title: A Multicenter Randomized Study on Operative Time When Using IFABOND™ Synthetic Glue in Laparoscopic Sacrocolpopexy

acronym: Procolle 2

summary: Laparoscopic sacrocolpopexy has now become the gold standard technique for correction of anterior and apical prolapse. In order to provide an alternative to stapling system and sutures involving vaginal erosion and shrinkage phenomena, there is a technique to fix material meshes by the use of a liquid, tissue, synthetic adhesive and sterile. The investigator hypothesizes that the use of IFABOND ™ adhesive in laparoscopic sacrocolpopexy significantly reduces the time of surgery compared to the classic suture technique. The prospective, randomized, multicenter study therefore aims to compare the time of surgery when using the IFABOND™ synthetic adhesive and the technique by sutures to fix material meshes in laparoscopic sacrocolpopexy.

location_facility: Gynaecology Department, Hôpital Femme Mère Enfant


type: Other Identifier

title: PREVATHLE: To Evaluate the Effectiveness of an Injury Prevention Program in Athletics

acronym: PREVATHLE

summary: The practice of Athletics leads to risk of injuries: about 61 to 76% athletes will occurred at least one injury during a season. The prevention of Athletics injuries thus represents a major challenge for all stakeholders around athletes. In team sports, injury prevention programs have been implemented and scientifically validated. However, no injury prevention programs have been implemented and scientifically validated for Athletics. In this context, a primary objective will be to analyze the effectiveness of an Athletics Injury Prevention Program (AIPP) to reduce the frequency (percentage) of athletes presenting at least one injury complaint related to athletic practice at long term (40 weeks). A statistician will carry out a randomized control trial in cluster (clubs with AIPP and clubs without AIPP), multicenter, including athletes between 15 and 40 years old and licensed in athletic clubs and followed during an athletic season.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Edouard P, Steffen K, Peuriere M, Gardet P, Navarro L, Blanco D. Effect of an Unsupervised Exercises-Based Athletics Injury Prevention Programme on Injury Complaints Leading to Participation Restriction in Athletics: A Cluster-Randomised Controlled Trial. Int J Environ Res Public Health. 2021 Oct 28;18(21):11334. doi: 10.3390/ijerph182111334.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: MDPI

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis

acronym: SCLEROLUNG

summary:
Systemic Scleroderma (SCS) is an autoimmune disease characterized by vascular involvement, a dysimmune condition, cutaneous and visceral fibrosis. Interstitial lung disease (ILD) affects 75% of SSc patients and is the leading cause of death in SSc. No diagnostic or prognostic biomarkers of SSc-associated ILD have been validated to date. The search for such a serum biomarker is essential to assess the severity of these patients and to help the therapeutic management.

We have shown that soluble fractalkine is elevated in SSc patients, especially in SSc patients with ILD. The fractalkine is both an endothelial adhesion molecule and a chemokine that binds to the CX3CR1 receptor expressed by immune populations. It would thus reflect the vasculopathy and inflammation that lead to the fibrosing pulmonary involvement of this disease.

Objectives and means: We aim to perform a low-risk interventional biomedical research which main objective is the quantitative evaluation of soluble fractalkine in SSc patients with ILD in comparison with SSc patients without ILD. This epidemiological, explanatory, analytical, single-center study will comprise three groups: 1 / SSc without ILD (control group in the context of SSc), 2/ SSc with ILD and 3/ patients with idiopathic pulmonary fibrosis (IPF) (control group of the ILD). Secondary objectives are evaluation of: 1 / fractalkine levels in the IPF, 2 / correlations between fractalkine levels and severity of ILD and of SSc disease over time, 3 / correlations between fractalkine and 2 other biomarkers: KL-6 (marker of pulmonary fibrosis) and soluble CD146 (sCD146, marker of vasculopathy), 4 / predictive values of the decline in lung function of these 3 markers.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Biological

status_simplified: Unknown


title: Hepatocellular Carcinoma in Patients With a Cirrhosis Due to an Alcoholic or a Non Alcoholic Fatty Liver Disease

acronym: CHALNA

summary:
Global prevalence of Non Alcoholic Fatty Liver Diseases (NAFLD) ranges from 22% to 28%.The spectrum of these hepatic abnormalities extends from isolated steatosis to steatohepatitis (Non Alcoholic Steato-Hepatitis, NASH) and steatofibrosis leading to cirrhosis and hepatocellular carcinoma. NAFLD is one of the main causes of cirrhosis and increases the risk of liver-related death and hepatocellular carcinoma (developed in patients with or without cirrhosis). Despite this major public health concern, apart from lifestyle changes, treatment of NAFLD is still elusive as there is lack of efficacious pharmacological treatment. Alcoholic liver diseases are also frequent in Western countries. Alcoholic liver diseases and NAFLD share common pathological lesions and molecular pathways. This is illustrated by the emerging role of abnormalities of the microbiota (dysbiosis) in these 2 diseases leading to the concept of " liver-gut axis ". Whereas the molecular mechanisms responsible for the progression from a "safety" state to NASH or to a severe alcoholic steato-hepatitis are still unclear, hepatic inflammation is a key factor involved in the progression of NAFLD and alcoholic liver disease.

The hypothesis is that cellular and molecular abnormalities and gut dysbiosis could be present in patients with simple steatosis or with steato-hepatitis and could be responsible for the occurrence of hepatocellular carcinoma particularly without cirrhosis.

The main objective is to compare cellular and inflammatory pathways in liver with and without hepatocellular carcinoma in patients with alcoholic or non-alcoholic fatty liver diseases.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity

acronym: MSPMI

summary:
Spasticity is a disorder of the muscular tonus that occurs in disease including the upper motor neuron (strokes, spinal cord injuries, multiple sclerosis, traumatic brain injuries or cerebral palsies). It begins few hours after the neural aggression and last until the grave.

The most accepted definition refers to a velocity-dependent increase in stretch reflexes elicited by passive stretch (Lance definition) but new approaches prefers to distinguish neural (reflex) and non-neural (soft tissues alterations) components of the increase resistance to a passive stretch. This deficiency is a major cause of complications as walking impairment, pain or bone deformities and may require intensive therapies (intrathecal baclofen infusion, intramuscular toxin botulinium injection, surgery, etc). Despite its high frequency and the potential complications, only clinical scales (modified Ashworth scale and modified Tardieu scale essentially) with criticized metrological properties are available for daily assessment. The SPASM Consortium has published on 2005 recommendations for developing devices using both mechanical and electrophysiological parameters. The principle challenge was to ally parameters accuracy and utilization facility allowing quickly evaluation to the patient's bed. Few research team works on this topic but mostly on specific population and nowadays, no device has really crossed the door of laboratories.

This kind of tool would help us to improve the quality of the follow-up and to guide us between the choices of specific therapies.

The MSPMI has been created following these recommendations in the University of Technology of Compiègne, thanks to the collaboration between researchers of the UMR 7338 CNRS and a brain surgeon of the Nantes University Hospital. The patent was obtained on 2012. This device allows the assessment of the ankle plantar extensor (triceps surae) during a manually applied stretch movement. This muscle was selected as it is frequently involved and treated for spasticity.

This study aims to evaluate the metrological properties of the MSPMI (reliabilities, responsiveness, known group validity, construct validity, measurement errors and internal consistency) among a large cohort of patients with no restriction of etiologies recruited in the Nantes University Hospital.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Bar-On L, Aertbelien E, Molenaers G, Van Campenhout A, Vandendoorent B, Nieuwenhuys A, Jaspers E, Hunaerts C, Desloovere K. Instrumented assessment of the effect of Botulinum Toxin-A in the medial hamstrings in children with cerebral palsy. Gait Posture. 2014 Jan;39(1):17-22. doi: 10.1016/j.gaitpost.2013.05.018. Epub 2013 Jun 20.

ReferenceCitation: Bar-On L, Van Campenhout A, Desloovere K, Aertbelien E, Huenaerts C, Vandendoorent B, Nieuwenhuys A, Molenaers G. Is an instrumented spasticity assessment an improvement over clinical spasticity scales in assessing and predicting the response to integrated botulinum toxin type a treatment in children with cerebral palsy? Arch Phys Med Rehabil. 2014 Mar;95(3):515-23. doi: 10.1016/j.apmr.2013.08.010. Epub 2013 Aug 27.

ReferenceCitation: de Vlugt E, de Groot JH, Schenkeveld KE, Arendzen JH, van der Helm FC, Meskers CG. The relation between neuromechanical parameters and Ashworth score in stroke patients. J Neuroeng Rehabil. 2010 Jul 27;7:35. doi: 10.1186/1743-0003-7-35.

ReferenceCitation: Schless SH, Desloovere K, Aertbelien E, Molenaers G, Huenaerts C, Bar-On L. The Intra- and Inter-Rater Reliability of an Instrumented Spasticity Assessment in Children with Cerebral Palsy. PLoS One. 2015 Jul 2;10(7):e0131011. doi: 10.1371/journal.pone.0131011. eCollection 2015.

ReferenceCitation: Gaverth J, Sandgren M, Lindberg PG, Forssberg H, Eliasson AC. Test-retest and inter-rater reliability of a method to measure wrist and finger spasticity. J Rehabil Med. 2013 Jul;45(7):630-6. doi: 10.2340/16501977-1160.

