title: Assessment of Screen Use and Impact of Excessive Smartphone Use on Adult Health

acronym: EVADD

summary:
This is an observational study questionnaire-based. This study will be carried out to evaluate the methods of consumption (work/outside work), the characteristics of the tools used, the addictive risk, the consequences on mental and physical health and the impact on quality of life of people exposed to screens and smartphones.

A sample of 800 000 people will be used to learn about the entire French population. Participants will be asked to respond to an anonymous digital survey.

The ultimate goal of this work is to have quality information to help facilitate therapeutic efforts in support of those who may need it.

status: Enrolling by invitation

lead_sponsor: Institut Rafael


type: Other Identifier

title: Phase Ib Study of the Combination of Regorafenib With Conventional Chemotherapy for the Treatment of Newly Diagnosed Patients With Multimetastatic Ewing Sarcoma

acronym: REGO-EWING

summary:
New drug efficacy in ES has been disappointing in the last decades and no new drugs have been successfully introduced up to now in front line treatment. Among the tested drugs, early clinical data suggest that strategies using multi-targeted tyrosine kinase inhibitors (TKI) with anti-angiogenic activities are among the most efficient and may be beneficial in the treatment of patients with ES.

Several TKI have been and are currently being tested as single-agent in patients with relapsed/refractory ES with encouraging results in phase II trials. Regorafenib has shown promising activity in Ewing sarcoma relapse setting, Nevertheless, regorafenib has never been combined with the intensive chemotherapy VDC/IE schedule and therefore this combination needs to be evaluated in order to avoid dose reduction of the current standard treatment and hence its efficacy.

The current clinical trial has been therefore designed to test the feasibility of regorafenib with ES conventional chemotherapy. It consists of a phase Ib that will only recruit patients with multi-metastatic (other than lungs/pleura only) ES, that present the highest unmet medical need (2 year EFS: 33%, similar to patients with relapse/refractory ES).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: Morbidity, Long-term Side Effects and Quality of Life in Germ-cell Tumor Long Survivors Treated With High-dose Chemotherapy and Autologous Stem Cell Transplant

acronym: HGT-QoL

summary: Intensified chemotherapy is an effective treatment in 30-70% of patients with refractory germ cell tumor. Since most cases are diagnosed before the age of 40, survivors can expect to live another 30 to 50 years after being successfully treated. Long-term side effects and physical and emotional consequences can therefore have a significant impact on daily life. To date, no data of this type is available in France. This study will help clinicians better understand the long-term consequences for relapsed patients receiving high-dose chemotherapy.

study_type: Observational

time_perspective: Prospective

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris


title: Staging System in Amyotrophic Lateral Sclerosis

acronym: Biostaging

summary:
Recently two staging systems have been proposed for amyotrophic lateral sclerosis (ALS), based on clinical milestones The King's college clinical staging system (1) and ALS Milano-Torino Staging (ALS-MITOS) (2). Further research to validate and develop an accurate staging system in different populations will improve our understanding of its pathogenesis, disease activity and progression.

General objective : To validate the two previously proposed staging system and to test the interest of considering Neurofilament biomarkers in these systems.

Specific objectives: 1) To validate the two classification systems in an independent cohort of patients with ALS followed-up in the ALS expert center of Limoges (France) 2) To assess the interest of Nf biomarkers to predict neurological decline

lead_sponsor: University Hospital, Limoges

location_facility:
Tours University Hospital
Limoges University Hospital


title: Transobturator Cystocele Repair by Vaginal Plastron

acronym: CYSPTO

summary:
The autologous vaginal route consists of repairing the genital prolapse through the vagina using the patient's tissues without a prosthesis. Vaginal prostheses are actually currently prohibited in France [1, 2].

The autologous vaginal route is the quickest surgery and it can be done under spinal anesthesia, which constitutes arguments for offering it to elderly and fragile patients. The autologous vaginal approach gives functional and subjective results similar to promontofixation [2].

There are many surgical techniques that make it difficult to assess the recurrence rate in the literature. Autologous vaginal surgery provides a good degree of satisfaction for patients despite the risk of recurrence [3].

We propose to describe the results of the transobturator cystocele repair by vaginal plastron, a technique which seems reproducible and effective to us.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

intervention_type: Procedure

status_simplified: Completed


title: Implementation of a Program Based on Adapted Physical Activity and Recommendations for Second Cancers Prevention for Teenagers and Young Adults With Cancer

acronym: PREVAPAJA

summary: About 700 new cases of cancer are recorded each year among TYAC aged 15 to 25 years old in Rhône-Alpes region (France); more than 200 are treated and supported within the TYAC Department of the Institute of Hematology and Oncology Pediatrics (Centre Léon Bérard-Civil Hospice of Lyon). These patients survive from their disease in 80% of cases; they have six times more likely to develop a risk of second primary cancer (SCP) than their peers. This risk of SCP is multifactorial and varies depending on the type of first cancer, treatment received and the prevalence of risk factors (smoking, overweight, sedentary lifestyle, environmental exposures...). This project aims to implement a clinical program based on adapted physical activity (APA) and cancer prevention recommendations for TYAC during the active treatment period (4-6 months). The methodology used series of assessments of APA sessions and information meetings dedicated to cancer prevention and SCP risk recommendations. It mobilizes regularly the health care team of TYAC Department, TYAC associations, sports structures and associations involved in cancer prevention at the regional level. Assessment of TYAC satisfaction regarding the project, benefits in terms of exercise practice, and knowledge improvement on cancer prevention recommendations, are assessed throughout the program.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Carretier J, Boyle H, Duval S, Philip T, Laurence V, Stark DP, Berger C, Marec-Berard P, Fervers B. A Review of Health Behaviors in Childhood and Adolescent Cancer Survivors: Toward Prevention of Second Primary Cancer. J Adolesc Young Adult Oncol. 2016 Jun;5(2):78-90. doi: 10.1089/jayao.2015.0035. Epub 2015 Dec 1.

ReferenceCitation: Duval S, Carretier J, Boyle H, Philip T, Berger C, Marec-Berard P, Fervers B. [Life style and occupational factors and prevention of second primary cancers after childhood and adolescent cancer: Current state of knowledge]. Bull Cancer. 2015 Jul-Aug;102(7-8):665-73. doi: 10.1016/j.bulcan.2015.03.017. Epub 2015 May 1. French.

lead_sponsor: Centre Leon Berard

intervention_type: Other


acronym: OPTI-TREX

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
Allograft vascular thrombosis is a devastating complication in kidney transplantation in adults and older children. Though uncommon, it is often irreversible and represents the main cause of graft loss within after kidney transplantation in adults and in the first post-operative year in children. Since allograft thrombosis is usually observed in the first 48h post-operatively, the need to promptly achieve appropriate anticoagulation in at-risk patients is of utmost importance.

However, no consensus exists regarding the optimal prophylaxis in the peri-transplant period and the following dose-adjustment, and practices are highly heterogeneous among centers. Moreover, the therapeutic target is very narrow and antithrombotic agents may conversely increase the risk of allograft hematoma. Enoxaparin is a low molecular weight heparin commonly used in this context, but off-label in children. Therapeutic ranges are based on anti-Xa levels 4 to 6 hours following injection and extrapolated from adults although evidences suggest that such extrapolation may be inappropriate in many circumstances. The current pediatric practice of dose adjustment to achieve and maintain a target anti-Xa range is empirical and dependent on the physician.

The aim of the proposed clinical trial is to assess the efficacy/safety profile of this bayesian-based dose optimization in the clinical setting, as compared to the current practices of empirical adjustment. This should greatly improve the personalized management of renal transplanted children, a subset of patients with singular renal function and little-investigated pharmacokinetics and help standardizing and rationalizing practices.

title: Dose-adjustment of Enoxaparin by a Bayesian Pharmacological Approach in Pediatric Kidney Transplant Recipients

type: EudraCT Number

source: euctr

design_allocation: Randomized


title: Evaluation of the EHPAD Caregiver/Pact & Pad Psycho-educational Program for Caregivers With an Institutionalized Parent

acronym: EAPP

summary:
Moving into an institution is a new stage in the life of the patient but also of the caregiver. The caregiver is overwhelmed by various feelings such as loss of control, powerlessness, guilt, sadness, the feeling of loneliness at home but also relief. This experience can be characterized by great anxiety and the feeling of being misunderstood by the family and professional environment.

This emotional state is not without consequences for the caregiver/resident and caregiver/care team relationship.

Several factors have been identified that may be at the origin of these states.

A new training, information and support program has been created to present these different factors to caregivers and to allow them to address them with professionals in a group setting.

location_facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Broca Hospital - Geriatric unit

intervention_type: Behavioral


title: Assess the 6-month Prognosis of Patients Who Presented With a State of Extreme Agitation: "Excited Delirium Syndrome" AGICOHORT

acronym: AGICOHORT

summary:
The main objective is to assess the 6-month prognosis of patients who presented with extreme agitation in the emergency room.

The primary endpoint is the 6-month mortality of agitated patients.

collaborators: Lariboisière-Saint Louis clinical research unit


title: National Register of Oesophageal Atresia

acronym: REGATE

summary:
The esophageal atresia is a group of birth defects including a break in continuity of the esophagus with or without persistent communication with the trachea (tracheoesophageal fistula), sometimes associated (from 50%) of other malformations (heart, kidney, digestive ...).

The current prognosis for this ailment is good. However he persists a mortality (<10%) and significant morbidity, firstly related malformations (heart, kidney, for example), and secondly with particularly difficult anatomical forms (Forms long defect) .

The prevalence of this condition is estimated to be 1/2500 in 3000 live births, making an estimated ± 2,500 new cases over to 10 years in France.

The current project aims to set up a national registry (Metropolitan France and Dom Tom) to measure the prevalence of esophageal atresia among live births, phenotypic characteristics, the circumstances of their diagnosis, and their initial future at short-term during the first year of life, at which time occurs the vast majority of deaths and complications in this disease.

