title: Evaluation of the Impact of Lock Down and End of Lock Down on the Management of Patients With Inflammatory and Dysimmune Diseases Followed in the Context of IMMINeNT FHU (Rheumatology, Dermatology, Internal Medicine, Pneumology, Gastroenterology, Neurology).

acronym: CONFIMID

summary:
This questionnaire is distributed via a mailing list (e-mail) of patients treated within the framework of the FHU for pathologies including chronic inflammatory bowel diseases or IBD (Crohn's disease and ulcerative colitis), inflammatory rheumatic diseases (such as rheumatoid arthritis and ankylosing spondylitis), but also asthma, psoriasis, atopic dermatitis as well as systemic autoimmune (such as scleroderma, lupus, angioedema) and neurological (multiple sclerosis) diseases.

A two-step analysis will be conducted: impact of lock down(March 17, 2020 - May 11, 2020) and a 2-month assessment of end of lock down (from May 11, 2020) on issues addressing: overall impact, impact on the disease, treatment and follow-up, and access to information related to the epidemic during these periods.


title: Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy

acronym: HYPNOMUSE

summary:
This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are anxious or very anxious during their radiotherapy treatment.

45 patients will be randomized into the following arms:

Arm A (standard): relaxation with music listening during radiotherapy treatment
Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment

For the study each patient will be followed during 2 months.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?

acronym: SAMHY SARCOME

summary:
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood.

The study will be conducted on a population of patients with sarcoma and treated in the context of routine care.

For each included patient, blood samples will be collected during baseline visit and after the initiation therapy.

At the end of the 2nd blood collection, the patient will have completed his participation in the study.

status: Active, not recruiting

primary_purpose: Other

enrollment_type: Actual


title: Evaluation of Clonal Heterogeneity and Tumor Evolution Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal

acronym: BOVARY CE

summary:
BOVARY-CE is a monocentric, pilot, longitudinal, real-life study with a total duration of 36 months. The purpose of this study is to assess the feasibility of using liquid biopsy as a substitute for tissue multisampling, in order to describe clonal heterogeneity and tumor evolution in patients with ovarian cancer. The method involves the inclusion of 20 patients with high-grade ovarian adenocarcinoma, fallopian tubes or primary peritoneal origin, not pretreated, newly diagnosed, and eligible for treatment who will participate in the research. These patients will have several samples throughout their treatment for a period of 2 years: blood samples which will be taken at each therapeutic moment of interest.

Tissue samples which will be taken at the time of the diagnostic laparoscopy and at the time of surgery.

The concentration of cfDNA and tumor heterogeneity will be used to predict disease-related events defined as relapse, progression or death.

primary_purpose: Diagnostic

ipd_sharing: Undecided

lead_sponsor: Institut de Cancérologie de Lorraine


type: Other Identifier

title: Difference in Central Fatigue During Two Ultra-endurance Practices: Running vs. Cycling

acronym: FAT-CENTR

summary: The mechanisms contributing to muscle fatigue in extreme long-duration exercise bouts are poorly understood. Ultra-endurance exercise is an excellent model for the study of adaptive responses to extreme loads and stress and it is an especially useful model for documenting the origins of central fatigue. This protocol will compare fatigue during and after ultra-endurance exercise bouts that result in moderate lower-limb tissue damage (i.e. cycling) or significant damage (i.e. running). The results of this protocol will allow us to further understanding of the reasons for major central fatigue, i.e. within the central nervous system, in ultra-endurance.

status: Completed

study_completion_date_type: Actual

primary_purpose: Basic Science

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

lead_sponsor_type: academique

status_simplified: Completed


title: The "Great Live and Move Challenge": a Program to Promote Physical Activity Among Children Aged 7-11 Years. Design and Implementation of a Cluster-randomized Controlled Trial.

summary: The Great Live and Move Challenge (GLMC) study is a 2-year cluster-randomized controlled trial designed to evaluate a multilevel and theory-based intervention to promote PA practice in children aged 7-11 years from French primary schools.

primary_purpose: Prevention

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut régional di Cancer de Montpellier (ICM)

intervention_type: Behavioral


title: Comparative Study of Differences in Food Preferences and Sensory Perceptions Between People With Obesity With or Without Bariatric Surgery

acronym: BariaTaste 2

summary: Several studies report changes in food preferences in favor of low energy density foods after bariatric surgery and changes in scores of liking and desire to eat, as well as changes in hedonic evaluation certain foods. However, only one study was held in a more realistic condition of consumption by using real food, looking at some aspects of food preferences and giving contradictory results. We hypothesise that food preferences are different between obese people with and without a bariatric surgery. The main objective of this study is to compare the differences in food quality (proportion of total energy intake from foods with high energy density versus foods with low energy density), evaluated during a standardized and validated buffet between adult women with severe complicated or morbid obesity and women who have undergone bariatric surgery in the last 12 months.

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon

location_facility: : Center for Research in Human Nutrition Rhône-Alpes, Institut Paul Bocuse Research Center


title: Evaluation of a ddPCR Technology for the SARS-CoV-2 Detection in Symptomatic Patients With Suspicion of COVID-19

summary: Evaluation of the ddPCR ability to detect the SARS-CoV-2 in nasopharyngeal samples of symptomatic patients with suspected COVID-19 infection using an IgG serological assay (EUROIMMUN Anti-SARS-Cov2 ELISA Ig) as gold/reference standard (FDA validated commercial serologic test).

lead_sponsor: Centre Leon Berard

intervention_type: Diagnostic Test


title: Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)

acronym: CISCO

summary: The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.

time_perspective: Retrospective

lead_sponsor: Rennes University Hospital


title: Comparative Study of Human Growth Hormone Measurements: Impact on Clinical Interpretation

summary: Human growth hormone (hGH) provocation test is an essential tool to assess growth hormone deficiency in children and young adults. It is important to have a robust and reliable method to determine the hGH peak of stimulation. This work aimed to compare three common automated immunoassays for hGH measurements and to assess whether there are still result-related differences influencing clinical decision.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Access to Maternity and Risk Factors in a Non-consultant Population - Longitudinal and Prospective Exploratory Study (PROXIMA)

summary: Characterize the psychic and medical disorders related to pregnancy and motherhood in a group of primiparous and primigratic women.

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment

acronym: Diaboulimia

summary: The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients

ipd_sharing: Yes

ipd_sharing_description: Contact icadom@agiradom.com for any data request. The researcher will be invited to complete a form (data sharing agreement) explaining the reasons and the aim of the data requests. The data will be de-identified.

lead_sponsor: Icadom


title: Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation

acronym: BKSEREIN

summary: Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing "Virus-like particles" (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Prospective, Single Center Study for the Clinical Evaluation of the Safety and Performance of a Dermal Filler in Correction of Mid-face Age-related Volume Deficit

summary: Prospective, single center study, on healthy subjects to evaluate the aesthetic improvement of facial volume, effect on the restoration and/or augmentation in subjects with mid-face age-related volume deficit after injection of a filler with lidocaine.

primary_purpose: Treatment

lead_sponsor: Relife S.r.l.

intervention_type: Device


title: Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy: Identification of Preclinical Models Predictive for Therapeutic Resistance

acronym: NEO-R

summary: The present project aims at identifying robust candidates for drug resistance in BC patients eligible for NAC. Its originality lies upon the combination of three different and complementary prospective approaches: from the molecular analyses of biopsies sampled before and after NAC, from in vitro BC Patient-Derived Organoids (PDO) mimicking patient's response to NAC, and from Circulating Tumor Cells (CTCs) isolated before/during/after NAC.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Institut Paoli-Calmettes


title: Prediction of Patient-specific Outcomes After Interventional Neuroradiology Procedures

acronym: PREDICTNRI

summary:
Stroke is either an obstruction (ischemic stroke) or the rupture of a blood vessel in the brain (ruptured aneurysm). It can happen at any age in adults. Because of the risk of irreversible brain damage, it is an absolute medical emergency.

An ischemic stroke (stroke) is the result of a lack of oxygen supply to a part of the brain. It can be one of many causes of stroke as a result of a thrombosis (occlusion) of the internal carotid artery or a cerebral embolism (migration of a clot or debris of fatty deposits) from a carotid stenosis. In both cases part of the brain is less irrigated. There will then be a neurological deficit (paralysis) more or less important corresponding to the affected cerebral territory. The deficit may concern the whole hemicorps (hemiplegia) or a part of the body (upper or lower limb) and sometimes is associated with facial paralysis and/or language disorders.

A brain aneurysm occurs when the wall of an intracranial artery expands abnormally, creating a pocket of blood. It is often caused by weakness in the vascular tissue, but it can also occur later in life due to illness, head injury, oral contraceptives or certain lifestyle habits (smoking, excessive alcohol consumption). Sudden increases in pressure due to stress or strenuous exercise can serve as a trigger.

Interventional Neuroradiology (INR) is a medical specialty that manages stroke patients using imaging to perform the medical procedure and thereby limit openings and their associated risks. This specialty has a growing place in modern medicine.

In order to improve the quality of care, patient safety and functional outcomes, it is necessary to keep patient information. A database storing patient data from the NRI department will make it possible to track patients since their arrival at the Brest University Hospital. Thanks to this structured database, clinical studies will be facilitated, making it possible to advance knowledge of the pathology and its treatments.