ReferenceCitation: Turk R, Notley SV, Pickering RM, Simpson DM, Wright PA, Burridge JH. Reliability and sensitivity of a wrist rig to measure motor control and spasticity in poststroke hemiplegia. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):684-96. doi: 10.1177/1545968308315599. Epub 2008 Sep 5.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Compiègne University of Technology

location_facility: Médecine Physique et Réadaptation Neurologique

intervention_type: Device


title: Transversal Study of Correlations Between Pain Catastrophizing Scale (PCS) and RAPID3 Score According to Ten Categories of Conditions Seen in an Outpatient Rheumatology Clinic

summary: Fulfilling by all patients consequently seen by 6 rheumatologists in a same outpatient rheumatology clinic (in at least one month period) of a set of 6 questionnaires, including RAPID3 and pain catastrophizing scales.


title: Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competence of Patients With Oesogastric and Bronchopulmonary Cancers as Compared to Standard Management

summary: The aim of this study is to test whether a short educational intervention about emotional skills can improve survivor cancer patient emotional skills and quality of life. Half of participants will follow the educational intervention about emotional skills, while the other half will practice relaxation followed by a non-directive talking group. The educational intervention should give better results on patient emotional skills and quality of life than the control group.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Lille

collaborators:
SIRIC ONCOLille
Santelys Association

sponsor_collaborators:
University Hospital, Lille
SIRIC ONCOLille
Santelys Association

intervention_type: Behavioral


title: Clinical Study to Investigate Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL

summary: Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)

primary_purpose: Treatment

lead_sponsor: Beaver-Visitec International, Inc.

location_facility: Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis

lead_sponsor_type: industriel


title: Detection of Pulmonary Nodules: Comparison of Ultra-low-dose Chest CT (Approaching a Two Views Chest X-ray Radiation) and Standard Low Dose CT. A Monocentric, Prospective, Non-randomized, Comparative, Open-label Study With Blind Reading of the Judgment Criteria.

acronym: npUBD

summary: Lung cancer screening programs are still discussed in Europe today, and one of the concern is radiation due to iterative CT. The aim of this monocentric, prospective, non randomized study is to compare an ultra low dose chest CT (approaching a two views X ray) versus a standard low dose chest CT for ≥4mm lung nodules detection, and secondary for lung nodule characterization and smoking associated findings (emphysema, bronchial abnormalities and coronary calcifications).

primary_purpose: Diagnostic

ReferenceCitation: Ludwig M, Chipon E, Cohen J, Reymond E, Medici M, Cole A, Moreau Gaudry A, Ferretti G. Detection of pulmonary nodules: a clinical study protocol to compare ultra-low dose chest CT and standard low-dose CT using ASIR-V. BMJ Open. 2019 Aug 15;9(8):e025661. doi: 10.1136/bmjopen-2018-025661.

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Grenoble


title: Connected Rehabilitation: an Alternative to Conventional Cardiovascular Rehabilitation? Randomised Controlled Non-inferiority Trial in Patients With Coronary Artery Disease

acronym: eRCV

summary: Cardiovascular rehabilitation (CVR) has major beneficial effects by improving physical capacity, accelerating return to activities and reinsertion and reducing mortality. It associates reconditioning to effort and therapeutic education for the optimal control of " risk factors ". It corresponds to a global approach to patients, thus counterbalancing the tendency to hyperspecialise in medicine. However, because of the lack of specialised centres, only a small proportion of patients (≈30%) are able to benefit. Numerical tools used in e-health, the deployment of the Internet and certain " connected " devices may provide alternatives outside hospital, by enabling the follow-up of patients and their physiological parameters (heart rate, blood pressure, weigh, physical activity…), and the adaptation - using an interactive web platform - of the physical activity programme, nutrition, compliance with medication and weaning from smoking. This project proposes to evaluate the effects of a so-called " connected " CVR programme, and to show its non-inferiority compared with a conventional CVR.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Biological Collection in Nephrology for the Study of the Links Between Kidney Disease, Immunity System and Cardiovascular Complications

summary:
The NephoMIC project is a biological collection in patients of Nephrology, allowing the study of the links between kidney diseases, Immunity system and Cardiovascular complications.

Its aim is to allow the development of a translational research on the theme of "Systemic Nephrology", which concerns both renal complications of autoimmune and inflammatory diseases, and systemic complications of patients with kidney disease, linked to both a state of immunosuppression and an increased risk of cardiovascular complications.

It is based on the proximity between the Clinical investigation Center (CIC) of the hospital, where the samples are received, techniqued and preserved, and the Center of Nephrology and Renal Transplantation of the hospital.

The collection includes blood samples (whole blood, serum, plasma, total blood RNA, PBMC cells), and urine samples (fresh urine).

Participation in the collection is particularly recommended for patients who require a medical renal biopsy in the Nephrology Department. Other well-phenotyped patients (well-defined renal disease diagnosis) may also participate in NephroMIC.

study_start_date_type: Anticipated

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique des Hôpitaux de Marseille Hôpital de la Conception


title: Effectiveness, Safety and Use of Nivolumab Administered During the French Temporary Authorization for Use in Patients With Advanced (Unresectable or Metastatic) Melanoma: A Multicentric, Observational Study

summary: This study will be conducted with the aim of estimating the effectiveness, safety, patterns of use of nivolumab, and characteristics of patients with unresectable or metastatic melanoma, treated with nivolumab monotherapy in the ATU setting.

time_perspective: Retrospective

lead_sponsor: Bristol-Myers Squibb


title: Evaluation of the Effect of a Speech Detection Tool on the Improvement of Phonation in Neuromuscular Patients Dependent on Mechanical Ventilation

acronym: Ventiphono

summary: Ventilation is a major treatment of respiratory failure due to neuromuscular disorders. First line treatment is noninvasive ventilation (NIV) but in some situations, especially in case of NIV inefficiency, invasive ventilation with tracheostomy (IVT) may be required. In both situations, patients may become dependent on ventilatory support with the disease evolution. Ventilation then can interfere speech and the quality of communication of the patients. Modification of the ventilation parameters may result in improved speech quality (for example, positive expiratory pressure (PEP) while not necessary for ventilation quality can dramatically improve speech in tracheostomized patients). Therefore, it would be of interest to allow patients to benefit from these specific parameters when they need to speak without maintaining them when patients are not speaking. We want to evaluate a specific ventilator feature which can detect speech and switch to specific ventilation parameters adapted for speech We believe that this feature will improve significantly speech quality in patients dependant either on NIV or IVT.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Anatomo-functional Study of the Brain Cortical and Sub-cortical Connectivity Using Diffusion MRI, Electrocorticography and Direct Electrical Stimulation

summary: Elucidating the structure-function relationship of the brain is one of the main open questions in neuroscience. The capabilities of diffusion MRI-based (dMRI) techniques to quantify the connectivity strength between brain areas, namely structural connectivity (SC), in combination with modalities such as electroencephalography (EEG) to quantify brain function have enabled advances in this field. However, so far the actual relationship between SC measures and measures of information transport between neuronal patches has not been determined. In this project, we aim to establish a relationship between dMRI SC measures, direct measures of electrical properties of the human brain cortex obtained with electrocorticography (ECoG), and response elicited by direct electrostimulation of the brain (DES). Ten patients operated on awake surgery for brain tumor removal will be included. First, a dMRI will be acquired prior to the surgery, in order to extract SC indices through probabilistic tractography. Then, intrasurgical cortico-cortical electrical measures will be obtained by ECoG electrodes positioned on the predefined cortical terminations of the designated bundles. These measures will be correlated to functional responses obtained during the cortical cartography, following the common DES procedure. The results of this multi-modal approach combining structure and function explorations of the brain should help to elucidate the relationship between non-invasive (dMRI) SC measures and cortico-cortical transmission properties (delays, transfer functions), and should boost the understanding of cognitive function as well as neurosurgical planning for the treatment of pathologies such as brain tumor resection and drug-resistant epilepsy.

ReferenceType: result

ReferenceCitation: Sporns O. The human connectome: origins and challenges. Neuroimage. 2013 Oct 15;80:53-61. doi: 10.1016/j.neuroimage.2013.03.023. Epub 2013 Mar 23.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Duffau H. Stimulation mapping of white matter tracts to study brain functional connectivity. Nat Rev Neurol. 2015 May;11(5):255-65. doi: 10.1038/nrneurol.2015.51. Epub 2015 Apr 7.

publisher_dissemination: Springer-Nature

ReferenceCitation: Yamao Y, Matsumoto R, Kunieda T, Arakawa Y, Kobayashi K, Usami K, Shibata S, Kikuchi T, Sawamoto N, Mikuni N, Ikeda A, Fukuyama H, Miyamoto S. Intraoperative dorsal language network mapping by using single-pulse electrical stimulation. Hum Brain Mapp. 2014 Sep;35(9):4345-61. doi: 10.1002/hbm.22479. Epub 2014 Feb 24.

oa_host_type: repository

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

repository_institution: Kyoto University - Kyoto University Research Information Repository

version: submittedVersion

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Bates E, Wilson SM, Saygin AP, Dick F, Sereno MI, Knight RT, Dronkers NF. Voxel-based lesion-symptom mapping. Nat Neurosci. 2003 May;6(5):448-50. doi: 10.1038/nn1050. No abstract available.

