title: Study of the Antipodal Capsular Fold and Its Potential Role in Antero-inferior Glenohumeral Instability - Instabio

acronym: INSTABIO

summary: In schoulders instabilty, the soft tissue has not been the subject of histological studies, as has the "bare area" or zone devoid of cartilage, the exact role of which in glenohumeral biomechanics is unknown. This research is based on the hypothesis that the antipodal lesions are constant, underestimated and that an architectural disorganization at the capsulo-ligament level could contribute to the instability of the shoulder. The aim of this study is therefore to better characterize these lesions which could be the subject of a complementary stabilization procedure even in the absence of a humeral notch

lead_sponsor: Ramsay Générale de Santé


type: Other Identifier

title: Place of Connected Tools in the Follow-up of the Bariatric Patient: Can They Allow Rapid Management of Complications and Reduce Lost of Follow-up During Postoperative Period?

summary: The aim of this study is to assess the safety (in terms of post-operative complications) of the use of connected devices for the monitoring of patients operated on by longitudinal laparoscopic gastrectomy (LSG) and discharged 24 hours after surgery according to the protocol Enhanced Recovery After Surgery (ERAS).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: background

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ReferenceCitation: Małczak P, Pisarska M, Piotr M, Wysocki M, Budzyński A, Pędziwiatr M. Enhanced Recovery after Bariatric Surgery: Systematic Review and Meta-Analysis. Obes Surg. 2017 Jan;27(1):226-235. doi: 10.1007/s11695-016-2438-z. Review.

ReferenceCitation: Khorgami Z, Petrosky JA, Andalib A, Aminian A, Schauer PR, Brethauer SA. Fast track bariatric surgery: safety of discharge on the first postoperative day after bariatric surgery. Surg Obes Relat Dis. 2017 Feb;13(2):273-280. doi: 10.1016/j.soard.2016.01.034. Epub 2016 Feb 2.

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ReferenceCitation: Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.

ReferenceCitation: Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;(2):CD007635. doi: 10.1002/14651858.CD007635.pub2. Review.

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ReferenceCitation: Svensson M, Nilsson U, Svantesson M. Patients' experience of mood while waiting for day surgery. J Clin Nurs. 2016 Sep;25(17-18):2600-8. doi: 10.1111/jocn.13304. Epub 2016 Jun 27.

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ReferenceCitation: Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4:CD006611. doi: 10.1002/14651858.CD006611.pub4. Review.

ReferenceCitation: Oosterveen E, Tzelepis F, Ashton L, Hutchesson MJ. A systematic review of eHealth behavioral interventions targeting smoking, nutrition, alcohol, physical activity and/or obesity for young adults. Prev Med. 2017 Jun;99:197-206. doi: 10.1016/j.ypmed.2017.01.009. Epub 2017 Jan 25. Review.

ReferenceCitation: Broekhuizen K, Kroeze W, van Poppel MN, Oenema A, Brug J. A systematic review of randomized controlled trials on the effectiveness of computer-tailored physical activity and dietary behavior promotion programs: an update. Ann Behav Med. 2012 Oct;44(2):259-86. doi: 10.1007/s12160-012-9384-3. Review.

ReferenceCitation: Stephenson A, McDonough SM, Murphy MH, Nugent CD, Mair JL. Using computer, mobile and wearable technology enhanced interventions to reduce sedentary behaviour: a systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2017 Aug 11;14(1):105. doi: 10.1186/s12966-017-0561-4. Review.

ReferenceCitation: Subbe CP, Duller B, Bellomo R. Effect of an automated notification system for deteriorating ward patients on clinical outcomes. Crit Care. 2017 Mar 14;21(1):52. doi: 10.1186/s13054-017-1635-z.

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lead_sponsor: Elsan

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Regional Anesthesia for Totally Awake Upper Limb Surgery in PEDiatric Population- RAPATED

acronym: RATAPED

summary:
Peripheral loco-regional anesthesia (LRA) for anesthetic purposes is a technique widely used in adults for upper limb surgery. In pediatrics, LRA is not classically considered on its own. It is usually performed for analgesic purposes during sedation or general anesthesia. It is entirely possible to carry out awakened peripheral blocks in communicating children, of school age, thus avoiding the issues of GA in pediatrics, in particular in an emergency context. The use of Emla anesthetic skin patches for punctures (perfusion and LRA) as well as the viewing of cartoons on touch tablets during treatment can improve the perception of painless care such as LRA and treatment.

In pediatrics, only ropivacaine at a concentration of 0.2% has Marketing Authorization in pediatrics in children under 12 for the production of peripheral blocks. On the basis of the experience of the Claude Galien Private Hospital in this area, it seems interesting to assess the feasibility of upper limb surgery under anesthetic LRA alone with a dose of ropivacaine at the concentration 0.35% in communicating children, of school age.

status: Completed

study_completion_date_type: Actual

primary_purpose: Supportive Care

enrollment_type: Actual

ipd_sharing: Undecided

intervention_type: Drug

status_simplified: Completed


title: Rapid Declarative Neocortical Declarative Learning in Aging and Memory

acronym: ANéRAVIMM

summary: Learning a person's name, new words, or simply remembering where the last conversation with a friend was held are examples of associative memory, frequently disturbed in brain pathologies, but also by aging. Although typically dependent on the hippocampus in the brain, a series of findings suggest that associative memory may persist, under certain circumstances, despite hippocampal damage. The ANéRAVIMM project aims to reveal this learning system, its cognitive and cerebral bases, and to evaluate its potential in patients with memory disorders.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Rennes University Hospital

intervention_type: Other

lead_sponsor_type: academique


title: Comparative Interest of Transcranial Doppler and Quantitative Pupillometry as Neurological Prognostic Factors at 12 Months in Brain Damaged Patients (Stroke or Head Trauma) Admitted to Intensive Care Unit

summary: Transcranial Doppler is performed daily in Intensive Care Unit in brain damaged patients. For a few years now, the measurement of the photomotor reflex by quantitative Pupillometry has been routinely performed in Intensive Care Units. The objective of this work is to see if Transcranial Doppler recorded parameters and Pupillary parameters are correlated to the neurological prognosis evaluated at 9 months by the Modified Rankin Score (mRS) and the Glasgow Outcome Scale Extended (GOS-E).

study_type: Observational

time_perspective: Other

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Device


title: Predictors of Attempted Inferior Vena Cava Filters Retrieval.

summary:
The InferiorVena Cava (IVC) with filters has been recommended when there is a contraindication or a failure of anticoagulation. Due to the side effects related to the filters, it is recommended to remove them as soon as possible. It's a retrospective study in a French hospital to evaluate the retrieval rate and predictors of filter removal.

All the data of consecutive patients who had a retrievable InferiorVena Cava Filter (IVCF) inserted in the investigator center between April 2012 and November 2019 are included.

time_perspective: Retrospective


title: Interest of Ultrasound in the Diagnosis of Severity of Lateral Ankle Sprain

summary: Ankle sprain is a frequent and widely trivialized trauma. Misdiagnosed or poorly treated, it can recur and thus develop into chronic ankle instability. It can be associated with complications which, if not detected early, can lead to long-term sequelae.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Prospective


title: Placental Expression of EG-VEGF and Its PROKR1 and PROKR2 Receptors in Preeclampsia Patients.

acronym: PRE-EVE

summary:
The pathophysiology of preeclampsia (PE) is thought to be endothelial dysfunction responsible for the maternal signs of de novo hypertension and proteinuria after 20 weeks. Current concepts suggest that the pathophysiology of preeclampsia and intrauterine growth retardation results from an imbalance of angiogenic factors.

A new angiogenic factor EG-VEGF (Endocrine Gland- Derived Vascular Endothelial Growth Factor) also known as Prokineticin 1 (PROK1) appears to be emerging in the pathophysiology of PE. EG-VEGF is a circulating factor which belongs to the family of prokinetics. Dr Alfaidy's MAB2 team at the Cancer and Infections Biology Laboratory (U1292 Biosanté INSERM / UGA / CEA, CEA Grenoble) demonstrated its key role in the control of key processes in placental development and provided evidence through the development of an animal model of preeclampsia. EG -VEGF is directly involved in the development of Pre-Eclampsia. Few studies have evaluated the expression of EG-VEGF in the human placenta.

intervention_type: Biological


title: Assessment of the Relationship Between Sleep Apnea Syndrome and Patent Foramen Ovale Among Young Subjects Victims of Cryptogenic Ischemic Stroke

summary: Obstructive sleep apnea syndrome (OSAS) and patent foramen ovale (FOP) are considered as risk factors for stroke. OSAS generates a pressure increase in the right cavity during inspiratory efforts, which increases the number of right-left shunt embolus and therefore the risk of stroke. OSA and FOP are often thought as two separate entities, however, due to their high frequencies, they sometimes coexist and can influence the pathophysiology of each other. More researches are needed in this area to confirm this complex association and its role in triggering stroke.

status: Enrolling by invitation

intervention_type: Diagnostic Test

status_simplified: Unknown


title: Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a Retrospective French Multicenter Study

summary:
After developing in pediatric hematology and nephrology, therapeutic apheresis is increasingly used in pediatric neurology despite a sparse level of evidence.

