title: Clinical and Psycho-Social Impact on Patients With Digestive Tumors of Treatment and Care Modifications Linked to COVID-19 in France

acronym: COVIDICA

summary: To limit Corona virus dissemination on its territory, France applied strict confinement from March 16th to May 11th. Scientific societies recommended treatment modifications and remote consultations that were applied. This study evaluates the clinical impact of these care adaptation on patients under treatment for a digestive tumor. A special focus is made on quality of life and psycho-social impact of treatment modifications on patients diagnosed with metastatic colorectal cancer and metastatic pancreatic cancer.

lead_sponsor: Poitiers University Hospital

location_facility:
BOURGEOIS Hugues
MOULIN Valérie
RANDRIAN Violaine


title: Respiratory Complications of Operated Esophageal Atresia in Children

acronym: ATRESIA

summary:
The respiratory complications of esophageal atresia have already been identified.

They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux.

In this context, symptoms of asthma (or bronchial hyperreactivity) occur more frequently than in the general population and persist into adulthood. Their pathogenesis is still poorly understood and is the subject of much discussion.

The therapeutic management of these respiratory complications, poorly codified, remains very heterogeneous from one center to another. In France, the summary of knowledge is updated by the Reference Center for chronic and malformative diseases of the esophagus.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France

lead_sponsor_type: academique

status_simplified: Completed


title: Descriptive Study of Anxiety and/or Depressive Disorders in a Population of Airline Pilots Employed in France and Unionized at the SNPL

acronym: AEROPSY

summary: Throughout their career, the medical abilities of airline pilots are regularly assessed. This population is exposed to occupational constraints and risks, in particular psychosocial, and could constitute a population at risk of developing anxiety and/or depressive disorders. However, mental health remains difficult to apprehend in this population because of a strong stigmatization of mental disorders and the risk of loss of medical certification to fly. In the literature, there are very few studies dealing with mental disorders in airline pilots and the results are heterogeneous, with a prevalence of anxiety and/or depressive disorders ranging from 1.9 to 12.6%. There is no study of this type among airline pilots employed in France. Therefore it seems useful to determine the prevalence of anxiety and/or depressive disorders in this population and to describe the co-factors associated with these disorders.

time_perspective: Cross-Sectional

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Behavioral


title: National, Multicentre, Prospective, Observational Study, to Evaluate the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side

summary:
HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal femur as percutaneous internal fixation to prevent contralateral hip fracture in case of osteoporosis.

The primary objective of this study is to evaluate the clinical efficacy of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation.

A total of 50 patients from France will be enrolled (until December 2020) and followed up to 24 months.

status: Terminated

time_perspective: Prospective

lead_sponsor: Hyprevention

location_facility: Nouvelle Clinique de Tours Plus St Gatien

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Case Control Study on Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction

acronym: CRACK-ANT

summary: The purpose of this study is to assess the phenotypic candidates symptoms, in patients with crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and neuropsychological evaluations apt to be associated with genetic and genotypic characterisations, notably on the polymorphisms of the genes coding or regulating dopaminergic, norepinephrine and serotoninergic systems.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital Center of Martinique

location_facility: Service de psychiatrie et addictologie - CHU de Fort-de-France

intervention_type: Genetic


title: Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa That Come for Their Annual/Biannual Check up at This Medical Rare Disease Reference Centers (MRDRC) of This Disease in France and Belgium

summary: Hereditary Epidermolysis Bullosa (EBH) are rare dermatologic diseases characterized by cutaneous and mucosa fragility. Oral manifestations of few small cohort have been published. The main objective of this multicentric cohort study first in Europe was to report the oral status of these patients that were consulted in the MRDRC of this disease in Nice (France), Toulouse (France) and Louvain (Belgium). Then a correlation between the oral characteristics and the EBH type will be made, in order to facilitate the management of patient care and the prevention program that can be established to improve their oral health.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility:
Nice Hospital
Toulouse University

intervention_type: Other


title: New Care Pathways to Achieve HCV Elimination in the Community: Real-world Outcomes From HCV Infected Patients Treated in Addiction Centers in France

acronym: NeoVie

summary:
Hepatitis C Virus is liver disease and is a leading cause of death and morbidity with around 71 million people affected worldwide. Widespread availability of highly effective direct-acting antivirals (DAAs) have dramatically changed the treatment landscape of HCV with a cure rate of over 95%. In May 2019, French Health Authorities expanded prescription abilities to all physicians treating adult treatment-naive patients with HCV without cirrhosis of the liver. This study will assess the treatment uptake and barriers to treatment by non-HCV specialist in France in community-based addiction centers. Beyond these evaluations, data on health resource utilization in addiction centers, level of knowledge of both patients and providers on HCV infection and treatment, care cascade, effectiveness and safety of Glecaprevir/Pibrentasvir among patients treated in addiction centers and evolution of addiction behavior after treatment are of specific interest.

Glecaprevir/Pibrentasvir is a drug approved to treat HCV. About 400 Adult participants with a confirmed positive HCV ribonucleic acid (RNA) test will be enrolled in the study at approximately 30 addiction centers in France.

All participants will attend an inclusion visit. Participants who are not prescribed Glecaprevir/Pibrentasvir at the inclusion visit will have no further follow-up in the study. Participants who are prescribed Glecaprevir/Pibrentasvir will take three tablets once daily. The duration of the study is approximately 12 months.

All study visits will occur during routine clinical practice but there may be a higher burden for participants prescribed Glecaprevir/Pibrentasvir. These participants will be asked to complete questionnaires after each visit.

status: Recruiting

ipd_sharing: Undecided

lead_sponsor: AbbVie

location_facility: Centre Hospitalier Le Vinatier - Service universitaire d'addictologie de Lyon /ID# 218695

location_facility: Centre de soin d'accompagnement et de prevention en addictologie- CHU Archet 2 /ID# 218682

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie-Boris Vian /ID# 221284

location_facility: Centre de soin d'accompagnement et de prevention en addictologie-Paul Guiraud /ID# 218710

location_facility: Association Tremplin 17 - Saintes /ID# 218708

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Cap /ID# 222776

location_facility: Centre de soin d'accompagnement et de prevention en addictologie- L'ENVOL /ID# 218680

location_facility: Centre de soins d'accompagnement et de prevention en addictologie-ANPAA 82 /ID# 218675

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Arc en ciel /ID# 218700

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Le Sémaphore /ID# 222954

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie - ARGILE /ID# 223792

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie- Malaussena /ID# 218703

location_facility: Centre de soin d'accompagnement et prevention en addictologie-UTTD Montpellier /ID# 218683

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie-ANPAA 21 /ID# 222909

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie-CICAT /ID# 221281

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie-Tempo Oppelia /ID# 218701

location_facility: Csapa Doaur Nevez de Ploermel /Id# 240583

location_facility: Centres de Soin d'Accompagnement et de Prevention en Addictologie -Bayonne /ID# 218673

location_facility: Centre de soin d'accompagnement et de prevention en addictologie -ITHAQUE /ID# 218678

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie-Antibes /ID# 221277

location_facility: Centre de Soins d'Accompagnement et de Prevention en Addictologie-Nova Dona /ID# 221516

location_facility: Centre de Soins Accompagnement et de Prevention en Addictologie - AGORA /ID# 223793

location_facility: Centres de Soin d'Accompagnement et de Prevention en Addictologie-Les WADS CMSEA /ID# 218671

location_facility: CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 221278

status_simplified: Ongoing


title: Qualitative Analysis Based on Medical Records of 300 Patients With Back Musculoskeletal Disorders Receiving a Physiotherapy Prescription From Primary Physicians in France

acronym: PresKi

summary:
"Prescription in France is a major act of medical activity and must be in accordance with the scientific evidence. The use of physiotherapy by primary physicians is becoming more and more frequent and involves the performance of a prescription given to the patients so that they can access to their care. The optimization of the use of this treatment is based on the respect of several legal and regulatory provisions allowing physiotherapists (PT) to offer the most appropriate treatment to the patient. Although these professionals can carry out a physiotherapy diagnosis and the objectives of care, as well as the choice of the acts and the techniques which seem to them the most appropriate. The performance of their treatment remains conditioned by the indication to physiotherapy and the anatomical region formulated by the prescription of the primary physicians. Primary physicians don't have the right to include their diagnostic hypothesis on the physiotherapy prescription. Therefore, they could transmit to the PT a supplementary report including all useful information for the PT which could influence the progress of the treatment.

It has been reported a frequent absence of diagnostic hypothesis formulated by the primary physicians to the PT to justify the indication to these treatment with the prescription. However, PT are led to formulate one or more diagnostic hypothesis following their clinical assessment. This can lead to questioning the interest of prescription for referring the patient from the primary physician to the PT.

The qualitative study by Panchout et al shows that 97.8% of the french private physiotherapists included treat patients with musculoskeletal disorders and 95.5% received those with back disorders. Back musculoskeletal disorders are the most common conditions reported from french private PT.

No French study has yet analyzed the quality of prescriptions formulated by primary physicians for private physiotherapists. Much foreign health systems have a different model of access to physiotherapy services compared to the French system, involving direct access physiotherapy for patients with musculoskeletal disorders. This care pathway gives patients the ability to refer themselves directly to a PT without having to see another health professional. Patients do not need a prescription in this model of access to physiotherapy care to use it.