ReferenceCitation: Szelenyi A, Bello L, Duffau H, Fava E, Feigl GC, Galanda M, Neuloh G, Signorelli F, Sala F; Workgroup for Intraoperative Management in Low-Grade Glioma Surgery within the European Low-Grade Glioma Network. Intraoperative electrical stimulation in awake craniotomy: methodological aspects of current practice. Neurosurg Focus. 2010 Feb;28(2):E7. doi: 10.3171/2009.12.FOCUS09237.

ReferenceCitation: Leclercq D, Duffau H, Delmaire C, Capelle L, Gatignol P, Ducros M, Chiras J, Lehericy S. Comparison of diffusion tensor imaging tractography of language tracts and intraoperative subcortical stimulations. J Neurosurg. 2010 Mar;112(3):503-11. doi: 10.3171/2009.8.JNS09558.

collaborators: Institut National de Recherche en Informatique et en Automatique

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation (ORFALU)

acronym: ORFALU

summary: The possibility of exploring the lungs by lung ultrasound, a non-invasive tool, is becoming increasingly popular for anesthesiologists. Recently, Lichtenstein has described the FALLS protocol (Fluid Administration Limited by Lung Sonography) which uses the potential of pulmonary ultrasound to evaluate early pulmonary overload due to fluid administration at a subclinical stage. Indeed, fluid administration can generate a sub-clinical interstitial syndrome that can be detected by passing from a profile A to a profile B in lung ultrasound. The transition from a profile A to a profile B therefore corresponds to the transition from a state of preload dependent to a state of preload independence. However, this tool has not been studied in the operating room. The main objective of this study will be to study the correlation between pulmonary ultrasound and SV variation measured by esophageal Doppler during fluid administration in patients with haemodynamic optimisation in the operating room during digestive, urological, gynecological and orthopedic surgeries. The main expected result is the following: good correlation between the absence of increased SV in the esophageal Doppler and the appearance of a B-profile lung ultrasound fluid administration in the operating room.

ReferenceCitation: Bar S, Yee C, Lichtenstein D, Sellier M, Leviel F, Abou Arab O, Marc J, Miclo M, Dupont H, Lorne E. Assessment of fluid unresponsiveness guided by lung ultrasound in abdominal surgery: a prospective cohort study. Sci Rep. 2022 Jan 25;12(1):1350. doi: 10.1038/s41598-022-05251-6.

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: One-Health Approach to Identify Threat Posed by Tick-borne Pathogens Responsible of Unexplained Infectious Syndrome in Humans

acronym: OHTICKS

summary:
Ticks are the major arthropod vectors transmitting pathogenic agents to humans and domestic animals in Europe, and currently, the incidence of tick-borne disease is rising. The most common European human tick-borne disease is Lyme borreliosis, with an estimated 90 000 new cases every year (compared to 300 000 new cases in the United States annually). This disease is initially clinically diagnosed by the presence of migrating erythema following a tick bite, which is then subsequently confirmed by serological tests. In parallel with classic Lyme borreliosis cases, tick-bitten patients can also present with polymorphic and on-specific clinical symptoms (asthenia, fever, myalgia, etc. …) for which there is no known etiological diagnosis. It is extremely difficult to determine the proportion of tick-bitten patients with these symptoms compared to patients which have actually contracted Lyme disease, although it is estimated that 50% of fevers following a tick bite have an unknown infectious origin.

Typical tick habitats are woodlands, prairies, pastures, and gardens. Ticks are extremely sensitive to environmental fluctuations, which are often brought about by human socio-economic changes, thus tick-borne diseases are excellent candidates for emergence. Consequently, it is incontestable that tickborne diseases pose a significant threat to our society. In addition to improving diagnostic techniques, one of the major hurdles relates to improving public and health professional knowledge about tick disease risk. The battle against tick-borne diseases is based on relatively simple prevention measures, and their effectiveness is immeasurably improved when citizens are more informed and involved.Therefore, a multidisciplinary project, bringing together veterinarians, doctors, scientists, and consultant sociologists has been designed to create a global "One Health" approach to tick-borne diseases. Specific scientific project objectives are to (1) detect, identify, and isolate new microorganisms-both unknown or unexpected-from patients or animals suffering from unexplainable symptoms following tick bites; (2) to demonstrate tick competence in their ability to transmit these agents; and (3) to generate concrete recommendations to improve tick-borne disease management.

lead_sponsor: Institut Pasteur

intervention_type: Diagnostic Test


title: Antenatal Diagnosis of Coarctations of the Aorta. Prospective Observational Study.

acronym: CoA

summary: Prenatal diagnosis of coarctation is difficult because the ductus arteriosus masks the isthmus narrowing. The problem lies in the fact that it is difficult to assert in utero diagnosis and to predict severity of neonatal symptomatology. However, it is essential to try to establish the diagnosis since it has been shown that the prenatal diagnosis improves survival and reduces morbidity.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Gynécologie Obstétrique Diagnostic Anténatal ; Hôpital Femme Mère enfant


type: Registry Identifier

title: Effects of Brisk Walking on Autonomic Nervous System Reactivation in Nursing Home Residents.

summary: It is well established that physical activity reduces the physiological effects of ageing. Among them, the decrease of the autonomic nervous system activity (ANS) is associated with the increase of cardiovascular events and sleep disorders occurence. It has been shown that high intensity cycle training can enhance the ANS activity by 30% in people aged of 70 years old. However, such trainings were done by old athletes used to train at intensities that could not be handled by nursing home elderly. Thus, an adapted activity such as brisk walking shall be defined to make it practicable for the many in convalescent homes. The investigators hypothesize that long term brisk walking training could lead to reactivate ANS in people living in convalescent homes.

lead_sponsor: Clinique Mutualiste Chirurgicale de la Loire

collaborators:
University Hospital of Saint-Etienne
University of Lyon


title: Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis

acronym: BIOSEP

summary: The purpose of this observational study is to collect efficacy and safety data in real life condition within the first year of treatment in patients with progressive multiple receiving a daily dose of biotine of 300 mg.


title: Analgesia-Nociception Index Guided Intraoperative Remifentanil Administration Versus Standard Practice : Evaluation of Perioperative Opioid Use

acronym: MONIDOL-ANI

summary: This study compares two groups of patients undergoing a gynecological surgey under general anesthesia: one group in which intraoperative analgesia is guided by the Analgesia-nociception index, and another group in which intraoperative analgesia is managed as in standard practice. The objective is to assess if the Analgesia Nociception Index may result in a decrease in total analgesic drugs consumption, a decrease in post-operative pain and in chronic pain development.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service d'Anesthésie-réanimation chirurgicale - Hôpital Trousseau


title: A Study on the Follow-up of Long-term Renal Function After Acute Kidney Injury in ICU

acronym: SURIA

summary:
Acute kidney injury (AKI) involves poor prognosis in ICU patients. The renal prognosis at long term is unknown.

The study will determine chronic kidney injury incidence and quality of life, five years after AK during ICU stay.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging

acronym: LICAS-MR

summary: Type II diabetes is a known risk factor for heart failure, particularly through the progressive development of diabetic cardiomyopathy. Cardiac metabolic parameters, including myocardial steatosis and epicardial fat, are altered in diabetic patients. The development of new anti-diabetics (incretins) has demonstrated protective cardiovascular effects independent of effects on glycemic control for the first time in the history of these therapies. Thus Glucagon-Like Peptide 1 (GLP-1) agonists improve the recovery of cardiac function after a heart attack and decrease atheromatous processes. It has also been demonstrated in a diabetic rat model that the administration of Liraglutide, a GLP-1 agonist, leads to normalization of myocardial steatosis associated with beneficial cardiac molecular remodeling involving pro-apoptotic, oxidative and metabolic processes. These beneficial cardiovascular effects were observed in the absence of any changes in blood glucose, insulin levels or body weight.

status: Recruiting

intervention_type: Drug

status_simplified: Ongoing


title: Diurnal Variations of Cerebral Metabolite Concentrations in Proton Magnetic Resonance Spectroscopy

summary:
Proton Magnetic Resonance Spectroscopy (1H-MRS) is a magnetic resonance imaging (MRI) technique. It allows the quantification of cerebral metabolite concentrations. Currently, MRS-1H is used regardless of the examination schedule. However, it is not possible to say if the brain metabolite concentrations are stable over 24 hours. Thus, the main objective was to study the diurnal variation of cerebral metabolite concentrations in 1H-MRS in healthy subjects.

Moreover, the investigators also want to investigate the association between choline concentrations (Cho, parameter reflecting membrane metabolism) in 1H-MRS and fractional anisotropy (AF) values, obtained with the diffusion tensor imaging sequence (DTI), in the white matter of the centrum ovale. The results obtained from this objective will allow to obtain reference values of an estimate of the association between Cho concentrations and AF values in healthy subjects. These data are intended to improve the diagnostic and therapeutic management of patients with neurological pathologies.

lead_sponsor: Poitiers University Hospital


title: Appreciation of the Possibility of Dosing Neopterin in Eye Liquids. Pilot Study of Neopterin Dosage in Eye Liquids.

acronym: CHA

summary: The purpose of the study is to determine whether neopterin can be dosed in the fluid of the eye's anterior chamber for patient with non-inflammatory and non-infectious ophthalmic pathology.

