title: Phenotypic Exploration of Autism Spectrum Disorders Retrospective and Prospective Data

acronym: EXPECT

summary:
Autism Spectrum Disorders (ASD) are a heterogeneous group of severe developmental abnormalities of the nervous system characterized by deficits in social interaction and verbal and nonverbal communication affecting approximately 1% of the general population.

In 5-40% of cases, genetic factors are identified as the cause of these disorders.

Despite this unique definition and the advancement of techniques, ASD is still a clinically and genetically heterogeneous condition, as several hundred genes have been identified to date.

Primary Objective and Endpoint Primary Objective:

Exploration of phenotypic heterogeneity in patients with ASD.

Primary endpoint:

Routine Care Clinical Investigation Criteria.
Scores on assessment scales,


title: Acute Kidney Injury and Drug-related Acute Kidney Injury : Use of Hospital Coding Data for Their Identification

acronym: IRA-PMSI

summary: AKI is a rapid and usually reversible impairment of kidney function that is life-threatening in the short term well described by the "Kidney Disease: Improving Global Outcomes - KDIGO" classification of 2012. Whatever etiology of acute renal failure, drug iatrogeny still has its place. Hospital data from the information systems medicalization program (PMSI) can be used for epidemiological research. No study has yet been performed on these data to assess drug-related AKI. However, it should be remembered that these databases were not originally designed for research purposes but for reimbursement of care. Therefore, before conducting a large-scale study, it remains important to determine the validity and representativeness of the codes used for coding the studied events. The objective of this project is therefore to validate the use of hospital coding to identify AKI.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens

lead_sponsor_type: academique

status_simplified: Ongoing


title: Nervous System Symptoms Associated With COVID 19 : NS-COV

acronym: NS-COV

summary: This study aim to prospectively evaluate the neuropsychiatric symptoms of patients infected with the SARS-CoV-2 virus by a standardized neuropsychiatric examination : the global CASE scale (Clinical Assessment Scale in Autoimmune Encephalitis), and the prevalence of disturbances of consciousness, focal neurological deficit, cognitive impairment, headache, anosmia, sleep disturbances, impaired autonomic nervous system and peritraumatic stress.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Health Services Research

enrollment_type: Actual

lead_sponsor: University Hospital, Toulouse

intervention_type: Other

status_simplified: Completed


title: Evaluation of the Impact of a Tonotopy Based Fitting on the Speech and Musical Perception in New Cochlear Implanted Subjects. Prospective Randomized Crossover Study.

summary:
Main objective:

Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception speech in noise.

Secondary objectives:

Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of musical elements (contour test).

Show the non inferiority of tonotopy based fitting strategy compared to default fitting strategy on the perception of speech elements in quiet.

Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the qualitative preference for the listening of musical pieces.

design_allocation: Randomized

primary_purpose: Other

lead_sponsor: MED-EL Elektromedizinische Geräte GesmbH

intervention_type: Device

lead_sponsor_type: industriel


title: Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment : a Pilot Study

acronym: MIhCFAO

summary: Molar Incisor Hypomineralization (MIH) is a disease causing a structural defect in the enamel of permanent teeth. The treatment of these teeth consists of the removal of the affected part of the tooth and its reconstitution. Classically, the restoration is done with a resin in direct method. With the development of Computer-aided design (CAD) and Computer-aided manufacturing (CAM), it is possible to make a custom-made part to replace the affected part of the tooth. The main objective is to describe the effect of the 6-month management of CAD/CAM type restorations compared to direct restorations, performed in children aged 7 to 12 years with mild to moderate MIH on permanent molar teeth.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Treatment

intervention_type: Procedure


title: Psychological Sequelae After Sudden Cardiac Death in the Patient and His Relatives

acronym: TEMPO

summary: This study will evaluate and describe the occurrence of Acute traumatic stress and persistence of Post Traumatic Stress Disorder (PTSD) after resuscitated sudden cardiac death (SCD) in patient and relatives present during the event. The population will be composed of 40 patients: 20 with resuscitated SCD and 20 relatives. Two interviews will be performed by a psychologist within one week after resuscitated SCD and at month 3. Questionnaire Stanford Acute Stress Reaction Questionnaire (SASRQ), Life Events Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (LEC-5) and Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) will be filled during these interviews.

lead_sponsor: University Hospital, Bordeaux

intervention_type: Behavioral


title: Evaluation of Electrocardiographic Measurements by High Density Electrode ECG (ECG-HD)

acronym: ECG-HD

summary: Cardiac electrical activity is detected on the body surface with conventional electrocardiography involving 12 leads (ECG 12). A limitation of the current ECG technique is that recordings are obtained from only 6 independent precordial leads pairs ; which may miss cardiac potentials from spatially limited regions. More extensive sampling of the body surface may contribute to additional clinical information. The present study investigates the additional sensitivity of ECG using 128 body surface leads (High Density (HD) ECG) in measuring global or regional cardiac activity.


title: Cross-sectional, Multi-center Study Comparing Diagnostic Performance Between the CAD EYE System and the Physician on Histological Prediction of Colonic Polyps in Screening of Colorectal Cancer by Colonoscopy

acronym: IA COLO

summary: Artificial Intelligence (AI) to predict the histology of polyps per colonoscopy, offers a promising solution to reduce variation in colonoscopy performance. This new and innovative non-invasive technology will improve the quality of screening colonoscopies, and reduce the costs of colorectal cancer screening. The aim of the study is to performed a cross-sectional, multi-center study evaluating the diagnostic performance of the CAD EYE automatic characterization system for the histology of colonic polyps in colorectal cancer screening colonoscopy.

primary_purpose: Diagnostic

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Interest of the Addition of Docetaxel to Standard Treatment in First-line Advanced HER2 Positive Gastroesophageal Adenocarcinoma in Selective Patients

acronym: TandHER

summary: The purpose of this retrospective study is to evaluate the efficacy and the safety of trastuzumab + chemotherapies with or without taxanes among HER2-positive advanced gastroesophageal adenocarcinoma patients.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Drug


title: Anesthetic and Perioperative Risk Assessment Before Programmed Surgery: Anesthetic Teleconsultation Versus Face-to-face Anesthesia Consultation.

acronym: TELANESTH

summary:
The anesthesia safety decree made it compulsory in 1994 to carry out a pre-anesthesia consultation before any operative or interventional act. With the inclusion of telemedicine in the Public Health Code then the publication of Addendum 6 in 2018 and finally the derogatory decree in March 2020, it is possible to perform and bill for pre-anesthesia consultation via telemedicine.

The consultation is always followed by a pre-anesthetic visit upon admission of the patient the day before or the day of the operation to verify the information recorded during the consultation and the patient's state of health. This identifies elements omitted during the pre-anesthesia consultation (face-to-face or remotely) and reduces the risks of potential postponement.

The study investigators hypothesize that there would be no difference in the quality of the information given, the collection of medical, paramedical and medication elements and the evaluation of the operative risk in anesthesia consultation via teleconsultation versus face-to-face. The critical points are the medication reconciliation of the patient's treatments, the overall assessment of the operative risk and anticipated difficulty of access to the airways (mouth opening: ≥ or <35 mmm).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes

acronym: VISUO-CEREBRO

summary: This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.


title: TOLERANCE STUDY OF N-ACETYLCYSTEINE FOR THROMBOLYSIS IN THE ACUTE PHASE OF ISCHEMIC STROKE / ETUDE DE TOLERANCE DE LA N-ACETYLCYSTEINE POUR LA THROMBOLYSE A LA PHASE AIGUË DE L'INFARCTUS CEREBRAL

acronym: NAC-S

summary: The primary objective of the study is to assess the safety of N-Acetylcysteine as a thrombolytic agent in acute ischemic stroke, especially regarding the risk of hemorrhagic transformation.

ReferenceType: background

ReferenceCitation: Martinez de Lizarrondo S, Gakuba C, Herbig BA, Repessé Y, Ali C, Denis CV, Lenting PJ, Touzé E, Diamond SL, Vivien D, Gauberti M. Potent Thrombolytic Effect of N-Acetylcysteine on Arterial Thrombi. Circulation. 2017 Aug 15;136(7):646-660. doi: 10.1161/CIRCULATIONAHA.117.027290. Epub 2017 May 9.

lead_sponsor: University Hospital, Caen


title: Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma (Vitilimel Study)

acronym: VITILIMEL

summary:
Skin diseases can have various origins. However, a number of them are linked to an imbalance in the immune system which will lead to either an excessively strong autoimmune response or a complete lack of response against cancer cells. Indeed, both melanoma and vitiligo are pathologies where the immune system plays an important role in the progression of the disease.

Advanced stage melanoma (metastatic lymph node and / or visceral) have a poor prognosis. Although targeted therapies and immunotherapies have improved the outcome for patient however significant proportion of these patients (~ 50%) developed resistance to therapies.

Vitiligo is a relatively common dermatosis affecting approximately 0.5% to 1% of the French population. Vitiligo results from the destruction of the melanocytes by the immune system. It is manifested by acquired depigmented macules, well limited and asymptomatic. Patients suffering from this condition have a marked decrease in their quality of life. There has been shown a strong link between vitiligo and melanoma. Indeed, patients with melanoma who develop vitiligo (~ 9% of patients treated with anti-PD-1 drugs) have a better prognosis compared to patients who do not develop vitiligo.

Interestingly, in melanoma cases where the immune system is inactive, the investigators have identified a new molecule secreted by melanoma cells, ITGBL1, leading to the exclusion of immune cells, decreased cytokines secretion and decreased immune cell activation. It is therefore essential to better understand the regulatory mechanism of the immune system in patients with vitiligo or in patients with melanoma treated by immunotherapy in order to be able to propose new therapeutic solutions for these patients.

No study to date has investigated the expression of ITGBL1 and serum inflammatory markers during the development of melanoma. Likewise in vitiligo, if a loss of ITGBL1 is observed, new treatments could be developed in order to limit the progression of the disease by re-expressing this protein.

