiology and Intensive Care, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden

family: Larsson

full_name: Anders Larsson

given: Anders

name: Centre for Experimental Medicine, Queen's University of Belfast, Belfast, Northern Ireland17Wellcome-Wolfson Institute for Experimental Medicine, Belfast, Northern Ireland18Regional Intensive Care Unit, Royal Victoria Hospital, Grosvenor Road, Belfast, No

family: McAuley

full_name: Daniel F. McAuley

given: Daniel F.

name: SAPIENZA Università di ROMA, Dipartimento di Anestesia e Rianimazione, Policlinico Umberto I, Viale del Policlinico 155, 00161 Roma, Italy

family: Ranieri

full_name: Marco Ranieri

given: Marco

name: Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada21Program in Trauma, Emergency and Critical Care, Sunnybrook Health Sciences Center, Toronto, Canada

family: Rubenfeld

full_name: Gordon Rubenfeld

given: Gordon

name: Division of Pulmonary and Critical Care Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston

family: Thompson

full_name: B. Taylor Thompson

given: B. Taylor

name: Department of Anesthesiology and Intensive Care Medicine, University of Leipzig, Liebigstr. 20, D-04103 Leipzig, Germany

family: Wrigge

full_name: Hermann Wrigge

given: Hermann

name: Keenan Research Center at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, the Interdepartmental Division of Critical Care Medicine, and the Department of Medicine, University of Toronto, Toronto, Canada

family: Slutsky

full_name: Arthur S. Slutsky

given: Arthur S.

family: Pesenti

full_name: Antonio Pesenti

given: Antonio

name: for the LUNG SAFE Investigators and the ESICM Trials Group

journal_name: JAMA

repository_institution: Queen's University Belfast - Research Portal

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

family: Amato

full_name: Marcelo B.P. Amato

title: Driving Pressure and Survival in the Acute Respiratory Distress Syndrome

ReferenceCitation: Allardet-Servent J, Castanier M, Signouret T, Soundaravelou R, Lepidi A, Seghboyan JM. Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With Acute Respiratory Distress Syndrome and Acute Kidney Injury: The Pulmonary and Renal Support in Acute Respiratory Distress Syndrome Study. Crit Care Med. 2015 Dec;43(12):2570-81. doi: 10.1097/CCM.0000000000001296.

publisher: Ovid Technologies (Wolters Kluwer Health)


title: Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

acronym: VARIASTRESS

summary:
The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the parasympathetic nervous system and a decrease of the sympathetic system. Various explanations of this these dysfunctions are proposed in literature, mainly malnutrition, physical hyperactivity, anxiety, that are known characteristics of anorexia nervosa.

The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety in anorexia nervosa.

Other objectives of this study are firstly to evaluate correlation between ANS dysfunction and others parameters (weight, body mass index, depression, physical activity, purgative ou restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if HRV is a predictive parameter of the evolution of anorexia nervosa.

lead_sponsor: Hospices Civils de Lyon


title: Identification Des barrières au dépistage du Cancer du Col utérin à la Réunion et Des Leviers d'amélioration

acronym: FOSFORE

summary: FOSFORE study aims at identifying the barriers of cervical cancer screening in Reunion Island and key levers for improvment.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients

acronym: RACO-MA

summary:
Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive to presbycusis and/or to central auditory dysfunction.

Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric tests as noisy and/or dichotic tests, are needed.

Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease; therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now, investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored the hearing ability of the patient. However, the major part of care management and investigations implies the patient's communication ability with caregivers. Hearing loss may be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline but this management must be investigate during longitudinal studies in order to demonstrate their efficiency and need to be compared with a placebo.

lead_sponsor: University Hospital, Tours


acronym: THROMBONETS

summary:
Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment and mortality worldwide despite the development of revascularization therapies (intravenous Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years, neutrophil extracellular traps (NETs) have been identified as major triggers and structural factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively correlated with the infarct size and negatively correlated with electrocardiogram (ST-segment) resolution. This later study revealed that in vitro addition of DNase I accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be promising targets for improved thrombolysis in AIS.