ReferenceCitation: Kuvbachieva-Benarrosh A, Nefzaoui C, Quadrio I, Remignon CH, Jullian E, Perret-Liaudet A. Neopterin level can be measured by intraocular liquid biopsy. Clin Chem Lab Med. 2022 Oct 14;61(1):e20-e21. doi: 10.1515/cclm-2022-0691. Print 2023 Jan 27. No abstract available.

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

repositories_concat: medRxiv

publisher_dissemination: De Gruyter

ipd_sharing_description: no plan

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


title: Comparison of Image Quality Between New Collimator LEHRS (General Electric - GE Healthcare) vs Siemens LEHR on Bone Scintigraphy

acronym: LEHRS

summary: Comparison of quality image with a new LEHRS GE collimator vs standard LEHR Siemens collimator on bone scintigraphy.

ReferenceCitation: Gilland DR, Welch BL, Lee S, Kross B, Weisenberger AG. Evaluation of a novel collimator for molecular breast tomosynthesis. Med Phys. 2017 Nov;44(11):5740-5748. doi: 10.1002/mp.12564. Epub 2017 Oct 13.

ReferenceCitation: Songy B, Lussato D, Guernou M, Queneau M, Geronazzo R. Comparison of myocardial perfusion imaging using thallium-201 between a new cadmium-zinc-telluride cardiac camera and a conventional SPECT camera. Clin Nucl Med. 2011 Sep;36(9):776-80. doi: 10.1097/RLU.0b013e31821a294e.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Feasability Study on the Use of Botulinum Toxin A in Primary Adductor Tendinopathies Refractory to Medical Treatment

acronym: PETRA

summary:
Pubalgia is a pain syndrome located in the groin area. This syndrome is mainly described in young male athletes and typically affect the superficial muscles defining the boundaries of the femoral triangle, i.e. gracilis, pectineus, adductor brevis and especially adductor longus, and less commonly the deep muscles.

Clinically, the pain is located in the inner aspect of the thigh, where the tendons attach onto the pubic symphysis. It is usually unilateral, and sometimes associated with neuropathic pain suggestive of obturator nerve irritation.

There is no official recommendation or expert consensus on the management of pubalgia. However, a few protocols recommend a period of rest with Non-Inflammatory Anti-Steroidien Drugs (NSAIDs), icing and massages, as well as rehabilitation with passive stretching and muscle reinforcement.

The use of botulinum toxin type A could be an option in cases of treatment failure. However, a feasibility study must be performed beforehand, and if results are positive, a controlled study on a larger cohort could be conducted.

The major potential impact is a great effective pain relief for patients with neurological diseases.

ipd_sharing_description: Any exploitation of the data by Ipsen or for another research will be submitted to the preliminary agreement of CHU de Bordeaux and, in case of agreement, of a negotiated contract between the parties.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Ipsen


title: Early Stage Retinal Abnormalities in Type 1 Diabetes, Screened With OCT Angiography.

acronym: AwARD

summary: The improvement of imaging techniques in ophthalmology has made it possible to carry out a precise non-invasive study of the retinal microvascular network and to detect early abnormalities in retinal disorders. The presence of such early retinal abnormalities remains poorly known during type 1 diabetes and may be detected with OCT-angiography. Furthermore, the association with glycemic variability, likely to have deleterious effects on microvessels, has never been studied.

intervention_type: Procedure


title: Multimodal MRI Study of Accumbofrontal Tract in Anorexia Nervosa and Obessional Compulsive Disorder : Search for Structural and Functional Changes Between Orbito-frontal Cortex and Accumbens Nucleus Subdivisions

acronym: ACCUMBENS

summary: Restrictive anorexia nervosa and TOCs are psychiatric diseases which shares a common pathophysiological substrate We hypothesize that anorexia patients and patients with OCD have structural and functional changes in the accumbofrontal tract. The main objective of this study will be to compare the structure and the connectivity of this tract in MRI with diffusion sequences (DTI tractography) and resting-state, in 3 distinct populations of anorexic patients, patients with OCD and healthy patients. The role of the accumbo-frontal tract in the cortico-striato-hypothalamo-cortical circuit seems to be established. DTI tractography will allow the measurement of functional anisotropy (FA), a parameter that evaluates the diffusion of water molecules along the white matter fibers, and therefore the potential alteration of the studied tract. Resting state sequences will allow to estimate the BOLD signal and the functionality of the tract.

intervention_type: Radiation


title: Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections

acronym: PRAPI

summary:
Retrospective reports from literature have shown a lower rate of infections for transperineal versus transrectal approach for prostate biopsies in the setting of prostate cancer suspicion.

The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal versus transrectal approach.

lead_sponsor: Institut Mutualiste Montsouris


title: Evaluation of Maxillary and Mandibulary Nerve Blocks on Morphine Consumption in Double-jaw Surgery, a Retrospective Study

summary: Background and Objectives: Double-jaw surgery is one of the most painful oral surgery, requiring multimodal analgesia including controlled morphine pump and its secondary effects. The aim of this study was to evaluate the effectiveness of face block (mandibulary and maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted for double jaw surgery.


title: Usefulness of Routine qSOFA Calculation at Triage to Fasten Antimicrobial Administration in Patients With Bacterial Infection in the Emergency Department: a Quasi-experimental Study

acronym: qSOFAST

summary:
The delayed administration of an adequate antimicrobial therapy is a strong predictor of impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be initiated within one hour following the recognition of sepsis or septic shock.

The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which has been recently proposed by the Third International Sepsis Consensus Definitions Task Force (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min) and altered mentation (Glasgow coma scale <15). The score ranges from 0 to 3 points. A qSOFA value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these outcomes being more common in infected patients who may be septic than in those with uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus improve the outcome of patients at risk of sepsis or septic shock.

Many patients admitted to the hospital for bacterial sepsis or septic shock are initially managed in the Emergency Department (ED). This study aims at investigating whether the routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial therapy in patients admitted to the ED with suspected or proven bacterial infection, especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3 definition).

ReferenceCitation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: acceptedVersion

repository_institution: King's College London - Research Portal

repositories:
PubMed Central
UCL Discovery
kclpure.kcl.ac.uk

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Petit J, Passerieux J, Maitre O, Guerin C, Rozelle C, Cordeau O, Cassonnet A, Malet A, Boulain T, Barbier F; qSOFAST study group. Impact of a qSOFA-based triage procedure on antibiotic timing in ED patients with sepsis: A prospective interventional study. Am J Emerg Med. 2020 Mar;38(3):477-484. doi: 10.1016/j.ajem.2019.05.022. Epub 2019 May 10.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

evidence: open (author manuscript)

unpaywall_oa_status: hybrid


title: Molecular Profile of the Evolution of Inclusion Body Myositis

acronym: IBM-RNAseq

summary: This study aims at assessing the gene expression in the muscles of patients suffering from sporadic Inclusion Body Myositis (sIBM) at various stages of the disease, by comparison with muscles of control subject. The investigators use the RNA-seq technique to analyze the gene expression levels and potential alternate transcripts, including long non-coding RNAs (lncRNAs), in muscle tissue samples. The gene expression profiles will point to the genes of interest that can then become the object of future studies, in which epigenetic changes of these genes will be explored further. The value of those possible biomarkers will be assessed. The investigators will also evaluate the correlation between the gene expression profile, the degree of functional impairment, the histological picture and the presence or absence of autoantibodies.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Hôpital Pasteur 2 - Service Système Nerveux Périphérique, Muscle et SLA


title: Cardiovascular Outcome of Cancer Patients: The "GMEDICO Cohort"

acronym: GMEDICO

summary:
The Mediterranean Group of Cardio-Oncology (GMEDICO) brings together French cardiologists and oncologists who have developed a protocol for the monitoring and cardio-oncological management of patients treated for cancer.

This unique organization makes it possible to envisage the creation of a large cohort from which the incidence and predictive factors of cardiovascular toxicity can be determined.

Primary objective: to determine the cardiovascular prognosis of patients treated for cancer and followed up in cardio-oncology.

Secondary objectives

To determine the clinical, biological and imaging factors associated with cardiovascular events under cancer treatment, in order to define a risk score including clinical, biological (biomarker) and imaging data.
To create a biological source for testing other biomarkers and conducting genome-wide association studies and genetic factors associated with cardiovascular events under cancer treatment.

ReferenceCitation: Dolladille C, Ederhy S, Allouche S, Dupas Q, Gervais R, Madelaine J, Sassier M, Plane AF, Comoz F, Cohen AA, Thuny FR, Cautela J, Alexandre J. Late cardiac adverse events in patients with cancer treated with immune checkpoint inhibitors. J Immunother Cancer. 2020 Jan;8(1):e000261. doi: 10.1136/jitc-2019-000261.

