title: Improving Care of Prader-Willi Syndrome : Evaluation of a New Care Program Combining Adapted Physical Activity, Nutrition and Therapeutic Education

acronym: APHYNET

summary:
Prader-Willi syndrome (PWS) is a rare and complex genetic disease characterized by hypothalamic-pituitary axis dysfunction combining eating disorders associated with hyperphagia and satiety deficiency, mild intellectual deficit and behavioral disorders. This disease requires continuous management through specific therapeutic education to prevent metabolic and cardiorespiratory complications related to obesity. Physical activity must therefore be regular, adapted to the disability, taking into account cognitive deficits and behavioral disorders.

Prader-Willi syndrome (PWS) is a rare and complex genetic disease characterized by hypothalamic-pituitary axis dysfunction combining eating disorders associated with hyperphagia and satiety deficiency, mild intellectual deficit and behavioral disorders. This disease requires continuous management through specific therapeutic education to prevent metabolic and cardiorespiratory complications related to obesity. Physical activity must therefore be regular, adapted to the disability, taking into account cognitive deficits and behavioral disorders.

The Unit of Care and Rehabilitation, of the Hôpital Marin d'Hendaye, receives patients with PWS or other obesity from rare causes, at a rate of 1 to 2 annual stays of 1 to 2 months, which allow the regulation of somatic disorders and the initiation of weight loss. However, the difficulty is to keep a stable weight curve between stays. Only 20% of patients over the last 2 years managed to stabilize or decrease their BMI during the 6 months following their hospitalization.

The proposed study aims to evaluate an innovative and individualized care program combining Physical activity, Nutrition and therapeutic education for adults with PWS who will be admitted to the hospital for 5 weeks.

We hypothesize that this program will allow to stabilize or decrease the BMI of patients at 6 months after hospitalization by inducing a behavioral change in terms of physical activity and eating behavior.

We will conduct a randomized controlled trial on 128 patients who will participate in this program, or will benefit from standard care.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service diététique Hôpital Marin d'Hendaye- AP-HP

acronyme: APHYNET

titre: Vers un meilleur accompagnement des personnes atteintes du syndrome de Prader-Willi : Evaluation d'un programme de soins alliant Activité Physique Adaptée, Nutrition et Education Thérapeutique

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: PASTRE

prenom_porteur: Hélène


type: Other Identifier

title: FollowMuco : Study of Satisfaction of Patients and Care Providers for an Alternate Follow-up With In-hospital Consults and Tele-consult for Patients With Cystic Fibrosis

acronym: FollowMuco

summary:
The pandemic forced us to develop home follow-up for patients with chronical diseases . In the same time, the new era of treatment for cystic fibrosis considerably improves the health of patients with this pathology.

This study aims to assess the satisfaction of patients and care providers for an alternated follow-up between tele-consults and in-hospital consults during one year for patients with cystic fibrosis treated by Kaftrio® since at least one year and stable.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Health Services Research

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Self and Body Perception in Otoneurological Disorders: Translation and Validation of Measurement Scales

acronym: PERSOCOR

summary:
Depersonalization-derealization (DD) disorders are a clinical phenomenon characterized by feeling disconnected or detached from one's self. Individuals may report feeling as if they are an outside observer of their own thoughts or body, and often report feeling a loss of control over their thoughts or actions.

Several scales have been developed to measure DD, and the Cambridge Depersonalization Scale (CDS) appears to be the most relevant and consistent to characterize the clinical symptoms of these disorders as well as their duration and frequency. This scale, originally written in English, must be translated and validated according to standardized methods that include testing steps patients with dizziness and in individuals with no vestibular disorder.

Persistent postural-perceptual dizziness (PPPD) is a chronic, persistent vestibular syndrome generally preceded by acute vestibular disorders. The main symptoms are rotational dizziness, unsteadiness and / or non-rotating dizziness that are exacerbated by upright posture, walking, active or passive movement, and exposure to moving visual stimuli or complex visual patterns. To help diagnose this syndrome, a questionnaire was developed in Japan in 2019, the Niigata questionnaire, however no French version has yet been validated. Similarly, this scale needs to be validated in patient with PPPD and in control populations.

The main objective of this study is to validate the French translation of these two scales, the CDS questionnaire and the Niigata PPPD questionnaire, according to standard methods (forward translation, back translation, consensus).

design_allocation: Non-Randomized

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Hôpital Européen Marseille


title: Evaluation of the Lived Experience of Overweight/Obese Patients Who Have Benefited From a Mindful Eating Program at Montpellier University Hospital by Semi-structured Face-to-face Interviews.

summary: The main objective is to understand the lived experience of overweight/obese patients who have followed the mindful eating program at Montpellier University Hospital. Semi-structured face-to-face interviews will be conducted in the Nutrition-Diabetes service by using a questionnaire.

study_type: Observational

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Impact of Complex Care Training of Hereditary Epidermolysis Bullosa on Caregiver Burden (FIREB)

acronym: FIREB

summary:
Hereditary epidermolysis bullosa (EBH) is a rare, orphan disease characterized by skin and mucous membrane fragility.

The latest scientific data show that the proposed treatments are still in the experimental stage and that no curative treatment is available. The repercussions of this chronic disease, with neonatal onset, are major.

Epidermolysis bullosa requires multidisciplinary medical management, nursing care, psychological and social care.

Skin care involves preventing and treating chronic wounds and identifying their complications. The very great cutaneous-mucous fragility makes these treatments painful, long and complex, the caring hand itself being able to cause new wounds. Analgesics of different levels are not effective enough during treatment.

Along with counseling and education, nursing takes a central role in multi-professional accompaniment interventions to support and relieve families.

Parents became home caregivers out of necessity, and developed specific skills in epidermolysis bullosa, their child and dressings. They have great and demanding expectations of caregivers facing this rare disease, for which they are not trained in their degree course. Despite the severe nature of the disease, few studies have been carried out on the impact and psychosocial consequences on patients and their families, yet there is an expressed need for support.

The burden on parents is heavy, assessed by specific scales, but to date there are no studies examining the impact of epidermolysis bullosa care on caregiver stress.

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Ingen-Housz-Oro S, Blanchet-Bardon C. Épidermolyses bulleuses héréditaires. EMC - Dermatol-Cosmétologie. 1 févr 2004 ; 1(1) :2 18.

ReferenceCitation: Chiaverini C, Bourrat E, Mazereeuw-Hautier J, Hadj-Rabia S, Bodemer C, Lacour JP. [Hereditary epidermolysis bullosa: French national guidelines (PNDS) for diagnosis and treatment]. Ann Dermatol Venereol. 2017 Jan;144(1):6-35. doi: 10.1016/j.annder.2016.07.016. Epub 2016 Dec 5. French.

ReferenceCitation: Lustre A, Levé-Corset I, Leeuwin G, Launay C, Blondy MF, Michaud MT, et al. Soins infirmiers de l'épidermolyse bulleuse. Rev Fr Allergol Immunol Clin. 2001 ; 41(7) : 659-663.

ReferenceCitation: Jérôme Palazzolo, Julie Arnaud, Anxiété et performance : de la théorie à la pratique, Annales Médico-psychologiques, revue psychiatrique, Elsevier, Volume 171, Issue 6, July 2013, Pages 382-388.

ReferenceCitation: Bandura, A. Auto-efficacité. Le sentiment d'efficacité personnelle (Trad. J. Lecomte). Bruxelles : De Boeck. 2003.

ReferenceCitation: Gadbois, C., Aides-soignantes et infirmières de nuit, conditions de travail et vie quotidienne, Paris : Etudes et Recherches, 1981.

ReferenceCitation: Van Daele A., Le stress chez les médecins généralistes : une approche transactionnelle, In B. Gangloff (Ed.), satisfactions et souffrances au travail (60-67), Paris : l'Harmattan.

ReferenceCitation: Verquerre R., Rusinek-Nisot, Etude du stress chez des infirmiers, In R.Jacob et R. Laflamme (Eds), Stress, santé et intervention au travail, (61-71), Québec : Presses Inter Universitaires.

ReferenceCitation: Borteyrou X, Bruchon-Schweitzer M, Spielberger CD. [The French adaptation of the STAXI-2, C.D. Spielberger's State-trait anger expression inventory]. Encephale. 2008 Jun;34(3):249-55. doi: 10.1016/j.encep.2007.06.001. Epub 2007 Oct 10. French.

intervention_type: Behavioral


type: Registry Identifier

title: Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home

acronym: EFIRAD

summary: The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home.

design_allocation: Randomized

primary_purpose: Supportive Care

location_facility: Pharmacy of Ambroise-Paré hospital, APHP


title: Study of Gynecological Follow-up Concerning Women With Multiple Sclerosis

acronym: GYNESEP

summary: The investigators want to evaluate gynecological follow-up concerning patients with multiple sclerosis. This study will include reproductive women (from 18 to 40 years old). Patients in the study have an aftercare at the neurology department at Pellegrin Hospital (Bordeaux).

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Merck Sharp & Dohme LLC

status_simplified: Completed


title: Automated Pupillometry and Delirium in Patients on Mechanical Ventilation in Intensive Care-intensive Care

acronym: PODIUM

summary:
Delirium in intensive care unit (ICU) is a serious event. It is associated with short-term complications (agitation, self-extubation, accidental removal of catheters, prolonged length of stay and ventilation), excess mortality, functional and cognitive impairment. It is particularly frequent in patients requiring mechanical ventilation but diagnosis is not easy. There are screening scales, but it is insufficiently used in clinical practice: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) or Intensive Care Delirium Screening Checklist (ICDSC). These scales are time consuming and require trained personnel. Automated pupillometry (AP) is a new device to objectively, rapidly, and reproducibly identify acute brain dysfunction. Recent data suggest that AP could be used to predict delirium in the ICU. This would need to be validated for routine use in the ICU.

Evaluate AP parameters on day 3 of invasive mechanical ventilation as a predictive tool for CAM-ICU diagnosed delirium during the first 14 days of ICU stay.