ReferenceType: derived

ReferenceCitation: Lejeune S, Sfeir R, Rousseau V, Bonnard A, Gelas T, Aumar M, Panait N, Rabattu PY, Irtan S, Fouquet V, Le Mandat A, Cocci SN, Habonimana E, Lamireau T, Lemelle JL, Elbaz F, Talon I, Boudaoud N, Allal H, Buisson P, Petit T, Sapin E, Lardy H, Schmitt F, Levard G, Scalabre A, Michel JL, Jaby O, Pelatan C, De Vries P, Borderon C, Fourcade L, Breaud J, Arnould M, Tolg C, Chaussy Y, Geiss S, Laplace C, Drumez E, El Mourad S, Thumerelle C, Gottrand F. Esophageal Atresia and Respiratory Morbidity. Pediatrics. 2021 Sep;148(3):e2020049778. doi: 10.1542/peds.2020-049778. Epub 2021 Aug 19.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Academy of Pediatrics (AAP)

lead_sponsor: University Hospital, Lille

location_country: Guadeloupe Martinique France

location_facility:
CHRU Brest
CHU Dijon Bourgogne
CHI Créteil
CHU de Poitiers
AP-HP Necker-Enfants malades
CHU Félix-Guyon
CHU de Rennes
AP-HP Robert-Debré
CHRU,Hôpital Jeanne de Flandres
CHU de Rouen
CHU de Nancy
CHU de Toulouse
CHU de Strasbourg
CHU d'Angers
CHRU Besançon
CHU de Nantes
CHR d'Orléans
CH Le Mans
Hôpitaux Civils de Colmar
CHU de Saint-Etienne
CHU de Nice
CHU de Reims
CHU de Martinique
CHU de Grenoble
CHU de Bordeaux
AP-HP CHU Kremlin-Bicêtre
CHU de Caen
HFME de Lyon
CHU de Clermont-Ferrand
CHU de Limoges
CHRU de Tours
AP-HM La Timone
CHU de Pointe-à-Pitre
CHU Amiens-Picardie
CHRU de Montpellier
AP-HP Armand Trousseau
AP-HM Nord


title: Impact of Venotrain UlcerteC Venous Compression Device in the Treatment of Venous Ulcers in Daily Practice

acronym: INVICTUS

summary:
The cornerstone of the management of venous leg or predominantly venous leg ulcers with IPS> 0.8 is venous compression as recommended by the HAS in June 2006. There is ample clinical evidence to support its importance to improve the chances of closure of this chronic lesion and shorten the healing time compared to the absence of compression.

In 2016, a system of re-usable compression stockings (Venotrain® Ulcertec, BAUERFEIND, France), and bringing an interface pressure of 30 to 45 mmHg to the ankle according to the prescription, was taken over by the Health Insurance in France. 'Indication' Ulcer of venous origin or predominantly venous component, stage C6 CEAP classification with a systolic pressure index greater than 0.9 '.

The investigators propose to study the efficiency of Venotrain® Ulcertec in a diverse population in which it is prescribed according to the usual practices of venous leg ulceration of venous or predominantly venous origin.

status: Active, not recruiting

ipd_sharing: Undecided

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility: Centre hospitalier universitaire d'Angers


title: Consultation d'Annonce d'Arrêt de la Chimiothérapie et Des Traitements Spécifiques en Contexte Ambulatoire: évaluation de l'Impact Psychologique et Des échanges d'Informations.

acronym: CACTuS

summary:
The average 5-year survival rate for patients diagnosed with cancer in France is estimated at 53%. Nearly half of all patients diagnosed with cancer are not alive 5 years after diagnosis Discontinuation of anti-tumor treatments is therefore a major issue in their care. Discussing the discontinuation of specific treatments requires scientific oncological skills but also communication skills. The difficulties encountered by oncologists concerning communication about the end of life are linked to the doctors' personal discomfort with death, their fear of the responsibility of stopping chemotherapy, and their distrust of their colleagues. On the other hand, they may also come from patients who are supposedly reluctant to talk about the end of life, a reluctance that is heightened in the case of language barriers, young age or pressure from families. Finally, the place of practice could explain some of the difficulties in talking about the end of life, notably because of a lack of training in delivering bad news or a stigma attached to palliative care.

This exploratory work should make it possible to describe the characteristics of the announcement of the cessation of anti-tumor treatments in ambulatory patients, to evaluate distress, anxiety, depressive symptomatology, as well as the satisfaction of the patients concerning the management received.

lead_sponsor: Institut Curie


title: Retrospective Evaluation of the Management of Children's Deep Neck Infections at the Montpellier Hospital

summary: To descride the clinical presentation, diagnosis, management and complications of children with a deep neck infection. A retrospective chart review was conducted at the Montpellier hospital in France. All children aged less than 18 years who had been admitted with a diagnosis of cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses between January 2015 and December 2017 were included. The investigators collected the demographic, biological, radiological data and treatment received of the patients to the admision. The results of the bacteriological samples were collected. The investigators compared our results to those of the 10-year cohort. The investigators wish to compare the duration of hospitalization and the duration of the fever enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: City-hospital Network: Evaluation of the Rate of Consultations in Gynecological Emergencies Under Non-emergency Management

summary:
The difference between the demand and the current medical supply poses a real public health problem in terms of the organization of health care systems.

For several years in France, there has been an increase in the number of consultations in emergency services, particularly gynaecological ones. The two causes put forward are a change in user behavior with an increase in requests for rapid but "non-urgent" care and the inadequacy of the supply of care in the private sector.

Few studies have been carried out concerning gynaecological emergencies, unlike general emergencies.

The aim of this study is to measure the frequency of consultations in gynaecological emergencies for non-emergency reasons.

The interest of this study is therefore mainly on the optimization of the care system with the emphasis on the city-hospital network in the management of these patients.


title: Reduction of Anterior Glenohumeral Dislocation in Ventral Decubitus Versus Dorsal Decubitus Under Procedural Sedation : a Prospective Randomized Trial

acronym: EPOLUX

summary:
The anterior glenohumeral dislocation is frequently encountered in emergency medicine. It represents about 50% of the total dislocation and affects 1 resident for 10 000 in France.

In Nord Franche-Comte Hospital, 1 to 2 patients per day present this diagnosis in the emergency department, which requires reduction by external manoeuvres.

A retrospective study shows the interest of the ventral decubitus compared to dorsal decubitus reduction in the care of patients with anterior glenohumeral dislocation. None prospective study has already demonstrate the interest of the ventral decubitus compared to the dorsal decubitus in the reduction of anterior glenohumeral dislocation.

The main objective is to evaluate the speed of the reduction of the anterior dislocation of the shoulder by the ventral decubitus technique compared to the conventional technique in dorsal decubitus.

lead_sponsor: Hopital Nord Franche-Comte


title: Burden of Care of Long COVID Patients After Hospital Discharge

acronym: BLOC

summary:
Since March 2020, 3.5 million people have been infected with SARS-COV2 in France, and about 250 000 patients have been hospitalized and successfully discharged.

In a majority of cases, the evolution of the disease is favourable, but both hospitalized or patients with a mild form of the disease may present so called "Long-COVID" syndrome - a patient-created term which describes the effects of COVID-19 that continue for weeks or months beyond the initial symptoms. There is thus an urgent need to evaluate the long-term medical resource utilisation (MRU) and health care burden incurred by patients with Long-COVID, as well as risk factors for Long-COVID.

We will use the SNDS database to extract and analyze the data relevant to the project objectives. Indeed, the SNDS database is the French NHS database providing individual anonymous information of primary and secondary care linked at individual level (data from PMSI, the French DRG-based medical information system). It currently covers more than 98% of the French population.

For the first time, our study will provide an estimation of MRU and associated costs of hospitalized COVID-19 patients. It will also provide an estimation of the rate of long COVID forms developed by hospitalized COVID patients, as well as detailed MRU and costs incurred by long COVID patients compared to patients with non-long COVID-19.

ipd_sharing_description: individual participant data are protected by the French legislation and are not shared

lead_sponsor: Mikhail Dziadzko, MD, PhD

sponsor_collaborators:
Mikhail Dziadzko, MD, PhD
PELyon

location_facility: Hopital de la Croix Rousse - Hospices Civils de Lyon

lead_sponsor_type: industriel


title: Assessing the Expression and the Activity of Rac1 Protein in the Airway Smooth Muscle of

acronym: NaRacAS

summary:
Asthma is a chronic inflammatory respiratory disease affecting 6 to 7% of the French adult population and responsible of 1000 deaths in France every year. Many anti-inflammatory treatments are available but few had been developed to target hyperresponsiveness.Investigators and searchers of the Institut du thorax have recently demonstrated the main involvement of Rac1 monomeric G protein in the contraction of airway smooth muscle cells. They show that Rac1 is expressed in the airway smooth muscle cells in mice and its activity is increased in the bronchi of asthma induced mice sensitized to House-Dust Mite. They further demonstrate that Rac1 inhibition in mice by nebulisation reduces airway hyperresponsiveness and pulmonary inflammation. Investigators and searchers of the Institut du thorax would like to seek whether targeting Rac1 would be interesting in asthmatic patients. Primary objective of this study is to determine if Rac1 expression and activity in airway smooth muscle cells are increased in asthmatic patients compare to controlled samples (deceased donor samples). Secondary objective is to determine whether there is a correlation between Rac1 activity and asthma severity.

If Rac1 activity in airway smooth muscles is indeed increased in asthmatic patients depending on asthma severity, Rac1 could be a potential target to treat airway hyperresponsiveness.

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Nantes University Hospital

collaborators: L'institut du thorax - INSERM UMR 1087 / CNRS UMR6291 - IRS-Université de Nantes

collaborators: IRSR-PL : Institut de Recherche en Santé Respiratoire des Pays de La Loire


title: International Normalised Ratio Evaluation by Generalist Practitioners in Full-time Care Establishments for the Elderly: a Pilot Study

acronym: INR-Cap pilote

summary: The main objective of this study is to evaluate, for a 6-month observation period, the concordance in terms of clinical decision making concerning therapeutic adjustment as determined by a weekly capillary International Normalised Ratio (INR) monitoring strategy versus the usual strategy in a population of dependent elderly people in nursing homes, treated with anti-vitamin K (AVK).