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

repository_normalized: HAL

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assiatnce Publique Hopitaux de Marseille


title: Iron Metabolism After Out of Hospital Cardiac Arrest

acronym: DESFER

summary: Out of hospital cardiac arrest is associated with a poor prognosis. The aim of this study is to provide a better understanding of perturbations of iron metabolism after cardiac arrest and to analyze the impact on clinical centered outcome.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Short and Fast Step Test: Feasibility, Validity and Tolerance of a Functional Evaluation Test of Lactic Anaerobic Capacities in Patients With Coronary Artery Disease

acronym: CORANAE

summary: Recommendations for cardiovascular rehabilitation (CVR) encourage exercise training, primarily involving the aerobic system, to allow patients to regain independence in daily activities. However, the lactic anaerobic process is also involved during these activities (stair climbing, carrying loads, etc.). Hence there is a major interest in accurately assessing patients' anaerobic capacities in order to tailor suitable exercise programs. However, there are no functional tests specifically dedicated to the evaluation of lactic anaerobic metabolism and adapted to people with coronary disease. The investigators offer a dedicated test, the short and fast test (SFST), which can be applied in current clinical practice and has already been evaluated in a population of healthy subjects. The purpose of this project is to evaluate the safety, feasibility and validity of SFST in a population of patients with coronary artery disease.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Effect of Labour on the Gastric Emptying of a Light Meal

acronym: VGObstetric

summary: Current recommendations permit the ingestion of all clear fluids (water, apple juice, black coffee..) during labour. However, regarding food during labour, the recommendations vary. British and European guidelines permit the ingestion of low-residue food during labour whilst guidelines from the United States prohibit having any solid food during labour. The reason for this variation in recommendations is the lack of data on gastric emptying during labour with a conservative approach adopted due to the fear of delayed gastric emptying increasing the risk of regurgitation and pulmonary aspiration in the case of general anaesthesia. This study aims, therefore, to evaluate if the gastric emptying of a light meal is slowed down during labour, using a validated, non-invasive ultrasound method, in four groups of women : Women in labour with epidural analgesia (Analgesia group), women in labor without any epidural analgesia (Parturient group), women in the third trimester of pregnancy (Pregnant group) and women who are not currently pregnant (Non-pregnant control group). The investigator propose the hypothesis that the gastric emptying of a light, solid meal is slowed by 30% during labour under epidural analgesia.


title: A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a

acronym: ANRS EP63

summary: To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.

time_perspective: Other

lead_sponsor: ANRS, Emerging Infectious Diseases


title: High-Flow Nasal Oxygen Therapy for Exacerbation of Chronic Pulmonary Obstructive Disease: A Randomized, Open-label, Single-center, Pilot Study.

acronym: OxyCOD

summary:
High-Flow Nasal Oxygen (HFNO) therapy has never been tested against Noninvasive ventilation, the reference standard therapy for acute exacerbation of chronic obstructive pulmonary disease (COPD), in randomized clinical trials.

The aim of the present study is to compare the effects of HFNO therapy on arterial blood gas variables over the first 24 hours of therapy, to those of Noninvasive ventilation, in patients experiencing a moderate (i.e. with arterial pH within 7.25-7.35) exacerbation of COPD.


title: THE INFLUENCE OF GRAVITY ON TARGET CUEING DURING VISUAL SEARCH USING AUGMENTED REALITY

acronym: ARGuide

summary:
Although most ground studies showed that an egocentric reference frame better supports spatial orientation, it is not proven it will be the same during weightlessness.

Although it might justify that visuomotor performance will be better supported by egocentric target cueing under altered gravity conditions, the fact that exocentric target cueing induces less head movements and called for least attentional and physiological workload could be the key factors for a more efficient task localization process. Moreover, weightlessness can induce spatial disorientation, which can be additionally influenced by the intrinsic and extrinsic spatial reference frames (Gurfinkel et al., 1993; Glasauer & Mittelstädt, 1997, 1998; Harm et al., 1998; Lipshits et al. 2005). We expect that during weightlessness the workload will be the key factor and thus we hypothesize that an exocentric target cueing will outperform egocentric target cueing.

To test this hypothesis, and find out which presentation scheme for target cueing (EGO, EXO, ED) contributes most to an efficient visual search, performance to a visuomotor task will be evaluated during parabolic flights in normogravity (1g), hypergravity (1.8g) and microgravity (0g). The visuomotor performance will be assessed by a multi-directional tapping task as defined by ISO9241-9, which requests for motor responses by aimed pointing movements. Besides analyzing the pointing performance, different workload indices will be additionally assessed to evaluate the effort spent on visuomotor coordination. The attentional workload will be evaluated by the performance of a secondary task (visual reaction-time task), which needs to be conducted in parallel to the visuomotor task. Furthermore, the workload will be also assessed subjectively by the NASA TLX rating scale and physiologically, by analyzing the heart rate variability (HRV).

lead_sponsor: University Hospital, Caen


title: Prevalence, Management and Follow-up of Patients With Addiction to Opioid Analgesics

summary:
The demand for addiction care for patients with addiction to analgesics increases with the number of prescription of analgesics grade 2; this is a public health problem There is no support for repositories to date in the context of addiction analgesics grade 2.

Risk factors of misuse as well as diagnostic tools were identified.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Prevalence of Pulmonary Embolism in Emergency Department Patients With Isolated Syncope

acronym: PEEPS

summary: Syncope is a rapid onset, transient, loss of consciousness with a short duration. This symptom has been reported to be a specific presentation of patients with pulmonary embolism. However, the prevalence of pulmonary embolism in patients with syncope remains debated. This prospective cohort study will recruit patients presenting to the emergency department with a syncope, who will systematically undergo formal workup for pulmonary embolism. The main objective of this study is to assess the prevalence of pulmonary embolism in ED patients with syncope


title: Multicenter Randomized Open-labelled Trial Which Aims to Show Non-inferiority of Adverse Events Risk During the Maintenance of Oral-anticoagulation in the Surgery of Benign Prostatic Hypertrophy by Laser Photovaporization

acronym: SOAP

summary:
Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine.

For benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical risk that new "minimally invasive" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue.

Given the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.

Numerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low.

No study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study.

This study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.

ReferenceCitation: Kaplan SA, McConnell JD, Roehrborn CG, Meehan AG, Lee MW, Noble WR, Kusek JW, Nyberg LM Jr; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol. 2006 Jan;175(1):217-20; discussion 220-1. doi: 10.1016/S0022-5347(05)00041-8.

ReferenceCitation: Rosen R, Altwein J, Boyle P, Kirby RS, Lukacs B, Meuleman E, O'Leary MP, Puppo P, Robertson C, Giuliano F. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol. 2003 Dec;44(6):637-49. doi: 10.1016/j.eururo.2003.08.015.

ReferenceCitation: Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.

ReferenceCitation: Misrai V, Roupret M, Guillotreau J, Bordier B, Bruyere F. [Greenlight((R)) photoselective vaporisation for benign prostatic hyperplasia: a systematic review]. Prog Urol. 2013 Feb;23(2):77-87. doi: 10.1016/j.purol.2012.10.013. Epub 2012 Nov 26. French.

ReferenceCitation: Peyronnet B, Cornu JN, Roupret M, Bruyere F, Misrai V. Trends in the Use of the GreenLight Laser in the Surgical Management of Benign Prostatic Obstruction in France Over the Past 10 Years. Eur Urol. 2015 Jun;67(6):1193-1195. doi: 10.1016/j.eururo.2015.01.003. Epub 2015 Jan 17. No abstract available.

ReferenceCitation: Ruszat R, Wyler S, Forster T, Reich O, Stief CG, Gasser TC, Sulser T, Bachmann A. Safety and effectiveness of photoselective vaporization of the prostate (PVP) in patients on ongoing oral anticoagulation. Eur Urol. 2007 Apr;51(4):1031-8; discussion 1038-41. doi: 10.1016/j.eururo.2006.08.006. Epub 2006 Aug 18.

ReferenceCitation: Reich O, Bachmann A, Siebels M, Hofstetter A, Stief CG, Sulser T. High power (80 W) potassium-titanyl-phosphate laser vaporization of the prostate in 66 high risk patients. J Urol. 2005 Jan;173(1):158-60. doi: 10.1097/01.ju.0000146631.14200.d4.

ReferenceCitation: Charbonneau H, Pathak A, Albenque JP, Misrai V. Greenlight photovaporization of the prostate in patients under rivaroxaban: Lesson learned after the first cases. Prog Urol. 2016 Apr;26(5):273-5. doi: 10.1016/j.purol.2016.02.002. Epub 2016 Mar 9. No abstract available.

ReferenceCitation: Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, Jacobson A, Jaffer AK, Kong DF, Schulman S, Turpie AG, Hasselblad V, Ortel TL; BRIDGE Investigators. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.

ReferenceCitation: Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.

ReferenceCitation: Malek RS, Kuntzman RS, Barrett DM. High power potassium-titanyl-phosphate laser vaporization prostatectomy. J Urol. 2000 Jun;163(6):1730-3.

ReferenceCitation: Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

ReferenceCitation: Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.

ReferenceCitation: Peyronnet B, Pradere B, Brichart N, Bodin T, Bertrand P; Members of French Group of GreenLight Users; Bruyere F. Complications associated with photoselective vaporization of the prostate: categorization by a panel of GreenLight users according to Clavien score and report of a single-center experience. Urology. 2014 Sep;84(3):657-64. doi: 10.1016/j.urology.2014.05.028.