Thus, in order to optimize the relevance of the use of physiotherapy for patients with back musculoskeletal disorders, we propose a prospective and cross-sectional observational study of 60 physiotherapists. The first aim of this study is to assess the relevance of the physiotherapy indication from primary care physicians for patients with back musculoskeletal disorders and consulting physiotherapists.

ReferenceType: result

ReferenceCitation: Demont A, Benaissa L, Recoque V, Desmeules F, Bourmaud A. Spinal pain patients seeking care in primary care and referred to physiotherapy: A cross-sectional study on patients characteristics, referral information and physiotherapy care offered by general practitioners and physiotherapists in France. PLoS One. 2022 Sep 6;17(9):e0274021. doi: 10.1371/journal.pone.0274021. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Assessment of the Consequences of the Abrupt Interruption of Physical and Rehabilitation Medicine Consultations During the Quarantine Period in France Between 2020 March 17th and May 11th

acronym: Handicall

summary:
Objectives This survey aims at reporting the immediate impact of the COVID-19 epidemic on outpatients followed in Physical and Rehabilitation Medicine (PRM). It focuses on the disruption of PRM healthcare services during the quarantine period in France between 2020 March 17th and May 11th and on its medical consequences.

Method This observational study was conducted in the PRM department of a French University Hospital. Outpatients whose PRM medical consultation had been cancelled were contacted by phone between April 9th, 2020 and May 7th, 2020. A structured questionnaire was fulfilled for each patient.

Demographical and medical data were recorded, including the disabling diseases motivating the PRM outpatients' follow-up. The necessity to perform an immediate phone consultation or to schedule an urgent consultation within the next 3 weeks constituted the main judgment criterion. Other recorded criteria were: the reason for this urgent need of a medical consultation, the access to other medical services during the quarantine period, the interruption of home-based rehabilitation services and its perceived consequences for the patients.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact

acronym: OTTAWAKIDS

summary:
Ankle sprain in children is a very common pathology. Currently in France, a standard X-ray is done in almost all cases. However, the literature has for several years validated the consideration of the Ottawa ankle rules in children to avoid the realization of these X-rays.

Our study is an evaluation of clinical practice. The aim is to assess the impact of the implementation of a new protocol using the Ottawa ankle rules from the age of 5. In particular, radiographic sparing and absence of diagnostic error.

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Diagnostic Test


title: Evaluation de la Mise en Place d'un Auxiliaire d'évaluation Dans la Prise en Charge de la Maladie d'Alzheimer et Des Maladies apparentées en France

acronym: AIDALZ

summary:
Context: The French Alzheimer plan 2008-2012 includes the implementation of "disease managers" or social workers, from the onset of the disease, for every patient with a diagnosis of Alzheimer disease or associated disorder. However, previous trials evaluating the efficacy of a systematic intervention for each case from the onset of the disease, including non complex cases, have shown little evidence.

Objective: To evaluate the efficacy of a social worker to prevent behavioural problem for patient with a new diagnosis of Alzheimer disease or associated disorder.

Design and setting: Multicentric cluster randomized control trial. Patients from several memory consultations and specialists (neurologist, psychiatrist or geriatrician) in France are included.

Intervention: In addition to usual care, patients in the intervention group have systematic home visits from a social worker and regular follow-ups by phone over a one-year period. This social worker informs the patient and caregiver, evaluates the needs, gives advices to prevent complications and is a link between the patient and the memory consultation or the specialist. Patient in the control group have absolutely no intervention and are followed-up as usually. In order to not modify the usual care, they have no information on their participation in this trial before the one-year evaluation.

Main outcome measure: NeuroPsychiatric Inventory (NPI) administrated at one year, which evaluates frequency, severity and repercussion of several behavioural problems. Secondary outcomes included disability, cognition, depression, health, quality of life, institutionalization, and resource use.

design_allocation: Randomized

primary_purpose: Supportive Care

lead_sponsor: Institut de Sante Publique, d'Epidemiologie et de Developpement

location_facility: ISPED (Institut de Santé Publique, d'Epidémiologie et de Développement)


intervention_type: Drug

lead_sponsor: Hoffmann-La Roche

summary: This is a multicenter, interventional, open-label, long-term extension study of Study WA28119 (NCT01791153) to evaluate the long-term safety of SC tocilizumab in participants with GCA who subsequently have flare or persisting disease activity. A maximum of 11 participants from six centers in France that participated in the WA28119 study will be enrolled. The entire study duration is anticipated to be approximately 160 weeks.

location_facility: Hopital Claude Huriez; Internal Medicine

title: An Extension Study to Evaluate Long Term Safety of Subcutaneous Tocilizumab in Patients With Giant Cell Arteritis Who Have Completed WA28119 Core Study in France, and Subsequently Having Flare or Persisting Disease Activity.

primary_purpose: Treatment

type: EudraCT Number

source: euctr


title: Sources of the Variability of the Response to Fluindione in Elderly Patients (PREPA) [Etude Des Sources de variabilité de la réponse à la Fluindione Chez Les Personnes âgées de 80 Ans et Plus (PREPA) ]

summary:
We propose to study the pharmacokinetic (PK) and pharmacodynamic (PD) components of the response to fluindione, the main oral anticoagulant used in France, in patients over 80.

We expect to gain a better understanding of the role of age, nutritional status, genetic factors and drug interactions in the variability of the response to fluindione.

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

location_facility:
CHU d'Angers
Hôpital Bichat-Claude Bernard


type: Other Identifier

title: Identification of High Risk People for Colorectal Cancer in Indre-et-Loire (France) and Evaluation of a Specific Surveillance System : a Randomized Trial Assessing the Efficacy of a Letter Encouraging People to Perform Colonoscopy Screening

acronym: ISIRECC

summary:
Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance.

The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer

The project will be divided into 2 phases:

Objectives of the first phase:

Identify high risk people for colorectal cancer in the department of Indre-et-Loire,
Fill in as completely as possible their colonoscopic history in the past 5 years,
Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years).

Objective of the second phase:

Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.

primary_purpose: Screening

lead_sponsor: University Hospital, Tours


title: Pupilometric Evaluation of Nociception in Patients With Orthopedic Impairment Under Procedural Sedation With Propofol in the Context of the Use of the ALGISCAN Device in the Vital Emergency Department in Pasteur 2 Hospital, Nice France

acronym: ALGISAP 2023

summary:
Procedural sedation involves the administration of sedative medications that allow patients to tolerate painful procedures. Procedural sedation has been formally recommended by experts from the French Society of Emergency Medicine (SFMU) since 2010 and procedural sedation using propofol in emergency departments has been recommended by the American College of Emergency Physicians in 2018.

Propofol monotherapy is now widely used in emergency medicine (EM) in France as part of procedural sedation for performing painful procedures, however propofol has no analgesic properties per se .

Pupilometry makes it possible to study the depth of analgesia by evaluating the body's nociceptive response via the ANS by studying the pupil diameter.

This technique would allow the evaluation of the analgesia level in patients sedated by PROPOFOL during the realization of painful procedures. Variations in pupil diameter during painful procedures under procedural sedation in an emergency department will be assesed in this study. Secondly, patients satisfaction following the procedure will also be evaluated by the use of the French version of the "ISAS-F", the Iowa Satisfaction with Anesthesia Scale.

study_start_date_type: Anticipated

status: Not yet recruiting


title: Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans in Ile de France: a Multidisciplinary Approach

acronym: SEINE

summary:
While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year.

The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents will be offered a detailed clinical evaluation of their child including: a clinical and neurological examination, a cognitive performance assessment, an auditory, speech and visual assessment and an evaluation of the child's progress at school.

ReferenceType: derived

ReferenceCitation: Baloche A, Jung C, Levy M, Elbez-Rubinstein A, Bechet S, Layouni I, Monguillot G, Taha MK, Cohen R, Levy C. Long-term impact of invasive meningococcal disease in children: SEINE study protocol. PLoS One. 2022 May 26;17(5):e0268536. doi: 10.1371/journal.pone.0268536. eCollection 2022.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Association Clinique Thérapeutique Infantile du val de Marne

location_facility: Centre Intercommunal de Villeneuve Saint Georges


title: Validation of a Clinical Interview for a Diagnosis of ADHD in Adults. Cross-validity of Screening Instruments ADHD in Adults. Estimation of Prevalence in France

summary:
ADHD is a neurodevelopmental disorder that affects about 5% of school-age children and 3.5% of adults worldwide. This condition is under-recognised in France and other European countries and, therefore, under-diagnosed.

As part of the European Network for Adult ADHD, the investigators translated into French a structure interview called the Diagnostic Interview for Adult ADHD (DIVA). The investigators also translated rating scales such as the ASRS and the WURS. Validation studies are rare in France.