Study design: Prospective, multicenter, non-interventional cohort

Measurement of the AP parameters at day 3 after ICU admission and their predictive performance for delirium: pupillary diameter, variation of the pupillary diameter, pupillary constriction speed, pupillary dilatation speed, photomotor reflex latency, NPi and symmetry of pupillary responses.


title: Impact Assessment of an Interdisciplinary and Multimodal Hospital Program of Pediatric Medical Emergencies' in Situ Simulation

acronym: Impact-SUrVIS

summary:
Simulation in healthcare is becoming more and more essential in the training of paramedical and medical caregivers. It is a powerful educational tool that can enrich knowledge and skills, whether technical (setting up a venous catheter, intubation, etc...) or transversal (teamwork, communication, stress management in crises, etc.).

The hospital environment requires nurses, nurses' aides, residents, and doctors to provide human care in increasingly technical work environments while exercising increasing responsibilities. These caregivers are therefore exposed to many stressors. Several studies highlight the benefits of simulation on the ability of professionals to deal with rare and/or complex crises which they have previously faced during simulation sessions.

Beginning January 2022, the Necker - Enfants Malades hospital will start a hospital' scale training program for pediatric medical emergencies using in situ simulation of the Necker - Enfants Malades hospital.

The SUrVIS (Simulation d'Urgences Vitales In Situ) project is based on interprofessional training courses divided into four parts theoretical training (recognition of the critically ill child / cardiorespiratory arrest, how to call for assistance), procedural simulation (ventilation / chest compression / set up an intraosseous access / call for help...), three in situ simulation scenarios of pediatric medical emergencies (with live audiovisual retransmission for observers) each ending with a debriefing and a conclusion of the day with handing over of best practice documents. The study investigation team plan to train 400 caregivers each year (including 300 nurses and nurses' aides).

The Impact-SUrVIS (Impact de la Simulation d'Urgences Vitales In Situ) study is built around the SUrVIS sessions. Through questionnaire, the study investigation team will assess the impact of this hospital program on self-confidence, the feeling of professional efficiency, interprofessional communication, and work-related stress.

study_start_date_type: Anticipated

status: Not yet recruiting


title: Quaternary Ammonium and Immunization in Hairdressers

acronym: AQTIFF

summary:
"Quaternary ammonium ions (QA) are surfactants and microbicide products found in a large number of household products, disinfectants and cosmetics.

Professional exposure to QA causes allergic diseases of the skin and lung (asthma). It is also the firs cause of occupational rhinitis since 2000.

Several studies have found a link between exposure to some disinfectants and asthma in specific population. Moreover, a study showed that exposure to QA found in hairdressing products could also be a risk factor to allergy to neuro-muscular blocking agents.

However, the prevalence of QA sensitization amongst hairdressers is not known, sensitization mechanisms have been poorly characterized. To date, there is no recommendation regarding QA exposure nor classification of QA by toxicity. Finally, the link between hairdressing QA and drug allergy have not been confirmed yet.

The investigator hypothesize that it is possible to sensitize to QA by exposure to hairdressing products and then to declare allergic diseases. The investigator plan to study this hypothesis in an observational prospective cohort of hairdressing students by measuring both sensitization markers in blood and QA exposure. "

intervention_type: Biological


title: Evaluation of Nexpowder Application to Prevent Delayed Bleeding After Large Colorectal Endoscopic Mucosal Resection

acronym: NEXBLEED

summary: Delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. Different preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. A newly developed endoscopic hemostatic powder generating gelation effect (Nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (EMR) for large superficial colorectal lesions.

primary_purpose: Treatment

lead_sponsor: Gabriel RAHMI

location_facility: Hopital Européen Georges Pompidou, 20 Rue Leblanc

intervention_type: Device

lead_sponsor_type: industriel


title: Study of Serum and Urinary Biomarkers and Radiation Cystitis in Patients Treated With Radiotherapy for Localized Prostate Cancer

acronym: RABBIO

summary:
Prostate cancer represents the 1st diagnosed cancer in men, with 50400 new cases and 8100 deaths in 2018. Improved diagnostic and therapeutic strategies have led to a 3.7% decrease in mortality between 2010 and 2018 with a 5- and 10-year survival rate of 93% and 80%, respectively.

Pelvic conformal radiotherapy is an important therapeutic technique in the management of pelvic cancers, particularly prostate cancer. However, despite the improvement in radiation techniques, this technique is responsible for acute and late adverse events at the bladder level, these symptoms being grouped under the term radiation cystitis. It has a clear impact on the quality of life of patients. Acute radiation cystitis is likely to occur during treatment or within 3 months after radiotherapy. Its incidence is estimated at nearly 50%. The late form appears on average 2 years after radiation, but can sometimes occur 10 or 20 years later. Its incidence is 5 to 10% of cases.

Although certain factors have been identified, such as the dose received, fractionation or comorbidities, the pathophysiology of radiation-induced cystitis remains unclear, particularly because of the risks of complications arising from access to bladder tissue post-irradiation, thus limiting our knowledge as well as the therapies targeting this process. The use of biomarkers in liquid biopsies allows us to understand the problem of access to irradiated tissues and to highlight protein changes, prognostic of radiation-induced visceral toxicity.

Few works are published on the evaluation of inflammatory and pro-fibrotic biomarkers of radiation-induced cystitis in liquid biopsies. Only 2 retrospective studies have shown a correlation between late radiation cystitis and increased levels of plasminogen activator inhibitor 1 (PAI-1), matrix metalloproteinase inhibitors (TIMP1 and TIMP2), hepatocyte growth factor (HGF), vascular endothelial growth factor (VEGF) and placental growth factor (PIGF) in urine. However, none of these studies explored the variation of biomarkers in the early stage of radiation-induced bladder toxicity.

This would suggest the feasibility of prospective assay of overexpression of these proteins in liquid biopsies.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Evaluation of PET/CT of Cephalic Arteries for the Diagnosis of Giant Cell Arteritis

acronym: Cervico-TEP et

summary:
Giant cell arteritis (GCA) is the most common vasculitis in adults. The diagnosis of GCA is evoked by the association of clinical signs and biological anomalies (inflammatory syndrome) in patients over 50 years of age. On the other hand, starting a treatment implies being certain of the diagnosis which requires performing a temporal artery biopsy under local anesthesia. This examination is therefore an invasive procedure for patients whose sensitivity is not optimal. This is why imaging techniques (echo-Doppler or MRI of the temporal arteries) have been developed to look for signs of vasculitis without the need to perform a biopsy. However, these examinations lack sensitivity (=falsely concluding the absence of GCA) and specificity (=falsely concluding the presence of GCA). Recently, advances in imaging, and in particular positron emission tomography (PET), have made it possible to visualize the cephalic arteries, including the temporal artery.

The aim of this study is therefore to evaluate the sensitivity and specificity of PET of the cephalic arteries for the diagnosis of GCA and to compare them with those of echo-Doppler and MRI of the temporal arteries.

ReferenceType: derived

ReferenceCitation: Thibault T, Durand-Bailloud B, Soudry-Faure A, Greigert H, Drouet C, Devilliers H, Ramon A, Bejot Y, Martin L, Creuzot-Garcher C, Falvo N, Audia S, Cochet A, Bonnotte B, Alberini JL, Samson M. PET/CT of cranial arteries for a sensitive diagnosis of giant cell arteritis. Rheumatology (Oxford). 2023 Apr 3;62(4):1568-1575. doi: 10.1093/rheumatology/keac430.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Oxford University Press

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Employment Retention Issues for Patient With Pseudoxanthoma Elasticum

acronym: MEE-PXE

summary:
Pseudoxanthoma elasticum (PXE) is a rare, autosomal recessive genetic disease characterized by progressive calcification and fragmentation of elastic fibers in connective tissues. PXE primarily affect the skin, retina and arterial walls. Given the age of onset and progression of the disease, the consequences of PXE affect a large number of patients of working age and are therefore likely to have an impact on their professional career and job retention.

To our knowledge, there are no studies on the occupational impact of PXE.

ReferenceType: result

ReferenceCitation: Gupta MA, Gupta AK. Age and gender differences in the impact of psoriasis on quality of life. Int J Dermatol. 1995 Oct;34(10):700-3. doi: 10.1111/j.1365-4362.1995.tb04656.x.

ReferenceCitation: Shimada BK, Pomozi V, Zoll J, Kuo S, Martin L, Le Saux O. ABCC6, Pyrophosphate and Ectopic Calcification: Therapeutic Solutions. Int J Mol Sci. 2021 Apr 27;22(9):4555. doi: 10.3390/ijms22094555.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: MDPI

ReferenceCitation: Finger RP, Fenwick E, Marella M, Charbel Issa P, Scholl HP, Holz FG, Lamoureux EL. The relative impact of vision impairment and cardiovascular disease on quality of life: the example of pseudoxanthoma elasticum. Health Qual Life Outcomes. 2011 Dec 12;9:113. doi: 10.1186/1477-7525-9-113.

lead_sponsor: University Hospital, Angers


title: STIMulation cérébrale Profonde Chez Des Patients Souffrant d'Anorexie Mentale Résistante et Sévère

acronym: STIMARS

summary: The somatic complications as well as the suicidal risk make Anorexia Nervosa (AN) the psychiatric disease with the highest mortality rate: the standardized mortality ratio is higher than 4 and 1 in 5 patients with AN who dies has committed suicide. Approximately 20% of patients suffering from AN evolves into a chronic form without prolonged remission. These patients are at high risk of serious complications (somatic and psychiatric). The peak incidence of AN lies between 15 and 19 years: patients suffering from severe and resistant AN are therefore mostly young people. At present, there is no treatment for severe and resistant AN. New insights in AN pathophysiology revealed that AN patients develop a kind of "addiction" to thinness which contributes to weight loss despite negative consequences. In parallel, Deep Brain Simulation (DBS) is now widely performed for movements disorders with good results and low morbidity. DBS is also currently under investigations for other indications such as obsessional compulsive disorder or pharmacoresistant epilepsy. Some case series reported promising results of DBS for severe and resistant AN. The aim of this study is to investigate the safety of nucleus accumbens chronic stimulation for patients enduring severe and resistant AN. Secondary objective is to evaluate patient's acceptance of this new treatment.

lead_sponsor: Centre Hospitalier St Anne

appel_a_projets: PHRCI

region: Île-de-France

nom_etablissement: GHU PARIS PSY ET NEUROSCIENCES

type_etablissement: EPSM

acronyme: STIMARS

titre: STIMulation cérébrale profonde chez des patients souffrant d'Anorexie mentale Résistante et Sévère

discipline_principale: autre

nom_porteur: ZANELLO

prenom_porteur: Marc


title: Bacterial Translocation in Spondyloarthritis: Evaluation Before and After Starting a Biomedicine.

acronym: TEARE-BIO

summary: The aim of this project is to evaluate the effect of anti-TNF and anti-IL17 biotherapies on bacterial translocation in patients with NSAID-resistant axial spondyloarthritis.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon

intervention_type: Drug


title: Incidence, Risk Factors and Outcomes for Early and Delayed Extubatiion Failure in Critically Ill Cirrhotic Patients

acronym: FREELIVER

summary:
Although a life-saving intervention, invasive mechanical ventilation (MV) prone to complications and side effects.