There are a few retrospective series with a small number of patients, concerning mainly autoimmune diseases (encephalitis, myasthenia gravis, polyradiculoneuritis).

The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: 3D Radiographic Evaluation of the Long Terms Results of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft: Comparison of Early Versus Late Secondary Grafting SABG : Secondary Alveolar Bone Grafting

acronym: SABG

summary:
Study about the comparison of post-operative results of secondary alveolar grafts according to two age groups: early secondary (4 to 7 years) versus late secondary (8 to 11 years) using a recently proposed score based on post-operative 3D CT analysis.

Comparison of the initial results of the graft in the two groups, with a reference 2D score and evaluation of the concordance between the results found with this score and those of the 3D score.

Finally, comparison of graft bone densities and nasal floor level (using 3D visualization) on post-operative TDMs in the 2 groups.

The aim of this study is to determine the optimal age for grafting using three-dimensional CT assessment.


title: Study of Cortisol Metabolism in Familial Partial Lipodystrophy Type 2

acronym: LIPOCORT

summary: Familial partial lipodystrophic syndromes are characterized by an increase in visceral adipose tissue and an atrophy of subcutaneous adipose tissue. They are associated with a severe metabolic syndrome especially when linked to the mutation of the R482 codon of the LMNA gene (Familial partial lipodystrophy type 2, FPL2). Data in lipodystrophy induced by antiretroviral therapy of HIV suggests an increase in the activity of 11β-hydroxysteroid dehydrogenase type 1 (11bHSD1). This enzyme reactivates cortisone in cortisol in adipose tissues and liver and has associated to obesity and type 2 diabetes mellitus. Hence, the hypothesis is that in patients suffering from FPL2 with the R482 codon mutation of the LMNA gene, there is an increase in the activity of HSD11B1 which could participate to the metabolic phenotype of the disease.

lead_sponsor: University Hospital, Lille


title: Prevalence of Migraine Disease in Electrohypersensitive Patients

summary: The investigators propose here by the use of the French version of the migraine disease screening questionnaire (ID Migraine ™) to study the prevalence of migraine disease in a population of electrohypersensitive patients


title: Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit - a Four Years Follow-up Study

summary:
In 2018, the investigators evaluated the treatment of 236 patients with heart failure (with preserved or reduced ejection fraction) before and after hospitalization in our internal medicine unit (from 2016 to 2017).

The investigators showed that patients, mainly elderly women with comorbidities, often had suboptimal heart failure treatment without an identified cause. The investigators tried, whenever possible, to optimize treatment before hospital discharge.

Our objective is now to analyze the 4-year outcome of these patients, including re-hospitalization for heart failure or death.


title: Idiopathic Purpura Fulminans Associated With Anti-PS Antibodies in Children: a French Multicenter Retrospective Study

summary: Idiopathic purpura fulminans by anti-protein S antibody is a very rare but potentially extremely serious entity. The data in the literature are poor with only isolated report boxes and a single series of less than 10 boxes. The creation of a larger series of cases would make it possible to better understand this pathology and to offer assistance in diagnosis and management.


title: A Protocol Investigating the Impact of Lungpacer PROTECT Diaphragm Pacing Therapy on Gas Exchange, Hemodynamics, Regional Lung Ventilation and Atelectasis in Patients Presenting With Moderate ARDS

acronym: PIRAT

summary: The Lungpacer PROTECT Diaphragm Pacing Therapy System (DPTS) is a temporary, percutaneously-placed, transvenous, phrenic nerve-stimulating device intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients. The purpose of the PROTECT DPTS is to improve gas exchange, regional lung ventilation, and hemodynamics, and decrease atelectasis in patients presenting with acute respiratory distress syndrome (ARDS).

primary_purpose: Treatment

lead_sponsor: Lungpacer Medical Inc.


title: High Resolution Electroencephalography Exploration of Tactile Prediction Development

acronym: DECODE

summary: This project aims to measure repetition suppression and tactile prediction using high-resolution electroencephalography in preschoolers, in order to describe the responses as a function of age, gestational age of birth and the presence of a neurodevelopmental disorder. We will include 100 children aged 2 or 6 years: 25 2-year-olds born prematurely, 25 2-year-olds born at term, 25 6-year-olds with typical development and 25 6-year-olds with neurodevelopmental disorders. We will perform several behavioral evaluations to analyze the results in view of the quality of development.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen

intervention_type: Behavioral


title: Creation of a Pleural Carcinomatosis Tissue Bank

acronym: TICP

summary:
Malignant pleural effusion is a common evolution of various cancers and is associated with poor prognosis and quality of life. About 28% of patients with primary malignancy will develop pleural metastasis. Malignant pleural effusion mostly occurs in lung, breast, ovarian and gastric cancers. Median survival ranges from 3 to 13 months according to primary malignancy. Currently, the therapeutic approach is mainly palliative with videothoracoscopic talc pleurodesis or indwelling pleural catheters insertion eventually associated with systemic chemotherapy if patient's general condition allows.

In a early-disseminated tumor cells profile, metastatic cells can accumulate alterations at a distant site and have a different profil from the original tumor cells. Metastatic cells can also accumulate alterations in the course if systemic treatments. Consequently, they may respond differently to drugs.

Recently, EGFR mutations and ALK status discordance between primary tumors and pleural metastases have been demonstrated in a significant portion of lung adenocarcinomas. These studies, realized on malignant pleural effusion isolated cells, enabled us to hypothesize a possible intratumoral heterogeneity within pleural metastases, but no study has been carried out on pleural tissue.

Our aim is to create a biocollection with tissues from pleural carcinomatosis in order to subsequently allow multiomics and bioinformatics analyzes and to characterize a possible intratumoral heterogeneity in pleural metastasis.

lead_sponsor: Hospices Civils de Lyon

intervention_type: Genetic


title: Comparison of Three Care Strategies in Cases of New-onset Supraventricular Arrhythmia During Septic Shock : a Randomized Controlled Trial

acronym: CAFS

summary:
New-onset supraventricular arrhythmia (NOSVA) is reported in 40 % of patients with septic shock and is associated with hemodynamic alterations and mortality. The lack of consensus regarding best practices for the management of NOSVA in this setting has led to major variations in practice patterns. Observational studies reported three usual strategies: (i) heart rate control (hereafter rate control) with the use of antiarrhythmic drugs, essentially based on low dose of amiodarone, (ii) rhythm control with the use of antiarrhythmic drugs, essentially based on high dose of amiodarone, and electrical cardioversionand (iii) modifiable NOSVA risk factors control (hereafter risk control) without using antiarrhythmic drugs.

Risk control would minimize adverse events of antiarrhythmic drugs. Rhythm control would rapidly improve haemodynamics via restoring diastole and decreasing cardiac metabolic demand, while minimizing exposure to anticoagulation. Rate control, would limit potential adverse events of high dose of amiodarone and of electrical cardioversion (only in patients intubated on mechanical ventilation), while controlling haemodynamics. Therefore, it seems important to compare these three strategies.

Our hypothesis is dual: first, that rate control and rhythm control each improve hemodynamics with in fine a decreased mortality, as compared to a risk control; second, that rhythm control outperforms rate control in this setting.