The aim of this study is to include two groups of 50 adults whether they have or not ADHD with respect of Diagnostic and Statistical Manual - Revision 4(DSM-IV) criteria as implemented in the DIVA (i.e. actual at adulthood and past in childhood). Subjects have to fill out a booklet of questionnaires including the WHO's Adult ADHD Symptom Rating Scale (ASRS) (screening tool for actual diagnosis) and the Wender Utah Rating Scale (WURS, a screening tool for ADHD in childhood with respect of the Utah criteria). The investigator will be able to compare the actual criteria for ADHD between the ASRS and the DIVA, and the past criteria for ADHD between the WURS and the DIVA. Finally, an estimate of the prevalence of ADHD in adults will be computed.

design_allocation: Non-Randomized


title: Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia in France

summary: The aim of the research is to improve patient management by rapidly identifying, based on the terrain and clinical and biological characteristics, those patients likely to present a severe form of ARDS at risk of leading to intensive care

time_perspective: Other

location_facility: Service des Maladies Infectieuses et Tropicales


title: A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™

acronym: ORCHESTRA

summary:
Prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study.

Primary objectives: To evaluate the psychometric characteristics of reliability and construct validity of the French, Italian and Spanish versions of the PAH-SYMPACT™.

To evaluate the ability of the French, Italian and Spanish versions of the PAH SYMPACT™ to detect change.

Secondary objective: To assess the safety of macitentan in patients with pulmonary arterial hypertension (PAH).

Exploratory objective: To explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT™) in patients with PAH in France, Italy and Spain.

lead_sponsor: Actelion

location_country: Italy Spain France

location_facility: Hospital Universitario Insular Gran Canarias

location_facility: Ambulatorio Scompenso Cardiaco e Trapiant

location_facility: Centro Per La Diagnosi E La Cura Dell'Ipertensione Polmonare

location_facility: UOC Immunologia Clinica B-PGRM Centro di Riferimento per la Sclerosi Sistemica


title: Induced Motion Illusions Through Vision and Tendon Vibrations: Study of Interactions in Hemiplegic Subjects

acronym: OPTIVIBE

summary: Two movement illusion techniques can currently be used in clinical practice for motor rehabilitation after stroke hemiplegia: visual illusion (mirror therapy) and proprioceptive illusion (tendon vibration). Mirror therapy, in its computerized version (IVS3, Dessintey, Saint-Etienne, France), is based on the substitution of the deficient visual feedback by a visual feedback of a correctly realized movement. The proprioceptive illusion is based on the external application of a vibrator on muscle tendons at a frequency between 50 and 120 Hz. These two techniques are currently used independently. They are, in theory, complementary and additive. No study has described the combinatorial properties of the illusions generated by these 2 techniques in hemiplegic subjects and healthy subjects.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Non-antibiotic Primary Prevention of Low Urinary Tract Infections: Evaluation of the Knowledge and Practices of Patients in the General Practitioner's Office, Observational and Descriptive Study in the Former Auvergne Region in France.

summary:
3436/5000 Urinary tract infections are a real public health issue. The frequency of these infections in France is estimated between 6 and 8 million in primary care (1) which represents 15% of antibiotics prescribed in primary care. Approximately 40-50% of women have had at least one UTI during their lifetime. (4) There is also an ecological issue by increasing the resistance of bacteria to antibiotics. (6) (7) The goal is to assess patients' knowledge and understandings to improve primary prevention.

The secondary objective will be to identify the demographic, sociological and ethiologic factors that may influence the knowledge and behavior of patients consulting in general medicine concerning means of prevention of cystitis.

This exploratory descriptive study is carried out on the basis of an anonymous questionnaire distributed in waiting rooms of GP offices after drawing lots in the former Auvergne region with prior approval of doctors. The inclusion criterion is to be a woman aged 18 to 65, consultant in general medicine.

24 general practitioners will be drawn in proportion to the distribution by department of the former region of Auvergne.

The primary outcome measure is to assess patients' knowledge and behaviors about how to prevent cystitis from responses to questionnaire items

. The duration of the study will be 6 weeks. The questionnaire consists of a section on the characteristics of patients including age, BMI, socio-professional category, current treatments, medico-surgical antecedents of interest and the other part consisting of 16 questions. on preventative measures to avoid cystitis with simple answers divided into "did you know" and "do it yourself", two questions about ecology and two other questions about lifestyle and other preventive practices.

It will also be collected data on the selected doctors: age, location, gynecological acts associated with general medicine.

The statistical analysis will be carried out with the software Stata . All statistical tests will be carried out at the risk of error of the first kind α of 5%. Patients will be described according to the variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and treatments. These analyzes will be complemented by the usual statistical tests, for example Chi2 test or Fisher-exact test for the comparison of categorical and anova variables or Kruskal-Wallis test if necessary for the quantitative variables. It seems difficult to propose for this exploratory observational study an estimate of the number of necessary subjects sufficiently robust and relevant. Nevertheless, it has been agreed to include at least 800 patients to establish possible specific profiles associated with patient knowledge and behavior The protocol, the information and consent form and the questionnaire were submitted for opinion to the Protection to Persons Committee.

ReferenceType: background

ReferenceCitation: Francois M, Hanslik T, Dervaux B, Le Strat Y, Souty C, Vaux S, Maugat S, Rondet C, Sarazin M, Heym B, Coignard B, Rossignol L. The economic burden of urinary tract infections in women visiting general practices in France: a cross-sectional survey. BMC Health Serv Res. 2016 Aug 9;16(a):365. doi: 10.1186/s12913-016-1620-2.

ReferenceCitation: Kunin CM. Urinary tract infections in females. Clin Infect Dis. 1994 Jan;18(1):1-10; quiz 11-2. doi: 10.1093/clinids/18.1.1. No abstract available.

ReferenceCitation: Arpin C, Quentin C, Grobost F, Cambau E, Robert J, Dubois V, Coulange L, Andre C; Scientific Committee of ONERBA. Nationwide survey of extended-spectrum beta-lactamase-producing Enterobacteriaceae in the French community setting. J Antimicrob Chemother. 2009 Jun;63(6):1205-14. doi: 10.1093/jac/dkp108. Epub 2009 Mar 28.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Clinical Presentation and Incidence of SARS-CoV-2 Infection in Different Cohorts of Solid Organ Transplant Patients and Follow-up in France

acronym: TX-COVID

summary: Patients with comorbid condition are known to be at high risk of severe forms of Covid-19. It is highly probable that immunocompromised patients like solid organ transplant (SOT) recipients are also at risk of severe forms of Covid-19. For this purpose, The investigators conducted a nationwide multicentric and multiorgan Registry to collect data about all French SOT recipients who develop a SARS-CoV-2 infection. The aim is to describe the clinical, biological and virological characteristics of these patients and to give information about evolution and prognosis of these particular population

ReferenceCitation: Gerard AO, Barbosa S, Anglicheau D, Couzi L, Hazzan M, Thaunat O, Blancho G, Caillard S, Sicard A; French SOT COVID Registry. Association Between Maintenance Immunosuppressive Regimens and COVID-19 Mortality in Kidney Transplant Recipients. Transplantation. 2022 Oct 1;106(10):2063-2067. doi: 10.1097/TP.0000000000004254. Epub 2022 Jul 27.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

location_facility: Service de Néphrologie et Transplantation


title: Assessment of Problematic Use of Benzodiazepines and Z Drugs in the Elderly in France: a Public Health Issue

summary: The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and zopiclone) usage in an outpatient population of chronic users over 65 years in France using a questionnaire assessing substance dependence according to DSM-IV (Diagnostic and Statistical Manual of mental disorders) international standards.

ReferenceCitation: Victorri-Vigneau C, Laforgue EJ, Grall-Bronnec M, Guillou-Landreat M, Rousselet M, Guerlais M; FAN-Network; Feuillet F, Jolliet P. Are Seniors Dependent on Benzodiazepines? A National Clinical Survey of Substance Use Disorder. Clin Pharmacol Ther. 2021 Feb;109(2):528-535. doi: 10.1002/cpt.2025. Epub 2020 Sep 23.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

lead_sponsor: Nantes University Hospital

location_facility:
CEIP Marseille
CEIP Caen
CEIP Toulouse
CEIP Bordeaux
CEIP Lyon
CEIP Grenoble
CEIP Nancy
CEIP Paris
CEIP Lille
CEIP Montpellier
CEIP Nantes


title: Obesity as a Risk Factor for Mortality of Critically Ill Patients With Coronavirus Disease 2019 (COVID-19): a Cohort Study of the First Wave in Nancy, France

acronym: COV-OB-ICU

summary:
Disproportionate impact of COVID-19 in patients with obesity is now well established.

Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19.

The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.

location_facility: Centre hospitalo-universitaire régional de Nancy


title: Potential Interest of Combined Fluorocholine Positron Emission Tomography and Magnetic Resonance Imaging (FCH-PET/MRI) for the Selection of Patients Proposed for Curative Treatment of a Hepatocellular Carcinoma

acronym: TOMIC

summary:
Hepatocellular carcinoma (HCC) is the fifth most common cancer in terms of incidence and the second in terms of mortality. At an early stage, which is based on a low number and size of liver nodules and the absence of extra-hepatic locations (Milan criteria), a curative treatment can be performed, i.e. liver transplantation, surgical resection, or thermo-ablation. These treatments can lead to severe complications, so patients benefiting from them must be carefully selected. The correct identification of all HCC lesions at the time of the therapeutic decision is crucial. MRI is the reference examination for diagnosis but its field of exploration is limited to the upper abdominal area and its sensitivity decreases for nodules of less than two centimetres. Such lesions could actually be HCC that will cause early post-operative progression.

Positron Emission Tomography (PET; functional imaging) with fluorodeoxyglucose can provide prognostic information but impacts initial staging in less than 5% of cases. However, PET with fluorocholine (FCH), available in France since 2010, could detect intra- and extra-hepatic HCC lesions not identified by conventional imaging, potentially impacting patient management (e.g. 52% of patients in a small case study).

FCH-PET/MRI could therefore be the ideal examination for the initial staging of HCC, combining in a single multimodality investigation the reference morphological imaging technique and an efficient functional one. The hypothesis of this study is that FCH-PET/MRI is able to detect, in patients eligible for curative treatment, additional preoperative intra- and extra-hepatic early or metastatic HCC unseen or equivocal with conventional imaging (CT and MRI) and responsible for recurrence or disease progression at 6 months.

lead_sponsor: Hospices Civils de Lyon

location_facility: HCL, Hôpital de la Croix-Rousse, service d'Hépato-gastro-entérologie

location_facility: CHU de Grenoble, Servide d'Hépato-gastro-entérologie

location_facility: Hospices Civils de Lyon, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie

location_facility: HCL, Hôpital Edouard Herriot, service d'hépato-gastro-entérologie


title: Evaluation of the Benefit/Risk Ratio of Restarting or Avoiding Antiplatelet Drugs in Patients Who Had a Spontaneous Intracerebral Hemorrhage While Treated With Antithrombotic Drugs : RESTART-FR Study

acronym: RESTART-Fr

summary:
RESTART- fr is a randomised controlled trial for adults surviving spontaneous intracerebral haemorrhage who had taken an antithrombotic drug (i.e. anticoagulant or antiplatelet medication) for the prevention of vaso-occlusive disease before the ICH.

RESTART- fr is testing whether a policy of starting antiplatelet drugs (one or more of aspirin, clopidogrel, or dipyridamole, chosen at investigator's discretion) results in a beneficial net reduction of all serious vascular events over two years compared with a policy of avoiding antiplatelet drugs.

primary_purpose: Prevention

ReferenceCitation: Cheng X, Dong Q. Towards individualised secondary prevention after intracerebral haemorrhage. Lancet Neurol. 2021 Jun;20(6):411-413. doi: 10.1016/S1474-4422(21)00130-7. No abstract available.

publisher_dissemination: Elsevier

ipd_sharing: Yes

ipd_sharing_description: we plan to make IPD analysis with sister trial: RESTART UK

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Région Hauts de France, France
Ministry of Health, France


title: Fertility and Temporality in Pediatric Oncology

acronym: FERTITOP

summary:
Background: When a cancer is diagnosed in a child, the urgency is to take therapeutic actions. Children and their families face the reality of cancer and the reality of the treatments that, in addition to be overwhelming, might cause infertility. Immediately after the diagnosis, a fertility preservation consultation is proposed to discuss fertility preservation options. In practice, it is often difficult to organize.

Several years after the end of treatments, a second information consultation is proposed to inform about fertility, evaluate the fertility status and propose a second line of Fertility Preservation when possible. The literature reflects a lack of knowledge regarding the degree of fertility-related distress among pediatric cancer patients as well as insufficient tools at the disposal of medical doctors and nurses to discuss about reproduction with children and young adolescents.

Project objective: Understand how young cancer patients and their parents felt about sterility risk at the diagnostic time and now as cured adolescents.

Patients & Methods:

300 patients (15-25 years) from 5 different centers (20 patients per year and per center for 3 years) will be included in this study at the information consultation. They will be surveyed through self-administered questionnaires and semidirected interviews that will 1) retrieve perceptions and emotional being of children during the fertility preservation consultation; 2) assess the decision-making process of parents and family since the fertility preservation consultation through the patient's speech; 3) interview the patients about personal history and experience of cancer and consequences of potential fertility impairment and 4) survey the current experience and projections in the future and evaluate their reaction to the proposition of a second line of Fertility Preservation.

Expected results: what points should the doctor / psychologist discuss with pediatric cancer survivors in response to their fertility stress? and how to do it? for better initial and follow-up care to improve their quality of life after cancer.

sponsor_collaborators:
Central Hospital, Nancy, France
National Cancer Institute, France

location_facility:
University Hospital of Dijon
University Hospital of Besançon
University hospital of Strasbourg
University hospital of Reims
University Hospital of Nancy, France


title: Surveillance of Nosocomial Influenza at Edouard Herriot University Hospital, Lyon, France.

acronym: NOSOGRIPPE

summary:
Hospital-acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Furthermore, it is also associated with a large economic impact for the hospitals.

The transmission of influenza has been mostly reported in pediatric and long-stay units. The chains of transmission of influenza in acute-stay units have to be describe in order to prevent and control potential outbreaks. Furthermore, to know clinical symptoms seems to be important in order to identify potential sources of virus as soon as possible and to set up appropriate hygiene prevention measures. Moreover, the definition of the hospital-acquired influenza has to be harmonized for all over the studies, especially concerning the delay between the admission in the hospital and the symptoms onset.

The aim of this study is to describe the hospital-acquired influenza in a french university hospital of around 800 beds

location_facility: Infection Control unit. Edouard Herriot hospital Lyon - France


title: PITUItary Carcinomas or Aggressive Tumors REgistry: Monocentric Study Form a Cohort of Patient Operated on for Pituitary Tumors in University Hospital of Lyon (France)

acronym: PITUICARE-Lyon

summary: The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity through computerized collection of comprehensive demographic, therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions of all types.

ReferenceCitation: Raverot G, Dantony E, Beauvy J, Vasiljevic A, Mikolasek S, Borson-Chazot F, Jouanneau E, Roy P, Trouillas J. Risk of Recurrence in Pituitary Neuroendocrine Tumors: A Prospective Study Using a Five-Tiered Classification. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3368-3374. doi: 10.1210/jc.2017-00773.

oa_host_type: publisher

publisher_dissemination: The Endocrine Society

location_facility: Groupement Hospitalier Est, Lyon, France


type: Registry Identifier

title: Does a Systematic Phone-call by a Medical Student/General Practitioner Team in Patients Suffering From a Chronic Condition During the COVID-19 Containment Period Impact One-month Hospitalization's Rate in France? A Cluster Randomized Trial

acronym: COVIQuest

summary:
Following the announcement of the containment of the population due to the COVID-19 epidemic on March 17, 2020 in France, a notable decrease in the number of consultations in general practice was reported. Patients no longer contact their general practitioner, including those with regular follow-up for one or more chronic conditions. This observation raised worries since it could lead to delay or failure in detecting decompensations / complications of these chronic conditions by a lack of recourse to care. Thus, an urgent message from the National Health Department (Direction Générale de la Santé - DGS) was adressed on April 8, 2020 to the health professionals regarding the organization of care aside from COVID-19. The main recommendation was "that the personal physician or the corresponding specialist should contact the most fragile patients with chronic condition to ensure follow-up and detect any risk of decompensation ".

Such fragile patients are in great numbers, up to more than 200 for an average general practitioner. Therefore, although this recommendation is regarded as "essential in view of the health needs of the population", it will prove quite difficult to follow without the help of a skilled external assistance that can be quickly mobilized.

primary_purpose: Health Services Research

ReferenceCitation: Dibao-Dina C, Leger J, Ettori-Ajasse I, Boivin E, Chambe J, Abou-Mrad-Fricquegnon K, Sun S, Jego M, Motte B, Chiron B, Sidorkiewicz S, Khau CA, Bouchez T, Ghali M, Bruel S, Lebeau JP, Camus V, El-Hage W, Angoulvant D, Caille A, Guillon-Grammatico L, Laurent E, Saint-Lary O, Boussageon R, Pouchain D, Giraudeau B; COVIQuest group. Impact of a phone call with a medical student/general practitioner team on morbidity of chronic patients during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial. BMJ Open. 2022 Jul 28;12(7):e059464. doi: 10.1136/bmjopen-2021-059464.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

ipd_sharing_description: One-month-data can be shared, whereas 6-month data are not legally sharable (electronic health records).

sponsor_collaborators:
University Hospital, Tours
INSERM CIC-P 1415


title: Surveillance of the Cohort of Patients Overexposed in a Course of Conformational Radiotherapy for a Prostate Adenocarcinoma in Jean MONNET Hospital, Epinal, France. Epinal: Patients Overexposed for a Prostate Adenocarcinoma

acronym: EPOPA

summary:
Background:

Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among them, twenty four patients received an additional mean dose about 20%, due to an inappropriate use of the treatment planning system. Severe adverse events (proctitis, cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We propose to develop several research programs in order to increase the scientific knowledge on iatrogenic effects related to overexposure of ionizing radiation, by studying their relationship with dosimetric, clinical, biologic and genetic characteristics.

Aim of the study:

To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.

Primary study endpoint:

Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT and CTCAE scales).

ReferenceCitation: Alsbeih G, El-Sebaie M, Al-Harbi N, Al-Buhairi M, Al-Hadyan K, Al-Rajhi N. Radiosensitivity of human fibroblasts is associated with amino acid substitution variants in susceptible genes and correlates with the number of risk alleles. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):229-35. doi: 10.1016/j.ijrobp.2006.12.050. Epub 2007 Feb 27.


title: The Role of CARdiovascular biOmarkers (NT-pro-BNP and CD146) in Predicting Lung Edema in Severely Burned Patients

acronym: CAROLE

summary:
Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema.

The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia .

Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.

lead_sponsor: Saint-Louis Hospital, Paris, France


title: Sarcopenia Mechanism and Therapeutic

acronym: SAMANTHA

summary: Sarcopenia is a loss of muscle mass and function that develops during aging. But sarcopenia is also observed in several other conditions: chronic diseases, cancers, viral infections, renal / respiratory insufficiency, immobility, obesity with low physical activity. This sarcopenia is named secondary sarcopenia to distinguish it from the age-associated primary sarcopenia. During prolonged hospitalizations in intensive care, a significant loss of muscular mass and function is also observed. This acute sarcopenia or Intensive Care Unit-Acquired Weakness (ICU-AW) may persist for several months after discharge from hospital. In addition to the loss of autonomy, the reduction of muscle mass has important metabolic implications, ranging from insulin resistance to modification of myokines production. Sarcopenia greatly increases the morbidity and mortality of patients regardless of its cause. The aim of our project is to identify the molecular mechanisms implicated in sarcopenia from different origin. We will particularly focus our work on the metabolic properties, the proliferation/ differentiation and regeneration capacities of the satellite cells (adult muscle stem cells). These satellite cells will be purified from quadriceps biopsies of human volunteers recruited at CHU Montpellier. These satellite cells will also be used to test the ability of some wild aromatic plants from south of France to improve cell survival and differentiation. This will allow us to identify the molecular mechanisms involved in sarcopenia development and identify potential therapeutic molecules.

status: Withdrawn

collaborators: INSERM U1046 CNRS UMR 9214, Montpellier University


title: Trisomy 21 in Adulthood. Evaluation of Health and Social State in Alsace (North-eastern France)

summary: Trisomy 21 or Down syndrome, is the most common genetic cause of cognitive disability. Currently, in Alsace, the birth prevalence is about 1 in 1600 live births, which means 10 liveborns with Down syndrome each year.If screening and prenatal diagnosis of children with trisomy 21, as well as medical care, social and educational integration in childhood was the subject of much research and has led to remarkable progress in terms of health and medical care, it is not the same for the knowledge about adolescents and adults.Despite a more and more higher life expectancy, the evolution of trisomy 21 in adulthood is often marked by a deterioration in health status, with a regression of acquired psychomotor skills, often attributed only to the precocious occurrence of Alzheimer's dementia. Nevertheless, it seems that the diagnosis of Alzheimer's dementia is often overdiagnosed, and it is well established that only a fraction of Down syndrome patients will develop this type of dementia. Too often a decline in general health, behavioral changes and decreased cognitive abilities are only attributed to the Down syndrome with an early dementia without looking for an underlying, potentially curable, disease.This study aims to better evaluate the health and social status of 100 adults with trisomy 21 in Alsace. The medical evaluation will include a comprehensive assessment of health status and quality of life conducted by the geneticist, a cardiac, sensory, hormonal, biological and radiological evaluation. A speech-language and psychomotor evaluation will also be conducted. A psychiatric consultation and a psychometric assessment will aim to assess cognitive function and to search for associated mood disorders.The expected results are to better know the natural history of trisomy 21 in adulthood, with the determination of the frequency of morbid events specific to adulthood, and also to improve the medical and paramedical care with the establishment of a monitoring program to prevent the occurrence of these morbid events.

ReferenceCitation: Dieudonne Y, Uring-Lambert B, Jeljeli MM, Gies V, Alembik Y, Korganow AS, Guffroy A. Immune Defect in Adults With Down Syndrome: Insights Into a Complex Issue. Front Immunol. 2020 May 8;11:840. doi: 10.3389/fimmu.2020.00840. eCollection 2020.

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

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

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

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repositories:
HAL
PubMed Central
univOAK

repositories_concat: HAL;PubMed Central;univOAK

publisher_dissemination: Frontiers

ReferenceCitation: Guffroy A, Dieudonne Y, Uring-Lambert B, Goetz J, Alembik Y, Korganow AS. Infection risk among adults with down syndrome: a two group series of 101 patients in a tertiary center. Orphanet J Rare Dis. 2019 Jan 11;14(1):15. doi: 10.1186/s13023-018-0989-x.

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Strasbourg, France


title: Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk

acronym: DHARMA

summary: Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.

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

location_facility: Service de Médecine néonatale, Hôpital de la Conception

intervention_type: Dietary Supplement


acronym: PTA Avalglucosidase

lead_sponsor: Genzyme, a Sanofi Company

summary:
This long-term open label safety and efficacy study is intended to follow up, and to provide post-trial access to enzyme replacement therapy (ERT) with avalglucosidase alfa to patients with Pompe disease in France who have completed Study EFC14028, LTS13769, or ACT14132, from market authorization until reimbursement of avalglucosidase alfa in France or until December 2024, whichever comes first.

- Study visit frequency: every 2 weeks

location_facility:
Investigational Site Number :2500002
Investigational Site Number :2500010
Investigational Site Number :2500001
Investigational Site Number :2500008
Investigational Site Number :2500006
Investigational Site Number :2500009
Investigational Site Number :2500011
Investigational Site Number :2500003
Investigational Site Number :2500005
Investigational Site Number :2500007

status: Active, not recruiting

title: A French Multicenter Open Label Phase 4 Extension Study of Long-term Safety and Efficacy in Patients With Pompe Disease Who Previously Participated in Avalglucosidase Alfa Development Studies in France

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org


title: Impact of the Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown on the Risk of Multiple Sclerosis Clinical Relapse or Clinical Worsening

acronym: CONFISEP

summary:
Multiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system, affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but previous studies highlighted that relapse rate increased during influenzae epidemics, and air pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and restrictive measures taken to limit contaminations have drastically decreased air pollution and seasonal viral infections exposure, but sanitary crisis also limited care access for MS patients (medical treatment, rehabilitation). Therefore, this particular period offers a unique opportunity to evaluate the impact of air pollution, viral infections, and health care access on the severity of MS.

The main objective is to evaluate the impact of air pollution and seasonal viral infections on the risk of MS relapse, using the year 2020 as a quasi-experimental model. The secondary objective will be to evaluate the impact of health care access limitations on the risk of neurological disability accumulation.

This study will include 1500 MS patients, living in Ile de France, followed in the neurological department of "Pitié-Salpêtrière" Hospital. This is a retrospective observational study nested in OFSEP registry (French Multiple Sclerosis Observatory), which is a prospective cohort of MS patients in France. Air pollution data will come from AIRPARIF, and viral infections data will come from "Santé Publique France".

A better knowledge of the impact of air pollution, viral infections, and health care access on the course of MS will enable to better guide information to patients and public health care decisions.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Neurology Department, Hopital de la Pitié Salpêtrière


title: Association Between Infant Colics and Parental Migraine ? Non Interventional Study in the Pediatric Emergency Unit of Nancy (France) University Hospital

acronym: COLIGRAINE

summary: According to recent studies, we want to find evidences that infant colics could be a episodic symptom associated to migraine as cyclic vomiting syndrome or abdominal migraine are. The main purpose is to compare the presence of colics in infants between 60 days and 180 days of life and the presence of migraine in their parents to determine if colicky children's parents are more migrainous than other parents.


title: Prevalence of Tick-borne Encephalitis (TBE) in the Pediatric Population Treated at the University Hospitals of Strasbourg (HUS) and Characterization of Confirmed Pediatric Cases

acronym: TBE-KID

summary:
Tick-borne encephalitis (TBE) is a zoonosis mainly transmitted to humans by the bite of ticks of the genus Ixodes and, to a lesser extent, by the consumption of contaminated and unpasteurized dairy products. During the last decade, the epidemiology of this arbovirosis has changed profoundly with the discovery of new human cases and/or new areas of circulation of tick-borne encephalitis virus (TBEV) throughout Europe and particularly in France. Historically, Alsace is the main endemic area for this pathology in France. The pathology is notifiable since June 2021 in France.

Although TBEV infection in children seems to lead to a milder clinical presentation, data are much less abundant than in adults and only a few cases reported in infants under 1 year old have been published. Data from the most recent ECDC Annual Epidemiological Report on TBE (2019) showed incidence rates of approximately 0.2 and 0.5 per 100,000 population in patients younger than 5 and 15 years, respectively.

However, several observations may moderate and challenge both the low incidence rate and the less severe clinical presentation reported in children

location_facility: Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France


title: Assessment of Cardiac Autonomic Function in Adulthood After Chemotherapy or Radiotherapy in Childhood. Ancillary Study of the "Long-term Follow-up of Childhood Cancer Survivors in the Rhône-Alpes and Auvergne Regions of France" Study

acronym: SALTO-SNA

summary:
The SALTO-SNA study is an ancillary study of the SALTO study (Suivi À Long Terme en Oncologie des enfants guéris d'un cancer pédiatrique en régions Rhône-Alpes et Auvergne) coordinated by Dr. Claire Berger, pediatric oncologist at the CHU, Saint Etienne. It aims at re-examining, in their initial treatment center, all patients (a cohort of 495 patients alive in 2011), diagnosed between 1987 and 1992, and cured of childhood cancer (except leukemia) in the Rhône-Alpes and Auvergne regions.

The rationale for this study is based on the observation that although the survival rate of childhood cancers has now reached 75%, complications of chemotherapy and radiotherapy are high and greatly increase the risk of mortality in later years (estimated to be 14% in the literature).

The morbidity risk of chemotherapy and radiotherapy can be quantified by assessing the activity of the intrinsic cardiac autonomic regulation, which represents a powerful predictor of cardiovascular morbidity to the individual.

sponsor_collaborators: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
IHOP
CHU de Clermont-Ferrand
CHU de Saint-Etienne
CHU de Grenoble


title: SARS-COV-2 Infection Among Hospital Staff: Study of Professional and Individual Factors of Covi-19 and Impact on Return to Work

summary: Started on January 9, 2020 with the announcement of the discovery of a new SARS-CoV-2 coronavirus, the Covid-19 pandemic is responsible as of June 21, 2020 for 160,377 confirmed cases in France, 29,640 deaths and 9,823 hospitalizations. The Grand Est region is one of the regions in France that was most precociously and strongly affected by the epidemic, in particular the Strasbourg University Hospital. Faced with the heavy use of the healthcare system, hospital staff of all categories are an essential resource to be preserved. Several studies have shown the significant impact of Covid-19 on doctors and caregivers. In order to better protect these personnel and avoid contamination that could be harmful to their health but also because of the consequences in terms of staff, it is necessary to better understand the risk factors for transmission of this infection, the means of protection, the evolution of the disease and the determinants of the return to work. Few studies have explored on such a large workforce and in detail the professional risk factors for developing Covid-19 within different groups of hospital professionals including also non-caregivers and the evolution when returning to work in an outpatient population.

location_facility: Service de Pathologie Professionnelle et Médecine du Travail - CHU de Strasbourg - France


title: REgistry of CrossBoss and Hybrid Procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom

acronym: RECHARGE

summary:
The successful re-opening of a blocked coronary artery has a beneficial effect on the further clinical course (e.g. improvement of clinical symptoms, improved quality of life, increased heart function, etc.). However, some types of blockages are more difficult to open by means of percutaneous coronary intervention (PCI), a procedure which is commonly used for these kind of problems. This procedure makes use of a technique in which special wires, balloons, stents (metal or polymeric tube-like structures) and devices are utilized to re-open or revascularize a blockage in one of the blood vessels of the heart. This type of blockages are chronic total occlusions (CTO). CTOs have certain characteristics which impede the revascularization of the blood vessel.

Nevertheless, remarkable progress has been achieved over the past few years in the area of CTO revascularization or CTO PCI. A large range of CTO dedicated materials, such as guidewires, guiding catheters, devices, balloons and stents, as well as different techniques have been developed. However, at present, reluctance to open CTOs still exists, due to the indications and outcomes of percutaneous revascularization as well as the technical difficulties which commonly arise during these interventional procedures. The presence of these difficulties results in suboptimal success rates worldwide (±70-80%), despite these many innovations.

To increase these success rates and to make sure more interventional cardiologists will treat CTOs, a hybrid treatment algorithm has been developed with the materials (e.g. CrossBoss™ catheter; Bridgepoint Medical, Inc.) and techniques, currently already available. The main purpose of this study is to evaluate the efficacy and efficiency of this hybrid algorithm as well as validating the efficacy of one of the materials (CrossBoss™ catheter), used in this algorithm. To be able to do this, data concerning the patients' demographics, CTO characteristics, procedure and outcome will be collected in the form of a registry. This registry will be performed in several European centra (Belgium, the Netherlands, United Kingdom, France). Since the study will only collect data and no intervention is performed, this will be an observational study. At regular time points, the data will be checked for errors or inconsistencies. To do this, site visits will be performed at pre-defined times.

ReferenceCitation: Maeremans J, Dens J, Spratt JC, Bagnall AJ, Stuijfzand W, Nap A, Agostoni P, Wilson W, Hanratty CG, Wilson S, Faurie B, Avran A, Bressollette E, Egred M, Knaapen P, Walsh S; RECHARGE Investigators. Antegrade Dissection and Reentry as Part of the Hybrid Chronic Total Occlusion Revascularization Strategy: A Subanalysis of the RECHARGE Registry (Registry of CrossBoss and Hybrid Procedures in France, the Netherlands, Belgium and United Kingdom). Circ Cardiovasc Interv. 2017 Jun;10(6):e004791. doi: 10.1161/CIRCINTERVENTIONS.116.004791.

evidence: open (via free pdf)

repository_institution: UHasselt - Document Server@UHasselt

lead_sponsor: Hasselt University

location_country:
United Kingdom
Netherlands
Belgium
France

location_facility: Universitair Medisch Centrum Utrecht (UMCU)


title: Survey on the Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis Followed in Cystic Fibrosis (CF) Center in France

summary:
Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. Despite this, vaccination coverage against HPV remains low in France. A proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. Particular attention to vaccination should therefore be included in this population.

Objectives of the study The main objective of the study is to estimate the frequency of HPV vaccination in young girls with CF over 9 years and followed in a pediatric CF center.

The secondary objectives are to know:

The type of vaccine used (bivalent / quadrivalent / nonavalent)
The proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses)
Reasons for non-use of vaccination

Study design The study will last 12 months. It is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire.

Population

young girls aged 9 years or older with Cystic fibrosis
Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
With parents who did not object to participation in the study

Number of subject: 62 patients

Expected results

Knowledge of HPV vaccination coverage in young girls with CF.
Sensitization of patients, their parents and health professionals to HPV vaccination. Understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.

location_facility: Centre de Ressources et de Compétences de la Mucoviscidose Adultes


title: Mucopolysaccharidosis Patients in France in the Era of Specific Therapeutics

summary: The goal of this observational study is to characterize the epidemiology and natural history of MPS diseases by building a retrospective and prospective collection of extensive phenotypic data from French MPS patients.

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

location_facility: Hôpital des Enfants - Groupe Hospitalier Pellegrin

location_facility: Centre Hospitalier Universitaire d'Angers


title: Séroprévalence Des IgG dirigés Contre le SARS-CoV-2 Chez Les Professionnels de santé en Soins Primaires et Leurs Contacts au Sein Des ménages

acronym: COVID-SeroPRIM

summary:
Many uncertainties remain regarding the epidemiological and clinical characteristics of COVID-19, including the number of people exposed to the disease, the persistence of the humoral response and its associated neutralisation capacity in recovered patients, and the long-term health consequences of the infection. The French national COVID-SeroPRIM survey aims to estimate the seroprevalence of IgG antibodies to SARS-CoV-2 in four populations of primary care health professionals: primary care physicians (general practitioners and paediatricians), health professionals working in city pharmacies (pharmacists and compounders) and in dental practices (dentists and dental assistants). Indeed, the majority of published studies target healthcare professionals in hospitals. It is therefore essential to provide new knowledge on the exposure of primary care workers to the virus in order to assess the impact of the pandemic, the level of immunity and the risk factors for exposure to the virus. These data will be very useful for public health decision makers to better adapt health protocols and provide useful information to better guide future vaccination campaigns. Assuming that vaccination against COVID-19 will start in January 2021, data on the vaccination rate of health professionals and their households will also be collected and made available to policy makers in a timely manner. This study will be conducted in collaboration with four primary care research and/or monitoring networks: the Sentinelles network (general practitioners), the Association de Formation Professionnelle en Pédiatrie (Association for Professional Training in Paediatrics), IQVIA (general practitioners and pharmacies), and the Réseau de Recherche Clinique en Odontologie Libérale (ReCOL, dental surgeons) Seroprevalence will be estimated using a high-sensitivity ELISA designed to detect SARS-CoV-2 specific IgG antibodies in humoral fluid and a high-specificity seroneutralisation test to assess seropositivity (i.e. excluding false positive ELISA results due to cross-reactivity with other coronaviruses) and to assess SARS-CoV-2 neutralising antibody levels. These techniques have already been used in two general population cohort studies (SAPRIS-SERO and EpiCoV) with the objective of describing SARS-CoV-2 seroprevalence and risk factors. The secondary objectives of the COVID-SeroPRIM study will be to assess the seroprevalence of IgG antibodies to SARS-CoV-2 in household contacts of health care workers, to identify risk factors for seropositivity to SARS-CoV-2, and to retrospectively describe the symptoms experienced by individuals diagnosed with COVID-19. Due to the use of the same methodology to assess seroprevalence, these results will be broadly complementary and comparable to those of seroepidemiological studies conducted in the general population, such as EpiCOV and SAPRIS-SERO. These surveys (EpiCOV, SAPRIS-SERO and COVID-SeroPRIM) as a whole are based on similar questionnaires and identical serological methods and will provide many health indicators such as the proportion of people who presented symptoms, who consulted for a suspicion of COVID-19, who were screened but also who did not seek care in the recent period. The COVID-SeroPRIM study, by targeting primary care health professionals and their households, will provide data to reinforce the knowledge from SAPRIS-SERO and EpiCOV and to better understand the dynamics of the epidemic in these four populations in order to guide public policy makers.