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Device


title: Switch From Intravenous to Subcutaneous Infliximab (REMSIMA®) in Clinical Practice in the Rheumatology Department of Cochin Hospital

summary: TNFα inhibitors have revolutionized the management of patients suffering from inflammatory diseases in the field of rheumatology. Infliximab remains widely used in France, and infliximab biosimilars have been routinely used since 2015 in Cochin Hospital with an interchangeability strategy validated by two real life studies. REMSIMA® 120 mg is the first authorized subcutaneous (SC) form of infliximab to be administered at a fixed dose of 120 mg every 2 weeks. Scarce information is available regarding the safety and efficacy of proposing a switch from IV infliximab to SC REMSIMA® in the subsets of patients suffering from different rheumatic diseases in daily care. The primary objective of the SIC2 study will be determine the retention rate of Remsima SC at 6 months. The investigators will recruit adult patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis.

location_facility: Rheumatology Department, Cochin Hospital


title: Rehabilitation After Admission in Intensive Care Unit for COVID-19: an Observational Study

acronym: RECOVER

summary:
France and especially the region "Grand Est" have been severely impacted by the COVID-19 pandemic. The first affected patients gradually began leaving the hospitalization sector and some of them required rehabilitation before returning home.

Because it has only been studied for few months, COVID 19 possible impairment remain unknown, especially in patients who required admission in ICU and needed rehabilitation.

In order to better understand the impact of the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient in rehabilitation center for Post-Covid-19 rehabilitation after ICU.

The purpose of this study was to describe the impairments and functional independency in patients addressed to a rehabilitation center after an ICU stay for COVID 19 and to explore the factors associated with their evolution.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
CHR Metz Thionville
Hopital Legouest
Etablissement de santé Filieris


title: Impact of the COVID-19 Pandemic on Vaccination in Patients at Risk of Infection

acronym: COVIDVacImpac

summary:
The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.

Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.

Two vaccines are recommended for person at risk of infection according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious in patients with chronic diseases (diabetes, cardiac insufficiency..) compared to the general population.

The vaccination coverage rate of at-risk populations is dramatically below the vaccination coverage targets set by the Ministry of Health. Indeed, there are many barriers to vaccination, medical and para-medical barriers, but also individual barriers.

The current COVID-19 pandemic has identified people at risk of severe infection and death risk, particularly those with co-morbidities (diabetes, cardiovascular disease, etc.). Thus, this pandemic may have contributed to change in patients' perceptions regarding both the risk of infection and the potential interest and benefit of vaccination.


title: A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies in Patients at High Risk of Severe Forms of Covid-19

acronym: COVIMAB

summary: Absence of anti-SARS-CoV-2 vaccine response or insufficient vaccine response may occur in immunocompromised patients. Being at high risk of a severe form of Covid-19, they may be eligible to receive recombinant anti-SARS-CoV-2 monoclonal antibodies (mAbs). This study aims to describe patients who received anti-SARS-CoV-2 mAbs, in prophylaxis and/or curative of covid-19, and to analyze the hospitalization and mortality rates. This study is multicentric on all the university hospitals of Paris (AP-HP).

location_facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital


title: Intra-muscular Botulinum Toxin A in Chronic Athletic Pubalgia: a Retrospective Observational Study

acronym: PUBATOX

summary:
Chronic athletic pubalgia is a frequent sport condition in which the effectiveness of medical treatment has not been proven. Intra-muscular injection of botulinum toxin A may have positive effects on pain in some chronic tendinitis.

The investigators hypothesized that similar analgesic effect of intra-muscular botulinum toxin A may be observed in individuals with chronic AP. In the present study, the investigators aimed to describe the short-term evolution of pain and of activity limitations and quality of life, after an injection of the adductor longus with botulinum toxin A, in individuals with chronic AP, for whom medical and/or surgical treatments have failed.

location_facility: Service de rééducation fonctionnelle, réadaptation de l'appareil locomoteur et Pathologies du Rachis - Cochin Hospital


title: Use of an Observer Tool to Improve the Learning of Non-technical Skills of Anesthesia Residents Observing High-fidelity Simulation Training Sessions: a Randomized Controlled Trial.

summary:
The use of simulation is recommended in anesthesiology education. Given a large number of residents, all of them will not be active participants during high-fidelity simulation sessions but will only be observers. To increase the positive effects of the simulation when the learner is in the role of observer, some authors have proposed to strengthen the educational effect through the use of an observer tool that observers must complete by analyzing the progress of the task performed by their colleagues. This is a list describing the set of key points to be achieved. However, data concerning the educational value of these observer tools are limited. Studies on the use of these tools during crisis management training in the operating room assessed by high-fidelity simulation have shown improved learning outcomes for technical skills but no study has evaluated yet their effect on non-technical skills. The effect on these skills can hardly be assessed by measuring the resident's perception or knowledge and an objective assessment of performance is necessary.

The objective of this study will be to evaluate if using an observer tool (OT) dedicated to non-technical skills improves the learning of these skills in anesthesia residents during high-fidelity simulation.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Other

lead_sponsor: Université Paris-Sud

location_facility: LabForSIMS - Faculté de Médecine Paris Saclay


title: Reorientation of Tripped Patients 4 and 5 in Emergency Department to the City Medicine

summary:
The increase in emergency room visits is partly related to the growing increase in unscheduled care, paradoxically associated with a decrease in the outpatient supply in the city. The "avoidable" passing rate is estimated at 43% in the last major DREES survey on hospital emergencies. Emergency services have been facing this challenge for years, but there is an urgent need to rethink its organizational model with the liberal system to meet this growing demand. Reorientation from the reception of emergencies is one of the avenues envisaged to face this challenge. It offers a different course from that of emergencies, provided that there are care structures equipped and adapted to unscheduled care. The Hospital in Saint-Denis is particularly faced with these challenges given a particular social ecosystem.

Methodology :

This single-center prospective observational study includes all adult patients sorted 4 and 5 by the reception organizing nurse, present during the survey.

The reorientation is one of the solutions proposed in the context of reorganizing access to care throughout the territory, appearing as one of the major public health issues in the coming years, it is appropriate to ask the question on a local scale. particularly exposed to the problem of unscheduled care, if patients are eligible for reorientation The non-medical factors identified as limiting the reorientation are: the absence of social cover, the language barrier, the patients referred by the samu or the fire brigade or a doctor, the patients who came by ambulance (because considered in theory as in the impossibility to move or having already been the subject of a "regulation")

Each 4 or 5 redirected patient is included and completes a questionnaire allowing the collection of information relating to their care pathways.

Primary endpoint :

Determine the proportion of patients not eligible for reorientation on non-medical criteria via a questionnaire, and identify the distribution of factors complicating reorientation

Secondary endpoints :

Identify the needs of patients re-orientated towards city medicine via the analysis of their passage to the emergency room, the reasons for their recourse to the emergency room (reasons, means and modes of arrival) their knowledge of the health system, and their relationship to general medicine

ReferenceCitation: Guttmann A, Schull MJ, Vermeulen MJ, Stukel TA. Association between waiting times and short term mortality and hospital admission after departure from emergency department: population based cohort study from Ontario, Canada. BMJ. 2011 Jun 1;342:d2983. doi: 10.1136/bmj.d2983.

ReferenceCitation: Marchetti M, Lepape M, Lauque D. La réorientation à l'accueil des services d'urgences : évaluation des pratiques professionnelles françaises. Ann Fr Médecine Urgence. 2014;4:349-353. doi:10.1007/s13341-014-0411-9

ReferenceCitation: Gilbert A, Brasseur E, Ghuysen A, D'Orio V. [New method to regulate unscheduled urgent care : the ODISSEE interactive self-triage platform]. Rev Med Liege. 2020 Mar;75(3):159-163. French.

lead_sponsor: Centre Hospitalier de Saint-Denis


type: Registry Identifier

title: Clinical Features of Hyperkinetic Involuntary Movements Controlateral to Hemiplegia in Acute Stroke

summary:
The occurrence of abnormal movements is a frequent reason for consultation in neurology. The etiologies are broadly separated into "primary causes", intrinsically neurological diseases (of genetic or degenerative origin), and "secondary causes". In addition to certain medications or toxic substances, brain damage can be a cause. In this register, 22% of involuntary abnormal movements are related to a stroke and 1 to 4% of strokes are complicated by abnormal movements.

These are manifested by a parkinsonian syndrome or conversely by hypercinesia which can take the form of chorea or ballisms. Most hyperkinetic movements occur in the acute phase of the neurovascular event.

The frequency of these abnormal movements is still uncertain and their semeiological description has been the subject of only rare publications. It seems relevant to be interested in the frequency of these neurological phenomena and has their semeiologic characteristic

ReferenceType: result

ReferenceCitation: Mehanna R, Jankovic J. Movement disorders in cerebrovascular disease. Lancet Neurol. 2013 Jun;12(6):597-608. doi: 10.1016/S1474-4422(13)70057-7. Epub 2013 Apr 19. Erratum In: Lancet Neurol. 2013 Aug;12(8):733.

publisher_dissemination: Elsevier

ReferenceCitation: Defebvre L, Krystkowiak P. Movement disorders and stroke. Rev Neurol (Paris). 2016 Aug-Sep;172(8-9):483-487. doi: 10.1016/j.neurol.2016.07.006. Epub 2016 Jul 28.

ReferenceCitation: Vercueil L, Andriantseheno ML, Umeda Y, Carre S, Sellal F. Hyperkinesia contralateral to acute hemiplegia: relevance of previous frontal lesions. Parkinsonism Relat Disord. 2000 Apr 1;6(2):107-110. doi: 10.1016/s1353-8020(99)00059-0.

ReferenceCitation: Ghika J, Bogousslavsky J, van Melle G, Regli F. Hyperkinetic motor behaviors contralateral to hemiplegia in acute stroke. Eur Neurol. 1995;35(1):27-32. doi: 10.1159/000117085.


title: Epidemiology of Neurological Complications to Nitrous Oxide Poisoning

acronym: EPI-NOX

summary:
N2O inactivates vitamin B12, impairing its ability to act as a cofactor of methionine synthase. In addition, the elimination of vitamin B12 is increased. Neurological damage is similar to that described in combined sclerosis of the marrow, and are probably related to induce vitamin B12 deficiency. The use of N2O can then precipitate the rapid appearance of signs (neurological, psychiatric and hematological) related to a true and/ or functional vitamin B12 deficiency.

In 1978, RB Layzer described the first 3 cases of peripheral neuropathy secondary to nitrous oxide (N2O) consumption. In 2016, a team collected the 91 published cases: among these, 72 had neurological complications, and 52 had a concentration of vitamin B12 considered "low" or "normal-low"

Since then, consumption patterns seem changed due to: an increasing ease of access, the change of container (packaging in cartridge 8 grams versus bottle of 600 grams) and a usually occasional and festive consumption that seems to become solitary and regular, This change in consumption patterns is explained by an increased incidence of neurological complications, although no epidemiological work is yet available.