This is a multicenter, parallel-group, open-label, randomized controlled superiority trial to compare the effectiveness and safety of these three strategies (risk control, rate control and rhythm control) for NOSVA during septic shock.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Médecine Intensive Réanimation-Hôpital Tenon


title: Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People

acronym: COVIVAC-ID

summary: Prospective, multicenter, non-comparative cohort study of immunocompromised people vaccinated against Covid-19 with the aim to know the humoral and cellular response to BNT162b2 vaccination against SARS-CoV-2 variants. This study will enroll patients in 5 parallel sub-cohorts of the same size, distinct according to the source of the immunosuppression: autoimmune or auto-inflammatory disease, HIV infection, multiple sclerosis, solid cancer, organ transplantation with prospective data collection and constitution of biological collections.


title: Impact of Regional Anesthesia on Blood Pressure in Lower Limb Traumatism : IRB (Impact of Regional Anesthesia on Blood Pressure)

acronym: IRB

summary: This study aims to compare the hemodynamic impact of two anaesthetic strategies 'Regional anesthesia' versus 'General anesthesia' in leg and ankle fractures surgery.


type: Registry Identifier

title: Prevalence of Orthostatic Tremor by Surface Electromyographic Recording in Patients Reporting Unsteadiness

acronym: EMG-SOT

summary: Clinical presentation of orthostatic tremor (OT) may be misleading and simply perceived by a postural instability such as in several peripheral neuropathies. In addition, peripheral neuropathies represent the leading cause of pathologies associated with OT. Among patients referred for an electroneuromyogram (ENMG) for peripheral neuropathy and presenting with postural unsteadiness, OT assessment will be systematically performed. Demographic, clinical and polygraphy characteristics of these patients will be analyzed and prevalence of OT in the general population of peripheral neuropathies will be assessed.

location_facility: APHP Lariboisière Hospital, Clinical Physiology Department


title: Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment

acronym: AMPHIBIA

summary: The AMPHIBIA study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis.

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ReferenceCitation: Klingel K, Hohenadl C, Canu A, Albrecht M, Seemann M, Mall G, Kandolf R. Ongoing enterovirus-induced myocarditis is associated with persistent heart muscle infection: quantitative analysis of virus replication, tissue damage, and inflammation. Proc Natl Acad Sci U S A. 1992 Jan 1;89(1):314-8.

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title: MESSAge Study : Ultrasound Measurement of Sarcopenia in the Elder Subject

acronym: MESSAGE

summary:
Sarcopenia is a generalized, progressive and multifactorial muscle impairment, causing multiple pathologies and their consequences such as falls, fractures, dependence, worsening of cognitive disorders and death. Interventions to combat the progression of sarcopenia should be introduced as soon as clinically suspected, based on functional tests to measure muscle strength. Diagnostic confirmation of sarcopenia can be done using several validated methods of estimating muscle mass: magnetic resonance imaging (MRI), computed tomography (CT), biphotonic absorptiometry (DEXA) or bio-impedanceometry. Their availability in clinical routine remains limited due to their high costs and/or lack of accessibility depending on the place of practice. On the other hand, there are certain pitfalls for carrying out these various examinations, in connection with several common clinical problems in the study population: mobility disorders and neurodegenerative disorders disabling for transport and access to the examination table for imaging examinations, hydration disorders distorting measures for bio-impedancetry.

Previous studies suggest that ultrasound may be as effective a tool as previous methods for diagnostic confirmation of sarcopenia. Because of its non-invasive and non-irradiating nature, its affordability, its short duration of realization, its availability and its low constraints of realization, the ultrasound could help to remove some of the current limits to the diagnostic confirmation of sarcopenia.

The investigators hypothesis is that ultrasound can be used to implement a simple and reliable protocol for assessing sarcopenia in the elderly. It could also be used to detect sarcopenia at an early stage ("presarcopenia") while the decrease in muscle mass is not yet accompanied by a decrease in skeletal muscle strength.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: PLATELET Function Assay With Flow Imaging on ImageSTREAM Cytometer

acronym: PLATELETSTREAM

summary:
Platelets are essential blood elements to maintain hemostasis. Quantitative or qualitative defects can be responsible of hemorrhagic (platelet disorders) or thrombotic (heparin induced thrombocytopenia [HIT]) troubles. Diagnosis of these pathologies is sometimes urgent and consists in delicate platelet functional assays that are mostly made in expert centers. These platelets functional assays measure platelets activation and/or aggregation in response to diverse inductors and may lack sensitivity. The investigators would like to propose a new diagnostic tool with the use of imaging flow cytometry which provides much more information than classic cytometer on cell morphology thanks to images collected by the optical channel of the ImageStream cytometer. The use of this cytometer offers an innovative approach.

This study is a monocentric prospective and non-interventional study. The investigators will analyze patient samples with the ImageStream cytometer and reference laboratory tests (light transmission aggregometry and serotonin release assay) in parallel and compare results from the different techniques. This new diagnostic technique will demonstrate a non-inferiority diagnosis compared to reference tests and maybe a better sensibility.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Determination of Normal Values of Parameters of Thrombin Generation in Fresh PRP and in PPP in Function of Different Tissue Factor Concentrations

acronym: NUAGE

summary: The thrombin generation assay (TGA) is a good tool for measuring clot formation in plasma.TGA using Calibrated Automated Thrombography method, enables the quantification of thrombin concentrations in platelet-rich plasma (PRP) and in platelet-poor plasma (PPP).According to the clinical context, different TF(Tissue Factor) concentrations (1, 5 and 10 pM) can be used to trigger the coagulation cascade.The aim of the study is to determine the normal values of TG (Thrombin Generation) in fresh PRP and in PPP with different TF concentrations.

location_facility: CHU de Saint-Etienne - Service d'Hématologie


title: Determinants of Successful Tracheostomy Removal in Difficult-to-wean Patients: A Prospective Cohort Study

acronym: DESCATRON

summary:
The factors of success of decannulation are not well known in the literature and the decision to decannulate is mainly based on clinical judgment. The failure rate of decannulation is between 2 and 25% with a poor prognosis in case of failure.

The objective of this study is to determine the factors associated with successful tracheostomy removal in patients hospitalized in a respiratory weaning unit.

The secondary objectives are to evaluate in tracheostomized and hospitalized patients in weaning unit:

The prevalence of successful tracheostomy removal;
The prevalence of successful weaning from mechanical ventilation;
Factors associated with successful weaning from mechanical ventilation;
Demographic characteristics of these patients at admission;
Ventilatory characteristics of these patients at admission;
Biological characteristics of these patients at admission;

This is a prospective, single-centre, interventional cohort study with an expected duration of 2 years. All patients admitted to the respiratory weaning unit in the Forcilles' hospital, with a tracheostomy and an expected duration of mechanical ventilation > 48 hours will be consecutively included.

All factors potentially associated with successful tracheostomy removal will be prospectively collected: severity factors related to the ICU stay, ventilatory factors, respiratory and extra-respiratory factors.

primary_purpose: Screening

ipd_sharing: Yes

ipd_sharing_description: All data that underlie results in a publication will be uploaded in a repository platform.

lead_sponsor: Hopital Forcilles


title: Dysfunction and Endothelial Repair in Sepsis Shock : RNAseq Transcriptomic Analysis of Circulating Endothelial Cells

acronym: TRACES

summary: Vascular dysfunction is an important mechanism involved in organ failure, in the setting of sepsis condition, with different types of circulating endothelial cells.Transcriptom analysis via RNAseq in different types of circulating endothelial cells, comapring critically ill patients with or without sepsis will allow determining differential gene expression for signal pathways in endothelial alteration and restoration associated with sepsis.


title: First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress

acronym: Stress-FC

summary:
Miscarriage is the spontaneous termination of pregnancy before 22 weeks of amenorrhea. The most frequent complication of pregnancy, it represents 10 to 25% of pregnancies and affects one in four women.

Miscarriage is considered by medical personnel to be common and trivial. however, for women, it is very often a traumatic event, a source of worry for futures pregnancies.

lead_sponsor: Université de Reims Champagne-Ardenne


title: Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium

acronym: MYCOCLEAR

summary:
It is a prospective, monocentric, interventional study on spontaneous vaginal clearance of Mycoplasma genitalium.

The main objective is to evaluate the spontaneous vaginal clearance of M. genitalium in patients coming to perform a voluntary termination of pregnancy at the University Hospital of Bordeaux at 9 weeks after a vaginal sample positive for M. genitalium

lead_sponsor: University Hospital, Bordeaux


title: French Registry of Patients Initiating Systemic Treatment for Cutaneous Psoriasis

acronym: PSOBIOTEQ

summary:
PSOBIOTEQ is a national multicentric prospective non interventional study which aims to constitute a French registry of cutaneous psoriasis patients initiating systemic treatment (excluding acitretin and phototherapy) for moderate to severe cutaneous psoriasis. The general objective of PSOBIOTEQ registry is to describe the use, benefits and risks of conventional, biological, biosimilar and small-molecule inhibitor of phosphodiesterase 4 (PDE4) systemic treatments in a real-life setting.