The aim of this study is to assess the impact of NETs composition of thrombi retrieved during endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and AIS etiologies.

status: Withdrawn

ReferenceCitation: Ducroux C, Di Meglio L, Loyau S, Delbosc S, Boisseau W, Deschildre C, Ben Maacha M, Blanc R, Redjem H, Ciccio G, Smajda S, Fahed R, Michel JB, Piotin M, Salomon L, Mazighi M, Ho-Tin-Noe B, Desilles JP. Thrombus Neutrophil Extracellular Traps Content Impair tPA-Induced Thrombolysis in Acute Ischemic Stroke. Stroke. 2018 Mar;49(3):754-757. doi: 10.1161/STROKEAHA.117.019896. Epub 2018 Feb 8.

name: From the Université Paris Diderot, Sorbonne Paris Cite, Laboratory of Vascular Translational Science, U1148 Institut National de la Santé et de la Recherche Médicale (INSERM), France (C. Ducroux, L.D.M., S.L., S.D., W.B., C. Deschildre, R.B., J.-B.M., M.P., M.M., B.H.-T.-N., J.-P.D.); Department of Interventional Neuroradiology (W.B., R.B., H.R., G.C., S.S., R.F., M.P., M.M., J.-P.D.) and Department of Clinical Research (M.B.M., L.S.), Rothschild Foundation Hospital, Paris, France; and DHU NeuroVasc...

family: Ducroux

full_name: Celina Ducroux

given: Celina

family: Di Meglio

full_name: Lucas Di Meglio

given: Lucas

family: Loyau

full_name: Stephane Loyau

given: Stephane

family: Delbosc

full_name: Sandrine Delbosc

given: Sandrine

family: Boisseau

full_name: William Boisseau

given: William

family: Deschildre

full_name: Catherine Deschildre

given: Catherine

family: Ben Maacha

full_name: Malek Ben Maacha

given: Malek

family: Blanc

full_name: Raphael Blanc

given: Raphael

family: Redjem

full_name: Hocine Redjem

given: Hocine

family: Ciccio

full_name: Gabriele Ciccio

given: Gabriele

family: Smajda

full_name: Stanislas Smajda

given: Stanislas

family: Fahed

full_name: Robert Fahed

given: Robert

family: Michel

full_name: Jean-Baptiste Michel

given: Jean-Baptiste

family: Piotin

full_name: Michel Piotin

given: Michel

family: Salomon

full_name: Laurence Salomon

given: Laurence

family: Mazighi

full_name: Mikael Mazighi

given: Mikael

family: Ho-Tin-Noe

full_name: Benoit Ho-Tin-Noe

given: Benoit

family: Desilles

full_name: Jean-Philippe Desilles

given: Jean-Philippe

journal_name: Stroke

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Effects of Cyclosporine A Pretreatment of Deceased Donor on Kidney Graft Function: A Randomized Controlled Trial

acronym: Cys-A-Rein

summary: Organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. According to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints and mortality during the first year after transplantation.

ReferenceCitation: Orban JC, Fontaine E, Cassuto E, Baumstarck K, Leone M, Constantin JM, Ichai C; AzuRéa network. Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial. Trials. 2018 Apr 17;19(1):231. doi: 10.1186/s13063-018-2597-4.