Thus, the investigators exploratory study will provide the first answers to the predictive value of these markers for these pathologies in order to adapt and develop new treatments.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Implementation and Effectiveness of a Community-based Exercise on Prescription Program for Adults With Chronic Diseases

acronym: SSOCaen

summary:
The objectives were (1) to evaluate the characteristics of the patients referred, and (2) the effect of a community-based Exercise on Prescription program on their physical capacities and their quality of life.

The program consisted in 30 supervised physical activity (PA) group sessions (75 min) over a 4-month period and participant were prescribed the program by their doctors.

The participants had chronic diseases among type 2 diabetes, mental disorders, musculoskeletal disorders, childhood and adult obesity and stabilized cardiovascular diseases.

Tests and questionnaires were completed before and after the program. Physical tests were the 6-minute walk test, the timed up & go, the 30-s stand up chair, the single leg support test and the back scratch and toe-touch tests. Questionnaires were the self-administered Ricci and Gagnon questionnaire about PA level and the 12-Item Short Form Survey for measuring quality of life.

Personal goal from the participants and medical objective from their doctors were collected before the program.

ipd_sharing: Undecided


title: Clinical and Functional Expression Associated With CELSR1 Mutations in Primary Lymphedema of Lower Limbs

summary: The investigators will describe the expression of mutation CELSR1 with codon stop and amino acids substitution mechanism in primary lymphedema, in both clinical examination and imaging exploration

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Post-vaccination Immunization Against SARS-CoV-2 in Patients Undergoing Maintenance With Anti-CD20 Antibodies for Follicular Lymphoma (FL) or Mantle Cell

acronym: VAXIMAB

summary:
The anti-CD20 monoclonal antibodies, rituximab (R) and obinutuzumab (G), are used as standard maintenance therapy every 2 months for 2 to 3 years in patients with follicular lymphoma (FL) or mantle cell lymphoma (MCL).

This treatment is associated with profound and prolonged B lymphopenia, hypogammaglobulinemia and increased infections. Severe forms of COVID-19 on Rituximab with prolonged carriage of the virus have been reported due to significant impairment of humoral immunity in this context of maintenance therapy.

Therefore, during the COVID-19 epidemic, clinicians are faced with the question of whether to discontinue maintenance therapy or continue treatment. However, the half-life of rituximab is 29 days and lymphopenia continues for up to 9-12 months after stopping injections. Therefore, it is not clear that discontinuation of maintenance therapy will alter the risk of severe SARS-CoV-2.

However, post-vaccination immunization against SARS-CoV-2 by an mRNA vaccine is not known in this context of prolonged treatment with rituximab or obinutuzumab. It is however well established that post-vaccination responses against diphtheria, tetanus, pneumococcus, HBV, or influenza in particular are altered after anti-CD20 antibodies. If the humoral response is crucial in the post-vaccination response, it is also suggested that the preservation of innate immunity and the CD8 response, unaltered by anti-CD20, could also play an important role in the post-vaccination response and virus clearance.

The aim of our study is to evaluate the humoral and post-vaccination T-cell response based on serological data and T-cell production of interferon gamma in response to SARS-CoV-2 specific antigens (Elispot interferon gamma) in this group of patients treated for lymphoma with a long-term anti-CD20 antibody.

lead_sponsor: Centre Henri Becquerel

intervention_type: Biological


title: Immunological Markers Predictive of Response and Toxicity to Checkpoint in Metastatic Non-Small-cell Lung Cancers

acronym: IMMUNO-PREDICT

summary: A prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


type: Registry Identifier

title: Observatory of Functionnal Digestive Disorders

acronym: OTFI

summary: Functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. These diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. The objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response.

ipd_sharing_description: No sharing plan

lead_sponsor: University Hospital, Rouen

location_facility: Physiology Unit, Hopital Charles Nicolle, 1 rue de Germont


title: Skin Sympathetic Nerve Activity and Cardiac Arrhythmia

acronym: SKNA

summary: Sympathetic tone is important in cardiac arrhythmogenesis. The simultaneous recording of sympathetic nerve activity (SNA) and electrocardiogram (ECG) was obtained by invasive method. The purpose of this protocol is to further develop this recording method to turn it into a new non-invasive tool for arrhythmia prediction and detection. This method may also be useful in validating the results of surgical procedures aimed at sympathetic denervation


title: Evaluation of the Sanitary Safety of the French Intensive Care Society Annual Meeting Held From June 9th to June 11th 2021 at the Paris Congress Centre

acronym: COVID-FREE

summary: The COVID-SRLF study will evaluate the sanitary safety of the French Intensive Care Society (FICS) annual meeting held in Paris Congress Center from June 9th to June 11th 2021 in the Coronavirus Disease 2019 (COVID-2019) pandemic situation. The primary objective is to determine the proportion of attendees with a positive antigenic COVID-19 screening test at day 7 (+/- 1) of their participation to the meeting. This rate will be compared to a cohort of health care professionals (medical doctors and paramedical professionals) from the same hospital ward as the attendees but who did not attend the meeting (stratified on centers, gender, age (< and >= 40 years, vaccination status (0, 1 or 2 doses) and socio-professional status (medical doctor, nurse, nurse assistant).

lead_sponsor: French Society for Intensive Care


title: Refractive Transepithelial Photo-keratectomy (T-PKR) Without Addition of Mitomycin-C in High Myopia: a Retrospective Study of 69 Eyes

acronym: TEPEHERKAHM

summary: The aim of this study is to evaluate the anatomical and refractive parameters following a single-step transepithelial photo-refractive keratectomy (T-PRK) without the addition of mitomycin-C for the treatment of high myopia of 6 diopters or more.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


type: Other Identifier

title: Comparison Between the Entry Portals Through the Rotator Cuff and Through the Rotator Interval Split for Anterograde Humeral Nailing in Humeral Fractures: a Prospective Randomized Study

acronym: HUNAAP

summary:
The aim of the study is to show if there is any speed difference of functional recovery for people with humeral fracture, treated by an anterograde nail, which will be inserted through the rotator cuff (the common way) or through the rotator interval split.

The patients included in this study will be randomized to one of the two groups.

The recovery will be evaluated by the Constant score over time, for a year. The main hypothesis is the rotator interval split approach allows a faster functional recovery after humeral nailing, by avoiding opening the rotator cuff.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Use of a Virtual Reality Mask in the Reduction of Pain and Anxiety During in Utero Surgical Procedures

acronym: VIRTUALFETO

summary:
"The virtual reality mask is an innovative technique, alternative to pharmacological medicine that would allow, in addition to its action on pain, to reduce anxiety and thus increase patient satisfaction by improving their experience of a risky situation. The therapeutic effects of the virtual reality mask are based on a distractive effect with attentive capture, an emotional effect due to ludic aspect and positive suggestion, and a behavioral effect.

In utero fetoscopy is a potentially painful procedure, particularly at the beginning of the procedure due to the introduction of a fetoscopy trocar in the amniotic cavity through the patient's uterus. It also generates anxiety in mothers because of the risks associated with the pathology and the procedure. This research focuses on the use of a virtual reality mask in the reduction of pain and anxiety during in utero surgical procedures.

The study is presented and proposed to the patient during the expert ultrasound examination by the obstetrician-gynecologist. Then the modalities are detailed by the anesthetist during the anesthesia consultation before the surgery. The patient is included in the study after the consent is signed. During the anesthesia consultation, the patient is informed of the possibility of analgesia through a virtual reality mask, associated with local anesthesia. It is explained that in case of pain despite the virtual reality mask and local anesthesia, remifentanil administration remains possible. During the anesthesia consultation, the patient's initial state of anxiety is assessed by the score Amsterdam Preoperative Anxiety and Information Scale.

The procedure takes place in the theatre room. Upon arrival in the theatre room (preoperative), an evaluation of the anxiety level is performed using a visual analog scale. The virtual reality mask is applied by the anesthesia team before skin disinfection and the placement of sterile drapes. During the procedure, a local anesthesia (non-adrenaline Xylocaine 1%) is performed as usual in order to insert the trocar in the amniotic cavity (diameter 3.5mm) which will be used to introduce the intra-amniotic fetoscope. If during the procedure, the patient feels pain, agitation, pain-related discomfort, morphine analgesia (Intravenous Remifentanil which means Intravenous Anesthesia with Objective Concentration) may be administered by the anesthesia team. Immediately after the procedure, the virtual reality mask will be removed.

primary_purpose: Supportive Care

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: "Family Caregiver Reflex": Family Support for Patients Followed for Systemic Sclerosis - Pilot Study Evaluating the Experience and Role of Family Caregivers in Order to Identify and Include Them in Therapeutic Educational Programs

acronym: RelativReflex

summary:
Systemic sclerosis (SSc) is a rare, serious disease that is part of chronic inflammatory rheumatism.

It requires multidisciplinary care and a specific therapeutic patient education program.

SSc actually affects every member of the family, the patient as well as those close to him. It deeply affects each member of the family (increased fatigue, stress, social isolation, exhaustion, financial difficulties …) which gives rise to threats of vulnerability and modulates the balance of family relations.

However, there are very few studies on family SSc caregivers. We have raised the question about the experience and needs of caregivers in order to better support them.

The main purpose of this pilot study is to better understand the particularities of relatives (caregivers) of patients suffering from systemic sclerosis and will allow us to refine our knowledge about the assistance they provide for SSc patients and its impact on family caregivers :

lived experience of the relatives (caregivers);
physical, mental and socio-professional health of the relatives (caregiver);
relationship between the relative (caregiver) and the patient.

The research will be carried out at Cochin Hospital, in collaboration with the French Scleroderma Association (ASF).

It will be offered to relatives of SSc patients identified by health team in the rheumatology or internal medicine department, as well as during consultations and patient education activities.

An information note and an informed consent will be given to each patient and his caregiver ; Self-questionnaires will then be offered to relatives.

They can fill them out while they are in the hospital, or at home and return the completed questionnaire.

Caregivers will be questioned about their quality of life, health, relationship with the patient and support situation.

They will also be asked for personal socio-demographic information concerning the patient.

The "caregiver reflex" project is part of the 2020-2022 mobilization and support strategy for caregivers "acting for the health of family caregivers", in which the establishment of a "caregiver reflex" among professionals health is put forward.

time_perspective: Cross-Sectional

ReferenceCitation: Brignon M, Vioulac C, Boujut E, Delannoy C, Beauvais C, Kivits J, Poivret D, Giraudet Le Quintrec JS, Untas A, Rat AC. Patients and relatives coping with inflammatory arthritis: Care teamwork. Health Expect. 2020 Feb;23(1):137-147. doi: 10.1111/hex.12982. Epub 2019 Nov 27.

ReferenceCitation: Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7.

ReferenceCitation: Brouwer WB, van Exel NJ, van de Berg B, Dinant HJ, Koopmanschap MA, van den Bos GA. Burden of caregiving: evidence of objective burden, subjective burden, and quality of life impacts on informal caregivers of patients with rheumatoid arthritis. Arthritis Rheum. 2004 Aug 15;51(4):570-7.

ReferenceCitation: Cañedo-Ayala M, Rice DB, Levis B, Carrier ME, Cumin J, Malcarne VL, Hagedoorn M, Thombs BD; Scleroderma Caregiver Advisory Committee. Factors associated with symptoms of depression among informal caregivers of people with systemic sclerosis: a cross-sectional study. Disabil Rehabil. 2020 Feb;42(3):394-399. doi: 10.1080/09638288.2018.1500647. Epub 2018 Aug 19.

ReferenceCitation: Given CW, Given B, Stommel M, Collins C, King S, Franklin S. The caregiver reaction assessment (CRA) for caregivers to persons with chronic physical and mental impairments. Res Nurs Health. 1992 Aug;15(4):271-83.

ReferenceCitation: Jacobi CE, van den Berg B, Boshuizen HC, Rupp I, Dinant HJ, van den Bos GA. Dimension-specific burden of caregiving among partners of rheumatoid arthritis patients. Rheumatology (Oxford). 2003 Oct;42(10):1226-33. Epub 2003 Jun 16.

ReferenceCitation: Kasle S, Wilhelm MS, Zautra AJ. Rheumatoid arthritis patients' perceptions of mutuality in conversations with spouses/partners and their links with psychological and physical health. Arthritis Rheum. 2008 Jul 15;59(7):921-8. doi: 10.1002/art.23821.

ReferenceCitation: Lam M, Lehman AJ, Puterman E, DeLongis A. Spouse depression and disease course among persons with rheumatoid arthritis. Arthritis Rheum. 2009 Aug 15;61(8):1011-7. doi: 10.1002/art.24510.

ReferenceCitation: Leplège A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23.

ReferenceCitation: Matheson L, Harcourt D, Hewlett S. 'Your whole life, your whole world, it changes': partners' experiences of living with rheumatoid arthritis. Musculoskeletal Care. 2010 Mar;8(1):46-54. doi: 10.1002/msc.165.

ReferenceCitation: Rice DB, Cañedo-Ayala M, Carboni-Jiménez A, Carrier ME, Cumin J, Malcarne VL, Hagedoorn M, Thombs BD; Scleroderma Caregiver Advisory Team. Challenges and support service preferences of informal caregivers of people with systemic sclerosis: a cross-sectional survey. Disabil Rehabil. 2020 Aug;42(16):2304-2310. doi: 10.1080/09638288.2018.1557268. Epub 2019 Jan 29.

ReferenceCitation: Untas A, Vioulac C, Boujut E, Delannoy C, Poivret D, Rat AC, Beauvais C, Giraudet Le Quintrec JS. What Is Relatives' Role in Arthritis Management? A Qualitative Study of the Perceptions of Patient-Relative Dyads. Patient Prefer Adherence. 2020 Jan 7;14:45-53. doi: 10.2147/PPA.S231919. eCollection 2020.


title: Observational Prospective Study Measuring the Impact of the Use of a Hypnotic Script Associated With Virtual Reality on the Pain of the Child's Sickle Cell During a Vaso-occlusive Crisis

acronym: DREPAReV

summary: The purpose of this study is to evaluate the effect of Virtual Reality induced Hypnosis on patients' pain scores, anxiety and the use of analgesics during a vaso-occlusive crisis

location_facility: Trousseau Hospital, General pediatric departement


title: Comparative Analysis of Anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome) Humoral and Memory T Cell Responses in Children With Various Degrees of Immunosuppression: a Case-control Study

acronym: PEDIMMCO

summary:
Adaptive immune responses are essential for clearing viral infections and retention of virus specific memory populations is required for long-term immunity. However, there is still uncertainty about whether adaptive immune responses to SARS-CoV-2 are protective. Such knowledge is of immediate relevance, as it will provide insights into immunity of SARS-CoV-2 infection and thus help define future immunization strategies. Because of the importance of asymptomatic cases in children, a specific study is needed in this population in order to determine their individual and collective protective capacity. This is even truer for immune compromised children that likely have severe forms of the disease with active and prolonged viral replication in whom it is therefore essential to determine the extent of sero conversion but also the quality and duration of the memory responses.

For this purpose, we plan to analyze the anti-SARS-CoV-2 humoral and memory T cell responses, in different groups of immuno-compromized children (i.e with different levels/type of immunosuppression; HIV, renal or stem cell transplantation, anti-TNF or methotrexate treatment) and healthy controls seen in 3 University Hospitals, in order to determine the proportion of children with SARS-CoV-2 specific humoral responses, their protective capacity, the magnitude and the quality of the SARS-Cov-2 memory T cells but also their long term persistence at 1 year.


title: Detection of Covid-19 in Tissue Samples of Orthopedic Origin: a Prospective Cohort Study

summary:
Background The presence of the Covid-19 virus has been detected in tissues of various origins: nasopharyngeal swabs, sputum, bronchoalveolar fluid, blood, stool and anal swabs. However, it does not appear that the virus is excreted in the urine. The REACTing group (Research & Action Emerging Infectious Diseases) has demonstrated the presence of the virus in the conjunctiva and pleural fluid. This detection was made possible by carrying out quantitative, real-time RT-PCR and sequencing of the viral genes, which are currently the benchmark for the diagnosis of COVID-19. However, it is not known at this time whether the Covid-19 virus is present in joint fluid or in bone.

However, some viruses have a particular bone tropism (Parvovirus B19, HHV6); others have joint tropism (parvovirus B19, HBV, HCV, rubella, HIV, HTLV-1). The presence in "orthopedic" tissues of the various coronaviruses (MERS, SARS, etc.) has never been evaluated in the past. However, cases of pulmonary contamination by coronavirus after bone marrow transplantation have been reported in the literature. A potential location at these levels could cause problems of different kinds.

Rationale First, and concretely, a possible direct transmission by these tissues. The current English and Spanish national recommendations in orthopedics show a controversy as to the risk of intraoperative contamination during medical procedures generating aerosols, in particular those involving instruments at high speed (saw blade, reamer, drill). This transmission could also be a problem during bone marrow transplants, from the iliac crests, for example.

Second, but hypothetically, Covid-19 could become quiescent at the level of the myelo-hematopoietic niches and reactivate at a distance, which could then explain the current interrogation on "absence of immunity" and cases of early revival in patients considered cured. This hypothesis is all the more likely since, always by analogy with Parvovirus B19 or HHV6, a recent alert on cases of myocarditis in children has been issued in Parisian pediatric hospitals and that treatment with tocilizumab, which blocks the action Interleukin 6 receptors, and initially used for joint manifestations of rheumatoid arthritis, appear promising.

ipd_sharing_description: Individual participant data will only be done on request and after acceptance of the sponsor's scientific committee if the request is properly justified

lead_sponsor: Centre de l'arthrose, Paris

intervention_type: Diagnostic Test


title: Comparative Study of the Histomolecular, Radiological and Prognostic Profiles Between Brain Gliomas of Children (0-14 Years) and Adolescents/Young Adults (15-25 Years) Treated in the Amiens University Hospital Between 2008 and 2020

acronym: BioMol GLIOMA

summary:
In the last decades, many advances have been made in the field of genetic abnormalities of glial and glioneuronal brain tumors. In the 2016 World Health organization (WHO) Classification of Tumors of the Central Nervous System, the concept of "integrated" diagnosis emerged: histological and genetic/molecular features now define many entities. Since 2016, six updates have been published by the c-IMPACT-NOW (the Consortium to Inform Molecular and Practical Approaches to CNS Tumor Taxonomy- Not Official WHO) to develop and clarify the "integrated" diagnosis. In the future WHO 2021 Classification of Tumors of the Central Nervous System, "integrated" diagnoses will take up even more importance. Even if they can have similar histological features, gliomas of children are very different from the "adult" gliomas in the molecular mechanism of oncogenesis. The histomolecular features of adolescents/young adults (AYAs) can have similarities with "pediatric-type" or "adult-type" gliomas, but few studies have focused specifically on the histomolecular profiles of gliomas in AYAs.

The investigators would like to study the cohort of patients treated for a glial and glioneuronal tumor diagnosed under the age of 25 in the Amiens University Hospital between 2008 and 2020. The investigators would like to compare the histomolecular profiles of gliomas in children (0-14 years) and AYAs (15-25 years).

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Are Standard Dosing Regimens of Piperacillin-Tazobactam Suitable in Critically Ill Patients With Open Abdomen and Negative Pressure Wound Therapy? A Population Pharmacokinetic Study.

acronym: PK-LAP

summary:
For several years, open abdomen with temporary abdominal closure using Negative Pressure Therapy (OA/NPT) has become one of the leading strategies to treat or prevent intra-abdominal hypertension in critically ill surgical patients after a wide range of complex abdominal injuries and conditions.

According to current practice, piperacillin-tazobactam (PTZ) is widely used as part of empirical combined antibiotic therapy to treat severe abdominal infections in the critically ill patients. On the other hand, little is known about the impact of OA/NPT on antibiotics pharmacokinetics and pharmacodynamics (PK/PD) and the optimal dosing regimens in this population remain unclear.

As PTZ is a small hydrophilic molecule with a very low level of protein binding, invesitigators hypothesized that OA/NPT should lead to significant changes in volume of distribution (Vd) and/or drug clearance (CL

The main objective of this study was to assess the incidence of underdosing and the pharmacokinetics of piperacillin in critically ill patients with OA/NPT.

The secondary objective was to assess the appropriateness of recommended regimens for empirical minimum inhibitory concentration (MIC) coverage.


title: Etude de faisabilité Portant Sur un Dispositif de Monitoring Physiologique et d'Une Chaine de téléassistance Des Travailleurs isolés au Sein d'Une société de Nettoyage Industriel.

acronym: TIGER

summary: The purpose of the study is to test the feasibility of the monitoring of physiological parameters during operations of industrial cleaning

primary_purpose: Device Feasibility

lead_sponsor: University Hospital, Angers


title: Pilot Study Among Type 2 Diabetes Patients Investigating Effects of Computerized Cognitive and Physical Activity Programs Combined or Single.

acronym: DIASCOP

summary: The purpose of this study is to assess the cognitive benefits of combined physical activity and cognitive training on cognitive health compare to physical activity or cognitive training programs singly administrated among type 2 diabetes. Two group in cross over will take part in either physical activity only (for the first one) or cognitive training only (for the second one) for one month then the other way around during the second month. A fallow up will be administrated 3 months later.

primary_purpose: Prevention


title: Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment

acronym: eRToMSy

summary: To assess the psychometric properties (validity, reliability and responsiveness) of the QuestOnco tool, an electronic Remote Toxicity Management System, in adult cancer patients receiving an active anti-cancer treatment.


title: Integrated Parkinson Care Networks: Addressing Complex Care in Parkinson Disease in Contemporary Society

acronym: ICARE-PD

summary: The researchers wish to determine what are patients/care partners priorities in terms of care delivery based at home/community and define the envisioning care delivery model that support both social care and medical care from the perspective of people living with Parkinson.

lead_sponsor: University Hospital, Toulouse


title: Probability and Factors Associated With Early Discontinuation of Insulin Pump Therapy in Adults With Diabetes at the Center Hospitalier Sud Francilien

acronym: STOPPOMPE

summary: The purpose of this study is to determine the rate of insulin pump discontinuation 18 months after initiation in patients with diabetes, and to determine factors associated with this discontinuation.

lead_sponsor: Centre Hospitalier Sud Francilien


title: Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study "ALAMBU"

acronym: ALAMBU

summary: Degenerative lumbar pathologies are characterised by functional impairment and the occurrence of severe chronic pain and disability Arthrodesis of the lumbar spine is a common surgery for the treatment of degenerative lumbar pathologies. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The development of mini-invasive techniques and the development of the Improved Rehabilitation after Surgery programmes, has considerably reduced the hospital stay of the patients. It is possible that in the future mini-invasive lumbar arthrodesis will be performed on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated.

ReferenceCitation: Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002. Review.

ReferenceCitation: Peng CW, Yue WM, Poh SY, Yeo W, Tan SB. Clinical and radiological outcomes of minimally invasive versus open transforaminal lumbar interbody fusion. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1385-9. doi: 10.1097/BRS.0b013e3181a4e3be.

ReferenceCitation: Dietz N, Sharma M, Adams S, Alhourani A, Ugiliweneza B, Wang D, Nuño M, Drazin D, Boakye M. Enhanced Recovery After Surgery (ERAS) for Spine Surgery: A Systematic Review. World Neurosurg. 2019 Oct;130:415-426. doi: 10.1016/j.wneu.2019.06.181. Epub 2019 Jul 2.

ReferenceCitation: Sivaganesan A, Hirsch B, Phillips FM, McGirt MJ. Spine Surgery in the Ambulatory Surgery Center Setting: Value-Based Advancement or Safety Liability? Neurosurgery. 2018 Aug 1;83(2):159-165. doi: 10.1093/neuros/nyy057.

ReferenceCitation: Wiltse LL, Bateman JG, Hutchinson RH, Nelson WE. The paraspinal sacrospinalis-splitting approach to the lumbar spine. J Bone Joint Surg Am. 1968 Jul;50(5):919-26.

ReferenceCitation: Harmon PH. A simplified surgical technic for anterior lumbar diskectomy and fusion; avoidance of complications; anatomy of the retroperitoneal veins. Clin Orthop Relat Res. 1964 Nov-Dec;37:130-44.

ReferenceCitation: Perneger TV, Leplège A, Etter JF, Rougemont A. Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol. 1995 Aug;48(8):1051-60.

ReferenceCitation: Hayashi K, Boissière L, Guevara-Villazón F, Larrieu D, Núñez-Pereira S, Bourghli A, Gille O, Vital JM, Pellisé F, Sánchez Pérez-Grueso FJ, Kleinstück F, Acaroğlu E, Alanay A, Obeid I. Factors influencing patient satisfaction after adult scoliosis and spinal deformity surgery. J Neurosurg Spine. 2019 May 10;31(3):408-417. doi: 10.3171/2019.2.SPINE181486.

ReferenceCitation: Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

lead_sponsor: Elsan

location_facility: Unité de Chirurgie de la Colonne Vertébrale


title: Malignity Predictive Factors on Breast MRI With Ultrasound and Mammography Occult Lesions

summary:
Sometimes, breast ultrasound and mammographic can't be diagnose suspsious lesions ( no substratum). So a MRI-guided breast biopsy is perfomed and disclosed ultimately benign lesions.

The aim of this retrospective study is to establish a predictive MRI score of occult breast lesions by mammography and ultrasound.

status: Enrolling by invitation

status_simplified: Unknown


title: Performance of Static and Dynamic Accessment of Inferior Vena Cava Diameter for the Diagnosis of Fluid Responsiveness

acronym: THE FRACS

summary:
Fluid expansion in critically ill patients following high risk surgery may induice fluid overload and worse outcome. Several tools have been developped to predict fluid reponsiveness in such situation in order to avoid inappropriate fluid administration but with several limitations. Inferior vena cava (IVC) distensibility is one of those tools which has the advantage to be non-invasive, dynamic and safe, is usually measured by subcostal (SC)approach. In post surgical setting this acess is limited du to practical reasons (scar, dressing...), therefore a transhepatic (TH) approach is used but has not been validated as a fluid responsiveness prediction tool. The correlation between SC approach with the TH approach vary according to studies. Therefore the performances, the threshold indentified for SC approach can not be translated to the TH approach. Further, fluid congestion status measured before IVC analyses, may be a usefull confounder and safety endpoint for fluid reponsiveness interpretation.

The primary objectif of this study is therefore to study the performance of the IVC measured using TH approach (IVCth) in predicting of fluid responsiveness defined as an increased of 10% and over of stroke volume.

Secondary objectives intend to analyse the correlation between TH and SC approaches, to compared their performances for fluid responsiveness prediction, and to analyse the weight of venous congestion on fluid responsiveness prediction.

lead_sponsor: University Hospital, Lille

location_facility: Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille


title: Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells

acronym: QOLD CAR-T

summary:
CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials.

The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies.

This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique


title: Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention

acronym: AblaJ

summary: The value of cytobacteriological examination of urine (CBEU) before double J catheter removal has not been demonstrated. The aim of this study is to define the interest of this CBEU.

lead_sponsor: University Hospital, Tours


title: About Oral and Gut Microbiota in Intensive Care Unit : SARS-CoV-2 (COVID-19) Infection Impact. (CO-MIC Study)

acronym: CO-MIC

summary: The objective of the present study is to describe the negative impact on oral and gut microbiota of a severe acute respiratory syndrome SARS-CoV-2 infection in patients hospitalized in intensive care units (ICU). The study would like to compare their microbiota to the microbiota of ICU patients, non-infected by the SARS-CoV-2.


title: Interest of Day Hospital Care for Patients With Chronic Regional Pain Syndrome Referred to the Chronic Pain Unit for the First Time

summary:
Chronic Regional Pain Syndrome (CRPS) is a chronic disabling disease. Patients present a variable picture associating pain localized to an articular or peri-articular region, motor and vasomotor disorders and trophic disorders.

Its pathophysiology, still poorly understood to this day, results from local inflammatory phenomena complicated by peripheral sensitization and central spinal and cerebral sensitization.

The diagnosis is made difficult by the fluctuating nature of the symptoms and the absence of specific complementary examination.

The treatment of CRPS is symptomatic and requires multidisciplinary care. CRPS is responsible for an alteration in the patient's quality of life. This pathology has a global impact because it affects not only the biomedical sphere but also the socio-family, professional and psychological spheres.

The investigators hypothesize that multidisciplinary intervention in the Day Hospital would improve the quality of life of patients with CRPS. The investigators also think that the passage in Day Hospital would make it possible to improve the pains, the functionality of the affected limb as well as the satisfaction of the patients.

lead_sponsor: Centre Hospitalier le Mans


title: Assessment of the Validity of the ANI in Children Over 2 Years of Age and Prepubescent Ventilated and Sedated in Pediatric Intensive Care.

acronym: ANI-EP

summary:
The ANI monitor is a medical device allowing to measure the response of the autonomic nervous system to a painful stimulus.

In the pediatric population under general anesthesia, the ANI score can detect failure of locoregional anesthesia; ANI decreases after painful stimulation during surgery, more markedly with smaller doses of Remifentanil.

To date, measurement of ANI in sedated children in pediatric intensive care has not been performed or validated as a method of assessing pain and discomfort.


title: Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis

acronym: VALALGON

summary: Ganymed Robotics develops a novel solution of surgical navigation to assist surgeons during knee remplacement surgeries. The aim of this study is to train and validate this novel algorithm.

lead_sponsor: Ganymed Robotics


title: Perceived Health After Hospitalization for COVID-19

acronym: PRO-COVID

summary: There are currently no precise data available on the impact of COVID-19 on the daily life of patients after hospitalization. For the moment, studies have only demonstrated a strong impact of the diagnosis on the domains of quality of life explored by the MOS-SF36 questionnaire and the PHQ-9 depression score. Concerning the impact of COVID-19 disease after conventional hospitalization, field reports indicate extremely intense fatigue and a major physical impact lasting several weeks

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery

acronym: PAPCAM

summary: Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.


title: Can Connected Devices Increase the Success Rate of Benzodiazepine Withdrawals in the Elderly?

acronym: BENZO-E-STOP

summary:
This is a prospective randomized open study, which aims to evaluate the benefit of a connected watch to help people aged 65 years and older to withdraw from BZD over a six-month period, compared with classical withdrawal (e.g without connected watch). The study will include 100 patients, 50 in the control group and 50 in the intervention group.

Participants will be identified during a 12-month period through either external geriatric consultations or during a brief hospitalisation.


title: VIrtual Reality Glasses Use to Improve Lateropulsion and the Post-stroke Postural Vertical (VIRGIL)

acronym: VIRGIL

summary: VIRGIL is a monocentric interventional study aiming to investigate the effect of immersion in a virtual tilted room on modulation of the verticality representation (postural vertical [PV] and visual vertical [VV]), which in turn might affect body orientation (head and trunk). To this end, the investigators will conduct a within-person randomized trial including post-stroke patients and healthy participants.

ReferenceCitation: Pérennou DA, Mazibrada G, Chauvineau V, Greenwood R, Rothwell J, Gresty MA, Bronstein AM. Lateropulsion, pushing and verticality perception in hemisphere stroke: a causal relationship? Brain. 2008 Sep;131(Pt 9):2401-13. doi: 10.1093/brain/awn170. Epub 2008 Aug 4.

ReferenceCitation: Piscicelli C, Pérennou D. Visual verticality perception after stroke: A systematic review of methodological approaches and suggestions for standardization. Ann Phys Rehabil Med. 2017 Jun;60(3):208-216. doi: 10.1016/j.rehab.2016.02.004. Epub 2016 Apr 11. Review.

ReferenceCitation: Odin A, Faletto-Passy D, Assaban F, Pérennou D. Modulating the internal model of verticality by virtual reality and body-weight support walking: A pilot study. Ann Phys Rehabil Med. 2018 Sep;61(5):292-299. doi: 10.1016/j.rehab.2018.07.003. Epub 2018 Jul 19.

ReferenceCitation: Dai S, Piscicelli C, Clarac E, Baciu M, Hommel M, Pérennou D. Balance, Lateropulsion, and Gait Disorders in Subacute Stroke. Neurology. 2021 Apr 27;96(17):e2147-e2159. doi: 10.1212/WNL.0000000000011152. Epub 2020 Nov 11.

lead_sponsor: University Hospital, Grenoble


title: Study of the Effect of an Elastic Compression Medical Device (Prototype), on Water Balance Change in Healthy Subjects. Exploratory, Randomized, Open-label, Controlled and Crossover Study

summary:
Obstructive sleep apnea-hypopnea syndrome (OSAHS) is characterized by the occurrence of abnormally frequent episodes of interrupted ventilation (apnea) or significant reduction of ventilation (hypopnea) during sleep. It is linked to a repeated collapse of the upper airways during sleep.

Episodes of apnea and hypopnea cause hypoxemia and micro-awakenings with a well-established impact on quality of life and daily activities. Physiologically, OSAHS can be aggravated when moving from a standing to a supine position through fluid shift from the lower limbs to the upper body, thereby modifying the opening of the upper airways. A decrease of the water balance by bilateral diurnal compression of the lower limbs (during daytime in standing position) may limit this nocturnal fluid shift (at night in supine position) and thus reduce the severity of OSAHS.

Two comparative clinical trials [Redolfi 2011; White 2015] have shown a clinically modest reduction of sleep apnea (-36% and -27%, respectively), which was however statistically significant versus untreated control group (p = 0.002 and p = 0.04, respectively), when elastic compression medical devices of 20 to 30 mmHg were worn during the daytime. The hypothesis of fluid shift influence on OSAHS has been tested [Berg 1993; Redolfi 2011; White 2015], but the decrease of the water balance when the device is used remains to be quantified.

The CVE101-15 exploratory clinical investigation sponsored by Laboratoires Innothera performed on healthy volunteers confirmed the hypothesis of a diuretic effect of elastic compression stockings applying a pressure of 33 mmHg at the ankle, worn for 13-14 hours during the daytime for 3 days, with a good safety profile of this device. Moreover, it enabled the identification of reliable parameters and the endpoints to be used to demonstrate a diuretic effect.

Based on this information, there may be a real interest in conducting further investigations about the evolution of water balance beyond a 3-day period of elastic compression use in the daytime.

Hence, the main objective of this clinical investigation is to compare precisely, under standardized test conditions, water balance changes in healthy subjects over 5 days with or without daytime use of the investigational medical device (IMD), an elastic compression device prototype specially designed for this study.

lead_sponsor: Laboratoires Innothera


title: Evaluation de l'Ischemie Musculaire au Cours de l'Artériopathie Oblitérante Des Membres Inférieurs

acronym: Tsingtao

summary: The goal is to compare the results observed in patients that had both an exercise oximetry and a thallium scintigraphy for lower limb claudication


title: Prevalence and Pathophysiology of Systemic Arterial Pressure Abnormalities in Childhood Sickle Cell Disease

acronym: DrépaPA

summary: It is usually found that the blood pressure of adults with sickle cell disease is lower than in non-sickle cell patients. On the other hand, three recent prospective studies in children with sickle cell disease show prevalence of hypertension diagnosed by ambulatory blood pressure measurement (ABPM) ranging from 32 to 45% but on small numbers of patients (n = 54 at most). This hypertension appears to affect kidney function and has been previously associated with the risk of hemorrhagic stroke. It is therefore important to know the prevalence of hypertension in children with sickle cell disease and to determine its mechanisms. The factors which could explain this high prevalence are the increase in arterial stiffness and the increase in systemic vascular resistance linked to the alteration of the sympathovagal balance contributing to the regulation of vascular tone. Indeed, a disturbance of this balance with an increase in vasoconstrictor sympathetic tone has already been found. Hypothesis: In a subgroup of sickle cell children there is systemic hypertension (prevalence: main objective) linked to the alteration of the sympathovagal balance already established during sickle cell disease (increase in sympathetic tone and decrease in parasympathetic tone) affecting systemic vascular resistance (secondary pathophysiological objectives).


title: Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine

acronym: GALI

summary:
Glycemic imbalances are very common in shock patients admitted to intensive care units. A blood glucose control every 2 hours is routinely performed in patients requiring insulin therapy. In practice, we use a protocol and management software called "CPG" (Personalized Control of Blood Glucose). This involves taking capillary samples from the fingertips. In addition to the pain generated, local haematomas and sensitivity disorders have been described. Night-time sampling also leads to repeated awakenings. The "CGM GUARDIAN 2" system has been validated for the measurement of glucose in interstitial fluid in insulin-dependent diabetic patients. An electrode is placed on the patient's abdomen or arm for up to 6 days. This electrode consists of a needle that is inserted subcutaneously only during the placement. The sugar level is read using a sensor placed on the electrode and an insulin pump (which will not deliver therapy (for our study) and which will be used only as an information reader to know the glucose level and trends). Interstitial fluid is automatically drawn from the electrode every minute and averaged every 5 minutes.

This device has not yet been validated in resuscitation patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Is Strong Desire to Void an Equivalent of Cognitive Task Affecting Balance in Older Women With Overactive Bladder?

acronym: SURFACE

summary:
Falls have multifactorial etiologies in older people. Lower urinary tract symptoms (LUTS) are one of those, with an increase prevalence over years (30% of people over 75 years old have overactive bladder [OAB]). Previous studies showed that older women with OAB with or without urinary incontinence (UI) are prone to have gait disorders (decrease of gait speed and step width and increase of number of step). Besides UI, it is more likely the strong desire to void (SDV) that seems to impact gait and balance control. In older women with UI, balance on stabilometric parameters have been affected with an increase of the center of pression (COP) sway range, COP area and rambling trajectory. SDV seems to act like an additional cognitive task. A similar and increased reaction time has been observed in comparing with a distracting task in healthy volunteers. In older people who are susceptible to distracting task, SDV may alters balance and gait.

The primary objective of this prospective study is to assess the impact of SDV on stabilometric parameters (center of foot pressure (COP) area, the distance travelled made by COP, the mean X-axis displacement and the mean Y-axis displacement) compared to the "empty bladder" condition.

The secondary objectives are to assess the impact of a cognitive task (verbal fluency) on stabilometric parameters in comparison with the "no cognitive task condition" and the "SDV condition"; to assess the impact of "SDV condition" on balance and gait clinical evaluation (Timed up and go test, unipedal stance test, Berg scale, 10m walking speed, 5 chair stand) Thus, showing that SDV may impact balance in geriatric population will lead to the importance to identify and LUTS as potential fall risk factor in order to decrease falls incidence in this population.


title: Medico Economic Evaluation of Fluocinolone Acetonide Implant Versus Dexametheasone Implant in Resistant Diabetic Macular Oedema

acronym: EMMA

summary:
Diabetic macular oedema (DME) is the main cause of visual impairment (or visual acuity) in patients with diabetic retinopathy, as it leads to progressive thickening of the retina, which in the long term leads to progressive death of the photoreceptor cells. It is therefore important to continue to treat macular oedema that has been progressing for several months or even years (resistant DME).

The management of DME necessarily involves controlling diabetes (improving glycated haemoglobin levels) and blood pressure, but this is often not enough.

Thus, when DME is significant and leads to a decrease in visual acuity, treatments are administered directly into the eye (intravitreal injections). For some years now, corticosteroids have been injected into the vitreous body (the gel that fills the eyeball) through the white of the eye for their anti-inflammatory properties. Indeed, these drugs improve the permeability of the retinal vessels and thus reduce oedema. These intravitreal implants are most often used in patients who have already undergone cataract surgery (pseudophakic) because corticosteroids also tend to aggravate a cataract. Currently, there are two implants containing corticosteroids that can be injected: the dexamethasone implant and the fluocinolone acetonide implant. These two implants have different properties, particularly with regard to their duration of action.

Today, the overall management at 3 years and the quality of life associated with the treatments deserve to be evaluated.

This study is the first multicenter controlled trial comparing the two reference corticosteroid treatments in terms of overall cost of treatment and follow-up and patient quality of life, while considering their efficacy and side effects. This evaluation will make it possible to precisely define the respective place of each implant in the management of resistant DME.


title: Prediction of Lymph Node Invasion in Patients Operated on for Prostate Adenocarcinoma

acronym: PRED-NCHIR

summary: Despite lymph node involvement (LNI) being one of the main prognostic factors in patients with prostate cancer (PCa), pelvic lymph node irradiation remains debated, possibly due to an insufficient selection of patients. Significant advances in LNI risk modelling have been achieved with the addition of visual interpretation of magnetic resonance imaging (MRI) data, but it is likely that quantitative analysis could further improve prediction models. In this study, the investigators aimed to develop and internally validate a novel LNI risk prediction model based on radiomic features extracted from pre-operative multimodal MRI.

lead_sponsor: University Hospital, Brest


title: Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)

acronym: Entero-TAVI

summary:
The general rules of antibiotic prophylaxis in surgery or interventional medicine include the choice of an antibiotic active on the bacteria most frequently encountered in surgical site infections. This antibiotic must cover, the bacteria present on the skin and recognized as responsible for surgical site infections.

The aim of this study is to identify bacteria found in skin flora in the inguinal region of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Flora found will allow to evaluate the impact of skin preparation and antibiotic prophylaxis protocols as they are currently practiced.

lead_sponsor: Clinique Pasteur


title: New Methods of Dynamic Pupillometrics in Subjects With Visual and Color Vision Pathologies for the Detection, Functional Diagnosis and Follow-up of These Pathologies

acronym: PupDyn

summary:
The development of new oculometry techniques allows fine and dynamic measurements of pupillary diameter and use in routine clinical practice.

The preliminary results obtained with innovative devices on healthy sjuets make it possible to envisage a clinical study on a population of patients suffering from retinal pathologies.

This is a "proof of concept" study, which, if the expected results are confirmed, will make it possible to consider a study on a larger population, as well as the industrial development of a commercial device.

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

location_facility: Centre Hospitalier National D'Ophtalùmologie des Quinze-Vingts


title: Impact of Environmental Labelling on Food Choices : a Randomized Controlled Trial in a Virtual Reality Supermarket

summary: A 2-arm randomised control trial (with and without labels) will be conducted to test the effects of an environmental label on food choices in a virtual supermarket. A sample of 130 participants will take part in two shopping tasks: 1/ selection of 3 products to prepare a home-made dish, and 2/ selection of a ready-to-eat dish. These two tasks will be repeated for two scenarios: 1/ participants will be asked to select the foods for usual meals, and 2/ participants will be asked to select the foods for environmentally-friendly meals. This experimental design will allow to compare food choices in the presence vs. the absence of an environmental label and to investigate whether the label is informative and likely to help individuals to choose more environmental-friendly food options when explicitly asked to do so.

ipd_sharing_description: Share on Open Science Framework

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation


title: Multicenter Phase II Study Evaluating the Efficacy and Safety of a Stereotaxic Prostatic Radiotherapy Delivered on Linac MRI, With Integrated Boost in the Case of an Index Tumor, in Patients With Prostate Adenocarcinoma of Favorable, Intermediate or Risky Risk. High Risk Very Localized.

acronym: STEREO-RML

summary:
Stereotaxic prostatic radiotherapy on Linac MRI, with monitoring of movements of the pelvic organs per fraction on the prostate in real time, in 4 sessions, with integrated boost on the index tumor (if it is visible on the diagnostic MRI), could reduce the digestive, urinary and sexual toxicities accumulated at 5 years and guarantee excellent local tumor control, for patients with localized prostate cancer, with a favorable prognosis, intermediate or very local high risk, according to the D'Amico classification.

The benefits that patients participating in this research could obtain are:

Better disease control efficiency
A reduction in the duration of treatment to 4 radiotherapy sessions (2 weeks maximum) instead of 40 sessions (8 weeks) for usual treatment.
Avoid the risks associated with the implantation of prostate markers necessary for stereotaxic radiotherapy on a standard accelerator (anesthetic risks, infectious risks, hemorrhagic risks, pain risks)
Better quality of life

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Radiation


title: PneumoVIH : Prevention of Missed Opportunities for HIV Diagnosis by Promoting HIV Testing of Patients With Pneumococcal Pneumonia at Nice University Hospital

acronym: PneumoVIH

summary: According to usual practices, HIV testing should be performed for each patient diagnosed for pneumococcal pneumonia. Unfortunately, in 2018, only 27% of patients were tested for HIV following pneumococcal pneumonia in Nice University Hospital. The aim of PneumoVIH protocol is to promote HIV testing by reminding good practices to physicians. To achieve this, the team of the bacteriology laboratory will contact physicians for each patient positive for pneumococcal antigenuria to suggest HIV testing. This prospective public health action will aim to integrate this HIV test into routine care and to evaluate benefits through the number of HIV positive patients that will be diagnosed.

ipd_sharing_description: No data sharing is planned


title: Olfactory and Taste Disturbances in Sjogren's Syndrome

summary:
Sjögren syndrome is an autoimmune disease, responsible for xerostomia and xerophthalmia. Other organs and tissues can be affected: the skin, vaginal and nasal mucous membranes. As well, olfactory disorders have been also described in Sjögren syndrome.

Xerostomia often causes significant functional impairment of taste function. Impairment of taste function has been poorly evaluated in Sjögren syndrome like olfactory or (intra-nasal and oral) trigeminal disorders.

lead_sponsor: Université de Reims Champagne-Ardenne


title: Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation

acronym: EPOC

summary: It has been shown that in deaf people, cortical reorganisation occurs and can accelerate age-related cognitive decline. Therefore, even though a number of Cochlear Implantation Reference Centres are setting up tests to detect cognitive disorders, these remain global and not very specific to deafness. Similarly, auditory rehabilitation could make cognitive decline reversible and bring about major changes in the cognitive functioning of patients which will be decisive for the effectiveness of speech therapy and the effectiveness of implantation. Indeed, it has been shown that, in the deaf postlingual patient, less neuronal activity in the auditory cortex and a reallocation of the cortical regions dedicated to auditory processing to visual tasks took place. This could subsequently influence the outcome of the cochlear implant. The aim of this study is therefore to evaluate the effectiveness of targeted speech therapy aimed at cognitive reorganisation on post-implant gain.


title: Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue

acronym: ODCOTA

summary: This research aims at describing the relationship between white adipose tissue inflammation and post-operative cognitive dysfunctions.The possible link between inflammatory cytokines secretions of the white adipose tissue of a surgical wound and the arising of patient's cognitive dysfunction in the post-operative course will be investigated. The hypothesis is that obese patient's inflammation of the white adipose tissue leads to cognitive dysfunction.

lead_sponsor: University Hospital, Toulouse


title: Forensic Dental Age Estimation : Validation of Computed Tomography for Third Mandibular Molar Demirjian's Staging Method in a 0- 25 Years French Living Population

acronym: SCAO

summary:
Age can be estimated in different ways by using skeletal age and dental age. Currently, bone age is determine thanks to the wrist x-rayed, and the dental age using variation in mineralization (Demirjian's score) on the dental panoramic (Mincer 1993).

More recently, reviews indicate the Computed tomography (CT) scan of the medial clavicular epiphysics can contribute to improve the accuracy of individual's age estimation (Houpert, 2016).

Furthermore, with the recent advances, the very low dose CT scan acquisitions can be perform with sufficient quality for the teeth analysis.

The goal of this study is to validate the use of dental CT for Demirjdian's staging method.

lead_sponsor: University Hospital, Montpellier


title: Évaluation de l'Impact du Compressed Sensing Sur le Signal QSM

acronym: CS-QSM

summary:
Patients who have agreed to participate in the study will complete the MRI protocol as part of routine care, to which a maximum of four additional 25-minute sequences will be added.

MRI of routine care includes at least the following sequences:

3D T1 TFE (2 minutes)
T2 TSE (2 minutes)
3D FLAIR (3 minutes)

The sequences added by the research lasting 25 minutes are:

SWI QSM 1.0iso 8 echoes (10 minutes)
SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hhopital fondation adolphe de rothschild


title: Effects of Combining a Neuromuscular Electrical Stimulation Intervention With Nutritional Support in Deconditioned Patients With Advanced Gastrointestinal Cancer - DIG'ELECTROSTIM-01

summary: Dig' Electrostim-01 is phase II, single center (step 1) and multicentre (step 2), single-arm study to evaluate an 8-week NMES intervention combined with nutritional support in addition to usual patient care

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group


title: Assessment of the Impact of Gadolinium Injection on the Measurement of the QSM Signal

acronym: GADO-QSM

summary: Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.


title: Evaluation of the Performance of a 3D FGAPSIR Sequence by MRI in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis

acronym: ESPOIR 2

summary:
verification of inclusion and non-inclusion criteria
information and collection of consent
standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.
3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)


title: Pre TAVI Membranous Septum Measurement Predicts High Grade Iatrioventricular Conduction Disorders in Patients With Specific Pacemaker Implanted After TAVI. The STIM TAVI-MS Study

acronym: STIM TAVI MS

summary: Conduction disturbances are a major complication of TAVI. There is no predictor of post-TAVI conduction disorder. The study of the membranous septum on the pre-TAVI scanner and the valve implantation height are promising and little studied data on the occurrence of post-TAVI conduction disorders.

lead_sponsor: Association de Recherche en Cardiologie des Alpes


title: Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology

acronym: PREMOLF

summary:
At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment. The sensory signals within the mother-infant dyad will lead to behavioural and metabolic adaptations in both individuals. Currently, the conditions of reception of a very premature newborn in the neonatal intensive care unit of the CHU of Nice lead to a separation between mother and child, with a reduction in sensory interactions.

The immediate and long-term consequences of this "sensory rupture" are widely documented in the child, but little studied in the mother.

The hypothesis at the origin of this work is that olfactory stimulations emanating from the newborn would allow a perceptive continuity between the newborn and his mother. In the pathological situation of the birth of a premature child, these stimulations would lead to neurobiological and behavioural modifications in the mother and would play a role in the attachment process.


title: Impact of Specific Monitoring of Intraoperative Analgesia Under General Anesthesia on Chronic Pain After Ovarian Cancer Surgery. The MONIALC Study.

acronym: MONIALC

summary: This is a single-center, randomized, phase II, non-comparative, single-blind clinical study that will determine whether morphine reduction through intraoperative monitoring by ANI (Analgesia Nociception Index) significantly reduces chronic post-surgical pain at three months after laparotomy for ovarian carcinoma with regard to standard care.

lead_sponsor: Institut Bergonié


title: Contribution of Virtual Reality on Patient Satisfaction in Ambulatory Orthopedic Surgery

acronym: SATISVIR

summary: Few studies were interested in the patient satisfaction after ambulatory surgery. Most of them showed negative results due to psychological factors. The intervention including surgery and hospitalization is still perceived as painful memory for most of patients. Several improving axes have been explored to change global patient experience. One new idea could be to offer a virtual reality experience during the surgery or local regional anesthesia. Some studies showed that immersive experience can reduce the anxiety, the pain, improve the patient comfort and recovery after surgery. The virtual reality is commonly used but it has to be evaluated in terms of efficiency with a prospective study and objective outcomes to go further in the improvement of the experience and the care offer to patients.

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


title: Prospective Multi-center, Single-arm Registry to Evaluate the Efficacy of the Solitaire AB Neurovascular Remodeling Device in the Treatment of Wide-neck Intracranial Aneurysms

summary: The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.

status: Withdrawn

lead_sponsor: Medtronic Neurovascular Clinical Affairs


title: Involvement of Perilipin-1 Variants in Precocious Acute Coronary Syndrome

summary: This study aims to identify a genetic predisposition factor of precocious acute coronary syndrome occurrence (ACS). ACS is a major public health problem and the first cause of mortality in the world. It can be due to several risk factor such as heredity. the investigators make the hypothesis that occurrence of early ACS (defined as <50yo for men and <55yo for women) could be the initiatory event of a mild form of genetic lipodystrophy . Our previous study shown an occurrence risk of ACS about 8.3 in patients carrying a mutation in the PLIN1 gene versus patients without a mutation. The PLIN1 gene encode for perilipin 1 protein localized on the lipid droplet surface. This protein phosphorylation activates the triglycerides lipolysis. Our goals in this study are multiple: to validate the high frequency of mutations in this gene in patients with early ACS, to determine differences in triglycerides metabolism and also relapse rate between carrier and non-carrier patients of mutation in PLIN1. Our first aim will be to carry out the inclusion of 200 patients with precocious ACS. This will allow us to obtain around 15 patients carrying a mutation in the PLIN1 gene based on our previous study. the investigators will reprogramme patients' cells (carrying or not a PLIN1 mutation) in human Induce Pluripotent Stem cells (hIPSc). These hIPSc will be differentiated in cell types of interest as adipocytes or macrophages. the investigators will then study triglycerides metabolism (lipid droplet formation, localization and phosphorylation of perlipin 1) in these cells and atheroma plaque formation. Finally, the investigators will study clinical data such as relapse rate and searching for correlation with PLIN1 mutation.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Genetic


title: Fetal Microchimerism and Fetal Stem Cells in Breast Cancer: Analysis of Circulating Fetal Cell Sub-populations in Women With Breast Cancer. CIRCULATING FETAL CELLS AND BREAST CANCER

summary: After pregnancy, fetal cells remain in a woman's body for years. These cells may be involved in different physiological situations (e.g. wound healing) and diseases (e.g. cancer).The study will evaluate the level of circulating fetal immune cells in patients with breast cancer vs controls with benign breast tumors, and further characterize these fetal cells. Patients participation will be limited to accepting that an additional blood sample is collected on the day of their preop consultation and blood test.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital de Tenon-Service de Gynécologie Obstétrique et Médecine de la Reproduction


title: Epidemiology of ICU-acquired Infections in Patients With Fecal Carriage of Extended Spectrum Betalactamase Enterobacteriaceae (ESBL-E)

acronym: BMREA

summary:
Worldwide emergence of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) had become a major problem in ICU, with at least 10% of incidence at the admission in Europe. A systematic rectal swab is used in 70% of French ICU to detect intestinal ESBL-E carriage The relationship between intestinal carriage and ICU-acquired infection is not perfectly known. The investigators conducted a five years study monocentric retrospective observational cohort in patients with presence of extended-spectrum β-lactamase-producing Enterobacteriaceae in systematic rectal swabs to investigate which type of infections and which bacteria are involved.

The investigators also collect data about antibiotherapy used to treat these infections.


title: Comparison of the Use of Conventional Ancillary Reaming and Single-use Ancillary Reaming Material in Total Hip Replacement

acronym: LUUC

summary:
The main objective of the study is to compare the use of single-use ancillary reaming material during total hip replacement and conventional reusable ancillary reaming material.

The assessment will focus on the medico-economic differences found in this prospective randomized study

lead_sponsor: University Hospital, Clermont-Ferrand


title: Can the Affects Conveyed by Baroque Music and Its Rhetoric Reduce Anxiety in Patients With Major Depressive Disorder Associated With Anxiety Symptoms?

acronym: BARHEPSY

summary:
Major depressive disorder, or characterized depressive episode, is a common illness that limits psychosocial functioning and impairs quality of life. The initial goal of treatment for a major depressive episode is complete remission of depressive symptoms. The most commonly used treatments are antidepressants, psychotherapy or a combination of medication and psychotherapy.

Music therapy can be considered as one of the complementary therapies in the treatment of the characterized depressive episode and many studies have shown a beneficial effect of musical interventions, even of short duration, on depression and anxiety.

In depressive disorders, therapies such as hypnosis or phenomenological psychotherapies lead to modifications of consciousness during which the subject finds the means, notably non-reflexive and in the realm of the imaginary, to overcome anxiety.

Generally speaking, in the field of musical cognition, it is considered that music affects the emotions. Unfortunately this approach is often insufficiently refined in cognitive psychology since it is most generally interested in the 6 fundamental emotions: joy, anger, fear, sadness, surprise, disgust. However, during the Baroque period (end of the 16th and 17th centuries), various philosophers and musicians analyzed with great finesse not these fundamental emotions, but more precisely the passions, or "shocks of the soul", that is to say the affects in their great diversity. These affects or passions are thus at the center of Baroque musical composition.

In the Barhepsy project, it is suggested that listening to Baroque music, thanks to the rhetoric of the passions included in it, would allow the mobilization of the patients' affects and thus reduce their state of anxiety. During a follow-up consultation, the effects of a 30-minute "musical path" of baroque pieces will be evaluated, exemplifying the reduction of anxiety and the subsequent appeasement, on the conscious experience of subjects suffering from a characterized depressive state associated with anxious symptoms.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer


title: Assessment of the Impact of Acquisition Time, Respiratory Gating and New Qclear Reconstruction Modalities on the Quantification of Dosimetry in Selective Internal Radiotherapy

acronym: PYR

summary: Post-processing of Positron Emission Tomography (PET) acquired images, performed following radioembolization treatment with microspheres at 90Y in hepatocellular carcinoma patients, is subject to changes commercialized by General Electric : respiratory motion correction, specific reconstruction algorithms. We propose to test the possible combinations of these reconstruction parameters to determine which ones to apply for an optimal quality exam with the shortest scan time possible

lead_sponsor: University Hospital, Bordeaux


title: Effects of Enriched Gardens on Cognition and Independence of Nursing Home Residents With Dementia: a Cluster-controlled Trial

summary: Comparing the effect of the frequentation of an enriched garden vs sensory conventional garden by nursing home residents with Alzheimer disease. The effects will be evaluated as regards to cognitive impairment (MMSE), autonomy (ADL) and prevention of falls (Unipodal stance and UpandGo Test)

ipd_sharing_description: IPD will only be available to study reviewers

lead_sponsor: RIVAGES

location_facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université


title: French Version of the Short Form of Neurogenic Bladder Symptom Score: Cross-Cultural Adapta-tion and Validation.

summary:
Lower urinary tract symptoms (LUTS) are frequent in worldwide population. In neurogenic condition, LUTS can occur from beginning of neurologic disease (SCI, MS) or during its progression (MS). Neurogenic bladder may be responsible for upper urinary tract complications such as urinary tract infection or renal failure. It can also decrease quality of life and have an important socio-economic impact. For the last few years, patient-reported outcomes (PRO) have been the main way to assess functional urinary symptoms such as urinary incontinence or overactive bladder. Fortunately, Welk and al. developed and validated a new questionnaire in 2013 to allow a multimodal evaluation of LUTS specifically designed for a neurogenic population. The Neurogenic Bladder Symptom Score (NBSS) is composed of 24 items and explores 3 domains (urinary incontinence, bladder storage and voiding, consequences). In addition, NBSS includes two additional questions related to bladder management and quality of life. In 2020, Welk and al. developed a short version of NBSS (NBSS-SF), composed of 10 items exploring the 3 same domains as the NBSS original long version. However, there is no French-validated multi-dimensional questionnaire specifically assessing neurogenic LUTS, the USP questionnaire being a generic tool (Urinary Symptoms Profile (USP)).

The objective of our study was to validate the French linguistic version and the cross-cultural adaptation of the NBSS-SF.

METHODS:

The investigators conducted a prospective monocentric study between June and October 2020 in our neuro-urology clinic.

Step 1, translation and back-translation:

With the author's agreement, two bilingual translators (fluent in English and native French) created a French version of the NBSS. Both versions were combined and disagreement in wording or item redaction were resolved to maintain a better understanding. Next step was the back-translation with an native English translator.

Then, a bilingual expert committee, composed by urologists and neuro-urologists, compared the different versions to create a pre-final version of the questionnaire. Cross-cultural equivalence with analysis of the semantic, idiomatic, conceptual, and empirical equivalence of the source and pre-final versions of the NBSS-Short Form have been validated by the expert committee.

Step 2, Pilot study : n = 30 subjects. During this pilot study, acceptability and understanding were evaluated. Participant had to answer with a 3 level Likert scale (A: perfectly; B: good; C: poor) for each item. Comprehension and acceptation were considered as good if they answered A or B. All difficulties and remarks were collected to incorporate these comments in the final version after validation by a panel of experts.

Step 3, Validation stud:

To perform validation study, the investigators used the same inclusion criteria than Welk and al. and included patients with a neurogenic bladder due to multiple sclerosis (MS), spinal cord injury (SCI) or other neurologic condition such as spina bifida or Parkinson disease.

Validation study was performed to determine the psychometric properties of the questionnaire.

The investigators calculated the Cronbach's α coefficient, a measure of internal consistency (reliability) ranging from 0-1, with a coefficient greater than 0.7 considered as very good. The NBSS-short form is composed of 2 first items (covering quality of life and bladder management) and 8 items covering 3 subdomains (items 3, 4, 5 for urinary incontinence, items 6, 7, 8 for storage and voiding) and finally 2 items covering the consequences. The investigators calculated a Cronbach's α coefficient for each subscale and a coefficient for the whole questionnaire.

For test-retest reliability, the intraclass correlation coefficient (ICC) has been used. An ICC greater than 0.7 is considered as a good test-retest reproducibility. Participants completed the final version of the questionnaire and they had to mail the second questionnaire within 7 to 14 days. As this second questionnaire was completed at home, all participants were called to avoid missing data.

Correlations were computed between NBSS-SF scores obtained overall and for each domain on two different occasions, separated by a 7-14-day interval.

lead_sponsor: Pierre and Marie Curie University


title: Prevalence of Internet Addiction Among Adolescent

acronym: ADDICT-NET

summary:
Internet is now a tool available 24 hours a day, at a lower cost and accessible almost anywhere. Internet addiction could be defined as the inability to control one's Internet use and the continuation of this behavior despite the occurrence of negative consequences.

Adolescence is a time of vulnerability to addiction, due to social and neurobiological factors.


title: Role of Mechanical Load on Metabolic Exercise Adaptations in Response to Weight Loss in Obese Adolescents: The POWELL Study

acronym: POWELL

summary: While interdisciplinary weight loss intervention have been shown successful among adolescents with obesity, a weight regain is most of the time observed within the following weeks or months. The aim of the present project will be to better identify the independent role played by both the metabolic and mechanical load and their modification during weight loss, on the energy expenditure and energy metabolism of adolescents with obesity.


title: Feasibility of a Multi-site Screening Strategy in HPV+ Patients at High Risk of Cancer, With Characterization of the HPV Subtypes Involved by High Throughput Sequencing Technique: DEP-HPV

acronym: DEP-HPV

summary: The main risk of developing cervical cancer is the persistence of an High risk human papillomavirus (HPV-HR) infection, the mechanisms of which are still not understood. These chronically infected patients could develop multi-site lesions. The main objective is to assess the feasibility of setting up a personalized screening in patients at high risk of cervical cancer (chronically infected with HPV), by evaluating documenting the acceptability of these patients to be sampled from the ENT sphere and anal spheres for HPV analysis with next-generation sequencing.


acronym: ARNCOMBI

type: EudraCT Number

source: euctr

title: Multicenter, Randomized, Open-label Trial Comparing the Immunological Efficacy of a Vaccine Regimen Combining Two Covid19 mRNA Vaccines (Pfizer-BioNTech and Moderna) With That of a Homologous Vaccination of Each Covid19 mRNA Vaccine: Non-inferiority Trial

summary:
As part of the COVID 19 vaccine campaign, the two mRNA vaccines, BNT162b2 (COMIRNATY®) and mRNA-1273 COVID-19 vaccine Moderna, are administered in two doses in subjects without a history of SARS-CoV-2 infection . In accordance with the marketing authorization for vaccines, HAS recommends that subjects who have received one dose of an mRNA vaccine receive a second dose of the same vaccine with an interval between the 2 doses of 4 to 6 weeks. These two vaccines are based on very similar technologies but were developed independently. Given the similarities between these two vaccines, the choice between the two, for the moment, is based solely on the availability of doses and on logistical constraints. Since April 14, the interval between the two doses of the mRNA vaccines is 42 days.

WHO has announced that in the absence of available data, vaccine interchangeability cannot be recommended. However, to facilitate the organization of the vaccination campaign and allow faster vaccination of the population, it would be desirable to be able to use either one or the other mRNA vaccine for the 2nd dose.

In order to be able to recommend the interchangeability of the 2 mRNA vaccines, it is proposed to evaluate the immunogenicity of a scheme combining the two Covid 19 mRNA vaccines (i.e. a 2nd dose of vaccine with the Moderna vaccine after a first dose of the Pfizer vaccine or 2nd dose of Pfizer vaccine after a first dose of Moderna vaccine) compared to that of a standard vaccination schedule with two doses of the same Covid 19 mRNA vaccine.


title: Behavioral Adaptation to Negative and Positive Social Signals in Healthy Volunteers

summary:
Social interactions are part of our daily lives. Communicating with others is a recurring choice which is based on emotional cues, such as facial expression. Our action must be adapted to the emotional state of our interlocutor, otherwise the investigators will have poor quality interactions An emotional stimulus would cause a conditioned response (innate reaction). Thus, the presence of an angry person would automatically trigger flight behavior. More recently, however, it has been envisioned that this same avoidance behavior could be the result of a goal-directed behvior. In this case, the avoidance behavior would be the result of an evaluation of the consequences of the selected action. These goal-directed behaviors are guided by a mental representation of consequences The project aims to study behavioral choices (approach and avoidance) in response to negative and positive social cues (anger and joy) in 40 healthy volunteers using a computerized neuropsychological task, and to determine wheter these choices are the result of goal-directed behavior.

The study also aims to assess the modulation of behavioral adaptation by the level of impulsivity, lonilness, empathy, and by the capcity to understand others' intenstions.


title: ODORAJA:Evaluation of the Impact of Chemotherapy on Body Odor in Adolescents and Young Adults in Oncology

acronym: ODORAJA

summary: The appearance of unpleasant body odors in adolescent Young adult (aya) wille be evaluated undergoing chemotherapy

lead_sponsor: Institut Curie


title: Compares Changes in Pulmonary ITV Secondary to Vascular Filling to Reference Values Represented by Changes in Subaortic ITV in the Management of Sepsis in the Emergency Department.

acronym: CIAOP

summary:
This is a multicenter study conducted in the emergency department of the Nantes University Hospital and the Confluent Private Hospital, over a period of 5 months, based on hemodynamic ultrasound.

For each patient admitted to an emergency department with a sepsis syndrome requiring vascular filling, the pulmonary ITV and the aortic ITV were measured at each phase of vascular filling.

This is a non-interventional study, the management of patients will not differ from usual practices and vascular filling should not be delayed in any case. Emergency doctors who are already experts in ultrasound, monitoring vascular filling by measuring the aortic ITV, will have to measure the pulmonary ITV after each filling of 250cc of Ringer's Lactate in 10 minutes with a limited amount of time.

The evolution of ITV measurements and vital parameters should be recorded for each patient.

In order to ensure quality, the emergency doctors will first receive a short training (presentation of the study and review of the measurements requested). In addition, measurement records will be analyzed at random.

At the end of this study, the correlation between the variation of the aortic and pulmonary ITV could be compared. The objective would be to promote the monitoring of these unstable patients via the pulmonary ITV. This measurement would be easier to perform than the aortic ITV, which is currently only performed by emergency doctors who are experts in hemodynamic ultrasound.

lead_sponsor: Nantes University Hospital


title: MEDIBIOTE 3: Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

acronym: MEDIBIOTE 3

summary:
Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs. Classically, SpA has been classified into several subtypes, such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD)-associated.

Several studies have shown specific changes in the gut microbiota during SpA. A recent, uncontrolled study suggested that the therapeutic response to anti-TNFα (Tumor Necrosis Factor) therapy could be predicted by analysis of the gut microbiota.

The purpose of the study MEDIBIOTE 3 is to confirm that in SpA, the composition of the intestinal microbiota at the initiation of treatment is predictive of the response to treatment with biotherapy (anti-TNFα / anti-IL17).

lead_sponsor: Hôpital Européen Marseille