The registry aims to meet many specific objectives and to fulfill ancillary studies. The PSOBIOTEQ registry concerns a largely similar population and has same objectives than the PSOBIOTEQ Cohort (NCT01617018). Indeed, data from the PSOBIOTEQ cohort will constitute the historical part of the registry and the cohort patients will pursue their follow-up in the registry framework, in order to enrich their follow up with new collected data.

ipd_sharing_description: Undecided


title: Analysis of the Blood Signature of the Microbiota as a Diagnostic Marker of Alzheimer's Disease in the Early Stages of the Process: Pilot Study

acronym: MICMALZ

summary: This study aims to validate a difference in blood microbial signature between Alzheimer's patients and control subjects in order to propose potential innovative strategies


title: NEURodevelopmental Outcome in Children Between One and Five Years After Persistent Pulmonary Hypertension Of the Newborn

acronym: NEUROPHON

summary:
Neonatal pulmonary hypertension is a rare but serious condition resulting from a lack of adaptation to extra-uterine life in some newborns. In the short term, the risk of death requires rapid and appropriate management of this transient pathology.

In the long term, these newborns present a greater brain vulnerability, a consequence of the pathology itself with cerebral hypoxia but also invasive and aggressive therapies. Although current scientific evidence indicates a correlation with the existence of neurological developmental disorders, the understanding of the long-term neurological outcome of these babies remains poorly documented. Better knowledge of remote neuro-psychomotor development of the critical period

lead_sponsor: University Hospital, Toulouse


title: Comparison of Two Diagnostic Strategies in Indeterminate Biliary Stenosis: Exploration by Retrograde Cholangioscopy From the Outset or After Failure of Conventional Techniques

summary:
Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting.

The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness.

The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).

lead_sponsor: Frederic PRAT, MD, PhD


title: Effect of 4% Albumin Prime Solution for Cardiopulmonary Bypass on Postoperative Pulmonary Complications In Patients Undergoing Pulmonary Endarterectomy: A Propensity-adjusted Analysis

acronym: ALBUTEP

summary: In 2019, the investigators initiated a new priming fluid therapy strategy in the cardiopulmonary bypass (CPB) machine for patients undergoing pulmonary endarterectomy surgery. It consisted in a transition from a "pure" primarly balanced crystalloid priming fluid strategy to a 4% human albumin priming fluid-strategy in addition to a low volume of balanced crystalloid solution. The rationale was the theoritical assumption that albumin leads to better intravascular volume expansion compared to crystalloid and therefore could reduce overall volume requirement during surgery and consequently potentially decrease the incidence of postoperative pulmonary complications. The objective of this propensity-matched study was to evaluate the effectiveness of this intervention

lead_sponsor: Erasme University Hospital


title: PREVALENCE OF OBESITY-HYPOVENTILATION SYNDROME IN PATIENTS WITH METABOLIC SYNDROME

summary: The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.

lead_sponsor: SOS Oxygene Mediterranee


title: Does Hirschsprung Disease Increase the Risk of Febrile Urinary Tract Infection in Children ? A Case-control Study

summary:
Febrile urinary tract infection (FUTIs) are the most common bacterial infections in children under the age of 2 years. They represent 7% of children presenting with fever without a source. In case of recurrent or undertreated FUTIs there is a risk for kidney function with the threat of chronic renal failure [7]. They are more often isolated but some FUTIs may reveal an underlying and facilitating condition. Beside the well-known congenital anomalies of the kidneys and urinary tract such as reflux or obstructions, others risk factors for FUTI are reported. Age less than 1 year, uncircumcised males, poor fluid intake, bladder bowel dysfunction (BBD) including dysfunctional voiding pattern and constipation increase the risk of FUTI. The prevalence of BBD in children with FUTIs is far higher than in the general population. Recommendations emphasize on an efficient treatment of BBD in the first-line management of recurring FUTIs and it has been proven to be efficient (ref).

One of the BBD may include Hirschsprung's Disease (HD). HD is the first congenital malformation of the enteric nervous system with a reported prevalence of 1 in 5000 live birth. It's characterized by an aganglionosis and subsequent dysmotility affect by always the anal canal, most commonly there is a rectosigmoid form (74-80%), and less commonly involves a long segment of colon (12-22%) or a total colonic aganglionosis with ileal involvement upto 50 cm proximal to ileocecal junction (4-13%). The treatment is based on the resection of dysfunctional segment of colon with an anastomosis between the normally innervated bowel to the anus, while preserving normal sphincter function. But significant bowel dysfunction may persist postoperatively. 20% of the children present a fecal incontinence, and 14% a constipation in long-term studies. Bladder dysfunction and associated urological anomalies are also reported in these patients. All of that may facilitate the occurrence of febrile urinary tract infections (FUTI) in patients with HD. Unfortunately, few studies focused on this specific population.

The objective of this study was to find out whether children with HD are more prone to develop FUTIs than controls and which patient with HD are more at risk to develop UTIs.


title: Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation

acronym: DATACOL

summary:
Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation.

Each dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample.

lead_sponsor: Hopital Foch


title: A Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of FR104, a Novel Antagonist Pegylated Anti-CD28 Fab' Antibody Fragment in de Novo Renal Transplant Patients

acronym: FIRsT

summary: The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) of FR104 as well as its potential clinical effect on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.

lead_sponsor: Nantes University Hospital


title: Study of Humoral and Cellular Immune Responses Following SARS-CoV-2 Vaccination to Predict Immune Responses in Cancer Patients

acronym: CACOV-VAC

summary: T-cell adaptive immunity is known to be required to sustain a long term immunoglobulin production and a long term memory against several infections. Previous results suggest a lack in the generation of T-cell responses against CoV-N, M and S proteins among cancer patients exposed to SARS-CoV-2 virus highlighting that cancer patients failed to mount a protective T-cell immunity. Given this context, our hypothesis is that COVID-19 vaccine candidates are not immunogenic in some cancer patients. Thus, the monitoring of CD4 and CD8 T-cell responses before and after vaccination might provide information related to the correlation between induction of CD4 T-cells (including helper follicular T-cells) by the vaccine and long-term IgG production (serological index). Additionally, the failure of COVID-19 vaccines in some patients should be monitor carefully in order to provide specific recommendations to avoid COVID-19 infections. The main objective is to assess humoral immune responses following COVID-19 vaccination in a population of cancer patients.

ReferenceCitation: Gomez-Cadena A, Spehner L, Kroemer M, Khelil MB, Bouiller K, Verdeil G, Trabanelli S, Borg C, Loyon R, Jandus C. Severe COVID-19 patients exhibit an ILC2 NKG2D(+) population in their impaired ILC compartment. Cell Mol Immunol. 2021 Feb;18(2):484-486. doi: 10.1038/s41423-020-00596-2. Epub 2020 Dec 14.

ReferenceCitation: Kroemer M, Spehner L, Vettoretti L, Bouard A, Eberst G, Pili Floury S, Capellier G, Lepiller Q, Orillard E, Mansi L, Clairet AL, Westeel V, Limat S, Dubois M, Malinowski L, Bohard L, Borg C, Chirouze C, Bouiller K. COVID-19 patients display distinct SARS-CoV-2 specific T-cell responses according to disease severity. J Infect. 2021 Feb;82(2):282-327. doi: 10.1016/j.jinf.2020.08.036. Epub 2020 Aug 25.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Cannabinoides Concentrations and Hyperemesis Syndrom Occurrence in Regular Cannabis Consumer (CANEMESE)

summary:
The Cannabinoide Hyperemesis Syndrom (CHS) is defined as a recurrent syndrome of intractable vomiting that occurs in chronic cannabis consumers. The diagnosis is linked to clinical criteria only. The physiopathology of CHS is unknown and we observe an increase of cases with this syndrom since 2016 (Schreck et al., 2018).

The aim of this study is to investigate the involvement of exogenous cannabinoids concentrations in chronic cannabis users in the occurrence of CHS.

lead_sponsor: Poitiers University Hospital


title: Prospective Monocentric Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer

acronym: PROSNACO

summary: Esophageal surgery is a complex surgery, with high post-operative morbidity and mortality. The incidence of complications associated with esophagectomy varies from 17% to 74%, in the literature. A section of vagus nerves is conventionally performed during esophagectomy for cancer, because of oncological margins. The vagus nerve is responsible for the parasympathetic innervation at the gastrointestinal level, but also at the cardiac and pulmonary level. The post-operative morbidity of these procedures could be linked in part to the bilateral section of the vagus nerves, because of their impact on the autonomous regulation of this vital functions. The main objective of the study is to find a modification of the sympathomimetic balance pre and post operatively, in patients undergoing esophagectomy.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre Hospitalier Universitaire de Saint-Etienne


title: Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair

acronym: SEX-RPC

summary:
Vaginal laxity" syndrome is an increasingly frequent reason for gynecological consultations. Patients complain above all of a sensation of excessive vaginal looseness. This syndrome can be isolated or associated with genital prolapse. Women with vaginal laxity may experience sexual dysfunction manifested by hypersensitivity during penetration and vaginal gas, resulting in decreased libido. Among urogynecology patients, vaginal laxity has been reported in up to 24% of cases, with a mean discomfort of 5.7 (on a scale of 0 to 10). Vaginal laxity is more common in younger women who have given birth vaginally. Gynecologic examination usually finds widening of the urogenital hiatus during the Valsalva maneuver, suggesting that vaginal laxity may be a manifestation of hyperdistensibility or disinsertion of the levator ani muscles. Campbell et al. noted that vaginal laxity was reported by 38% of 22621 women attending a urogynecology clinic and was associated with vaginal parity, prolapse symptoms, stress, and urinary urgency incontinence, reduced sensation on the ePAQ-PF questionnaire. In an IUGA survey of member physicians, 83% of respondents felt that vaginal laxity was underreported by patients.