Cirrhotic patients with a need of prolonged MV have a poor prognosis in ICU compared to general population of critically ill patients. The optimal time for weaning from MV and extubation is therefore a crucial objective. Extubation failure is defined as the need for reintubation within 48-72 hours (early). This time frame is sometimes extended to 7 days (delayed), especially when noninvasive ventilation is used during extubation (SFAR-SRLF 2018 recommendations). Some studies have investigated the risk factors for extubation failure in general population of critically ill patients, and in some specific subpopulations (COPD, brain injury, elderly). But little is known about extubation failure in cirrhotic patients admitted in ICU.

The aim of the present study is to describe the incidence and identify specific risk factors for extubation failure in cirrhotic critically ill patients. Ultrasound and clinical data will be collected and analysed during the ICU stay.


title: Oculomotor Response While Using a Helmet Display Incorporating an Accommodation-vergence Stress Reduction Algorithm

acronym: ALGO-HMD

summary:
Operational military personnel are increasingly using virtual or augmented reality headsets in the field or in training. However, these devices cause a conflict between accommodation (focus to see clearly) and vergence (alignment of both eyes on the object being viewed) that can be a source of visual fatigue and altered visual and perceptual abilities. Although techniques exist to limit this conflict for screen-based stimuli, the use of helmet visuals (or immersive headsets) adds technological complexity. Indeed, since accommodation on the screen of the helmet visual is impossible (i.e., distance too small) for the human visual system, lenses are used to virtually shift the image (referred to as a collimated image) so that accommodation can occur much further away. However, this material configuration also modifies the vergence, thus causing a conflict between accommodation and additional vergence that persists regardless of the attenuation technique used.

In this study, the investigator proposed to modify the image display to take into account the technical features of the helmet to correct this techno-dependent conflict. This study is aimed at determining whether the setting recommended by the algorithm developed by the investigator limits visual fatigue better than the conventional setting recommended by manufacturers or a subjective setting controlled by the user.

sponsor_collaborators: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Validation of the 3-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM) and the Ultra-Brief CAM (UB-CAM) in French.

acronym: French-UB-CAM

summary:
Delirium is very common in hospitalized older patients and associated with serious clinical bad outcomes (e.g. increased risk of functional decline and death). Despite its high prevalence in the hospital setting, delirium remains underdiagnosed. A better identification would allow an early management and a reduction of its complications.

The validation of easy-to-use and quick and formalized tools for the identification of delirium and their implementation in the clinical practice are necessary.

Recently, the 3D-CAM (3-minutes Diagnostic interview for Confusion Assessment Method -defined delirium) and the UB-CAM (Ultra-Brief CAM) showed very high sensitivity and specificity (> 90%), compared to the reference standard (Diagnostic and Statistical Manual of Mental Disorders (DSM criteria)) for the diagnosis of delirium.

The investigators aimed to evaluate the sensitivity and specificity of the French versions of the 3D-CAM and the UB-CAM used in delirium screening in older adults hospitalized in geriatric units, compared to reference standard.

time_perspective: Cross-Sectional

location_facility: Hôpital des Charpennes, Institut du Vieillissement, Hospices Civils de Lyon

intervention_type: Diagnostic Test


title: Prevalence and Clinical Significance of Anti-annexin A2 Antibodies in COVID-19 Infection

acronym: IMMUNOCOVID

summary:
In January 2020, researchers isolated and sequenced in China from patients with severe atypical pneumonia a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 has rapidly spread throughout the world. SARS-CoV-2 may trigger hyperstimulation of immune system with an autoinflammatory response but also the development of an autoimmune process. These autoimmune responses may also develop through the molecular mimicry between virus and human-self components. Multiple autoantibodies have been described in COVID-19 patients.

Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator has been identified as a new autoantigen in antiphospholipid syndrome. ANXA2 has been identified as candidate autoantigen recognized by SARS patient sera. ANXA2 contributes also to pulmonary microvascular integrity. These data lead to identify anti-ANXA2 antibodies in COVID-19 patient sera and to know if the presence of these antibodies is associated with pulmonary injury or thrombosis in COVID-19 and represents a marker of severity.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Open-label, Multicenter, Prospective Phase 2 Study to Evaluate the Duration of Treatment With Cabozantinib Among Patients With Metastatic or Locally Advanced Renal Cell Carcinoma on Hemodialysis (HD).

acronym: Cabo-POLARIS

summary:
Among patients with renal cell carcinoma (RCC), 2.7 to 4.7 % of patients are at risk of progressing to dialysis or transplantation after partial and radical nephrectomy respectively. Of note, similar risk factors can be seen in both disease: RCC and renal impairment leading to dialysis. Currently, three types of systemic therapies (ST) are mainly used among patients with metastatic renal cell carcinoma (mRCC): anti-angiogenics (mostly tyrosine kinase inhibitors and bevacizumab), mTOR inhibitors and immune checkpoint inhibitor.

ST prescription for patients undergoing HD may be more dangerous than in other patients. This is partially explained by the fact that several adverse events can be induced by both the ST and HD e.g. thromboembolic disease, or hypertension.

Patients in HD are usually excluded from major clinical trials and available data concerning safety and activity of ST in this specific population are lacking. In most cases, drugs' label is driven by the eligibility criteria of large randomized phase 3 trials that exclude this type of patients. The main source of information for these patients comes from academic publications of patients' cases or small cohorts, but they are not included within the drug label. Moreover, no clear guidelines are given by savant societies regarding those patients.

It is known that patients with HD are at high risk of specific adverse events that can sometimes overlap with the safety profile of anti-cancer drugs: thromboembolic complications, cardio-vascular comorbidities, hematologic and metabolic abnormalities.

Having a dedicated clinical trial to this particular population would definitely help the community to improve the care of HD patients by getting prospective data in order to increase the level of evidence and therefore to optimize anticancer drug use in this specific population.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: Engaging Elderly People Living in Institutions in Eating Situations

acronym: ENGAGE

summary:
Several recent studies have revealed a significant under-consumption of food in hospitals and nursing homes. For instance, at the Dijon University Hospital, 8 out of 10 patients consume less than 80% of the meals served. This has two consequences: an increase in the risk of malnutrition (some patients leave the hospital in such a poor nutritional state that they must be re-hospitalized within six months) and significant food waste. At the heart of this problem, the taste of the food is the subject of frequent and recurrent complaints from users. Although the food industry widely uses sensory methods to adapt its products to the taste of consumers, these methods are rarely used by the organizations that provide meals to care institutions.

The objective is to establish "taste commissions" in the daily practice in institutions for the elderly (hospital, nursing home), in order to improve the organoleptic quality of the meals served according to the expectations and preferences of the users. The principle of this system is to allow the users to taste the dishes produced by the kitchen of the establishment and to transmit these evaluations to the cooks so that they can rework the recipes according to the users' feedback.


acronym: BARICENTRE

summary:
Rheumatoid arthritis (RA) is a frequent and disabling disease, requiring early management to achieve clinical remission. Recently, baricitinib (jak1-jak2 inhibitor) has been shown to as an efficient treatment in placebo-controlled trials, and compared to the reference treatment with TNF inhibitor (adalimumab). Its efficacy has been reported on the inflammatory parameters, but more importantly on patient-reported outcomes. Baricitinib is thought to have anti-inflammatory effects, via its inhibition of the JAK pathway. Importantly, it has also been suggested to affect mood and pain.

Hypotheses: Inhibition of JAK Kinase pathway in patients with RA will improve emotional and cognitive processing involved in mood disorders and decrease pain sensitization.

The primary objective of this study is to evaluate early emotional impact of the JAK 1/2 inhibitor Baricitinib assessed by a facial emotion recognition task. This precocious effect on emotion processing is a surrogate marker of clinical imporvement in mood.

Phase 4 study, Double-blind randomized control study with patients receiving placebo or baricitinib for 7 days, then open label study until day 42 with all patients receiving baricitinib during 5 weeks.

status: Terminated

title: BARIcitinib Cognitive Emotional and Neural signaTuRE (BARICENTRE)

type: EudraCT Number

source: euctr

ipd_sharing_description:
Data are available upon reasonable request. 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.

ipd_sharing: Yes

status_simplified: Unknown


title: Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.

acronym: OBEVIE

summary: We postulate that childhood traumas are associated with deregulation of the glucocorticoid axis and the inflammatory system in obese women. The main objective of the study is to compare the salivary cortisol awaking response in obese women according to the presence of childhood trauma (assessed using the Childhood Trauma Questionnaire, CTQ).

lead_sponsor: University Hospital, Limoges


title: Caractérisation Clinico- Biologique et Survie Des Patients Porteurs d'Une lymphoprolifération HTLV-1 Induite (ou Lymphome/leucémie lié au Virus HTLV-1) et Des Patients infectés Par le Virus HTLV-1

acronym: HTLV-OBS

summary: The purpose of this study is to evaluate the outcome (survival) of Adult T-cell leukemia / lymphoma (ATL) patients who receive or not specific treatment for their hemopathy (cohort 1) and the outcome (survival) of HTLV-1 chronically infected patients with / without extra-haematological disorders (cohort 2).


title: Cerebral Hemodynamic Impact in Children Depending on the Technique of Carotid Artery Decanulation Technique After Extracorporeal Membrane Oxygenation: Modeling of Intra-cerebral Vascular Flows

acronym: MoVa-ECMO

summary:
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis.