From the bibliographical research, we can conclude as to the current state of the facts: there is currently no method for predicting the functional results of the interventional neuroradiologist's patient based on automated learning.

A strategy based on an innovation programme is therefore being implemented over several years, the first stage of which is the retrospective data study which was approved by the ethics committee on 12/09/2019 and the second stage is the prospective data study.

This innovation program requires the most complete and homogeneous data possible.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Physical - Cognitive Training Programs in Older Adults: A Comparison of Three Training Protocols

acronym: EXECO

summary:
Understanding how to delay age-related physical and mental declines is an issue for aging research. It has been shown that isolated aerobic, coordination and cognitive training improve brain functions and cognitive performances. Moreover, the combination of them leads to greater effects. Different combination modalities are possible: training programs demanding cognitive resources within the activity performed in a natural environment like Nordic Walking (or Tai chi, Dance...); or as in a conceptually-grounded circuit training where training components are systematically combined and their intensity controlled. The aim of this study is to compare three training programs: a Nordic walking one (NW), and two conceptual grounded, circuits training (CT-c; CT-fit). CT-c implemented by dual-task (DT) exercises, while CT-fit characterized by cognitive charge embodied in the movements through the use of technology. An improvement in physical, motor, and cognitive functions is expected by all three groups. However, our primary hypothesis is that the CT-fit will impact executive functions more.

45 healthy independent living community dwellers participants aged 65 to 80 will be recruited. Participants will be included after a general medical examination (geriatric screening and cycle-ergometer maximal effort test). The main exclusion criteria are signs of cognitive impairment, (MMSE <26/30), and physical impairments. Participants will be randomly divided into the 3 groups (NW, CT-c, CT-fit): The training program will last 8 weeks, 1 hour 3 times a week. Pre and post-tests will include cognitive assessment (MoCA; TMT; Stroop task, Happy Neuron™ working memory test, Rey Complex Figure copy task and dual-task capacities through the DT-OTMT); motor fitness assessment (Bipedal upright standing, Unipedal balance test, walking speed and size of the base of support, Timed Up & Go, Chair sit and reach test and Four square stepping test) and physical assessment (10 m incremental shuttle walking test, maximal handgrip force, 30s chair rise stand).

Improving cognitive functions by adding new technology embodied in a systematically combined training (exergame), would result to be the best solution to optimize training for aging people.

lead_sponsor: Aix Marseille Université

location_facility: Institut des Sciences du Mouvement Etienne-Jules Marey (UMR 7287)


title: Pulmonary and Ventilatory Effects of End-expiratory Positive Pressure Optimization in Intubated ICU Patients With Healthy Lungs or Acute Respiratory Distress Syndrome. A Randomized Controlled Trial

acronym: PEEP-Réa

summary: PEEP titration is a recommended during invasive mechanical ventilation of ICU patients. However, little is known about the right way to conduct this titration. PEEP titration can be conducted by a stepwise increase in PEEP level, or following an ARM and a consecutive stepwise decrease in PEEP level. Those 2 methods will be explored in intubated ICU patients either with healthy lung or ARDS lungs. Physiological exploration will include end-expiratory lung volume measurements, driving pressure, compliance and electro-impedance tomography at each PEEP level.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Baroreflex Sensitivity in Patients Undergoing Atrial Fibrillation Ablation: Association With Arrhythmia Recurrences

acronym: BARO-AF

summary:
Atrial fibrillation is the most common arrhythmia. The posterior surface of the left atrium is covered by an extensive network belonging to the autonomic nervous system that can be damaged during the ablation. The involvement of the autonomous nervous system in the genesis and maintenance of atrial fibrillation remains poorly understood. Baroreflex sensitivity is a non-invasive method assessing autonomous nervous system activity.

The rate of atrial fibrillation recurrence after ablation is currently high and a better understanding of the mechanisms associated with recurrence is essential to improve selection of the patients who will benefit the most from this procedure.

The aim of this study is to evaluate the association between the baroreflex sensitivity and atrial fibrillation recurrences and to analyze the prognostic contribution of the baroreflex measurement compared to other published criteria.

lead_sponsor: Poitiers University Hospital

intervention_type: Procedure


title: Measurements of Displacement Amplitude and Angular Velocities During Passive Extension of the Wrist and Hand Complex in Stroke Patients

acronym: PHYSIOHAND

summary:
The main objective of this monocentric prospective study is to evaluate the amplitudes and angular velocities of extension of the hand and wrist joints during passive mobilization by a physiotherapist in healthy subjects and stroke patients with spastic hands.

Secondary objectives:

To compare amplitude and angular velocity values between the group of stroke patients and the group of healthy volunteers,
To compare amplitude and angular velocity values according to the two types of mobilization (i,e, thumb or fifth finger),
To assess pain due to mobilization in stroke patients.

status: Terminated

design_allocation: Non-Randomized

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

location_facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

status_simplified: Unknown


title: Therapeutic Drug Monitoring of Antifungals in Patients From Intensive Care Units: a Retrospective Study

acronym: Fungi-up

summary: Antifungals under- and over-dosing are frequently deplored in patients treated with antifungals and receiving recommended doses, mostly in critically-ill patients. This situation is well-described for antifungals from the azoles class mostly in patients with liver dysfunction or having concomitant drugs that may interact with azoles. This situation is less-described using echinocandins, although recent studies reported caspofungin underdosing for critically-ill patients. Considering that antifungals under-dosing was demonstrated to be associated with an increase in mortality, it is of utmost importance to analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive care units (ICU). This will help to identify which patients are the more prone to antifungal under or over-dosing. Indeed, antifungals under-dosing may favour the development of clinical resistance to antifungals and increase mortality, whereas over-dosing may result in adverse events that may lead to treatment discontinuation.

location_facility: Hospices Civils de Lyon, Croix-Rousse Hospital

intervention_type: Drug


title: Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients

acronym: STADIA

summary: The objective of the study is to measure changes in compliance to statin therapy in patients with type 2 diabetes after an educational intervention. This intervention is part of the therapeutic education of the diabetic patient, carried out throughout the follow-up of his/her diabetes.

lead_sponsor: Lille Catholic University


title: Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique

acronym: OMEDIA

summary: The main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

intervention_type: Dietary Supplement


title: Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial

acronym: QuITO

summary:
Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.

Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.

The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.

The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.

lead_sponsor: Clinique Medipole Garonne


title: Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma

acronym: MEMO-GCAO

summary:
Open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric alterations, and wose only current therapeutic target is the lowering of the intra-ocular pressure (using eye drops, surgery or laser). MEMOPTIC is a tablet combining citicoline, magnesium and Gingko biloba, which have a neuroprotective effect already used in neurodegenerative diseases such as Alzheimer's disease for example. Citicoline has also shown several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently in ischemic optic neuropathies). The citicoline used in eye drops (NEURODROP) has already shown results on the preservation of the vision of glaucomatous patients.

The purpose of this project is to determine if MEMOPTIC can have an effect, in addition to the conventional treatments, in the preservation of vision of patients treated for an open-angle glaucoma.


title: Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis Treated With Subcutaneous Biologic DMARDs

summary:
There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential.

The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.

lead_sponsor: Hôpital Cochin


title: Methodology of " CoCo 20 ": a Longitudinal Follow-up Study of the Paediatric Population and Their Families During and After the Coronavirus Pandemic and the Confinement

summary:
In the context of a viral outbreak and of widespread quarantine measures, a significant increase in psychological disorders, such as stress or fear behaviours, had previously been observed. This distress has been described on adults, but no data have been collected yet for paediatric populations.

After a traumatic event, children and adolescents may present several clinical consequences, the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior problems.

The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of the pandemic of coronavirus disease 2019 (Covid-19) and of seclusion measures on mental health and on the development of psychological disorders in children in the short to medium term

ReferenceType: derived

ReferenceCitation: Gindt M, Fernandez A, Richez A, Nachon O, Battista M, Askenazy F. CoCo20 protocol: a pilot longitudinal follow-up study about the psychiatric outcomes in a paediatric population and their families during and after the stay-at-home related to coronavirus pandemic (COVID-19). BMJ Open. 2021 Apr 8;11(4):e044667. doi: 10.1136/bmjopen-2020-044667.

family: Gindt

full_name: Morgane Gindt

given: Morgane

sequence: first

family: Fernandez

full_name: Arnaud Fernandez

given: Arnaud

sequence: additional

family: Richez

full_name: Aurelien Richez

given: Aurelien

family: Nachon

full_name: Ophelie Nachon

given: Ophelie

family: Battista

full_name: Michele Battista

given: Michele

family: Askenazy

full_name: Florence Askenazy

given: Florence

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: EPIdemiological Approaches to the Cardiovascular Consequences of COVID-19

acronym: EPI CV COVID

summary: The COVID-19 pandemic highlights the importance of the prognosis of co-morbidities, such as coronary artery disease, which significantly increase the risk of mortality in patients infected with SARS-CoV2. Investigators have recently studied the complex links between respiratory infections, particularly pneumonia, and type 2 myocardial infarction (MI) in many respects. The etiology of type 2 MI is based on an imbalance of myocardial oxygen supply/need in the absence of rupture/erosion of atheromatous plaques. Based on the RICO survey data, the investigators investigated whether COVID-19-related sepsis and/or respiratory failure could be an underlying mechanism of MI2.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: MYocardial DOmmages Related to COVID-19

acronym: DOMY COVID

summary: Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial inflammation, the origin of Tnc elevation is unknown to date. Several cardiac causes, such as myocarditis, non-ischemic myocardial injury (NIMI), or myocardial infarction (MI) may lead to Tnc kinetic. Our work will test the hypothesis that during SARS-Cov2 infection, the elevation of cardiac biomarkers could be linked to the occurrence of myocarditis.


title: Assesment of the Metabolomic Signature in COVID-19 Patients (SignCov Study)

acronym: SignCov

summary: Metabolomics is the analysis of small molecules in a biological sample (cells, tissues or biological fluids). It can potentially detect very sensitively any change related to a pathology or exposure to a toxic agent. The analyses are fast, inexpensive and therefore applicable in routine, particularly in health care. Given the emergence of this new disease, COVID-19, there is a real need to better understand the pathophysiological mechanisms of SARS-CoV-2 infection. In this context, metabolomics could have a place and could lead to the development of interesting diagnostic or prognostic tools. The objective of this study is to identify, through the analysis of biological samples (blood and urine), whether there is a metabolomic signature in patients with COVID-19.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Using Tele-evaluation and Teleconsultation Instead of Classical Consultation for the Follow-up of Obese Patients After Bariatric Surgery : a Pilot Study.

acronym: TELECHIRO

summary: An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. To design a large randomized clinical trial (RCT) comparing teleevaluations and teleconsultations to classical follow, aiming to prove that the quality of the follow-up is maintained and the patient-experience is improved, at a lower cost in people living far from the reference centre, this pilot study aims at describing the distribution of the collected criteria.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Toulouse


title: Comparison of Pharmacokinetic (PK) Levels Before and After Conversion From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus (LCPT) in Diabetic Transplant récipients

acronym: SPK-PK

summary:
The investigators believe that the pharmacological properties of Envarsus®, well studied in kidney transplantation, may be also suitable after simultaneous kidney and pancreas transplantation than Prograf. Indeed, Envarsus® has demonstrated a clinical efficacy and safety in a complete clinical development plan.

This study is to establish the pharmacokinetic profile of tacrolimus prolonged-release (hereafter referred to as 'ENVARSUS®') in diabetics who have undergone kidney and pancreas transplantation, and compare it to the pharmacokinetic profile of standard twice-daily tacrolimus. The study will be conducted in 25 patients hospitalized at Nantes University Hospital.

lead_sponsor: Nantes University Hospital


title: Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection

acronym: ROSCO

summary: Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to sensible staphylococcus strains. However, in the elderly, inter-individual variability of the pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin side effects is likely to be increased in case of higher exposition. However, the serum concentration-toxicity relationship has not yet been determined. The purpose of this project is to assess the association between the residual serum concentration of ofloxacin at day 3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS

acronym: HearCog

summary: The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years compared with normally hearing subjects (NHS). To do this, the investigator will use functional Near InfraRed Spectroscopy (fNIRS) during 4 tasks that engage the childs perceptual and cognitive skills over a period of 18 months. The performance scores obtained by each participants as well as the cortical activity will be analysed and decrypted.


title: The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

acronym: Pre-BLS-Sterno

summary: The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications, improves patient comfort and satisfaction and reduced hospital costs. In this study our hypothesis is to test the efficacity of local anesthetic administration via the catheters in the BLS position placed before the surgical incision.

location_facility: CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire


title: Implementation of a Next-generation Sequencing Analysis of a Panel of Genes Implicated in Incomplete Forms of Albinism

acronym: DIA

summary: Implementation of a next-generation sequencing panel of genes to identify deleterious variants in patients with incomplete forms of albinism.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux

intervention_type: Biological


title: Left Elective Colectomy in Renal Transplanted Patients : a Case-control Study (LECoRT Study)

acronym: LECoRT

summary:
Aim of the study :

To evaluate postoperative outcomes of elective left-sided colectomy in a renal transplanted population.

Methods :

From 2010 to 2015, all consecutive patients who underwent left elective colectomy in a referral center were prospectively collected.

Considering our exclusion criterial, data from 120 patients were analyzed. The cohort was separated into 2 groups : renal transplanted patients (KTR-group) and non-renal transplanted patients (C-group) Short and longterm outcomes were compared between the two groups.

Primary outcome :

90 days postoperative anastomotic leak rate

ReferenceCitation: Bardol T, Souche R, Genet D, Ferrandis C, Guillon F, Pirlet I, Fabre JM. Outcomes of elective left colectomy in renal-transplanted patients: a single-center case-control study (LECoRT study). Int J Colorectal Dis. 2021 Jun;36(6):1209-1219. doi: 10.1007/s00384-021-03860-7. Epub 2021 Jan 28.

family: Bardol

full_name: Thomas Bardol

given: Thomas

family: Souche

full_name: Regis Souche

given: Regis

family: Genet

full_name: Diane Genet

given: Diane

family: Ferrandis

full_name: Charlotte Ferrandis

given: Charlotte

family: Guillon

full_name: Françoise Guillon

given: Françoise

family: Pirlet

full_name: Isabelle Pirlet

given: Isabelle

family: Fabre

full_name: Jean-Michel Fabre

given: Jean-Michel

journal_name: International Journal of Colorectal Disease

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Montpellier


title: Evaluation of a Psycho-educational Program Based on the Prevention of the Risks Related to the Impact of Cognitive Disorders on Driving in Geriatrics and Neurology

acronym: ACCOMPAGNE

summary: ACCOMPAGNE study proposes to evaluate an educational program for the patient / caregiver dyad, intended to accompany the patient towards the implementation of self-regulation strategies in the driving activity. The program, based on group workshops with the presence of the patient and the caregiver, is led by an interdisciplinary team. It follows all the intervention recommendations described in the literature: to make the patient a decision-maker, to allow advanced planning of discussions between the family member and the caregiver, to give information on the consequences of TNCs and sensory disorders. This program provides psychological support in the management of the problems and the mourning of a future cessation of the driving activity, an awareness of the risky and avoidable situations, information on alternative solutions and available resources in the event of reduced driving. The program is created to support the implementation of self-regulation strategies for safe driving and a gradual reduction of driving activity. This study may be included in Measure 5 of the Neuro-Degenerative Diseases Plan (PMND) 2014-2019. This plan recommends to strengthen the self-management of patients and their relatives in the disease.

lead_sponsor: Hospices Civils de Lyon


title: Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap

acronym: HLNS

summary: Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap

lead_sponsor: University Hospital, Brest


title: Evaluation of the Occurrence of Postoperative Surgical Site Infection in Otolaryngology Flap Surgery With Bone Graft, a Retrospective Analytic Study Between 2012 and 2019

acronym: SSI-flap

summary:
In 2017, the French Society in anesthesia and reanimation published new recommendations on intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis applies to any otolaryngology surgery, regardless of patient's medical history or type of flap used to rebuild. This has resulted in an alignment of our local protocol in Croix-Rousse hospital.

However, after few years, our local impressions are that bone flap surgeries are very likely to provide surgical site infections (osteo-articular or non-osteo-articular infections).

The prejudice of these postoperative site infections is significant, with serious consequences,. of both functional and aesthetic sides.

We wanted to objectify this impression by retrospectively analyzing the data relating to patients operated on for bone flapsurgeries.

Knowing the operation site infection rate after surgery for otolaryngology bone flap surgery will allow us to objectively understand the infectious risk of these surgeries, in particular the risk of osteoarticular infection. Identifying operation site infection factors will allow us to better target and prevent them.

The goal is to find out if the antibiotic prophylaxis currently recommended is sufficient and effective for this type of surgery.


title: Comparison of Plasmatic Concentrations of Propofol and Remifentanil During Monitored Anesthesia in Obese and Non Obese Patients.

acronym: COCOPOPONO

summary: This prospective monocentric phamacokinetics study aims to compare plasmatic concentrations of Propofol and Remifentanil required to target a specific range of monitored anesthesia and analgesia during sus-mesocolic surgery in obese and non obese patients.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Service d'Anesthésie-Réanimation, Pôle Médecine Périopératoire - Hôpital Estaing, CHU de Clermont-Ferrand


title: Family Impact of Polyhandicap: Mixed Methodological Approach

acronym: PolyMiMe

summary: Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction occurring in an immature brain, leading to the combination of profound mental retardation and serious motor deficit, resulting in an extreme restriction of autonomy and communication. In a preliminary work, we demonstrated that French families reporteda deterioration of the quality of life. This first study, based on a cross-sectional study and quantitative methods, did not allow to explore: 1) the dynamic aspect and the evolution over time of this experience, 2) the mechanisms underlying the difficulties encountered, the needs and expectations of families

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpiatuix de Marseille


title: COVID-19 Infection Screening in Cancer Patients (NEOSCREENCOVID)

acronym: NEOSCREENCOVID

summary:
Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. Cancer patients seem to be at higher risk of infection and evolution to severe forms related to immunosuppression, according to the first published data from Chinese experience. However, the role of confounding factors such as age and smoking habits cannot be independently assessed. Supplementary data from a large retrospective Italian cohort suggest that the proportion of cancer patients with severe form of COVID-19 could be lower than expected. In addition, the proportion of asymptomatic SARS-Cov-2 infected cancer patients is unknown. Based on academic and expert's recommendations, most of cancer units have already modified cancer treatment during the pandemic, in order to limit the number of outpatient visits / inpatient admissions and then reduce or avoid cross infection of COVID-19, although the negative impact on patient's outcome (cancer recurrence or mortality) has not been established. Thus, a large screening for SARS-Cov-2 infection in treated cancer patients could help to: - Define an accurate prevalence of COVID-19 immunization in this population - Aggregate data on the relationship between clinical characteristics in cancer patients and COVID-19 risk. - Provide information about asymptomatic COVID-19 cases. - Organize effectively cancer units to separate infected and non-infected patients.

The RT-PCR gold-standard test for COVID-19 on nasal and pharyngeal swabs has limitations, as the test is not universally available, turnaround times can be lengthy, and reported sensitivities vary. It does not provide information about immunization status. Serological assays may be important for understanding the epidemiology of emerging SARS-Cov-2, including the burden and role of asymptomatic infections. Thus, the development of new devices or techniques for accurate diagnosis of SARS-CoV-2 infections, of fast and safe use, that could be spread in the local hospitals and clinics, would be a major advance for identifying and treating patients. In addition, information about the immunization of fragile people, such as cancer patients, could help to plan a safe strategy for anti-cancer treatment schedule and for the end of quarantine.

primary_purpose: Screening

lead_sponsor: Centre Antoine Lacassagne


title: Impact of Containment Measures in People With Eating Disorders: a Descriptive Study

acronym: COVITA

summary:
Since March 17, 2020, the French government has implemented national containment measures due to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives, loss of liberty, concern about the infectious status, boredom, can negatively affect mental health, with the emergence of anxiety and depressive symptoms.

In addition, confinement can disrupt usual physical activity, a major destabilization criterion for patients suffering from eating disorders (ED). Finally, conditions of confinement can harm social support, yet identified as a protective and resilience factor in stress contexts. Thus, the current context of confinement and social distances could be source of an increase in eating behavior disorders symptoms in people suffering from ED.


title: Evaluation of Discomfort Symptoms in Patients With Refractory Cancer Pain and Intrathecal Analgesia Management

acronym: IT-ESAS

summary: Intrathecal analgesia is used in refractory cancer pain because of drug sides effects or intractable pain. The aim of this approach is to improve pain management, and also to improve patient comfort. This study will assess patient discomfort symptoms before and after setting up intrathecal analgesia.


title: Seroprevalence and Immunoprotection Against SARS-CoV2 in Children Hospitalized in Paris

acronym: AP-PEDCOVID

summary: The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of age hospitalized for no more than 4 days and whose clinical status requires blood sample regardless of the symptoms Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology.

lead_sponsor: Hôpital Necker-Enfants Malades


title: Characterization of Postoperative Myocardial Lesions by Cardiac MRI and Anatomo-biological Correlations With Serum Troponin in Cardiac Surgery.

acronym: MITEC

summary:
Cardiac surgery under cardiopulmonary bypass (CPB) induces myocardial ischemia-reperfusion injury. This myocardial attack is a well-identified independent prognostic factor of postoperative morbidity and mortality. The quantification of these myocardial lesions by the postoperative plasma release of troponin has proven its diagnostic and prognostic value.

Cardiac magnetic resonance imaging (MRI) can accurately measure and characterize the size of myocardial lesions. These lesions are associated with a poor prognosis. MRI can also characterize myocardial edema secondary to ischemia-reperfusion which has not yet been studied in the context of CPB. It is therefore necessary, in a mechanistic approach, to quantify the respective share of necrosis, edema and reperfusion lesions during cardiac surgery under CPB in order to better understand these phenomena and to propose effective strategies for the prevention of these myocardial lesions.the relationship between the postoperative release of troponin and the amount of myocardial necrosis and edema measured by cardiac MRI will be assessed.The hypothesis is to demonstrate a positive correlation between imaging and biology in order to better understand the perioperative myocardial lesion processes.

This is an interventional study prospective, exploratory, in cardiac imaging, non-comparative and single-center, including 30 patients.


title: Detection of Urinary Tract Stones on Ultra-low Dose Abdominopelvic CT Imaging With Deep-learning Image Reconstruction Algorithm

acronym: URO DLIR

summary: Urolithiasis has an increasing incidence and prevalence worldwide, and some patients may have multiple recurrences. Because these stone-related episodes may lead to multiple diagnostic examinations requiring ionizing radiation, urolithiasis is a natural target for dose reduction efforts. Abdominopelvic low dose CT, which has the highest sensitivity and specificity among available imaging modalities, is the most appropriate diagnostic exam for this pathology. The main objective of this study is to evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in urolithiasis patients.


title: Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients

acronym: CirCo

summary:
80% of patients with alcohol use disorders (AUD) present cognitive impairments, such as memory and executive functions. These disorders may have repercussions in addiction treatment by altering the patient's adherence to care. The level of impairment is dependent on the onset of addiction, and also the duration of abstinence.

A complete neuropsychological evaluation is necessary to highlight cognitive impairments. In practice, the evaluation of these disorders by practitioners, is done with the help of tools of screening like the MoCa (Montreal cognitive assesment) and the BEARNI (Brief evaluation of alcohol related neuropsychological impairment).

However, none of these tools have been evaluated in patients with alcoholic cirrhosis. Indeed, some studies have suggested that liver disorders including cirrhosis may be a factor aggravating cognitive disorders.

The purpose of this study is to evaluate the ability of the BEARNI tool to detect alcohol-related cognitive problems in patients with alcohol-related cirrhosis.


title: DELTA-CAPNO: Identification of Risk Factors for Alteration of the Cellular-arterial Gradient of CO2 in Pre-hospital Patients

acronym: DELTA-CAPNO

summary: Monocentric, prospective, observational and descriptive study on the evaluation of risk factors for alteration of the alveoarterial gradient of CO2 in pre-hospital patients, intubated and then ventilated in an invasive manner; and their impact on intra-arterial fatehospital.

lead_sponsor: University Hospital, Angers


title: Translation and Validation of the French Version of the ObsQoR-10 Questionnaire for the Evaluation of Recovery After Childbirth: the ObsQoR-10F Questionnaire

summary:
Until recently, there was no validated scoring tool to assess recovery after childbirth. Ciechanowicz et al. developed and validated a postpartum recovery score for women with a caesarean section (scheduled or unscheduled): the ObsQoR-11. The psychometric validation of the ObsQoR-11 confirms its reliability, its response to change, its acceptability and its feasibility (average filling time of 2 minutes, and the possibility to print the questionnaire on one page). The use of this score allows the investigators to quantify the quality of the patient's recovery between 0 and 110 (0 being a really poor recovery, and 110 a total recovery), by allocating a score from 0 to 10 for each item.

Since then, the initial version of ObsQoR-11 has evolved into a smaller version, ObsQoR-10, for which the pain items have been merged. Similarly, by assigning a score from 0 to 10 for each item, the ObsQoR-10 score allows to quantify the quality of the patient's recovery between 0 and 100 (0 being a very poor recovery, and 100 being full recovery).

There are currently no translations of this score into another language, but the investigators can easily assume that they will be done in the near future. French remains the fifth most spoken language in the world. The investigators therefore feel it is necessary to validate the translated version of the ObsQoR-10 score.

ReferenceType: background

ReferenceCitation: Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.

ReferenceCitation: Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20.


title: Optimal Duration of Magnetic Resonance Imaging (MRI) Follow-up to Safely Identify Middle Ear Residual Cholesteatoma

summary: Previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted magnetic resonance imaging (non-EP DWI) for residual cholesteatoma. However, limited data are available regarding a suitable length of imaging follow-up. The present study aimed to determine the optimal duration of non-EP DWI follow-up for residual cholesteatoma


title: P-glypoprotein Inhibition Effect on the Pharmacokinetics of Two Tacrolimus Formulations: Prolonged and Extended-release

acronym: DIPLOID

summary:
Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named LCP-Tacro (Envarsus®), formulated using the Melt-Dose process.

Tacrolimus is a lipophilic macrolide drug able to passive transmembrane diffusion. Its bioavailability displays a large interindividual variability, from 9 to 43%. Indeed, tacrolimus is a substrate of P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4). P-gp is an efflux protein mainly located at the apex of the epithelia of the intestine, lymphocyte, kidney and blood-brain barrier. P-gp therefore limits the intestinal resorption of tacrolimus and also its diffusion into its target compartment (i.e the lymphocyte. The expression of this protein is different throughout the digestive tract with maximum expression at the ileal level. CYP3A4 is a coenzyme that is responsible of more than 90% of the metabolism of tacrolimus, at the digestive and hepatic level. Both P-gp and CYP3A4 play a role in tacrolimus absorption/diffusion process.

A new formulation of tacrolimus, LCP-Tacro, (Envarsus®) was approved in 2014. Its efficacy was compared to Prograf® in two phase III de novo or switch Prograf® trials in kidney transplantation.

With tacrolimus, there is a strong inter-individual pharmacokinetic variability which, to date, has not been fully characterized. Variations in bioavailability may partly explain this high variability. The different formulations are resorbed at distinct gastrointestinal sites which could explain different absorptions between Prograf/Advagraf and LCP-Tacro forms.

These findings raise the question of the role of P-gp in explaining the difference in bioavailability between formulations. The use of a P-gp inhibitor could therefore have a different impact on exposure to different galenic formulations.

Verapamil is an inhibitor of P-gp and CYP 3A4, which is frequently prescribed and recommended by FDA for drug-drug interaction studies aiming at evaluating P-gp substrates, used in healthy volunteers at dosages up to 240 mg/D13-14. Otherwise, verapamil-tacrolimus interaction has been characterized in vitro.

It has also been shown that inhibitory effect of verapamil at a single dose of 120 mg administered one hour prior to the administration of a P-gp substrate exhibited an optimum power of inhibition.

The safety of Advagraf® and Envarsus® administrations have already been subjected to several phase I trials in healthy volunteers reinforcing the knowledge of their safety profile.

The aim of the study is to compare the interaction profile of Advagraf® and Envarsus® when co-administered with verapamil in healthy subjects and to provide guidelines on tacrolimus dosage adjustment in such cases.

lead_sponsor: Rennes University Hospital

intervention_type: Genetic


title: Assessment of the Interest of Intravenous Administration of Molar Sodium Lactate on the Quality of Brain Relaxation for Resection Surgery of Supratentorial Brain Tumors by Craniotomy.

acronym: LSD

summary:
Resection surgery of brain tumors by craniotomy requires efficient brain relaxation intraoperatively in order to avoid injuries caused by the brain retractors (such as ischemic-reperfusion and cerebral oedema). The gold standard for the brain relaxation during a surgery is Mannitol 20%.

Molar sodium lactate is now used to induce brain relaxation in patients with traumatic brain injury and intracranial hypertension due to its osmotic effect. Furthermore, the injection of sodium lactate may lead to better neuronal metabolism during cerebral aggression, and may participate to the reduction of cerebral oedema and secondary injuries.

LSD is a pilot randomised trial which tries to assess the interest of intravenous administration of molar Sodium Lactate on the quality of brain relaxation in surgical resection of supratentorial brain tumors by craniotomy.

The primary outcome measure is the quality of brain relaxation, evaluated by neurosurgeon at the opening of the dura, by a validated brain relaxation scale.

ReferenceCitation: Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia: COVAP Study

acronym: COVAP

summary: A Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe forms, it may require mechanical ventilation or even lead to an acute respiratory distress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lower than that of previous strains, notably MERS-CoV, its spread is considerably big. As a result, the number of patients developing respiratory distress requiring invasive mechanical ventilation is high, with prolonged ventilation duration in these situations

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Medical and Serological Follow-up of the Staff of the Paris Saint-Joseph Hospital Group

acronym: PERSO-COVID

summary:
The Coronavirus SARS CoV-2 (COVID-19) pandemic is causing a major global health crisis that is disrupting our hospital organizations and creating potential infectious risks for hospital staff on the front line when it comes to the support of infected people.

In this context, the Paris Saint-Joseph Hospital Group (GhPSJ) very early on wanted to implement an institutional approach aimed, on the one hand, at enabling each of its employees at its two sites (Hôpital Paris Saint-Joseph (HPSJ), Paris 14ème and Hôpital Marie Lannelongue (HML), Le Plessis Robinson, 92) to access their serological status with regard to SARS-CoV-2 and, on the other hand, to identify the risk factors for contracting COVID-19.

This collective approach consisted of an evaluation of its professional practices aimed at assessing the protective measures put in place to protect hospital personnel and identifying sources of potential improvement in the management of the infectious risk required to put in place in case of upcoming COVID-19 cases or any other epidemics in the future.

ReferenceType: result

ReferenceCitation: Janice Oh HL, Ken-En Gan S, Bertoletti A, Tan YJ. Understanding the T cell immune response in SARS coronavirus infection. Emerg Microbes Infect. 2012 Sep;1(9):e23. doi: 10.1038/emi.2012.26. Epub 2012 Sep 5. Review.

name: Singapore Immunology Network, Agency of Science Technology and Research (A*Star), Singapore 138648, Singapore

name: Institute of Molecular and Cell Biology, Agency of Science Technology and Research (A*Star), Singapore 138673, Singapore

family: Janice Oh

full_name: Hsueh-Ling Janice Oh

given: Hsueh-Ling

name: Bioinformatics Institute, Agency of Science Technology and Research (A*Star), Singapore 138671, Singapore

family: Ken-En Gan

full_name: Samuel Ken-En Gan

given: Samuel

name: Singapore Institute for Clinical Sciences, Agency of Science Technology and Research (A*Star), Singapore 117609, Singapore

name: Program of Emerging Viral Diseases, Duke-NUS Graduate Medical School, Singapore 169857, Singapore

name: Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore

family: Bertoletti

full_name: Antonio Bertoletti

given: Antonio

name: Department of Microbiology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore

family: Tan

full_name: Yee-Joo Tan

given: Yee-Joo

journal_name: Emerging Microbes & Infections

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Li G, Fan Y, Lai Y, Han T, Li Z, Zhou P, Pan P, Wang W, Hu D, Liu X, Zhang Q, Wu J. Coronavirus infections and immune responses. J Med Virol. 2020 Apr;92(4):424-432. doi: 10.1002/jmv.25685. Epub 2020 Feb 7. Review.

name: Guangdong Provincial Key Laboratory of Virology, Institute of Medical MicrobiologyJinan UniversityGuangzhou China

name: Laboratory Animal CenterGuangzhou University of Chinese MedicineGuangzhou China

family: Li

full_name: Geng Li

given: Geng

name: The First Clinical Medical CollegeGuangzhou University of Chinese MedicineGuangzhou China

family: Fan

full_name: Yaohua Fan

given: Yaohua

family: Lai

full_name: Yanni Lai

given: Yanni

family: Han

full_name: Tiantian Han

given: Tiantian

full_name: Zonghui Li

given: Zonghui

family: Zhou

full_name: Peiwen Zhou

given: Peiwen

family: Pan

full_name: Pan Pan

given: Pan

family: Wang

full_name: Wenbiao Wang

given: Wenbiao

name: State Key Laboratory of Virology, College of Life SciencesWuhan UniversityWuhan China

family: Hu

full_name: Dingwen Hu

given: Dingwen

name: The First Affiliated HospitalGuangzhou University of Chinese MedicineGuangzhou China

family: Liu

full_name: Xiaohong Liu

given: Xiaohong

name: School of Pubic HealthSouthern Medical UniversityGuangzhou China

family: Zhang

full_name: Qiwei Zhang

given: Qiwei

family: Wu

full_name: Jianguo Wu

ReferenceCitation: Rajendran K, Krishnasamy N, Rangarajan J, Rathinam J, Natarajan M, Ramachandran A. Convalescent plasma transfusion for the treatment of COVID-19: Systematic review. J Med Virol. 2020 Sep;92(9):1475-1483. doi: 10.1002/jmv.25961. Epub 2020 May 12.

name: Multidisciplinary Research Unit (MRU)Madras Medical CollegeChennai Tamil Nadu India

name: Madras Medical CollegeInstitute of Hepatobiliary SciencesChennai Tamil Nadu India

name: Institute of Internal MedicineMadras Medical CollegeChennai Tamil Nadu India

title: Convalescent plasma transfusion for the treatment of COVID‐19: Systematic review

ReferenceCitation: Prompetchara E, Ketloy C, Palaga T. Immune responses in COVID-19 and potential vaccines: Lessons learned from SARS and MERS epidemic. Asian Pac J Allergy Immunol. 2020 Mar;38(1):1-9. doi: 10.12932/AP-200220-0772. Review.

journal_name: Asian Pacific Journal of Allergy and Immunology

publisher: Allergy, Asthma, and Immunology Association of Thailand

ReferenceCitation: Salje H, Tran Kiem C, Lefrancq N, Courtejoie N, Bosetti P, Paireau J, Andronico A, Hozé N, Richet J, Dubost CL, Le Strat Y, Lessler J, Levy-Bruhl D, Fontanet A, Opatowski L, Boelle PY, Cauchemez S. Estimating the burden of SARS-CoV-2 in France. Science. 2020 Jul 10;369(6500):208-211. doi: 10.1126/science.abc3517. Epub 2020 May 13. Erratum in: Science. 2020 Jun 26;368(6498):.

name: Mathematical Modelling of Infectious Diseases Unit, Institut Pasteur, UMR2000, CNRS, Paris, France.

name: Department of Genetics, University of Cambridge, Cambridge, UK.

name: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

name: Collège Doctoral, Sorbonne Université, Paris, France.

name: DREES, Ministère des Solidarités et de la Santé, Paris, France.

name: Santé Publique France, French National Public Health Agency, Saint-Maurice, France.

name: Emerging Diseases Epidemiology Unit, Institut Pasteur, Paris, France.

name: PACRI Unit, Conservatoire National des Arts et Métiers, Paris, France.

name: Epidemiology and Modelling of Antibiotic Evasion Unit, Institut Pasteur, Paris, France.

name: Anti-infective Evasion and Pharmacoepidemiology Team, CESP, Université Paris-Saclay, UVSQ, INSERM U1018, Montigny-le-Bretonneux, France.

name: Institut Pierre Louis d’Epidémiologie et de Santé Publique, Sorbonne Université, INSERM, Paris, France.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

publisher: American Association for the Advancement of Science (AAAS)


title: Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant

acronym: ENDOCALLOGREFF

summary:
Allogeneic hematopoietic stem cell transplantations (allo-HSCT) is often indicated in malignant hematologic diseases. Conditioning regimens, used to reduce the tumor burden and to prevent transplant rejection, are based on chemotherapy alone or combined with total body irradiation (TBI). Endocrine complications are frequent transplant-related side effects. Investigators have been well described in children studies but less in adulthood.

The objective of this study is to assess retrospectively endocrine, bone and metabolic disorders in adult patients, 12 months after allo-HSCT.

location_facility: CHRU de Brest - Endocrinology and Diabetology Department


title: European Study of Cerebral Aspergillosis Treated With Isavuconazole

acronym: ESCAI

summary:
Study clinical context Cerebral aspergillosis (CA) is a rare location of invasive aspergillosis (IA), associated with a high morbidity and mortality. Since 2002, voriconazole is the recommended first line treatment of invasive aspergillosis. More recently, isavuconazole appeared to be not less effective than voriconazole in the treatment of filamentous IFI, with a better tolerance profile.

The investigators aim to evaluate better the efficacy and the safety of isavuconazole in the treatment of cerebral aspergillosis by a descriptive, multicentric, international retrospective cohort study.

lead_sponsor: Imagine Institute


title: Immunohistochemical Study of Chordomas to Improve Their Diagnosis and Prognosis Care

acronym: CHORDOMES

summary: Chordomas are very rare malignant tumors, chemo-resistant with high propensity for recurrence. The role of immunotherapy in these patients remains largely unexplored while PD-L1 and CD8 status in the micro-environment of chordomas is basically not known. Similarly, this tumor often poses diagnostic difficulties due to its resemblance with metastasis or chondrosarcoma, thus, it would be useful to know the expression status of factors used during the work-up of metastatic or mesenchymal tumors, like CDX2, INSM1 and FOXA1, which remains unknown for chordomas. Thus, the aim of the study is to explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression in a series of chordomas and compare it with clinico-pathological and prognostic features.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Shoulder Muscle Imbalance as a Risk Factor for Shoulder Injury in Elite Adolescent Badminton Players: a Prospective Pilot Study

acronym: BADEPAULE

summary:
Background: To assess the impact of pre-season clinical measures and rotator muscles strength on the risk of significant shoulder injury (SSI) in elite badminton players Design: Prospective cohort study Participants: Nineteen elite adolescents badminton players were included and followed over the badminton season (from september 2018 to may 2019 and/or from september 2019 to may 2020) .

Independent variables: A pre-season visit consisted in clinical and isokinetic shoulder strength testing. Clinical testing consisted in the shoulder range of motion (ROM) measurements and the table-to-acromion distance (TAD)Isokinetic internal and external rotator shoulder muscles strength was tested at 60 and 240°/s. Conventional and functional (eccentric-to-concentric) ratios (FR) were calculated. SSI collection was performed by an experienced sport physician.

lead_sponsor: University Hospital, Caen


title: Feasibility of Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for the Treatment of Venous Malformations.

acronym: SCLERONAV

summary: The aim of this study is to evaluate the feasibility of assisted electromagnetic navigation in percutaneous echo-guided sclerotherapy of slow-flow vascular malformations. Feasibility will be defined in terms of the percentage of patients for whom the procedure is successful.

lead_sponsor: University Hospital, Toulouse


title: Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia: BioCovid Study

acronym: BIOCOVID

summary: The research is a prospective, multicentric (Groupe hospitalier Paris Saint-Joseph, Centre Hospitalier de Versailles André Mignot and Centre Hospitalier Victor Dupouy), non-interventional, prospective study. It aims at measuring eicosanoids at different stages of Covid-19 infection.

ReferenceCitation: Bradley BT, Bryan A. Emerging respiratory infections: The infectious disease pathology of SARS, MERS, pandemic influenza, and Legionella. Semin Diagn Pathol. 2019 May;36(3):152-159. doi: 10.1053/j.semdp.2019.04.006. Epub 2019 Apr 17. Review.

family: Bradley

full_name: Benjamin T. Bradley

given: Benjamin T.

family: Bryan

full_name: Andrew Bryan

given: Andrew

journal_name: Seminars in Diagnostic Pathology

oa_host_type: repository

license: implied-oa

license_normalized: implied-oa

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Yin Y, Wunderink RG. MERS, SARS and other coronaviruses as causes of pneumonia. Respirology. 2018 Feb;23(2):130-137. doi: 10.1111/resp.13196. Epub 2017 Oct 20. Review.

name: Department of Infectious Diseases and Clinical Microbiology; Beijing Chao-Yang Hospital, Capital Medical University; Beijing China

family: Yin

full_name: Yudong Yin

given: Yudong

name: Division of Pulmonary and Critical Care, Department of Medicine; Northwestern University Feinberg School of Medicine; Chicago Illinois USA

family: Wunderink

full_name: Richard G. Wunderink

given: Richard G.

journal_name: Respirology

oa_colors: green hybrid

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Vijayanand P, Wilkins E, Woodhead M. Severe acute respiratory syndrome (SARS): a review. Clin Med (Lond). 2004 Mar-Apr;4(2):152-60. Review.

ReferenceCitation: Fehr AR, Channappanavar R, Perlman S. Middle East Respiratory Syndrome: Emergence of a Pathogenic Human Coronavirus. Annu Rev Med. 2017 Jan 14;68:387-399. doi: 10.1146/annurev-med-051215-031152. Epub 2016 Aug 26. Review.

family: Fehr

full_name: Anthony R. Fehr

given: Anthony R.

family: Channappanavar

full_name: Rudragouda Channappanavar

given: Rudragouda

name: Department of Microbiology, University of Iowa, Iowa City, Iowa 52242;

family: Perlman

full_name: Stanley Perlman

given: Stanley

bso_classification: Biology (fond.)

journal_name: Annual Review of Medicine

oa_colors: green other

evidence: open (via free pdf)


title: Evaluation of the Incidence and Prevalence of Sarcopenia in Patients 70 Year and Older With Localized and Locally Advanced Porstate Cancer, Treated by Radiotherapy and Androgen Deprivation Therapy. a Monocentric Cohort Trial

acronym: HoSAGE

summary:
Prostate cancer is the most common cancer among men 50 years and older and mainly affets patients 75 years old.

Androgen deprivation therapy is indicatated in intermediates and high risks form of prostate cancer, in association with radiotherapy for 6 monts to 3 years. It is also indicated after surgery. Current therapies induce inhibition of sexual hormones as androgens among which testosterone. These therapies present side effects which have to be acknowledeged during the elaboration therapeutic startegies in older patients: hypogonadism induced by androgen deprivation therapy (ADT) causes loss of bone mineral density, diminution of lean body mass and increase of fat body mass.

Sarcopenia is defined by a loss of muscle strength associated to a decrease in skeletal muscle mass. In addition to aging, many factors may contribute to sarcopenia as cancer and/or ADT. This cohort study aims to evaluate risk factors associated to sarcopenia prevalence and the relationship between ADT and sarcopenia incidence, in patients 70 years or older with localized or locally advanced prostate cancer

location_facility: Assistance Publique Hôpitaux de Marseille


title: External Validation of the Rotterdam Prostate Cancer Risk Calculator

acronym: PCaRisk

summary:
Prostate multiparametric MRI (mpMRI) can detect ISUP ≥2 prostate cancer with high sensitivity. Adding biopsies targeting suspicious lesions seen on mpMRI to the classical 'systematic biopsies' (that sample the gland in a blinded way) improves the detection of ISUP ≥2 cancers. As a result, it is now recommended to perform a prostate mpMRI before biopsy and to combine targeted and systematic biopsy.

However, mpMRI suffers from a lack of specificity. In a recent meta-analysis, the pooled sensitivity and specificity of prostate mpMRI for detecting ISUP ≥2 cancers were 0.91 (95% confidence interval, 0.83-0.95) and 0.37 (95% confidence interval, 0.29-0.46) respectively. Thus, accurate triage of patients suitable for biopsy might not be possible using mpMRI findings alone.

The Rotterdam Prostate Cancer Risk Calculator (RPCRC) combines mpMRI results (Prostate Imaging-Reporting And Database System score) and basic clinical and biochemical data to predict the results of prostate biopsy. If validated, this tool could help selecting patients for prostate biopsy.

In this study, the investigators propose to retrospectively use the data of the prospective multicentric MRI-FIRST trial (NCT0285379) to perform an external validation of the RPCRC.

In addition, the PCaRisk study has two secondary objectives:

To confirm that Prostate Specific Antigen density (i.e. PSA level divided by prostate volume) can stratify the risk of ISUP ≥2 cancer in patients with negative (PI-RADS 1-2) or inconclusive (PI-RADS 3) mpMRI, as suggested by recent literature
To perform a preliminary evaluation of a lobe-specific risk calculator developed by our group and combining mpMRI results and clinical and biochemical data to predict the risk of ISUP ≥2 cancer at the lobe level.

location_facility: Department of Radiology, Hôpital Edouard Herriot, Hospices Civils de Lyon


title: Infrared Thermography and Apgar Score: Evaluation in Delivery Room for Term Newborn

acronym: VIRGINA

summary:
Background: The Apgar score assesses the newborn's adaptation in the first minutes of life. It is rated between 0 and 10 by the midwife, at 1-3-5 and 10 minutes of life. A low Apgar score at 5 minutes of life is associated with increased neonatal mortality and neurological impairment. However, this score has limitations and its measurement remains subjective: it does not guide resuscitation actions in the event of poor adaptation, significant inter-observer variability in scoring, variations according to the physiological maturation of the newborn, in particular according to gestational age.

Infrared thermography is a rapidly developing imaging technique based on the measurement of infrared radiation. It is an accurate, reliable and easy instrument of providing rapid non-contact, non-invasive and non-irradiating diagnosis. A recent 2018 study showed that the use of thermography would allow accurate and non-invasive monitoring of newborns in neonatal intensive care unit for early diagnosis of certain pathologies such as infection. During the transition, during the first minutes of life, the circulatory and respiratory systems of the newborn change. Vasodilatation occurs progressively in the central and peripheral areas. Thermoregulation is also a crucial stage of adaptation.

In view of this physiopathological knowledge, it seems interesting to correlate this adaptation , with the analysis of thermographic images. The principle of this technique is indeed based on the analysis of the heat emitted, and would thus make it possible to evaluate the blood perfusion of the newborn, and its evolution in the first minutes of life in an objective way. Our hypothesis is that a poor adaptation could be detected more efficiently on photographs taken at time T, contrary to the calculation of the Apgar score for which there are several limitations mentioned above.

Main objective of the study: To study the ability of the thermographic image to objectively evaluate the adaptation to ectopic life of newborns compared to existing evaluations (Apgar, pH, Lactates).

lead_sponsor: Poissy-Saint Germain Hospital


title: Platelet Activation by a Collagen Analogue in Hemorrhagic Situations

acronym: CAPTURE

summary: Dijon University Hospital and the Dijon-based NVH Medicinal Company have developed a recombinant mini-collagen NVH020B with platelet and Willebrand factor binding activity. Its small size and granular, non-fibrillar presentation make it suitable for use as an injectable hemostat in patients with a hemorrhage or other emergency under antiplatelet therapy.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.

acronym: AERIO

summary: Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus Achromobacter is not known in these conditions. An epidemiological study including a large number of patients is needed to compare the prevalence of these bacteria in sick and healthy subjects, and to highlight the characteristics of the strains and the factors favouring their emergence.


title: Phase I Study, Prospective, Monocentric, Uncontrolled, Non-randomized, Open, Interventional. First Human Administration of an Inflammation Tracer (99mTc-cAbVCAM1-5) Using the Scintigraphy in Healthy Volunteers and Asymptomatic Patients.

acronym: ATHENA

summary:
Clinical Transfer of a Tracer of the Vulnerable Atheroma Plate: 99mTc-cAbVCAM1-5. (ATHENA).

This is a phase I/IIa, prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

ReferenceCitation: GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9. Erratum in: Lancet. 2017 Oct 28;390(10106):e38.

ReferenceCitation: Little WC, Constantinescu M, Applegate RJ, Kutcher MA, Burrows MT, Kahl FR, Santamore WP. Can coronary angiography predict the site of a subsequent myocardial infarction in patients with mild-to-moderate coronary artery disease? Circulation. 1988 Nov;78(5 Pt 1):1157-66.

lead_sponsor: University Hospital, Grenoble


title: Food Matrices Based on Fruit Pastes as Vectors of Carbohydrates for the Prevention and Management of Protein-energy Undernutrition in the Elderly: Proof of Clinical Concept

acronym: Fruisenior

summary: To develop more natural fruit pastes matrices that can effectively act as carbohydrate vectors in the elderly population and that are part of a normal diet while maintaining the pleasure of eating.


title: Histological Prediction and Choice of the Resection Strategy in Front of a Colorectal Lesion > 2 cm: Prospective Comparison of Endoscopic Characterization, Non-targeted and Targeted Biopsies

summary: Colorectal cancer has become a public health priority considering its increased prevalence and high mortality rate when diagnosed late. As a consequence, many countries have promoted and uptaken of colorectal cancer screening programs leading to an increasing detection of advanced but also superficial lesions ESGE (European Society of Gastrointestinal Endoscopy) guidelines states that the majority of those colonic and rectal superficial lesions can be removed in a curative way by standard polypectomy and/or by EMR (Endoscopic Mucosal Resection) and that ESD (Endoscopic Submucosal Dissection) can be considered for removal of colonic and rectal lesions with high suspicion of limited submucosal invasion. Histologically, a resection is curative for the patient when the adenocarcinoma is well-differentiated (G1/G2), with a depth of invasion ≤ sm1 (≤ 1 mm submucosal invasion), with no lymphovascular invasion nor budding and with lateral and deep margins free of cancer

lead_sponsor: Hôpital Edouard Herriot


title: Comparison Between the Old Diagnostic Tools for Paediatric Undernutrition and the New HAS 2019 Recommendations

acronym: EDEN

summary:
Undernutrition is a widely under-diagnosed public health problem, including in pediatrics department. Undernutrition prevalence in pediatrics departments is about 15 to 20%.

Until now, there has been no national consensus on the criteria to be used to diagnose paediatric undernutrition. Until now, assessment focused on a range of non-consensus arguments that allowed the health care team to make its diagnosis. So, in the absence of well-defined criteria, diagnosis was based in part on experience and assesment team.

Since November 2019, the French High Authority of Health (Haute Authorité de Santé - HAS) has suggested recommendations to standardize pediatric undernutrition diagnosis.

The investigators offer to evaluate undernutrition prevalence differences diagnosed according to new HAS criteria compared to the previous diagnostic methodology.

The investigator's secondary aim is to identify profiles of children who do match between the two diagnostics methods.

lead_sponsor: University Hospital, Montpellier


title: Detection and Volumetry of Pulmonary Nodules on Ultra-low Dose Chest CT Scan With Deeplearning Image Reconstruction Algorithm (DLIR)

acronym: DLIRTHORAX

summary: evaluate the diagnostic performance of ultra-low dose CT using deep learning-based reconstruction in the detection of pulmonary nodules.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Radiation


title: Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy

acronym: ThyroVir

summary: Study the interest of hypnosis techniques by virtual reality based on the use of a virtual reality headset with the AQUA® application on the reduction of pre-operative stress in patients candidates for total thyroidectomy

lead_sponsor: Centre Francois Baclesse


title: ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis

acronym: ENDOCHAP

summary: The purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. We also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Acute Renal Insufficiency (ARI) Rate and Predictive Score of ARI in Hospitalized Patients for Acute Coronary Syndrome With ST-segment Elevation Needing Urgent Coronarography

acronym: COROAKI

summary:
The primary objective of the study aims to evaluate frequence of acute renal insufficiency in patients with ST-segment elevation who need urgent coronary angiography in Ambroise Paré hospital.

The secondary objectives are:

identify factors of risks associated with the occurrence of acute renal insufficiency after coronarography.
establish a preprocedure score, predicting of acute renal insufficiency after urgent coronary angiography in patients with ST+ acute coronary syndrome.

location_facility: Nephrology department, Ambroise Paré hospital, APHP


title: Evaluation of Reporting of Road Traffic Accidents With Drugs Responsible for Cognitive and Psychomotor Side Effects (ERoADS)

acronym: ERoADS

summary: Drugs responsible for cognitive and psychomotor side effects may lead to impaired driving skills and road traffic accidents. This study investigates reports of road traffic accident for different class of drugs responsible for cognitive and psychomotor sides effects (pyschotropic agents, neurotropic agents, antineoplasic agents) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

location_facility: Caen University Hospital, Department of Pharmacology


title: Study of the Technological and Operational Feasibility of a Remote Automated Monitoring System for the Post-operative Care of Surgical Patients

acronym: REDASUR

summary: In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 60 patients immediately after in-ward surgery and over 7 days.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC


title: Observational and Monocentric Study of Complications in Adults With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein Initiated in Hospitalization

acronym: ONAC

summary: This observational study will evaluate the frequency of complications in adult cancer patients with central venous parenteral nutrition and the identification of aggravating factors.