The objective of this work is to describe the epidemiology of this condition, to correlate it with major recent social phenomena (confinement related to the SARS-Cov2 pandemic), and finally to compare the incidence of myelopathies secondary to N2O with the incidence of other frequent inflammatory neurological diseases (autoimmune myelitis and Guillain-Barré syndrome).

ReferenceCitation: Layzer RB, Fishman RA, Schafer JA. Neuropathy following abuse of nitrous oxide. Neurology. 1978 May;28(5):504-6. doi: 10.1212/wnl.28.5.504.

ReferenceCitation: Sanders RD, Weimann J, Maze M. Biologic effects of nitrous oxide: a mechanistic and toxicologic review. Anesthesiology. 2008 Oct;109(4):707-22. doi: 10.1097/ALN.0b013e3181870a17.

ReferenceCitation: Garakani A, Jaffe RJ, Savla D, Welch AK, Protin CA, Bryson EO, McDowell DM. Neurologic, psychiatric, and other medical manifestations of nitrous oxide abuse: A systematic review of the case literature. Am J Addict. 2016 Aug;25(5):358-69. doi: 10.1111/ajad.12372. Epub 2016 Apr 1.

ReferenceCitation: Vollhardt R, Mazoyer J, Bernardaud L, Haddad A, Jaubert P, Coman I, Manceau P, Mongin M, Degos B. Neurological consequences of recreational nitrous oxide abuse during SARS-CoV-2 pandemic. J Neurol. 2022 Apr;269(4):1921-1926. doi: 10.1007/s00415-021-10748-7. Epub 2021 Aug 21.


title: Validation of a Screening Tool for Swallowing Disorders for the Elderly

acronym: DéGluT'G

summary:
Swallowing disorder, or dysphagia, is a lack of protection of the airways during the passage of the food bolus towards the esophagus. Swallowing disorder is characterized by a feeling of discomfort when swallowing, difficult swallowing in elderly people or a blockage felt during the progression of food between the mouth and the stomach, sometimes with falsities. These disorders can be the cause of a loss of appetite and a reduction in food consumption in older people.

In the most serious cases, they can lead to aspiration, weakening the pulmonary passages and possibly leading to suffocation.

Swallowing disorders constitute an important public health problem due to their prevalence among the elderly. Many early readmissions could be avoided thanks to better quality of care in these patients.

In the elderly, the number of comorbidities and the multiplicity of medications and drug intake increase the incidence of swallowing disorders in this population. They constitute a common pathology, probably underestimated and underdiagnosed in the geriatric population.

Given the aging of the Martinique population, it is appropriate to offer an easy-to-use, quickly achievable tool for diagnostic purposes, making it possible to quickly identify potential swallowing disorders, and therefore to anticipate meal intake, and on the adaptation of the prescription to a medicinal alternative (before any food or medication taken during hospitalization).

In the Geriatric Short-Stay Unit of the Martinique University Hospital, a tool called "Deglut'G", was developed, and has been used since 2015, in order to allow caregivers a rapid, reliable and relevant assessment of swallowing disorders in the elderly, in order to guide care and medication alternatives.It now appears important to validate this tool, by comparing it with the results of examinations of swallowing disorders obtained from a speech-language pathologists (SLPs) and an ENT doctor.

lead_sponsor: University Hospital Center of Martinique

intervention_type: Diagnostic Test


title: LASER FiLaC™ (FISTULA LASER CLOSURE) : First-line Treatment of Complex Anal Fistulas

summary:
Complex anal fistula is a fistula whose treatment with fistulotomy would expose the patient to an excessive risk of post-operative continence disorders. It is a challenge in proctological surgery because of the complexity of its therapeutic management in relation to the recurrences' frequency and the need to preserve sphincter function. Indeed, management is mainly based on fistulotomy techniques, but the latter expose patients to a significant alteration of their continence (less than 10% incontinence for simple fistulas but 30-50% for complex fistulas). In addition, these fistulas' management is constraining for patients due to the need for multiple interventions, long-term post-operative care and repeated discontinuation of activity.

Sphincteral saving techniques have therefore developed over the last three decades and have enriched the therapeutic panel of complex fistulas. They aim to block fistula pathways without risking altering sphincter function. In addition, their surgical consequences are often simple. However, they are associated with a greater risk of failure than after fistulotomy and sometimes disappointing to the point that some of these techniques have been gradually abandoned (biological glue and plug for example).

Among these sphincteral saving techniques, the investigators know the advancement flap, the injection of biological glue, plug's installation, the LIFT (Ligation of Inter sphincteric Fistula Tract), the clip's use but also, more recently a laser treatment, FiLaC™ (for Fistula Laser Closure), knowing that the idea was not new since the ND-YAG3 and CO24.5 lasers were already used in the treatment of anal fistulas, about twenty years ago, in experimental studies.

This technique consists of radiating 360° laser energy radially into the fistula path to "burn" it and causing thermal destruction by coagulation of the fistula wall ans granulation tissue2. It can bo offered to any type of fistula at risk on continence, including horseshoe extensions that can be treated at the same time. It is well suited for outpatient management because the postoperative period is simple and painless.

The literature is still poor on the subject with some studies published openly but the preliminary results are encouraging with a success rate of about 70%. No continence disorders reported.

ReferenceCitation: Limura E, Giordano P. Modern management of anal fistula. World J Gastroenterol. 2015 Jan 7;21(1):12-20. doi: 10.3748/wjg.v21.i1.12.

ReferenceCitation: Wilhelm A. A new technique for sphincter-preserving anal fistula repair using a novel radial emitting laser probe. Tech Coloproctol. 2011 Dec;15(4):445-9. doi: 10.1007/s10151-011-0726-0. Epub 2011 Aug 16.

ReferenceCitation: Ellison GW, Bellah JR, Stubbs WP, Van Gilder J. Treatment of perianal fistulas with ND:YAG laser--results in twenty cases. Vet Surg. 1995 Mar-Apr;24(2):140-7. doi: 10.1111/j.1532-950x.1995.tb01308.x.

ReferenceCitation: Bodzin JH. Laser ablation of complex perianal fistulas preserves continence and is a rectum-sparing alternative in Crohn's disease patients. Am Surg. 1998 Jul;64(7):627-31; discussion 632.

ReferenceCitation: Slutzki S, Abramsohn R, Bogokowsky H. Carbon dioxide laser in the treatment of high anal fistula. Am J Surg. 1981 Mar;141(3):395-6. doi: 10.1016/0002-9610(81)90207-5.

ReferenceCitation: Giamundo P, Geraci M, Tibaldi L, Valente M. Closure of fistula-in-ano with laser--FiLaC: an effective novel sphincter-saving procedure for complex disease. Colorectal Dis. 2014 Feb;16(2):110-5. doi: 10.1111/codi.12440.

ReferenceCitation: Dudukgian H, Abcarian H. Why do we have so much trouble treating anal fistula? World J Gastroenterol. 2011 Jul 28;17(28):3292-6. doi: 10.3748/wjg.v17.i28.3292.

ReferenceCitation: Soltani A, Kaiser AM. Endorectal advancement flap for cryptoglandular or Crohn's fistula-in-ano. Dis Colon Rectum. 2010 Apr;53(4):486-95. doi: 10.1007/DCR.0b013e3181ce8b01.

ReferenceCitation: Lindsey I, Smilgin-Humphreys MM, Cunningham C, Mortensen NJ, George BD. A randomized, controlled trial of fibrin glue vs. conventional treatment for anal fistula. Dis Colon Rectum. 2002 Dec;45(12):1608-15. doi: 10.1007/s10350-004-7247-0.

ReferenceCitation: Swinscoe MT, Ventakasubramaniam AK, Jayne DG. Fibrin glue for fistula-in-ano: the evidence reviewed. Tech Coloproctol. 2005 Jul;9(2):89-94. doi: 10.1007/s10151-005-0204-7. Epub 2005 Jul 8.

ReferenceCitation: Johnson EK, Gaw JU, Armstrong DN. Efficacy of anal fistula plug vs. fibrin glue in closure of anorectal fistulas. Dis Colon Rectum. 2006 Mar;49(3):371-6. doi: 10.1007/s10350-005-0288-1.

ReferenceCitation: Ortiz H, Marzo J, Ciga MA, Oteiza F, Armendariz P, de Miguel M. Randomized clinical trial of anal fistula plug versus endorectal advancement flap for the treatment of high cryptoglandular fistula in ano. Br J Surg. 2009 Jun;96(6):608-12. doi: 10.1002/bjs.6613.

ReferenceCitation: Ozturk E, Gulcu B. Laser ablation of fistula tract: a sphincter-preserving method for treating fistula-in-ano. Dis Colon Rectum. 2014 Mar;57(3):360-4. doi: 10.1097/DCR.0000000000000067.

ReferenceCitation: Rojanasakul A, Pattanaarun J, Sahakitrungruang C, Tantiphlachiva K. Total anal sphincter saving technique for fistula-in-ano; the ligation of intersphincteric fistula tract. J Med Assoc Thai. 2007 Mar;90(3):581-6.

ReferenceCitation: Liu WY, Aboulian A, Kaji AH, Kumar RR. Long-term results of ligation of intersphincteric fistula tract (LIFT) for fistula-in-ano. Dis Colon Rectum. 2013 Mar;56(3):343-7. doi: 10.1097/DCR.0b013e318278164c.

ReferenceCitation: Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a.

ReferenceCitation: Giamundo P, Esercizio L, Geraci M, Tibaldi L, Valente M. Fistula-tract Laser Closure (FiLaC): long-term results and new operative strategies. Tech Coloproctol. 2015 Aug;19(8):449-53. doi: 10.1007/s10151-015-1282-9. Epub 2015 Feb 28.


title: Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study

summary:
Determine the consequences of COVID-19 pandemic on routine targeted surgeries.

Five surgical procedures were considered : cataract surgery, hip and knee arthoplasties, coronary revascularisation by angioplasty and definitive cardiac stimulation.