The most common clinical definition of vaginal laxity is a urinary meatus to vulvar fork distance (GH measure of the POP-Q classification) > or = 4cm.

The first-line treatment for vaginal laxity is perineal rehabilitation. If this fails, surgical perineal repair, combining posterior perineorrhaphy and myorrhaphy of the pubo-rectal bundles of the levator ani muscles, can be performed with the aim of narrowing the introital vaginal caliber and improving the symptoms of laxity. This procedure is poorly evaluated in the literature.

The purpose of this study is to evaluate the functional and sexological results of surgical perineal repair.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Characters) Dyspnea Assessment in Adult Patients With Myotonic Dystrophy Type 1: a Monocentric Pilot Study

summary:
Myotonic dystrophy type 1 (DM1) is one of the most common neuromuscular diseases in adults. As respiratory dysfunction is the most common cause of death in patients with DM1, a respiratory disease progression must be monitored combining symptom screening and respiratory function testing, in order to identify the appropriate time to initiate non invasive ventilation (NIV).

Dyspnea, one of the main respiratory symptoms, has been little studied in patients with DM1.

The main objective of this study is to provide the first multidimensional description of dyspnea in patients with DM1.

The secondary objectives are:

To compare respiratory symptoms according to the presence or not of criteria from respiratory function testing to initiate NIV
To assess associations between dyspnea and respiratory function testing
To assess associations between dyspnea and number of Cytosine Thymine Guanine (CTG) repeats
To assess associations between dyspnea and muscular strength
To assess associations between dyspnea and BMI
To assess associations between dyspnea and anxiety or depression
To assess associations between dyspnea and cognitive impairment
To assess associations between dyspnea and quality of life.

lead_sponsor: CHU de Reims


title: Hemodynamic Effect of Prone Positioning in Non-intubated Patient With COVID 19 Pneumonia: a Monocentric Prospective Cohort Study

summary: Prone position in non-intubated patient has shown some respiratory physiological benefits. Prone positioning in patient intubated with ARDS has shown hemodynamic benefits. We aim to compare hemodynamic assessment before and after prone positioning in non-intubated patient with COVID 19 pneumonia. The study hypothesis is that prone positioning in non-intubated patient improve right ventricular preload, reduce afterload and increase Cardiac index compared to supine position.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Anesthésie-Réanimation, Hôpital Louis Pradel,


title: Burnout, Stress and Coping Strategies: Impact of the Covid-19 Epidemic on the Medical and Paramedical Staff in Reims University Hospital and EPSM Marne

summary:
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a novel coronavirus detected in Wuhan, China on December 2019. This virus is responsible for the infectious respiratory disease called Covid-19.

The psychological effects of this epidemic are found among the general population, but also healthcare workers. Some studies have shown that psychological disorders such as stress, anxiety, depressive symptoms, insomnia, denial, anger and fear, post-traumatic stress disorder are emerging among healthcare workers. However, there is currently insufficient data to evaluate the burnout during the COVID-19 pandemic.

The purpose of this study is to understand the impact of the covid-19 epidemic on stress and burnout on healthcare workers and their coping strategies.

time_perspective: Cross-Sectional


title: Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal

acronym: OOPS

summary: Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer

lead_sponsor: University Hospital, Angers


acronym: KLOE

title: Ketamine Low dOse Evaluation on Morphine Consumption in Traumatic Patient

lead_sponsor: Assistance Publique Hopitaux De Marseille

type: EudraCT Number

source: euctr

location_facility: Service Anesthésie Réanimation - Hôpital nord

summary: The aim of this study is to demonstrate a significant reduction of at least 25% in opioid consumption at 48 hours of management of severe trauma, while demonstrating non-inferiority in terms of analgesia, in a group of patients receiving a continuous infusion of low dose ketamine compared to a placebo group.


title: Quantification of Motor Function in Infants With Spinal Muscular Atrophy Treated With Innovative Therapies, IMUSMA Project

acronym: IMUSMA

summary: The aim of the study is to propose a method for quantifying motor function in infants with spinal muscular atrophy treated with innovative therapies using inertial sensors.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Effect of Individualized Training Versus Non-individualized Training to Improve Quality of Life of Sedentary Employees: Controlled Randomized Trial

acronym: SELFIT

summary: The practice of a physical activity, even moderate, plays an important role in the prevention and the management of the main chronic non-communicable diseases (cardiovascular diseases, certain cancers, diabetes, obesity, osteoporosis ...) as well as by improving psychological health. Several studies have shown that physical activity has a positive impact on the economy of companies via the reduction of absenteeism and the improvement of productivity. However, it seems important to individualize these recommendations in order to prescribe the best possible dose of physical activity for each individual. In this project, the investigators want to test the physical qualities of employees in order to prescribe the best possible dose of physical activity with the ultimate goal of improving quality of life.

status: Terminated


title: Early Results of ULD CT-scan for Extremity in Emergency Room

acronym: ULD E

summary:
extremity trauma is a frequent reason for emergency room visits. There is an increase in the use of CT scanners in extremity trauma, due to a greater sensitivity of detection than X-rays, particularly for "occult fractures" and for the organization of treatment, particularly surgical treatment. As the number of CT scans increases, the reduction of the delivered dose has become a subject of interest.

Among the many methods used, the use of iterative reconstruction has enabled a substantial reduction in the delivered dose without compromising image quality: low-dose and ultra-low-dose protocols (effective dose equivalent to the effective dose of the Diagnostic Reference Levels of radiographs from the same region of interest) have been developped, but have not yet been evaluated in extremity trauma.

The subject of our feasibility study is to evaluate the diagnostic performance of ultra-low dose CT compared to radiographs in patients consulting for extremity trauma in the emergency room.

The recent implementation in our department of a scanner dedicated to low-dose explorations as well as the optimization of protocols has allowed the realization of ultra-low-dose scans since June 2017.

ReferenceType: derived

ReferenceCitation: Addala TE, Greffier J, Hamard A, Snene F, Bobbia X, Bastide S, Belaouni A, de Forges H, Larbi A, de la Coussaye JE, Beregi JP, Claret PG, Frandon J. Early results of ultra-low-dose CT-scan for extremity traumas in emergency room. Quant Imaging Med Surg. 2022 Aug;12(8):4248-4258. doi: 10.21037/qims-21-848.


title: Longitudinal Follow-up of Patients With Chronic Inflammatory Rheumatisms (CIRs) Vaccinated Against COVID-19 Compared to Patients Refusing Vaccination

summary: To date, studies on SARS-CoV2and vaccines have been mostly from the general population not exposed to immunosuppressants. The efficacy and safety of COVID-19 vaccines need to be evaluated in these populations.

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier

location_facility: Centre hospitalier universitaire de Montpellier


title: Comparison for Sensitivity and Tolerance of Self-swabbing and Conventional Nasopharyngeal Swabbing for SARS-CoV-2 Detection for Pain, Discomfort and Acceptability: a Randomized Controlled Non-inferiority Study

acronym: COVISWAB

summary:
Self-swabbing requires less personal protective equipment and could allow to test more people and even to do quick self-diagnosis if antigenic tests are available.

In a preliminary study on 190 medical students, the investigators have shown that self and conventional swabbing were identically well-accepted with equivalent level of pain and discomfort induced by swabbing. In a sub-group of this sample, the investigators have shown that the quality of the 2 sampling methods were equivalent.

The goal of this large study in the general population is to confirm these findings in an adequately powered study. Such results would allow to develop self-swabbing for large screening campaigns and eventually self-diagnosis using antigenic tests.

lead_sponsor: University Hospital, Clermont-Ferrand


title: MARQUEURS DE DEVELOPPEMENT DE L'ATTENTION EXECUTIVE CHEZ L'ENFANT : POPULATIONS VARIEES

acronym: MEDiATE-PRV

summary:
Executive attention is essential for emotional and behavioral self-regulation. There is inter-individual variability in the level of efficiency of executive attention from kindergarten entry, and this variability predicts children's academic performance at entry to elementary school and beyond. It is therefore essential to better understand the early stages of executive attention development and self-regulation from an early age in order to develop tools for early detection of executive attention disorders, so that school accommodations can be proposed as early as possible.