This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).


title: Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach

acronym: PRECILITH

summary:
Nephrolithiasis is a disease caused by the formation of kidney stones in the urinary tract which can then partially or completely obstruct the latter causing an extremely sharp pain called renal colic. In industrialized countries, it affects 10 to 20% of the population, and is the most common kidney disease.The primary objective of this study is to identify the clinical, biological, genetic, molecular and environmental determinants predictive of recurrence of renal lithiasis.

The study follow-up visit schedule corresponds to the visits usually scheduled as part of patient care: 1 year from the inclusion visit (A1), 3 years (A3) then 5 years (A5). Samples for research (additional volume of blood, urine) will be taken by a registered nurse along with the routine check-up samples.Samples intended for research will be sent by staff to the Biobanque de Picardie (CHU Amiens-Picardie) for processing and conservation.

primary_purpose: Screening

collaborators:
Institut Pasteur de Lille
Université de Lille

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Evaluation of Sound Therapy in a Population of Women With Fibromyalgia Aged Between 30 and 60 Years

acronym: SONOMYAL

summary: This study focusing on sound therapy in patients with fibromyalgia is a single-centre, prospective, randomized study which evaluates the improvement or not of painful symptoms following relaxation sessions with sound therapy.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


title: Relationship Between Hip Abductor Strength and Ankle Stability

acronym: HIAS

summary:
Ankle sprains are one of the most common injuries in sports. The analysis of risk factors is a priority in order to guide rehabilitation and prevention programs. Among risk factors identified in the literature, weakness of the hip abductor muscles represent a factor favoring recurrent ankle sprains. However, only few studies have investigate the link between the strength of the hip abductor muscles and the deficits in stabilization of the ankle joint. Furthermore, these few studies analysed landing task or undisturbed balance task. It would be interesting to further understand the impact and role of hip abductor muscles on ankle stability during specific ankle-destabilizing task.

The main objective of this study is to establish a link between the strength of the hip abductor muscles and the dynamic postural control performance measured by the modified Star Excursion Balance Test (SEBTm). Secondly, it will be necessary to study the kinematic and neuromuscular control characteristics of the ankle during 4 functional tests:

SEBTm
Static unipodal balance
Weight-bearing inversion test
Weight-bearing eversion test

These tests will be realized with an ankle destabilizing device. The device is a sandal equipped of an articulator under the rear foot which allow movements in inversion and eversion. Furthermore, tests are realized two times, before and immediatly after a fatiguing exercise. The fatiguing exercise consists to implemented local fatigue on hip abductor muscles by repeating abductions.

primary_purpose: Prevention


title: Efficiency of an Optimized Care Organization for Fatigue Management for Patients With COVID-19.

acronym: CoviMouv

summary: Length of hospitalization for COVID-19 infection may be increased due to the persistence of fatigue in 29-46% of cases. Its management is essential to prevent the chronic fatigue . Chronic fatigue syndrome affected between 30 and 40% of patients with SARS in 2003 or MERS in 2005 and persisted beyond 3 years. There is currently no specific treatment for acute or <4 months asthenia. To avoid the transition to chronicity, some authors recommend respecting a long rest period. However, a program combining adapted physical activity and therapeutic patient education has already shown significant benefits for combating recent or semi-recent fatigue following a cardiovascular pathology and even during cancer treatments. Therefore, the existing care pathway for hospitalized patients with COVID-19 was adapted, combining exercise training and therapeutic patient education workshops.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Assessment of Tolerance to the Treatment of Obstructive Sleep Apnea by Shear Wave Inducer Collar

acronym: ET-SAOS-OC

summary:
Obstructive sleep apnea syndrome (OSAS) is a common disease, affecting 10-15% of the general adult population. This pathology is characterized by iterative nocturnal episodes of complete or partial obstruction of the upper airways during sleep leading to chronic intermittent nocturnal hypoxia and sleep fragmentation. The number of nocturnal respiratory anomalies per hour of sleep characterizes the severity of the disease with a gradual gradation of severity from mild (from 5 to 15 anomalies per hour) to moderate (15 to 30 anomalies per hour) and severe (over 30 anomalies per hour). The rationale for this severity classification is the increase in morbidity and mortality proportional to the severity of OSA as defined.

OSA is accompanied by a fragmentation of sleep often responsible for excessive daytime sleepiness, causing an increase in occupational accidents with work stoppage and traffic accidents.

The second consequence of repeated nocturnal obstructions is chronic intermittent nocturnal hypoxia which has deleterious cardiovascular effects, constituting an independent cardiovascular risk factor.

Shear waves are elastic waves of low frequency (less than 1000 oscillation per second - 1000Hz). It propagates only in solids and soft solids such as the human body. The propagation of a shear wave generates a reversible micrometric displacement of the particles that make up this medium. The energy of these waves is related to the amplitude of movement of the particles.

Elastography is an imaging modality for measuring the elasticity of biological tissues by shear waves. The shear wave is a mechanical wave sensitive to the change in the elasticity of its propagation medium. This sensitivity is manifested by the variation of its propagation speed. Hardness results in acceleration of the wave and softness in its slowing down.

The therapeutic use of shear waves has never been used for the treatment of sleep apnea but its use could be an additional therapeutic arsenal of Continuous Positive Pressure.

The technology developed by BREAS MEDICAL AB is based on the use of shear waves for the treatment of sleep apnea. The treatment is delivered using a cervical collar equipped with six sources (vibrating pistons) generating shear waves. The treatment generates shear waves at frequencies that vary from 20 to 250 Hz continuously, and at amplitudes less than 50 microns of the same order of magnitude of vibration as snoring. In view of the innovative nature of the treatment, the medico-technical team of BREAS MEDICAL AB carried out an analysis of the risks related to the device and to the propagation of waves, including the norms and standards imposed by the competent bodies.

The investigators would like, in a first-dose study in humans, to assess safety in patients with sleep apnea syndrome.

location_facility: Department of sleep and respiratory disorders, Hopital Nord Croix-Rousse - Hospices Civils de Lyon


title: Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation

summary: The purpose of this open, monocenter pilot trial is to evaluate the tolerance of the SclerFIX product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular implants in patients who underwent enucleation due to an eye malignant tumor resection.

lead_sponsor: TBF Genie Tissulaire


title: Evaluation of the Performance of Six-month Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries. A Single-center, Randomized, Double-blind Study.

acronym: ECHOGUIDE

summary:
The main hypothesis of the study is that in situ infiltration of the meniscal lesion would provide patients with lasting and greater relief than intra-articular infiltration. A statistically significant difference would be if the Lysholm score of the meniscal wall group at 3 months is 9.5 points higher than that of the intra-articular infiltration group.

The aim is to evaluate the effectiveness of meniscal wall infiltration under ultrasound in the treatment of stable degenerative meniscal lesions versus intra-articular infiltration (Gold standard) at 3 months by Lysholm's algo-functional score.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Study of Vascular Endothelial Glycocalyx and Ophthalmic Injury in a Single-center, Cross-sectional, Prospective Cohort of Patients With Prolonged Post-COVID-19 Symptoms

acronym: GLYCOVLONG

summary:
The glycocalyx is a membrane coat composed of glycoproteins attached to the surface of cell membranes. Recent publications have drawn attention to the potential role of a degradation of the endothelial glycocalyx (a kind of gel that lines all the vessels of the body) during the SARS-CoV-2 (Severe Acute Respiratory Syndrome - coronavirus 2) epidemic.

The work of Yamaoka-Tojo et al. reveals vascular endothelial dysfunction in patients at high risk for developing a severe form of COVID 19. This observation prompts further investigation of vascular endothelial function in SARS-CoV-2-infected patients, and particularly those with long COVID.

As of the end of the first COVID-19 epidemic wave in May 2020, persistence of symptoms several weeks or months after the first manifestations of COVID-19 was described in more than 20% of patients after 5 weeks and in more than 10% after 3 months). The term "long COVID" describes this phenomenon of prolonged symptoms following COVID-19.

The French National Authority for Health has established criteria to identify people with prolonged symptoms after an initial episode of clinically and/or biologically documented COVID-19: an initial symptomatic episode, the presence of at least one of the initial symptoms beyond 4 weeks after the onset of the acute phase of the disease, and initial and prolonged symptoms not explained by another diagnosis not known to be related to COVID-19.

Among the observations reported in patients with long COVID, ophthalmic involvement is poorly described.

A team of ophthalmologists of the Rothschild Foundation has demonstrated (using indocyanine green angiography, adaptive optics and optical coherence tomography techniques) disorders of the choroidal circulation, with abnormalities of the vascular walls, presence of "pachyvessels" and "caverns", in COVID-positive patients hospitalized at 6 months of their hospitalization.

time_perspective: Other

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hospital-Foundation Adolphe de Rothschild

intervention_type: Procedure


title: Impaired Tissue Oxygen Delivery in Patients With Coexistent COPD-heart Failure: What Consequences on Neuromuscular Fatigue During Exercise?

acronym: FIBOX

summary:
Rationale. Chronic obstructive pulmonary disease (COPD) and heart failure (HF) coexist in approximately one third of patients presenting with one of these conditions. From a clinical standpoint, impaired tissue oxygen (O2) delivery stands as a common pathological mechanism of these cardiorespiratory diseases. Recent evidence suggest that muscle and cerebral blood flow and oxygenation are further impaired during exercise in patients with COPD-HF overlap compared to isolated diseases. However, it remains unknown whether impaired O2 delivery is associated with exaggerated manifestations of peripheral and central fatigue in COPD-HF overlap. In addition, improving cardiopulmonary interactions through non invasive positive pressure ventilation or through the addition of a hyperoxic gas mixture during exercise have been associated with enhanced cerebral and muscle O2 delivery and oxygenation in patients with COPD or HF. It is, therefore, conceivable that improved O2 delivery to these structures have beneficial influence on exercise capacity in patients with COPD-HF overlap due to less peripheral and central fatigue.

Aims. To investigate the influence of impaired O2 delivery during exercise, and its alleviation with different interventions (non invasive positive pressure ventilation ± hyperoxia), on neuromuscular fatigue in patients with COPD-HF.