The objective of the study is to quantify changes of these procedures in 2020 and in 2021 (up to June) compared to 2019 taking into account their annual evolution and according to the type of operation (primary or reoperation/revision) and emergency status, if applicable.

lead_sponsor: EPI-PHARE


title: Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique

acronym: QVP-Dia

summary: The aim of this study is to compare quality of life of diabetics with and without foot ulcer. Investigators will compare their quality of life based on the mental health impact of foot ulcer.

sponsor_collaborators: University Hospital Center of Martinique


title: Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease: a Feasibility Study

acronym: Synch Fit

summary:
Sleep benefit (SB) consists of a spontaneous, transient and inconsistent improvement of the mobility occurring on morning awakening in approximately 40% of Parkinson's disease (PD) patients, before taking the first morning dose of dopaminergic drugs.

The SB could represent a pathway for the development of new therapeutic strategies for motor symptoms in PD.

Being a seemingly unpredictable phenomenon and a great variability daily, inter- and intra-subject, the SB study requires multiple and repeated assessments of mobility for several days. An experimental home setting would be optimal for this purpose in terms of cost-effectiveness and patient acceptability.

In addition, since the extent and nature of SB have not been well characterized so far, and the magnitude of its variability is unknown, a reliable assessment method, independent of observers and situation, the SB is a requirement of further research in this area.

A recently developed technique combining machine learning algorithms with wireless portable sensors (accelerometers and gyroscopes) and software applications could be particularly promising for characterizing the complexity and multiplicity of SBs in. With this technique, repeated and multiple assessments of mobility can be performed in the homes of patients without the constant presence of a researcher.

This approach offers several advantages in terms of cost-effectiveness, feasibility and acceptability of study protocols by patients. It also improves the ecological validity of subjective and objective estimates of mobility in these patients.

The investigators chose to conduct this preliminary study on patients with PD rather than on healthy subjects, because SB is a phenomenon that has been described so far only in this population. Investigators also consider that the feasibility of the study will depend mainly on the patients' ability to move and the context of their own illness.

SB is a phenomenon induced by sleep. The propensity and timing of sleep depend on the coordinated interaction of the duration of the previous awakening (homeostatic process) and a circadian signal (circadian process). In order to better understand SB, it is necessary to study the reciprocal influences of the circadian and homeostatic process.

Investigators have devised a new paradigm to "shift" the circadian process phase around the homeostatic process, maintained under constant conditions, in order to observe the effect of the synchronism or desynchronization of these two processes on the awakening mobility of patients with an MP. This experimental approach was approved by Professor Aleksandar Videnovic (Harvard University School of Medicine, USA), opinion leader on circadian rhythmicity in the MP and scientific collaborator of this study.

As a first step, the investigators plan to implement a technology-assisted home-based methodology, to validate it in PD patients and to verify the logistic feasibility of this method-assisted approach in a small group of patients, in order to to be able to apply this paradigm in larger scientific projects.

status: Withdrawn

status_simplified: Unknown


title: Efficacy of a Contract-Relax Technique in the Physical Therapy Management of Diaphragmatic Paresis After Cardiac Surgery

acronym: COREDIA

summary:
Postoperative respiratory complications are common complications of patients after cardiac surgery and increase morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction accounts for between 2 and 15% of these complications. Diaphragmatic paresis is one of these dysfunctions and could be due to an intra-operative phrenic nerve injury or harvesting of a mammary artery responsible for diaphragmatic devascularization. It alters the ventilatory mechanics and causes acute respiratory distress often requiring the use of mechanical ventilation. The diagnosis of this dysfunction can be made by thoracic ultrasound with assessment of diaphragmatic excursion. For patient with paresis, ultrasound criteria is an excursion < 25 mm after deep inspiration for at least one of the two hemidiaphragms. This dysfunction is most often transient in the postoperative period, but it can also become persistent.

Contract-Relax (CR) physical therapy technique can be applied to any muscle, providing muscle strengthening, neuromotor stimulation, and a gain in joint amplitude.

Currently, post-cardiac surgery management of respiratory physiotherapy is the same for a patient with or without paresis. Moreover, the CR technique of the diaphragm is not part of this "standard" rehabilitation.

The objective of this study is to determine if the CR technique associated with the current respiratory management allows an early rehabilitation of patients with diaphragmatic paresis after cardiac surgery.

lead_sponsor: CMC Ambroise Paré


title: Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery

summary: The main objective of this multicentric, prospective and interventional study is to assess the feasibility of multimodal prehabilitation in patients aged 75 years or older with surgical indication for coxarthrosis or severe gonarthrosis

primary_purpose: Supportive Care

lead_sponsor: Gérond'if

location_facility: Geriatric Perioperative Unit, Pitié-Salpêtrière hospital


title: Psychometric Validation of the "Antillanisée" Version of the Mini Mental State Examination

acronym: MMENSEA

summary:
The main objective of the study is to analyze the psychometric properties of the "antillanisée" version of the Mini Mental State Examination (MMSEa).

The methodology used will permit to explore the feasibility, acceptability, validity and reliability of the tool.

The psychometric validation of a version adapted transculturally will increase the value of the results obtained with this test and will make it possible to refine the screening of existing cognitive disorders for elderly subjects with Alzheiner's disease or related disorders.

status: Terminated


title: Lupus and Observance

acronym: LUPOBS

summary:
A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis.

New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential.

Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study.

The study primary objective is to determine risk factors for non-observance

The secondary objectives are to:

Measure the observance rate of patients with systemic lupus in Martinique.
Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.

intervention_type: Biological


title: Humoral and Cellular Responses to Vaccination Against Coronavirus Disease 2019 (COVID-19) in the Very Elderly Living in Geriatric Institutions

acronym: COGEVAX-BIO

summary: The main objective of this study is to describe the humoral and cellular response to BNT162b2 vaccination in people over age 75 institutionalized in the long-term care units of the Paris Public Hospitals (APHP)

status: Unknown status

primary_purpose: Screening

location_facility: Geriatric Department, Charles Foix hospital


title: Interest of the Kleihauer in Patients With Decreased Active Fetal Movements

acronym: MAF

summary:
Fetomaternal hemorrhage is the passage of fetal red blood cells through the placental barrier into the maternal blood. This phenomenon frequently occurs in the third trimester for small quantities of blood < 0.5 ml and is without fetal consequences in rhesus positive patients.

This hemorrhage can sometimes be more important and be the cause of fetal anemia or even fetal death in utero.

Diagnostic confirmation is biological and is performed using the Kleihauer test. It is based on the identification by the biologist of fetal cells circulating in the maternal blood by counting acid-fast fetal cells under the microscope. It is therefore a time-consuming examination with significant inter- and intra-observer variability.

The clinical sign most often reported in the literature, and the earliest sign that may suggest fetomaternal hemorrhage complicated by fetal anemia, is a decrease in active fetal movements. However, this is an aspecific sign and is one of the most common reasons for consultation in obstetric emergencies.


title: Personalized Dietary Advice 3 Months After Discharge From Hospitalization in Geriatrics: Effect on Nutritional Status According to Coronavirus Disease 2019 (Covid-19) Status (Positive or Negative) During Hospitalization

acronym: COVINUT

summary:
The principal aim of this interventional, multicentre study is to compare the impact of a follow-up by monthly telephone dietetic consultations, started 3 months after discharge from hospital, for a period of 3 months, on the energy intake in patients elderly people recently hospitalized for Coronavirus disease 2019 (Covid-19), Coronavirus disease Positive group "Covid (+)", or not, Coronavirus disease Negative group"Covid (-)".

The main outcome measure is to compare the total energy intake at 6 months, after 3 months of dietary consultations, between Coronavirus disease Positive group "Covid (+)" and Coronavirus disease negative group "Covid (-)".

location_facility: Geriatric Department, Bichat, Beaujon and Bretonneau hospitals


title: Diagnostic Yield and Influence on Length of Stay of Brain Computed Tomography for Elderly Patients With Altered Mental Status in an Emergency Setting

acronym: DISCUSS-CT

summary:
The confusional syndrome is defined by the acute or subacute onset of a deficit syndrome (temporo-spatial disorientation, memory and concentration disorders, abnormal behavior, impairment of intellectual efficiency, fluctuation of disorders with an increase in the evening) that may be associated with a productive syndrome (visual or auditory hallucinations, delusional elements) (French College of Neurology). It is a frequent, serious and costly problem in hospitalized patients and in emergency rooms.

Its prevalence is between 10 and 31% of cases in emergency rooms and concerns up to one out of two elderly patients during a hospitalization. The potential morbidity and mortality of the confusional syndrome is due in part to the difficulty of identifying and treating rapidly the triggering and aggravating factors that are often interrelated in the elderly. Most often, these are drug effects, metabolic disorders, infections, consequences of prolonged immobilization or physical restraint. The lack of rapid treatment of these causes increases the risk of medium and long-term cognitive problems.

Because of the aging population, this is an increasingly expensive problem. In 2012, the World Health Organization Regional Office for Europe study conducted in 18 European countries combined estimated its cost at $182 billion per year. The management of confusional syndrome in the elderly is now a major public health issue. It is a targeted indicator of the safety and quality of care for the elderly.


title: Accuracy and rEliabilitY of the vEstibuLo-ocular ExAmination Performed by inteRNs IN the emerGency Department

acronym: EYE LEARNING

summary:
Dizziness, loss of balance, and unsteadiness of gait are common symptoms reported by Emergency Department (ED) patients. The incidence of acute vestibular syndrome (AVS) is increasing and reaches 2-4% of ED visits. In the ED of the Paris Saint Joseph Hospital Group, its incidence was 5% during the year 2019 and 2% during the year 2020 (COVID-19 pandemic period).

Emergency medicine is based on a dichotomous principle for any acute pathology in the initial phase. For AVS, the diagnostic dilemma for emergency physicians is usually to differentiate a benign vestibular cause from a potentially serious cerebral cause such as ischemic stroke of the vertebro-basilar territory. The majority of AVS are related to acute vestibulopathies, yet it is necessary to recognize and distinguish a benign paroxysmal positional vertigo (BPPV) from a vestibular neuritis, a vestibular migraine, or a labyrinthine hydrops, to exclude with certainty a cerebral involvement. However, posterior fossa strokes mimic 5% of BPPV and 25% of vestibular neuritis. Among these strokes, about 20% are therefore revealed by a VAS without associated localizing neurological sign. In the absence of a clear neurological sign, the emergency physician must therefore decide whether to treat the patient as an outpatient when he or she suspects a AVS of "peripheral" origin (otolaryngology), or as an inpatient when he or she suspects a "central" origin, in particular a stroke.

ReferenceCitation: Gerlier C, Fels A, Vitaux H, Mousset C, Perugini A, Chatellier G, Ganansia O. Effectiveness and reliability of the four-step STANDING algorithm performed by interns and senior emergency physicians for predicting central causes of vertigo. Acad Emerg Med. 2023 May;30(5):487-500. doi: 10.1111/acem.14659. Epub 2023 Jan 30.

publisher_dissemination: Wiley


title: Amotivational Syndrome and Fatigue in Neurosurgery: The Impact of Neuroinflammation

acronym: DENI-CARE

summary: Depression is a major public concern associated with profound distress, intense suffering, and impairment in social, professional and familial functioning. Among the numerous symptoms defining depression, fatigue and motivation are not only frequent but also highly associated with poor quality of life and resistance to conventional antidepressant. Recent data, mainly obtained in animals, suggest that these symptoms may be linked to inflammatory processes within the central nervous system. Yet access to the brain is too invasive for exploring this link in patients with psychiatric conditions. However, certain conditions in neurosurgery, such as aneurysm rupture, require external evacuation, over several days or weeks, of the fluid bathing the brain through a catheter directly inserted into it. Critically, these patients also exhibit extreme exhaustion and fluctuating motivation, allowing to investigate the involvement of neuroinflammation in lack of motivation and fatigue by carrying out repeated motivation assessments with short behavioral tests (around ten minutes), while performing an analysis of inflammation markers in the fluid evacuated from the brain. The identification of inflammatory mechanisms underlying lack of motivation and fatigue could lead to the development of treatments for both resistant depression and motivation deficits that largely hamper rehabilitation in neurosurgery.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Neurologic Symptoms After Non-severe COVID-19 : Analysis and Diagnosis Assessment of Somatic Spectrum Disorder

acronym: SOMATiC

summary: A growing number of studies highlight the persistence of symptoms after the acute phase of SARS-CoV-2 infection, including in outpatients with mild to moderate forms of the disease. More than 80% of patients with persistent post-COVID-19 symptoms reported neurologic and neurocognitive disturbances. The pathophysiological mechanism is currently unknown, and several hypotheses have been put forward. Involvement of a Somatic Symptom Disorder (SSD) is plausible given the similarity of these symptoms with the Chronic Fatigue Syndrome identified as a SSD subtype. The objective of the SOMATiC study (SOMAtic symptom disorders Triggered by COVID-19) is to determine whether a positive diagnosis of SSD can be asserted in patients with persistent post-COVID-19 neurological symptoms.

ReferenceCitation: Kachaner A, Lemogne C, Dave J, Ranque B, de Broucker T, Meppiel E. Somatic symptom disorder in patients with post-COVID-19 neurological symptoms: a preliminary report from the somatic study (Somatic Symptom Disorder Triggered by COVID-19). J Neurol Neurosurg Psychiatry. 2022 Aug 25:jnnp-2021-327899. doi: 10.1136/jnnp-2021-327899. Online ahead of print.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: British Medical Journal


title: Assessment of SARS-CoV-2 Effect on Post-traumatic Stress of Patients Hospitalized in Intensive Care

acronym: FAMILY-COVID

summary:
Patients admitted to the intensive care unit develop psychiatric disorders, such as anxiety, depression or post-traumatic stress disorder, which can be prolonged.

During the COVID crisis, the presence of relatives in the intensive care unit was reduced and this, in a lasting way.

The hypothesis is that there is a difference in the experience of the stay in the intensive care unit whether or not one is affected by SARS-CoV-2 and that this difference is likely to have an impact on the long-term outcome of the patients and their relatives.

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Estimating the Prevalence of Postpartum Anxiety and Depression in the Context of the COVID-19 Pandemic

acronym: PsyCOVIDUM

summary:
In December 2019, infection with a new coronavirus Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. In addition to the direct effects of the virus on the pregnant woman and the fetus, the pandemic context itself is likely to act as a psychological risk factor and to alter the protective factors for mental disorders. This pandemic context is in itself anxiety-provoking, even traumatogenic, particularly because of the potentially lethal infectious risk that it conveys, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, the fear of childbirth and the postpartum period, which includes a more or less important part of anxiety-provoking uncertainty, is added to the fear of viral contamination in the perinatal period. This addition of stress factors is likely to increase the prevalence of perinatal depressive disorders and anxiety disorders, particularly the psychotraumatic experience of childbirth. Sanitary and social measures, such as quarantine, restriction of access of accompanying persons to maternity unit, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a separation of mother and child, are also likely to have psychopathological consequences.

In this context, three maternity wards of the PREMA University Hospital Federation (UHF PREMA) : Groupe hospitalier Paris Saint-Joseph (GHPSJ), Louis Mourier Hospital (APHP) and Port-Royal Hospital (APHP), in partnership with the "Centre de Psychopathologie du Boulevard Brune (CPBB)" and the psychiatry department of the Louis Mourier Hospital have set up a care protocol consisting of a systematic screening offered to women following childbirth on the first day of their pregnancy, aimed at identifying those with perinatal anxiety and depressive symptoms. Women presenting symptoms are then treated according to the modalities adapted to the organization of each of these three centers.


title: Cervical Preparation for Surgical Abortion at 12-14 Weeks: a Prospective, Randomized, Evaluator-blinded, Multicenter, Controlled Comparison Between Mifepristone, Misoprostol and Their Combination

summary:
More than 100 000 surgical abortions are annually performed in France. About four in ten women will have an abortion in their life. Abortion complications are cervical tearing (0.1-1.18%), uterine perforation (0.09-19.8‰), hemorrhage (1.5‰) and infection (5-20%). These complications can first compromise the vital prognosis and are involved in 10% of the worldwide maternal mortality (20 000 women by year), then lead to infertility which is hard to treat (uterine synechiae) or impossible to treat (hysterectomy for control of bleeding), and are finally responsible for obstetrical pathologies as late miscarriages or premature delivery due to cervical insufficiency. All that complications are linked to cervical laceration of the surgical abortion, that can be reduced by the recommended use of mifepristone or misoprostol as cervical preparation for the abortions after 12 weeks. However, it does not exist data evaluating the superiority of one of the two molecules or their combination. These data could optimize the cervical preparation and thus reduce the abortion complications with a direct impact on maternal mortality, infertility and obstetrical complications. Thus, it seems to be important to evaluate these two molecules and their combination.

Objectives To compare mifepristone, misoprostol and their combination in the cervical preparation of the surgical abortion between 12 and14 weeks for their efficacy, complications and side-effects.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy: Randomized Control Trial

summary:
Cerebral palsy (CP) is defined as a group of movement and posture disorders that cause activity limitation due to brain damage during fetal development or in the first year of life. Motor activities, and in particular walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity. Theories of gait training guide rehabilitation management strategies. Among these, intensification, variability and specific training of walking parameters (speed, step length, cadence) have shown their effectiveness. Delivering sensory feedback during gait rehabilitation exercises is a complementary approach to improve motor learning during rehabilitation. On the other hand, motivation is a key factor in the success of rehabilitation. The addition of walking exercises performed through a serious game in augmented reality (AR) appears relevant for the rehabilitation of children with CP after surgery.

The serious game ARRoW-CP is based on the latest advances in the literature in terms of gait rehabilitation protocol but also on the results of a clinical study conducted by our team, to identify the best feedback modalities to be delivered during the serious rehabilitation game.

ReferenceCitation: Guinet AL, Bams M, Payan-Terral S, Khouri N, Otmane S, Bouyer G, Desailly E. Effect of an augmented reality active video game for gait training in children with cerebral palsy following single-event multilevel surgery: protocol for a randomised controlled trial. BMJ Open. 2022 Oct 10;12(10):e061580. doi: 10.1136/bmjopen-2022-061580.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

lead_sponsor: Fondation Ellen Poidatz


title: Evaluation of Relationship Between Hypersexuality and Psychostimulant Among Men Who Have Sex With Men

acronym: HYPERCHEM

summary:
Survey of fifty new psychoactive substances consumers in a context of MTM sexual intercourse.

Evaluation using an hetero-assessment questionnaire about the link between hypersexual disorder and the use of synthetic cathinone.

Evaluation on psychoactive drug addiction, the induced or pre-existing sexual practices and the medico-psycho-social consequences of those practices.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of the Use of a Continuous Glucose Monitoring System on Glycemic Equilibrium and Hypoglycemia in Diabetic Patients With Acute Coronary Syndrome Admitted in Intensive Care

acronym: EVASION

summary:
The investigators hypothesize that the use of a continuous glucose monitoring system (CGMS) can reduce glycemic variability assessed by coefficient of variation (CV) during the acute phase of acute coronary syndrome (ACS) in patients with diabetes treated by insulin infusion.

The purpose of this project is to assess the impact of the use of CGMS on glycemic variability in diabetic patients with ACS .

This is a randomized, multicenter (2 centers), open study. The patients included, as soon as possible, after admission will be randomized before the beginning of insulin therapy with intravenous insulin .


title: Diuretic Versus Placebo in Pulmonary Embolism With Right Ventricular Enlargement: a Double-blind Randomized Controlled Study

acronym: DiPER

summary:
Pulmonary Embolism (PE) is a frequent and severe disease with an annual incidence of about 75000 cases in France and a short-term mortality rate of about 10%. Death is usually related to an acute right ventricular (RV) failure due to the increase in right ventricular afterload. Treatment of PE with RV failure consists in fluid expansion and thrombolysis in case of shock. However several studies suggest that fluid expansion may worsen acute RV failure by increasing RV dilatation and ischemia and left ventricular compression by RV dilatation. Thus, current guidelines regarding PE treatment remain unclear about the use of fluid expansion. In a preliminary study published by our group, we showed that diuretic treatment in the setting of PE with RV dilatation is safe and is associated with an increase in urine output, a decrease in heart rate and an increase in SpO2 in normotensive patients with oliguria. This may be related to the decrease of ventricular interdependence and enhancement of both LV and RV function.

The main objective of the study is to evaluate the 24-hours clinical benefit of furosemide in patients referred for acute PE with RV dilatation compared to placebo. The combination of urine output and sPESI clinical parameters reflects hemodynamic status. It is relevant as it indicates the disappearance of pre-shock symptoms and is therefore associated with a lower event risk. Thus, it allows early discharge of the patients from the intensive care unit.