family: Orban

full_name: Jean-Christophe Orban

given: Jean-Christophe

family: Fontaine

full_name: Eric Fontaine

given: Eric

family: Cassuto

full_name: Elisabeth Cassuto

given: Elisabeth

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Leone

full_name: Marc Leone

given: Marc

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Ichai

full_name: Carole Ichai

given: Carole

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repositories:
HAL
PubMed Central

lead_sponsor: University Hospital, Clermont-Ferrand


title: Feasibility of Breast Cancer Risk Evaluation in Women From the General Population

acronym: RIVIERA

summary: This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to informing women about their risk of breast cancer and the screening methods recommended for them according to the recommendations in force during a routine consultation at a general practitioner, a gynecologist or a radiologist.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Randomised Phase III Multicentric Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin in Non-progressive Patients Versus Doxorubicine Alone as First-line Therapy in Patients With Metastatic or Unresectable Leiomyosarcoma (Uterine or Soft Tissue)

summary:
The objective of LMS04 study is to better define the treatment strategy for patients with metastatic leiomyosarcoma (uterine or soft tissue), as well as identifying the best first line therapeutic option for these patients. LMS04 will test a new strategy for first line therapy LMS sarcoma compare to the reference therapy (6 cycles of doxorubicin alone): the interest of the association of trabectedin to doxorubicin in first line treatment followed by trabectedin alone for non-progressive patients after 6 cycles of the association of trabectedin and doxorubicin (the LMS02 design).

LMS04 will be the first phase III randomized study specifically dedicated to soft tissue leiomyosarcoma in first line metastatic disease.

It is planned to compare a new doxorubicin combination (including trabectedin) with very encouraging results followed by trabectedin maintenance therapy for non-progressive patients to doxorubicin alone. Prospective ancillary translational studies will attempt to define profiles of patients who could benefit from this new chemotherapy in an exploratory way.

The validation of a new first line option specific for LMS, identifying clinical factors that characterize aggressiveness and responsiveness to treatment aims to have an important in the spirit of personalized medicine in this rare and deadly disease.

ReferenceCitation: Hanvic B, Ray-Coquard I. Gynecological sarcomas: literature review of 2020. Curr Opin Oncol. 2021 Jul 1;33(4):345-350. doi: 10.1097/CCO.0000000000000753. Review.

family: Hanvic

full_name: Brunhilde Hanvic

given: Brunhilde

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

journal_name: Current Opinion in Oncology


title: Objective Measures of Pain Sensitivity in NREM Sleep Parasomnia

acronym: NOCISOMNIE

summary:
Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent and disabling sleep disorders characterized by arousal specifically from slow wave sleep (SWS) with dissociated brain activity that may be related to lower nociceptive state. The investigators recently reported frequent subjective complaints of chronic pain, migraine and headache during wakefulness in adult sleepwalkers. They also described frequent analgesia during severe and injuring episodes, suggesting a relationship between dissociated brain activity and nociceptive dysregulation. However, this study did not included objective nociceptive measures and the retrospective assessment of perceived pain during parasomnia episodes over a lifetime span might also introduce a recall bias.

The aims of the present study are to measure objective pain sensitivity in patients with NREM parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS, and 3) wakefulness.

Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the nociceptive threshold. During the recovery sleep following the sleep deprivation, the investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive responses.

The investigators hypothesized a lower nociceptive threshold during wakefulness in sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This study may help to better understand the etiology and mechanisms underlying the clinical enigma of the nociceptive dysregulation in NREM sleep parasomnias.

study_start_date_type: Anticipated


title: Evaluation of the Effectiveness and Security of the Prophylactic Platelet Transfusion in Thrombocytopenic Patients Requiring the Placement of a Central Venous Catheter

acronym: PLATCAT

summary: PLATCAT study's purpose is to evaluate platelet kinetics after platelet transfusion


acronym: POOL-BM

summary: The investigators compared a pooled mother's expressed breastmilk for 24 hours with individual pump session collection of milk to provide a more consistent caloric product without increasing bacterial contamination.

lead_sponsor: University Hospital, Brest


title: Elastometry of the Salivary Glands in Sicca Syndrome

acronym: ELSA

summary: Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS.