ReferenceCitation: Charbonneau H, Pasquie M, Peyronnet B, Descazeaud A, Barry-Delongchamps N, Della Negra E, Mathieu R, Karsenty G, Long JA, Ballereau C, Azzouzi AR, Pradere B, Bruyere F, Fournier G, Lebdai S, Calves J, Corbel L, Vincendeau S, Fiard G, Thuillier C, Descotes JL, Colin P, Culty T, Hesbois A, Fuzier V, Savy N, Pathak A, Albaladejo P, Samama CM, Guerrero F, Misrai V. Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial. Trials. 2018 Dec 27;19(1):705. doi: 10.1186/s13063-018-3066-9.

lead_sponsor: Dr Vincent Misrai

sponsor_collaborators:
Dr Vincent Misrai
Boston Scientific Corporation
Iqvia Pty Ltd


title: Role of Innate Lymphoid Cells in the Immunosuppression of Septic Shock

acronym: CriSIs

summary:
Less than ten years after their intial description, the comprehension of Innate Lymphoid Cells (ILCs) biology is rapidly improving. They can be classified into four subgroups (ILCs 1, 2, 3 and NK cells) on the basis of their cytokine production and transcription factor expression.

They seem to be players in infectious diseases in animals but their role in human anti-bacterial defense remains unknown.

In this prospective work, the investigators will compare ILCs phenotyping in ICU patients managed for a septic shock, comparing them to ICU patients without any infectious disease on their inclusion. The investigators will also make a large immune mapping in all patients, to place ILCs in the global immune depressed state observed in septic patients.

ReferenceCitation: Carvelli J, Piperoglou C, Bourenne J, Farnarier C, Banzet N, Demerle C, Gainnier M, Vely F. Imbalance of Circulating Innate Lymphoid Cell Subpopulations in Patients With Septic Shock. Front Immunol. 2019 Sep 20;10:2179. doi: 10.3389/fimmu.2019.02179. eCollection 2019.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - @rchiveSIC

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

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

publisher_dissemination: Frontiers

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille


title: Paracetamol Metabolism Research in Postoperative Hepatic Surgery

acronym: PARAFOI

summary:
The main objective of this study was to evaluate the 5-day kinetics of plasma paracetamol levels in postoperative major hepatic surgery (resection greater than or equal to three hepatic segments) compared with less extensive liver resection and hepatic re-intervention. The clearance of indocyanine green is a marker of hepatic perfusion but also of the proper hepatocyte functioning, if hemodynamic conditions are stable.

Some patients may be operated on up to four or five times in the liver. Moreover, these patients probably present an increased risk of postoperative hepatocellular insufficiency due to a quantitative and qualitative decrease in their hepatic parenchyma. It is therefore interesting to evaluate the use of paracetamol in this situation.

lead_sponsor: University Hospital, Lille


title: Population Pharmacokinetic-pharmacodynamic (PK-PD) Study of 9 Broad-Spectrum Anti-infective Agents in the Cerebro Spinal Fluid (CSF) of Brain Injured Patients With an External Ventricular Drainage (EVD).

summary:
Nosocomial Central Nervous System infections are difficult to treat and an early appropriate therapy can improve prognosis. The two main reasons for treatments failure are the difficulty to reach high concentrations of antibiotics (ATB) in CNS because of brain barriers (BB), and the emergence of Multi-Drug-Resistant (MDR) pathogens that require high ATB concentrations for being killed. Therefore a better knowledge of ATB CNS distribution and PK-PD characteristics is essential for efficiency of treatments and to avoid resistance progression. Because of BB and cerebrospinal fluid (CSF) turnover, unbound (active) concentrations of ATB in CSF are frequently much lower than corresponding plasma concentrations, which therefore may not be used to predict efficacy. However except for patients with EVD, CSF access is difficult. Overall the litterature about ATB distribution within CSF exist but PK-PD publications are rarer. Especially for Broad Spectrum ATB which are recommended in case of invasive infection in ICU patients due to MDR pathogens such as Acinetobacter baumanii, extended spectrum ß-Lactamase producing (ESBL) pathogens or Multiresistant Staphylococcus aureus.

Furthermore, measuring ATB concentrations within the CSF at certain time-points is necessary but not sufficient to predict antimicrobial efficacy. First PK modelling is required to describe the full CSF concentrations versus time profiles. Then targets must be obtained from literature or determined for the relevant PD index, which may be, depending of the antibiotic, Time over Minimal Inhibitrice Concentration (T>MIC), Area Under the Curve over MIC (AUC/MIC) or peak concentration over MIC (Cmax/MIC). Eventually Monte-Carlo simulations can be conducted to predict the probability of target attainment according to various dosing regimens to find the optimal one.

The goal of this multicenter population PK-PD study is to characterize CSF distribution and challenge recommended dosing regimens of 8 ATB indicated in CNS infections (vancomycin, daptomycin, ceftazidime, meropenem, colistin, linezolid, piperacillin-tazobactam and ceftaroline) and to study the Cefepime diffusion in the CSF, known to be highly neurotoxic.

appel_a_projets: PHRCN

region: Nouvelle-Aquitaine

nom_etablissement: CENTRE HOSP. UNIVERSITAIRE DE POITIERS

type_etablissement: CHUR

acronyme: PKpop LCR

titre: Etude pharmacocinétique-pharmacodynamique de population de 7 antibiotiques à large spectre, chez des patients cérébro-lésés porteurs d'une dérivation ventriculaire externe.

discipline_principale: anesthésiologie / réanimation

nom_porteur: DAHYOT

prenom_porteur: Claire


title: Improving Medication Safety: Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication

summary:
The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department.

The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.

ipd_sharing_description: Not determined


title: Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children - MEIBO-ROSACEE

acronym: MEIBO-ROSACEE

summary: The aim of this study is to describe the clinical, meibographic and interferometric manifestations of phlyctenular keratitis in children.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Continuous Monitoring of Right Ventricular Function, Based on the Correlation Between the C-X Segment of the Central Venous Pressure Curve, and the Echocardiographic Evaluation of Right Ventricular Systolic Function

acronym: CourbePVC

summary:
Close analysis of right ventricular function is still not done by all clinicians, even though it is indispensable; notably in cardiovascular ICUs.

Right ventricular dysfunction is responsible for increased morbidity and marks a turning point in the patient's prognosis.

It is difficult to analyse, and is principally assessed using echocardiography and by measuring the peak of the S' wave with pulsed Doppler and by measuring the tricuspid annular plane systolic excursion (TAPSE) in the TM mode. New studies have shown the interest of using 2D strain as a marker of systolic and diastolic function of the right ventricle. Finally, the use of 3D ultrasound seems to be more reliable than cardiac MRI for fine analysis of the right ventricle, even though it is rarely used in routine practice.

Study of the right ventricle using ultrasonography alone requires experienced and available operators for closely repeated evaluations making it possible to detect right ventricle dysfunction quickly.

US monitoring of left and right heart function is done systematically and repeatedly during post-operative care following heart surgery. This US evaluation could be optimized by finding a way to monitor the right ventricle continuously.

From a physiological point of view, we know about the tight relationship between the aspect of the central venous pressure curve and more precisely the C-X segment (tricuspid bulging into the atrium and start of contraction of the right ventricle) and right ventricular function. We wish to analyse this segment, combined with a US evaluation, and to look for a possible correlation so as to allow continuous, easy-to-interpret monitoring of right ventricular systolic function.

This will be facilitated by the systematic presence of a central venous catheter in every patient undergoing heart surgery, thus allowing central venous pressure to be monitored.

To this end, we wish to collect different data from patients in the cardiovascular ICU, especially the central venous pressure curve, the ventilatory pressure curve and settings of the respirator, and to carry out an echography evaluation of each patient.


title: Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases

acronym: GHTT

summary: Introduction: Giant thoracic disc herniation is a rare condition for which surgical treatment is indicated when there are signs of spinal cord injury. To date, several surgical techniques have been described in the treatment of this condition on small patient series. The main objective is to evaluate the long-term results of a series of 53 patients treated with a minimally invasive endoscopic procedure. The secondary objective is to explain our pre-operative planning and the technical details of our procedure. METHOD: Retrospective monocentric study on a cohort of patients treated in our department. The following medical data from our database are analyzed: Morbidity of operative gesture (duration of procedure, bleeding, postoperative complications), clinical results at the last follow-up visit (thoracic Japanese Orthopedic Association (JOA) score, Frankel score, parietal pain , ability to walk, wish to carry out the same intervention again if necessary). On the radiological level, we evaluated the quality of the resection (total, subtotal, incomplete and impossible), the reappearance of a border of cerebrospinal fluid perimedullary and the presence of an intramedullary T2 hyperintense signal MRI post- operative. All these data are collected and analyzed anonymously. Expected Results: We believe we can demonstrate that thoracoscopy is a valid therapeutic option in the treatment of thoracic disc herniation responsible for spinal cord compression. This with a low morbidity given the minimally invasive nature of the approach.

lead_sponsor: Hopital Foch


title: Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study

acronym: EXTUB ECLS

summary: There are no clear recommendations concerning the management of patients on ECLS (Extra-Corporeal Life Support). Many teams keep patients sedated until removal of the ECLS so as to avoid accidents, notably decannulation. Moreover, there are few publications on the subject, all the more so as the extubation of patients on ECLS (Extra-Corporeal Life Support) is a recent practice. Nonetheless, it is becoming more and more frequent in the cardiovascular ICU of Dijon University Hospital. We therefore wished to evaluate the benefits of this practice by comparing 2 populations: those with extubation while on ECLS (Extra-Corporeal Life Support) and those without.


title: Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)

acronym: DD

summary:
Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery.