In previous work, we have identified early tactile information processing skills that underpin the development of executive attention. We would like to extend this work to a diverse population of preschool children, in order to consider new tools for the early detection of attention disorders. The MEDiATE-PRV project aims to compare the performance obtained in a validated attentional task in preschool children with assessments of tactile information processing, in relation to the psychomotor and executive development of the child. We will include 200 children aged 4 years to 5 years 11 months with different risk factors for ADHD.

lead_sponsor: University Hospital, Caen


title: Analysis of the Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke

summary: Undernutrition is a frequent problem in hospitals (at least 30% of patients, SENECA-NHANES studies). Its impact on morbidity and mortality is well known in gerontology, oncology and intensive care. There are very few neurovascular studies dealing with the consequences of undernutrition present before the stroke. Indeed, most of the medical literature concerns only undernutrition acquired after a stroke. The investigator propose to analyze medical data from a cohort of patients over 70 years of age thrombolysed and/or thrombectomized in the neurovascular department between the years 2014 and 2019.

ReferenceCitation: Zhang J, Zhao X, Wang A, Zhou Y, Yang B, Wei N, Yu D, Lu J, Chen S, Wang Y, Wang C, Xue R, Zhang Y, Li Y, Yu L, Wang S, Chen Z, Zheng T, Zhang Z, Xia M, He M, Li W, Zhang Z, Zeng F, Chen S, Fu Y, Liu G, Wang L, Huang Z, Ma J, Mu F, Xu Y, Huang R, Wang L, Wang Y. Emerging malnutrition during hospitalisation independently predicts poor 3-month outcomes after acute stroke: data from a Chinese cohort. Asia Pac J Clin Nutr. 2015;24(3):379-86. doi: 10.6133/apjcn.2015.24.3.13.

ReferenceCitation: Yoo SH, Kim JS, Kwon SU, Yun SC, Koh JY, Kang DW. Undernutrition as a predictor of poor clinical outcomes in acute ischemic stroke patients. Arch Neurol. 2008 Jan;65(1):39-43. doi: 10.1001/archneurol.2007.12.

ReferenceCitation: Unosson M, Ek AC, Bjurulf P, von Schenck H, Larsson J. Feeding dependence and nutritional status after acute stroke. Stroke. 1994 Feb;25(2):366-71.

ReferenceCitation: Euronut - SENECA. Nutrition and the elderly in Europe. 1st European Congress on Nutrition and Health in the Elderly. The Netherlands, December 1991. Eur J Clin Nutr. 1991 Dec;45 Suppl 3:1-196.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant-Analysis of Two Pharmacovigilance Databases

summary: To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.


title: Factors Associated With the Absence of Contraception at the Time of Unplaned Pregnancy Among Women Seeking a Voluntary Termination of Pregnancy

summary: The study will be offered to all women who are consultant for an abortion plan are seen in consultation at the orthogeny center where the study will be conducted. Of these 700 women, about 10% will not agree to participate in the study and 10% will not meet the inclusion criteria. Thus it's plane to include 560 patients in the study.

status: Suspended

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Assessment of Pain After Intra-articular Botulinum Toxin Injections in Carpometacarpal Osteoarthritis of the Thumb

summary: Only 4 randomized controlled clinical trials have been published to date to assess the short-term effectiveness of intra-articular Botulinum Toxin injection on pain, function and quality of life in patients suffering from chronic knee pain related or not to knee osteoarthritis and also in the context of ankle osteoarthritis. The analgesic properties and the reported safety make intra-articular Botulinum toxin a strong candidate in the treatment of symptomatic manifestations of osteoarthritis disease and more particularly in certain locations such as the trapezo-metacarpal joint. Investigators hypothesize that injection of intra-articular Botulinum toxin into the trapezo-metacarpal joint will be of benefit in reducing pain and improving function in patients with rhizarthrosis. Investigators will begin a monocentric randomized controlled trial comparing intra-articular injections of Botulinum toxin and placebo.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of a Screening Strategy for Sarcopenia: a Monocentric Prospective Cohort Study

acronym: STRAS

summary: The main objective of this study is to determine the prevalence of sarcopenia in patients hospitalized in the follow-up care and rehabilitation units of the geriatrics department of the Mulhouse French hospital.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: Anesthetic Management of Patients With Chronic Sleep Disorders

acronym: ANEST-SLEEP

summary:
The aim of this study is to describe and compare the anaesthesia history and possible problems encountered in 3 groups of patients with 3 chronic sleep diseases: narcolepsy, idiopathic hypersomnia, and restless legs syndrome followed at the Montpellier Sleep Unit.

For each participant, existing data from the medical record will be used, with their consent. All participants will complete a standardized questionnaire, concerning their history of anaesthesia, the course and possible complications, and questions about their treatment for their sleep disorder.

ReferenceCitation: Hershner S, Kakkar R, Chung F, Singh M, Wong J, Auckley D. Narcolepsy, Anesthesia, and Sedation: A Survey of the Perioperative Experience of Patients With Narcolepsy. Anesth Analg. 2019 Nov;129(5):1374-1380. doi: 10.1213/ANE.0000000000003954.

ReferenceCitation: Hershner S, Dauvilliers Y, Chung F, Singh M, Wong J, Gali B, Kakkar R, Mignot E, Thorpy M, Auckley D. Knowledge Gaps in the Perioperative Management of Adults With Narcolepsy: A Call for Further Research. Anesth Analg. 2019 Jul;129(1):204-211. doi: 10.1213/ANE.0000000000004088. Review.

ReferenceCitation: Ohshita N, Yamagata K, Himejima A, Kaneda K, Yasutome T, Matsuda Y, Tsutsumi YM, Momota Y. Anesthetic Management of a Patient With Restless Legs Syndrome: A Case Report. Anesth Prog. 2020 Dec 1;67(4):226-229. doi: 10.2344/anpr-67-02-10.

ReferenceCitation: Raux M, Karroum EG, Arnulf I. Case scenario: anesthetic implications of restless legs syndrome. Anesthesiology. 2010 Jun;112(6):1511-7. doi: 10.1097/ALN.0b013e3181de2d66. Review.


title: Assessment of the Effect of Restriction on Alimentary AGE (Advanced Glycation Products) in Progression of Chronic Kidney Disease (CKD)

acronym: CKD AGE

summary: Normal-protein and low-AGE through raw or rare proteins diet versus normal-protein and high-AGE diet in stage IIIa-b renal failure patients

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon


title: Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child (Parents Psychic Preterm)

acronym: PoPPY

summary: The objective of the study is to assess the psychic profile of parents of children born prematurely


title: USE OF 18FDG PET-CT TO PREDICT THE RESPONSE OF MANDIBULAR OSTEORADIONECROSIS TO THE PENTOCLO PROTOCOL WITH DOCUMENTED ANTIBIOTHERAPY

acronym: PENTOTEP

summary: This study is created in order to refine and reduce the duration between the medical and surgical therapeutic sequences (when the surgery is necessary) in these fragile patients knowing that conventional radiological changes can only be observed with a delay comprised between 3 and 6 months starting from observed clinical changes.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Efficacy and Feasibility of Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis - a Phase II Randomized Multicentric Trial

acronym: PASIREOCHIP

summary: To assess the efficacy of pasireotide in the reduction of clinically relevant postoperative digestive leakage after CRS plus HIPEC compared to placebo


title: An Open-label, Multicentric, Phase Ib/II Study to Assess the Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to Niraparib in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With Niraparib Since at Least 6 Months

acronym: REVOCAN

summary: The objective of REVOCAN study is to assess the abrogation of PARP inhibitors resistance in patients with relapsed platinum sensitive ovarian cancer treated with PARP inhibitors in maintenance since at least 6 months and who have only an increase of CA 125 without any progression according to RECIST criteria. AsiDNATM at 600 mg will be tested in addition to PARP inhibitors given according to the label in REVOCAN study.


title: Prospective Study on the Risks of Symptomatic Dengue on Pregnancy

acronym: ERiDenG

summary:
Dengue fever is the most common arbovirus worldwide (390 million people infected per year) and is a global public health problem. This public health problem is also becoming European due to its rapid expansion over the past decade with an increase in cases of 400% and the appearance of the first indigenous cases of dengue in Europe. Studies on the consequences of dengue fever on pregnancy find contradictory results. In fact, most of these studies are observational studies describing the risk of dengue fever for pregnancy, without comparison with a control group or comparing the different pregnancy morbidities to those found during pregnancy in the general population. Other research is retrospective case-control studies with major biases in the definitions of obstetric complications, which makes the results questionable.