ReferenceCitation: Wood KE. Major pulmonary embolism: review of a pathophysiologic approach to the golden hour of hemodynamically significant pulmonary embolism. Chest. 2002 Mar;121(3):877-905. doi: 10.1378/chest.121.3.877.

ReferenceCitation: Lee FA. Hemodynamics of the right ventricle in normal and disease states. Cardiol Clin. 1992 Feb;10(1):59-67.

ReferenceCitation: Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.

ReferenceCitation: Perlroth DJ, Sanders GD, Gould MK. Effectiveness and cost-effectiveness of thrombolysis in submassive pulmonary embolism. Arch Intern Med. 2007 Jan 8;167(1):74-80. doi: 10.1001/archinte.167.1.74.

ReferenceCitation: Goldhaber SZ, Haire WD, Feldstein ML, Miller M, Toltzis R, Smith JL, Taveira da Silva AM, Come PC, Lee RT, Parker JA, et al. Alteplase versus heparin in acute pulmonary embolism: randomised trial assessing right-ventricular function and pulmonary perfusion. Lancet. 1993 Feb 27;341(8844):507-11. doi: 10.1016/0140-6736(93)90274-k.

ReferenceCitation: Lim P, Delmas C, Sanchez O, Meneveau N, Rosario R, Bouvaist H, Bernard A, Mansourati J, Couturaud F, Sebbane M, Coste P, Rohel G, Tardy B, Biendel C, Lairez O, Ivanes F, Gallet R, Dubois-Rande JL, Fard D, Chatelier G, Simon T, Paul M, Natella PA, Layese R, Bastuji-Garin S. Diuretic vs. placebo in intermediate-risk acute pulmonary embolism: a randomized clinical trial. Eur Heart J Acute Cardiovasc Care. 2022 Jan 12;11(1):2-9. doi: 10.1093/ehjacc/zuab082.

evidence: open (via free article)

publisher_dissemination: Oxford University Press

ReferenceCitation: Gallet R, Meyer G, Ternacle J, Biendel C, Brunet A, Meneveau N, Rosario R, Couturaud F, Sebbane M, Lamblin N, Bouvaist H, Coste P, Maitre B, Bastuji-Garin S, Dubois-Rande JL, Lim P. Diuretic versus placebo in normotensive acute pulmonary embolism with right ventricular enlargement and injury: a double-blind randomised placebo controlled study. Protocol of the DiPER study. BMJ Open. 2015 May 22;5(5):e007466. doi: 10.1136/bmjopen-2014-007466.

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: DiPER

titre: Diurétique versus placebo dans l'embolie pulmonaire avec dilatation du ventricule droit

discipline_principale: cardiologie

nom_porteur: DUBOIS RANDE

prenom_porteur: Jean Luc


title: Mitochondrial Respiratory Chain and Peripheral Muscle Dysfunction in COPD Patients

summary: The purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in COPD patients after training program.

lead_sponsor: 5 Santé

collaborators: Centre Hospitalier Régional Universitaire Montpellier

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Clinique du Souffle La Vallonie
Clinique du Souffle la Solane


title: Contribution of High Resolution EEG Functional Connectivity Measures to Presurgical Evaluation of Patients With Intractable Epilepsy

acronym: conneXion

summary:
Electroencephalography (EEG) with very high spatial resolution (HR-EEG, 256 electrodes) allow for better analysis of local and global activity of the cerebral cortex, as compared with conventional EEG. Since January 2012, the Neurology Department of CHU Rennes is the first clinical service in France equipped with such a system.

Applied to HR-EEG recordings, brain connectivity methods are likely to provide essential information (in the form of "connectivity graphs") on cortical networks, either dysfunctional or not, involved in the generation of interictal paroxysms (like spikes or spike-waves) and during seizures.

So far, many methods have been proposed (see for a review: Wendling et al., 2009; Wendling et al., 2010). However, since each method is highly sensitive to the type of model that is assumed for the underlying relationship between distinct brain regions (Ansari-Asl et al., 2006), none of them has yet demonstrated its effectiveness.

ReferenceCitation: Mheich A, Hassan M, Khalil M, Gripon V, Dufor O, Wendling F. SimiNet: A Novel Method for Quantifying Brain Network Similarity. IEEE Trans Pattern Anal Mach Intell. 2018 Sep;40(9):2238-2249. doi: 10.1109/TPAMI.2017.2750160. Epub 2017 Sep 8.

oa_host_type: repository

repository_institution: Cornell University - arXiv

repository_normalized: arXiv

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

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

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

repositories: HAL arXiv

repositories_concat: HAL;arXiv

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Bretagne Occidentale

unpaywall_oa_status: green

publisher_dissemination: IEEE

ReferenceCitation: Kabbara A, El Falou W, Khalil M, Wendling F, Hassan M. The dynamic functional core network of the human brain at rest. Sci Rep. 2017 Jun 7;7(1):2936. doi: 10.1038/s41598-017-03420-6.

license: cc-by

license_normalized: cc-by

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

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

repositories:
HAL
PubMed Central
Zenodo

repositories_concat: HAL;PubMed Central;Zenodo

publisher_dissemination: Springer-Nature

ReferenceCitation: Mheich A, Hassan M, Khalil M, Berrou C, Wendling F. A new algorithm for spatiotemporal analysis of brain functional connectivity. J Neurosci Methods. 2015 Mar 15;242:77-81. doi: 10.1016/j.jneumeth.2015.01.002. Epub 2015 Jan 10.

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

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

ReferenceCitation: Hassan M, Merlet I, Mheich A, Kabbara A, Biraben A, Nica A, Wendling F. Identification of Interictal Epileptic Networks from Dense-EEG. Brain Topogr. 2017 Jan;30(1):60-76. doi: 10.1007/s10548-016-0517-z. Epub 2016 Aug 22.

ReferenceCitation: Rizkallah J, Benquet P, Kabbara A, Dufor O, Wendling F, Hassan M. Dynamic reshaping of functional brain networks during visual object recognition. J Neural Eng. 2018 Oct;15(5):056022. doi: 10.1088/1741-2552/aad7b1. Epub 2018 Aug 2.

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

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

ReferenceCitation: Hassan M, Shamas M, Khalil M, El Falou W, Wendling F. EEGNET: An Open Source Tool for Analyzing and Visualizing M/EEG Connectome. PLoS One. 2015 Sep 17;10(9):e0138297. doi: 10.1371/journal.pone.0138297. eCollection 2015.

ReferenceCitation: Hassan M, Dufor O, Merlet I, Berrou C, Wendling F. EEG source connectivity analysis: from dense array recordings to brain networks. PLoS One. 2014 Aug 12;9(8):e105041. doi: 10.1371/journal.pone.0105041. eCollection 2014.

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

ReferenceCitation: Hassan M, Benquet P, Biraben A, Berrou C, Dufor O, Wendling F. Dynamic reorganization of functional brain networks during picture naming. Cortex. 2015 Dec;73:276-88. doi: 10.1016/j.cortex.2015.08.019. Epub 2015 Sep 28.


title: Demonstration Study of the Interest of the MEDTRUM A7+ TouchCare Insulin Patch Pump Versus INSULET Omnipod® Patch Pump

acronym: MedInPS

summary: Demonstration study of the interest of the MEDTRUM A7+ TouchCare insulin patch pump versus INSULET Omnipod® patch pump

lead_sponsor: Medtrum France


title: Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase

summary: The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.

ReferenceCitation: Rousselot P, Cony-Makhoul P, Nicolini F, Mahon FX, Berthou C, Rea D, Reiffers J, Bornand A, Saint-Jean O, Guilhot J, Guilhot F; French Intergroup For Chronic Myelogenous Leukemia (Fi-LMC). Long-term safety and efficacy of imatinib mesylate (Gleevec(R)) in elderly patients with chronic phase chronic myelogenous leukemia: results of the AFR04 study. Am J Hematol. 2013 Jan;88(1):1-4. doi: 10.1002/ajh.23330. Epub 2012 Sep 17.

ReferenceCitation: Deau B, Nicolini FE, Guilhot J, Huguet F, Guerci A, Legros L, Pautas C, Berthou C, Guyotat D, Cony-Makhoul P, Gardembas M, Michallet M, Hayette S, Cayuela JM, Weiss IR, Rea D, Castaigne S, Mahon FX, Guilhot F, Rousselot P. The addition of daunorubicin to imatinib mesylate in combination with cytarabine improves the response rate and the survival of patients with myeloid blast crisis chronic myelogenous leukemia (AFR01 study). Leuk Res. 2011 Jun;35(6):777-82. doi: 10.1016/j.leukres.2010.11.004. Epub 2010 Dec 10.

lead_sponsor: Poitiers University Hospital

collaborators:
Ministry of Health, France
Novartis

sponsor_collaborators:
Poitiers University Hospital
Ministry of Health, France
Novartis


title: A Randomized Placebo-Controlled Double Blind Trial Comparing Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture in Combination With Local Local 1% Xylocaine Anesthetic Versus Placebo in Order to Evaluate Pain Intensity During Bone Marrow Biopsy.

summary:
Bone marrow biopsy is a painful medical procedure often performed with local anesthetic.

Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler

sponsor_collaborators:
Poitiers University Hospital
Ministry of Health, France
Air Liquide Santé International


title: Cardiac AMyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation (CAMPOS-TAVI)

acronym: CAMPOS-TAVI

summary:
Aortic stenosis (AS) is the most frequent valvulopathy in the general population in France and more generally in developed countries, due to populations aging. Its standard treatment is historically surgical aortic valve replacement (SAVR). In the 2000s, the management of this valvulopathy was revolutionized by the development of the technique of per-cutaneous aortic valve replacement (TAVI). TAVI opens the possibility of curative treatment to patients at high operational risk not operable by conventional surgery, and for whom outcome was affected with high mortality under medical treatment alone.