In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler is a validated technique to study heart contractility. Its use in the analysis of diaphragm function must be evaluated to determine its interest as a diagnostic tool.

Better understanding of diaphragm dysfunction following heart surgery will lead to earlier management of post-operative respiratory complications and the implementation of preventive pre-operative measures.

We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in the assessment of diaphragm mobility.


title: Nontechnical Skills Assessment of Emergency Physicians and Quality of Care in a Virtual Emergency Department

summary: The investigators will study nontechnical skills of emergency physicians in a virtual standardized emergency room and their impact on quality of care.

lead_sponsor: University Hospital, Toulouse


type: EudraCT Number

title: Safety and Efficacy of the ONCOlytic VIRus Armed for Local Chemotherapy, TG6002/5-FC, in Recurrent Glioblastoma Patients

acronym: ONCOVIRAC

summary:
Glioblastoma is the most common and the most aggressive primary brain cancer in adults. Indeed, despite very intensive treatments (i.e. maximal safe surgery, radiotherapy and several lines of cytotoxic chemotherapies), inducing significant adverse events, the prognosis of glioblastoma patients remains dismal with a median overall survival of ~15 months. Therefore, more efficient and less toxic therapies are urgently needed to improve survival and quality of life of glioblastoma patients.

The oncolytic virus TG6002 has shown efficacy and good safety profile in several preclinical models of glioblastoma in vitro (i.e. cell line) and in vivo (i.e. xenografts in Swiss/Nude mice). Comprehensive toxicology studies of TG6002/Flucytosine have been completed in rabbits and monkeys supporting safety investigations of TG6002/Flucytosine in human patients.

Taken these data all together, TG6002/Flucytosine appears as a very promising therapeutic strategy in glioblastoma patients that merits consideration for early phase clinical trial.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Transgene

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: ONCOVIRAC

titre: ONCOVIRAC : Safety and efficacy of the ONCOlytic VIRus Armed for local Chemotherapy, TG6002/5-FluCytosine, in recurrent glioblastoma patients

discipline_principale: cancer

nom_porteur: IDBAIH

prenom_porteur: Ahmed


title: Incidence and Risk Factor of Drug Related Problem Detected in Inpatient

acronym: DRPINPAT

summary:
Drug Related Problem (DRP) is defined as an event that may potentially affect the health outcomes in the patients. DRPs can occur at all stages of the medication usage process starting from prescribing to dispensing stage. Lack of follow-ups and reassessment of therapeutic outcomes may also contribute to DRPs. Pharmaceutical care is a co-operative activity in concert with other health care professionals and offered directly to the patient for improved quality use of medicines and achieving achieve the desired therapeutic outcomes. Pharmaceutical care identifies and resolves actual or potential DRPs.

DRPs pose a challenge to the clinician, and that may affect patient's clinical outcomes and may result in morbidity or mortality and increased health care costs. Health care costs may become a burden to the patient or may be to the government or to the third parties. Clinical Pharmacy is a discipline that promotes the quality use of medicines through evidence-based medicine and helps in identification and resolving DRPs. A clinical pharmacist through his/her clinical accuracy checking may identify DRPs and come out with suitable solutions to resolve the same.

Consequently, the aims of our study were to assess prevalence and characteristics of DRPs identified in inpatient and to identify factors associated with DRPs.


title: Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery: a Multi Center Double-Blinded Randomized Controlled Trial (COLONPREP Study)

acronym: COLONPREP

summary:
This study aims to demonstrate that a preoperative combination of mechanical bowel preparation and oral antibiotics, before elective laparoscopic colon cancer surgery, is associated with a reduction of postoperative surgical site infection rate, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

Our Hypothesis is that a preoperative colonic preparation including a combination of mechanical bowel preparation and oral antibiotics before elective laparoscopic colon cancer surgery is associated with a reduced rate of 30-day postoperative surgical site infection, as compared to mechanical bowel preparation alone, oral antibiotics alone, or no colonic preparation.

ipd_sharing_description: There is not a plan to make IPD available

location_facility: Service de chirurgie Colorectale / Hôpital Beaujon

acronyme: COLONPREP

titre: COLONPREP. Préparation colique et antibiotiques oraux avant chirurgie du cancer colique: un essai randomisé multicentrique en double aveugle.

nom_porteur: PANIS

prenom_porteur: Yves


title: Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?

acronym: OCCIA

summary: The study aims to show a difference of observation and data integration between novice and expert during anaesthetic induction, in a population of nurse anesthetists.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: EXADOM: Early Supported Discharge and Enhanced Homecare After Emergency Department Admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

acronym: EXADOM

summary:
The prevalence of chronic obstructive pulmonary disease (COPD) is between 8 and 15% of the adult population in 2010. This prevalence is expected to increase over the coming decades as the population ages and exposure to the risk factors for the disease continues. The evolution of COPD is marked by the occurrence of exacerbations of varying severity responsible for 1% of emergency department admission. Thus,95% of COPD patients admitted to emergency department for exacerbation are hospitalized.

Several recent studies seem to show that an early discharge from hospital with home care can reduce the rate of rehospitalisation and mortality of COPD patients. These preliminary data on low numbers need to be confirmed. In addition, it seems necessary to identify the phenotypes of patients who benefit most from these early exits.

Exadom project (supported by Rhône-Alpes-Auvergne Regional Health Authorities (ARS), AstraZeneca and Grenoble Alpes University Hospital) aims to establish a safe and effective way of discharging patients by providing enhanced home-based care for AECOPD.

ipd_sharing_description: Not provided

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
AGIR à Dom

location_facility: Emergency Department of University Hospital Grenoble


title: Adaptation of a Knowledges Exchange Portal (KEP) Between Healers and Patients : Study of Obstacles and Sources to the Use of a KEP in the Case of Women Affected by a Breast Cancer in Nouvelle Aquitaine(Sav-AQ)

acronym: Sav-AQ

summary: The project is imbued with the whole problematic of patient follow-up and patient support, taking into account the experiences and needs of breast cancer patients. It concerns the dissemination of knowledge through the implementation of a specific clinical innovation designed to optimizing breast cancer patient pathway. The " Patients en réseau " association offers us to participate at the web platform evolution Mon Réseau Cancer du Sein in adapting it. The feasibility study focuses on (1) the platform utilization and (2) sources and obstacles to its utilization in the French context

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
SRIOP 2016, SIRIC BRIO


title: Retrospective Analysis of a Population of Patients With With Severe Traumatic Head Injury and Woken Early

acronym: PRECOCE TC

summary:
Observational retrospective study that included all patients meeting the inclusion criteria from 1st January 2014 to 31st December 2015.

The objective of the study is to describe and compare two populations of patients with severe traumatic head injury arriving under sedation in the Department in whom the sedation was not continued.


title: Measurement of the Cervix During Pregnancy According to Age of Conization

acronym: MesCon

summary: Treatment of precancerous lesions of the cervix by conization has been shown to increase the risk of premature delivery and premature rupture of the membranes. It has now been clearly established that the cervix is a growing organ during adolescence and early adulthood, It has been hypothetized that cervical conization during the growth phase reduced its growth potential, and induced shorter cervix during the upcoming pregnancy. No studies have been conducted investigating the age at which conization no longer had an impact on cervical size during pregnancy. This will help to identify the age at conisation below which patients will be identified as being at risk event, and thus offer increased monitoring and possibly prophylactic management by programmed strapping. We propose to measure the length of the cervix of pregnant patients who have benefited from conization, which is currently recommended by the Collège National des Gynécologues Obstetriciens Français .In addition, the investigators will use a control group consisting of non-con conical, parity-matched pregnant patients in whom a cervical measurement will also be performed.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Work Productivity in Hyperventilation Syndrome

acronym: WHY

summary: Hyperventilation syndrome is associated with impaired quality of life. The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome


title: Nomogram Control of Predictive Factors of Early Withdrawal After Gynecologic Oncology Surgery in the Enhanced Recovery After Surgery (ERAS) Protocol and Assessment of Practices

acronym: NomogramGyneco

summary: Validation of a predictive nomogram of a short hospital stay (less than two days after surgery) on a prospective cohort of patients.

ReferenceCitation: Chapman JS, Roddy E, Ueda S, Brooks R, Chen LL, Chen LM. Enhanced Recovery Pathways for Improving Outcomes After Minimally Invasive Gynecologic Oncology Surgery. Obstet Gynecol. 2016 Jul;128(1):138-144. doi: 10.1097/AOG.0000000000001466.

ReferenceCitation: Nicholson A, Lowe MC, Parker J, Lewis SR, Alderson P, Smith AF. Systematic review and meta-analysis of enhanced recovery programmes in surgical patients. Br J Surg. 2014 Feb;101(3):172-88. doi: 10.1002/bjs.9394.

ReferenceCitation: Yoong W, Sivashanmugarajan V, Relph S, Bell A, Fajemirokun E, Davies T, Munro K, Chigwidden K, Evan F, Lodhi W; Enhanced Recovery After Surgery (ERAS) Team for Gynaecology and Anaesthesia. Can enhanced recovery pathways improve outcomes of vaginal hysterectomy? Cohort control study. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):83-9. doi: 10.1016/j.jmig.2013.06.007. Epub 2013 Jul 10.

ReferenceCitation: Kroon UB, Radstrom M, Hjelthe C, Dahlin C, Kroon L. Fast-track hysterectomy: a randomised, controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):203-7. doi: 10.1016/j.ejogrb.2010.04.001. Epub 2010 May 10.

ReferenceCitation: Borendal Wodlin N, Nilsson L, Kjolhede P; GASPI study group. The impact of mode of anaesthesia on postoperative recovery from fast-track abdominal hysterectomy: a randomised clinical trial. BJOG. 2011 Feb;118(3):299-308. doi: 10.1111/j.1471-0528.2010.02697.x. Epub 2010 Sep 14.

ReferenceCitation: Minig L, Chuang L, Patrono MG, Fernandez-Chereguini M, Cardenas-Rebollo JM, Biffi R. Clinical outcomes after fast-track care in women undergoing laparoscopic hysterectomy. Int J Gynaecol Obstet. 2015 Dec;131(3):301-4. doi: 10.1016/j.ijgo.2015.06.034. Epub 2015 Sep 8.

ReferenceCitation: Bruneau L, Randet M, Evrard S, Damon A, Laurent FX. [Total laparoscopic hysterectomy and same-day discharge: Satisfaction evaluation and feasibility study]. J Gynecol Obstet Biol Reprod (Paris). 2015 Nov;44(9):870-6. doi: 10.1016/j.jgyn.2015.02.003. Epub 2015 Mar 13. French.

ReferenceCitation: Chase DM, Lopez S, Nguyen C, Pugmire GA, Monk BJ. A clinical pathway for postoperative management and early patient discharge: does it work in gynecologic oncology? Am J Obstet Gynecol. 2008 Nov;199(5):541.e1-7. doi: 10.1016/j.ajog.2008.04.037. Epub 2008 Jun 2.

ReferenceCitation: Wijk L, Franzen K, Ljungqvist O, Nilsson K. Enhanced Recovery after Surgery Protocol in Abdominal Hysterectomies for Malignant versus Benign Disease. Gynecol Obstet Invest. 2016;81(5):461-7. doi: 10.1159/000443396. Epub 2016 Jan 23.

ReferenceCitation: Lindemann K, Kok PS, Stockler M, Jaaback K, Brand A. Enhanced Recovery After Surgery for Advanced Ovarian Cancer: A Systematic Review of Interventions Trialed. Int J Gynecol Cancer. 2017 Jul;27(6):1274-1282. doi: 10.1097/IGC.0000000000000981.

ReferenceCitation: Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.

ReferenceCitation: Schlaerth AC, Abu-Rustum NR. Role of minimally invasive surgery in gynecologic cancers. Oncologist. 2006 Sep;11(8):895-901. doi: 10.1634/theoncologist.11-8-895.

ReferenceCitation: Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.

ReferenceCitation: Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.

ReferenceCitation: Miralpeix E, Nick AM, Meyer LA, Cata J, Lasala J, Mena GE, Gottumukkala V, Iniesta-Donate M, Salvo G, Ramirez PT. A call for new standard of care in perioperative gynecologic oncology practice: Impact of enhanced recovery after surgery (ERAS) programs. Gynecol Oncol. 2016 May;141(2):371-378. doi: 10.1016/j.ygyno.2016.02.019. Epub 2016 Mar 9.

ReferenceCitation: Kalogera E, Dowdy SC. Enhanced Recovery Pathway in Gynecologic Surgery: Improving Outcomes Through Evidence-Based Medicine. Obstet Gynecol Clin North Am. 2016 Sep;43(3):551-73. doi: 10.1016/j.ogc.2016.04.006.

ReferenceCitation: Bauchat JR, Habib AS. Evidence-based anesthesia for major gynecologic surgery. Anesthesiol Clin. 2015 Mar;33(1):173-207. doi: 10.1016/j.anclin.2014.11.011. Epub 2014 Dec 31.

ReferenceCitation: Touijer K, Scardino PT. Nomograms for staging, prognosis, and predicting treatment outcomes. Cancer. 2009 Jul 1;115(13 Suppl):3107-11. doi: 10.1002/cncr.24352.

ReferenceCitation: Potters L, Roach M 3rd, Davis BJ, Stock RG, Ciezki JP, Zelefsky MJ, Stone NN, Fearn PA, Yu C, Shinohara K, Kattan MW. Postoperative nomogram predicting the 9-year probability of prostate cancer recurrence after permanent prostate brachytherapy using radiation dose as a prognostic variable. Int J Radiat Oncol Biol Phys. 2010 Mar 15;76(4):1061-5. doi: 10.1016/j.ijrobp.2009.03.031. Epub 2009 Jun 18.

ReferenceCitation: Nixon IJ, Ganly I, Hann LE, Lin O, Yu C, Brandt S, Shah JP, Shaha A, Kattan MW, Patel SG. Nomogram for predicting malignancy in thyroid nodules using clinical, biochemical, ultrasonographic, and cytologic features. Surgery. 2010 Dec;148(6):1120-7; discussion 1127-8. doi: 10.1016/j.surg.2010.09.030.

ReferenceCitation: Barsoum WK, Murray TG, Klika AK, Green K, Miniaci SL, Wells BJ, Kattan MW. Predicting patient discharge disposition after total joint arthroplasty in the United States. J Arthroplasty. 2010 Sep;25(6):885-92. doi: 10.1016/j.arth.2009.06.022. Epub 2009 Sep 2.

ReferenceCitation: Kelly DM, Bennett R, Brown N, McCoy J, Boerner D, Yu C, Eghtesad B, Barsoum W, Fung JJ, Kattan MW. Predicting the discharge status after liver transplantation at a single center: a new approach for a new era. Liver Transpl. 2012 Jul;18(7):796-802. doi: 10.1002/lt.23434.

ReferenceCitation: Wan KM, Carter J, Philp S. Predictors of early discharge after open gynecological surgery in the setting of an enhanced recovery after surgery protocol. J Obstet Gynaecol Res. 2016 Oct;42(10):1369-1374. doi: 10.1111/jog.13045. Epub 2016 Jun 29.

ReferenceCitation: Schiavone MB, Herzog TJ, Ananth CV, Wilde ET, Lewin SN, Burke WM, Lu YS, Neugut AI, Hershman DL, Wright JD. Feasibility and economic impact of same-day discharge for women who undergo laparoscopic hysterectomy. Am J Obstet Gynecol. 2012 Nov;207(5):382.e1-9. doi: 10.1016/j.ajog.2012.09.014. Epub 2012 Sep 17.

lead_sponsor: Institut Paoli-Calmettes


title: Venous to Arterial Carbon Dioxide Difference (P₍ᵥ-ₐ₎CO₂): Predictor of Septic Patient Prognosis Depending on the ScvO₂

summary: the investigators will include 120 patients with a diagnosis of septic shock in accordance with the definition given by the 2001 expert consensus. Two groups of patients are likely to participate in this study: Patient hospitalized in intensive care for a septic shock = Primary patient + patient who develops, the waning of his hospitalization in intensive care for another reason, a septic shock = Secondary patient. Haemodynamic monitoring by transpulmonary thermodilution allow a patient's close monitoring during the initial phase supported. The clinical and biological data, demographic and the severity scores are collected for each patient during the first three days of stay. To predict the unfavorable evolution of the patients, a measure of the SOFA score at the input (J0) and third day (J2) is performed. the investigators analyzed mortality at day 28 in patients with increased P₍ᵥ-ₐ₎CO₂ and those with increasing of organ failure. This research will be conducted according to good clinical practice. An information will be distributed to patients.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assisitance Publique Hopitaux de Marseille


title: Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study

acronym: FLEGME

summary: Fluorescence guidance is a safe and efficient tool for glioblastomas resection. The most widely used technique is based on 5-aminolevulinic acid (5ala), which stains glioblastoma cells through a metabolic abnormality and thus helps in defining tumoral edges through a modified microscope. A multicentric, randomized study comparing 5ala guided surgery with conventional procedures showed that this technique doubles the rate of complete removal on post-operative magnetic resonance imaging (MRI), and increases the 6 months progression-free survival. More recently, fluorescein appeared as an interesting alternative fluorophore for glioblastomas, with a highly reduced cost (2.5 euros versus 1000 euros per dose). However its use remains scarcely studied and its clinical benefit unsure. In that context, the investigators propose a randomized trial comparing conventional " white light " surgery with fluorescein-guided resection of glioblastomas, in order to assess the relevance of this technique in glioblastomas removal.

lead_sponsor: Rennes University Hospital