ReferenceCitation: Touré A, Vanhems P, Lombard-Bohas C, Cassier P, Péré-Vergé D, Souquet JC, Ecochard R, Chambrier C. Totally implantable central venous access port infections in patients with digestive cancer: incidence and risk factors. Am J Infect Control. 2012 Dec;40(10):935-9. doi: 10.1016/j.ajic.2012.01.024. Epub 2012 May 26.

family: Touré

full_name: Abdoulaye Touré

given: Abdoulaye

family: Vanhems

full_name: Philippe Vanhems

given: Philippe

family: Lombard-Bohas

full_name: Catherine Lombard-Bohas

given: Catherine

family: Cassier

full_name: Philippe Cassier

family: Péré-Vergé

full_name: Denis Péré-Vergé

given: Denis

family: Souquet

full_name: Jean-Christophe Souquet

given: Jean-Christophe

family: Ecochard

full_name: René Ecochard

given: René

family: Chambrier

full_name: Cécile Chambrier

given: Cécile

journal_name: American Journal of Infection Control

title: Totally implantable central venous access port infections in patients with digestive cancer: Incidence and risk factors

ReferenceCitation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum in: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.

name: Division of Infectious Diseases, Warren Alpert Medical School of Brown University, Providence, Rhode Island

family: Mermel

full_name: Leonard A. Mermel

given: Leonard A.

name: University of Alabama-Birmingham Hospital, Birmingham, Alabama

family: Allon

full_name: Michael Allon

given: Michael

name: Servicio de Microbiología Cliínica y E. Infecciosas Hospital General “Gregorio Marañón,”  Madrid, Spain

family: Bouza

full_name: Emilio Bouza

given: Emilio

name: Tufts University School of Medicine, Lahey Clinic Medical Center, Burlington, Massachusetts

family: Craven

full_name: Donald E. Craven

given: Donald E.

name: St. Jude Children's Research Hospital, Children's Infection Defense Center, Memphis, Tennessee

family: Flynn

full_name: Patricia Flynn

given: Patricia

name: National Institutes of Health, Critical Care Medicine Department, Bethesda, Maryland

family: O'Grady

full_name: Naomi P. O'Grady

given: Naomi P.

name: Section of Infectious Diseases, University of Texas-Cancer Center, Houston

family: Raad

full_name: Issam I. Raad

given: Issam I.

name: Internal Medicine and Infectious Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands

family: Rijnders

full_name: Bart J. A. Rijnders

given: Bart J. A.

name: Section of Infectious Diseases, Wake Forest University School of Medicine, Winston-Salem, North Carolina

family: Sherertz

full_name: Robert J. Sherertz

given: Robert J.

name: Division of Infectious Diseases, Washington University School of MedicineSt Louis, Missouri

family: Warren

full_name: David K. Warren

given: David K.

journal_name: Clinical Infectious Diseases

title: Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infection: 2009 Update by the Infectious Diseases Society of America

ReferenceCitation: O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. The Hospital Infection Control Practices Advisory Committee, Center for Disease Control and Prevention, U.S. Pediatrics. 2002 Nov;110(5):e51.

ReferenceCitation: Ullmann AJ, Cornely OA, Donnelly JP, Akova M, Arendrup MC, Arikan-Akdagli S, Bassetti M, Bille J, Calandra T, Castagnola E, Garbino J, Groll AH, Herbrecht R, Hope WW, Jensen HE, Kullberg BJ, Lass-Flörl C, Lortholary O, Meersseman W, Petrikkos G, Richardson MD, Roilides E, Verweij PE, Viscoli C, Cuenca-Estrella M; ESCMID Fungal Infection Study Group. ESCMID* guideline for the diagnosis and management of Candida diseases 2012: developing European guidelines in clinical microbiology and infectious diseases. Clin Microbiol Infect. 2012 Dec;18 Suppl 7:1-8. doi: 10.1111/1469-0691.12037.

title: ESCMID* *Information in this manuscript was presented in part at ECCMID 2011. European Society for Clinical Microbiology and Infectious Diseases guideline for the diagnosis and management of Candida diseases 2012: developing European guidelines in clinical microbiology and infectious diseases

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: "COTIDEA COmparison Between Continued Inpatient Treatment Versus Day Patient Treatment (Partial Hospitalization) After Short Inpatient Care in Early Onset Anorexia Nervosa: a Non-inferiority Trial A Non-inferiority Study"

acronym: COTIDEA

summary:
"In so-called ""early onset"" anorexia nervosa (AN), a rare and severe form affecting 8-13 year olds, experts recommend that, as soon as possible, treatment should take place on an outpatient basis, at an age when separation from the usual environment would be particularly unpleasant and deleterious. However, in severe AN, full-time hospitalisation (FTH) is still indicated when somatic and psychiatric instability criteria are met. Thus, the severity and rapidity of undernutrition in children aged 8-13 years suffering from AN (linked on the one hand to the frequency of total aphagia with refusal to drink and on the other hand to the lack of early detection of the disorder, frequently requires emergency FTH, contrary to expert recommendations. This FTH, which lasts on average 3 months in our specialized unit, has certain disadvantages: poor acceptability by the patient and/or his family, increased anxiety symptoms on entry and exit, school dropout, social isolation, coercive experience. In addition, the rate of premature FTH exits - before weight targets are reached - and the frequency of relapses after FTH remain high, making FTH unsatisfactory in terms of cost-effectiveness. Some families refuse FTH, which is classically long, exposing themselves to the risk of complications that can occur if the disorder is inadequately treated: somatic, acute and chronic complications; risk of progression to another eating disorder.

In recent years, day hospitalization (DH) care has been developed for adolescents aged 11 to 18 years and adults (Madden, 2015). The few studies available are in favour of comparable efficacy, better acceptability and lower cost in the management of moderate AN compared to prolonged FTH, but also better social adaptation.In children aged 8 to 13 years with AN, whose somatic condition requires continuous monitoring in a hospital setting (the usual indication for FTH), a DH cannot reasonably be proposed immediately given the severity of the situation. Our hypothesis is that it would however be possible, in these children, to shorten the duration of FTH and to continue DH treatment once the critical period has passed at the somatic level, with comparable efficacy, best acceptability, best progress in terms of school and social integration, and lower cost.


title: Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease

acronym: COVIDEP

summary:
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.

The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE).

Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients.

To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.

The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.

lead_sponsor: Hopital Foch


title: Perceived Burden and Quality of Life of Primary Caregivers of Cancer Patients Aged 70 and Older After 5 Years of Management

acronym: FARAPPAC

summary:
Cancer is a disease that requires long-term management, especially now that medical advances have transformed most cancers from an acute to a chronic condition. Most of the time, therefore, the help provided by family and friends is long-term.

The negative impact of oncological care on the quality of life of family caregivers has already been studied. The UCOGB carried out a study in 2014 on the primary caregivers of cancer patients aged 70 and over at inclusion and at 3 and 6 months of oncogeriatric care. This study showed that several factors were significantly related to the caregiver's quality of life: the caregiver's age, perception of burden and patient autonomy (18). However, the evolution of quality of life and burden at 5 years has, to our knowledge, never been evaluated.


title: Effect of the Use of HYPNO VR on Pain Experienced During Chest Drain Insertion in Resuscitation Vigilant Patients.

acronym: VeRHiTY

summary: The main objective of this study is to evaluate, in vigilant resuscitation patients, the effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology - DISSPO Parcours Dig' Study

acronym: DParcoursDig

summary:
Patients with advanced gastrointestinal (GI) cancers are very often sarcopenic/malnourished at diagnosis (> 60% of cases) and at high risk of rapid clinical deterioration. These patients have important supportive care needs that represent a major challenge for improving treatment tolerance and patient survival and health-related quality of life (HRQoL).

Malnutrition and sarcopenia (muscle wasting and dysfunction) are associated with an increased risk of death, complications from chemotherapy, infections, emergency procedures and hospitalizations, and increased costs of care. Therefore, malnutrition and sarcopenia represent a major clinical target in GI cancers.

Interventions targeting malnutrition/sarcopenia should be implemented as early as possible in patients' pathways, these syndromes being reversible at early stages but not at late stages.

A multidisciplinary assessment at diagnosis and therapeutic approach combining nutritional support and and adapted physical activity (APA) in addition to anticancer treatments should be systematically implemented in patients with advanced GI cancers.

This type of intervention complies with the standards recommended by the National Cancer Institute (INCa) to promote the practice of physical activity during and after treatment in oncology.

lead_sponsor: Institut Curie


title: Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults in Therapeutic Failure or Relapse and Not Eligible for a Clinical Trial: a Project of the SFCE

acronym: SACHA

summary: It involves collecting safety and efficacy data, under the actual conditions of use of medicines in children and adolescents, using a validated tool (VIGINOM) and relying on the network of Interregional pediatric oncology appeal organizations (OIR) identified by INCa since 2010 and responsible for the organization of Pluridisciplinary Pediatric Interregional (RCPPI) and National Consultative Meetings which discuss each case of relapse in order to define the best therapeutic options.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Screening of Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism

acronym: CHIPS

summary:
The aim of the study is to investigate the existence of clonal hematopoiesis of indeterminate potential (CHIP) in patients with a history of venous thromboembolism.

The study investigators make the assumption that these patients present mutations involved in CHIP occurrence.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Verification of the Safety of Normal Food Before a Cerebral Arteriography

acronym: VIANAC

summary:
Fasting is currently required before elective cerebral angiography, despite numerous arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose to assess frequency of nausea and vomiting among patients having taken their breakfast at home before day care angiography.

The investigators hypothesise that less than 1% of non fasting patients will suffer of vomitint.

lead_sponsor: Nantes University Hospital