This project has received funding from the French National Research Agency (ANR) as part of the COVID-19 call for research projects, which aims to support urgent and rapid projects whose results could be implemented in society in the coming months.

Main objective To estimate the seroprevalence of IgG antibodies to SARS-CoV-2 in four distinct populations of primary care health professionals (general practitioners, paediatricians, health professionals practising in city pharmacies and dental practices) in metropolitan France.

primary_purpose: Other

location_facility: Institut Pierre Louis Epidemiologie Et Sante Publique


title: Study of Memory Problems Perceptions With the French Adaptation of the Illness Perception Questionnaire Memory, Among Patients Who Come for the First Time at a Memory Center Until Diagnosis Disclosure Post-visit

acronym: REMAD

summary: This study aims to prospectively examine the memory problem perceptions of patients with memory complaints [MCs] and their accompaniers during the diagnostic process.

lead_sponsor: Central Hospital, Nancy, France

collaborators: Laboratoire APEMAC :Maladies chroniques, santé perçue, processus d adaptation, France

location_facility: University Hospital of Nancy ,CHU Brabois, France


title: Prospective, Multicenter, Non-Controlled, Non-Randomized, Open-Label Study To Evaluate The Efficacy And Performance Of The Mpact® Dual Mobility Hemispheric Cup

summary:
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.

The primary endpoint is the 10-year life span of the prosthesis according to the Kaplan Meier curve.

lead_sponsor: Medacta International SA

location_facility: Centre Orthopédique Médico-Chirurgical de Dracy Le Fort


title: Evaluation of Deaf Men's Knowledge About Sexual Health, in Nancy's CHRU

summary:
Evaluation of Deaf men's knowledge about sexual health in Nancy, France. The study consists of interviews with voluntary deaf men from Nancy, France, in order to assess their knowledge about sexual health, and determine if there is a lack of sexual health awareness.

If there is indeed a lack of information about sexual health, the study aims at finding ways of improving the situation, and see how the deaf men would like to have this information delivered to them.


title: Prophylaxis and On-demand Treatment for Persons With Haemophilia and Other Coagulation Deficiencies: a Comparison of Perceived and Observed Accessibility in the Auvergne-Rhône-Alpes Region (France)

acronym: PHAREO

summary: The current treatment of people with haemophilia and other bleeding deficiencies is largely based on clotting factor replacement therapy. The injections can be repeated several times a week according to a personalized schedule. To date, medications are exclusively dispensed in hospital pharmacies to ensure traceability and safety. This retrocession imposes accessibility constraints on patients and on their caregivers, increasing the burden of the disease, particularly in the organization of personal and professional daily life. The PHAREO study aims to investigate patients' perception of accessibility to anti-haemophilia drugs in relation to an evaluation of spatial accessibility in the Auvergne-Rhône-Alpes region (France) in order to consider, if necessary, ways of improving the pathway for patients and their caregivers.

ReferenceCitation: Leroy V, Freyssenge J, Renard F, Tazarourte K, Negrier C, Chamouard V. Access to treatment among persons with hemophilia: A spatial analysis assessment in the Rhone-Alpes region, France. J Am Pharm Assoc (2003). 2019 Nov-Dec;59(6):797-803. doi: 10.1016/j.japh.2019.07.006. Epub 2019 Aug 9.

ReferenceCitation: Susen S, Gruel Y, Godier A, Harroche A, Chambost H, Lasne D, Rauch A, Roullet S, Fontana P, Goudemand J, de Maistre E, Chamouard V, Wibaut B, Albaladejo P, Negrier C. Management of bleeding and invasive procedures in haemophilia A patients with inhibitor treated with emicizumab (Hemlibra(R) ): Proposals from the French network on inherited bleeding disorders (MHEMO), the French Reference Centre on Haemophilia, in collaboration with the French Working Group on Perioperative Haemostasis (GIHP). Haemophilia. 2019 Sep;25(5):731-737. doi: 10.1111/hae.13817. Epub 2019 Jul 11.

ipd_sharing_description: Patient information is held under legal and ethical obligations of confidentiality. As the disease is rare, information should not be used or disclosed in a form that might identify a patient without his or her consent.

lead_sponsor: RESCUe - RESeau Cardiologie Urgence / RESUVal - RESeau des Urgences de la vallée du Rhône

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Hôpital Edouard herriot, Hospices Civils de Lyon

location_facility: Hôpital Nord Ouest de Villefranche-sur-Saône

location_facility: Pharmacie Centrale, Hospices Civils de Lyon

location_facility: Centre Hospitalier Intercommunal Sud-Léman Valserine

location_facility: Centre Hospitalier Henri Mondor d'Aurillac

location_facility: Centre Hospitalier Universitaire Grenoble - Alpes

location_facility: Centre Hospitalier de Chambéry - Hôpital Savoie

location_facility: Centre Hospitalier Uuniversitaire Nord, Saint-Étienne

location_facility: Centre Hospitalier d'Ardèche Méridionale

location_facility: Groupement Hospitalier Est, Hospices Civils de Lyon

location_facility: Hôpital de la Croix-Rousse, Hospices Civils de Lyon


title: Retrospective Study of Pediatric Patients With Covid-19 in Alsace in 2020-2021

acronym: Pedia-Cov

summary:
Covid-19 is an illness that appeared in China between the end of December 2019 and the beginning of 2020 after several cases of pneumonia of undetermined etiology were reported in the Hubei province in central China. These are caused by a previously unknown coronavirus, initially named 2019-nCoV then SARS-CoV-2, which was identified on January 7, 2020 in the Bronchoalveolar Lavage (BAL) of patients hospitalized in China. As for the first European cases, they were diagnosed in France on January 24, 2020.

A Chinese study published in April 2020 (4) concerning adult patients showed that 14% of these cases could be defined as severe and that 5% of cases could be defined as critical.

Another Chinese study showed that all children, regardless of age, could be infected and that asymptomatic, mild and moderate cases accounted for more than 90% of cases.

In France, the Covid-19 epidemic hit Alsace hard from March 2020, mainly due to the cluster formed by the evangelical assembly of the Christian Open Door Church taking place from February 17 to 21 in Mulhouse in the Haut-Rhin.

Thus, it is interesting to study pediatric patients hospitalized for Covid-19 in Alsace during 2020 in order to discover the clinical characteristics of these patients.

location_facility: Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France


title: Impact on the Quality of Life of Dialysis Patients of the Routine Collection of Symptoms by the Patients Themselves, With Feedback to the Dialysis Team - Pilot Study

acronym: FSWIFT-PILOT

summary:
Chronic kidney disease (CKD) affects 85,000 people in France. Medical care for this disease represents 2% of the Health Insurance budget.

Patients on dialysis frequently experience severe or overwhelming symptoms which contributes to poor health related quality of life (HRQoL). However, taking into account the measurement of the patients' symptoms by the patients themselves would allow to improve their HRQoL by putting more emphasis on the results that matter the most to the patients. It would also improve information and decision-making between nephrology care team and patients.

Systematic use of patients reported outcomes measures (PROMs) is not widely used due to a number of barriers including logistics and feasibility.

How will the F-SWIFT Pilot project address the barriers associated with PROMs? By choosing short questionnaires to complete By providing feedback on the severity of symptoms to the dialysis team and to patients By making links to good practice recommendations included in the feedback Allowing electronic collection of PROMs The research question therefore asks whether regular symptom monitoring with feedback to dialysis staff improves dialysis patient's outcomes? To do this, a pilot study must be carried out with the following main objectives Test the feasibility of integrating electronic measurements of PROMs with feedback to the dialysis team.

Three centers are participating in this pilot study:

The nephrology department of the Nancy CHRU
The Lorraine Association for the Treatment of Renal Insufficiency (ALTIR)
The nephrology department of the Nîmes University Hospital

The project will take place in 2 phases :

Phase 1 To identify the needs and expectations of patients and health professionals in relation to a systematic electronic measurement of symptoms made by the patients themselves.

Focus groups (interviews) will be conducted with patients (n=15) and healthcare professionals (n=15).

Phase 2 (n=50-60 patients) To develop and test an electronic PROMs system allowing

Collect patients' symptoms
Identify patients with severe symptoms
Alert the dialysis team in case of severe symptoms
Suggest appropriate management strategies

ReferenceCitation: Weisbord SD, Fried LF, Mor MK, Resnick AL, Unruh ML, Palevsky PM, Levenson DJ, Cooksey SH, Fine MJ, Kimmel PL, Arnold RM. Renal provider recognition of symptoms in patients on maintenance hemodialysis. Clin J Am Soc Nephrol. 2007 Sep;2(5):960-7. doi: 10.2215/CJN.00990207. Epub 2007 Aug 8.

ReferenceCitation: U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006 Oct 11;4:79. doi: 10.1186/1477-7525-4-79.

ReferenceCitation: Evangelidis N, Tong A, Manns B, Hemmelgarn B, Wheeler DC, Tugwell P, Crowe S, Harris T, Van Biesen W, Winkelmayer WC, Sautenet B, O'Donoghue D, Tam-Tham H, Youssouf S, Mandayam S, Ju A, Hawley C, Pollock C, Harris DC, Johnson DW, Rifkin DE, Tentori F, Agar J, Polkinghorne KR, Gallagher M, Kerr PG, McDonald SP, Howard K, Howell M, Craig JC; Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative. Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey. Am J Kidney Dis. 2017 Oct;70(4):464-475. doi: 10.1053/j.ajkd.2016.11.029. Epub 2017 Feb 24.

oa_host_type: repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories_concat: UCL Discovery

unpaywall_oa_status: green

ReferenceCitation: Sautenet B, Tong A, Williams G, Hemmelgarn BR, Manns B, Wheeler DC, Tugwell P, van Biesen W, Winkelmayer WC, Crowe S, Harris T, Evangelidis N, Hawley CM, Pollock C, Johnson DW, Polkinghorne KR, Howard K, Gallagher MP, Kerr PG, McDonald SP, Ju A, Craig JC. Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic Review. Am J Kidney Dis. 2018 Jul;72(1):62-74. doi: 10.1053/j.ajkd.2017.11.010. Epub 2018 Feb 21.

ReferenceCitation: Davison SN, Jhangri GS. Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients. J Pain Symptom Manage. 2010 Mar;39(3):477-85. doi: 10.1016/j.jpainsymman.2009.08.008.

ReferenceCitation: Davison SN, Jhangri GS. The impact of chronic pain on depression, sleep, and the desire to withdraw from dialysis in hemodialysis patients. J Pain Symptom Manage. 2005 Nov;30(5):465-73. doi: 10.1016/j.jpainsymman.2005.05.013.

ReferenceCitation: Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99. doi: 10.1053/j.ackd.2006.10.001.

ReferenceCitation: Tong A, Crowe S, Chando S, Cass A, Chadban SJ, Chapman JR, Gallagher M, Hawley CM, Hill S, Howard K, Johnson DW, Kerr PG, McKenzie A, Parker D, Perkovic V, Polkinghorne KR, Pollock C, Strippoli GF, Tugwell P, Walker RG, Webster AC, Wong G, Craig JC. Research Priorities in CKD: Report of a National Workshop Conducted in Australia. Am J Kidney Dis. 2015 Aug;66(2):212-22. doi: 10.1053/j.ajkd.2015.02.341. Epub 2015 May 2.

repository_institution: The University of Sydney - The Sydney eScholarship Repository

ReferenceCitation: Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4.

ReferenceCitation: Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories_concat: PubMed Central;g158bt22w

publisher_dissemination: American Medical Association

ReferenceCitation: Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085.

repositories_concat: PubMed Central;w9505913t

ReferenceCitation: Naylor KL, Kim SJ, McArthur E, Garg AX, McCallum MK, Knoll GA. Mortality in Incident Maintenance Dialysis Patients Versus Incident Solid Organ Cancer Patients: A Population-Based Cohort. Am J Kidney Dis. 2019 Jun;73(6):765-776. doi: 10.1053/j.ajkd.2018.12.011. Epub 2019 Feb 6.

sponsor_collaborators:
Central Hospital, Nancy, France
Agence de La Biomédecine
CIC 1433 EC CHRU de Nancy
Association France REIN


title: Genetics of Mendelian Forms of Young Onset Alzheimer Disease. Identification of Novel Genetic Causes of AD Are of Importance in Completing the Mechanisms of the Amyloid Hypothesis. This Project is Useful to Promote the Guidelines on the Genetic Diagnosis of AD in France.

acronym: GMAJ

summary:
Genetics of mendelian forms of young onset Alzheimer Disease (GMAJ project)

Introduction : Autosomal dominant forms of Alzheimer disease (AD) are characterized by young age of onset. In France the prevalence was estimated at around 1000 cases. The Phenotypical Expression: There is diversity in phenotypical expression, associating dementia, spastic paraplegia, early extrapyramidal syndrome, ataxia or stroke caused by severe cerebral amyloid angiopathy. Diversity in neuropathological expression is demonstrated by the presence of cotton wool plaques, Lewy bodies with Lewy neurites and severe cerebral amyloid angiopathy.

The study of mendelian forms is decisive in the physiopathological comprehension of AD and related diseases, since the alteration of those genes involved is sufficient to cause the disease. In AD, identification of these genetic causes allows the formulation of the amyloid hypothesis, which is the basis of current therapeutic developments concerning the Ab peptide. Currently three genes (APP, PSEN1, PSEN2) are identified in early onset mendelian forms and their mutations are involved in 80% of the 139 French families, studied since 1993 within the framework of U614 and the National Reference Centre for Alzheimer Disease in young subjects (CNR-MAJ).These results are arguments in favor of the GMAJ project and have two main objectives:

(i) to identify new genes in mendelian AD forms without detectable alteration on known genes.

(ii) to correlate phenotypes and genotypes within families associated with known mutations and extend the description of the phenotypical spectrum.

Population: Families eligible for this study are those with at least 2 individuals with AD criteria (clinical or neuropathological) with onset before 65 years of age. Duration of inclusion is 3 years. This multicentre study groups 23 clinical centres. The inclusion number is 50 new families per year.

Method: Extension and description of families with unknown genetic causes, inclusion of novel families with autosomal dominant AD. The successive steps of the project are the following:

(i) Thorough phenotypical characterization in order to document family history and characterize the probands and affected related subjects according to standardized protocol for clinical, neuropsychological, biological (biomarker determination in plasma and cerebrospinal fluid) and imaging data (MRI, TEMP).

(ii) Identify known genetic causes (PSEN1/2, APP) with novel autosomal dominant families.

(iii) Extend analysis of the pedigrees of families with unknown genetic causes.

(iv) Identify novel genetic causes within these families which are negative for known mutations.

This study uses 3 methods:

pangenomic search is performed for microalterations (Copy Number Variants or CNV) by Comparative Genomic Hybridization (CGH) with high resolution (10 kb on average).
potential targets are then validated by the study of large control populations, intrafamilial cosegregation and functional validation.

the remaining families at the end of this stage will be characterized by means of high throughput sequencing of all exonic areas.

(v) Follow up study of patients and siblings with 2 goals:

evaluation of the disease course and consequences (individual, familial and social);
occurrence of novel AD cases within the family.

(vi) Neuropathological description with potential novel description of atypical AD cases.

Results and consequences: Identification of novel genetic causes of AD are of importance in completing the mechanisms of the amyloidergic hypothesis. This project is useful to promote the guidelines on the genetic diagnosis of AD in France.

lead_sponsor: University Hospital, Rouen


title: Staphylococcus Aureus Nasal Carriage Among Technical Staff of a Teaching Hospital: An Unexpected Group at Risk of Colonization

acronym: SANAC

summary:
The repeated exposition to S. aureus is considered as a determining factor of acquisition of the nasal colonization. The healthcare professionals are regularly in touch with this pathogenic bacterium. Prevalence of the nasal carriage of S. aureus in this population was the object of several studies but little took into account the respect for the rules of good hygienic practice. The results of our previous study carried out during the international congress of staphylococci (ISSSI, Lyon in August 26-30th, 2012) showed an association between the work in a hospital environment and the increase of the risk of nasal carriage. On the contrary, the use of the hydro-alcoholic solutions had a protective effect against this carriage. However, sized of the health care population of our study was limited.

The goal of this study is to confirm our previous results on a larger cohort of healthcare professionals. The main objective is to estimate the prevalence of nasal carriage according to the professional category and by taking into account the degree of conformity with good hygiene practices including the use of hydro-alcoholic solutions.

location_facility: National Reference Center for Staphylococci, 59 boulevard Pinel


title: Study of Variations of Pleural and Esophageal Pressures Under Mechanical Ventilation After Lung Transplantation

summary:
The primary objective of the study is to determine the correlation between mean pleural pressure and oesophageal pressure in the immediate aftermath of bi-pulmonary transplantation.

In this research, oesophageal pressure will be measured by a nasogastric tube with an esophageal balloon (also suitable for feeding the patient) usually installed at the time of transplantation, pleural pressure will be measured by several Pleurocath-type catheters (Prodimed Inc, France) which the thoracic surgeon will have positioned at the end of the surgery without additional skin intrusion.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital Nord Assistance Publique Hôpitaux de Marseille


title: Inventory of Inappropriate Prescriptions of Proton Pump Inhibitors (PPIs) in People Over 75 Years of Age When Taking Over a Patient Base in the SOULTZ Haut-Rhin Sector

acronym: Etaliepre-IPP

summary:
This study would have as a starting point the results of a request carried out by the Medical Service Grand Est of the Health Insurance aiming to evaluate the number of boxes of PPI reimbursed in town pharmacy, in patients over 75 years old in the Grand Est of France from 01/01/2018 to 31/12/2018.

It aims to highlight and quantify a possible inappropriate use of PPIs in private practice.

location_facility: Service de Gériatrie - CHU de Strasbourg - France


title: Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study

acronym: VacciPrema

summary:
Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants.

Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered.

The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.

location_facility: Centre Hospitalier Regional et Universitaire, Maternite Regionale

intervention_type: Biological