ReferenceCitation: Rutten FH, Cramer MJ, Grobbee DE, Sachs AP, Kirkels JH, Lammers JW, Hoes AW. Unrecognized heart failure in elderly patients with stable chronic obstructive pulmonary disease. Eur Heart J. 2005 Sep;26(18):1887-94. doi: 10.1093/eurheartj/ehi291. Epub 2005 Apr 28.

ReferenceCitation: Oliveira MF, Zelt JT, Jones JH, Hirai DM, O'Donnell DE, Verges S, Neder JA. Does impaired O2 delivery during exercise accentuate central and peripheral fatigue in patients with coexistent COPD-CHF? Front Physiol. 2015 Jan 7;5:514. doi: 10.3389/fphys.2014.00514. eCollection 2014.

ReferenceCitation: Oliveira MF, Alencar MC, Arbex F, Souza A, Sperandio P, Medina L, Medeiros WM, Hirai DM, O'Donnell DE, Neder JA. Effects of heart failure on cerebral blood flow in COPD: Rest and exercise. Respir Physiol Neurobiol. 2016 Jan 15;221:41-8. doi: 10.1016/j.resp.2015.10.005. Epub 2015 Oct 31.

ReferenceCitation: Oliveira MF, Arbex FF, Alencar MC, Souza A, Sperandio PA, Medeiros WM, Mazzuco A, Borghi-Silva A, Medina LA, Santos R, Hirai DM, Mancuso F, Almeida D, O'Donnell DE, Neder JA. Heart Failure Impairs Muscle Blood Flow and Endurance Exercise Tolerance in COPD. COPD. 2016 Aug;13(4):407-15. doi: 10.3109/15412555.2015.1117435. Epub 2016 Jan 20.

ReferenceCitation: Borghi-Silva A, Oliveira CC, Carrascosa C, Maia J, Berton DC, Queiroga F Jr, Ferreira EM, Almeida DR, Nery LE, Neder JA. Respiratory muscle unloading improves leg muscle oxygenation during exercise in patients with COPD. Thorax. 2008 Oct;63(10):910-5. doi: 10.1136/thx.2007.090167. Epub 2008 May 20.

ReferenceCitation: Borghi-Silva A, Carrascosa C, Oliveira CC, Barroco AC, Berton DC, Vilaca D, Lira-Filho EB, Ribeiro D, Nery LE, Neder JA. Effects of respiratory muscle unloading on leg muscle oxygenation and blood volume during high-intensity exercise in chronic heart failure. Am J Physiol Heart Circ Physiol. 2008 Jun;294(6):H2465-72. doi: 10.1152/ajpheart.91520.2007. Epub 2008 Mar 28.

ReferenceCitation: Oliveira MF, Rodrigues MK, Treptow E, Cunha TM, Ferreira EM, Neder JA. Effects of oxygen supplementation on cerebral oxygenation during exercise in chronic obstructive pulmonary disease patients not entitled to long-term oxygen therapy. Clin Physiol Funct Imaging. 2012 Jan;32(1):52-8. doi: 10.1111/j.1475-097X.2011.01054.x. Epub 2011 Oct 3.

ipd_sharing_description: Data will be available on reasonable request to the Investigators (unidentified patients' data).

lead_sponsor: University Hospital, Grenoble

location_facility: CHU Grenoble Alpes - Hopital Sud (Laboratoire HP2)


title: Identification of Image Phenotypes to Predict Recurrence After Resection of Hepatocellular Carcinoma

acronym: LIVERIBIOPSY

summary:
Tumor recurrence, which occurs in 70% of patients with HCC within 5 years after hepatic resection, is a major cause of post-resection-death. This recurrence can be true recurrence (intrahepatic metastases), which occurs sooner than 2 years later, or it can be due to the development of de-novo tumors at least 2 years later. Despite this high rate of tumor recurrence, no anti-recurrence adjuvant therapies are currently recommended.

Imaging phenomics is the systematic, large scale extraction of imaging features for the characterization and classification of disease phenotypes. Combining imaging and tissue phenomics could be a solution to predict HCC recurrence. With the emergence of molecular therapies and immunotherapies, identifying patients with HCC at high risk of post-resection recurrence would help determine additional therapeutic and management strategies in clinical practice.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Median Technologies


title: The Effect of Sleep Misalignment on the Cognitive Empathetic Ability to Recognize Pain and to Evaluate the Pain Intensity in Others as Competence for Qualitative Care

acronym: PAIN-EASE

summary: Cognitive Empathy is relevant in clinical practice and will be assessed based on the accuracy of pain recognition and the pain intensity evaluation in a computerised task using facial expressions. Repeated measures across day and night shifts will provide the basis to understand the impact of shift work on those abilities in health care professionals.

ReferenceCitation: Czeisler CA, Pellegrini CA, Sade RM. Should sleep-deprived surgeons be prohibited from operating without patients' consent? Ann Thorac Surg. 2013 Feb;95(2):757-66. doi: 10.1016/j.athoracsur.2012.11.052. No abstract available.

ReferenceCitation: Gelinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006 Jul;15(4):420-7.

ReferenceCitation: Geyer NM, Coetzee SK, Ellis SM, Uys LR. Relationship of nurses' intrapersonal characteristics with work performance and caring behaviors: A cross-sectional study. Nurs Health Sci. 2018 Sep;20(3):370-379. doi: 10.1111/nhs.12416. Epub 2018 Feb 28.

ReferenceCitation: Guadagni V, Burles F, Ferrara M, Iaria G. The effects of sleep deprivation on emotional empathy. J Sleep Res. 2014 Dec;23(6):657-663. doi: 10.1111/jsr.12192. Epub 2014 Aug 13.

ReferenceCitation: Hirsh AT, Jensen MP, Robinson ME. Evaluation of nurses' self-insight into their pain assessment and treatment decisions. J Pain. 2010 May;11(5):454-61. doi: 10.1016/j.jpain.2009.09.004. Epub 2009 Dec 16.

ReferenceCitation: Hojat, M. (2016). Empathy in health professions education and patient care.

ReferenceCitation: Killgore WDS, Balkin TJ, Yarnell AM, Capaldi VF 2nd. Sleep deprivation impairs recognition of specific emotions. Neurobiol Sleep Circadian Rhythms. 2017 Jan 21;3:10-16. doi: 10.1016/j.nbscr.2017.01.001. eCollection 2017 Jun.

ReferenceCitation: Kozlowski D, Hutchinson M, Hurley J, Rowley J, Sutherland J. The role of emotion in clinical decision making: an integrative literature review. BMC Med Educ. 2017 Dec 15;17(1):255. doi: 10.1186/s12909-017-1089-7.

ReferenceCitation: Kyle SD, Beattie L, Spiegelhalder K, Rogers Z, Espie CA. Altered emotion perception in insomnia disorder. Sleep. 2014 Apr 1;37(4):775-83. doi: 10.5665/sleep.3588.

ReferenceCitation: Kang Y, Moyle W, Venturato L. Korean nurses' attitudes towards older people with dementia in acute care settings. Int J Older People Nurs. 2011 Jun;6(2):143-52. doi: 10.1111/j.1748-3743.2010.00254.x. Epub 2010 Oct 28.

ReferenceCitation: Mercer SW, Reynolds WJ. Empathy and quality of care. Br J Gen Pract. 2002 Oct;52 Suppl(Suppl):S9-12.

ReferenceCitation: Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

ReferenceCitation: Owens JA. Sleep loss and fatigue in healthcare professionals. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):92-100; quiz 101-2. doi: 10.1097/01.JPN.0000270624.64584.9d.

ReferenceCitation: Rosen IM, Gimotty PA, Shea JA, Bellini LM. Evolution of sleep quantity, sleep deprivation, mood disturbances, empathy, and burnout among interns. Acad Med. 2006 Jan;81(1):82-5. doi: 10.1097/00001888-200601000-00020.

ReferenceCitation: Sampson FC, Goodacre SW, O'Cathain A. The Reality of Pain Scoring in the Emergency Department: Findings From a Multiple Case Study Design. Ann Emerg Med. 2019 Oct;74(4):538-548. doi: 10.1016/j.annemergmed.2019.02.018. Epub 2019 Apr 5.

ReferenceCitation: Tempesta D, Socci V, De Gennaro L, Ferrara M. Sleep and emotional processing. Sleep Med Rev. 2018 Aug;40:183-195. doi: 10.1016/j.smrv.2017.12.005. Epub 2017 Dec 22.

lead_sponsor: Claude Bernard University


title: COVID-19 Vaccines Induced Malaise: A Retrospective Study and Analysis of the WHO Pharmacovigilance Database

summary:
COVID-19 vaccines induced malaise have recently been reported in the literature. Our study aims to identify risk factors associated with the onset of COVID-19 vaccines induced malaise and to assess if certain COVID-19 vaccines could be more prone to cause malaise compared to influenza vaccines.

To do so we performed a disproportionality analysis adjusted on age class, sex, region and type of reporter in VigiBase®, the WHO pharmacovigilance database, restricted to data from 01/01/2021 to 26/01/2022 to assess the association between all COVID-19 vaccines on the market and malaise. Demographic data were also analyzed.

lead_sponsor: University Hospital, Caen

location_facility: Caen University Hospital, Department of Pharmacology


title: Does an Augmented Reality-based Navigation System in Total Knee Arthroplasty Allow a Better Alignment of the Lower Limb and Does it Improve Functional Results ? An Equivalence, Monocentric, Prospective and Randomized Study

summary:
The purpose of Total Knee Replacement (TKR) is to remove worn cartilage surfaces and replace them with artificial parts of the same shape. TKR can be used in cases of osteoarthritis, inflammatory rheumatism, bone necrosis of the knee or following malformative or traumatic sequelae.

Implant alignment is paramount in TKR and the last years have seen a proliferation of alignment techniques following the introduction of computer and robotic-assisted surgery. Among Computer-assisted surgery, the augmented reality-based navigation system can be an option to improve accuracy in orthopaedic surgery.

The hypothesis of this study is: the use of augmented reality-based navigation system allows a prosthesis alignment and positioning that is at least as good as with the traditional mechanically aligned technique, and therefore improves knee functional results. This study also aims at assessing the cost-effectiveness of this new technology.

ReferenceCitation: Panjwani TR, Mullaji A, Doshi K, Thakur H. Comparison of Functional Outcomes of Computer-Assisted vs Conventional Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of High-Quality, Prospective Studies. J Arthroplasty. 2019 Mar;34(3):586-593. doi: 10.1016/j.arth.2018.11.028. Epub 2018 Dec 2.

ReferenceCitation: Cheng T, Pan XY, Mao X, Zhang GY, Zhang XL. Little clinical advantage of computer-assisted navigation over conventional instrumentation in primary total knee arthroplasty at early follow-up. Knee. 2012 Aug;19(4):237-45. doi: 10.1016/j.knee.2011.10.001. Epub 2011 Nov 29.

lead_sponsor: Elsan

location_facility: Centre Médico-Chirurgical de Tronquières


title: Prognostic's Factors of Head and Neck Paragangliomas Evolution

acronym: PRONO-PARAG

summary:
Cervical paragangliomas (HNPG) are rare tumors (0.6% of head and neck tumors) arising from chromaffin tissue, of cervical paraganglia (PGL). The most common locations are carotid body (60% of cases), jugulo-tympanic region and vagal body.

More than 30% are proved to occur in a context of genetic predisposition, more often in young people, and genetic screening is recommended in all patients. Multifocal tumors represent 12% of all HNPG and until 50% of familial forms. Most of HNPG are non-secreting, benign and slow growing tumors, but up to 30% present complications of local growth, and up to 10% can develop distant metastasis that define malignancy since there is no pathological marker.

Historically, surgical treatment was the standard of care but represents nowadays around 50% of the treatment, mostly due to the identification of high morbidity rates. The rate of recurrence is probably around 10% at 5 years. Radiotherapy and active follow-up represent the main therapeutic alternatives.

The standard of care is classically surgical but may expose to important sequelae leading to a review of its primary indication. Indeed, cranial nerve palsies (VII, IX, X, XI and XII) may complicate up to 20% of carotid PGL surgeries and up to 95% of vagal PGL surgeries. They are leading to significant functional sequelae, sometimes requiring recourse to a gastrostomy (4/79 patients operated on in a retrospective cohort). First bite syndrome, Claude Bernard Horner syndrome, baroreceptor failure, xerostomia, and ischemic events complicate 5.8%, 4.9%, 1.9%, 1%, and 1% of surgeries respectively. In a local retrospective study conducted by the Hospices Civils de Lyon on 34 operated cervical PGL, the overall complication rate reached 62%. These complications depend mainly on the location tumor and its size.

Control rate of irradiated HNPG at 5 years from retrospective series seems to be around 90%. They seems also to have a possible better progression-free survival at 15 years than surgery. The tolerance is correct, the risk of induced malignancy is estimed at 1/1000 to 1/2000. Without treatment, 44% of cervical PGL show a significant progression (median follow-up 51 months). Progression is estimated at 0.41 mm/year for jugulo-tympanic PGL and 1.6 mm/year for vagal and carotid PGL.

Currently, there is no clear and robust consensus regarding the follow-up of cervical PGL and the indications for different therapeutic strategies. Data available are represented by retrospective studies only, mostly small in size, with heterogeneous and often inadequate follow-up compared to slow tumor growth.

Thus, this prospective cohort study with a standardized long-term follow-up will allow to characterize the management modalities and the evolution of this population.

lead_sponsor: Hospices Civils de Lyon

location_facility: Fédération d'endocrinologie Hôpital Cardiologique/Groupement Hospitalier Est


title: Percutaneous Treatment of Iatrogenic False Femoral Aneurysms by Ultrasound-guided Thrombin Injection

acronym: EGTI

summary:
Since the 2000s, endovascular procedures have been expanding rapidly in multiple disciplines: cardiology, radiology, interventional neuroradiology, and of course vascular surgery. Most procedures are performed by puncture of the common femoral artery with introducers ranging in size from 4F to 26F for aortic procedures.

The most frequent complications of percutaneous punctures are false femoral aneurysms due to failure to close the arterial gap (up to 8% in some studies). A false aneurysm is a pocket of blood communicating with an artery and secondary to the rupture of the arterial wall. The blood is then contained by the adjacent structures and often a fibrous shell which distinguishes it from an aneurysm which retains the integrity of its wall.

The management of false femoral aneurysms is variable. Below 2 cm, monitoring may be performed with or without manual or ultrasound-guided compression. In case of persistence of the false aneurysm and/or complication, open surgery can be performed.

Endovascular treatment of false aneurysms was first proposed in 1986. Different endovascular techniques can be proposed to occlude false aneurysms such as the use of coils, biological glue, the use of arterial closure systems...

Echoguided injection of thrombin to occlude the false aneurysm in a manner has been published since the late 1990s. The treatment is evaluated as reliable and safe. A recent article in the EJVES (6) investigates the value of low-dose thrombin for this indication, and the results appear to be very encouraging for low-dose thrombin in false femoral aneurysms.

Thrombin injection for the treatment of iatrogenic false femoral aneurysms is the technique currently favoured by the vascular surgery team at the Paris Saint Joseph Hospital Group (GHPSJ). Open surgery is a second-line treatment and remains indicated in case of acute symptoms (radiculalgia, motor/sensory deficits; ischemia, skin necrosis), a false aneurysm that is too deep or without a neck, an infectious origin or a patient treated with dabigatran. Patients will be reviewed at 1 and 12 months according to the usual follow-up.

In this work, investigators will study the efficacy of false aneurysm closure using human thrombin injection. This work is intended to confirm previous work. A socio-economic study may be conducted in parallel. Follow-up after the use of percutaneous closure systems and in the context of bypass surgery may also be of interest.

ReferenceCitation: Boge G, Laroche JP, Alric P. [Treatment of post-catheterization pseudoaneurysms by ultrasound-guided thrombin injection: A single-center experience and practical guideline]. J Med Vasc. 2017 Jul;42(4):198-203. doi: 10.1016/j.jdmv.2017.05.003. Epub 2017 Jun 28. French.

ReferenceCitation: Gummerer M, Kummann M, Gratl A, Haller D, Frech A, Klocker J, Fraedrich G, Gruber H. Ultrasound-Guided Fibrin Glue Injection for Treatment of Iatrogenic Femoral Pseudoaneurysms. Vasc Endovascular Surg. 2020 Aug;54(6):497-503. doi: 10.1177/1538574420934631. Epub 2020 Jun 19.

ReferenceCitation: Cope C, Zeit R. Coagulation of aneurysms by direct percutaneous thrombin injection. AJR Am J Roentgenol. 1986 Aug;147(2):383-7. doi: 10.2214/ajr.147.2.383.

ReferenceCitation: Liu W, Liu C, Lu SY. Percutaneous suture technique with ProGlide to manage vascular access pseudoaneurysm after percutaneous coronary intervention procedure: A case report. Chin J Traumatol. 2020 Feb;23(1):34-37. doi: 10.1016/j.cjtee.2019.11.002. Epub 2019 Dec 18.

ReferenceCitation: Kang SS, Labropoulos N, Mansour MA, Baker WH. Percutaneous ultrasound guided thrombin injection: a new method for treating postcatheterization femoral pseudoaneurysms. J Vasc Surg. 1998 Jun;27(6):1032-8. doi: 10.1016/s0741-5214(98)70006-0.

ReferenceCitation: Kurzawski J, Janion-Sadowska A, Zandecki L, Sadowski M. Comparison of the Efficacy and Safety of Two Dosing Protocols for Ultrasound Guided Thrombin Injection in Patients with Iatrogenic Femoral Pseudoaneurysms. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):1019-1025. doi: 10.1016/j.ejvs.2020.01.009. Epub 2020 Feb 1.

lead_sponsor: Fondation Hôpital Saint-Joseph


acronym: PETDEXDOCOVID

summary:
ICU Patients admitted after ARDS due to COVID infection should be weaned from invasive mechanical ventilation as quickly as possible.

60% of ARDS patient after COVID infection admitted in ICU developp a delirium during mechanical ventilation weaning, serious event that can lead to death or acute and late complications since 30% of patients who had a delirium in ICU develop cognitive sequelae. Based on epidemiological arguments and mouse models, severe neuroinflammation is considered to be one of the physiopathological mechanisms causing delirium during ventilatory weaning.

In addition to its sedative properties, dexmedetomidine exhibits neuroprotective effects. In experimental models, dexmedetomidine reduces brain inflammation acting directly on the microglial phenotype. The role of this chronic neuroinflammatory condition on cognitive abilities and reserve begins to emerge in the literature no matter the initial stress is (surgery, head trauma, or Alzheimer's type dementia) and is therefore able to influence quality of life. The evaluation of this neuroinflammation by non-invasive tools appears essential in the management and follow-up of post-COVID cerebrolesed patients, as well as the potentially neuroprotective evaluation of dexmedetomidine.

location_facility: Anesthesy department - Hôpital Pitié Salpêtrière

title: Impact of Post-ARDS Covid Sedation on Persistent Neuroinflammation (PETDEXDOCOVID)

ipd_sharing_description:
Data are available upon reasonable request 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: Identification of the Causative Drug in Drug-induced Acute Interstitial Nephritis

acronym: IDENIAM

summary: Drug-induced acute interstitial nephritis (DAIN) is a rare entity characterized by acute renal failure linked to inflammation of the renal parenchyma secondary to allergenic drug exposure. Treatment is based primarily on the precise identification of the causative drug and its final elimination. Currently, the identification of the causative drug is based on clinical presumption. There is no test to formally identify the causative drug. On the other hand, in-vitro allergological tests (lymphocyte transformation test in particular) have been developed in the course of immuno-allergic drug toxiderma linked to delayed type IV hypersensitivity to identify the causal drug. These tests have not been studied during DAIN, but their value in drug-induced eruption is indisputable. The objective of our study is to determine whether in vitro allergy tests can identify the causative drug during DAIN. If the in vitro tests fail, they will be supplemented by allergological skin tests.

primary_purpose: Diagnostic

location_facility: Nephrology department, Tenon hospital - APHP


title: Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction

acronym: LEONARD

summary: A Prospective, multicenter, randomized (two arms, parallel groups); double-blind, placebo-controlled in order to assess the ability of preoperative levosimendan to prevent post-operative low cardiac output in high-risk patients referred to cardiac surgery for correcting functional tricuspid regurgitation. The primary end point is a composite element that includes peri-operative mortality and low cardiac output syndrome at day-90: 1) catecholamine infusion persisting beyond 48 hours after cardiac surgery, 2) the need for circulatory mechanical assist devices in the postoperative period, 3) or the need for renal replacement therapy at any time during intensive care unit stay. If a patient had at least 1 of these criteria, he or she was considered as meeting the primary end point.The secondary end points were 1) each component of the primary end point, and 2) the study drug safety defined as refractory hypotension.

location_facility: Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor


title: Personalized Massive Online Open Course After Childhood Cancer: Impact Study START-MOOC2

summary: Many studies have shown Childhood Cancer Survivors (CCS) are ill-informed about long-term follow-up (LTFU). Massive open online courses (MOOCs) could easily allow a deployment at an international level and make reliable information available for all CCS, wherever they live. The MOOC team (specialists of LTFU care, communication professionals and CCS associations), bringing together nearly 130 people, designed a MOOC named "Childhood Cancer, Living Well, After" including three modules addressing transversal issues (lifestyle, psychological support, fertility problems) and eight modules covering organ-specific problems.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Effects of t-DCS Combined With Concurrent Cognitive Training on Apathy in Elderly Subjects With Minor Neurocognitive Impairment

summary: Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique using a low intensity electric current to modify cortical excitability. Apathy is a pervasive neuropsychiatric symptom characterized by a reduction in goal-directed behavior and activity that persists over time and causes identifiable functional impairment. The aim of this study is to evaluate the effects of repeated sessions of tDCS combined with simultaneous cognitive training on apathy in older people with minor neurocognitive disorders.

status: Enrolling by invitation

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Centre Memoire Ressources et Recherche, CHU de Nice


title: Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA Catheters Family

summary: The purpose of this Post market Study is to collect clinical data of the Arthesys PTCA catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.

lead_sponsor: Arthesys


title: Contribution of a High-resolution Diffusion Sequence at 3T for the Detection of Acute Punctate Ischemic Brain Lesions

summary:
Stroke is a public health issue and a priority for our institution. MRI plays an essential role in the management of stroke, its contribution being diagnostic, etiological and prognostic.

Among the MRI sequences used in stroke emergencies, the diffusion sequence plays a key role in highlighting ischemic lesions as early as the hyperacute phase, even though the other sequences in the protocol do not reveal any anomaly. This sequence alone conditions the management of patients, particularly in the context of "thrombolysis emergencies".

It has been shown that the sensitivity of the diffusion sequence for the detection of ischemic lesions can directly depend on acquisition parameters such as b value, slice thickness or spatial resolution.

Recent advances in MRI now allow us to perform diffusion sequences with higher spatial resolution. The matrix is an important acquisition parameter of MRI sequences defining the ability of the sequence to distinguish 2 pixels in the acquisition plane. The higher the matrix, the higher the spatial resolution of the sequence in the acquisition plane.

At the Saint-Joseph Hospital, we have a new 3T MRI since September 2020 allowing the acquisition in clinical routine of a more resolved diffusion sequence: 160x200 matrix ("high resolution" diffusion, HR), against 128x140 ("standard" diffusion usually). These two sequences are acquired in particularly short acquisition times (1 minute 37 seconds). This HR diffusion sequence is performed as part of routine care since September 2020 for specific situations: absence of lesion highlighted on the standard diffusion sequence while the patient has a suggestive symptomatology (especially for lesions of the brainstem), search for lesion in other vascular territories (thus in favor of an embolic origin) in a patient who presents an isolated ischemic lesion or ischemic lesions in a single territory.

It has been reported in the literature that increasing the spatial resolution can reveal small lesions that were not visible on more conventional sequences. There is a clear rationale for seeking to improve the detection of small lesions (<5 mm) because their detection may have important therapeutic implications for many patients (particularly in the context of thrombolysis emergencies, transient ischemic attacks, or amnesic strokes).

ReferenceCitation: Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. Erratum In: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:

oa_colors: green other

evidence: open (via free pdf)

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

repositories_concat: CiteSeerX

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Cihangiroglu M, Citci B, Kilickesmez O, Firat Z, Karlikaya G, Ulug AM, Bingol CA, Kovanlikaya I. The utility of high b-value DWI in evaluation of ischemic stroke at 3T. Eur J Radiol. 2011 Apr;78(1):75-81. doi: 10.1016/j.ejrad.2009.10.011. Epub 2009 Nov 13.

ReferenceCitation: Pereira RS, Harris AD, Sevick RJ, Frayne R. Effect of b value on contrast during diffusion-weighted magnetic resonance imaging assessment of acute ischemic stroke. J Magn Reson Imaging. 2002 May;15(5):591-6. doi: 10.1002/jmri.10105.

ReferenceCitation: Kim HJ, Choi CG, Lee DH, Lee JH, Kim SJ, Suh DC. High-b-value diffusion-weighted MR imaging of hyperacute ischemic stroke at 1.5T. AJNR Am J Neuroradiol. 2005 Feb;26(2):208-15.

ReferenceCitation: Benameur K, Bykowski JL, Luby M, Warach S, Latour LL. Higher prevalence of cortical lesions observed in patients with acute stroke using high-resolution diffusion-weighted imaging. AJNR Am J Neuroradiol. 2006 Oct;27(9):1987-9.


title: Sexual Intercourse and Vaginal Absorption of Progesterone : Cross-over Prospective Study

acronym: SexVAP

summary: The objective of this project is to compare the vaginal absorption of progesterone administered in the vaginal ovum by measuring progesteroneemia in 3 situations (or "sexual event"): abstinence, sex protected by condoms and unprotected sex.

lead_sponsor: University Hospital, Montpellier


title: Using Embryo Organoids (i.e. Embryoids) to Discover Human-specific Mechanisms of Preimplantation Embryo Development and Early Pregnancy

acronym: EMBRYOx

summary: EMBRYOx study aims to establish and validate the use of trophoblast organoids (embryoids) from trophoblast placental stem cells as a 3D research model in understanding further preimplantation embryo development in vitro. The organoids are capable of proliferation, differentiation, and implantation in a matrix, reproducing early human embryo development.


title: Optimization of the Sensitivity of Histological Diagnosis of Pulmonary Nodules Using Cryoprobes Versus Standard Biopsy Forceps During Distal Sampling Guided by Mini Radial Ultrasound Probes

acronym: CRYOPROBE

summary:
In pulmonary oncology, the diagnosis of medium-sized pulmonary nodules (10 to 20 mm), too distal to be reached by standard bronchial fibroscopy but remaining proximal, is difficult.

There are 2 techniques: transthoracic puncture-biopsy under CT scan, usually performed by radiologists, and distal sampling guided by radial ultrasound mini-probe.

The limitations of the last technique could be overcome by the use of cryoprobes for sampling, as they would take more tissue by freezing.

ReferenceCitation: Dhooria S, Sehgal IS, Aggarwal AN, Behera D, Agarwal R. Diagnostic Yield and Safety of Cryoprobe Transbronchial Lung Biopsy in Diffuse Parenchymal Lung Diseases: Systematic Review and Meta-Analysis. Respir Care. 2016 May;61(5):700-12. doi: 10.4187/respcare.04488. Epub 2016 Mar 1.

ReferenceCitation: Hagmeyer L, Theegarten D, Treml M, Priegnitz C, Randerath W. Validation of transbronchial cryobiopsy in interstitial lung disease - interim analysis of a prospective trial and critical review of the literature. Sarcoidosis Vasc Diffuse Lung Dis. 2016 Mar 29;33(1):2-9.

ReferenceCitation: Montufar F, Moral LD, Labarca G, Folch E, Majid A, Fernandez-Bussy S. [Transbronchial cryobiopsies and cryotherapy in lung diseases]. Rev Med Chil. 2018 Sep;146(9):1033-1040. doi: 10.4067/s0034-98872018000901033. Spanish.

ReferenceCitation: Gershman E, Fruchter O, Benjamin F, Nader AR, Rosengarten D, Rusanov V, Fridel L, Kramer MR. Safety of Cryo-Transbronchial Biopsy in Diffuse Lung Diseases: Analysis of Three Hundred Cases. Respiration. 2015;90(1):40-6. doi: 10.1159/000381921. Epub 2015 May 20.

ReferenceCitation: Schumann C, Hetzel J, Babiak AJ, Merk T, Wibmer T, Moller P, Lepper PM, Hetzel M. Cryoprobe biopsy increases the diagnostic yield in endobronchial tumor lesions. J Thorac Cardiovasc Surg. 2010 Aug;140(2):417-21. doi: 10.1016/j.jtcvs.2009.12.028. Epub 2010 Mar 11.

ReferenceCitation: Hetzel J, Eberhardt R, Herth FJ, Petermann C, Reichle G, Freitag L, Dobbertin I, Franke KJ, Stanzel F, Beyer T, Moller P, Fritz P, Ott G, Schnabel PA, Kastendieck H, Lang W, Morresi-Hauf AT, Szyrach MN, Muche R, Shah PL, Babiak A, Hetzel M. Cryobiopsy increases the diagnostic yield of endobronchial biopsy: a multicentre trial. Eur Respir J. 2012 Mar;39(3):685-90. doi: 10.1183/09031936.00033011. Epub 2011 Aug 18.


title: Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial

acronym: SexIA-CT

summary: Patients with Inflammatory Bowel Disease (IBD) have higher rates of sexual dysfunction than the general population. We offer an educational program on IBD including a specific discussion on intimacy and sexuality for IBD patients. Our objective is to investigate the benefit of this intervention on sexual function in patients with IBD.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Comparison of an Anatomy-based Fitting and a Conventional Fitting in Newly Implanted Cochlear Patients. Prospective Monocentric Randomized Double-blind Crossover Study.

summary:
Main objective:

Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.

Secondary objectives:

Compare speech recognition in quiet with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.

Compare speech recognition in noise with an anatomy-based fitting and with a default fitting in adult patients newly implanted with a MED-EL cochlear implant.

lead_sponsor: MED-EL Elektromedizinische Geräte GesmbH


title: Social Cognition Dysfunctions in Parkinson's Disease

acronym: cognition 2

summary: Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system (NMS)), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS

location_facility: Neurology C department, P. Wertheimer Hospital


title: The Choice of a Violent Suicidal Means: a MRI Study With Computational Modeling of Decision-making

summary:
The study authors hypothesize a combination of cognitive, brain structural, brain functional and brain connectivity impairments in Suicide Attempters compared to Patient Controls and Healthy Controls, with deficits more marked in suicide attempters using violent suicidal means including:

Impaired choices at the reversal learning task with responses influenced by immediate outcome. This deficit would be correlated with brain activity in ventromedial Prefrontal Cortex during resting state and with several peripheral markers of the 5HT-system.
Reduced loss aversion. These deficits would be related to altered dynamics of Blood-Oxygen Level Dependent signal in the dorsal and ventral striatum as well as in ventral Prefrontal Cortex/ orbitofrontal cortex during the loss aversion task. These deficits would also be correlated with several peripheral markers of the 5HT-system.
Increased pain tolerance facilitating the execution of a violent and possibly painful act. These deficits measured with the algometer would be correlated with several peripheral markers of the 5HT-system.
Reduced behavioral inhibition in aversive context at the orthogonalized GoNoGo task facilitating the choice of a violent means. These deficits would be associated with altered Blood-Oxygen Level Dependent signal in ventral Prefrontal Cortex/ orbitofrontal cortex and parietal cortex during the resting state and correlated with several peripheral markers of the 5HT-system.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Description of the Neurovisual and Radiological Specificities of Patients With Visual Snow

acronym: NEVICOG

summary: NEVICOG is a single-center study evaluating neurovisual and radiological specificities in patients with visual snow syndrome (VSS) compared to a control population.

status: Withdrawn

sponsor_collaborators: Fondation Ophtalmologique Adolphe de Rothschild


title: Bio Impedance Electrical Analysis to Predict Outcome After Cardiac Surgery

acronym: BiPOCS

summary: Phase angle determined by bioelectrical impedance analysis is a strong prognostic factor in several medical areas as clinical nutrition, nephrology, infectious disease, oncology. Inflammation, frailty status and fluid overload can lead to a phase angle decreased. Some studies support its use for risk stratification in intensive care unit and other in preoperative for cardiac surgery. The investigators would like to evaluate its relevance for risk stratification at intensive care unit admission in the context of postoperative cardiac surgery with cardiopulmonary bypass.

location_facility: Hôpital cardiologique Louis Pradel Groupe Hospitalier Est


title: Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

acronym: BIOPOSE

summary:
With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.

During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.

New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.

Herein we propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.

lead_sponsor: University Hospital, Lille


title: Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis

acronym: RECONEX

summary:
The World Health Organization (WHO) estimates, with 800,000 annual deaths, that suicide is the second leading cause of death in people aged 10 to 44 and thus recognizes suicide prevention as a public health priority. The psychological impact of the COVID-19 pandemic, the social isolation and the economic consequences engendered by the confinement, as well as the direct effects of this viral infection increase suicidal mortality.

Sensitivity to social rejection in suicide : Epidemiological and clinical studies indicate that social isolation and loneliness are very strongly associated with suicide. Our works suggests that suicide vulnerability is associated with specific processing of social information related to brain regions playing a role in psychological pain and inflammation. In fact, social stresses are powerful inducers of inflammation, also associated with suicide. Thus, we hypothesize that patients at risk of suicide could be particularly sensitive to social adversity (social stress / lack of social support), via the activation of specific brain regions regulating social cognitions, psychological pain and 'inflammation.

The VigilanS device: a monitoring tool in suicide prevention. VigilanS is a national telephone recontact system initiated in 2015, which has already shown its effectiveness in preventing suicidal recurrence. Patients admitted to the Emergency Department of the Montpellier and Nimes CHUs for SA benefit from VigilanS monitoring for 6 months (period of major risk). These organized calls aim to assess the patient's condition, manage a possible suicidal crisis and ensure the compromise for discharge from the emergency room. It is important to determine the factors explaining the effectiveness of this device.

Thus, we formulate the hypothesis that VigilanS prevents suicidal recurrence by acting on the restoration of the social bond in subjects vulnerable to suicide and isolated. We will test the hypothesis that the preventive effect of the VigilanS device on suicidal recurrence during the 6 months of the day before depends on the sensitivity to social stress of the suicidal patients (measured by the response to an experimental task of social stress).

status: Active, not recruiting


title: Comparison of the Perception of Metallic Taste According to Lingual Locations in Healthy Volunteers

summary:
This is a mono center , observational study carried out within otorhinolaryngology department in CH Valence.

This is a descriptive and exploratory study in healthy volunteers. Based on the hypothesis that Metallic taste is imperfectly assessed, this study will provide a better understanding of the Metallic Taste.

lead_sponsor: Centre Hospitalier de Valence


title: 3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)

acronym: WHINUME

summary:
The aim of this study is to compare the 3D OPTIMIZED MPRAGE WMN sequence to "conventional sequences" used in spinal cord analysis.

The patients will be explored at the cervical level with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 2D sagittal PSIR, 3D T1 MPRAGE sequences, and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE and 3D axial OPTIMIZED WMN MPRAGE. At the thoracic level, with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 3D T1 MPRAGE sequences and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE.


title: Descriptive Study of Clinical and Pulmonary Ultrasound Signs of Acute Respiratory Infections Associated With COVID-19 in Primary Care

acronym: ECHOVID-MG

summary:
COVID-19 infection are characterized by fever and signs of acute respiratory infection. A worsening of respiratory symptoms that can lead to respiratory failure. The decompensation can then be brutal and require rapid recourse to respiratory assistance. The contribution of clinical examination (auscultation and monitoring of oxygen saturation in particular) remains unsatisfactory in predicting an unfavorable course. The interest of pulmonary ultrasound is known in the management of pulmonary infections. However, estimating the severity of lung damage at an early stage could be of great help in monitoring and caring for patients. Ultrasound could meet this need in general practice, the chest scanner is often unavailable in these situations.

Ultrasound signs are associated with severe forms. The contribution of pulmonary ultrasound seems particularly interesting in the context of the reassessment of patients during the worsening phase of symptoms (D5-D10).

Estimate the prevalence of ultrasound signs in patients with an acute respiratory infection suspected or confirmed to be COVID-19, at the time of the worsening phase (between D5 and D10 of the onset of symptoms).

The prevalence of ultrasound lung lesions under COVID-19 may be essential to consider the development of the ultrasound tool in primary care. Indeed, if the contribution of ultrasound is now recognized in intensive care or emergency, its place in general medicine still raises questions.

lead_sponsor: Geprovas


title: Clinical-immunological Features of DNER Ataxia

acronym: CLIMDA

summary: Using a retrospective cohort of 34 patients with DNER ataxia, we will characterize clinical presentation, tumor associations, and outcomes.

location_facility: HCL Hôpital Neurologique / Groupement EST

intervention_type: Genetic


title: GEnome-wide Association Study in N-methyl-D-Aspartate Receptor and Other autoiMmune Encephalitis.

summary:
Autoimmune encephalitis are characterized by the subacute development of memory deficits, altered mental status, and psychiatric symptoms, generally in association with anti-neuronal antibodies. Two main groups of autoimmune encephalitis may be distinguished based on the location of the targeted antigen: 1) Intracellular antigens, in which the antibodies are thought not to be pathogenic, and the disorders are usually strongly associated with cancer, constituting therefore paraneoplastic neurological syndromes; 2) Synaptic proteins and surface receptors, in which the antibodies are pathogenic and the frequency of cancer is variable depending on the antibody and the demographic characteristics of the patient.

Encephalitis with antibodies against N-methy-D-aspartate receptor is the most common autoimmune encephalitis, being even more frequent than infectious etiologies. It is characterized by subacute onset of memory deficits, psychiatric symptoms, speech dysfunction, seizures, movement disorders, decreased level of consciousness, dysautonomia and central hypoventilation. Nearly 50% of women with anti-NMDAR encephalitis have an ovarian teratoma, while associated tumors in elderly patients are usually carcinomas. In contrast, most cases in children and young men are non-paraneoplastic. Recently, herpes-simplex encephalitis has been described as another trigger of NMDAR encephalitis. Conversely, for the vast majority of the non-paraneoplastic autoimmune encephalitis, no acquired triggers have been described so far.

In addition to acquired susceptibility, genetic predisposition may also be important in the pathogenesis of autoimmune encephalitis. The human leukocyte antigen (HLA) is the genetic factor most frequently associated with autoimmune diseases, and it has been already linked to a few autoimmune encephalitis, such as anti-leucine rich glioma inactivated 1 (LGI1), contactin-associated protein-like 2 (CASPR2), IgLON5, and glutamic acid decarboxylase 65 (GAD65) encephalitis. However, no HLA association has been reported for NMDAR encephalitis, suggesting that in this condition, and likely in others, non-HLA loci might be involved in the pathogenesis as well.

Genome-wide association studies (GWAS) are useful tools to identify variants at genomic loci that are associated with complex diseases, and in particular, to detect associations between single-nucleotide polymorphisms (SNPs) and diseases. The aim of the study is to detect genetic variants in NMDAR encephalitis and other autoimmune encephalitis.

location_facility: Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes


title: Effect of Fine Motor Training on Swallowing Skills After Stroke: Pilot Study

acronym: MOFIDA

summary:
Swallowing disorders are a common consequence of stroke. After stroke, some patients retain a dysphagia responsible for an alteration of the quality of life, respiratory diseases and a degradation of the general health status.

The oral phase of the swallowing involves a significant control of the various intraoral organs. These allow the formation of the bolus, its propulsion, and the emptying of the oral cavity after swallowing. Precise and coordinated mobility of the tongue, lips and mandible is essential during this time. During the speech therapy after a stroke, targeted analytical training, coupled with passive stimulations of the swallowing reflex, is typically used.

Previous studies have shown a functional link between fine manual motor skills and oral motor skills, particularly during child development. Little data are available for adult subjects. A pilot study is therefore needed before a larger scale comparative study can be considered. Our hypothesis is that there is a functional link between digital and oral motor areas that could, through co-activation during rehabilitation sessions, promote the recovery of swallowing disorders after stroke.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice