title: Evaluation of the Effect of the Implementation of a Candida PCR Diagnosis Strategy on the Time Required to Obtain Results in Patients From Intensive Care Units With Suspected Systemic Invasive Candidiasis: Pilot Study

acronym: CANDI-PCR

summary: The aim of this study is to evaluate the implementation of a new technique for invasive candidiasis diagnosis by PCR. The main objective will be to evaluate the effect of this strategy on the time required to obtain results in patients from intensive care units with suspected systemic invasive candidiasis. This PCR method could allow an antifungal switch to be made earlier, limiting the appearance of resistance and reducing the cost of antifungals for healthcare facilities.

lead_sponsor: University Hospital, Toulouse


title: From Genetics to Transcriptomics to Unravel the Mechanisms Behind a Poor Outcome in Multiple Sclerosis

acronym: OUTCOMS

summary: MS is a heterogeneous disease either in its response to treatment or clinical manifestation. Indeed, the natural history of MS is varying from a benign condition to a devastating and rapidly incapacitating disease. Clinical heterogeneity could also be cellular and / or molecular. The aim is to identify from OMIC analyses, at the early stage of the disease, differentially expressed molecules and / or cell subpopulations derived from CD8 + T lymphocytes and / or CD4 + T lymphocytes and / or B lymphocytes and monocytes from patients with aggressive versus non-aggressive, compared to a cohort of healthy controls

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Nantes University Hospital

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Artificial Intelligence With DEep Learning on COROnary Microvascular Disease

acronym: AIDECORO

summary: Despite the progress made in the management of myocardial infarction (MI), the associated morbidity and mortality remains high. Numerous scientific data show that damage of the coronary microcirculation (CM) during a STEMI remains a problem because the techniques for measuring it are still imperfect. We have simple methods for estimating the damage to the MC during the initial coronary angiography, the best known being the calculation of the myocardial blush grade (MBG), but which is semi-quantitative and therefore not very precise, or more precise imaging techniques, such as cardiac MRI, which are performed 48 hours after the infarction and which make the development of early applicable therapeutics not very propitious. Finally, lately, the use of special coronary guides to measure a precise CM index remains non-optimal because it prolongs the procedure. However, the information is in the picture and this information could allow the development of therapeutic strategies adapted to the patient's CM. Indeed, the arrival of iodine in CM increases the density of the pixels of the image, this has been demonstrated by the implementation in 2009 of a software allowing the calculation of the MBG assisted by computer. But the performances of this software did not allow its wide diffusion. Today, the field of medical image analysis presents dazzling progress thanks to artificial intelligence (AI). Deep Learning, a sub-category of Machine Learning, is probably the most powerful form of AI for automated image analysis today. Made up of a network of artificial neurons, it allows, using a very large number of known examples, to extract the most relevant characteristics of the image to solve a given problem. Thus, it uses thousands of pieces of information, sometimes imperceptible to the naked eye. We hypothesize that a supervised Deep Learning algorithm trained with a set of relevant data, will be able to identify a patient with a pejorative prognosis, probably related to a microcirculatory impairment visible in the image.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Grenoble


title: Acquisition and Retention of Motor Memories in Adults and Typically Developing Children. IRM f Study

acronym: MOTORMEMO

summary: Our motor skills require motor memories without which our behavior is only reflexes and stereotypies. The way which these memories form in the human brain constitute therefore a major challenge for neuroscience research. Some a lot of evidence suggests that any new motor skills is acquired in the cerebellum and then persisted in the cortex. This vision seems however caricature, the formation of memories motor probably requiring complex remodeling of cortico-cerebellar networks. The MotorMemo project aspires to better understand this remodeling, by testing more specifically the hypothesis of cerebellar weakening and strengthening cortical as a substrate for the formation of motor memories. A longitudinal study using a sensorimotor adaptation protocol, fMRI as well as a developmental perspective is proposed to verify this hypothesis.

status: Unknown status

sponsor_collaborators:
University Hospital, Grenoble
TIMC-IMAG

status_simplified: Unknown


title: IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex

summary:
Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia.
Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure.
The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery
Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist.
Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner.
The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Drug


title: Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event

acronym: SPRING

summary:
The objective is to demonstrate if there is no increase in the risk of Sars-Cov-2 salivary carriage 7 days after a concert in the group participating in the event compared to a non participating group who stayed at home.

The hypothesis is that a systematic screening of Sars-Cov-2 within the 3 days before the event allows to control the risk of transmission and prevent cluster of transmission during the concert.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Delaugerre C, Foissac F, Abdoul H, Masson G, Choupeaux L, Dufour E, Gastli N, Delarue SM, Nere ML, Minier M, Gabassi A, Salmona M, Seguineau M, Schmitt S, Tonglet S, Olivier A, Poyart C, Le Goff J, Lescure X, Kerneis S, Treluyer JM; SPRING study group. Prevention of SARS-CoV-2 transmission during a large, live, indoor gathering (SPRING): a non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2022 Mar;22(3):341-348. doi: 10.1016/S1473-3099(21)00673-3. Epub 2021 Nov 26.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: PRODISS WEEZEVENT

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
PRODISS
WEEZEVENT

intervention_type: Diagnostic Test

status_simplified: Completed


title: Immunomonitoring and Multiple Myeloma: Impact of Lenalidomide on Immune Checkpoint

acronym: IMMUNO-MYELO

summary:
The myeloma microenvironment is the target of many drugs in development, and it is unclear how they can be combined with reference treatments such as lenalidomide. This pilot study consists of an extensive phenotypic characterisation of the impact of lenalidomide combined with dexamethasone on the bone marrow microenvironment of a homogeneous cohort of non-pretreated MM patients. Blood sampling will be systematically performed in a matched fashion to monitor the general effect of lenalidomide on the immune system and to detect possible peripheral markers.

This study will provide rational guidance for future combination therapies with lenalidomide.

lead_sponsor: Rennes University Hospital


title: Biological Collection for the Study of the Relationship Between the Biological Profiles Observed and the Clinical Evolutions Within the Same Cluster of Transmission of the Coronavirus SARS-CoV-2

acronym: COVIDCOLLECT

summary:
The hypothesis is that from a cluster defined by a confirmed positive case of COVID-19 and its contact cases, it is possible to study the different expressions and clinical evolutions of COVID-19 infection and to explore the biological profiles related to the observed clinical history. Certain biological determinants (virological, immunological, microbological or gentic) could indeed be correlated with the clinical presentation and/or be useful for personalized care.

The main objective is to study the relationship between the biological profiles observed and the clinical evolutions within the same cluster of transmission of the coronavirus SARS-CoV-2 (positive COVID-19 cases and contact subjects).

study_start_date_type: Anticipated

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Biological


title: Reduction of Breast Enlargement Using the Da Vinci Xi Robot

acronym: R-HTM-R

summary:
Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove.

The expected result is to achieve a reduction in breast enlargement with no visible scar using Da Da Vinci Xi robot.

primary_purpose: Device Feasibility

lead_sponsor: Ramsay Générale de Santé

sponsor_collaborators:
Ramsay Générale de Santé
Hôpital Privé d'Antony - Dr Dunet

intervention_type: Procedure

lead_sponsor_type: industriel


title: Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix

summary:
Phase 1:

25 patients with a PCR-based diagnosis of Covid-19 will be be included to give 500 microliters of saliva and a 3 ml sample of blood for proteomic analysis; a drop of blood will also be put in a device connected to a silica matrix to perform spectrometric analyses. 25 patients with a non-Covid-19 respiratory infection will be included for the same samples. The proteomic analyses will be performed from classicaly draught blood, blood drop on silica, and saliva, to search for discriminating profiles between Covid-19 and non-Covid-19.

Phase 2:

150 patients with a suspected Covid-19 will be included at the same time than the Covid-19PCR is performed ; they will have a sample of saliva and of a drop of blood for proteomic analysis, whose results will be matched with PCR results.

intervention_type: Device


title: Evaluation of Predictive Factors for Right Ventriculaire Dysfunction Post Implantation of Left Mono Ventricular Assistance in Patients in Cardiogenic Shock Under Veno Arterial ECMO

acronym: ECPELLA

summary: An observational study of patients in cardiogenic shock under veno-arterial ECMO is designed to describe the clinical, ultrasound and hemodynamic parameters of these patients and to establish a predictive score for right-sided dysfunction in a patient within 48 hours of ECMO withdrawal after placement of IMPELLA®.


title: Protocol Validation of Dynamometric Measurement of Passive Inter-segmental Stiffness and Spasticity in Children With Cerebral Palsy: (DYNA_PC)

summary:
Cerebral palsy (CP) refers to a group of movement and posture disorders responsible for activity limitation due to brain damage that occurs during fetal development or during the first year of a child's life.

Given the multitude of treatment options available, the choice of treatment is a key determinant that greatly influences the potential for improvement in motor function. This choice is based in particular on a diagnosis resulting from the comparison of a Clinical Gait Analysis (CGA) and a clinical examination, carried out by a practitioner, aimed at evaluating as accurately as possible the deficiencies present in children with CP.

During the latter examination, passive inter-segmental stiffness and spasticity, both limiting factors in the mobility of the child with CP, are assessed. However, there are significant uncertainties in these measurements, which depend, among other things, on the examiner's feelings. The enrichment of this clinical assessment therefore requires the introduction of quantitative and objective measures. Portable dynamometers are increasingly used to measure the resistance of a joint during passive solicitations.

Thus, both passive inter-segmental stiffness and spasticity can be characterized using instrumental methods. However, in the majority of studies proposed in the literature, the biomechanical computational model used is not unified with that of the CGA, thus altering the approximation of the parameters measured on the table with those estimated during gait. However, in order to evaluate the extent to which these phenomena occur during gait, it is important to follow the same biomechanical calculation procedure.

Thus, our team proposes a new dynamometric measurement protocol for passive inter-segmental stiffness and spasticity adapted to the PC child. Nevertheless, in order to guarantee the reliability of the measurements, manual dynamometric solicitation methods must follow standardized protocols, and their psychometric properties must be defined before they can be used in clinical practice. This is why we wish to study the reliability of this new solution for dynamometric quantification of passive inter-segmental stiffness and spasticity in children with CP.

primary_purpose: Screening

lead_sponsor: Fondation Ellen Poidatz


title: Gastrointestinal Tolerance Assessment of T2309

acronym: GATA

summary: Gastrointestinal Tolerance assessment of T2309 compared to a food supplement in 50 subjects.

primary_purpose: Treatment

lead_sponsor: Laboratoires Thea


title: Relationships Between Sleep Spindle and Cognitive Process in Healthy Adults

acronym: FUSO

summary: Meta-analyses demonstrate that sleep spindles, characterizing NREM sleep, may be a physiological index of high-level cognitive processes. The aim of the study is to determine if sleep spindles can predict interindividual variation in attention and cognitive performance. Relationship between attention and cognitive performance and sleep spindles characteristics (density, frequency and amplitude) recording during 1 night in 80 healthy subject (aged between 18-75y), will be calculated.

lead_sponsor: University Hospital, Bordeaux


title: Efficiency of the Use of Benevolent Memories in the EMDR Protocol in Complex Psychotrauma (Benevolence Study)

summary: This study wants to demonstrate the effectiveness of combining a positive memory with "recommended" therapy based on EMDR in reducing the disturbance that patients with complex psychotrauma may experience. The positive memory will be called "benevolent memory" (SB) or "less worse memory" (SMP).

primary_purpose: Other

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


title: Female Sexual Function and Sexual Quality of Life After Cystectomy or Urinary Diversion in Patients With Non-malignant Disease

acronym: FSFAC

summary:
Cystectomy with bladder replacement, with or without urinary diversion, is the preferred treatment option for benign pathologies responsible for neurogenic bladder or sphincter dysfunction after failure of conservative treatments.

This surgery has both the objective of preventing urological complications and improving quality of life.

We know that women are especially affected by these conditions, as demonstrated by the high prevalence of demyelinating diseases such as multiple sclerosis in this population. Patients are often young and sexually active before the surgery.

Despite the existence of validated evaluation tools since the early nineties, there is poor data exploring effects of invasive procedures such as cystectomy on sexual activity and quality of sexual life in female patients.

Indeed, existing literature largely focuses on sexual function in male population after cystectomy for urothelial cancer.

Data on sexual function after stoma formation in women with colorectal cancer show a significant change after the surgery, partly due to body image issues. We can easily suppose that there's also an important impact of cystectomy that may affect sexual quality of life.

Thus, the objective of the study is to assess sexual function and determine factors that may influence sexual quality of life in female patients following cystectomy or urinary diversion.

time_perspective: Other

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Lyon Sud (Hospices Civils de Lyon)


title: Evaluation of Performances and Safety of the Medical Device Blueback® Physio for Patients With Chronic Low Back Pain

acronym: ABC-TRACC

summary: The main objective of this clinical investigation is to show the superiority of a rehabilitation based on the use of Blueback® Physio compared to a rehabilitation without the use of Blueback® Physio in terms of reducing the time needed for a patient to control the voluntary contraction of the transversus abdominal muscle and to return to autonomy.

lead_sponsor: Blueback

sponsor_collaborators:
Blueback
Slb Pharma


title: Evaluation of the Effect of Neurofeedback Targeting EEG Theta / Beta Activities on the Strengthening of Wakefulness Maintenance Capacities and Cognitive Performance.

acronym: NEUROWAKE

summary: Neurofeedback is a cognitive remediation technique that allows a subject to learn to regulate their cognitive and brain activity through information provided in real time about their brain activity, in particular electroencephalographic (EEG) brain activity. Neurofeedback could, through its impact on the degree of neuronal synchronization, help to reduce the impact of sleep deprivation on wakefulness and cognitive performance. The main objective is to study the effect of a program of 8 sessions of neurofeedback targeting EEG theta / beta activities, to modify the degree of neuronal synchronization, on the ability to maintain objective wakefulness measured by a maintenance wakefulness test (MWT) in healthy subjects presenting objective excessive daytime sleepiness after a full night of sleep deprivation under controlled experimental conditions. The objective of this study will also provide a better understanding of the learning modulation mechanisms of arousal systems.

intervention_type: Behavioral


title: Study of Musical Perception and Post-operative Auditory Performance as a Function of the Depth of Stimulation in Subjects Implanted With a MED-EL Cochlear Implant and Using a FineHearing Strategy Single-center Randomized Cross-over Study

summary:
Main objective:

Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the apical areas) is greater.

Secondary objectives:

Evaluate the effect of stimulation depth on vocal audiometric results, results of differential frequency threshold test and on qualitative sound perception.

lead_sponsor: MED-EL Elektromedizinische Geräte GesmbH


title: Monitoring and Pharmacodynamics Effect of Recombinant Factor IX Fc in Severe Haemophilia B Patients: a Real-life Study

acronym: BIOPAL

summary: The purpose of this study is to evaluate the performance of different methods for measuring factor IX activity levels in haemophilia B patients treated with eftrenonacog-alfa and assess its pharmacodynamics (PD) in a real-life setting.

ReferenceType: background

ReferenceCitation: Peyvandi F, Garagiola I, Boscarino M, Ryan A, Hermans C, Makris M. Real-life experience in switching to new extended half-life products at European haemophilia centres. Haemophilia. 2019 Nov;25(6):946-952. doi: 10.1111/hae.13834. Epub 2019 Aug 16.

ReferenceCitation: Sommer JM, Buyue Y, Bardan S, Peters RT, Jiang H, Kamphaus GD, Gray E, Pierce GF. Comparative field study: impact of laboratory assay variability on the assessment of recombinant factor IX Fc fusion protein (rFIXFc) activity. Thromb Haemost. 2014 Nov;112(5):932-40. doi: 10.1160/TH13-11-0971. Epub 2014 Aug 21.

ReferenceCitation: Kitchen S, Tiefenbacher S, Gosselin R. Factor Activity Assays for Monitoring Extended Half-Life FVIII and Factor IX Replacement Therapies. Semin Thromb Hemost. 2017 Apr;43(3):331-337. doi: 10.1055/s-0037-1598058. Epub 2017 Mar 6.

ReferenceCitation: Dargaud Y, Beguin S, Lienhart A, Al Dieri R, Trzeciak C, Bordet JC, Hemker HC, Negrier C. Evaluation of thrombin generating capacity in plasma from patients with haemophilia A and B. Thromb Haemost. 2005 Mar;93(3):475-80. doi: 10.1160/TH04-10-0706.

ReferenceCitation: Bowyer AE, Shepherd MF, Kitchen S, Maclean RM, Makris M. Measurement of extended half-life recombinant factor IX products in clinical practice. Int J Lab Hematol. 2019 Apr;41(2):e46-e49. doi: 10.1111/ijlh.12953. Epub 2018 Dec 7. No abstract available.

ReferenceCitation: Collins PW, Fischer K, Morfini M, Blanchette VS, Bjorkman S; International Prophylaxis Study Group Pharmacokinetics Expert Working Group. Implications of coagulation factor VIII and IX pharmacokinetics in the prophylactic treatment of haemophilia. Haemophilia. 2011 Jan;17(1):2-10. doi: 10.1111/j.1365-2516.2010.02370.x. Epub 2010 Aug 22.

ReferenceCitation: Srivastava A, Brewer AK, Mauser-Bunschoten EP, Key NS, Kitchen S, Llinas A, Ludlam CA, Mahlangu JN, Mulder K, Poon MC, Street A; Treatment Guidelines Working Group on Behalf of The World Federation Of Hemophilia. Guidelines for the management of hemophilia. Haemophilia. 2013 Jan;19(1):e1-47. doi: 10.1111/j.1365-2516.2012.02909.x. Epub 2012 Jul 6.

location_facility: Service d'hématologie biologique - Hôpital Cochin


title: Impact Des Performances Cognitives et métacognitives Sur l'Apprentissage de Connaissances Lors de la réalisation de Programmes d'éducation thérapeutique

acronym: MetaCOGNITION

summary: People with schizophrenia and bipolar disorder display alterations in cognition and metacognition. These alterations may have an impact on learning during therapeutic education programs.

primary_purpose: Supportive Care

ReferenceCitation: Xia J, Merinder LB, Belgamwar MR. Psychoeducation for schizophrenia. Cochrane Database Syst Rev. 2011 Jun 15;2011(6):CD002831. doi: 10.1002/14651858.CD002831.pub2.

ReferenceCitation: Soo SA, Zhang ZW, Khong SJ, Low JEW, Thambyrajah VS, Alhabsyi SHBT, Chew QH, Sum MY, Sengupta S, Vieta E, McIntyre RS, Sim K. Randomized Controlled Trials of Psychoeducation Modalities in the Management of Bipolar Disorder: A Systematic Review. J Clin Psychiatry. 2018 May/Jun;79(3):17r11750. doi: 10.4088/JCP.17r11750.

ReferenceCitation: Flavell J.H. Metacognition and cognitive monitoring. A new area of cognitive-developmental inquiry. Am Psychol. 1979; 34(10):906-11

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux


title: Impact of a Monoamine Oxidase Inhibitor on the Phenotype of Blood Mononucleated Cells in Patients With COVID-19

summary: The principal objective is to determine the impact of phenelzine on the activation phenotype of T cells and myeloid cells during SARS-CoV2 infection


title: Interest of Thromboelastometry as a Biomarker of Post-thrombolysis or Post-thrombectemia Revascularization Success in Ischemic Stroke: a Prospective, Single-center, Observational Study in an Emergency Department

summary: In ischemic stroke, the recanalization rate after intravenous thrombolysis has been estimated to be less than 50% in patients with proximal intracranial artery occlusion; this rate is greater than 80% after endovascular thrombectomy. Thromboelastometry is a method of analysis of coagulation and fibrinolysis in whole blood. The main objective of this study is to evaluate whether the parameters obtained by thromboelastometry are predictive of revascularization at arteriography during mechanical thrombectomy, after treatment with rt-PA thrombolysis.

status: Not yet recruiting

ipd_sharing: Yes

ipd_sharing_description: Sample and clinical could be share with private researcher (STAGO)

lead_sponsor: University Hospital, Caen

location_facility: University hospital of Caen, emergency department


title: Innovative Device for Pain Management by Millimeter Band Radiation : Electronic-Pain Killer. Evaluation in Patients With Peripheral Osteoarthritis: A Single Center, Prospective, Randomized in Cross-over, Comparative and Open-label Study

acronym: Epikarthrose

summary: In this study, in addition of conventional treatment, the efficacy of the medical device, Remedee One, in medical care of patients with peripheral osteoarthritis pain is evaluated.

ReferenceType: result

ReferenceCitation: Usichenko TI, Edinger H, Gizhko VV, Lehmann C, Wendt M, Feyerherd F. Low-intensity electromagnetic millimeter waves for pain therapy. Evid Based Complement Alternat Med. 2006 Jun;3(2):201-7. doi: 10.1093/ecam/nel012. Epub 2006 Apr 24.

collaborators: Clinical Investigation Centre for Innovative Technology Network


title: Immunological Response to COVID-19 Vaccine in Patients With Autoimmune and Inflammatory Diseases Treated With Immunosuppressants and/or Biologics

acronym: COVADIS

summary:
Vaccination against the new coronavirus (SARS-CoV-2) was extended to patients at risk of severe forms of Covid-19, including in particular patients with autoimmune and inflammatory diseases treated by immunosuppressants and/or biologics.

In this particular population, the effectiveness of vaccines, in particular influenza and pneumococcal vaccinations, is often reduced, especially in case of treatment with rituximab and / or methotrexate.

Regarding the SARS-CoV-2 vaccine, the studies that allowed the marketing authorization of the available vaccines did not include patients treated with immunosuppressants or immunomodulators.

Thus, the impact of treatments on the production of neutralizing antibodies and specific T lymphocytes is not known.

The goal of this study is to assess the immune response to the SARS-CoV-2 vaccine in patients with autoimmune and inflammatory diseases treated with immunosuppressants or immunomodulators.

status: Terminated

ReferenceCitation: Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26.

ReferenceCitation: Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

ReferenceCitation: Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

ReferenceCitation: Sacre K, Goulenok T, Bahuaud M, Francois C, Van der Haegen MC, Alexandra JF, Aucouturier P, Hurtado-Nedelec M, Moins-Teisserenc H, Batteux F, Papo T. Impaired long-term immune protection following pneumococcal 13-valent/23-valent polysaccharide vaccine in systemic lupus erythematosus (SLE). Ann Rheum Dis. 2018 Oct;77(10):1540-1542. doi: 10.1136/annrheumdis-2017-212789. Epub 2018 Feb 14. No abstract available.

ReferenceCitation: Hadjadj J, Planas D, Ouedrani A, Buffier S, Delage L, Nguyen Y, Bruel T, Stolzenberg MC, Staropoli I, Ermak N, Macraigne L, Morbieu C, Henriquez S, Veyer D, Pere H, Casadevall M, Mouthon L, Rieux-Laucat F, Chatenoud L, Schwartz O, Terrier B. Immunogenicity of BNT162b2 vaccine against the Alpha and Delta variants in immunocompromised patients with systemic inflammatory diseases. Ann Rheum Dis. 2022 May;81(5):720-728. doi: 10.1136/annrheumdis-2021-221508. Epub 2022 Jan 12.

oa_host_type: publisher

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: British Medical Journal

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Immunov

location_facility: Internal medicine Service - Cochin Hospital


title: Evaluation of Practices, Knowledge and Expectations of Medical Students for Intimate Protection

acronym: STUDENT-PROTEC

summary:
Intimate protections, designed to absorb menstrual flow during menstruation, are classified into two categories: internal intimate protections (tampon, menstrual cup) and external intimate protections (disposable or washable sanitary pads, panty liner, menstrual panty).

Recently, women's expectations have changed with a demand for transparency regarding intimate protection's composition and potential health risks.

The choice and use of a type of intimate protection will depend on multiple factors specific to each woman. The cost of intimate protectioncould influence patient choice, as disposable sanitary pads are often less expensive.

time_perspective: Cross-Sectional

lead_sponsor: Université de Reims Champagne-Ardenne


title: Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock? A Multicenter Randomized Controlled Study

acronym: VITAKI

summary: Sepsis is the most common cause of acute kidney injury (AKI) in critically ill patients and is associated with a high mortality rate. Currently there is no available specific treatment to prevent or treat AKI in this setting. Many experimental and clinical data suggest that Nicotinamide, a safe and inexpensive vitamin, could be effective to prevent major adverse kidney events during septic shock. The main objective of the study is to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care. A 15% reduction in the incidence of major renal adverse events at day 30 is expected in the "Nicotinamide" group.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators:
Centre Hospitalier de Dieppe
Centre Hospitalier d'Abbeville
Centre Hospitalier de Laon
University Hospital, Caen
Centre Hospitalier de Cherbourg
University Hospital, Rouen
Centre Hospitalier de Roubaix
Centre Hospitalier de Bethune
Hôpital Saint Philibert, Lomme
Tourcoing Hospital
Centre Hospitalier de Valenciennes
Centre Hospitalier Arras
Centre Hospitalier de Lens
Centre Hospitalier de Calais

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

type_etablissement: CH

acronyme: VITAKI

titre: La supplémentation à forte dose en vitamine B3 permet-elle de prévenir les évènements rénaux majeurs au cours du choc septique? Etude randomisée contrôlée multicentrique

discipline_principale: sans priorité thématique , hors cancer , nicotinamide , insuffisance rénale aigue , choc septique , vitamine b3 , epuration extrarénale

nom_porteur: TITECA

prenom_porteur: Dimitri


title: Recurrent Acute Myocarditis : Characteristics, Etiology, Prognosis and Genetic Basis.

acronym: RAM

summary: The association between myocardial inflammation (clinically represented by acute myocarditis episodes) and the later development of an arrhythmogenic cardiomyopathy is widely elusive.

ReferenceCitation: Burke AP, Farb A, Tashko G, Virmani R. Arrhythmogenic right ventricular cardiomyopathy and fatty replacement of the right ventricular myocardium: are they different diseases? Circulation. 1998 Apr 28;97(16):1571-80. doi: 10.1161/01.cir.97.16.1571.

ReferenceCitation: Bauce B, Basso C, Rampazzo A, Beffagna G, Daliento L, Frigo G, Malacrida S, Settimo L, Danieli G, Thiene G, Nava A. Clinical profile of four families with arrhythmogenic right ventricular cardiomyopathy caused by dominant desmoplakin mutations. Eur Heart J. 2005 Aug;26(16):1666-75. doi: 10.1093/eurheartj/ehi341. Epub 2005 Jun 7.

ReferenceCitation: Bowles NE, Ni J, Marcus F, Towbin JA. The detection of cardiotropic viruses in the myocardium of patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy. J Am Coll Cardiol. 2002 Mar 6;39(5):892-5. doi: 10.1016/s0735-1097(02)01688-1.

ReferenceCitation: Chimenti C, Pieroni M, Maseri A, Frustaci A. Histologic findings in patients with clinical and instrumental diagnosis of sporadic arrhythmogenic right ventricular dysplasia. J Am Coll Cardiol. 2004 Jun 16;43(12):2305-13. doi: 10.1016/j.jacc.2003.12.056.

ReferenceCitation: Asimaki A, Tandri H, Duffy ER, Winterfield JR, Mackey-Bojack S, Picken MM, Cooper LT, Wilber DJ, Marcus FI, Basso C, Thiene G, Tsatsopoulou A, Protonotarios N, Stevenson WG, McKenna WJ, Gautam S, Remick DG, Calkins H, Saffitz JE. Altered desmosomal proteins in granulomatous myocarditis and potential pathogenic links to arrhythmogenic right ventricular cardiomyopathy. Circ Arrhythm Electrophysiol. 2011 Oct;4(5):743-52. doi: 10.1161/CIRCEP.111.964890. Epub 2011 Aug 22.

ReferenceCitation: Tanawuttiwat T, Sager SJ, Hare JM, Myerburg RJ. Myocarditis and ARVC/D: variants or mimics? Heart Rhythm. 2013 Oct;10(10):1544-8. doi: 10.1016/j.hrthm.2013.06.008. Epub 2013 Jun 14. No abstract available.

ReferenceCitation: Protonotarios A, Wicks E, Ashworth M, Stephenson E, Guttmann O, Savvatis K, Sekhri N, Mohiddin SA, Syrris P, Menezes L, Elliott P. Prevalence of 18F-fluorodeoxyglucose positron emission tomography abnormalities in patients with arrhythmogenic right ventricular cardiomyopathy. Int J Cardiol. 2019 Jun 1;284:99-104. doi: 10.1016/j.ijcard.2018.10.083. Epub 2018 Oct 26.

ReferenceCitation: Lopez-Ayala JM, Pastor-Quirante F, Gonzalez-Carrillo J, Lopez-Cuenca D, Sanchez-Munoz JJ, Oliva-Sandoval MJ, Gimeno JR. Genetics of myocarditis in arrhythmogenic right ventricular dysplasia. Heart Rhythm. 2015 Apr;12(4):766-73. doi: 10.1016/j.hrthm.2015.01.001. Epub 2015 Jan 20.

ReferenceCitation: Martins D, Ovaert C, Khraiche D, Boddaert N, Bonnet D, Raimondi F. Myocardial inflammation detected by cardiac MRI in Arrhythmogenic right ventricular cardiomyopathy: A paediatric case series. Int J Cardiol. 2018 Nov 15;271:81-86. doi: 10.1016/j.ijcard.2018.05.116. Epub 2018 May 31.

ReferenceCitation: Brown EE, McMilllan KN, Halushka MK, Ravekes WJ, Knight M, Crosson JE, Judge DP, Murphy AM. Genetic aetiologies should be considered in paediatric cases of acute heart failure presumed to be myocarditis. Cardiol Young. 2019 Jul;29(7):917-921. doi: 10.1017/S1047951119001124. Epub 2019 Jun 14.

ReferenceCitation: Ader F, Surget E, Charron P, Redheuil A, Zouaghi A, Maltret A, Marijon E, Denjoy I, Hermida A, Fressart V, Gandjbakhch E. Inherited Cardiomyopathies Revealed by Clinically Suspected Myocarditis: Highlights From Genetic Testing. Circ Genom Precis Med. 2020 Aug;13(4):e002744. doi: 10.1161/CIRCGEN.119.002744. Epub 2020 Jun 10. No abstract available.

ReferenceCitation: Piriou N, Marteau L, Kyndt F, Serfaty JM, Toquet C, Le Gloan L, Warin-Fresse K, Guijarro D, Le Tourneau T, Conan E, Thollet A, Probst V, Trochu JN. Familial screening in case of acute myocarditis reveals inherited arrhythmogenic left ventricular cardiomyopathies. ESC Heart Fail. 2020 Aug;7(4):1520-1533. doi: 10.1002/ehf2.12686. Epub 2020 May 1.

ReferenceCitation: Caforio ALP, Re F, Avella A, Marcolongo R, Baratta P, Seguso M, Gallo N, Plebani M, Izquierdo-Bajo A, Cheng CY, Syrris P, Elliott PM, d'Amati G, Thiene G, Basso C, Gregori D, Iliceto S, Zachara E. Evidence From Family Studies for Autoimmunity in Arrhythmogenic Right Ventricular Cardiomyopathy: Associations of Circulating Anti-Heart and Anti-Intercalated Disk Autoantibodies With Disease Severity and Family History. Circulation. 2020 Apr 14;141(15):1238-1248. doi: 10.1161/CIRCULATIONAHA.119.043931. Epub 2020 Mar 2.

ReferenceCitation: Belkaya S, Kontorovich AR, Byun M, Mulero-Navarro S, Bajolle F, Cobat A, Josowitz R, Itan Y, Quint R, Lorenzo L, Boucherit S, Stoven C, Di Filippo S, Abel L, Zhang SY, Bonnet D, Gelb BD, Casanova JL. Autosomal Recessive Cardiomyopathy Presenting as Acute Myocarditis. J Am Coll Cardiol. 2017 Apr 4;69(13):1653-1665. doi: 10.1016/j.jacc.2017.01.043.

ReferenceCitation: Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036.

ReferenceCitation: Smith ED, Lakdawala NK, Papoutsidakis N, Aubert G, Mazzanti A, McCanta AC, Agarwal PP, Arscott P, Dellefave-Castillo LM, Vorovich EE, Nutakki K, Wilsbacher LD, Priori SG, Jacoby DL, McNally EM, Helms AS. Desmoplakin Cardiomyopathy, a Fibrotic and Inflammatory Form of Cardiomyopathy Distinct From Typical Dilated or Arrhythmogenic Right Ventricular Cardiomyopathy. Circulation. 2020 Jun 9;141(23):1872-1884. doi: 10.1161/CIRCULATIONAHA.119.044934. Epub 2020 May 6.


title: Eating Disorders Non Otherwise Specified (EDNOS) in a Population of Subjects Consulting for Severe Obesity (BMI> 35) : Prevalence and Characterization Study

acronym: OSCAR

summary:
In anorexia nervosa,the eating disorder (ED) is the cause of thinness. In severe obesity, the overweight is a symptom. This symptom, however, is only the consequence of possibly deregulated eating behavior. The literature, focusus a specified ED of DSM-V: Binge Eating Disorder (BED) or Binge Eating, whom estimated prevalence in the severely obese population varies from 1.4 to 49% depending on the studies. The other ED, called unspecified ED (or EDNOS for Eating Disorder Non Otherwise Specified in the English literature), are much less known.

The main objective of this study is to assess the prevalence rate of unspecified ED (EDNOS or "non-BED ED") in subjects with severe obesity (BMI> 35) consulting for medical or surgical management in a General Hospital Center CSO (Specialized Obesity Center) using an adapted version of the QEWP-R, called the QEWP-RA.

ReferenceCitation: de Zwaan M. Binge eating disorder and obesity. Int J Obes Relat Metab Disord. 2001 May;25 Suppl 1:S51-5. doi: 10.1038/sj.ijo.0801699.

ReferenceCitation: Hudson JI, Lalonde JK, Berry JM, Pindyck LJ, Bulik CM, Crow SJ, McElroy SL, Laird NM, Tsuang MT, Walsh BT, Rosenthal NR, Pope HG Jr. Binge-eating disorder as a distinct familial phenotype in obese individuals. Arch Gen Psychiatry. 2006 Mar;63(3):313-9. doi: 10.1001/archpsyc.63.3.313.

ReferenceCitation: Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.

ReferenceCitation: Yanovski SZ. Binge eating disorder: current knowledge and future directions. Obes Res. 1993 Jul;1(4):306-24. doi: 10.1002/j.1550-8528.1993.tb00626.x.

ReferenceCitation: Spitzer RL, Yanovski S, Wadden T, Wing R, Marcus MD, Stunkard A, Devlin M, Mitchell J, Hasin D, Horne RL. Binge eating disorder: its further validation in a multisite study. Int J Eat Disord. 1993 Mar;13(2):137-53.

ReferenceCitation: Striegel-Moore RH, Dohm FA, Solomon EE, Fairburn CG, Pike KM, Wilfley DE. Subthreshold binge eating disorder. Int J Eat Disord. 2000 Apr;27(3):270-8. doi: 10.1002/(sici)1098-108x(200004)27:33.0.co;2-1.

ReferenceCitation: Striegel-Moore RH, Wilson GT, Wilfley DE, Elder KA, Brownell KD. Binge eating in an obese community sample. Int J Eat Disord. 1998 Jan;23(1):27-37. doi: 10.1002/(sici)1098-108x(199801)23:13.0.co;2-3.

lead_sponsor: Centre Hospitalier Arras


title: Diagnosis of Endocrine Dysfunctions in Covid-19 : Explorations of the Plasma Renin and Aldosterone Levels in Patients With Covid-19 Infection.

summary:
As observed with SARS-CoV responsible for SARS 2003, the new coronarovirus SARS-CoV-2 uses the angiotensin converting enzyme type 2 (ACE2) as cellular receptor to infect cells. The renin aldosterone angiostensin system (RAAS) has known effects in the lungs: some receptors are pro-inflammatory, others are anti-inflammatory. Thus the deregulation of the RAAS induced by the SARS-CoV-2 could explain the inflammatory response of Covid-19 infection and be a modulator of the severity of its course.

Furthermore, the SARS 2003 experience suggests that there may be others endocrine involvment, particularly an failure on the hypothalamus-pituitary and adrenal axis. Indeeed, cases of hypocorticism and hypothyroidism of central origin were described.

Altogether, the endocrine system might play a role both in the pathophysiology of Covid-19 infection and in the activity and severity of the disease.

In this study, the investigators proposed to explore endocrine functions on biological samples in a series of patients admitted for Covid-19 in our clinic.

lead_sponsor: University Hospital, Montpellier


title: Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy : GLUCAL2

summary: a food collection will be performed in this study with type 1 diabetic patients trained to carbohydrate counting, to collect data on the meals consumed daily and their quantities for a period of 1 month.


title: Economic Evaluation of Robot-assisted Laparoscopic Radical Prostatectomy vs Conventional Laparoscopic Radical Prostatectomy and Open Retropubic Radical Prostatectomy in Prostate Cancer: a Real-life Study Based on the French National Healthcare Data System (SNDS)

acronym: ECOREPAR

summary: This study aims to assess the cost-effectiveness ratio and the clinical benefit (survival, disease recurrence, functional results) of the robot-assisted laparoscopic radical prostatectomy compared with other procedures using real-life data from SNDS. The population of patients who benefited from robot-assisted surgery will be identified in the SNDS through a practices survey, allowing the identification of centres fully converted to robotics.

sponsor_collaborators:
University Hospital, Bordeaux
Bordeaux PharmacoEpi

location_facility: Centre Hospitalier Universitaire de Bordeaux

appel_a_projets: PRME

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

acronyme: ECOREPAR

titre: Evaluation médico-ECOnomique, comparative, en vie REelle de la Prostatectomie totale Robot Assistée vs laparoscopie classique et chirurgie ouverte dans le cancer de la prostate, à partir du Système National des Données de Santé (SNDS)

discipline_principale: economie de la santé

nom_porteur: Hayes

prenom_porteur: Nathalie


title: Atteintes Myocardiques, péricardiques et Vasculaires Sous Simple et/ou Double immunothérapie Anti-cancéreuse Anti-PD1, antiPDL1 et Anti-CTLA4

acronym: AMICI

summary: Our knowledge on cardiovascular side effects of immune checkpoint inhibitors (ICIs) is restricted to this date to observational retrospective data (mainly case series and pharamcovigilance analysis). We aim at assessing the incidence of cardiovascular adverse side effects of ICIs by means of a prospective interventional single centre study using multiple biomarkers.

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Fédération Française de Cardiologie
BioSerenity

location_facility: AP-HP - Hôpital européen Georges-Pompidou


title: Postoperative Hypotension Management With Computer-guided Vasopressor Titration in High-Risk Patients After Cardiac Surgery: A Randomized Controlled Trial

acronym: COMAP

summary:
The investigators have developed an automated vasopressor controller to improve the titration of vasopressor in order to maintain mean arterial pressure (MAP) within a narrow range and have recently shown the controller was effective in both the operating room and intensive care unit. The controller has been used recently in a case series of three patients undergoing cardiac surgery and in five patients after cardiac surgery.

The investigators want to compare now a manual to a closed-loop titration of vasopressor infusion in patients admitted in the Intensive Care unit after cardiac surgery

ReferenceCitation: Desebbe O, Rinehart J, Van der Linden P, Cannesson M, Delannoy B, Vigneron M, Curtil A, Hautin E, Vincent JL, Duranteau J, Joosten A. Control of Postoperative Hypotension Using a Closed-Loop System for Norepinephrine Infusion in Patients After Cardiac Surgery: A Randomized Trial. Anesth Analg. 2022 May 1;134(5):964-973. doi: 10.1213/ANE.0000000000005888.

oa_host_type: repository

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

repository_institution: California Digital Library - eScholarship

version: submittedVersion

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Clinique de la Sauvegarde

sponsor_collaborators:
Clinique de la Sauvegarde
Bicetre Hospital
Erasme University Hospital


title: Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.

acronym: SD-ICU

summary: The progression of brain lesions after severe head trauma or subarachnoid hemorrhage results from extra cranial aggression which is well controlled in intensive care and intracranial aggression which is less well known and therefore less well managed. The detection of events that can generate new lesions from intracranial monitoring is limited and late once the lesions are irreversible. Invasive cortical depolarizations (SD) can be observed using cortical electrodes and an acquisition system having access to the usually filtered DC signal (0 to 1 Hz). SD are observed at the onset of a new attack of the cortex and spread widely away from the site of aggression. During their propagation, SD generate a significant metabolic demand, and can cause ischemic injury, particularly after meningeal or post-traumatic hemorrhage. SDs are therefore both a marker of new lesion and a mechanism of progression of primary lesions. Yet this type of monitoring is only performed in some expert centers around the world. The analysis of the feasibility and safety of the placement of cortical electrodes in this indication is therefore an essential step to study the clinical benefit of individualized management on the basis of this monitoring.

location_facility: Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer


title: Pilot Study to Assess the Efficacy of the ATLAS Medical Device on Pain in Patients With Subacute or Chronic Low Back Pain With Lumbar Disc Disease: Prospective, Randomized Trial (AmbuTract)

acronym: AmbuTract

summary: Monocentric, comparative, randomized, controlled interventionnal study in 2 parallel groups, aiming to compare the efficacy of the ATLAS device with that of a standard lumbar belt on the reduction of pain felt in patients with subacute or chronic low back pain with lumbar disc disease.

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


title: Study of the Impact on the Therapeutic Alliance of a Short Initial Psychoeducation Programme in Patients With Early Schizophrenia

acronym: EPPICS

summary: Schizophrenia is a serious, disabling and unfortunately common disease. Its prevalence is in the order of 0.6 to 1% in the general population, a figure that remains relatively stable in the various cultures. The overall prognosis, particularly in terms of function, remains largely negative. The investigators know that a global management can considerably slow down this unfavourable evolution: according to the recommendations, the patient suffering from schizophrenia requires an effective and well-tolerated pharmacotherapy, associated with an adapted psychotherapy as well as cognitive remediation workshops, training in social skills, and psycho-education. There are indeed a large number of studies that have shown these elements in patients with schizophrenic disorders that have been present for several years. The investigators now know that early treatment is a key prognostic element. Indeed, the earlier care is provided during the first psychotic episode, the better the subsequent prognosis: the probability of further decompensation is reduced, as is the risk of developing deficits, such as cognitive difficulties. However, there is a lack of access to all the recommended aspects of management in the initial phase of the disorder, particularly concerning early psycho-educational programmes for patients, which have been relatively little studied in clinical research. In this context, it seems relevant to study the impact of a new programme of this type on a fundamental parameter, conditioning the subsequent access to care: the therapeutic alliance. "PPIC" is a short psycho-educational programme in 4 sessions, specifically designed to accompany young patients, and focused on the issues of this crucial period of the care process.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Pilot Study to Detect SARS-CoV-2 Virus in Sperm : a COVID-19 Study.

acronym: COVSPERM

summary:
This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.

The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

evidence: open (via free article)

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

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_normalized: medRxiv

repositories:
PubMed Central
medRxiv

repositories_concat: PubMed Central;medRxiv

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Gallien S, Moro A, Lediguerher G, Catinot V, Paboeuf F, Bigault L, Berri M, Gauger PC, Pozzi N, Authie E, Rose N, Grasland B. Evidence of porcine epidemic diarrhea virus (PEDV) shedding in semen from infected specific pathogen-free boars. Vet Res. 2018 Jan 24;49(1):7. doi: 10.1186/s13567-018-0505-2.

ReferenceCitation: Gallien S, Moro A, Lediguerher G, Catinot V, Paboeuf F, Bigault L, Gauger PC, Pozzi N, Berri M, Authie E, Rose N, Grasland B. Limited shedding of an S-InDel strain of porcine epidemic diarrhea virus (PEDV) in semen and questions regarding the infectivity of the detected virus. Vet Microbiol. 2019 Jan;228:20-25. doi: 10.1016/j.vetmic.2018.09.025. Epub 2018 Oct 11.

ReferenceCitation: Baud D, Greub G, Favre G, Gengler C, Jaton K, Dubruc E, Pomar L. Second-Trimester Miscarriage in a Pregnant Woman With SARS-CoV-2 Infection. JAMA. 2020 Jun 2;323(21):2198-2200. doi: 10.1001/jama.2020.7233.

lead_sponsor: University Hospital, Toulouse


title: Effects of a Supervised Exercise on Sleep in Patients With Non Metastatic Breast Cancer During Chemotherapy

acronym: FATSOMCAN

summary: Insomnia affects about 60% of the patients treated with radio-chemotherapy, a percentage twice higher compared to that observed in the general population. This sleep disorder increases cancer-related fatigue (CRF), the side effect most often reported by patients. Conversely, it is well accepted that adapted physical activity (APA) improves tolerance to treatment, decreases the risk of recurrence, increases survival, and reduces CRF. The present study aims to evaluate, in non-metastatic breast cancer patients, the composition and architecture of sleep by ambulatory polysomnography and to verify the effects of an APA rehabilitation program (3 times a week during 12 weeks), on the quality and quantity of sleep, daytime sleepiness. The biological markers: melatonin and body temperature will be studied to better understand the chronobiological mechanisms of the sleep-wake rhythm. Finally, the physiological responses to exercise, pain, CRF and finally quality of life will be studied at the beginning, at the end of the program and at a distance from it. Improved sleep-wake rhythm by a physical activity may reduce CRF, prevent recurrence and comorbidities.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Qualitative and Quantitative Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Their Hospitalization in Neonatology

summary: The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Drug Survival of Omalizumab in Chronic Urticaria : a Retrospective Multicentric Study

acronym: XO-DS

summary:
Chronic urticaria affects up to 1% of the population. Chronic urticaria refractory to updosing antihistamines can benefit from OMALIZUMAB, which is an anti-IgE IgG1 monoclonal antibody administrated every 4 weeks subcutaneously which represents a cost of nearly 800€/month excluding nurse fees. Efficacy and good tolerance have already been demonstrated in real-life large cohorts of patients. A 6 months treatment duration is proposed before evaluating the efficacy and discontinuating the treatment in the absence of adequate response. Mean duration of chronic urticaria is 3 to 5 years with high standard deviations. Therefore, optimal duration of treatment with OMALIZUMAB is unknown and discontinuation modalities differ between physicians.

The aim of this study is to evaluate the mean duration between initiation and first discontinuation of OMALIZUMAB in patients treated for chronic urticaria and explore the different factors influencing this duration and its outcome.

collaborators: Lyon Civil Hospitals - Lyon Sud Hospital Center

collaborators: Centre Hospitalier Universitaire de Saint Etienne


title: Study of the Impact on the Evolution of the Disease in the Medium Term of the Implementation of a System of Extended Follow-up by Telephone Interview of Patients With an Eating Disorder Organized by the Nurses of the Eating Disorder Referral Center

acronym: SPETCA

summary: The referral center for eating disorders provides for a systematic many years follow-up of patients under care with an annual assessment at the center. The investigators have recently shown the frequency of relapse in the first 7 years after diagnosis, but the literature remains poor on this epidemiology and on the risk factors for relapse. The investigators would therefore like to extend this follow-up for an additional 3 years after remission with an annual telephone nursing interview for all cured patients.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

appel_a_projets: PHRIP

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE SAINT-ETIENNE

acronyme: SPETCA

titre: Etude de l'impact sur l'évolution de la maladie à moyen terme de la mise en place d'un système de Suivi Prolongé par Entretien téléphonique des patients présentant un Trouble du Comportement Alimentaire organisé par les IDE du centre référent TCA

discipline_principale: psychiatrie,pédopsychiatrie

nom_porteur: HUGONARD

prenom_porteur: Genevieve


title: Evaluation of Left Ventricular Function by Speckle Tracking Echocardiography in Patient Hospitalised in Intensive Care Unit for Vaso-occlusive Crisis

summary: Vaso-occlusive crisis in Sickle cell disease might alter myocardial function through micro vascular obstruction. Evaluation of strain alteration using speckle tracking echocardiography is a non invasive technique that may allow us to observe such myocardial dysfunction. No such study has yet been conducted in patient hospitalised in intensive care unit. Our hypothesis is that strain alteration during vaso-occlusive crisis, if they do exist, can be correlated with other markers of myocardial injury such as troponin level or thoracic pain.

lead_sponsor: Bicetre Hospital


title: Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes : Longitudinal Cohort Study of Immuno-inflammation, Cardiac Energetics and Cognition.PreciDIAB-HEART&BRAIN

acronym: PreciDIAB-H&B

summary:
Type 2 diabetes is a risk factor of heart failure and cognitive decline. Heart failure at its early stage is often silent. At present, primary prevention for heart failure is not available. Our aim is to identify diabetic patients at risk of heart failure in order to develop personalized preventive strategies.

Type 2 diabetes is vascular and metabolic risk factor for cognitive decline though a direct lesional effect but also through an interaction with underlying neurodegenerative lesions. Our aim is to identify diabetic patients at risk of cognitive decline in order to develop personalized preventive strategies

lead_sponsor: University Hospital, Lille


title: Tobacco and Nicotine Consumption and the Risk of Acquisition of COVID-19: A Case Control Study Among Healthcare Workers

acronym: NICORISCOVID

summary: The purpose of this case-control study is to assess the association of the current and former consumption of tobacco and nicotine in the risk of acquisition of severe acute respiratory syndrome 2 (SARS-CoV-2). the investigators will send a structured interview by mail regarding use of tobacco and nicotine to 2500 healthcare workers (1250 cases with a positive Real Time Polymorphism Chain Reaction (RT-PCR) and 1250 controls with a negative PCR) who were tested in Paris for in March and April, 2020. OR will be estimated by conditional logistic regression modelling with matching for sex and age.


title: Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria

acronym: INTENXO

summary: This is an observational study whose main objective is to estimate the frequency of patients benefiting from an intensification of AOM treatment at 3 months.


title: Pharmacodynamics and Tolerance Study of Nicotinamide Mononucleotide (NMN) Supplementation at 400 mg/Day

summary: The purpose of this study is to evaluate the physiological and/or biological actions of nicotinamide mononucleotide (NMN-C) in healthy adults receiving a repeated-dose over the course of 28 days by studying the tolerance and pharmacodynamics of this product.

lead_sponsor: Seneque SA

collaborators:
CEN Biotech
LGD

sponsor_collaborators:
Seneque SA
CEN Biotech
LGD

intervention_type: Dietary Supplement


title: Measurement of Physical Activity in the First Days After Thoracic Surgery

acronym: Marchez

summary:
Objective measurement of physical activity has several advantages compared to declarative measures: exemption from memory bias and desirability bias, more precise evaluation, taken into account activities of low intensity, measurement of physical activity and sedentariness profiles (number and duration of periods of activity, number of breaks in sedentary lifestyles).

The aim of this study is to assess the early postoperative mobility of patients who have undergone pulmonary excision by thoracoscopy or robot surgery using ActiGraph GT3X accelerometer. This assessment will serve as a reference element for further studies.

lead_sponsor: Hopital Foch


title: Study of the Relationship(s) Between Clinical, Biological and Pharmacokinetic Metrics and Toxicities When Niraparib is Used as Maintenance Treatment (300mg or 200 mg/Day) for Ovarian Cancer Patients.

acronym: NIRAPK

summary:
Ovarian cancer is the seventh most common cancer in women worldwide and is the leading cause of gynecologic cancer deaths in high-income countries.

Standard treatment for newly diagnosed advanced ovarian cancer consist of cytoreductive surgery and platinum-based chemotherapy with or without concurrent and maintenance bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor.

A majority of women with epithelial ovarian cancer respond well to first-line platinum-based chemotherapy. There is however a high rate of relapse/recurrence (disease progression ranging from 10 to 26 months).

Poly ADP ribose polymerase inhibitors (PARPi), a new class of therapeutic molecules have recently revolutionized this paradigm, demonstrating progression-free survival (PFS) advantages in several trials.

The PARPi molecule Niraparib has obtained its market authorization after the NOVA trial as second maintenance treatment line, irrespectively of patients' BRCA-mutated gene or HR status.

Since, results of the Phase III trial PRIMA, have demonstrated that Niraparib can also provided a significant PFS increase as first line maintenance treatment, for adult patients with platinum-sensitive, relapsed, high grade serous epithelial ovarian cancer who are in response (complete response or partial response) to platinum-based chemotherapy, irrespectively of their BRCA-mutated gene or HR status.

However, despite its high therapeutic potential, Niraparib at standard dose (200 or 300mg/day) is known to lead to hematologic toxicity and/or nephrotoxicity. This was demonstrated during the NOVA trial (the dose of Niraparib having to be reduced in 80% of the patients to reduce toxicity).

A retrospective study of the NOVA trial indicates that 2 predictive factors leading to hematologic toxicity were a weight <77kg and an initial platelet count <175 G/L. However, it seems more complex as 50% of patients with an initial weight between 58 and 77kg have not reported thrombocytopenia. Same for platelet count. Creatinine clearance below 60ml/min and an hypoalbuminemia <35 g/l have also been identified in another study as predictive factors to thrombocytopenia.

The inter-individual heterogeneity in terms of toxicity regarding Niraparib is high and still not well understood.

The aim of our study is therefore to better identify which clinical, biological and pharmacokinetic metrics can be considered as toxicity induction causes when Niraparib is used as maintenance treatment (200 or 300mg/day) for ovarian cancer patients.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Lyon sud, Institut de Cancérologie des Hospices Civils de Lyon


title: Women and Women's Hygienic Protection: Evaluation of Women's Practices, Knowledge and Expectations for Intimate Protection

summary:
Intimate protections are designed to absorb menstrual flow during menstruation. A woman will use an average of 6,000 intimate protections during her lifetime. Intimate protections are classified into two categories: internal intimate protections including tampon, menstrual cup, menstrual sponge, and external intimate protections including disposable or washable sanitary pads, panty liner, menstrual panty. The choice and use of a type of intimate protection will depend on multiple factors specific to each woman. Due to a growing media interest in this area, women have become extremely critical and suspicious of these devices, particularly about the Toxic Shock Syndrome, attributed to the use of tampon in women previously colonized vaginally by strain of toxin-producing Staphylococcus aureus (Toxic shock syndrome toxin-1 (TSST-1)). Similarly, chemical residues have been found in sanitary napkins.

As a result, women's expectations have changed and there is a greater demand for transparency with regard to intimate protection of their composition and their potential health risks. Women want more and more alternative to conventional intimate protections in today's climate of increasing environmental awareness.

It is a cross-sectional, observational, prospective, unicentric inclusion study (CHU de Reims). The primary objective is to describe women's intimate protection practices. The secondary objectives are to study the determinants of women's choice for intimate protection, to describe women's knowledge of the potential risks of these intimate protections. and women's information sources on intimate protections. Finally describe the expectations of women in terms of intimate protections. The results are intended to give a photograph of the practices and knowledge of women consulting in the Obstetrics and Gynecology Department of the University Hospital of Reims concerning intimate protections.

Patients aged 18 to 50, presenting menstrual cycles, consulting in the obstetrics and gynecology department of the University Hospital of Reims whatever the reason for consultation can participate in the study after signing the consent of no opposition. Participation in the study will not change the patient's medical management. Participation in the study will result in the completion of a questionnaire concerning intimate protections. The filling time of the questionnaire is estimated at 10 minutes.

This subject is evolving with a growing awareness of women on the management of their rules, the products used, their potential risks and the environment. This study will allow us to see if women are really informed and feel concerned by these changes. And in the end, find out if they are ready to turn to intimate protections called "alternatives" The results will give us a vision of the expectations of our patients in this area as well as the information received, and thus allow us to publish an information guide and good practices of the intimate protections available in the waiting rooms of our consultations.

In addition, this study will allow health professionals to discuss this subject more easily and easily with their patients.

lead_sponsor: CHU de Reims


title: Thuflep/SOLEP : Initial Experience and Results of Prostate Laser Enucleation With Thulium-fiber Laser (TFL)

summary: Thuflep TLF: initial experience and results of prostate laser enucleation with fibrous thulium laser (TLF)

lead_sponsor: Clinique Saint-Hilaire


title: Different Approaches to Thoracic Paravertebral Block: a Monocentric Randomized Study Comparing Ultrasounded-guided Method to Intrathoracic Visual Method

acronym: VAP BLOCK

summary: Thoracic paravertebral block (TPB) in thoracic surgery is practiced since the development of minimally invasive surgery. Historically, thoracic epidural analgesia is done in open thoracic surgery. Thoracotomy with rib spacing causes strong post-operative pain that is well controlled with epidural analgesia and allows less use of morphine. However, this method causes frequent side effects. Minimally invasive surgery, when it is possible and recommended, has the main benefit of not spacing the ribs and therefore preventing nerve stretching, rib fractures and less post-operative pain. This less aggressive method has other benefits: less inflammation, better recuperation especially for vulnerable patients (the elderly; limited pulmonary functions), less time of thoracic drainage, less in hospital stay and better quality of life (1). Less invasive surgery has brought us to use less invasive analgesic methods. Thoracic paravertebral block is a good alternative to thoracic epidural analgesia but is unfortunately not done everywhere due to the lack and need of professional training. The objective of our study is to compare two methods of TPB: ultrasound guided method undergone by the anesthesiologist, and intrathoracic method undergone through video assisted surgery (VATS) or robotic assisted surgery (RATS).

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: assistance publique hôpitaux de Marseille


title: ROLE OF IMMUNE ACTIVATION PROFILES IN CORONARY ATHEROTHROMBOSIS IN PATIENTS HIV-1-INFECTED ON EFFECTIVE ANTIRETROVIRAL THERAPY

acronym: CoroVIH

summary: HIV-infected patients with intermediate-high risk have a high prevalence of CAD and a substantial proportion of obstructive CAD. Degree of stenosis is associated with immunoactivation (lymphocyte and monocyte) and microbial translocation

lead_sponsor: Hôpital Européen Marseille


title: Prevalence and Risk Factors for the Carriage of Multi- and Highly Resistant Bacteria and Clostridioid Difficile Toxigenic in Residents and Healthcare Workers in Nursing Home (PREMS)

acronym: PREMS

summary:
Brief summary : Very few studies have evaluated the prevalence of multi-drug resistant (MDR), highly resistant emerging bacteria and Clostridioides difficile toxinogenic (CDt) in residents and in healthcare workers (HCW) in nursing home (NH). Most of study were conducted in acute care services and were limited to specific bacterial species.

Hypothesis : The carriage of MDR bacteria in resident may be a risk factor for an outbreak in NH or in healthcare facility.

Primary outcome: The objective of this study is to estimate the prevalence for carriage of MDR bacteria and CDt in residents in NH.

Secondary outcomes:

Estimate the prevalence for carriage of MDR bacteria and CDt toxigenic in HCW in NH.
Identify the risk factors for carriage of MDR bacteria and CDt in residents in nursing home
Identify the risk factors for carriage of MDR bacteria and CDt in healthcare workers in NH
Evaluate the presence of cross-transmission of MDR bacteria and CDt in one or several NH
Evaluate the association between the presence of cross-transmission of MDR bacteria and CDt in a NH and the management of infection control
Establishment a collection of stool samples

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes, Hôpital Universitaire Carémeau


title: Micromegaly and Discrepancy Between Growth Hormone and IGF1 at the Diagnosis and Follow-up of Acromegalic Patients : What About Their Consequences ?

summary: The diagnosis and the follow-up of acromegalic patients are based on the mesurement of Growth hormone (GH) and IGF1 rates. However, the literature described some cases of patient for whom the investigators observed a discrepancy between GH and IGF1 rates. Since the acromegaly is a rare disease and this phenomenon concerns about 30% of these patients, there is a lack of investigations about consequences that this discordance may induces. In this study, the investigators aimed at assessing if patients with discordance between GH and IGF1 rates present a different risk of recurrence and complications related to acromegaly, from patients with concordant results.

lead_sponsor: University Hospital, Montpellier


title: A Prospective, Observational (Non-interventional), International Study to Assess Conservative Treatments Effectiveness in Acute Phase of Hemorrhoidal Disease

acronym: CHORALIS

summary: The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease

lead_sponsor: Servier Affaires Médicales


type: Registry Identifier

title: Immune Profiles Evolution in Patients Treated by Immunotherapy for Melanoma

acronym: EPITHEM

summary: The primary objective of the study aims to compare the immune profiles (circulating cytokines and lymphocytes) before and after (6 to 8 weeks) the first infusion of immune checkpoint inhibitors in patients with melanoma treated in the adjuvant setting(cohort A) or in metastatic setting(cohort B); and to study the association of these immune profiles with relapse- or progression-free survival.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Dermato-oncology department, Ambroise Paré hospital, APHP


title: How Bariatric Surgery Impacts Pelvic Floor Disorders Evolution : Analysis on a Cohort From a French Hospital.

acronym: ICONES

summary: Bariatric surgery is increasingly practiced, as it is the most efficient treatment for morbid obesity. More than eighty percent of the operated patients are women. Nethertheless, few is known about gynecologic long-term impact of such surgeries, especially regarding pelvic floor disorders (PFD). This work aims at studying the evolution of PFD in women following a bariatric surgery more than 18 months ago in a French university center Hospital.

lead_sponsor: Poitiers University Hospital


title: Prevalence of COVID-19 Infection in a Cohort of Patient Infected by the HIV and Patients Taking PrEP Pre-exposure Prophylaxis

summary: The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.


title: Translational and Multimodal Brain Imaging of the Neural Correlates of Arousal and Awareness During Coma and Post-coma

acronym: IMAGINA

summary:
In last decades, several advances in the neuro-intensive management have lead to decrease mortality in Intensive Care Units. A significant morbidity remains as patients survive after a traumatic coma with uncertain quality of awakening and a high risk of functional disability. Predicting awareness recovery and functional disability of those who will awake constitutes a major challenge to inform patients' relatives, to give the best chances in terms of rehabilitation resources or to adapt intensive cares to a reasonable level. Tools currently available are not sufficient neither to predict bad awakening outcome nor to predict good functional outcome. In many countries, life's support cessation is a constant call for robust evaluation as soon as possible in ICU but it is mandatory to reach a positive predictive value of non-awaking close to 100%. Many clinical, electro-physiological, biological, radiological and functional parameters have been conducted with comatose patients assuming the purpose to predict outcome. Regarding unfavourable outcome, the gold standard is the abolition of the N20 component of somatosensory evoked potentials but the specificity is high enough only for patients with anoxic coma. Several neurophysiological markers such as MMN, P300 are correlated to a favourable outcome but the sensitivity and specificity remains low for patients who suffered a severe traumatic brain injury. New Diffusion Tensor imaging sequences provide complementary information to detect small structural lesions (diffuse axonal lesions). Recently, functional MRI analyzing Resting State has also been proposed as a prognostic marker during coma. PET using Fluoro-Desoxy-Glucose is able to assess the metabolism in key regions of the awakening network in either anaesthesia or sleep. Recent studies have reported interesting results at the chronic stage but to our knowledge, these tools have only been used to address pathophysiology's issues and never to improve coma prognosis at the initial stage. We hypothesize that the heterogeneity of the population requires a global and accurate assessment of the central nervous system, combining structural, metabolic and functional information in order to refine the prognosis.

Our protocol integrates in one-sequence most radiological markers of brain injury within a unique PET-MRI in Lyon. Our most relevant originality consists in confronting FDG-PET and MRI sequences to a large clinical, electrophysiological and biological battery. The added clinical value would be to question the synergistic effect of each parameter and to find out which ones are the most useful for awakening prediction, as they have not been compared in a multi-parametric database.

PET-MRI, as a new device combining physiological and prognostic questioning, allows us:

to implement a more integrative physio-pathological analysis
to avoid the cofounding effect of awareness' fluctuations in recording simultaneously multiple functional imaging techniques.

The RS will be analyzed at 2 epochs in order to assess the stability of brain connectivity, related to neuronal activity (glucose metabolism) and brain perfusion.

The interest of imaging result will be compared across morphological and functional sequences and in comparison, to classical marker (clinical, electrophysiological and behavioural) to build the most precise prognostic tool for acute comatose patients in ICU or diagnostic/prognostic tool for chronic patients in rehabilitation unit.


title: RPSA as a Potential Prognostic Biomarker of PDAC

acronym: PaCaBioMarkeR

summary:
PDAC (Pancreatic ductal adenocarcinoma) represents 90% of pancreatic tumors. The prognosis of PDAC remains poor at this time. Its management is based on surgery for early stages, associated with neoadjuvant and adjuvant chemotherapy. However, around 80% of patients will relapse after surgery. There is a lack of efficient biological biomarkers of PDAC, especially for prognosis. To date, CA19-9 is commonly used despite its lack of sensitivity and specificity.

Ribosomal protein SA (RPSA) is a transmembrane receptor localized at the cell surface but also in the cytosolic and nuclear regions. RPSA interacts with many proteins in the extracellular matrix (ECM), including laminin-1 and elastin. RPSA in involved in different cellular functions such as cell adhesion, migration, proliferation and differentiation. The expression of RPSA is increased in many cancers including breast, lung, prostate, pancreatic, etc. It could represent a molecular biomarker of tumor invasion and metastatic abilities. Moreover, the concentration of RPSA could be measured in the serum of patients with PDAC. Recent data suggest that a modification of the RPSA concentration could be a prognostic biomarker of PDAC.


title: Impact of Routine Electronic Monitoring of Health-related Quality of Life on Care Relationship of Cancer Patients With Non-small Cell Lung Cancer, Locally Advanced or Metastatic, Systemic Treatment-naïve: a Randomized Trial

summary:
Routine electronic monitoring of health-related quality of life (REMOQOL) consists of collecting HRQoL patients' data via an electronic device in order to provide these data to healthcare providers. Collected data could be used by professionals to personalize care through for instance, orientation towards personalized supportive care; assessment of toxicities related to treatments or adapted treatments.

The aim of this study is to investigate the impact of REMOQOL on the care relationship in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are naïve for systemic treatment. To do this, the investigators want to conduct a randomized trial at the Besançon University Hospital.

Several teams are collaborating on this project: Methodology and Quality of Life Unit in Oncology (UMQVC), pneumonology and medical oncology services of the Besançon University Hospital and psychology laboratories of Franche-Comté and Burgundy Universities.

The original aspects of this research are the particular interest in the care relationship between physicians and patients, also taking an interest in the physician's experience, the strong collaboration with researchers in psychology, the use of mixed quantitative and qualitative analysis techniques as well as the design of randomized study.

collaborators:
University of Franche-Comté
University of Burgundy

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: Randomized, Open-label Bioavailability Study of the Kinetics of Plasma, Urinary and Salivary Concentrations of Melatonin and 6-sulfatoxymelatonin Subsequent to the Consumption of Melatonin-rich Food Supplements With Different Galenic Forms

summary: This study is conducted to clinically document the melatonin bioavailability of two dietary supplements containing melatonin : one prolonged release tablet dosed at 1.9mg and one spray dosed at 1mg for 2 oral sprays.

ipd_sharing_description: no sharing

lead_sponsor: PiLeJe


title: Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder

summary: This study aims to assess the effectiveness of serious EUREKOI gambling on the anxiety of family caregivers of patients with newly diagnosed Alzheimer's disease.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: PsyDoMa :Non-drug Approaches at Home for Alzheimer's Patients With Psycho-behavioural Disorders and Psycho-education for the Caregivers

acronym: PSYDOMA

summary:
Recruitment is carried out directly at the geriatric unit of the CIMIEZ University Hospital Center by geriatric doctors during day consultation or in short stay unit. The doctor wil select carer -patient couples more likely to take part in the study. The investigator will give them an informative leaflet and they will have to sign the consent form.

A diagnosis is made by the investigator. The patient will first have to undergo a neurocognitive assessment carried out at the Cimiez Hospital (test for the evaluation of a cognitive deficit) by a psychologist.

The non-drug approaches presented will be carried out directly at the participant's home with the help of the carer for therapeutic purposes.

The therapeutic objectives and the choice of approaches are specified within the Personalised Accompaniment Project (PAP).

The carer, if he or she wishes, participates in the sessions in order to reproduce the behaviours implemented by the psychologist.

Different workshops will be offered : Cooking, Art Therapy, Games, Multi-sensory, Soft Gymnastic, Relaxation, Music and Reminisence.

Patients will received three visits per week during six months. The carer will receive one visit per week for six months.

primary_purpose: Health Services Research

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Placement of Peripheral Venous Catheters Under Echo Guidance in a Post-emergency Medical Service

acronym: KatECHO

summary: Compare the number of attempts to place a peripheral venous catheter in the group of patients hospitalized in the post-emergency unit and benefiting from echo guidance and therapeutic communication, to the group of patients hospitalized on the post-emergency unit using traditional technique.

lead_sponsor: University Hospital, Grenoble


title: Clinical Characteristic and Quality of Life Assessment in Adulthood of Patients With Cryopyrin Associated Periodic Syndrome

acronym: CAPS

summary:
The patients included in this study were followed up in the Internal Medicine and Paediatrics Departments of the Lille CHU, the Paediatric Rheumatology and Immunology Department of the Necker Enfant Malade Hospital in Paris and the Paediatric Rheumatology Department and Internal Medicine of the Bicêtre Hospital in Paris. All patients selected presented one of the 3 CAPS clinical phenotypes (CINCA/NOMID, Muckle-Wells or Cold Urticaria). The mutation and the determination of the variant had to be confirmed by genetic analysis.

Patient data were collected from their medical records, retrospectively. Data collected concern childhood period from appearance of symptoms, adulthood period, in the last year and patients' way of life and quality of life upon the assessment. In addition, we collected demographic data related to the patients' lifestyle (intoxications, living arrangements, level of education) and we conducted individual telephone interviews lasting 15 minutes to complete a quality of life questionnaire including the SF36 questionnaire.

The study aimed to describe the clinical symptoms of patients in adulthood and to assess quality of life. We also wanted to compare the clinical phenotypes of patients according to their genetic variant.


title: Efficacy and Safety of Transcutaneous Tibial Neuro-stimulation to Improve Voiding Dysfunction in Multiple Sclerosis Patients.

summary:
The present trial is designed to assess the efficacy and safety of transcutaneous tibial neuro-stimulation (TTNS) in improving bladder emptying in multiple sclerosis (MS) patients.

Patients presenting with MS and performing clean intermittent self-catheterization (CISC) to empty the bladder in the context of voiding dysfunction, will be eligible.

Included patients will be randomly assigned to two distinct arms

PTNS de verum : patients will be treated with transcutaneous tibial neuro-stimulation at a rate of one session of 30 consecutive minutes daily for a period of 12 weeks.
PTNS placebo : Patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for a period of 12 weeks (same treatment regimen as the experimental group).

Efficacy in improving voiding dysfunction will be assessed 12 weeks after randomization using the BVE ratio (Bladder Voiding Efficiency) = Ratio of urine volume / total bladder volume.


title: Benefit of a Systematic Proposition of Nicotine Replacement Therapy Preoperatively for Patients Undergoing Planned Surgery and With Tobacco or Cannabis Addiction, Regardless of the Intention to Quit

acronym: PATCHIR

summary:
Smoking is associated with a higher rate of surgical complications. For example, in orthopedics, the risk of complications is 31% in smokers against 5% in non-smokers. The management of this addiction is recommended and particularly interesting in scheduled surgery, because it allows smoking cessation well before the procedure. However, for patients who cannot consider this smoking cessation, the mere information of the risk cannot be sufficient and a real strategy must be constructed and evaluated.

Currently, studies results indicate that a patient reducing the number of smoked cigarettes will unconsciously modify their smoking behaviour to obtain the usual nicotine level, this effect is called self-titration. Conversely, nicotine replacement while continuing consumption could induce an improvement in smoking behaviour, therefore less intoxication which would be beneficial in terms of reduction of post-operative complications. This study seeks to assess the effectiveness of a systematic proposition of nicotine replacement therapy (NRT) in regular smokers. Tobacco addiction specialists have demonstrated that intoxication and dependence are well correlated with the exhaled carbon monoxide (CO) level, so this measurement will be used in addition to the patient's interview.

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Groupe hospitalier Mutualiste de Grenoble


title: Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury : an Observational Study

acronym: PREDICT-TCM

summary: Patients with moderate traumatic brain injury (mTBI) are 1,5 times more frequent than those with severe TBI and some of them will develop secondary neurologic deterioration (SND) within the first 7 days. However, identifying at risk patients of SND is still challenging. This study aimed to determine risk factors associated with SND after mTBI.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.

summary:
Prostate adenoma or benign prostatic hypertrophy (BPH) is a benign disease of the prostate gland. It results in an increase in the volume of the prostate area located in contact with the urethra. Compression of the prostatic urethra by the adenoma can cause lower urinary tract disorders.

The classic treatments in case of failure of medical treatment are endoscopic resection of the prostate and adenomectomy, but these techniques are characterized by a significant hemorrhagic risk that may require transfusions and prolonged hospitalization.

Minimally invasive treatments with low morbidity have been developed to overcome these drawbacks. They allow to propose a therapeutic solution adapted to patients: not tolerating their medical treatment, wishing to keep antegrade ejaculation, elderly and/or frail, at risk of bleeding, wishing an ambulatory treatment, refusing the conventional surgical techniques.

The Focal One® device was developed to treat prostate cancer using ultrasound energy. This energy is delivered through a probe placed in your rectum. Connected to this probe, an ultrasound machine will allow your doctor to see precisely which part of your prostate is being treated. By heating the prostate tissue to a very high temperature in one treatment session, the energy delivered will then destroy the tissue. Ultrasound guidance coupled with the localized nature of the treatment allows the targeted area to be treated while respecting the prostate tissue and structures adjacent to the prostate and thus reducing side effects.

Treatment of prostate adenoma with HIFU would allow for localized destruction to reduce prostate volume. The reduction of the compression of the prostatic urethra thus obtained would allow an improvement of the urinary disorders. The treatment is performed transrectally under real-time ultrasound control, which allows the adjacent structures to be respected, thus preserving antegrade ejaculation and limiting the side effects.

lead_sponsor: EDAP TMS S.A.

location_facility: Hopital Edouard Herriot, service d'urologie


title: Improve Adherence to Weak or Strong Opioid Analgesics at the Time of Care in Children With Hereditary Epidermolysis Bullosa

acronym: ODEB

summary:
Hereditary epidermolysis bullosa (HEB) are rare genodermatoses, clinically characterized by epithelial and subepithelial fragility leading to the formation of blisters and spontaneous erosions on skin at the slightest contact, with possible mucosal damage.

The care of these patients consists of therapeutic baths leading to renew bandages that sometimes covering the entire integument. These are difficult, delicate and painful moments that patients experience daily at home.

For an unexplained reason for 70 to 80% of them, the weak or strong opioid analgesics, deemed necessary and prescribed for good pain control, are not taken on a regular basis as a premedication for baths and dressing changes.

The aim of the study is to understand the child's brakes on taking weak or strong opioid analgesics at the time of care and the parents' difficulties in giving these treatments by means of individual interviews.

ReferenceCitation: Understanding noncompliance with opioid-based analgesic premedications in the care of children with hereditary epidermolysis bullosa Authors : Sarah Chaumon, Christine Bodemer, Céline Greco Douleurs : Évaluation - Diagnostic - Traitement Volume 23, Issue 1, February 2022, Pages 14-24


title: The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis

acronym: RUMINOSPA

summary: The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).

ReferenceCitation: Breban M, Tap J, Leboime A, Said-Nahal R, Langella P, Chiocchia G, Furet JP, Sokol H. Faecal microbiota study reveals specific dysbiosis in spondyloarthritis. Ann Rheum Dis. 2017 Sep;76(9):1614-1622. doi: 10.1136/annrheumdis-2016-211064. Epub 2017 Jun 12.

ReferenceCitation: Crost EH, Tailford LE, Monestier M, Swarbreck D, Henrissat B, Crossman LC, Juge N. The mucin-degradation strategy of Ruminococcus gnavus: The importance of intramolecular trans-sialidases. Gut Microbes. 2016 Jul 3;7(4):302-312. doi: 10.1080/19490976.2016.1186334. Epub 2016 May 25.

location_facility: Service de Rhumatologie, Hôpital Ambroise Paré, APHP


title: Modality of Pain Management in Ambulatory Tonsillectomy Surgery in Adults: External Pilot Study

acronym: DACAA

summary: No SFORL recommendation for adult ambulatory tonsillectomy. This study would allow the establishment of an ambulatory management during an adult tonsillectomy. This would allow a return home from J0 for the patient and therefore would improve the comfort of the patients and reduce the cost associated with a conventional hospitalization over several days.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Study of the Sexual Health of Patients Treated for Non-metastatic Breast Cancer and Followed up in the Observatory of Fertility at Jeanne de Flandre Hospital : a Prospective Monocentric Cohort With Repeated Anonymous Self-administered Questionnaires.

acronym: ENVIE

summary: Study of sexual health by repeated anonymous self-administered questionnaires in patients treated for non-metastatic breast cancer and referred to Jeanne de Flandre hospital for possible preservation of their fertility. Sexual health is affected by treatments and improves after the treatments. Sexual health is influenced by multiple factors : oncology treatments received, self-esteem, body image, anxiety, depression, professional activity

lead_sponsor: University Hospital, Lille


title: Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study"

acronym: NELI

summary:
This study includes 30 patients with Meniere's disease confirmed with AAO-HNS criteria.

The aim of this study is to compare the new optimized 3D FLAIR sequence developed at our site with a standard 3D FLAIR sequence performed 4h after a single intravenous dose of macrocyclic gadolinium-based contrast agents for the detection of endolymphatic hydrops.

The patients will be explored with the new 3D FLAIR optimized sequence before injection (method to validate) and again 4 hours after contrast media administration with the same sequence 3D FLAIR

lead_sponsor: University Hospital, Bordeaux


title: Impact of the Implementation of a qSOFA Score on the Care of Adult Patients Referred to the Emergency Department for Suspected Infection

summary: The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score <2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.


title: Evaluation of Biological Response to SARS-COV2 in Patients With Pre-existing Neurological Disease or With New Neurological Manifestations of COVID-19

summary: Patients with neurological or psychiatric symptoms or pre-existing disease will be sampled (blood for serum and DNA or saliva for DNA) at inclusion and at M6 (blood) and M12 (blood) depending on their pathology. Sampling will be done either at hospital if patient is on site for routine care or at home if no consultation is scheduled at hospital.

ReferenceCitation: Louapre C, Ibrahim M, Maillart E, Abdi B, Papeix C, Stankoff B, Dubessy AL, Bensa-Koscher C, Creange A, Chamekh Z, Lubetzki C, Marcelin AG, Corvol JC, Pourcher V; COVISEP and Bio-coco-neuroscience study group. Anti-CD20 therapies decrease humoral immune response to SARS-CoV-2 in patients with multiple sclerosis or neuromyelitis optica spectrum disorders. J Neurol Neurosurg Psychiatry. 2022 Jan;93(1):24-31. doi: 10.1136/jnnp-2021-326904. Epub 2021 Aug 2.

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

repository_normalized: HAL

repositories_concat: HAL

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Brain & Spine Institute (ICM)


title: A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer

acronym: RECC-EV

summary: Routine clinical and radiological assessment of response of patients with rectum cancer to neoadjuvant chemoradiotherapy does not allow accurate identification of complete pathological response, and leads to frequent false positive and negative results. Molecular markers reflecting the initial and post-nCRT status of the tumor would be ideal to select patients eligible for organ preservation. This project will test the detection of tumor extracellular vesicles (EVs) in liquid biopsy as a reliable marker for the identification of poor versus good responders to nCRT.