Amyloidosis, a pathology with multiple etiologies, is a rare condition and its cardiac form (AC) even more (8 to 17 / 100,000 people / year). However, its prevalence is increasing. Some autopsies series have found prevalence up to 50% of cardiac amyloidosis with transthyretin (AC-TTR) after 60 years. In addition, recent data suggested that AC-TTR prevalence is higher in the population of patients with heart disease: 13% in heart failure with preserved ejection fraction and up to 16% in patients with AS. The outcome of patients with AC-TTR remains unknown after TAVI. Thus, the diagnosis of AC-TTR in patients undergoing TAVI represents an important issue. Indeed, a treatment stabilizing the process of accumulation of transthyretin deposits, effective on the survival of these patients, is now available. In addition, a non-invasive screening strategy for AC-TTR, alternative to biopsy, is now validated.

lead_sponsor: CHU de Reims

intervention_type: Radiation


title: Modeling of Patient-patient Expert-caregiver Interactions During the Addiction Care Pathway

acronym: IPEXA

summary:
"In France and abroad, patient involvement is increasingly encouraged through the development of experiences involving patients in their care or that of their peers.

The Association of PEs in Addictology (APEA) and the Addictology Department of the Bichat Hospital (APHP- Nord, University of Paris) have established a partnership in which PEs volunteer to work with patients throughout the course of their care. To date, no study has evaluated the impact of the PE program in addictology. A preliminary study within the department and the APEA is needed to evaluate the benefits to patients and caregivers, the feasibility and the cost in terms of staff time of implementing the PE program.

The main objective of the project is to describe the care pathways of patients through their interactions with the PEs and the overall addiction care system, over a period of one year, within the Psychiatry-Addictology Department of the Bichat Hospital and then in the outpatient setting.

The secondary objectives are to characterize and describe the patients' profiles according to these pathways; as well as to describe the contribution of EPs in the process of coordinating the care of these patients (interaction between patients - EPs - health professionals).

This is a non-interventional monocentric cohort study in the Psychiatry-Addictology Department of the Bichat Hospital.

In practice, data concerning interactions between patients and EPs and caregivers and EPs will be collected by EPs directly on an eCRF after each contact, for 12 months from inclusion. Patients will be followed during their care pathway for a total of one year, by two telephone assessments at 3 months and 6 months of hospital discharge. A final visit will be made 12 months after hospital discharge by face-to-face interview. Participation will end at the time of the debriefing interview, one year after inclusion.

Modeling the interactions between patients and EPs, and between caregivers and EPs during a course of care in addictology, will lead to a better knowledge of the EP system and the place of EPs in the trajectories of addictology care.

The effectiveness of the PE system can thus be recognized in the management of addictions, in complementarity with the caregivers. The driving factors for implementation will be identified in order to improve the dissemination of the PE system to other centers."


title: A 3-months, Controlled and Double-blind Trial of the Effectiveness of Music Therapy in the Treatment of Sleep Disorders in General Medicine.

summary: The purpose of this study is to determine whether listening to music before falling asleep can improve sleep quality in patients with sleep disorders.

ReferenceCitation: Harmat L, Takacs J, Bodizs R. Music improves sleep quality in students. J Adv Nurs. 2008 May;62(3):327-35. doi: 10.1111/j.1365-2648.2008.04602.x.

ReferenceCitation: Jespersen KV, Koenig J, Jennum P, Vuust P. Music for insomnia in adults. Cochrane Database Syst Rev. 2015 Aug 13;2015(8):CD010459. doi: 10.1002/14651858.CD010459.pub2.

ReferenceCitation: Blais FC, Gendron L, Mimeault V, Morin CM. [Evaluation of insomnia: validity of 3 questionnaires]. Encephale. 1997 Nov-Dec;23(6):447-53. French.

ReferenceCitation: Gottlieb DJ, Redline S, Nieto FJ, Baldwin CM, Newman AB, Resnick HE, Punjabi NM. Association of usual sleep duration with hypertension: the Sleep Heart Health Study. Sleep. 2006 Aug;29(8):1009-14. doi: 10.1093/sleep/29.8.1009.

ReferenceCitation: Gangwisch JE, Heymsfield SB, Boden-Albala B, Buijs RM, Kreier F, Pickering TG, Rundle AG, Zammit GK, Malaspina D. Short sleep duration as a risk factor for hypertension: analyses of the first National Health and Nutrition Examination Survey. Hypertension. 2006 May;47(5):833-9. doi: 10.1161/01.HYP.0000217362.34748.e0. Epub 2006 Apr 3.

ReferenceCitation: Spiegel K, Knutson K, Leproult R, Tasali E, Van Cauter E. Sleep loss: a novel risk factor for insulin resistance and Type 2 diabetes. J Appl Physiol (1985). 2005 Nov;99(5):2008-19. doi: 10.1152/japplphysiol.00660.2005.

ReferenceCitation: Leger D, Guilleminault C, Dreyfus JP, Delahaye C, Paillard M. Prevalence of insomnia in a survey of 12,778 adults in France. J Sleep Res. 2000 Mar;9(1):35-42. doi: 10.1046/j.1365-2869.2000.00178.x.

ReferenceCitation: Young TB. Epidemiology of daytime sleepiness: definitions, symptomatology, and prevalence. J Clin Psychiatry. 2004;65 Suppl 16:12-6.

ReferenceCitation: Feng F, Zhang Y, Hou J, Cai J, Jiang Q, Li X, Zhao Q, Li BA. Can music improve sleep quality in adults with primary insomnia? A systematic review and network meta-analysis. Int J Nurs Stud. 2018 Jan;77:189-196. doi: 10.1016/j.ijnurstu.2017.10.011. Epub 2017 Oct 23.

ReferenceCitation: Wang CF, Sun YL, Zang HX. Music therapy improves sleep quality in acute and chronic sleep disorders: a meta-analysis of 10 randomized studies. Int J Nurs Stud. 2014 Jan;51(1):51-62. doi: 10.1016/j.ijnurstu.2013.03.008. Epub 2013 Apr 9.

ReferenceCitation: Guetin S, Coudeyre E, Picot MC, Ginies P, Graber-Duvernay B, Ratsimba D, Vanbiervliet W, Blayac JP, Herisson C. [Effect of music therapy among hospitalized patients with chronic low back pain: a controlled, randomized trial]. Ann Readapt Med Phys. 2005 Jun;48(5):217-24. doi: 10.1016/j.annrmp.2005.02.003. Epub 2005 Mar 4. French.

ReferenceCitation: Guetin S, Portet F, Picot MC, Pommie C, Messaoudi M, Djabelkir L, Olsen AL, Cano MM, Lecourt E, Touchon J. Effect of music therapy on anxiety and depression in patients with Alzheimer's type dementia: randomised, controlled study. Dement Geriatr Cogn Disord. 2009;28(1):36-46. doi: 10.1159/000229024. Epub 2009 Jul 23.

ReferenceCitation: Jaber S, Bahloul H, Guetin S, Chanques G, Sebbane M, Eledjam JJ. [Effects of music therapy in intensive care unit without sedation in weaning patients versus non-ventilated patients]. Ann Fr Anesth Reanim. 2007 Jan;26(1):30-8. doi: 10.1016/j.annfar.2006.09.002. Epub 2006 Nov 3. French.

ReferenceCitation: Guetin S, Ginies P, Siou DK, Picot MC, Pommie C, Guldner E, Gosp AM, Ostyn K, Coudeyre E, Touchon J. The effects of music intervention in the management of chronic pain: a single-blind, randomized, controlled trial. Clin J Pain. 2012 May;28(4):329-37. doi: 10.1097/AJP.0b013e31822be973.

ReferenceCitation: Guetin S, Portet F, Picot MC, Defez C, Pose C, Blayac JP, Touchon J. [Impact of music therapy on anxiety and depression for patients with Alzheimer's disease and on the burden felt by the main caregiver (feasibility study)]. Encephale. 2009 Feb;35(1):57-65. doi: 10.1016/j.encep.2007.10.009. Epub 2008 Feb 20. French.

ReferenceCitation: Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

ReferenceCitation: Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

ReferenceCitation: Savard MH, Savard J, Simard S, Ivers H. Empirical validation of the Insomnia Severity Index in cancer patients. Psychooncology. 2005 Jun;14(6):429-41. doi: 10.1002/pon.860.

ReferenceCitation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

ReferenceCitation: Edinger JD, Wohlgemuth WK. Psychometric comparisons of the standard and abbreviated DBAS-10 versions of the dysfunctional beliefs and attitudes about sleep questionnaire. Sleep Med. 2001 Nov;2(6):493-500. doi: 10.1016/s1389-9457(01)00078-8.

ReferenceCitation: Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8. Erratum In: Sleep 1992 Feb;15(1):83.

ReferenceCitation: Wang Q, Chair SY, Wong EM, Li X. The Effects of Music Intervention on Sleep Quality in Community-Dwelling Elderly. J Altern Complement Med. 2016 Jul;22(7):576-84. doi: 10.1089/acm.2015.0304. Epub 2016 May 25.

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD010459. doi: 10.1002/14651858.CD010459.pub3.

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

location_facility: Versailles-Saint Quentin en Yvelines University


title: Prevalence and Development of Post-traumatic Stress Disorder and Anxiety and Depressive Symptoms Among AP-HP Staff During the Covid-19 Epidemic

acronym: Covid-Impact

summary: The epidemic of coronavirus induces a major influx of patients implying a rapid modification of the organizations, a work overload and a significant stress for the care teams and supports of the hospitals of the Assistance Publique - Hôpitaux de Paris (AP-HP) . To this is added the impact on each professional of the large number of very severe patients to be treated, of death and the anxiety of contamination, reinforced by the actual cases of staff themselves sick. Emergency phone numbers for professionals in the event of psychological suffering were quickly put in place at the AP-HP and Hospitals level. The objective of this study is to assess the psychopathological and psycho-traumatic consequences of this exceptional situation on the staff, during the epidemic and at a distance from it, in order to be able to target the solutions to be implemented. Hypothesis is that some personnel may develop one or more of the following disorders: adjustment disorder or other anxiety disorder, acute stress disorder, post-traumatic stress disorder (PTSD), and depressive episodes as defined in the DSM-5. This study also aimes to assess effect of support measures put in place, by comparing the evolution of those who benefited from those who did not use them, as well as the risk factors specific. The results will make it possible to have an estimate of the percentage of people who may require specific support, and to identify the staff most at risk, and thus predict the importance of the circuits and structures for support of staff which will be necessary in the short and long term. The main anticipated risk factors are: being a nurse, having a low number of years of professional experience, and being on the front line of care for affected patients.

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION