title: Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer: First in Human Evaluation in Perioperative With Regard to a Control Group

acronym: EPIKARD

summary:
The objective of this study is to evaluate a new medical device in the management of pain. The principle of this new treatment is based on the emission of electromagnetic radiation in millimeter band. This new modality of pain management is evaluated in a perioperative management in patients undergoing surgery for aortic valve replacement.

The hypothesis is that the use of this medical device in perioperative would reduce the consumption of postoperative morphine with an identical quality of analgesia. The decline in morphine consumption would allow a decrease in opioid adverse effects.

collaborators: Clinical Investigation Centre for Innovative Technology Network


type: EudraCT Number

title: Effects of Tofacitinib on Body Composition, Bone Mineral Density and Bone Marrow Adiposity in Patients With Rheumatoid Arthritis: the TOFAT Project

acronym: TOFAT

summary:
Inflammatory rheumatic diseases (IRD), such as rheumatoid arthritis, are characterized by adverse changes in body composition. Lean mass and bone mineral density are usually reduced while adiposity (total fat mass, visceral adiposity…) is increased in comparison with healthy controls. Many factors may influence the body composition of those patients such as aging, Disease Modifying Anti-Rheumatic Drugs (DMARDs), nutrition and physical activity.

However, data on body composition and adverse changes under DMARDs in patients with rheumatoid arthritis (RA) are actually scarce. This is the case with tofacitinib (targeted synthetic DMARD or tsDMARD) while preliminary data let us think that this treatment may influence body composition and bone mineral density.

This study is going to be the first to focus on changes in body composition (fat mass and lean mass), bone mineral density and bone marrow adiposity under tofacitinib.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Dodington DW, Desai HR, Woo M. JAK/STAT - Emerging Players in Metabolism. Trends Endocrinol Metab. 2018 Jan;29(1):55-65. doi: 10.1016/j.tem.2017.11.001. Epub 2017 Nov 27.

ReferenceCitation: Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.

ReferenceCitation: Tatsumi Y, Nakao YM, Masuda I, Higashiyama A, Takegami M, Nishimura K, Watanabe M, Ohkubo T, Okamura T, Miyamoto Y. Risk for metabolic diseases in normal weight individuals with visceral fat accumulation: a cross-sectional study in Japan. BMJ Open. 2017 Jan 16;7(1):e013831. doi: 10.1136/bmjopen-2016-013831.

ReferenceType: result

ReferenceCitation: Book C, Karlsson MK, Akesson K, Jacobsson LT. Early rheumatoid arthritis and body composition. Rheumatology (Oxford). 2009 Sep;48(9):1128-32. doi: 10.1093/rheumatology/kep165. Epub 2009 Jul 13.

ReferenceCitation: Haugeberg G, Uhlig T, Falch JA, Halse JI, Kvien TK. Bone mineral density and frequency of osteoporosis in female patients with rheumatoid arthritis: results from 394 patients in the Oslo County Rheumatoid Arthritis register. Arthritis Rheum. 2000 Mar;43(3):522-30. doi: 10.1002/1529-0131(200003)43:33.0.CO;2-Y.

ReferenceCitation: Toussirot E, Mourot L, Dehecq B, Wendling D, Grandclement E, Dumoulin G; CBT-506. TNFalpha blockade for inflammatory rheumatic diseases is associated with a significant gain in android fat mass and has varying effects on adipokines: a 2-year prospective study. Eur J Nutr. 2014 Apr;53(3):951-61. doi: 10.1007/s00394-013-0599-2. Epub 2013 Oct 31.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer

ReferenceCitation: Marouen S, Barnetche T, Combe B, Morel J, Daien CI. TNF inhibitors increase fat mass in inflammatory rheumatic disease: a systematic review with meta-analysis. Clin Exp Rheumatol. 2017 Mar-Apr;35(2):337-343. Epub 2016 Dec 13.

ReferenceCitation: Engvall IL, Tengstrand B, Brismar K, Hafstrom I. Infliximab therapy increases body fat mass in early rheumatoid arthritis independently of changes in disease activity and levels of leptin and adiponectin: a randomised study over 21 months. Arthritis Res Ther. 2010;12(5):R197. doi: 10.1186/ar3169. Epub 2010 Oct 21.

ReferenceCitation: Tournadre A, Pereira B, Dutheil F, Giraud C, Courteix D, Sapin V, Frayssac T, Mathieu S, Malochet-Guinamand S, Soubrier M. Changes in body composition and metabolic profile during interleukin 6 inhibition in rheumatoid arthritis. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):639-646. doi: 10.1002/jcsm.12189. Epub 2017 Mar 18.

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 OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: Australian Catholic University - Research Bank

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
researchbank.acu.edu.au

unpaywall_oa_status: gold

publisher_dissemination: Wiley

ReferenceType: derived

ReferenceCitation: Letarouilly JG, Paccou J, Badr S, Chauveau C, Broux O, Clabaut A. Stimulatory Effect of Tofacitinib on Bone Marrow Adipocytes Differentiation. Front Endocrinol (Lausanne). 2022 Jul 6;13:881699. doi: 10.3389/fendo.2022.881699. eCollection 2022.

license: cc-by

license_normalized: cc-by

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

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


type: Other Identifier

title: Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

acronym: TOCAF

summary: This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceCitation: Dubosq M, Goueffic Y, Duhamel A, Denies F, Dervaux B, Goyault G, Sobocinski J. Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial. Ann Vasc Surg. 2021 Jan;70:362-369. doi: 10.1016/j.avsg.2020.06.061. Epub 2020 Jul 4.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repositories_concat: HAL

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

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

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Abbott

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

acronym: SPOC

summary: Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.

status: Completed

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Drug

status_simplified: Completed


title: Prognostic Value of sST2 in Cardiac Surgery on Long Term Morbimortality

summary:
Evaluation of the prognosis value of sST2 dosed before cardiac surgery on prognosis of long terme prognosis after cardiac surgery.

The patients where initialy recruted for another cohort named micro-SIRS and inflammation but the gaved their consent to analyse the blood samples for other studies

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

acronym: TEMPET

summary:
Connected medicine "2.0" is a major challenge that will lead in the near future to profound changes in medical practices. Our study is part of this technological transformation, which is already taking the form of multiple devices available to practitioners: connected pill dispensers, integrated monitoring and surveillance systems (telemedicine), connected sensors, etc.

However, a symptom as crucial and simple as body temperature has not been measured by real-time enteric capsule in a context of neutropenia. We therefore wish to study the concordance between the peripheral (tympanic) temperature and that measured by a capsule ingested in a cohort of patients hospitalized in the USIH. If the measurements are clinically reliable and truly allow anticipation of antimicrobial treatments, a medico-economic evaluation will be proposed between the two options in the context of USIH before its possible generalization.

status: Unknown status

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Centre Henri Becquerel

lead_sponsor_type: industriel

status_simplified: Unknown


title: Study of the Effectiveness of a Guided Compensatory Cognitive Remediation Program for Family Caregivers in Schizophrenia: a Randomized Pilot Study

acronym: CIRCUS

summary:
Cognitive impairments are extremely common in schizophrenia and strongly predict deficit in daily functioning, the poor managing medication and multiple hospitalizations. Cognitive remediation is recognized to have an impact on cognitive impairments by engaging preserved cognitive functions or by implementing environmental supports that sustain independent living.

Pr. Velligan (University of San Antonio) developed and tested a manualized intervention, called Cognitive Adaptation Training. In this program, trained mental health specialists implement compensatory technique such as environmental supports in the individual's living environment to live more independently and achieve greater self-sufficiency.

However, implementing this program needs a lot of professionals and time to maintain CAT effects. This type of intervention is not often done in community care and explains the large number of patients who are dependent on family members for daily living activities. Training family members in this form of intervention would be an appropriate way to resolve these issues. Families expressed a real interest in these types of home-support strategies that CAT offers. Recently, Pr. Kidd and Pr. Velligan developed a CAT version for families and created a manual accessible to people without any knowledge of cognitive deficit. This manual helps families to select specific cognitive-adaptative strategies with their relative to achieve targeted goals. Thism ethod has been translated in French.

The aim of this study was to examine whether Web-based family Cognitive Adaptation Training can improve functioning, medication adherence and negative symptoms for individuals with schizophrenia and reduce burden for family members.

A total of 60 Dyads consisting of one caregiver and one supported individual with schizophrenia will be randomized to either a Web-based family Cognitive Adaptation Training or an Internet-based control condition. Primary outcome measured will be the score on the life skills profile. Secondary outcomes will include the global score of the Zarit burden Interview, PANSS negative score, and medication adherence.

This type of intervention is expected to be developed in territorial area where professionals are not trained to cognitive remediation and therefore substantially lowers the barrier to the deployment of cognitive intervention with other psychosocial interventions for individual with schizophrenia and their caregivers.

primary_purpose: Supportive Care

location_facility: Service Universitaire de psychiatrie adulte

intervention_type: Behavioral


title: Systematic Screening and Identification of Psychoactive Substances Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department

acronym: DRUGS

summary:
Adolescence is a time for great physical and psychological change and it's often at that period of life that first use of psychoactive substances occurs. Although addiction is rare in teenagers, psychoactive substances abuse can have serious long-term health consequences on them. This is therefore a priority for all healthcare providers to identify early use and abuse of drugs in the youth's population.

The addictive process underlies environmental, genetic and individual causes. That is why it is somehow possible to identify individuals at risk based on some common sociological, cultural and environmental risk factors.

Due to the acute consequences of psychoactive substances abuses, Emergency Departments are main checkpoints for the screening of young drug users. Indeed, one patient out of five admitted in an Emergency Department shows a positive blood alcohol concentration regardless of the reason for their admission. This rate is twice as high as in the overall population. Hence, Emergency Departments are at the front-line for screening, caring, referral and transfer of psychoactive substances users. That is why the Emergency Department is the best place for this study.

In 2004, the special consultations of young consumers were founded in order to deal with these special cases where dependence is not yet established or installed and care has to be adapted to the age. Offering help to this age range represents a real challenge since only 20% of the teenagers come to visit this special consultations on their own initiative. The rest of teenagers are either obliged by their parents or sentenced by a court. The investigators assume that the repetition of care offered to the teenagers by repeated emergency admissions could trigger their own desire to overcome their drug use disorders and visit the Addictionology Department.

lead_sponsor: Hospices Civils de Lyon


title: Is Short Antibiotherapy Duration After Drainage Suitable for Patients Admitted in Intensive Care Medicine With a Severe Acute Cholangitis?

acronym: CASCAD

summary:
Acute cholangitis (AC) occurs when biliary stenosis, due to various benign causes (often gallstones) or the presence of a tumour, leads to cholestasis and biliary infection. AC is a life-threatening infection if not diagnosed and treated in time, its mortality ranges from 1.4% to 5.2%. AC can be classified into different stages of severity depending on organ failure. A severity classification has been proposed by the Asian recommendations of Tokyo 2013: Grade I (Benin), Grade II (Moderate) and Grade III (Severe).

AC treatment includes endoscopic or percutaneous bile drainage in combination with systemic antibiotic treatment. It is currently recommended that patients with severe CA (Grade III) have biliary drainage within 24 hours, although it has not been shown to improve their survival. The emergence of antibiotic-resistant germs, which is a public health issue, calls for reasonable and considered use of antibiotics. Reducing the duration of antibiotic therapy is a fundamental measure of antimicrobial management and antibiotics sparing. 7 to 10 days of antibiotic treatment is common in the treatment of CA. A 14-day treatment is recommended in case of associated bacteremia. A recent study of 263 patients showed that reducing the duration of antibiotic therapy to less than 7 days in patients with CA associated with bacteremia with effective drainage does not increase the risk of recurrence or mortality at 30 days. However, this study was monocentric retrospective and compared groups that were unbalanced in terms of CA severity. The optimal duration of antibiotic therapy in the treatment of CA in critically ill patients hospitalized in intensive care remains poorly known.

The main purpose of this study is to compare short antibiotic therapy with long antibiotic therapy in terms of mortality in patients with AC admitted in intensive care unit (ICU).

lead_sponsor: Nantes University Hospital

intervention_type: Procedure


title: Diagnostic Value of Antibodies Against Carbamylated Proteins in Psoriatic Arthritis.

acronym: CARPAPA

summary: Anti-carbamylated protein (anti-CarP) antibodies are present in approximately one-fourth of the patients who are seronegative for both rheumatoid factor and anti-citrullinated protein antibody and who may therefore have psoriatic arthritis. The investigators hypothesized that detection of anti-CarP antibodies in serum may be useful for diagnosis of psoriatic arthritis.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Association pour la Recherche Clinique et Immunologique

intervention_type: Diagnostic Test


title: Perceptions, Representations and Experiences of Septic Isolation of Hospitalized

summary:
The aim of this study is to analyze the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection.

This analysis could lead to better understanding and communication between the medical profession and patients in septic isolation in hospital. It would also provide patient-specific responses to their expectations, as to their families.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Villeneuve St Georges

intervention_type: Other


title: Screening for Fabry Disease in Renal Transplantation

acronym: DEFYT

summary: Single centre, prospective pilot study examining the relevance to screen for Fabry disease in a cohort of patients who have undergone renal transplantation for nephropathy of indeterminate cause, vascular nephropathy, diabetic nephropathy or secondary focal segmental hyalinosis with no established cause.


title: Source Monitoring Déficit in Neuropsychiatric Population

summary: the investigators will measure source-monitoring ability in patients with several neuropsychiatric condition and in healthy controls appaired in age, sex and educational level. Source-monitoring will be measured thanks to internal- and reality-monitoring informatic tasks.The investigators hypothesized patients with fronto-temporal abnormalities would show more marked deficits than patients with only frontal abnormalities.

primary_purpose: Basic Science

lead_sponsor: Hôpital le Vinatier


title: Impact of HMS Plus Device on Postoperative Blood Loss During Cardiac Surgery

acronym: POC/HMS

summary:
Activated clotting times (ACT) is employed most commonly to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). However, many studies have demonstrated a lack of correlation between plasma heparin levels and ACT during CPB.

HMS Plus device estimate the free plasma heparin level from a whole-blood sample and also include the dose of protamine necessary to neutralize the circulating heparin at the end of CPB. It could predict a higher heparin dose and lower protamine dose but it's interest on postoperative bleeding and perioperative transfusion is unclear.


title: Assessment of Clinical Competence of Medical Students: a Comparison of High-fidelity Simulation, Serious Game and Multiple-choice Questions

acronym: SIMEVAL

summary:
This study, focusing on the management of pediatric asthma exacerbations, assesses the clinical skills of medical students using three different evaluation tools: (i) the simulation game "Effic'Asthme" developed to train individuals on the management of pediatric asthma exacerbations; (ii) a multiple choice questionnaire (MCQ) on the same subject developed for the purpose of the study and (iii) high fidelity (HF)-simulation, considered as the gold-standard for its enhanced realism.

Its objective is to determine which of the simulation game or the MCQ reflects the best the clinical competence of medical students evaluated on a HF simulator.

ReferenceCitation: Norcini JJ, Swanson DB, Grosso LJ, Webster GD. Reliability, validity and efficiency of multiple choice question and patient management problem item formats in assessment of clinical competence. Med Educ. 1985 May;19(3):238-47. doi: 10.1111/j.1365-2923.1985.tb01314.x.

ReferenceCitation: Drummond D, Delval P, Abdenouri S, Truchot J, Ceccaldi PF, Plaisance P, Hadchouel A, Tesniere A. Serious game versus online course for pretraining medical students before a simulation-based mastery learning course on cardiopulmonary resuscitation: A randomised controlled study. Eur J Anaesthesiol. 2017 Dec;34(12):836-844. doi: 10.1097/EJA.0000000000000675.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Adjedj J, Ducrocq G, Bouleti C, Reinhart L, Fabbro E, Elbez Y, Fischer Q, Tesniere A, Feldman L, Varenne O. Medical Student Evaluation With a Serious Game Compared to Multiple Choice Questions Assessment. JMIR Serious Games. 2017 May 16;5(2):e11. doi: 10.2196/games.7033.

ReferenceCitation: Fonteneau T, Billion E, Abdoul C, Le S, Hadchouel A, Drummond D. Simulation Game Versus Multiple Choice Questionnaire to Assess the Clinical Competence of Medical Students: Prospective Sequential Trial. J Med Internet Res. 2020 Dec 16;22(12):e23254. doi: 10.2196/23254.

repositories_concat: PubMed Central

publisher_dissemination: JMIR Publications

ipd_sharing: Yes

ipd_sharing_description:
Participants' characteristics anonymized
Participants' correct and incorrect actions and answers when evaluated on the 3 different modalities: multiple choice questionnaire, high-fidelity simulation and simulation game

lead_sponsor: Ilumens


title: Comparison Between Alveolar Bone Graft With Only Cancellous Bone, and Alveolar Bone Graft With Cancellous Bone Combined With Nasal Cavity Floor's Reconstruction Using a Cortical Block

summary:
Alveolar bone graft is one of the main step of the surgical care of the patients who are suffering from cleft lip and palate. They are usually performed before the lateral incisor eruption, at about 5 years old and using cancellous bone taken from the iliac crest.

The aim of the study is to show if adding a cortical graft to the cancellous cause more complications, which may be source of partial or total graft loss in the 6 month following the observation


title: Interest of Cognitive-behavioral Therapies Based on the CBSM (Cognitive Behavior Stress Management) for the Management of Patients Suffering From Pain Related to Cancer.

acronym: CBSM

summary: The CBSM is a program combining cognitive and behavioral therapies, relaxation provided in groups of 8 to 10 patients. This program has demonstrated benefits in stress management skills, adaptive strategies, anxiety, quality of life, social inclusion, medication adherence, depression, therapeutic alliance, and general well-being. It would also improve breast cancer survival after adjuvant therapy. This program has been put in place at the center of pain for patients with cancer pain in any stage. This study aims to evaluate the benefits of this technique on a patient population suffering from chronic pain related to cancer.

lead_sponsor: University Hospital, Grenoble


title: French Cohort of Carotid Web Associated With Cerebral Infarctions

acronym: CAROWEB

summary: Carotid Web located at the bulb level is a rare condition and is often associated with severe cerebral infarction in the carotid territory. This condition has been described predominantly in the black population. However, limited data are available for the epidemiology of carotid web and often result from selected population studies. It has been shown that the carotid web is a focal intimal dysplasia. Rate of ischemic stroke recurrence is high, even in patients treated with antiplatelet therapy. This subtle lesion is often unknown and misdiagnosed including in stroke unit. We assume that the implementation of a multicentric cohort would allow a comprehensive analysis of the carotid web condition.

lead_sponsor: University Hospital, Bordeaux


title: AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies

acronym: AngioCHIC

summary: In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management.

status: Active, not recruiting

sponsor_collaborators: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Retrospective Study of Causes Associated With Small Fiber Neuropathies.

acronym: EtioNPF

summary:
Small fiber neuropathy (SFN) is an injury of cutaneous nerve fibers, mainly by a decrease in their density within the cutaneous tissue. The symptomatology associated with this SFN is broad with symptoms that are essentially sensory, but also autonomic. The etiologies of SFN are numerous (diabetes, drug, infectious, immunological...) and clinically non-specific, justifying a broad etiological assessment. The appearance of staged skin biopsies in the SFN balance sheet has greatly helped to improve diagnosis.