title: A Single-arm Phase 2 Study of Atezolizumab as Induction Therapy in Stage IB-IIIA Non N2 Resectable and Untreated Non-small Cell Lung Cancer (NSCLC)

acronym: PRINCEPS

summary:
Based on the efficacy of immunotherapies in advanced disease with a reasonable safety profile/tolerability we could hypothetisize that, immunotherapy should work best in the situation of minimal residual disease, Two clinical trials are ongoing to test the role of immunotherapeutic agents in the adjuvant setting: PEARLS trial, a randomized phase III trial with anti-PD1 monoclonal antibody pembrolizumab (MK-3475 or pembrolizumab) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy, and the second randomized phase III trial (NCT02273375) will evaluate the efficacy of an anti-PD-L1 (MEDI 4736) for a maximum of 12 months versus placebo as adjuvant therapy in completed resected stage IB-IIIA NSCLC and completed standard ACT.

The role of immunotherapeutic approaches for NSCLC in the neoadjuvant setting is currently unknown. However, based on the survival efficacy of immunotherapeutic strategies in advanced NSCLC where the tumor has not been removed which could produce higher immunogenicity and based on the efficacy of neoadjuvant treatments in NSCLC, we propose to test the safety and efficacy of atezolizumab as neoadjuvant therapy in subjects diagnosed with stage I, II, or IIIA (non N2) NSCLC and who are deemed suitable for surgical resection.

Clinical staging of NSCLC is based on computed tomography (CT) of the chest and upper abdomen, brain CT or magnetic resonance imaging and 18F-FDG PETscan to rule out metastatic disease and assess the potential for curative-intent resection. Adjuvant chemotherapy will be performed according the standard clinical guidelines.


title: Interest of Plasma Copeptin Levels in Management of Children With Diabetic Ketoacidosis

acronym: COPACD

summary:
Children with diabetic ketoacidosis risk neurological complications such as cerebral edema with high morbidity. To prevent cerebral edema, it is essential to control correction of hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic ketoacidosis don't always permit an optimal care.

Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.

Therefore, monitoring of plasma copeptin levels could be of interest in children with diabetic ketoacidosis and risk of sévère neurological complications.


title: Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity

acronym: ARMONIC

summary:
The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer involves axillary lymph node dissection (ALND). To preserve arm lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is uncertain.

The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future


title: Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis

acronym: EFX

summary: The objective of study is to prospectively determine if CPET with blood gas analysis should have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients. Inclusion criteria will be: age >15 years, cystic fibrosis confirmed by chloride sweat test or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients will perform a maximal exercise test on a cycloergometer during the inclusion visit, with pulmonary function testing and a six-minute walk test. The study will also include a visit every 6 months with: body mass index calculation, pulmonary function testing with DLCO (diffusing lung capacity for carbon monoxide), a six minute walk test, and antibacteriological study of sputum. The results of this study could help identify earlier the patients for referral to a lung transplantation centre, by using the usual criteria and the CPET abnormalities.

lead_sponsor: University Hospital, Lille


title: Effect of Sleep Apnea Screening and Treatment on Atrial Fibrillation Recurrence : a Randomized Controlled Trial

acronym: SAAFIR

summary: The main aim of this project is to assess the effect of Sleep apnea syndrome (SAS) screening (and treatment if SAS is moderate to severe, defined by an apnea hypopnea index >15 / h) on recurrence of atrial fibrillation (AF) over a twenty-four month follow-up period, in patients on optimal medical treatment after AF ablation.

status: Active, not recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Efficacy of Nebulized Versus Intravenous Colimycin for Treating Ventilator-associated Pneumonia Caused by Gram-negative Multidrug-resistant Bacteria: a Prospective, Multicenter, Randomized and Double-blind Study

acronym: COLIVAP

summary: Few antimicrobials are available to treat ventilated associated pneumonia (VAP) caused by Gram negative multi-resistant (MDR) bacteria. Colimycin often remains the only active antibiotic. The aim of the study is to demonstrate the superiority of nebulized colimycin over intravenous colimycin to treat VAP caused by Gramnegative MDR bacteria.

ReferenceCitation: Solé-Lleonart C, Rouby JJ, Chastre J, Poulakou G, Palmer LB, Blot S, Felton T, Bassetti M, Luyt CE, Pereira JM, Riera J, Welte T, Roberts JA, Rello J. Intratracheal Administration of Antimicrobial Agents in Mechanically Ventilated Adults: An International Survey on Delivery Practices and Safety. Respir Care. 2016 Aug;61(8):1008-14. doi: 10.4187/respcare.04519. Epub 2016 Mar 8.

ReferenceCitation: Solé-Lleonart C, Rouby JJ, Blot S, Poulakou G, Chastre J, Palmer LB, Bassetti M, Luyt CE, Pereira JM, Riera J, Felton T, Dhanani J, Welte T, Garcia-Alamino JM, Roberts JA, Rello J. Nebulization of Antiinfective Agents in Invasively Mechanically Ventilated Adults: A Systematic Review and Meta-analysis. Anesthesiology. 2017 May;126(5):890-908. doi: 10.1097/ALN.0000000000001570. Review.

ReferenceCitation: Rello J, Rouby JJ, Sole-Lleonart C, Chastre J, Blot S, Luyt CE, Riera J, Vos MC, Monsel A, Dhanani J, Roberts JA. Key considerations on nebulization of antimicrobial agents to mechanically ventilated patients. Clin Microbiol Infect. 2017 Sep;23(9):640-646. doi: 10.1016/j.cmi.2017.03.018. Epub 2017 Mar 25.

ReferenceCitation: Solé-Lleonart C, Roberts JA, Chastre J, Poulakou G, Palmer LB, Blot S, Felton T, Bassetti M, Luyt CE, Pereira JM, Riera J, Welte T, Qiu H, Rouby JJ, Rello J; ESGCIP Investigators. Global survey on nebulization of antimicrobial agents in mechanically ventilated patients: a call for international guidelines. Clin Microbiol Infect. 2016 Apr;22(4):359-364. doi: 10.1016/j.cmi.2015.12.016. Epub 2015 Dec 23.


title: Epidemiology and Prognosis of Encephalitis in Intensive Care

acronym: ENCEPHALITICA

summary:
Introduction: Acute encephalitis (AE) is a severe neurological disorder associated with significant morbidity and mortality. Approximately 50% of patients with AE require ICU admission because of coma, seizures or acute respiratory failure. Determinants of neurological prognosis in these patients are not known.

Objectives:

Main objective: To identify determinants of outcome in adult patients admitted to the ICU; Secondary objectives: a) To study the impact of diagnostic studies (Brain MRI, CSF analysis, EEG) on neurologic outcome; b) to describe the epidemiology of patients admitted to the ICU with AE; c) to study the impact of early appropriate therapy on neurologic outcomes; d) to describe morbidity and mortality associated with AE at 90 days and 1 year following diagnosis.

Methods: prospective observational multicenter study in French ICUs. All patients admitted to the ICU for probable or confirmed AE (2013 IDSA criteria)with a Glasgow coma scale score < or =to 13 will be eligible for inclusion. Factors associated with a poor prognosis at 90 days will be identified by multivariable logistic regression analysis.

Duration of study: 30 months (recruitment 18 months, follow-up 12 months).

Patients: 300 patients

Endpoints:

Primary endpoint: The primary endpoint is the modified Rankin scale score 90 days following onset of abnormal status (GCS < or =13). This score will be determined by contacting the patient. A poor outcome will be defined as a mRS >2 at 90 days.
Secondary endpoints: a) neurological findings within 7 days following onset of altered mental status; b) abnormal findings on diagnostic studies (MRI, EEG, CSF analysis) within7 days following onset of altered mental status; c) Time between onset of altered mental status and completion of diagnostic studies; d)Time between onset of altered mental status and start of appropriate specific therapy; e) neurologic outcomes at 1 year mRS score and extended Glasgow outcome scale (GOS); f) causes of death in non-survivors at 1 year; g) quality of life and posttraumatic stress at 1 year: IADL and SF36 scales;


title: Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : a Double Blind Randomized Pilot Study in Adult Elective Conventional Cardiac Surgery

acronym: OPTIMUS-PRIME

summary:
Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.

The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic effect.

location_facility: Hospices Civils de Lyon - Hopital Louis Pradel


title: Artificial Shrinkage of Fresh Blastocyst: Impact on Success Rates in Assisted Reproductive Technology

acronym: BlastoCollapse

summary:
The aim of the study is to determine if collapsing an embryo (or making it fold compactly by taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in assisted reproductive technology (ART).

Women coming to our ART center will be randomized in two groups : the collapsing group and a control group.

Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be determined in each group and correlated to pregnancy occurrence.


title: Efficacy of Furosemide Versus Vascular Filling in Patients With Acute Myocardial Infarction With Right Ventricular Extension: A Multicentric Randomized Controlled Trial

acronym: FAMIE

summary:
Right ventricular necrosis increases patient in hospital mortality and can be observed in 20-50% of patients admitted for during acute myocardial infarction. Current guidelines recommend managing cardiogenic shock related to right ventricular necrosis by optimizing RV load using fluid expansion and if insufficient adding inotropic support. However, several experimental studies reported a potential deleterious effect of right ventricular dilation related to fluid expansion because right and left ventricular interaction decreases stroke volume and cardiac output. Consistently with these finding, a study on a small patient sample conducted at Henri Mondor Hospital demonstrates the safety and efficiency of furosemide in patients with right ventricular necrosis.

The present study is a phase 3, interventional, prospective, randomized, multicenter, double-blind analysis by intention to treat.

The main objective is to demonstrate improved hemodynamic parameters in the short term in patients admitted for acute myocardial infarction with extension RV treated with furosemide.

The primary endpoint is compare the change in cardiac output in patients admitted and treated by either fluid expansion or furosemide.

The study population will consist in 88 patients and the duration of subjects' participation will be one month.


title: Nicotine Replacement Therapy in Nicotine-dependent Arrestees: a Monocentric Randomized Simple Blind Study

acronym: SUBNIGAV

summary:
Tobacco use affects more than 50% of adult arrestees, of which 70% are dependent on nicotine. However, they have no access to tobacco during detention in police cells. Nicotine withdrawal symptoms, that include irritability, anxiety and lack of concentration, may worsen the arrestee's health status during detention. Nicotine withdrawal is a treatable condition. Validated treatments in other situations than police custody include nicotine replacement therapy.

This study is based on the following hypotheses: Manifestations related to nicotine withdrawal could increase the discomfort due to detention in police cells, A nicotine replacement therapy initiated during detention could improve the course of detention in police cells and could be useful in a perspective of long-lasting smoking cessation.

The primary objective is to evaluate the efficacy of nicotine replacement therapy among nicotine-dependent arrestees on the course of detention as perceived by the arrestees. Our secondary objectives are to evaluate the efficacy of nicotine replacement therapy on desire to smoke during detention in police cells and to improve long-term smoking cessation among dependent smokers.

Interventions consist in the single administration of an active treatment (nicotine patch) or of a control treatment (placebo patch). Evaluations will include the results of a medical examination during detention, a self evaluation by the arrestees of their desire to smoke, and medical consultations and evaluations of tobacco use 7-10 days, one month and six months later.

ReferenceCitation: Chariot P, Lepresle A, Lefèvre T, Boraud C, Barthès A, Tedlaouti M. Alcohol and substance screening and brief intervention for detainees kept in police custody. A feasibility study. Drug Alcohol Depend. 2014 Jan 1;134:235-241. doi: 10.1016/j.drugalcdep.2013.10.006. Epub 2013 Oct 23.

ReferenceCitation: Chariot P, Beaufrère A, Denis C, Dang C, Vincent R, Boraud C. Detainees in police custody in the Paris, France area: medical data and high-risk situations (a prospective study over 1 year). Int J Legal Med. 2014 Sep;128(5):853-60. doi: 10.1007/s00414-014-0990-4. Epub 2014 Mar 27.

ReferenceCitation: Cropsey KL, Jones-Whaley S, Jackson DO, Hale GJ. Smoking characteristics of community corrections clients. Nicotine Tob Res. 2010 Jan;12(1):53-8. doi: 10.1093/ntr/ntp172. Epub 2009 Dec 8.

ReferenceCitation: Richmond R, Indig D, Butler T, Wilhelm K, Archer V, Wodak A. A randomized controlled trial of a smoking cessation intervention conducted among prisoners. Addiction. 2013 May;108(5):966-74. doi: 10.1111/add.12084. Epub 2013 Mar 11.

ReferenceCitation: Tzelepis F, Paul CL, Walsh RA, Knight J, Wiggers J. Who enrolled in a randomized controlled trial of quitline support? Comparison of participants versus nonparticipants. Nicotine Tob Res. 2013 Dec;15(12):2107-13. doi: 10.1093/ntr/ntt114. Epub 2013 Aug 3.


title: Evaluation of Spectral Cardiac CT for the Diagnosis of Acute Myocarditis

acronym: MYOCARDITESCAN

summary:
Spectral cardiac CT scan performed in an emergency setting in patients with suspected acute myocarditis and presenting one selves with an acute chest pain, allows the non-invasive assessment of both the coronary arteries and the myocardium. Delayed iodine contrast-enhanced CT imaging should show the inflamed area with an increased uptake of iodine contrast agent in the interstitial space, such as the well-known hypersignal seen on the myocardial delayed enhancement sequence with MRI (corresponding of an uptake of gadolinium contrast agent in the abnormal myocardium).

This technique has the potential to replace MRI, thus allowing the diagnosis of acute myocarditis with a rapid and easily accessible technique. Moreover, it has the additional benefit of avoiding invasive coronary angiography in the specific population of patients without any significant risk factors of atheromatous disease.


title: Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear

acronym: EPISIO

summary: The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.


title: Comparative Study, Randomized in Parallel Groups, Evaluating the Consequences of the Management of Diabetic Foot Ulcers by Telemedicine Versus Conventional Monitoring on the Number of Hospital Days in Diabetic Patients

acronym: TELEPIED

summary:
The TELEPIED project aims to show that it is possible to reduce the number of hospitalization days of a patient with ulcers of the foot thanks to a new organization of care, based on the intervention of a coordinating nurse interacting with the nurse in charge of the patient thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular follow-up of the evolution of the wound and adapting the support nurse to the home if necessary.

It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of the foot.

Patients included in the conventional group will be followed according to the usual practice Patients included in the "telepied" group will benefit from a personalized accompaniment by a nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting by delegating tasks of the investigator.

The patient will be visited by the referring nurse every 15 days. During these visits, the referring nurse will have the objective to evaluate the evolution of the ulcer as well as the care performed. This visit also allows a close personalized accompaniment for the patient, who will benefit from an education adapted to the characteristics of ulcer (discharge modalities for example ..) and its way of life.

Every patients will be followed for one year (12 months).

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète


title: Is Fixation of Percutaneous Akin Osteotomy Enhanced First Ray Post-operative Mobility? A Prospective Randomized Study.

acronym: AKIN

summary: The study is a prospective randomized study about hallux valgus surgery. The investigator try to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an incidence in the first ray mobility since the two technics ( fixation and no-fixation) are described and practiced, and since the stiffness of the first metatarso-phalangeal joint is determinant in the result of this functional surgery.

lead_sponsor: University Hospital, Bordeaux

location_facility: University Hospital of Bordeaux - Hospital Pellegrin