The study therefore proposes to carry out a prospective case-control study with rigorous matching criteria, strict definitions of cases, controls and obstetric complications.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Randomized Study Evaluating the Impact on the Cost and Quality of Life of Follow up by Systematic Imaging in Patients With Advanced Stage Ovarian, Fallopian Tube or Primary Peritoneum Cancer

acronym: QUALOV

summary:
After well-conducted treatment of ovarian, tubal and primary peritoneum cancer by maximum tumor reduction surgery and chemotherapy including platinum salt and paclitaxel, the clinical remission rate is over 50%. However, 75-80% of patients with ovarian, tube or primary peritoneum cancer recur within 2 years of the end of treatment. In the latest INCa recommendations for 2018, systematic imaging (thoraco-abdomino-pelvic scanner (CT), MRI, PET CT) is not recommended based on the literature because of its low added value compared to CA 125 dosage (sensitivity ranging from 67% to 95%, and specificity of 87% to 93%), its irradiating character (CT) and its cost. However, the recommendations are based on imaging studies dating back at least a decade. Since these studies, technological advances have improved the diagnostic performance of imaging: sensitivity is 78% for whole-body CT scans and 98% for full-body MRI for the diagnosis of ovarian cancer recurrence. Furthermore, previous randomized studies showed no survival benefit with early treatment of relapse on the basis of a high concentration of CA125 alone, so the value of routine CA125 measurement in the follow-up of ovarian cancer patients may be limited. These recent studies lead to heterogeneity in surveillance protocols for ovarian cancer patients despite recommendations. In addition, treatments for recurrences have evolved as well as maintenance treatments to become chronic treatments, with the emergence of the maintenance new treatments detecting early recurrence is particularly important (notably through the development of new molecules given in maintenance treatment). But early detection have to be balanced with the quality of life of these patients.

In usual care, imaging surveillance is often carried out despite the absence of recommendations or data from the literature of high level of evidence.

The question arises as to whether radiological monitoring could make an impact on patient survival without being a source of excessive false positives, patient stress and non-productive costs.

QUALOV trial is a multicenter randomized study for patients in remission after treatment of advanced stage serous epithelial ovarian, fallopian tube or primary peritoneum cancer (stage III and beyond).

The main objective is to assess the effectiveness of systematic imaging for patients followed after advanced stage serous epithelial ovarian, fallopian tube or primary peritoneum cancer

status: Withdrawn


title: Diagnosis of Toxoplasma Gondii Infection by Exploration of Cellular Immunity

acronym: TOXCELL

summary:
Toxoplasmosis is a parasitic disease caused by Toxoplasma gondii and transmitted to humans through the consumption of raw or undercooked infected meat and / or by poorly washed vegetables. It can be transmitted from the pregnant woman to the fetus when infection occurs during pregnancy leading to congenital toxoplasmosis. Once infected, it is considered that the subject harbors cyst forms of the parasite in the muscles and brain for life with a risk of reactivation when immunocompromised. Recently, questions have been raised about the persistence of these cysts.

Currently, only serological diagnosis can demonstrate the infection. This is done by detecting IgM and IgG directed against the parasite. Although humoral immunity is useful to diagnose toxoplasmosis, the cellular immunity is responsible of the main protective role during infection with the secretion of cytokines such as gamma interferon. In some situations, the serological diagnosis is limited: in immunocompromised subjects, some immunocompetent patients, in children with congenital toxoplasmosis, in which the anti T. gondii antibodies are no longer detectable. In order to have a true evaluation of the capacities of the immune system of each individual against T. gondii infection, it is necessary to evaluate the effector immune cells.

The main objective of this protocol is to set up a cellular test with the stimulation of lymphocyte by T. gondii. For this objective, 20 subjects (10 positive, 10 negative for Toxoplasmosis serology) will be included. The secondary objective will be to compare the cellular diagnosis (evaluation by ELISA of the secretion of gamma interferon in the supernatant of cells stimulated by the Ag) with the serological diagnosis (IgG and IgM Alinity Abbott and Western blot LD Bio) in 3 groups of 10 patients: chronically infected patients, uninfected patients, patients with congenital toxoplasmosis as well as to assess the persistence or not of cellular and humoral immunity against T. gondii in 10 patients who had acute toxoplasmosis with a known date infection more than 10 years. Thus, 60 patients will be included for a total study period of 24 months.

This study will thus allow the sponsor to have a clear understanding whether a subject is able or not to react against T. gondii infection.

ipd_sharing_description: no data sharing plan is schedule


title: Extension Protocol for Patients Previously Treated in Avapritinib Clinical Trials

summary: This is an open-label extension study to provide long term safety data for GIST patients who are deriving clinical benefit from avapritinib upon the completion of avapritinib clinical trials.

lead_sponsor: Blueprint Medicines Corporation

location_facility: Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy


title: Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient

acronym: EASY

summary: This work aims to study the effect of an acetate-free dialysate on protein-energy wasting syndrome in patients with chronic hemodialysis renal failure, in comparison to a conventional dialysate with acetate. The hypothesis is that a dialysate without acetate would improve patients nutritional status


title: Immunogenetic Characteristics in Autoimmune Encephalitis and Related Disorders: HLA Analysis: Part II

acronym: ICARE-II

summary:
Autoimmune encephalitis (AE) are characterized by subacute onset of memory deficits, altered mental status or psychiatric symptoms, frequently associated with seizures, inflammatory cerebrospinal fluid and in cases with prominent limbic involvement, typical magnetic resonance imaging. Several autoantibodies (Abs) may be detected in AE, although its detection is not mandatory to establish a diagnosis. These Abs mainly recognize different synaptic and cell-surface proteins in the central nervous system, and are thought to be pathogenic as they alter the normal location or function of its antigens. Paraneoplastic neurological syndromes (PNS) are immune-mediated, remote complications of cancer. The clinical presentation is highly diverse, from central nervous system disorders (limbic encephalitis, cerebellar ataxia) to peripheral neuropathies and neuromuscular junction diseases. Two different kinds of Abs are associated with PNS: a first group known as onconeural Abs, which recognize intracellular antigens and are thought not to be pathogenic; and a second one whose targeted synaptic and cell-surface antigens shared with some non-paraneoplastic AE.

The primary trigger of the immune response is unknown for most of AE. In addition to acquired susceptibility such as herpes simplex encephalitis, genetic predisposition may also be important in the pathogenesis of AE. Human leukocyte antigen (HLA) is the genetic factor most frequently associated with autoimmune diseases, due to its genetic complexity and key role in the adaptive immune response. Others and we already described the HLA haplotypes associated with three types different of AE: anti-leucine-rich glioma inactivated 1 (LGI1), anti-contactin-associated protein-like 2 (CASPR2), and anti-glutamic acid decarboxylase (GAD). Nevertheless, the genetic predisposition of many other AE has not been investigated yet.

Cancer is considered as the trigger of the immune response that lead to PNS development, as the neural antigens recognized by the onconeural Abs are also expressed by tumor cells. Nevertheless, it is still unknown why some patients develop PNS and others do not, even if they present the same histological type of tumor, suggesting that some particular, maybe genetic, characteristics of the patients may play a role in this susceptibility. Furthermore, there is already evidence that, for those neurological diseases that may appear either as PNS or as non-paraneoplastic autoimmune disorder (i.e. Lambert-Eaton myasthenic syndrome), HLA profiles are not the same.


title: Transarterial Chemoembolization Plus Hypofractionnated Radiotherapy vs. Surgery in Locally Advanced Hepatocellular Carcinoma: an IPTW Comparison

acronym: TACE-hypoRT

summary: Patients with non-metastatic unresectable hepatocellular carcinoma

location_facility: Croix-Rousse Hospital, Hospices Civils de Lyon


title: A Phase I Study Evaluating Safety and Efficacy of Hepatic Intra-Arterial Administration of Ipilimumab in Combination With Intra-venous Nivolumab for Advanced Hepatocellular Carcinoma

acronym: HIPANIV

summary: To determine the Maximum Tolerated Dose (MTD), and the recommended Phase 2 dose of HIA Ipilimumab in combination with IV Nivolumab by monitoring the Dose Limiting Toxicity (DLT) within 1 month after IA Ipilimumab administration in dose-escalation phase.


title: Development of Cellular Models of the Ear and Nose From Patient Samples to Study the Mechanisms of Hearing

acronym: CMAG

summary:
Development of cells culturesissued from Nose and Ear to study auditory mecanisms.

Study of the cis-Modulation of the gene GJB2 for the patients with early presbycusis to identify the genetic cause of hearing loss.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method.

acronym: BAROC

summary:
The definitive treatment of disabling metatarsalgia requires surgery. In recent years, a percutaneous technique has been developed, the "Distal Metatarsal Mini-invasive Osteotomy" (DMMO). It consists of performing extra-articular osteotomies that are not osteosynthesized and maintained during the time of bone consolidation by a dressing and specific offloading footwear.The patient is encouraged to resume walking immediately after the procedure, as full plantar support is an integral part of the surgical concept. The goal is to actively modify the distribution of all metatarsal supports by the pressure exerted on the ground during walking and by tendon tensions, in order to reduce forefoot deformities.

DMMO offers many advantages over traditional techniques, but it remains a painful forefoot surgery in the short term despite the systematic use of analgesics and the wearing of a dedicated therapeutic shoe.

The study will seek to identify the predictive character of podobarometric parameters at walking (D+7 and D+30 post-op), between patients who will require a palliative solution versus those who will not (D+90)

lead_sponsor: Centre Hospitalier le Mans


title: Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health

acronym: OPTI'SOINS

summary:
Pregnant women who live in rural area have fewer prenatal consultations. It has been demonstrated that maternal and neonatal morbidity and mortality increase if time travel to a maternity ward is longer than 30 min.

Home visitation in isolated area may improve prenatal follow-up as it gives full access to women to health care professionals as well as biological and ultrasound exams without travelling.

Our aim is to assess the impact of home visitation on prenatal follow-up as compared to prenatal follow-up in maternity ward and in primary care.

Isolated areas will be randomized, for women living in areas included in the intervention group, home visitations will be planned for prenatal follow-up. Ultrasound screening as well as blood exams will be performed during home visitations. For women living in control areas, they will be free to choose prenatal follow-up modalities.


title: Evaluation of Prevenar 13's Vaccine Response in Patients Hospitalized in Infectious Disease Department for Sepsis

acronym: Vaccis

summary:
Vaccination is established as an effective means of individual and collective protection. Hospitalization is an opportunity not to be missed to catch up on vaccinations in certain fragile patients. Patients hospitalized in infectious diseases are generally treated for an acute or chronic infection that can modulate their immunity and therefore their vaccine response. Current vaccine immunogenicity data in immunocompromised patients support a lower percentage of responders than observed in immunocompetent patients.

There is little data to assess the vaccine response (VR) in patients treated for an infection (bacteremia, pneumonia, urinary tract infection, etc.). In order to respond to this problem, the investigators have chosen to evaluate the vaccine response to Prevenar 13 (PCV13), a conjugate vaccine recommended as a prime-boost since 2013, which must be followed by a vaccination at 2 months with Pneumovax, an unconjugated vaccine of 23 valences.

Anti-pneumococcal vaccine coverage in frail people (immunocompromised, heart failure, respiratory failure, kidney failure, diabetics) remains low and is estimated at less than 10% in 2011, while the bacteria is responsible for severe invasive infections.

In total, the investigators would like to study the vaccine response at 1 month of vaccination with Prevenar 13 in patients hospitalized in infectious disease for sepsis, in order to demonstrate the benefit of vaccination per hospitalization.


title: TRIAL EVALUATING EFFICACY and SAFETY OF BEVACIZUMAB (ZIRABEV®) IN PATIENTS WITH SEVERE HYPOXEMIC COVID-19, NESTED IN THE CORIMUNO-19 COHORT

acronym: BEVA

summary:
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are the most frequent complications of the COVID-19 pandemic. In these conditions, hypoxemia may result from : i) a pulmonary vascular dilatation resulting from an impaired hypoxic pulmonary vasoconstriction and leading to ventilation-perfusion mismatching within the lungs and ii) thrombosis-mediated perfusion defects. Pulmonary vascular dilation might be due to a relative failure of the physiological acute hypoxic pulmonary vasoconstriction, in the context of an over-activation of a regional vasodilatation cascade, as part of a dysfunctional inflammatory process. Perfusion abnormalities associated with pulmonary vascular dilation are suggestive of intrapulmonary shunting toward areas where gas exchange is impaired, ultimately leading to a worsening ventilation-perfusion mismatch, a regional hypoxia and a profound hypoxemia.

Increased plasma levels of VEGF have been reported in moderate to severe COVID-19 pneumonia, highlighting the role of VEGF in the pathophysiology of the disease. A better prognosis has been reported in critically ill patients with lower levels of growth factors, HGF and VEGF-A at the time of ICU admission. Recent data of the study NCT 04275414 by Pang J et al have suggested that patients receiving a single-dose of bevacizumab have improved their oxygen support status in 92% of cases during a 28-day follow-up period, as compared with 62% of cases in an external cohort receiving standard care.

Correcting endothelial permeability and vasodilatation with VEGF-targeted therapy could allow repair damaged vascular endothelium, have an indirect anti-inflammatory effect (limiting alveolar exudation of circulating inflammatory and procoagulant mediators) and improve oxygenation and therefore reduce the proportion of patients with severe forms requiring ICU referral and finally patient death. This clinical trial will therefore focus on the specific efficacy of bevacizumab in COVID-19 patients with severe hypoxemia.


title: Allogeneic Hematopoietic Cell Transplantation Versus Best Available Standard of Care Therapy in Elderly Patients With Acute Myeloid Leukemia: a Randomized Phase 3 Trial

acronym: ALLO-BEST

summary:
A subject of major interest for researchers, clinicians, patients, and payers, is the role of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the treatment of these older patients with AML. With conventional induction chemotherapy or hypomethylating agents, the expected 2-year overall survival (OS) is less than 25% in patients with intermediate- or high-risk disease. The 2-year OS ranges from 50 to 56% with allo-HSCT in AML patients older than 65 years.

Performing an allo-HSCT in older patients is however still controversial because of the higher risk of non-relapse mortality (15 to 35%) and graft-versus-host disease. Depending on the center policy, patients older than 65 years will either be contraindicated for transplant or will receive allo-HSCT.

With a phase III comparative, randomized, controlled, prospective, multicenter study, the trial aim to assess prospectively the outcomes and quality of life of older patients with AML receiving allo-HSCT strategy compared to those receiving a non-transplant approach.

location_facility: Saint Antoine Hospital - Hematology Department


title: Prospective Study on the Risks of Dengue Fever for the Fetus.

acronym: ERiDenF

summary:
Dengue is the most common arbovirus worldwide (390 million people infected each year) and belongs to the Flavivirus genus of the Flaviviridae family like Zika. Its expansion has been rapid since the last decade with an increase in the number of cases of 400% and the first cases of indigenous dengue described in Europe.

Current data on the consequences of dengue fever on the fetus are incomplete. The risk of maternal-fetal transmission of dengue during the peripartum period has now been recorded in numerous case reports and a few case series for patients who contracted dengue in the 12 days preceding childbirth or at the time of delivery. However, the transmission of dengue is highly variable depending on the studies ranging from 1.6 to 15% and the consequences for the newborn are very variable ranging from simple thrombocytopenia to death in severe neonatal dengue.

Regarding the risk of malformation, a few old cases of heart disease, hydrocephalus and neural tube closure abnormalities have been described in the literature following exposure to dengue fever during pregnancy. Since no malformative case has been described, however, to our knowledge, no prospective study with specialized ultrasound monitoring has been performed for pregnant women who contracted dengue during their pregnancy.


title: MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

acronym: ThermoPro

summary: The objective of this project is to offer a very innovative solution for measuring temperature variations in MRI on the prostate. Multiparametric prostate MRI can detect target lesions, on which targeted biopsies are then performed. The use of a temperature mapping on the prostate in MRI would make it possible to evaluate a focal treatment of the prostate by laser under MRI guidance

lead_sponsor: University Hospital, Bordeaux


title: Consequences of SARS-CoV2 Pandemic on Childhood Asthma Control and Exacerbations: French Multicenter Cross-sectional VIRASTHMA COVID G4 Study

acronym: VIRASTHCOVID

summary:
The SARS-CoV2 pandemic, which emerged in the first quarter of 2020, has led to an unprecedented health crisis in our modern healthcare systems and has resulted in strong national public health measures. The impact of the pandemic and its indirect environmental consequences on pediatric asthma is currently being assessed. In particular, the study of its role on the risk of exacerbations and modification of control is one of the priority research objectives defined by European societies.

The primary aim is to study the impact of the pandemic on asthma control in children aged 3-16 years with a medical diagnosis of asthma, compared to data from other observational cohorts conducted in the same region prior to the pandemic.

A sub-population of children 3-16 years will be assessed at exacerbation and at a follow-up visit, 2-4 months later, with clinical data, biological and microbiological samples.

lead_sponsor: University Hospital, Lille