Despite this, a significant part of SFN remains without associated etiology and is considered idiopathic.

As the distribution of the different causes of SFN remains a missing data to date, the completion of this cohort study by one of the SFN reference centres should make it possible to establish the prevalence of SFN causes over a large population.

Only patients with clinical symptoms that may be related to SFN and who have been sampled for SFN, positive or not, will be eligible for recruitment.

The result of the anatomopathological sampling will allow patients to be separated into two groups, with or without SFN.

The main judgement criteria will be the prevalence of etiologies associated with SFN: diabetes, medication, systemic lupus erythematosus, Gougerot-Sjögren syndrome, amylosis, dysthyroidism, alcoholism, vitamin B12 deficiency, HIV infection, hepatitis C, paraneoplastic syndrome, hereditary disease (Fabry disease, Friedreich ataxia,...), idiopathic, others.

study_start_date_type: Anticipated

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement

acronym: CovImmune 2

summary:
This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study.

The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality.

The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Balance REhabilitation With Modified Visual Input in Patients With acQuired Chronic Demyelinating Neuropathy and PROprioceptive Disorders

acronym: REQ-PRO

summary:
This research focuses on the effects of rehabilitation on balance, in patients with acquired chronic demyelinating neuropathy. Rehabilitation will be performed with or without vision.

It is planned to include 40 subjects consulting for walking instability related to sensitivity disorders.

This multicenter study will take place in Paris's area. Each participant will benefit from 20 rehabilitation sessions with a Physical Therapist and 3 assessments.

Thanks to randomization, patient will be allocated in one of the 2 following groups:

Control group, Patients will benefit from balance rehabilitation with open eyes.
Experimental group, they will perform the same exercises while keeping their eyes closed or their vision will be obstructed by a mask or disturbed by moving luminous dots projected on the environment in darkness.

ReferenceCitation: Barrois RP, Ricard D, Oudre L, Tlili L, Provost C, Vienne A, Vidal PP, Buffat S, Yelnik AP. Observational Study of 180 degrees Turning Strategies Using Inertial Measurement Units and Fall Risk in Poststroke Hemiparetic Patients. Front Neurol. 2017 May 15;8:194. doi: 10.3389/fneur.2017.00194. eCollection 2017.

ReferenceCitation: Bonan IV, Yelnik AP, Colle FM, Michaud C, Normand E, Panigot B, Roth P, Guichard JP, Vicaut E. Reliance on visual information after stroke. Part II: Effectiveness of a balance rehabilitation program with visual cue deprivation after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004 Feb;85(2):274-8. doi: 10.1016/j.apmr.2003.06.016.

ReferenceCitation: Yelnik AP, Le Breton F, Colle FM, Bonan IV, Hugeron C, Egal V, Lebomin E, Regnaux JP, Perennou D, Vicaut E. Rehabilitation of balance after stroke with multisensorial training: a single-blind randomized controlled study. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):468-76. doi: 10.1177/1545968308315996.

ReferenceCitation: Provost CP, Tasseel-Ponche S, Lozeron P, Piccinini G, Quintaine V, Arnulf B, Kubis N, Yelnik AP. Standing postural reaction to visual and proprioceptive stimulation in chronic acquired demyelinating polyneuropathy. J Rehabil Med. 2018 Feb 28;50(3):278-284. doi: 10.2340/16501977-2314.

ReferenceCitation: Missaoui B, Thoumie P. Balance training in ataxic neuropathies. Effects on balance and gait parameters. Gait Posture. 2013 Jul;38(3):471-6. doi: 10.1016/j.gaitpost.2013.01.017. Epub 2013 Mar 5.

ReferenceCitation: Filiatrault J, Gauvin L, Fournier M, Parisien M, Robitaille Y, Laforest S, Corriveau H, Richard L. Evidence of the psychometric qualities of a simplified version of the Activities-specific Balance Confidence scale for community-dwelling seniors. Arch Phys Med Rehabil. 2007 May;88(5):664-72. doi: 10.1016/j.apmr.2007.02.003.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Médecine Physique et de Réadaptation (MPR)


title: Population Pharmacokinetics and Dosing Regimens Optimization of Ceftazidime in Critically Ill Burn Children

acronym: CEFTAZOPTIM

summary:
Concentrations and effects of Ceftazidime in critically ill burn children are unpredictable and the risk of under-exposure may be associated with poor clinical outcomes. In addition, between-subject variability (BSV) is known to be substantial in critically ill burn children.

Optimization of Ceftazidime dosing is therefore desirable for all. The investigators aim to investigate, using a population approach, the pharmacokinetics (PK) of Ceftazidime including PK/pharmacodynamic (PD) targets (fT(%) > minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill burn children. The effects of covariates on Ceftazidime PK and PK/PDs are investigated in order to better explain the BSV and to ultimately suggest individualized dosage regimens.

It will be a prospective PK study. Six blood samples were taken from each patient during dosing interval. The primary PK/ PD targets were Ceftazidime concentrations above the MIC of the pathogen at both 50% (50% f T>MIC) and 100% (100% f T>MIC) of the dosing interval. The investigators used skewed logistic regression to describe the effect of Ceftazidime exposure on patient outcome.

location_facility: Hospital Necker - Enfants Malades (Public Hospitals of Paris)


title: Emotional and Social Impact on the Relatives of Hospitalized Children for Severe Trauma of 3 to 6 Months After the Intensive Care Unit Leaving

acronym: RESPET

summary: This research aims to study the occurrence of post-traumatic stress, anxiety or depression in the parents of a child who has been hospitalized in intensive care unit following a severe trauma.


title: Retrospective Descriptive Study on Retroplacental Hematomas in Finistère

acronym: HEMOPLACENTA

summary: Cases with placental abruption will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018. First trimester PAPPA and bhCG levels will be recorded. PlGF levels will be measured in women with an available first trimester serum sample. Histological findings in placentas, course of pregnancies, maternal and fetal characteristics will described and compared between cases with and without placental chronic inflammation.


title: Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?

summary:
Visceral hypersensitivity is frequent in IBS population up to 60% and is correlated with severity and altered quality of life. Sleeping troubles are most frequent in IBS population. Insomnia is a frequent disorder with an important cost for healthcare. Insomnia could decrease pain threshold.

Visceral hypersensitivity was never measure in patients with insomnia. The hypothesis is IBS patients with insomnia probably have lower visceral pain threshold.

The objective is to assess pain threshold during a barostat procedure in in IBS patients with or without insomnia in comparison with healthy volunteers or patients with insomnia.

If the hypothesis are confirmed, insomnia should be look at in IBS patients and its treatments could improve visceral hypersensitivity and IBS symptoms.

lead_sponsor: University Hospital, Rouen


title: Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy

acronym: AJIACT

summary: This study aims to describe physical activity among juvenile idiopathic arthritis children, according to the disease's and patient's characteristics.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis

acronym: TractoCA

summary:
Urinary and faecal incontinences generally come from a dysfunction of the pelvic floor muscles, and more particularly the sphincters. Among other causes, they may be related to accidental trauma, obstetric or iatrogenic. On this last point, the incidence of surgical interventions on the bladder collar and on the anal canal on the prevalence of incontinences can be underlined.

MRI tractography could be an interesting tool to visualize in 3D the structure of pelvic sphincters and their lesions. It may thereby establish the link with observed dysfunctions, thus potentially providing a complement to the urological and proctographic examinations already carried out.

The objective of this study is, first, to define the sensitivity of the MRI tractography for the visualization of the pelvic sphincters architecture regardless of the gender. In a second time, it will give a description of normal and abnormal (pathological cases) tractography, as well as a descriptive post-surgery. The other interest of this study is the assessment of the information provided by pelvic sphincters tractography on a panel of various and frequently encountered situations in clinical routine at the IHU.

ReferenceCitation: Zijta FM, Froeling M, van der Paardt MP, Lakeman MM, Bipat S, van Swijndregt AD, Strijkers GJ, Nederveen AJ, Stoker J. Feasibility of diffusion tensor imaging (DTI) with fibre tractography of the normal female pelvic floor. Eur Radiol. 2011 Jun;21(6):1243-9. doi: 10.1007/s00330-010-2044-8. Epub 2011 Jan 1.

ReferenceCitation: Zijta FM, Lakeman MM, Froeling M, van der Paardt MP, Borstlap CS, Bipat S, Montauban van Swijndregt AD, Strijkers GJ, Roovers JP, Nederveen AJ, Stoker J. Evaluation of the female pelvic floor in pelvic organ prolapse using 3.0-Tesla diffusion tensor imaging and fibre tractography. Eur Radiol. 2012 Dec;22(12):2806-13. doi: 10.1007/s00330-012-2548-5. Epub 2012 Jul 14.

ReferenceCitation: Rousset P, Delmas V, Buy JN, Rahmouni A, Vadrot D, Deux JF. In vivo visualization of the levator ani muscle subdivisions using MR fiber tractography with diffusion tensor imaging. J Anat. 2012 Sep;221(3):221-8. doi: 10.1111/j.1469-7580.2012.01538.x. Epub 2012 Jul 4.

lead_sponsor: IHU Strasbourg

location_facility: Service de Radiologie et d'Echographie, NHC Strasbourg


title: Efficacy of a Dialectical Behavior Therapy and Acceptance Commitment Therapy Short Program for Prevention of Suicidal Behavior in Patients With Borderline Personality Disorder

acronym: DIABOLO

summary:
According to the World Health Organization 1 death by suicide occurs every 40 seconds, leading suicide prevention to one of the public health priority.

Borderline personality disorder (BPD) is a common condition affecting 6% of the population.

This disorder is characterized by unstable emotions, unstable mood, difficulties with relationship and feer of abandonment.

BPD is also the psychopathology the most related to suicidal attempts. Indeed, up to 50% of the patients admitted to hospital after a suicide attempt are diagnosis with a BPD.

Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt.

People with a BPD are highly sensitive to it. Unfortunately, patient care for this disorder is limited. Pharmacological strategies didn't show any efficacy and psychotherapies, although proven effective, are difficult to set up.

As BPD is strongly related to suicidal attempts it appears to be a good model to study suicidal behavior. Thus, this study could improve knowledge in this field.

Suicidal behavior in patients receiving the standard therapy (dialectic behavioural therapy: DBT) will be compared to patients receiving dialectical behavior therapy and acceptance commitment therapy (ACT).

Clinical data reflecting how the participant is feeling will be collected as well.

status: Withdrawn

primary_purpose: Prevention

collaborators: INSERM 1061, " Neuropsychiatry: epidemiological and clinical research", Montpellier


title: Dental Implants in Patients With X-linked Hypophosphatemia

acronym: IMPLANTS-XLH

summary: X-linked hypophosphatemia (XLH) is a rare genetic skeletal disease where increased phosphate wasting in the kidney leads to hypophosphatemia and prevents normal mineralization of bone and dentin, with osteomalacia as a principal manifestation. In previous works, the investigators have shown that adults with XLH present with more frequent and severe periodontitis than in the general population, and that vitamin D and phosphate supplementation improves their periodontal health, as it does for the osteomalacia. Their medical records also reveal that early implant failure is dramatically increased in these patients, when no supplementation is implemented, and standard surgical protocols followed. In contrast, the investigator's preliminary data showed that successful osseointegration was achieved with supplementation prior and after implant placement and extended healing time. Here, the investigators propose to assess the current recommendations for implant therapy in XLH patients, with 24 implants placed. The current recommendations consist of: 1) supplementation with vitamin D and phosphate for 3 months prior to implant placement and 6 months after; 2) implant healing time extended to 6 months. If osseointegration is achieved, prosthesis will be fabricated. Radiographic and clinical examination at 6, 12, 18 and 24 months after placement of the definitive restoration will evaluate the implant osseointegration, crestal bone level and peri-implant tissues health.

location_facility: Service d'Odontologie - Hôpital Bretonneau - 23 rue Joseph de Maistre


title: Treating Phobias Using Emotional Regulation Developed by the Tipi Association

acronym: RE

summary:
Background In emotional regulation, the patient remembers an emotional situation, focuses his attention on his physical sensations when he relives a recent emotion, and let evolve his sensations.
Method Evaluate the relevance of this method by an interventional study, in a pre-post mono group, on patients suffering from phobia.
Objective The investigators aim to validate the effectiveness of this emotional regulation method and compare its results with that of conventional methods. Sessions are individual and repeated until the disappearance of phobic fear.

The present study may contribute to propose a new possibility to treat phobias in a simple and fast way.

collaborators: Luc Nicon, Education Specialist, Founder of "Tipi", a non-profit French association


title: Seniors'Health Paths " PAERPA ", a Support Being Made Available to General Practionners for Assistance in the Management of Elderly Persons at Risk of Losing Their Independence. Review of the Implementation of the Arrangement on the Est-héraultais Territory.

acronym: PAERPA

summary:
•Background: PAERPA experimentation implemented in the East-Herault region since September 2017 aims to identify fragility and prevent the risk of loss of autonomy in elderly persons older than 60 years by facilitating coordination between Professionals taking care of the patient with the personalized health plan " PPS". The main objective of this study was to evaluate the implementation of this device through the achievement or not of the objectives set by the PPS.

•Methods: Descriptive cohort study with retrospective inclusion and prospective follow-up from the East Herault CTA database. All patients over 60 years old living at home and having a PPS written between September 2017 and April 2018 were included. PPS monitoring for 1 year. Description of this population then analysis of PPS.

•Discussion: Our study aims to evaluate the implementation of the device to identify ways to improve the device for the management of subjects at risk of loss of autonomy.


title: Evaluation of the Establishment of a Hospital Medication Report for Pharmacists and General Practitioners

acronym: EvalMedReport

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

In our clinical practice, during the patient admission in internal medicine unit, a medication reconciliation process was conducted according to a validated protocol. The first step consists of getting the Best Possible Medication History (BPMH), defined as the most comprehensive list of all medications taken by the patient. The second step consists of comparing the BPMH with admission prescription made by the physician in charge. During pharmacist interview, pharmacist discussed about medication adherence and knowledge. The third step consists of characterizing, solving and documenting DRPs.

During the patient's hospitalization, the pharmacist participates at the medication prescription revision. At the discharge of hospitalization, a pharmaceutical standardised interview is carried out during which the pharmacist explains the modifications of treatments to the patient. During this interview, the hospital pharmacist updates the latest treatment changes. For patient with more than 65 years old and long-term affection (or patient with more than 75 years old with or without long-term affection) and 5 medications, the hospital pharmacist write a medication discharge report (MDR) to patient, community pharmacist and general practitioner.

For each medication, the investigators collected its name, dosage, dosage forms and frequency of administration. For each DRP, the investigators collected the type of DRP and the drug classes (according to anatomical therapeutic chemical classification system).

For each MDR, the investigators collected number of medication, number and type of DRP including inappropriate prescription.


title: Impact of Barriers and Facilitators to Physical Activity in Patients With Inflammatory Arthritis and Link With Physical Activity Collected by Mobile Phone Apps: a Cross-sectional Study

acronym: ImBAIA

summary:
Background: Patients with inflammatory arthritis (IA), such as spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) are more prone to physical inactivity but derive specific benefits from regular physical activity. Barriers and facilitators to physical activity (B&F-PA) are key elements and knowledge of their correlation to physical activity is essential for developing interventions to promote physical activity that have a greater likelihood of success.

Objectives: primary objective will be to measure the correlation of these B&F-PA to physical activity collected through apps. Secondary objective will be to (I) to quantify physical activity collected through apps in IA patients and (II) to observe the link between physical activity, B&F to physical activity and adherence to treatment.

Patients and methods: This is an international, multicentric, cross-sectional study.

Patients: From the first of September to the first of February 2020, all patients with definite axSpA, RA or PsA, aged above 18 and able to walk, who have a mobile phone compatible with apps that can track steps, who agree to participate and give his oral informed consent and with ability to read and write in the language of the participating country, seen in outpatient visits in the participating centers, will be asked to participate. The planed inclusion was 200 participants.

Data collection: clinical data and information about physical activity and B&F-PA will be entered by rheumatologists during or electronically by patients at the same time point.

Questionnaire for B&F-PA: a patient reported questionnaire was recently developed for this study in 2019 based on a systematic review to identify the main B&F-PA. A list of questions was generated from the systematic review reviewed and tested for face validity by 11 experts and confronted to 20 patients with IA through a cognitive debriefing.

Physical activity: Physical activity will be measured objectively during the last 7 days by apps already installed by default on the mobile phone of participants and subjectively with the International Physical Activity Questionnaire short version (IPAQ-S).

Other outcomes: Stage of exercise behavior change and adherence to treatment will also be collected.

Planned analyses: Perceived B&F-PA will be described using frequencies. A score will be calculated for each participant representing the limitations or facilities to perform physical activity.

Analysis of the physical activity: The distribution of mean number of steps will be assessed visually for outliers. Univariate analysis will be completed between mean number of steps and gender, age, disease and stages of change. Correlation between mean number of steps and IPAQ-S score will be calculated.

Link between physical activity and barriers and facilitators: The link between B&F questionnaire score and mean number of steps will be tested using linear regression. Then multivariate regression including demographic variables, psychological status and disease characteristics will be performed.

Outcomes of the study: The expected outcomes of the ImBAIA study are a better understanding of B&F to physical activity in patients with IA and their impact to limit or to favor physical activity. We also expect to observe the level of physical activity of an IA population objectively measured with apps. Finally, a validation was expected to use questionnaire of B&F.

time_perspective: Cross-Sectional

ReferenceCitation: Davergne T, Tekaya R, Sellam J, Tournadre A, Mitrovic S, Ruyssen-Witrand A, Hudry C, Dadoun S, Avouac J, Fautrel B, Gossec L. Influence of perceived barriers and facilitators for physical activity on physical activity levels in patients with rheumatoid arthritis or spondyloarthritis: a cross-sectional study of 150 patients. BMC Musculoskelet Disord. 2021 Oct 30;22(1):915. doi: 10.1186/s12891-021-04792-7.

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

publisher_dissemination: Springer-Nature

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere


title: Keratoconus, Corneal Diseases and Transplant Registry (KCDTR)

acronym: KCDTR

summary:
The cornea is the clear layer in front of the iris and pupil. It protects the iris and lens and helps focus light on the retina. Corneal diseases are serious conditions that can cause clouding, distortion, scarring and eventually blindness. There are several types of corneal disease with keratoconus being one of the most prominent.

Keratoconus is a weakening and thinning of the central cornea. This thinking causes the cornea to develop a cone-shaped deformity leading to vison loss. Keratoconus is usually bilateral affecting people between 10 and 25.

This project aims to collect data on patient suffering with corneal diseases and the treatments they receive, including corneal transplantation, over a period of time during routine clinical practice.

A clinical registry such as this can be a very useful tool to provide a real-world view of clinical practice, patient outcomes, safety, and comparative effectiveness.

•Methods:

Data will be collected from the medical records of patients who have suffered from corneal disease and have undergone treatment in the Ophthalmology department of the CHU Montpellier.

A standardized set of data will be collected for all patients. This will include, demographic and social date such as lifestyle and occupation, current and past pathologies and treatment received. This is data that is already collected as part of routine clinical practice.

This will be an ongoing registry with the aim of collecting the maximum data possible. The more patients that are entered and the longer the follow up for each patient, the more valuable the data will become.

•Discussion:

The aim of this registry to help create a better understanding of variations in treatment and outcomes; to examine factors that influence prognosis; to describe treatment patterns, including appropriateness and effectiveness of treatment and disparities in the delivery of care; to monitor safety and harm and to measure quality of care.

In the long term the data collected in the registry may serve as a basis for the development of evidence-based clinical management guidelines to help clinicians deliver the most appropriate treatment for corneal diseases in the safest and most efficient manner.

lead_sponsor: University Hospital, Montpellier


title: Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study

acronym: Glisodin

summary: Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: VAlidation of an Self Administered Questionnaire in French for Assessment of Cardio Respiratory Reserve

acronym: VAQAR

summary:
The guidelines of the European Society of Cardiology (ESC) for preoperative management in non-cardiac surgery make the estimation of patients' maximum oxygen uptake (VO2peak) one of the cornerstones of preoperative evaluation.

Indeed, below a certain threshold of VO2 peak fixed in the literature at 15 milliliters/kilogram/minutes (ml/kg/min) (or 4 Metabolic Equivalent of Task - MET), the ESC recommends to carry out additional non-invasive examinations to evaluate the coronary risk of these patients.

In current practice, this evaluation is performed in anesthesia consultation by non-standard interview. The question "Can you go up a floor or climb a hill?" permits to classify patients with more or less VO2 peak than 4 MET.

However, several studies, including one published in the Lancet in 2018, show that this evaluation doesn't assess correctly the VO2peak of the patients nor predict post-operative cardiac complications.

In the same study, the evaluation of a standardized self-questionnaire, the Duke Activity Status Index (DASI), found a good correlation between the value of this pre-operative score and the 30-day mortality as well as the occurrence of infarction.

This self-questionnaire contains a dozen questions about the physical activities of daily life that patients are able or not to perform (household, various physical activity). It has also been validated in medical patients as being well correlated with the value of VO2 peak in the case of an answer by a third party (r = 0.81, p <0.001) and satisfactory in the case of a self-questionnaire (r = 0.58 , p <0.001).

This self-questionnaire exists in English but there is no validated translation in French. Given the cultural differences, it seems necessary in order to use it in a French-speaking context to go through a scientific validation stage. A validation study of DASI in Portuguese has already been published recently, serving as a methodological basis for a French translation.

The purpose of this study is to carry out a validation of a standardized self-questionnaire in French. It will be distributed to patients referred for a VO2peak test as part of their standard management in the Louis Pradel Hospital (Hospices Civils de Lyon, Lyon). The results of VO2peak predicted by the self-questionnaire will be compared to the VO2 peak measured during the examination.


title: NTM-net Study: Liposomal Amikacin Inhalation in M.Abscessus Patients

summary:
Mycobacterium abscessus is one of the many species of non-tuberculous mycobacteria. M. abscessus infections are known to be common in patients with cystic fibrosis (CF). Mycobacterium abscessus yields poor cure rates. Liposomal amikacin inhalation (LAI) might be a good alternative for intravenous treatment as the first results with mycobacterium avium treatment yield good results.

The objective of this study is to summarize the clinical data of patients with M.abscessus treated with LAI on compassionate use basis to assess treatment outcomes


title: Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans

acronym: DETTECH

summary:
NIRS technology is therefore a technique that exploits the different absorption properties of oxygenated and deoxygenated hemoglobin to evaluate the degree of tissue oxygenation. This hemodynamic response is measured in a completely non-invasive and silent manner, by the simple emission of light passing through different layers of biological tissue.

In the literature, some studies concerning the use of the NIRS method for the study of urodynamics exist. They seem to show a correlation between the data of the urodynamic assessment and the data obtained with the NIRS method. Certain trends seem to be repeated with, for example, an increase in oxyhemoglobin at the beginning of the filling phase and the beginning of the urination phase.

The aim of the study is to analyze the NIRS signal and find correlation with urodynamic data.

primary_purpose: Device Feasibility

lead_sponsor: BioSerenity


title: A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

acronym: VIRTOPSY+

summary: The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.

ReferenceCitation: Addison S, Arthurs OJ, Thayyil S. Post-mortem MRI as an alternative to non-forensic autopsy in foetuses and children: from research into clinical practice. Br J Radiol. 2014 Apr;87(1036):20130621. doi: 10.1259/bjr.20130621.

ReferenceCitation: Brookes JA, Hall-Craggs MA, Sams VR, Lees WR. Non-invasive perinatal necropsy by magnetic resonance imaging. Lancet. 1996 Oct 26;348(9035):1139-41. doi: 10.1016/S0140-6736(96)02287-8.

ReferenceCitation: Breeze AC, Jessop FA, Set PA, Whitehead AL, Cross JJ, Lomas DJ, Hackett GA, Joubert I, Lees CC. Minimally-invasive fetal autopsy using magnetic resonance imaging and percutaneous organ biopsies: clinical value and comparison to conventional autopsy. Ultrasound Obstet Gynecol. 2011 Mar;37(3):317-23. doi: 10.1002/uog.8844.

ReferenceCitation: Kang X, Cannie MM, Arthurs OJ, Segers V, Fourneau C, Bevilacqua E, Cos Sanchez T, Sebire NJ, Jani JC. Post-mortem whole-body magnetic resonance imaging of human fetuses: a comparison of 3-T vs. 1.5-T MR imaging with classical autopsy. Eur Radiol. 2017 Aug;27(8):3542-3553. doi: 10.1007/s00330-016-4725-4. Epub 2017 Jan 23.

ReferenceCitation: Cannie M, Votino C, Moerman P, Vanheste R, Segers V, Van Berkel K, Hanssens M, Kang X, Cos T, Kir M, Balepa L, Divano L, Foulon W, De Mey J, Jani J. Acceptance, reliability and confidence of diagnosis of fetal and neonatal virtuopsy compared with conventional autopsy: a prospective study. Ultrasound Obstet Gynecol. 2012 Jun;39(6):659-65. doi: 10.1002/uog.10079. Epub 2012 May 22.

ReferenceCitation: Griffiths PD, Paley MN, Whitby EH. Post-mortem MRI as an adjunct to fetal or neonatal autopsy. Lancet. 2005 Apr 2-8;365(9466):1271-3. doi: 10.1016/S0140-6736(05)74816-9.

ReferenceCitation: Sebire NJ, Weber MA, Thayyil S, Mushtaq I, Taylor A, Chitty LS. Minimally invasive perinatal autopsies using magnetic resonance imaging and endoscopic postmortem examination ("keyhole autopsy"): feasibility and initial experience. J Matern Fetal Neonatal Med. 2012 May;25(5):513-8. doi: 10.3109/14767058.2011.601368. Epub 2011 Aug 10.

ReferenceCitation: Woodward PJ, Sohaey R, Harris DP, Jackson GM, Klatt EC, Alexander AL, Kennedy A. Postmortem fetal MR imaging: comparison with findings at autopsy. AJR Am J Roentgenol. 1997 Jan;168(1):41-6. doi: 10.2214/ajr.168.1.8976917.

ReferenceCitation: Thayyil S, Sebire NJ, Chitty LS, Wade A, Olsen O, Gunny RS, Offiah A, Saunders DE, Owens CM, Chong WK, Robertson NJ, Taylor AM. Post mortem magnetic resonance imaging in the fetus, infant and child: a comparative study with conventional autopsy (MaRIAS Protocol). BMC Pediatr. 2011 Dec 22;11:120. doi: 10.1186/1471-2431-11-120.

ReferenceCitation: D'Hondt A, Cassart M, De Maubeuge R, Soto Ares G, Rommens J, Avni EF. Postmortem fetal magnetic resonance imaging: where do we stand? Insights Imaging. 2018 Aug;9(4):591-598. doi: 10.1007/s13244-018-0627-0. Epub 2018 Jun 4.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic - PRO-SERO-COV

acronym: PRO-SERO-COV

summary: The question of the immune response of the population, particularly of professional populations in contact with vulnerable populations (such as those with chronic conditions such as cancer), is an important issue. Knowing the evolution of this response over time in this population can help answer outstanding questions. The PRO-SERO-COV study is a seroprevalence study of caregivers working in the hospital sector with a follow-up at 3 months and 12 months. The objective is to evaluate and monitor at 3 and 12 months the serological immune status to an infection by the SARS-CoV-2 virus in active volunteer professionals working at the Institut Bergonié with different types of exposure: healthcare professionals and professionals in other services.

lead_sponsor: Institut Bergonié


title: The Effect of Nonverbal Vocalisations on Pain Tolerance

acronym: VOCPAIN

summary:
Humans produce non-verbal vocalizations (shouting, growling, screaming), laughter, ...) in various contexts that are likely to perform biological functions.

and important social issues. Yet despite their importance in the human vocal repertoire, the mechanisms and functions of non-verbal vocalizations remain little studied and poorly understood including in humans. In this context, the investigators wish to examine how the production of vocalizations non-verbal communication influences pain tolerance in healthy adults.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Laboratoire ENES-CNPS (Université Lyon/Saint Etienne)

location_facility: Centre Hospitalier Universitaire Saint-Etienne


title: Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)

acronym: SALOME

summary: Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.

primary_purpose: Health Services Research

lead_sponsor: Institut Curie


title: Gut Microbiota Dysbiosis and Translocation Within Patients Suffering From Diseases Associated With Increased Intestinal Barrier Permeability : IBD and Parkinson

summary:
Inflammatory bowel diseases (IBD) and Parkinson disease (PD) are complex and multifactorial pathologies. Gut microbiota seems to play an active role. Indeed the digestive microbiota of patients with IBD or PD exhibits different compositions compared with asymptomatic subjects.

Bacterial translocation from gut to blood has been reported.

primary_purpose: Screening

lead_sponsor: Hôpital Européen Marseille


title: Learning Mental Visualization to Improve Performance in Anesthesia: a Randomized Controlled Trial by Simulation

summary: The purpose of this study is to evaluate the benefit of adding mental visualization to a training program in medical education. Undergraduate medical students will be randomized before participating in a training program on airway management during rapid sequence induction. In the control group, participants will receive traditional teaching including theoretical courses and procedural simulation. In the intervention group, in addition to traditional teaching, participants will be trained and encouraged to practice mental visualization. The main outcome will be clinical performance during a standardized high-fidelity simulation of rapid sequence induction assessed using a specific pre-established checklist.

lead_sponsor: University Grenoble Alps


title: Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia or Fungemia From Positive Blood Culture Bottles, Combining Fast Identification of Bacteria and Fungi and Evaluation of Bacterial Resistance to First Line Antibiotics.

acronym: HEMOFAST

summary: This study evaluates the clinical benefit of a rapid test for fast diagnosis of bacteremia and fungemia from positive blood cultures in case of sepsis. This assay enables rapid identification of bacteria and fungi and allows to evaluate bacterial resistance to first line antibiotics. The clinical and medico-economic impact of this assay used in addition to the current diagnosis strategy (half of the patients) will be compared to the current diagnostic strategy alone (other half of the patient).

ReferenceCitation: Huang TD, Melnik E, Bogaerts P, Evrard S, Glupczynski Y. Evaluation of the ePlex Blood Culture Identification Panels for Detection of Pathogens in Bloodstream Infections. J Clin Microbiol. 2019 Jan 30;57(2):e01597-18. doi: 10.1128/JCM.01597-18. Print 2019 Feb.

ReferenceCitation: Banerjee R, Teng CB, Cunningham SA, Ihde SM, Steckelberg JM, Moriarty JP, Shah ND, Mandrekar JN, Patel R. Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing. Clin Infect Dis. 2015 Oct 1;61(7):1071-80. doi: 10.1093/cid/civ447. Epub 2015 Jul 20.

ReferenceCitation: Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96. doi: 10.1097/01.CCM.0000217961.75225.E9.

ReferenceCitation: Patel TS, Kaakeh R, Nagel JL, Newton DW, Stevenson JG. Cost Analysis of Implementing Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry Plus Real-Time Antimicrobial Stewardship Intervention for Bloodstream Infections. J Clin Microbiol. 2016 Dec 28;55(1):60-67. doi: 10.1128/JCM.01452-16. Print 2017 Jan.

ReferenceCitation: Maubon D, Dard C, Garnaud C, Cornet M. Profile of GenMark's ePlex(R) blood culture identification fungal pathogen panel. Expert Rev Mol Diagn. 2018 Feb;18(2):119-132. doi: 10.1080/14737159.2018.1420476. Epub 2017 Dec 28.

ReferenceCitation: Timbrook TT, Morton JB, McConeghy KW, Caffrey AR, Mylonakis E, LaPlante KL. The Effect of Molecular Rapid Diagnostic Testing on Clinical Outcomes in Bloodstream Infections: A Systematic Review and Meta-analysis. Clin Infect Dis. 2017 Jan 1;64(1):15-23. doi: 10.1093/cid/ciw649. Epub 2016 Sep 26.

sponsor_collaborators:
University Hospital, Grenoble
GenMark Diagnostics


title: Prospective Multicenter Pilot Study to Evaluate the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)

acronym: NeoVAB

summary:
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. New generation of treatments or combinations lead to a high rate of pathological complete responses (pCR) in patients with human epidermal growth factor receptor 2 positive (HER2) and triple negative tumours. Safe omission of surgery in patients who receive NAC and achieve radiologic complete response depends on the ability to accurately estimate pCR preoperatively.

If pathological complete response after NAC could be accurately assessed by VAB, surgery could be avoided. In the context of new treatments or combinations with an increased pCR rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.

lead_sponsor: Centre Georges Francois Leclerc

appel_a_projets: PHRCK

region: Bourgogne-Franche-Comté

nom_etablissement: CLCC GEORGES-FRANCOIS LECLERC

type_etablissement: CLCC

acronyme: NeoVAB

titre: NeoVAB : Etude pilote prospective multicentrique évaluant la fiabilité de la macrobiopsie pour le diagnostic de réponse histologique complète chez les patientes ayant une réponse clinique et radiologique complète après chimiothérapie néoadjuvante.

discipline_principale: cancer

nom_porteur: COUTANT

prenom_porteur: Charles


title: Brain Connectome for Migraine Patients Treated Via Acupuncture: A Randomized, Controlled Study Under Single-blind Conditions, With a Placebo Group and Magnetic Resonance Imaging (MRI)

acronym: ACU-BRAIN

summary:
Acupuncture has been a means of treating headaches and migraine since 2002 and is now a World Health Organisation-recognized prophylactic treatment for migraine. Brain activation/de-activation via acupuncture modifies the haemodynamic responses in the brain which may impact the sensorial, cognitive and affective dimensions of pain. Randomized studies on patients suffering from aura-free migraine have shown that the painkilling effect of regular acupuncture sessions on the cerebral substratum, compared with simulated sham-type acupuncture, can reduce the frequency of bouts of migraine, number of days with headaches and also their intensity.

Modifications to the white matter (WM) and grey matter (GM) occur after repeated sessions of acupuncture treatment for pain and these are observable via magnetic resonance imaging (MRI). It is a very sensitive technique and often used to detect functional and structural brain changes.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Impact of a Task Delegation to ICU Nurses for Midlines' Placement on the Duration of Exposure to Central Venous Catheters

acronym: IDEM

summary:
The administration of medication, fluid resuscitation, or even nutrition in intensive care unit (ICU) patients, requires one or more infusion lines which can be peripheral or central. Midline catheter is a 10 to 20 cm long peripheral venous catheter, which can be used for up to 28 days. These features make it a good alternative to central venous and conventional peripheral venous catheters.

Midlines are routinely used in the ICU of Lorient Hospital, currently inserted by doctors. In association with the Regional Health Agency, the investigators are currently implementing a project of task delegation to ICU nurses, so that they could insert Midlines' catheters. The aim of the study is to increase the use of Midlines in the unit to reduce the exposure to central venous catheters and their complications, such as infections or thrombosis.

The investigators propose to conduct a prospective monocentric study to compare the frequency of Midlines'use, before and after the task delegation. The primary objective is to compare the duration of exposure to central venous catheters between the two periods. Secondary objectives are to compare the duration of exposure to peripheral venous catheters and Midlines, and the catheter-related infections and thrombosis.

ReferenceCitation: O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.

ReferenceCitation: Pathak R, Patel A, Enuh H, Adekunle O, Shrisgantharajah V, Diaz K. The Incidence of Central Line-Associated Bacteremia After the Introduction of Midline Catheters in a Ventilator Unit Population. Infect Dis Clin Pract (Baltim Md). 2015 May;23(3):131-134. doi: 10.1097/IPC.0000000000000237.

ReferenceCitation: Pathak R, Gangina S, Jairam F, Hinton K. A vascular access and midlines program can decrease hospital-acquired central line-associated bloodstream infections and cost to a community-based hospital. Ther Clin Risk Manag. 2018 Aug 21;14:1453-1456. doi: 10.2147/TCRM.S171748. eCollection 2018.

ReferenceCitation: Xu T, Kingsley L, DiNucci S, Messer G, Jeong JH, Morgan B, Shutt K, Yassin MH. Safety and utilization of peripherally inserted central catheters versus midline catheters at a large academic medical center. Am J Infect Control. 2016 Dec 1;44(12):1458-1461. doi: 10.1016/j.ajic.2016.09.010.

ReferenceCitation: Shokoohi H, Boniface K, McCarthy M, Khedir Al-tiae T, Sattarian M, Ding R, Liu YT, Pourmand A, Schoenfeld E, Scott J, Shesser R, Yadav K. Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients. Ann Emerg Med. 2013 Feb;61(2):198-203. doi: 10.1016/j.annemergmed.2012.09.016. Epub 2012 Nov 7.

ReferenceCitation: Alexandrou E, Spencer TR, Frost SA, Mifflin N, Davidson PM, Hillman KM. Central venous catheter placement by advanced practice nurses demonstrates low procedural complication and infection rates--a report from 13 years of service*. Crit Care Med. 2014 Mar;42(3):536-43. doi: 10.1097/CCM.0b013e3182a667f0.

lead_sponsor: Groupe Hospitalier de Bretagne Sud


title: Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?

acronym: Endo-DC

summary:
Terminal constipation affects 13 to 20% of the french population. Anismus is defined by an absence of relaxation or a paradoxical contraction of the striated anal sphincter muscle during defecation.

Anismus is one of the main causes of terminal constipation. Anismus diagnosis is retained if 2 out of 3 examinations (manometry, electromyogram, defecography) are positive.

EndoFLIP® is a new medical device developed to measure distensibility of a hollow organ. Anal EndoFLIP® l could be a more sensitive and specific tool for detecting anismus in patients with distal constipation.

60 patients suffering from distal constipation will be included in order to perform, in addition to the usual examinations, an anal EndoFlip in order to test the sensitivity and specificity of this method for the diagnosis of anismus.


title: Impact of the Working Shift Organization on the Caregivers' Satisfaction and Quality of Life at Work, and the Performance of the Intensive Care Units.

acronym: IOTA-REA

summary:
This is a prospective, non-randomized, multicenter, observational national study, involving centers with different working shift organizations.

Participating centers are 24 French adult intensive care units with different working shift organizations (12-hours shift vs. less than 12-hours shift) in public hospitals.

Caregivers (doctors, nurses and assistant nurses) constitute the population of the study.

The duration of the study is 13 months.

The aim of this study is to evaluate the impact of the working shift organizations on:

The intensive care units operation;
The use of outside staff;
The caregivers' quality of life at work;
The caregivers' satisfaction at work;
The nursing work environment;
Psychosocial and organisational work constraints
The performance of the intensive care units;
The costs and efficiency of the working shift organizations.

location_facility: medical-surgical intensive care unit - TENON hospital (AP-HP)

appel_a_projets: PREPS

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: IOTA-REA

titre: Impact de l'Organisation du Temps de trAvail sur la satisfaction du personnel soignant et la performance des services de REAnimation.

discipline_principale: anesthésiologie / réanimation

nom_porteur: Blanchard

prenom_porteur: Pierre-Yves


title: Needle Aspiration for Large Cephalohematoma : a Retrospective Study of Complications

summary: The cephalohematoma is a common pathology of newborns. Observation is the primary treatment for the most of small uncomplicated cephalohematoma. However large cephalohematoma can lead to calcification with anesthetic local deformation or deformational plagiocephaly. The objective of the study was to evaluate the iatrogenic risk associated with early puncture on local anesthesia.


title: Prospective Observational Study of the Non Invasive Objective Assessment of Pre-operative Anxiety Using the Heart Rate Variability and the Pupillary Reflex Measurement

acronym: INNOVANX

summary: The purpose of this study is to determine whether heart rate variability levels and pupillometric measures are effective objective predictors of anxiety among patients before surgery.


title: Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR

summary:
The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs.

The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is gladly recurrent.

The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments.

The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media.

The objective of this study is to translate and validate the test in French in children.


title: Comparison of Postoperative Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone: a Randomized Clinical Trial

summary:
This study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment.

The study design is a multicenter, doubled blinded randomized controlled trial. The comparator is the equivalent zinc oxide eugenol sealer without NSAID (allocation ratio is 1:1). The conventional endodontic treatment, using gutta percha and sealer, is done. Patients assess their pain for 7 days after permanent root obturation.

lead_sponsor: ACTEON Group

sponsor_collaborators:
ACTEON Group
Slb Pharma


title: Comparison of 250 ml Versus 500 ml of Fluid Challenge on Oxygen Consumption in Critical Care Patients: an Open Label Multicentre Prospective Study

acronym: KOBIAS

summary: The objective of fluid challenge is to increase oxygen delivery (DO2) in order to improve/restore tissue oxygen consumption (VO2). However the fluid challenge volume to administer stills in debate, some studies recommend to administer 250 mL. Previous studies suggested that 500 mL of fluid challenge administration may improve cardiac output and oxygen delivery. The relation between the amount of fluid expansion and oxygen delivery and oxygen consumption was not yet been studied in a randomized study in critical care patients. This is the purpose of this study.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation

acronym: LFP-DBS

summary:
Primary objective

Demonstrate functional markers derived from electrophysiological signals recorded during cognitive tests. These markers should make it possible to optimize the targeting procedures of electrode implantation sites for a better effectiveness of deep brain stimulation therapy.

Research hypotheses

The mechanisms of action of the deep brain stimulation (DBS) involve the modulation of the activity, locally and on a large scale, of functional cortical-subcortical networks showing pathological behavior beforehand. The electrophysiological measurements in response to different tasks make it possible to highlight precise dysfunctions of these neural networks, in relation with the behavioral and / or motor disorders associated with the pathologies treated by DBS.

Consequently, we hypothesize that the exploitation of electrophysiological responses during cognitive or sensorimotor tasks performed during the implantation procedure of stimulation electrodes in patients treated with DBS will allow :

To collect fundamental data to understanding the physiological functioning of basal ganglia in humans ;
To collect functional markers from the operating room in relation to the symptoms targeted by the DBS that will help in the choice of implantation site of the stimulation electrode ;
Define long-term predictive markers of DBS effects by comparing electrophysiological effects measured post-operatively and clinical scores under DBS.

lead_sponsor: University Hospital, Grenoble


title: Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.

acronym: PREDICT-TBI

summary:
Main objective : To compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score.

The Pitié-Salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the IMPACT score. The investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the IMPACT score.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière


title: Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.

summary: The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

lead_sponsor: Laboratoires Thea


type: Registry Identifier

title: A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury

acronym: REHAB-MDT

summary:
The study aims to demonstrate improvement of daily life functioning and improvement of cognitive tests in post traumatic brain injury (TBI) patients suffering from working memory deficit, by a 3-month specific cognitive rehabilitation program, in comparison with patients with usual non-specific rehabilitation of same duration.

As secondary objectives, the study aims to:

demonstrate improvement of specific neuropsychological tests of working memory;
demonstrate improvement of non-specific tasks involving working memory;
assess the evolution in not-targeted domains by the specific rehabilitation, which would give evidence of a global cognitive stimulation effect;
demonstrate improvement of social integration ability and quality of life;
demonstrate persistence of effects at 3 months and 6 months after the end of treatment;
demonstrate the acceptability, the tolerance and the feasibility of rehabilitation.

location_facility: Physical medicine and rehabilitation department, Raymond Poincaré Hospital


title: Plasma Levels of Danger-Associated Molecular Patterns (DAMPs) in Young Children After Cardiac Surgery Under Cardiopulmonary Bypass (IMMUNOPED 2)

summary: The investigators have previously reported that cardiac surgery with CPB ( cardiopulmonary bypass) in young infants induced a drastic reduction in mHLA-DR ( Human Leucocyte Antigen) expression, which represents one of innate immune mediator. Danger-Associated Molecular Patterns (DAMPs) can elicit immune response and may subsequentely induce an immune-suppressed state. The investigators hypothesize that CPB causes excessive DAMP release, leading to the development of immune suppression. Thus, DAMPs release will be assessed in patients undergoing CBP, and consequences on immune suppression will be evaluated.

lead_sponsor: Nantes University Hospital


title: Pilot Study Evaluating the Impact of the Intervention of a Pharmacist in the Operating Room on the Appropriate Use of Sterile Medical Devices and the Economic Repercussions

acronym: OPTIBLOC

summary: assess the impact of the intervention of a clinical pharmacist expert in sterile medical devices

time_perspective: Other

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


intervention_type: Biological

summary: This research is a multi-center French randomized and double blind phase IIb clinical trial evaluating 2 revaccination strategies against pneumococcal infections among splenectomised patients. The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone) in splenectomised adults.

sponsor_collaborators: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

sponsor_collaborators: I-REIVAC Innovative Clinical Research Network In Vaccinology

location_facility: CIC 1417 Cochin-Pasteur - GH Broca-Cochin-Hôtel-Dieu

title: Evaluation of Immunological Response Following a Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients

source: euctr

appel_a_projets: PHRCN

titre: Evaluation de la persistance immunologique de la revaccination avec le vaccin PPS23 boosté ou non paf PCV13 chez les patients splenectomisés

discipline_principale: médecine interne

nom_porteur: Rossi

prenom_porteur: Benjamin


title: Evaluation of the Unconformity of the Hormonal Status of Metastatic Lesions During a First Relapse of Breast Cancer Initially Expressing Estrogen Receptors: a Pilot Study on the Interest of Positron Emission Tomography (PET) With 16α- [18F] -Fluoro-17β-estradiol (FES).

acronym: EstroTEPCompar

summary:
Breast cancer is a major public health issue despite therapeutic advances, it is the first cause of death cancer of women in Europe.

Several treatments may be proposed depending on the general condition of the patient, the characteristics of the initial tumor and the stage of the disease. The different treatments in metastatic relapse of hormone receptor-positive breast cancer are systemic treatments, such as hormone therapy, chemotherapy, targeted therapies, and possible supportive care, but also in some cases local treatments such as surgery and radiotherapy.

Comparative analysis of primary mammary tumors and their metastases has demonstrated the essential role of tumor heterogeneity, both in time and space, in the progression of the disease and the occurrence of resistance to treatments. Taking into account this intratumoral heterogeneity represents a major axis of improvement in the management of patients with breast cancer.

The use of innovative radiotracers such as 16α- [18F] -fluoro-17β-estradiol (FES) may allow in the future to better evaluate this tumor heterogeneity in patients with metastatic breast cancer through non-metastatic characterization. invasive different lesions. It will be possible to propose to each patient a more personalized care with possibly the administration, in addition to the systemic treatment, of a local treatment adapted to the characteristics of some secondary lesions likely to respond less well to the systemic treatment.

In this pilot study, the investigators would like to estimate the number of patients and the number of metastatic sites affected by tumor heterogeneity of estrogen receptor expression, which could benefit from specific management.

This study will concern a population of patients with first metastatic recurrence of hormone receptor-positive breast cancer initially, with at least one metastasis, who are candidates for treatment with hormone therapy.


title: Evaluation of the Effectiveness of a Therapeutic Program for the Attentional Re-training of Chronic Pain Patients: Feasibility of E-care

acronym: ABCD

summary: Hyper-vigilance, focusing, avoidance are part of the vocabulary used by the clinician who deals with chronic pain. These notions refer to the functioning and dysfunction of so-called "selective" attention. These "selective attentional biases" are believed to be responsible, in part, for the development and maintenance of negative pain-related thoughts (such as catastrophic thoughts), inappropriate behaviours (such as inactivity and fear of movement) and unpleasant emotions (such as stress or anger). In addition, they would also be a powerful indicator of the onset of post-operative pain and could limit the effectiveness of therapeutic management. Therapeutically, attention bias can be "managed" through attentional re-training techniques (ABMs) that teach patients to direct their attention differently. These techniques have been widely validated in anxious or addictive populations but have never been used to date in chronic pain patients. This home-based attention bias management (e-retraining) would represent, for chronic pain patients, an additional tool aimed not only at reducing their pain but also at achieving other associated factors such as anxiety, stress, catastrophic thoughts, avoidance behaviours and quality of life.

sponsor_collaborators:
Nantes University Hospital
Fondation Apicil


title: Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case

summary: Evaluation of psychological impact of patients after pancreatectomy because of cancer diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3 control groups will be used to compare de psychological impact.

lead_sponsor: Institut Paoli-Calmettes


title: Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia

summary:
Severe Acute Respiratory Syndrome (SARS) SARS-CoV-2, name of the Coronavirus Group of international Committee on taxonomy of viruses, is an emerging virus from the family of coronaviridae, responsible for the COVID-19 pandemic. This infection can progress to viral pneumonia, and in 3% of cases up to acute respiratory distress syndrome (ARDS) which conditions the prognosis of the disease.

Due to its unusual clinical presentation with a risk of sudden deterioration on the 8th day as a result of possible hyperinflammatory response, the respiratory impairment of COVID is unique and many questions remain unanswered concerning its evolution once the acute phase has passed. Knowledge of the evolution of pulmonary involvement, particularly in patients requiring hospitalization, can help reduce the morbidity linked to the persistent abnormalities identified by establishing early therapeutic management. It can also provide a better understanding of the mechanisms of pulmonary involvement in the acute phase. Current data regarding the acute phase of COVID-19 suggest that persistent abnormalities remain distant from this infection at all levels of the respiratory system: gas exchange, perfusion, ventilatory mechanics, and interstitial lung disease.

The main objective is to characterize persistent gas exchange anomalies 4 months after documented COVID-19 pneumonia, resulting in oxygen desaturation and requiring hospitalization.

lead_sponsor: University Hospital, Toulouse


title: COVID 19 Serology in Pulmonologists : Pneumo Sero Cov

acronym: Pneumoserocov

summary: Respiratory physicians are highly exposed workers to Covid-19 as they perform spirometry, endoscopy, and manage Covid-19 in first line for most of them. Moreover, none reported to have apply increased levels of protection for performing these acts in the most active period of viral circulation, until the lockdown. Whether they were most frequently immunized against SARS-CoV-2 at the end of the first wave than the general population is of utmost importance individually but also worldwide

lead_sponsor: University Hospital, Montpellier


title: Pilot Study for the Evaluation of a T-shirt "Balance" Containing Ceramic Fibers

acronym: Equi-tee-shirt

summary:
Falls are frequent and often serious events in the elderly. The consequences of falls are often severe: traumatic (fractures, hematomas, ..) and psychological. Falls are among the top ten causes of death in this population and, for people older than 70, falls are the leading cause of accidental death.

The Damart company has developed a fabric containing ceramic fibers. Clothes containing such fibers have been found to improve balance.

This study aims to measure the effect of a t-shirt with a ceramic membrane ("ceramic" t-shirt) on the balance and walking compared to the effect of a "placebo" t-shirt (same weight, appearance and texture).

The hypothesis is that wearing the ceramic tee-shirt significantly improves balance and walking, suggesting that it can also reduce falls - the main consequence of the balance and walking disorder.

lead_sponsor: University Hospital, Lille


title: Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)

acronym: IMPROVE

summary: The main objective is to determine the performance of the simple eLIFT blood test for advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care.

lead_sponsor: University Hospital, Angers


title: OTTAPE : Observatory on the Use of New Therapies (LED Photobiomodulation, Radiofrequency, Laser and Injectable Hyaluronic Acid) in the Treatment of Women's Pelvic-perineal Pathologies After Failure, Partial or Total, of First-line Medical Treatment

acronym: OTTAPE

summary:
Women's pelvic-perineal pathologies are a very frequent reason for consultation in gynaecology. The symptoms reported are diverse and range from the most frequent (genital prolapse, urinary or anal incontinence, dysuria, chronic pain) to new complaints (dyspareunia, vaginal laxity, perineum scarring, vulvo-vaginal atrophy).

Currently, first-line medical treatments are no longer sufficient to improve patients. New therapies have emerged, namely LED photobiomodulation, radio frequency, Erbium or fractionated CO2 laser and injectable hyaluronic acid.

These new treatments have been used in common practice for several years, but no studies have standardized practices. There are no recommendations regarding these new therapies to give specific indications for their use.

The aim is to standardise the indications for these new technologies.

LED photobiomodulation: management of scar perineas with pain, scarring disorders or trophic disorders.
The Erbium laser or fractionated CO2: treatment of vulvo-vaginal atrophy.
radiofrequency: management of chronic pelvic-perineal and postpartum pain.
injectable hyaluronic acid: treatment of vestibulodynia and trophic disorders. Non-validated indications are proposed for these therapies (urinary incontinence, vaginal laxity and prolapse)


title: Usefulness of Cephalometry in the Second and Third Trimester of Pregnancy in the Diagnosis of Fetal Microretrognathia : Prenatal Cephal

summary:
Congenital retrognathia, with or without Pierre Robin Sequence (PRS), is a rare anomaly which can be associated with chromosomal abnormalities. Respiratory and feeding consequences can be present at birth. After birth, the diagnosis of retrognathia is based on the clinical examination. Cephalometry can be used to complete the diagnosis. Several authors have proposed the use of objective quantitative ultrasound parameters for the antenatal screening of PRS. In our study, the investigators evaluated fetal cephalometry.

The aim First, the investigators studied the inter- and intra-observer reproducibility of cephalometry. Second, the investigators established reference values for antenatal cephalometry in normal fetuses. Third, the investigators compared the diagnostic performance of cephalometry and the other angles described in the literature for the diagnosis of retrognathia.


title: COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers

acronym: COLETTE

summary: COLETTE is an interventional study for which blood, cerebrospinal fluid and post-mortem tissues are collected in patients with status epilepticus or epilepsy associated to dysimmune encephalitis as well as in control patients, to better understand the pathophysiology of these severe epileptic disorders.

ipd_sharing_description: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: Assessment of Surgical Correction of Patello-femoral Instability by EOS 3D Kinematics

summary: Assessment of surgical correction of patello-femoral instability by EOS 3D kinematics

ReferenceCitation: Dagneaux L, Thoreux P, Eustache B, Canovas F, Skalli W. Sequential 3D analysis of patellofemoral kinematics from biplanar x-rays: In vitro validation protocol. Orthop Traumatol Surg Res. 2015 Nov;101(7):811-8. doi: 10.1016/j.otsr.2015.07.017. Epub 2015 Oct 26.


title: Diagnostic Markers of Neuropathic Odontalgia : Proof of Concept Study

summary: The DIAMOND study aims to investigate the presence and diagnostic relevance of potential biomarkers of the blood-nerve barrier disruption as surrogate markers of painful post-traumatic trigeminal neuropathic pain in patients presenting with neuropathic odontalgia. The first part of the study explores the proof-of-concept and technical feasibility of intra-epithelial nerve fiber immunostaining in gingival/oral mucosa biopsies and the potential presence of these biomarkers in healthy patients (baseline condition).


title: Supplementation of Rheumatoid Arthritis Patients With Dietary Fibre to Improve Their Gut Microbiota

acronym: SUPER-FIBRES

summary:
Design: Randomized, double-blind, placebo-controlled study with 4 weeks of treatment with either fiber supplements or placebo.

Primary outcome: variation in SCFA between baseline and week 4. Secondary outcomes : variations in gut microbiota, disease activity (DAS28, RAID), immune cells (regulatory T and B cells, Th17) and heart-rate variability.

Population: 29 patients with rheumatoid arthritis treated with only csDMARDs and a moderate disease activity will be recruited in each arm and 29 controls with mechanic disease (osteoarthritis, tendinitis).

Collection: Blood, feces, disease activity and heart rate variability will be collected at baseline and week 4.

collaborators: Institut de Génétique Moléculaire de Montpellier