title: Chemsex Among Men Who Have Sex With Men : Perceived Risks and Coping Strategies, a Qualitative Study.

acronym: Chemsex

summary:
The research hypothesis is that access to prevention and harm and risk reduction associated with the use of psychoactive substances in a sexual context is insufficient for MSM practicing chemsex. This would lead to a lack of awareness of the risks taken and insufficient or inadequate strategies to protect themselves.

This qualitative study has a comprehensive objective. The aim is to identify the risks perceived by MSM practicing Chemsex and their coping strategies. The study is based on individual semi-directed interviews and focus group. The criteria for inclusion are: an age greater than or equal to 18 years, being a man having sex with men and having used psychoactive substances in a sexual context at least once in the past 12 months. Participants were recruited through a gay geo-social networking app on mobile phones on a voluntary basis. At the same tim+e, flyers presenting the study are also distributed to the "chemsex" consultations at the Montpellier University Hospital in France as well as to an association fighting against AIDS in Montpellier.

Data are subjected to an inductive method analysis, bringing out by constant comparison conceptualizing categories illustrating the experience and making it possible to identify and understand the risks felt and the coping strategies.

ipd_sharing_description: NC


title: Non-invasive Ventilation Following Extubation (Prophylactic) to Prevent Extubation Failure in Critically Obese Patients: a Prospective, Randomized, Multicenter Study

acronym: EXTUB-OBESE

summary: Mechanical ventilation is the first artificial support used in intensive care. After a period of invasive mechanical ventilation, patients should be separated from the ventilator (weaning period of mechanical ventilation). If weaning and extubation (removal of the tracheal tube) are successful in approximately 80 to 90% of resuscitation patients, 10 to 20% will develop acute respiratory failure (ARF) in the days following extubation. Obesity concerns 20 to 30% of resuscitation admissions in France. The pathophysiological changes in the obese patient explain the over-risk of desaturation and ARF in the post-extubation period. In order to decrease the incidence of extubation failure (need for reintubation within 48-72h post-extubation) of the most fragile patients, it is recommended in intensive care unit to prophylactically use various ventilatory support strategies and / or oxygenation, among which noninvasive ventilation (NIV) and oxygen therapy, which can be administered in two ways: High-Flow Humidified Nasal Oxygen Therapy (HFNO) or standard oxygen therapy. These strategies have never been compared in the obese post-extubation critically ill patient. Our hypothesis is that NIV is superior to oxygen to prevent the development of ARF in obese extubated patients in intensive care unit.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: De Jong A, Huguet H, Molinari N, Jaber S. Non-invasive ventilation versus oxygen therapy after extubation in patients with obesity in intensive care units: the multicentre randomised EXTUB-OBESE study protocol. BMJ Open. 2022 Jan 19;12(1):e052712. doi: 10.1136/bmjopen-2021-052712.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

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

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

repository_normalized: HAL

version: submittedVersion

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ipd_sharing: Yes

lead_sponsor: University Hospital, Montpellier

location_facility: Centre Hospitalier Universitaire Saint Eloi

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

acronyme: NIV-obese

titre: Ventilation Non Invasive (VNI) en post-extubation (prophylactique) pour prévenir l'échec d'extubation des patients obèses en réanimation: Etude prospective, randomisée et multicentrique

discipline_principale: anesthesiology / resuscitation

nom_porteur: DE JONG

prenom_porteur: Audrey


title: Benefits and Risks of Artificial Light Exposure: Characterisation of Effects on Alertness, Sleep, Cognitive Performance, Mood and Biological Rhythms

acronym: LumEnColor

summary: The purpose of this project is to study the influence of light on sleep, wakefulness, EEG activity and cognitive performances.

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Strasbourg, France

status_simplified: Ongoing


title: The Place of Men in Arrested Pregnancies

acronym: PHGA

summary:
An terminated pregnancy is defined as the cessation of cardiac activity before 14 weeks of amenorrhea. This early interruption of gestation can be induced by pathological, traumatic or idiopathic causes. In any case, it remains a physically and psychologically trying event for the woman, the couple as well as for the man.

Indeed, the loss of this embryo, which measures only a few millimeters, corresponds to the loss of a child for the triad: woman, man, couple. The termination of this pregnancy is experienced as a bereavement for the future parents.

The stopped pregnancy has always been a taboo in the society. The proof being that it was not until the 1980s that this was considered mourning and its psychological consequences were studied.

Following these studies, psychological follow-ups are democratized and are thus offered to women. However, when is it men? The investigators have always put the woman at the center of the care process. Which is legitimate. However, the man is often seen as "the person who influences the woman". This default categorization marginalizes the man who would like to be an actor in the care of his partner. In fact, men are increasingly asking to support women in their gynecological care procedures. Unfortunately, for lack of measures put in place. The men are more than abandoned.

study_start_date_type: Anticipated

status: Unknown status

study_type: Observational

time_perspective: Retrospective

location_facility: Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

status_simplified: Unknown


title: Efficacy of Platelet Rich Fibrin in the Prevention of Residual Neuropathic Pain Following Disc Herniation Surgery

acronym: NeuroPRF

summary: The prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. Poor response to the treatments recommended for neuropathic pain, namely antidepressants and/or gabapentinoids, requires the development of new techniques to prevent this chronic pain. Certain well-tolerated techniques, such as the administration of plasma enriched with platelets and fibrin (PRF), are increasingly used in regenerative medicine for their anti-inflammatory and analgesic properties. Thus, a periradicular intraoperative application of PRF may have an analgesic effect on the intensity of residual postsurgical neuropathic pain after disc herniation surgery.

primary_purpose: Treatment

ipd_sharing: Undecided

intervention_type: Biological


title: Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes From a 10 Year Follow-up Linking Datasets Between Patient Medical Records and Patient Claims: the ESTHYM Study

acronym: ESTHYM

summary:
A retrospective, systematic study of reimbursed healthcare costs over a 10 year period in patients suffering from Familial Chylomicronaemia Syndromes (FCS) or Multifactorial Chylomicronaemia Syndromes (MCS) in order to establish the relative healthcare burden of both syndromes by linking the Hospices Civils de Lyon (HCL) registry of FCS or MCS patients and data obtained from FCS or MCS patients followed in Paris, Nantes and Lyon to the French National Health System (NHS) healthcare claims database, the Système National d'Information Inter-Régimes de l'Assurance Maladie (SNIIR-AM).

A probabilistic approach will be used to link databases. This linkage will be based on the following variables: age, gender, date of discharge of any hospitalization, date of any imaging procedure.

This study will help to describe, in real life, the management of severe hyperglyceridaemia in France. In addition, the descriptive results will help obtain a better understanding of the patients suffering from this disease, the burden of the disease and the healthcare consumption linked to this disease. Even if this consumption of care has been relatively unexplored until this point, it is not negligible. The potential of merging genomics and claims data for cardiovascular research could help to identify ways to optimize disease

ReferenceCitation: Belhassen M, Van Ganse E, Nolin M, Berard M, Bada H, Bruckert E, Krempf M, Rebours V, Valero R, Moulin P. 10-Year Comparative Follow-up of Familial versus Multifactorial Chylomicronemia Syndromes. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1332-e1342. doi: 10.1210/clinem/dgaa838.

oa_colors: green other

evidence: open (via free article)

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

license: public-domain

license_normalized: public-domain

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

repositories_concat: Zenodo

unpaywall_oa_status: bronze

publisher_dissemination: The Endocrine Society

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment

summary: A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms

status: Active, not recruiting

time_perspective: Prospective

lead_sponsor: Microvention-Terumo, Inc.

lead_sponsor_type: industriel


title: Impact of Treatment With Amotosalen on the Practice of Platelet Transfusion in Adult Heart Surgery

acronym: TransAdult

summary:
Blood safety is ensured by the rigorous selection of donors and biological tests. However, infectious agents can escape this detection and be transmitted to recipients during transfusion. Amotosalen is a derivative of psoralens that intercalates with nucleic acids and inactivates them after UV exposure; it therefore makes it possible to inhibit any replication of an infectious agent present. Preliminary studies have shown its safety and efficacy in preventing the transmission of infectious agents during the administration of labile blood products (fresh frozen plasma and platelet concentrates) as well as the absence of loss of efficacy (absence of loss of pro-aggregating and procoagulant properties) of the transfused products. In addition, there is a significant reduction in side effects for platelet concentrates, especially compared to irradiated concentrates.

Treatment of platelet concentrates with Amotosalen may be responsible for a reduction in the platelet concentration in each concentrate with an overall decrease in efficiency and transfusion yield compared to untreated concentrates.

location_facility: Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg


title: Frequency of Serious Rhythmic Complications in Patients With Non-ST-segment Elevation Acute Coronary Syndrome

acronym: SCA

summary:
There are two types of acute coronary syndrome (ACS): ACS with persistent ST segment elevation (ACS ST +) and ACS without ST segment elevation (non-ST + ACS). The incidence of non-ST + ACS is increasing and currently accounts for the majority of myocardial infarction (MI) hospitalizations, while that of ST + ACS is declining. Complications of MI, which include rhythm and conduction disturbances, are mainly associated with ACS ST +. It is recognized that these complications can occur during non-ST + ACS, but with less frequency. This frequency is not clearly established, and has been the subject of few studies. Recent studies in this direction suggest that the frequency of rhythmic complications is low during non-ST + ACS. However, the data collected concerns inter-hospital transport.

The aim of the study is to estimate the frequency of occurrence of potentially fatal rhythmic complications in patients admitted to the emergency room and to the cardiology department for non-ST + ACS.

location_facility: Service des Urgences Médico-Chirurgicales Adultes - Hôpitaux Universitaires de Strasbourg


title: Idiopathic Scoliosis and Orthodontic Treatment

acronym: SITO

summary:
Scoliotic pathology remains to this day little known, on the one hand in its etiologies but also in its various implications and possible associations. One of the notable questions found in the literature is concerned with the link between idiopathic scoliosis and the stomatognathic system. This question arises from the study of the anatomy and function of its two entities.

The aim of the study is to determine the frequency of orthodontic treatment in adolescents with idiopathic scoliosis, and to compare it with that of adolescents without spinal dysmorphism.

location_facility: Service de Chirurgie Orthopédique Pédiatrique - Hôpitaux Universitaires de Strasbourg


title: Safety of Therapeutic Step-down in Neuromyelitis Optica

acronym: NMO

summary: Neuromyelitis Optica (NMO) is a neuroinflammatory disease related to multiple sclerosis (MS). It affects young subjects and causes a lot of handicap without treatment. Thus, aggressive treatments are frequently introduced early in the life of patients and maintained over the long term. A long duration of treatment exposes to iatrogenism. Therapeutic de-escalation trials in MS or other autoimmune diseases show rebound phenomena. In the NMO, there are no published data on the tolerance of desescalations to guide such strategies.

location_facility: Service de Neurologie - Hôpitaux Universitaires de Strasbourg


title: Spatio-temporal Parameters of Walking in Patients Hospitalized in Acute Geriatrics: Comparison of a Population of Fallers and Non-fallers

acronym: PST

summary:
The prevalence of walking disorders in the elderly is high. These can lead to falls which represent a major public health issue in terms of hospitalization, morbidity and cost. Numerous studies analyzing the link between spatio-temporal parameters of gait and fall have already been carried out, but most have been carried out in a population of elderly patients living at home and having no or few comorbidities. Very few studies have been carried out in a population of frail elderly people, with multiple comorbidities or multiple medication, which is the case with most patients hospitalized in acute geriatrics.

The objective of the study is to evaluate the spatio-temporal parameters of walking using the GAITRite® mat in patients hospitalized in acute geriatrics and to compare them between a population of falling patients and a population of patients. no faller.

location_facility: Service de Gériatrie Aigue - Hôpitaux Universitaires de Strasbourg


title: Role of MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors

acronym: Parotid

summary: What value is given to MRI diffusion and perfusion sequences in the diagnosis of parotid tumors? Is a fine needle aspiration associated with MRI systematically necessary? The aim of the research is to study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases.

location_facility: Service d'ORL et de Chirurgie Cervico-Faciale - Hôpitaux Universitaires de Strasbourg


title: Multicenter Retrospective Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients

acronym: FongiFoie

summary: Invasive filamentous fungal infections (aspergillosis, scedosporiosis, mucormycosis, fusarium wilt) are frequent and serious in immunocompromised individuals and especially in organ transplant patients. There is little recent data in liver transplantation, especially on the incidence and risk factors of fungal infections

location_facility: Service des Maladies Infectieuses et Tropicales - Hôpitaux Universitaires de Strasbourg


title: Development of a Risk Score to Predict the Vacuum Extraction Failure

acronym: FADS

summary:
Safe operative vaginal delivery requires a careful assessment of the clinical situation.

During the pushing efforts, the complexity of the delivery can lead to choose between an operative vaginal delivery attempt and a caesarean section straightaway. An emergency caesarean section for failed operative vaginal delivery is associated with a higher fetal and maternal morbidity, compared to a successful operative vaginal delivery and to a caesarean section straightaway.

The objective of this study was to develop a risk score of failed vacuum extraction leading to an emergency caesarean section.

This score could be an objective tool to help the obstetricians to choose between a vacuum extraction attempt and a caesarean section straightaway.

The investigators included patients who benefited from a vacuum extraction attempt in the Regional Teaching Hospital of Besançon (France) between January 2010 and December 2015. Patients were separated into two groups : the vacuum extraction failure group and the vacuum extraction success group.

The investigators selected maternal, fetal and labor characteristics which could influence success or failure of the vacuum extraction and compared them between the two groups.

The score was developed with the characteristics which significantly influence the vacuum extraction failure.

ReferenceType: background

ReferenceCitation: Verhoeven CJ, Nuij C, Janssen-Rolf CR, Schuit E, Bais JM, Oei SG, Mol BW. Predictors for failure of vacuum-assisted vaginal delivery: a case-control study. Eur J Obstet Gynecol Reprod Biol. 2016 May;200:29-34. doi: 10.1016/j.ejogrb.2016.02.008. Epub 2016 Mar 2.

ReferenceCitation: Miot S, Riethmuller D, Deleplancque K, Teffaud O, Martin M, Maillet R, Schaal JP. [Cesarean section for failed vacuum extraction: risk factors and maternal and neonatal outcomes]. Gynecol Obstet Fertil. 2004 Jul-Aug;32(7-8):607-12. doi: 10.1016/j.gyobfe.2004.04.003. French.

ReferenceCitation: Palatnik A, Grobman WA, Hellendag MG, Janetos TM, Gossett DR, Miller ES. Predictors of Failed Operative Vaginal Delivery in a Contemporary Obstetric Cohort. Obstet Gynecol. 2016 Mar;127(3):501-506. doi: 10.1097/AOG.0000000000001273.

ReferenceCitation: Alexander JM, Leveno KJ, Hauth JC, Landon MB, Gilbert S, Spong CY, Varner MW, Caritis SN, Meis P, Wapner RJ, Sorokin Y, Miodovnik M, O'Sullivan MJ, Sibai BM, Langer O, Gabbe SG; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Failed operative vaginal delivery. Obstet Gynecol. 2009 Nov;114(5):1017-1022. doi: 10.1097/AOG.0b013e3181bbf3be.

ReferenceCitation: Langeron A, Mercier G, Chauleur C, Varlet MN, Patural H, Lima S, Seffert P, Chene G. [Failed forceps extraction: risk factors and maternal and neonatal morbidity]. J Gynecol Obstet Biol Reprod (Paris). 2012 Jun;41(4):333-8. doi: 10.1016/j.jgyn.2011.11.001. Epub 2012 Jan 9. French.

ReferenceCitation: Gopalani S, Bennett K, Critchlow C. Factors predictive of failed operative vaginal delivery. Am J Obstet Gynecol. 2004 Sep;191(3):896-902. doi: 10.1016/j.ajog.2004.05.073.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Other


type: Other Identifier

title: Ultrasonography Features of the Salivary Glands in Patient With Systemic Sclerosis: Comparison With Gougerot-Sjogren Syndrome and Sicca Asthenia Polyalgia Syndrome

summary:
Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). Several criteria have been validated to classify the SS but require a labial salivary gland biopsy, invasive act which complications can sometimes be reported (hematoma, lip sensory defect).

Several scores based on the evaluation of the ultrasound homogeneity of the salivary glands were developed but no studies have evaluated ultrasound abnormalities of salivary glands in patients with systemic sclerosis.

lead_sponsor: University Hospital, Clermont-Ferrand


title: FERTilité féminine, Agents ENvironnementaux et Stress OXydant

acronym: FERTENOX

summary:
Synthetic products used in industrial, pharmaceutical, agro-alimentary or agricultural fields are found in our environment. Thus, humans could be simultaneously exposed to several of these pollutants. Furthermore, these environmental agents exert or could exert adverse actions on fertility, by altering gamete and embryo quality through endocrine disruptor effects or through increase in oxidative stress in gonads (cellular pathway known to be involved in several human reproductive pathologies).

In this context, the objectives of the present project are to obtain descriptive and analytical data on woman and oocyte exposure to several environmental agents (bisphenols, ethynylestradiol and glyphosate). The relation between these pollutant measures in follicular fluid and urine (from women receiving follow-up of in vitro fertilization (IVF) protocol in the University hospital of Tours, France) and the oocyte quality, the IVF and pregnancy successes will be studied. Several oxidative stress biomarkers in blood and follicular fluid will be also measured for these women, who will complete a questionnaire on their lifestyles. Finally, thanks to in vitro approaches, the effects and the mechanisms of action (including oxidative stress) of these pollutants (alone or in cocktails) will be studied on granulosa cells from these patients.

lead_sponsor: University Hospital, Tours

location_facility: Department of Reproductive Medicine and Biology, Univesity Hospital, Tours


title: Study of Kinetics and Efficacy of the Immune Response Against COVID-19 Among Hospital Staff

acronym: IMMUNO-COVID

summary:
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae family that emerged in China in December 2019 before rapidly becoming a pandemic according to the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic, potentially responsible for more than 250 symptomatic people in the hospital as of April 6. The outbreak was identified by Percy hospital management on March 16, and barrier measures were immediately put in place. From March 20, a mixed investigation unit set up a chain of nasopharyngeal swabs for Percy hospital staff.

A COVID-19 case reporting unit was set up at Percy hospital in response to the identification of the outbreak within the hospital. This unit carried out rapid identification and regular follow-up until the return to work of the staff. Thus all symptomatic patients are identified and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers recruited to deal with the epidemic, throughout the duration of the epidemic. This population, captive by nature, will be one of the few described in the world during this epidemic.

Current data on short-, medium- and long-term immunity induced by COVID-19 infection are fragmentary, as is the existence of a large asymptomatic population, making it difficult to cut the chains of transmission in the absence of an effective diagnostic tool.

Another important issue is the quality of immunity induced by the infection, as it conditions the future of the pandemic, which could become endemic and recurrent if immunity were not sterilizing. As yet unpublished data in primates show that in the primate model re-infection is not possible in the short term, while patients cured from the Wuhan epidemic seem to be detected again positive for virus shedding.

The objective of this study is to characterize the immunity (systemic and local) induced by SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in a period of confinement.

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: Maintenance of Remission After Discontinuation of Somatostatin Analogues in the Treatment of Relapsing GH Pituitary Adenomas After Surgery

acronym: STOP-SST

summary:
At present there are no recommendations regarding the possibility of discontinuing treatment in cases of recurrent acromegaly with good hormonal control. Discontinuation of treatment is therefore most often decided by the practitioner, on the basis of his experience and knowledge of the patient, the long-term course with somatostatin analogues being very little described.

Thus, although hormonal control is achieved in a majority of cases under medical treatment, we do not know if it is possible to stop treatment and in this case how the pathology evolves. It would appear that approximately 40% of patients defined as very good responders to somatostatin analogues may gradually space their injections.

location_facility: Service Médecine Interne, Endocrinologie et Nutrition - Hôpitaux Universitaires de Strasbourg


title: Evolutionary Profile of Isolated Lateral Semicircular Canal Deficits on the Video Head Impulsed Test (VHIT)

acronym: CSL

summary:
There are only a few cases of isolated lateral canal deficit described in the literature. This study would focus on this group of patients in order to establish an evolving profile, a recovery behavior that we could compare to that in the literature.

In addition, the evolving profile as well as the other clinical criteria identified would allow investigators to make hypotheses as to the pathology responsible for a given evolutionary profile.

The population studied is represented by adult patients admitted by the emergency consultation service of otolaryngology of the University Hospitals of Strasbourg for an acute unilateral vestibular deficit whose examination at the VHOT shows a reduced and isolated gain of a lateral semicircular canal.

location_facility: Oto-rhino-laryngologie et Chirurgie cervico-faciale - Hôpitaux Universitaires de Strasbourg


title: Evaluation of Preimplantation Genetic Diagnosis for Neurofibromatosis Type 1 (NF1), Emphasizing on the Molecular Aspects

summary:
Neurofibromatosis 1 (NF1) is a multisystem disorders characterized by skin abnormalities, such as café-au-lait spots and neurofibromas, learning disabilities, skeletal anomalies and vascular complications. Experience learns that this disorder is a great burden for patients. NF1 is an autosomal dominant disorder with 50% risk of transmission. The penetrance is nearly 100%, but the expression varies greatly even within families, which makes it nearly impossible to predict severity in offspring. Preimplantation genetic diagnosis (PGD) is a reproductive option for couples at risk of transmitting NF1 to their offspring. We perform a retrospective and observational multicentric study in the Maastricht University Medical Center, the University Hospital of Brussel and Strasbourg University Hospital. Our specific (and first) goal is to evaluate the molecular aspects of PGD for NF1 in an international cohort of couples requesting PGD for NF1.

About 50% of the patients with NF1 have a de novo mutation that can complicate development of a PGD test. Earlier studies from 1990 and 1992 have shown that de novo NF1 mutations usually occur on the paternal allele. We want to confirm these findings with collected data from our cohort. The high incidence of de novo mutations results in a higher chance of finding mosaicism in patients or their parents. As a result of this, it can become apparent during PGD test preparation that PGD treatment is no longer possible or indicated. The investigators will evaluate these aspects of PGD for NF1 in our cohort.

They are also interested, as a second goal, in other aspects of PGD treatment for NF1, such as the success rate in thier cohort. They expect the success rate to be the same as for other autosomal dominant disorders

location_facility: Service Laboratoire de Diagnostic Génétique - Hôpitaux Universitaires de Strasbourg


title: Study of the Prevalence of Peripheral Artery Occlusive Disease (PAOD) in Women Hospitalized for Type 1 Myocardial Infarction in Intensive Cardiology Care

acronym: AOMI

summary:
The cardiovascular risk of women has been the subject of particular interest in recent years, in the world, in particular under the impetus of Cardiology companies, with more and more work focusing on the specificities of these diseases in women as well as differences in terms of management and prognosis with a literature mainly based on American data and which focuses particularly on ischemic heart disease.

The expected results are to have a prevalence of PAOD in an Alsatian cohort, most of the data we currently have from American data, with analysis of the impact of specific and non-specific risk factors in this cohort and their weight in PAOD.

location_facility: Service des Maladies VASC-HTA-Pharmacologie Clinique - Hôpitaux Universitaires de Strasbourg


title: State of Play in Strasbourg University Hospital of the Place of Consultations Specializing in the Diagnosis of Mood Disorders

acronym: MOOD

summary:
Mood disorders (depressive disorders and bipolar disorders) are among the ten most worrying diseases of the 21st century according to the WHO.

In order to support psychiatrists in their diagnostic reflection, structures have been created. Since 2009, the Psychiatry Service 2 within the Psychiatry, Mental Health and Addictology Pole of the University Hospitals of Strasbourg has offered specialized consultations in mood disorders.

More than 10 years after the creation of these consultations, it seems interesting to study the profile of the users and to describe the nature of the reports of these in-depth evaluation consultations (diagnosis, therapeutic advice)

location_facility: Service de psychiatrie 2 - Hôpitaux Universitaires de Strasbourg


title: Patients Returning to Work After Acute Coronary Syndrome

acronym: ACS

summary:
The literature is quite rich concerning the factors which influence the return to work after acute coronary syndrome. They can be divided into three categories: factors linked to the patient, those linked to the workstation and factors linked to an external intervention. A study published in 1992 evaluated a set of predictive factors for recovery one year after acute coronary syndrome and showed that the proportion of clinical factors accounted for 20%, functional factors for 27% but above all socio-economic factors for 45. %.

On the other hand, there are only a few studies that are interested in the return to work after acute coronary syndrome according to the management in occupational medicine, and in particular the realization or not of a pre-return visit.

The results of a survey published in 2016 show that the recommendations made during the return visit were significantly different depending on whether or not there was a pre-return visit and concerned all types of pathology.

In view of all of these elements, it seems important to the investigators to study the expected benefit of an early orientation towards occupational medicine via the pre-return visit, and to study the factors delaying or favoring the return to work. .

location_facility: Service de Pathologie Professionnelle - Médecine de Travail - Hôpitaux Universitaires de Strasbourg


title: Incidence of Actue Kidney Injury in Patients Treated With Amoxicillin and Cloxacillin Combination Therapy

acronym: Amox-Cloxa

summary:
2015 European Society of Cardiology Guidelines have proposed the combination of Ampicillin and Cloxacillin for initial empirical treatment of infective endocarditis in acute severely ill patients (before pathogen identiﬁcation). Yet this combination has never been studied in clinical trials. High dose penicillin treatments are associated with a risk of nephrotoxicity.

The investigator's primary purpose is to describe patients treated with high dose Amoxicillin and Cloxacillin combination and to evaluate its renal tolerance.

location_facility: Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg


title: Local Analgesia Versus Local Peroperative Infiltration After Total Hip Replacement

acronym: ALRIAL

summary:
Clinical study, comparative, prospective, interventional, randomized, single-center, single-blind The fast resumption of the walking after surgery of total prosthesis of hip (PTH) requires an effective analgesia from the immediate post-operative period. In France, whatever is the peroperative anesthesia, the analgesic reference technique is a locoregional anesthesia (ALR) ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh. In the Anglo-Saxon countries, in particular in Australia and in the United States, the techniques of peroperative infiltration of local anesthetics (IAL) by the surgeon supplanted the techniques of traditional ALR. However, no French study compares the IAL with the conventional ALR with a rigorous methodology. Our occasional practice of IAL suggests us that it is more effective in terms of post-operative analgesia with Analog Visual Scales decreased (EVA) and a lesser consumption of morphine. Furthermore, the resumption of the upright posture in bipedal support as well as the resumption of the walking would be earlier.

The main objective is to show that the post-operative analgesia by local peroperative infiltration is superior to that obtained by locoregional anesthesia (ALR by femoral block associated with a side cutaneous block of the thigh) after the surgery of total prosthesis of hip, with decrease of the consumption of morphine within first 72 post-operative hours.

The secondary objectives are to compare the Analog Visual Scales of pain (EVA) with the rest and with the mobilization during various times (in post-surgery care room, then at H4, H8, H12, H24, H48, H72), the period between the end of intervention (out of the operating room) and the first support by the upright posture in bipedal support), the period between the end of intervention and the resumption of the walk, the satisfaction of the patients at the exit of the hospital, the duration of hospitalization after the surgical operation and the possible unwanted events (systematic toxicity of the local anesthetics, the infection of prosthesis, disease thromboembolic venous) during the hospitalization.

location_facility: Hôpital Edouard Herriot - Département d'anesthésie réanimation

intervention_type: Drug


title: Reproductive Outcomes Following Uterine Septum Resection- a Bicentric Retrospective Study

acronym: UTER-SEPTUM

summary:
Nowadays, there is little data to validate the performance of surgical hysteroscopies in the case of septate uterus, particularly in the case of incidental discoveries. Clinical practice and the experience of teams leads to propose this procedure, but strong evidence for this recommendation is lacking and there is an urgent need for solid data.

A recent randomized trial contradicts this recommendation, but the methodology is questionable on several points.

Investigators wished to associate 2 reference centers with current practice and expertise on this procedure in order to have a cohort of many patients and to have more powerful results.) Investigators purpose a retrospective observational data-based study. The aim is to describe the profile of patients with a partitioned uterus in terms of obstetrical history and to study the consequences of uterine partition resection in terms of obstetrical prognosis (live births, at term, number of miscarriages or premature births).

The aim of this study is to take into account the evaluation of the surgical hysteroscopy gesture by postoperative imaging with in particular the indication of a resection in several stages in case of residual postoperative septum.

location_facility: Service de Gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg


title: Personalized Repetitive Transcranial Magnetic Stimulation (rTMS) in Cognitive Fluctuations of Dementia With Lewy Bodies (DLB): Proof of Concept

acronym: STIMLEWY

summary: The present study is a monocentric, therapeutic clinical trial involving forty patients diagnosed with Dementia with Lewy Bodies (DLB). The aim of this clinical trial is to evaluate the feasibility and relevance of repetitive transcranial magnetic stimulation (rTMS); a non-invasive neuromodulation technique, with a main emphasis on the evaluation of the outcome on cognitive fluctuations. For this purpose, we will compare two distinct rTMS conditions (control and experimental) in a pre-post rTMS setting. The experimental condition will be targeting the insular cortex which has been shown to be affected at prodromal DLB stages, in the form of decreased grey matter concentration and a decreased regional Cerebral Blood Flow (rCBF hypoperfusion) [Blanc et al., 2015 ; Roquet et al., 2016 ; Roquet et al., 2017]. Furthermore, these insular alterations are correlated to cognitive fluctuations [Chabran et al., 2020]. In DLB, cognitive fluctuations are particularly pervasive and manifest in the form of alertness alterations and modifications of arousal states. Participants will repeatedly undergo a series of clinical and cognitive assessments in addition to several neuroimaging examinations, namely multimodal Magnetic Resonance Imaging (MRI) and electroencephalogram (EEG) recordings, in order to evaluate potential physiological modifications and clinical changes of symptoms, pre-/post-rTMS.


title: Analysis of Corrections of Adolescent and Young Adulte Scoliosis by Posterior Instrumentation

acronym: AIS

summary:
Thoracic hypocyphosis and greater lumbar lordosis after correction of idiopathic scoliosis in adolescents and young adults may adversely affect overall sagittal alignment and increase the risk of proximal junctional kyphosis.

The objective of this study is to analyze surgical corrections and maintenance of correction over time using modern posterior instrumentation strategies by comparing technical developments.

location_facility: Service de Chirurgie du Rachis - Hôpitaux Universitaires de Strasbourg


title: Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

acronym: EHPAFAVE

summary: Anticoagulation monitoring is done by monitoring the ACT (Activated Clotting Time) with an objective greater than 300 s. Until now, treatment with direct oral anticoagulant (for the prevention of thromboembolic events of atrial fibrillation) was interrupted a few days before the procedure in order to limit the risk of per-procedural bleeding. However, 3 recent randomized studies concerning the 3 DOACs available suggest that treatment should not be interrupted during the entire operative period. The operation therefore takes place under double anticoagulation with a direct oral anticoagulant and unfractionated heparin. Under these conditions, ACT monitoring can no longer be considered a reliable means of measuring the level of anticoagulation. It was therefore necessary to explore the hemostasis of these patients in a broad way in order to avoid any risk of overdose of UFH (Unfractionated Heparin) during the procedure.

location_facility: Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg


title: Development of a Codified Preventive Approach for the Management of the Main Geriatric Risks

acronym: Ger-e-Tec

summary: Nowadays, EHPAD residents are polypathological (cognitive and psycho-behavioral pathologies, undernutrition, IC, diabetes, COPD, IR, etc.) and multi-medicated. From a medical point of view, this implies the need for regular monitoring and a high level of medical or even multidisciplinary expertise for the healthcare team. The objective of the GER-e-TEC ™ project is to provide these complex patients with telemedicine tools allowing protocolized and personalized, non-intrusive monitoring. The GER-e-TEC ™ project more specifically takes into account the significant issues in nursing homes of aging residents with the main geriatric syndromes (fall, undernutrition, cognitive-behavioral disorders, iatropathogeny, etc.) The objective of the work undertaken is to develop a codified preventive approach for the management of the main geriatric risks, in order to avoid the occurrence of an acute decompensation factor in the elderly.

location_facility: Médecine interne, Diabète, et Maladies Métaboliques - Hôpitaux Universitaires de Strasbourg


title: Platelet Transfusion in Pediatric Heart Surgery and Impact of Amotosalen Treatment

acronym: TransPédia

summary:
High level of security during blood transfusion has been achieved by donor selection and pathogen detection using serology or direct identification. Nevertheless, blood banking becomes hazardous during epidemic outbreaks or facing new pathogens. Amotosalen, a psoralen, targets nucleic acids and destroys them after ultraviolet exposure, resulting in inactivation of pathogens.

Treatment inoccuity and efficacy have been demonstrated but preservation of platelet functions after treatment is still debated. Previous studies focused on hematological patients. There is no evidence for an increased requirement of transfused platelets to achieve platelet count target. Studies in heart surgery are lacking.

The investigators perform a multicenter, retrospective, "before/after", controlled study in minor patients requiring heart surgery with cardiopulmonary bypass. One center (Strasbourg) uses Amotosalen-treated platelet concentrates since 2006 (control arm). This treatment becomes available in Bordeaux in October 2017 (intervention arm). There is two periods of inclusion: one "before" (January 2016 to June 2017) and one "after" (January 2018 to June 2019).


title: Geriatric COVID-19 Serology

acronym: SeroGerCov

summary:
Coronaviruses are important human and animal pathogens. At the end of 2019, a new coronavirus was identified as the cause of a cluster of pneumonia cases in Wuhan, a city in China's Hubei province. It quickly spread, leading to an epidemic across China, followed by an increasing number of cases in other countries around the world. In February 2020, the World Health Organization designated the disease COVID-19, which stands for coronavirus disease 2019. The virus that causes COVID-19 is SARS-CoV-2.

The duration of protection during which a patient after infection and / or vaccination remains clinically protected and the evolution of their serology as well as their titre remains unknown

location_facility: Service SSR Gériatrique - Hôpitaux Universitaires de Strasbourg


title: Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome. OBEFITT Study.

acronym: OBEFITT

summary:
Android obesity contributes, via insulin resistance and endothelial dysfunction, to the development of cardiovascular atherosclerosis. It leads to poor quality of life. It is often associated with metabolic syndrome which includes, whatever the definitions used (National Education Cholesterol Program, NECP / Adult Treatment Panel III, ATP III or International Diabetes Federation, IDF), an increased waist measurement, an arterial high blood pressure and disorders of the glucide and lipid metabolism. The treatment of the current "epidemic" of obesity and metabolic syndrome in France (12.4 % of obese and 14 % of subjects with metabolic syndrome) thus requires new therapeutic approaches.

A well-balanced diet and a daily physical activity are the indispensable requirements for the treatment of obesity and metabolic syndrome. It is possible to associate it to pharmacological agents, but the results are often partial and transient. Preliminary data suggest that leucine or arginine supplementation could facilitate the loss of fat mass. Moreover, the physical exercise has also demonstrated benefits.

Sessions of physical reconditioning (aerobic work + muscular intensification) associated with a program of specific nutritional supplementation by a mixture of Leucine and Arginine (in the daytime) could improve the treatment of obese subjects affected by metabolic syndrome.

lead_sponsor: University Hospital, Rouen


title: Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates

acronym: EDELWEISS

summary:
Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. In critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. Sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. Late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter.

In this context, a new multiperfusion device was developed (Multiline Néo®, Doran, France) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. But also to allow the administration of several drug solutions simultaneously avoiding contact between drugs.

Our hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.

ipd_sharing_description: The individual participant data will not be shared


title: Retrospective Analysis of Degenerative Scoliosis Corrections by Posterior Instrumentation

acronym: DS

summary:
Several deformities of the spine exist such as degenerative lumbar scoliosis. These deformities can generate functional discomfort and limit the patient's quality of life.

In the event of severe trunk imbalance and progression of the deformity, operative correction of the spinal deformity by instrumentation and posterior arthrodesis may be indicated.

Surgical techniques and instrumentation have evolved over the past 5 years. These changes in surgical strategies have a potential impact on the patient's quality of life and the correction results in the medium and long term.

The aim of the study is the analysis of surgical corrections obtained and radiological changes over time with classic 2-rod techniques versus modern 4-rod instrumentation techniques


title: Rapid Quantitative Neutrophil CD64 Measurement for Early Diagnosis of Nosocomial Infection in Preterm Newborns

summary:
Diagnosis of late-onset sepsis is difficult in the absence of specific clinical signs and biological markers in the infection initial phase .The aim of this study is to determine the performance of a new infection marker : Neutrophil CD64 for early diagnosis in nosocomial infection (NI) in preterm newborns.

METHODS :

Monocentric prospective study including preterm newborn infants (<37 weeks of gestationnal age ) with clinical suspicion of nosocomial infection in a neonatal intensice care unit (Neonatal intensive care unit of Montpellier, France).
Patients will be enrolled in the study after informed consents. Rapid and automated CD64 measurment will be realized during the conventional blood sample including C-Reactive Protein (CRP), Procalcitonin (PCT) and blood culture.

Broad-spectrum antibiotic therapy can be started on the advice of clinician and blinded the result of CD64. Patients will be then classed in three groups using CDC criteria (center for disease control) : 1-no infection, 2-infection, 3-possible infection during the multidisciplinary staff. Specificity, sensitivity, negative and positive value of CD64 will be calculated and the performances of CRP, PCT and CD64 will be compared.

153 patients are needed in the study enrolled during a period of 12 months.

PERSPECTIVES Neutrophil CD64 monitoring might be help clinicians to manage nosocomial infections in neonates.CD64 allow to integrate in a decision algorithm with the determination of the best cut-off value to faster processing nosocomial infections and could help to reduce unnecessary antibioc therapy. A rapid technique for determination of CD64 should be readily available in our unit.

primary_purpose: Diagnostic


title: Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel Associated To Aspirin: Double-Blind Randomized Trial Against Placebo

summary:
Objectives: A prospective investigation of the effect of omeprazole, a proton pump inhibitor, on the anti-platelet action of clopidogrel.

The main decision criterion will concern change in VASP protein phosphorylation under treatment. Phosphorylation will be measured before and after administration of omeprazole versus placebo in patients undergoing clopidogrel treatment.

Type of study: Single center, double blind, randomized parallel group study versus placebo, comparing two treatment groups:

clopidogrel + omeprazole + standard regime (beta-blockers, atorvastatin, IEC, aspirin)
clopidogrel + placebo+ standard regime (beta-blockers, atorvastatin, IEC, aspirin)

Study population: 120 patients from the Cardiology Department of Brest University hospital, Brest (France), receiving a standard treatment comprising a loading dose of clopidogrel followed by a daily dose of 75 mg associated to 75 mg aspirin, will be randomized between 20 mg/day omeprazole and 20 mg/day placebo treatment groups. The efficacy of clopidogrel will be assessed by inter-group comparison on the VASP test.

Study period: 7 days' treatment per patient. Total study period estimated at 6 months.

Expected findings: The results should confirm the suspected negative effect of omeprazole on clopidogrel's impact on arterial thrombosis risk, secondarily allowing new recommendations to be drawn up for this association.

ReferenceCitation: Gilard M, Arnaud B, Cornily JC, Le Gal G, Lacut K, Le Calvez G, Mansourati J, Mottier D, Abgrall JF, Boschat J. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA (Omeprazole CLopidogrel Aspirin) study. J Am Coll Cardiol. 2008 Jan 22;51(3):256-60. doi: 10.1016/j.jacc.2007.06.064.

lead_sponsor: University Hospital, Brest


title: Post-Resuscitation Interdisciplinary Consultation System: a Randomized, Multicenter, Interventional Study to Assess Quality of Life After a Stay in the COPRéa Intensive Care Unit

acronym: COPRéa

summary:
A patient's stay in the ICU is not without consequences and can cause various physical and/or psychological sequelae such as anxiety, depression, post-traumatic stress disorder (PTSD), physical weakness and memory problems. These sequelae are grouped under the name "post intensive care syndrome" or PICS.

Numerous studies have shown that PICS affects 50-70% of patients; however, very few studies have been conducted on the medical and psychological support devices needed for these patients following their hospitalization. Despite recommendations to set up an early and specific rehabilitation program, post-resuscitation consultations are not very frequent in France. The aim of the study is to measure the impact of an interdisciplinary post-resuscitation consultation on the quality of life of patients who have stayed more than 6 days in an intensive care unit.

All patients who agreed to participate will be followed for a period of 9 months after discharge from the ICU.

One month after discharge from the ICU, the patients will be randomly assigned to

either in the "intervention" group who will benefit from an interdisciplinary post resuscitation consultation 4/5 months after their discharge from the intensive care unit
or in the "control" group without post resuscitation consultation. They will all be contacted at 4/5 and 9 months to complete psychological and quality of life questionnaires.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Predictive Electrophysiological Score of the Neurological Prognosis Post Cardiac Arrest

acronym: CA-EEG

summary:
Cardiac arrest (CA) is a major public health problem (1) because of its frequency (30000 to 50000 new cases of CA per year in France), a high mortality 80-90% and a relevant morbidity : 50% of survivors have cerebral sequela. Neurologic prognostication after CA is paramount. The American Academy of Neurology identifies accurate predictors of poor neurologic outcome (2): clinical examination findings such as no pupil response, no corneal reflexes, no motor response to stimulation and early myoclonus status epilepticus; biologic parameters like high neuron specific enolase (NSE) greater than 33 μg/L (3-4) and electrophysiologic results like flat electroencephalogram (EEG) or with burst suppression and Somatosensory evoked potentials (SEP) with no response to N20. Brain imaging may provide additional informations but not recommended yet. However, these pronotic markers were developed before the introduction therapeutic hypothermia (TH) (5-6). TH is now recommended after cardiac arrest by international guidelines, based on demonstration of improved survival and neurological recovery in comatose survivors of CA (7). TH and its associated use of sedative and paralytic agent may delay neurologic recovery and affect the optimal timing of prognostic variables (8).

Many classifications of electroencephalogram (EEG) (9-12) exist but no one is generally accept and recommended and they were created before TH.

In a preliminary study based on a retrospective cohort of 64 patients in CA with initial TH, we developped an electroencephalographic score to predict precocity the neurologic outcome according to the Cerebral performance category (CPC) (13-14).

The purpose of this study is to evaluate a simple and objective electroencephalographic score helpful to predict neurologic outcome after CA. Then, we would like to create a composite score to have a multimodal prognostication.

Patients and methods After CA resuscitation, all patients underwent coronary angioplasty if indicated and then were immediately admitted in emergency room of ICU. All patients were intubated and mechanically ventilated. Sedation was performed with continuous infusion of midazolam 0,15-0,2 mg/kg/h and sufentanil 0,15-0,2 μg/kg/h. All our patients were curarized with cisatracurium 0,2-0,3 mg/kg/h to prevent shivering during TH and took anti-epileptic medication phenobarbital 10-15 mg/ kg two times a day to prevent infra-clinic convulsive seizure.

Mild TH between 33 -34 °C was performed by active cooling with intravascular device (CoolGard® - Zoll, Chelmsford, UK) for 24 hours. Mean arterial pressure was maintained between [75-80] mmHg by titrated norepinephrine with or without inotropics (dobutamine, epinephrine) according cardiac output monitored by echocardiography.

After 24 hours of hypothermia, warming was started at a rate of 0.2 ° C/hr; neuromuscular blocking agents were arrested at 35.5°C and sedation at 36.5°C.

Neurological evaluation performed at 48 hours off sedation included a clinical evaluation (Glasgow score, myoclonus status, response to orders, motor response to stimulation, brain-stem reflexes). NSE was sampled between 48 and 72 H. EEGs were performed at Day-2, Day-3 and Day-5 off sedation and SEP at Day-5 off sedation. All EEGs were interpreted by two certified electroencephalographers blind from clinical neurologic outcome.

Survival and neurologic outcome according to CPC were assessed at ICU discharge and three months later.

location_facility: Hôpital Lapeyronie - Département Anesthésie Réanimation A


title: Study of Neurological Damage From Coronavirus Disease (COVID-19): Extraction of Quantitative Imaging Biomarkers for the Characterization of Pathological Profiles

acronym: NeuroBiomarK

summary: The objective of this study is to support the exploration of the NEURO-COVID-19 database and in particular to carry out the post-treatments necessary to derive quantitative information on the characterization of the lesion load, in particular with regard to of the vascular tree

location_facility: Service d'Imagerie 2 - Neuroradiologie et Radiologie Ostéo-articulaire - Hôpitaux Universitaires de Strasbourg


title: Diagnostic Performance and Predictive Impact of the CT Scan in Patients With Suspected Covid-19

acronym: SCAN-COV-HUS

summary:
The diagnostic performance of the scanner in the indication of suspected Covid-19 is not yet well known, especially in comparison with the results of RT-PCR.

The potential use of the scanner as a tool for quantifying the severity of Covid-19 disease is not yet well established, especially the variations between readers or between measurement techniques.

The impact of the scanner in predicting the fate of patients with confirmed Covid-19 is not yet known.

location_facility: Service de Radiologie B - Hôpitaux Universitaires de Strasbourg


title: EVALUATION OF THE RESPONSE TO mRNA SARS-CoV-2 VACCINE IN A COHORT OF LIVER TRANSPLANTED OR LISTED PATIENTS

acronym: VACCHEPA

summary:
The goal of this retrospective study is to evaluate the proportion of seroconversion after 2 doses mRNA anti-SARS-CoV2 vaccination in a cohort of high risk liver transplanted patients.

Seroprevalence is a secondary objective in order to identify seronegative patients with a history of COVID-19 (ie who lost antibodies) and seropositive patients with no history of COVID-19.

The hypothesis is that the degree of immunosuppression is determinant on the seroconversion rate and therefore, although at higher risk of severe forms of COVID-19, liver transplanted patients have a lower chance of being protected after vaccination.

Seroconversion rate in previously seronegative and with no history of COVID-19 liver transplanted patients is the main evaluation criteria.

The factors associated with the absence of seroconversion will be identified as a potential tool to better adapt the vaccination strategy in this population.

The rate of seroconversion after the 1st dose will also be evaluated. Safety of the 1st and 2nd injection will be reported as well as their value to predict seroconversion.

A control group of patients listed for transplantation will also be included both in the seroprevalence and the seroconversion analysis.

Persistance of the antibodies in long-term after transplantation and after transplantation for the patients who have been vaccinated before transplantation will also be reported.

location_facility: Service deChirurgie Générale Hépatique-Endocrinienne,et transplantation - Hôpitaux Universitaires de Strasbourg


title: HPV Vaccination (Human Papilloma Virus), or How to Address Male Homosexuality in General Practice in Alsace?

acronym: HPV

summary:
The main objective of this study is to find out whether young MSM (men who have sex with men) believe it is important for their GP to be informed of their sexual orientation, in order to improve their clinical, especially with HPV vaccination.

The secondary objective is to analyze the state of knowledge about the HPV vaccine and the value of HPV vaccine in this target population.

location_facility: Service du Trait d'Union - Hôpitaux Universitaires de Strasbourg


title: Minimal Invasive TLIF Arthrodesis Using Augmented Reality Navigation for Percutaneous Pedicle Aiming

acronym: ARSN

summary: Surgery for degenerative spondylolisthesis requires decompression of the narrow lumbar canal and fixation by osteosynthesis-arthrodesis. Conventional surgery is done through the open route. For 10-15 years, minimally invasive techniques have been established, allowing faster postoperative recovery for the patient. The downside to these techniques is the use of intraoperative fluoroscopy. This is why surgical navigation systems have been developed, allowing safe positioning of implants (pedicle screws). A new process (augmented reality navigation) has been tested in vitro and applied in open surgery. The HUS were the first establishment to apply this new method in minimally invasive surgery in a hybrid room of surgery and interventional radiology.


title: Pelvic-perineal Disorders in Women With Sphincter Tears, a Retrospective Study

acronym: PAPOASI

summary:
According to INSEE, in 2016, in France, there were 785,000 births. According to the latest national perinatal survey in 2016, 80.4% of women gave birth by vaginal delivery. Of these, 52.1% had perineal tears and 0.8% had 3rd and 4th degree tears. Of these 3rd and 4th degree tears, 2.2% occurred during instrumental delivery and 0.5% during spontaneous delivery. In recent years, there has been an increase in the prevalence of obstetric anal sphincter injuries. Mc Pherson et al. found a prevalence of LOSA (Obstetric Anal Sphincter Injury) of 2% in 2004 versus 4.6% in 2008. Gurol-Urganci et al. also found an increase in prevalence from 1.8% in 2000 to 5.9% in 2012. This increase is probably due to improved diagnosis by obstetrical teams. Indeed, a large number of LOSAs remained undiagnosed at birth and these occult lesions were subsequently found by endoanal ultrasound. In the Andrews et al. study, when women were reexamined, the prevalence of LOSA increased from 11% to 24.5%. As practitioner training improved, the prevalence of LOSA at birth became increasingly accurate. Obstetric anal sphincter injuries are responsible for significant physical and psychological morbidity. These obstetrical lesions of the anal sphincter can generate functional consequences (including anal incontinence in the first rank), which will have harmful effects on the quality of life of the women, they can involve a social isolation passing by the limitation of displacements and physical and social activities. The daily life of these women can remain impacted by the consequences of LOSA until more than 10 years after delivery. In addition, a loss of self-esteem as well as feelings of guilt, shame and frustration are reported in these women. Thus, some will speak of a LOSA syndrome, which includes emotional, social and psychological consequences, including the ability to assume one's role as a mother. LOSA are perineal tears corresponding to the 3rd and 4th degree, formerly and respectively called complete perineum and complicated complete perineum. The Sultan classification for perineal tears proposed in 1999 was adopted by the Royal College of Obstretricians and Gynecologists (RCOG) and is the most widely used in the scientific literature worldwide. It defines the 3rd degree as a perineal injury involving the anal sphincter complex alone.

Anal continence is a balance between several factors such as rectal sensitivity, stool quality, the smooth and striated muscles of the anal sphincter, the pubo-rectal muscle webbing and the innervation of these structures. Obstetrical trauma of the stretching and compression type affects all these structures. All of these lesions can contribute to the development of anal incontinence. However, these structures are not routinely evaluated in women who have had an obstetric anal sphincter injury.

Pelvic-perineal pain was studied in 2 studies and involved 24.7% to 35% of women with obstetric anal sphincter injuries.

Compared to women without LOSA, women with LOSA had a later return to sexual intercourse, with more severe anal incontinence during the first week after LOSA. Indeed, at 12 weeks postpartum, the rate of women who resumed sexual intercourse was lower in the group of women with LOSA than in the group without LOSA.

The pelvic-perineal disorders faced by women with LOSA affect their quality of life, their sexuality, and their health. Thus, early identification of all pelvic-perineal disorders appears to be a priority in this population.

ReferenceCitation: McPherson KC, Beggs AD, Sultan AH, Thakar R. Can the risk of obstetric anal sphincter injuries (OASIs) be predicted using a risk-scoring system? BMC Res Notes. 2014 Jul 24;7:471. doi: 10.1186/1756-0500-7-471.

ReferenceCitation: Gurol-Urganci I, Cromwell DA, Edozien LC, Mahmood TA, Adams EJ, Richmond DH, Templeton A, van der Meulen JH. Third- and fourth-degree perineal tears among primiparous women in England between 2000 and 2012: time trends and risk factors. BJOG. 2013 Nov;120(12):1516-25. doi: 10.1111/1471-0528.12363. Epub 2013 Jul 3.

ReferenceCitation: Andrews V, Sultan AH, Thakar R, Jones PW. Occult anal sphincter injuries--myth or reality? BJOG. 2006 Feb;113(2):195-200. doi: 10.1111/j.1471-0528.2006.00799.x.

ReferenceCitation: Cornell K, De Souza A, Tacey M, Long DM, Veerasingham M. The effect of implementing a new guideline and operative pro forma on the detection and management of third- and fourth-degree perineal tears. Int J Womens Health. 2016 May 5;8:131-5. doi: 10.2147/IJWH.S101188. eCollection 2016.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Transfusion and COVID-19

summary:
Alsace was particularly and early on affected by SARS-CoV-2 and quickly implemented a reduction in scheduled admissions and non-urgent surgical interventions, making it possible to reduce requests for labile blood products linked to non-urgent surgical procedures. as has been reported in the literature; the population containment measures also led to a major reduction in traffic - and consequently accidents on the public roads. At the same time, other demands for blood products related to activities such as onco-hematology were little affected. Finally, the blood banks have adapted their collection procedure.

To answer these questions, we propose to conduct a retrospective study over two parallel periods of 2019 and 2020 of the consumption of blood products on the one hand and the availability of stocks on the other hand.


title: Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)

acronym: TeSLa-PD

summary:
Primary purpose: Fluctuations and dyskinesia evolution in Parkinson's disease patients, one year after initiation of deep brain stimulation, apomorphin pump or duodopa pump

Secundary purposes:

Motor complications evolution at 6 months, 2 and 3 years
MDS UPDRS III score at 6 months, 1, 2 and 3 years
non motor complications evolution at 6 months, 1, 2 and 3 years
cognition and psychiatric complications evolution at 6 months, 1, 2 and 3 years
cutaneous and digestive complications at 6 months, 1, 2 and 3 years
neuropathy occurrence at 6 months, 1, 2 and 3 years
medical treatment and Levodopa equivalent dose modifications at 6 months, 1, 2 and 3 years

status: Not yet recruiting


title: Effects of Antibiotic Therapy on the Short and Long-term Results of Periodontitis Treatments: Impact of Risk Factors and Treatment Characteristics

acronym: PERIODONTITIS

summary: Antibiotics are currently used in periodontology to specifically target the most pathogenic bacteria in subgingival biofilms and to improve treatments. The multiplicity of protocols / dosages tested and the variability of the results did not make it possible to reach an international consensus on antibiotic therapy and its cost / benefit ratio, in particular with regard to the significant side effects of taking antibiotics (resistance bacterial). The care environment as well as the clinical, biological and microbiological parameters can strongly influence the results in usual treatment.

location_facility: Service de Médecine et de Chirurgie Bucco-Dentaires - Hôpitaux Universitaires de Strasbourg


title: Transcriptional Map of Ovarian Cancer at the Single Cell Level

acronym: Ova-seq

summary:
In 2020, epithelial ovarian cancer (EOC) accounts for 313,959 new cases and 207,252 deaths worldwide. The standardized 5-year net survival of a woman with EOC is 44% for cases diagnosed between 2005-2010. This is because 2 out of 3 cancers are found at an advanced stage with invasion beyond the ovaries to the entire peritoneum or distant metastasis. Treatment of EOC is currently based on platinum-based chemotherapy combined with paclitaxel and maximal cytoreduction surgery. Newer combination therapies may be introduced such as bevacizumab and oral poly ADP-ribose polymerase (PARP) inhibitors. Despite the combination of different therapeutic modes, the 5-year survival has not progressed much since the 1980s. The development of new and more effective therapies is essential but requires a better understanding of cancer heterogeneity and the identification of new therapeutic targets.

Cancer heterogeneity results from genetic and transcriptional variations between tumors but also between cells of the same tumor. This heterogeneity has an impact on the development of the tumor and its resistance to treatment. One of the methods to study this heterogeneity is single cell RNA sequencing (scRNAseq) which allows to analyze individually and simultaneously the gene expression (transcriptomics) of thousands of cells. Studies on EOC using this technique have already been performed but they were based on small numbers with very different tumor types and stages.

The objective of this protocol is to characterize by scRNA-seq the architecture and microenvironment of primary and secondary tumors of 50 patients with EOC at the single cell level and to correlate the data with the clinical characteristics of the patients, especially during recurrence and/or chemoresistance, in order to identify the molecular parameters allowing tumor cells to acquire survival, invasion, metastasis and chemoresistance capacity as well as to carry out the inventory of cell populations within the different sites of EOC. We will also analyze the interaction between tumor cells and the microenvironment, by studying on the one hand the involvement of immune cells in the antitumor response and on the other hand how tumor cells modulate the microenvironment to make it permissive to the development of the EOC. We will compare the data obtained for each patient with healthy tissue (from the same patient) in order to determine the common and specific tumor molecular signatures in EOC, the latter point allowing us to evaluate the intra and inter-patient variability. Similarly, the comparison of the transcriptomic profile of the same tumor subtype in several patients will allow us to determine if certain transcriptional perturbations are ubiquitous. The identification of these common pathways would allow the discovery of potential therapeutic targets.

Furthermore, the molecular processes leading to chemoresistance are still unknown. We will investigate whether known chemoresistance markers are present in tumor cells from primary sites and whether their presence correlates with the response to treatment in patients. We will also study the molecular mechanisms of resistance to treatment in our patients which will ultimately allow the development of new therapies. We will also try to find new prognostic markers which is made possible by the clinical follow-up of the patients.

The existence of this heterogeneity will be confirmed by complementary genetic analyses of the genome and exome (search for mutations, variation in gene copy number or chromosome copy number, epigenetic effects) by different molecular biology techniques (qPCR, NGS sequencing) and the markers that will be identified can be confirmed by histochemical analysis.

location_facility: Service Gynécologie Obstétrique, Hôpital de Hautepierre


title: Infectious Mediastinitis Among the Strasbourg Universitary Hospital, a Retrospective Cohort

acronym: MEDIASTINITIS

summary:
Mediastinitis are rare but serious infections, with mortality rates varying from 6 to 30% according to the literature. They are essentially linked to surgical management (cardio-thoracic in particular), but some forms can be spontaneous, after extension of an ENT infectious focus, for example.

Despite their seriousness, there is no strong recommendations to define their management, especially concerning antibiotic therapy and its duration.

The aim of this research is to make a descriptive analysis of the cases of mediastinitis at HUS in recent years, and to study the therapeutic strategy used


title: Infections With Enterobacteria Producing Carbapenemases at the University Hospitals of Strasbourg - Descriptive Epidemiology and Risk Factors for Infection in the Event of Colonization

acronym: CARBA

summary:
Infections with enterobacteria producing carbapenemases at the University Hospitals of Strasbourg - descriptive epidemiology and risk factors for infection in the event of colonization

There is a worrying situation of an increase in the number of patients colonized with carbapenemase-producing Enterobacteriaceae (CPE) at HUS.

7 to 15% of patients colonized with EPC would develop an infection with EPC. The cohorts published mainly concern patients hospitalized in intensive care. The associated mortality reported in the literature is high (> 25%) and greater than that associated with infection with the same bacterium sensitive to carbapenems.


title: Multicenter Randomized Two Arms Study Evaluating the Efficacy of Prophylactic Rituximab in Adult EBV Negative Kidney Transplant Recipients on Incidence of EBV Primary Infection and Post-transplant Lymphoproliferative Disorders

acronym: REPLY

summary:
Epstein Barr virus infects over 90% of human population and persists during lifetime. After infecting B lymphocytes, EBV remains latent in memory B cells. In immunocompromised patients, primary infection could lead to an uncontrolled EBV infected B cells proliferation because of impaired T cell specific cytotoxicity. The latent EBV infection is characterized by expression of restricted latent gene products, which drive cell proliferation and progression to PTLD. As a consequence, EBV seronegativity and EBV mismatch are major risk factors for developing PTLD. The investigators reported in a previous work from the French Registry that the incidence of PTLD was multiplied by ten in adult EBV negative kidney transplant recipients. Moreover, even if the event is relatively rare after transplantation, the prognosis is severe with high morbidity and an overall mortality rate around 50%.

Nowadays, few and inconsistent data exist regarding beneficial preventing strategies like antiviral therapy, reduction of immunosuppression or immunoglobulin infusion in this high-risk population of EBV negative recipients. Therefore, an efficient and safe preventive treatment is still lacking to decrease PTLD incidence.

Rituximab, has been already proposed in stem cell transplant recipients as a preemptive therapy in patients with a persistent EBV viremia independently of their EBV status. A pilot study was performed in EBV negative kidney transplant recipients but in a very small population. Schachtner60 reported the cases of 5 EBV negative recipients receiving kidney from EBV positive donors after a treatment with Rituximab. Only 2 patients showed a seroconversion and no patients developed neither a viremia nor a PTLD after 49 months of follow-up.

The main objective of the investigators study is to evaluate the efficacy of early infusion of Rituximab in the prevention of EBV primary infection and post-transplant lymphoproliferative disorder (PTLD) occurrence in adult EBV negative kidney transplant recipients transplanted with an EBV positive donor.

location_facility: Les Hôpitaux Universitaires de Strasbourg

region: Grand Est

nom_etablissement: HOPITAUX UNIVERSITAIRES DE STRASBOURG

acronyme: REPLY

titre: Étude prospective multicentrique randomisée évaluant l'efficacité d'un traitement préventif par Rituximab chez des adultes patients transplantés rénaux EBV négatifs sur l'incidence de la primoinfection EBV et des syndromes lymphoprolifératifs.

discipline_principale: néphrologie

nom_porteur: CAILLARD

prenom_porteur: Sophie


title: Somatic and Neurobehavioral Clinical Characterization of Frequent Monogenic Forms of Neurodevelopmental Disorders

acronym: MONOGENETND

summary:
The main objective is to constitute a precise and exhaustive collection of clinical data (somatic and neurobehavioral data) of individuals affected by various frequent monogenic forms of neurodevelopmental disorders to better characterize the clinical phenotype of these disorders.

A better knowledge of these manifestations is necessary to improve the management of individuals with these disorders.

The secondary objectives of this research are to inform practitioners, patients and their families about the clinical characteristics of these disorders to better understand their diversity and, finally, to improve their screening and diagnosis. Thus, our study aims at establishing clinical scores, linking genotypes and phenotypes and producing documents for professionals (such as the PNDS (National Diagnostic and Care Protocols))

location_facility: Service de Génétique Moléculaire Hôpitaux Universitaires de Strasbourg


title: Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome (RETINOCOCHLEOCEREBRAL Vasculopathy)

acronym: CARESS

summary:
SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of patients with SS, mostly young women, have been reported. However, comprehensive epidemiological, clinical and etiological features of SS have never been specifically addressed so far.

The objective of this study is to characterize the epidemiological, clinical, and etiological features of SUSAC's Syndrome. In this aim, the investigators will constitute a national clinical-based cohort including all SS cases retrospectively reported in France since the last 20 years and all new cases prospectively observed. French Society of Neurology, Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed by an expert comity of internists, neurologists and neuroradiologists to validate the diagnosis. The exhaustive and systematic analysis of each case will help to better define different aspects of the disease such as the incidence and prevalence, the clinical presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease. Serum, cerebrospinal fluid, and DNA samples from each patient will also be collected to study potential autoimmune, thrombotic and infectious markers.

time_perspective: Other

ReferenceCitation: Scheifer C, Henry Feugeas MC, Roriz M, Cohen Aubart F, Doan S, Jouvent E, Klein I, Machado C, Rouzaud D, Papo T, Sacre K; French Susac Study Group. Brain magnetic resonance imaging lesion load at diagnosis, severity at onset and outcomes in Susac syndrome: A prospective cohort study. Eur J Neurol. 2022 Jan;29(1):121-129. doi: 10.1111/ene.15062. Epub 2021 Aug 23.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: David C, Papo T, Ba I, Ollivier E, Boileau C, Dieude P, Keren B, Kannengiesser C, Sacre K. Hunting for the genetic basis of Susac syndrome. Eur J Neurol. 2021 Jul;28(7):e57-e59. doi: 10.1111/ene.14836. Epub 2021 Apr 7. No abstract available.

ReferenceCitation: Machado S, Jouvent E, Klein I, De Guio F, Machado C, Cohen-Aubart F, Sacre K, Papo T. Cognitive dysfunction and brain atrophy in Susac syndrome. J Neurol. 2020 Apr;267(4):994-1003. doi: 10.1007/s00415-019-09664-8. Epub 2019 Dec 11.

publisher_dissemination: Springer-Nature

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study of Cell Markers of Marginal Zone Lymphoma and Other B-cell Chronic Lymphoid Malignancies

acronym: MALYZOMA-II

summary:
Lymphoid chronic B-cell malignancies are frequent pathologies that affect adults, with a very variable prognosis and treatment (some of them can remain untreated). The diagnosis of these malignancies relies on the study of the morphology of tumoral cells and the expression by these cells of several markers, mainly via a technical approach called flow cytometry. Because the markers currently used remain imperfect, additional ones are needed for an accurate diagnosis that affect both prognosis and treatment.

In addition, because numerous markers are used at the diagnosis, there is a need of tools that synthetize the multi-dimensional structure of the data obtained.

The primary purpose of this study is to detect new markers that can be of help for the diagnosis of Marginal Zone Lymphoma and other B-cell chronic lymphoid malignancies.

The secondary purpose of this study is to obtain a statistical algorithm that allow a good prediction of the different sub-types of chronic B-cell malignancies mainly using the results of flow cytometry.

location_facility: Hematology Laboratory - Strasbourg University Hospitals


title: Prospective Validation of the Prognostic Value of Long Non-coding MFI2-AS1 RNA in Localized Clear Cell Kidney Cancers

summary: An exploratory analysis of the expression of MFI2-AS1 will be performed at the plasma level with the objective of comparing this expression with tumor tissue. The objective would be to be able to use long non-coding RNA as a biomarker for diagnosis before tissue analysis and for patient follow-up. In addition, correlations will be made between tumor expression of MFI2-AS1 and genetic and immune alterations in tumors in order to better clarify the link between the expression of this long non-coding RNA and the characteristics of the tumor and of the tumor. tumor microenvironment.

intervention_type: Procedure


title: Characterization of Hamstring and Quadriceps Neuromuscular Fatigue After Different Modality of Training in Soccer Players

acronym: QIF

summary:
This is a monocentric study comparing hamstring and quadriceps neuromuscular fatigue after simulated soccer game, anaerobic and aerobic training sessions. The purpose of this study was:

To quantify the decrease of isometric force immediately after a simulate soccer game.
To characterize peripheral and central fatigue between hamstring and quadriceps muscles and described the kinetics of recovery after specific tasks of soccer training.
To compare the level neuromuscular fatigue induced by anaerobic and aerobic training.
To highlight correlation between neuromuscular fatigue and performance markers.


title: Prevalence of Cardiovascular Risk Factors in People With Upper Vestibular Neuritis

acronym: NEVRITE

summary:
Vestibular neuritis is the second cause of vertigo, it constitutes 5 to 6% of the aetiologies of vertigo in an otoneurological consultation.

Infection or reactivation of a neurotropic virus of the herpes group (HSV-1) in the vestibular lymph node is thought to be the cause of the unilateral vestibular deficit.

Upper vestibular neuritis is more common than lower, or total involvement. Goebel (2) explains this by an anatomical predisposition of the vestibular nerve canal to inflammation, unlike the singular nerve canal which is shorter and wider giving way to a certain degree of edema without consequence on its contents.

However, the innervation territory of the superior vestibular nerve is superimposable on the territory supplied by the anterior vestibular artery. The anterior, lateral semicircular canals and the utricle are affected. Current complementary vestibular and imaging examinations cannot differentiate between inflammatory or vascular involvement in upper vestibular neuritis.

The increased presence of cardiovascular risk factors in patients with upper vestibular neuritis would be an argument in favor of ischemic involvement of the anterior vestibular artery.

location_facility: Service ORL et de CCF - Hôpitaux Universitaires de Strasbourg


title: Search for Diagnostic and Prognostic Biomarkers (Molecular Signatures) in Systemic Sclerosis and Inflammatory Myopathies by a Multi-OMIC Strategy Integrating a Single Cell Analysis Approach

acronym: SCLEROMYOMICS

summary: Systemic sclerosis and inflammatory myopathies, which sometimes combine (scleromyositis), have shared pathophysiological elements. In both diseases, many cell subtypes are involved in damage to organs such as T lymphocytes, B lymphocytes, and unconventional (non-B, non-T) lymphocytes called innate lymphoid cell (ILC). The increasing complexity of our understanding of the immune system (multiplication of recognized cell subtypes) also makes the strategies for analyzing pathophysiological mechanisms more complex. Currently, no biomarker perfectly predicts the phenotype and evolution of patients. Multi-OMIC analyzes will be performed (identification of cell populations as well as genomic, transcriptomic and proteomic characterization) in blood and tissue samples (skin and muscle biopsy) in patients with systemic sclerosis and inflammatory myopathies, with the objective of identifying discriminating molecular signatures (biomarkers) according to the characteristics of the disease and its evolution.


title: Evaluation of the Predictive Value of Compression Venous Ultrasound by the Emergency Physician for Excluding the Diagnosis of Proximal Deep Vein Thrombosis (DVT) in Patients With Non-high Clinical Pretest Probability

acronym: EPREVUP

summary: Compression ultrasound is commonly used in emergency department. Accuracy to rule out deep vein thrombosis is excellent but lower then Ddimer assessment which is actually gold standard. With progress in formation of emergency physicians (EP), quality of material used, the investigators hypothesize that compression ultrasound can rule out deep vein thrombosis in case of non high probability, as standard care and DDimer assay.

appel_a_projets: PHRCI

acronyme: EPREVUP

titre: Evaluation de la valeur prédictive de l'échographie veineuse de compression par l'urgentiste dans l'élimination du diagnostic de thrombose veineuse profonde (TVP) proximale chez les patients avec probabilité clinique non forte.

discipline_principale: soins primaires

nom_porteur: LE BORGNE

prenom_porteur: Pierrick


title: Leukemic Phase of ALK+ Anaplastic Lymphoma in Real-life Practice: Experience of a University Clinical Hematology Laboratory

acronym: LEUK-ALCL

summary: Collecting data about the rare leukemic presentation of anaplastic lymphoma to study the characteristics of patients with leukemic phase of ALCL


acronym: TRAAP

lead_sponsor: University Hospital, Angers

summary: The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.

ReferenceCitation: Novikova N, Hofmeyr GJ. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007872. doi: 10.1002/14651858.CD007872.pub2.

ReferenceCitation: Peitsidis P, Kadir RA. Antifibrinolytic therapy with tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011 Mar;12(4):503-16. doi: 10.1517/14656566.2011.545818. Epub 2011 Feb 4.

ReferenceCitation: Sentilhes L, Daniel V, Darsonval A, Deruelle P, Vardon D, Perrotin F, Le Ray C, Senat MV, Winer N, Maillard F, Deneux-Tharaux C. Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial. BMC Pregnancy Childbirth. 2015 Jun 14;15:135. doi: 10.1186/s12884-015-0573-5.

ReferenceCitation: Sentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8.

ReferenceCitation: Sentilhes L, Winer N, Azria E, Senat MV, Le Ray C, Vardon D, Perrotin F, Desbriere R, Fuchs F, Kayem G, Ducarme G, Doret-Dion M, Huissoud C, Bohec C, Deruelle P, Darsonval A, Chretien JM, Seco A, Daniel V, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery. N Engl J Med. 2018 Aug 23;379(8):731-742. doi: 10.1056/NEJMoa1800942.

oa_host_type: publisher

publisher_dissemination: Massachusetts Medical Society

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

title: Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery: a Multicenter Randomised Double Blind Placebo Controlled Trial

source: euctr

region: Pays de la Loire

nom_etablissement: CHR ANGERS

acronyme: TRAAP

titre: Acide tranéxamique pour la prévention de l'hémorragie du postpartum après un accouchement par les voies naturelles : une étude multicentrique randomisée en double aveugle contre placébo.

discipline_principale: obstétrique

nom_porteur: SENTILHES

prenom_porteur: Loïc


title: Assessment of the Efficacy of Early Intrauterine Tamponade With a Belfort-Dildy Balloon Obstetric Tamponade System in the Treatment of Immediate Postpartum Hemorrhage

acronym: TUB

summary: The purpose of this study is to evaluate the impact of early intrauterine tamponade with a Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal delivery and refractory to first-line uterotonic treatment, ie performed at the same time as second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case of failure of second line uterotonic treatment, on the final severity of PPH. ).

ReferenceCitation: Laas E, Bui C, Popowski T, Mbaku OM, Rozenberg P. Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage. Am J Obstet Gynecol. 2012 Oct;207(4):281.e1-7. doi: 10.1016/j.ajog.2012.08.028. Epub 2012 Aug 17.

ReferenceCitation: Georgiou C. Balloon tamponade in the management of postpartum haemorrhage: a review. BJOG. 2009 May;116(6):748-57. doi: 10.1111/j.1471-0528.2009.02113.x.

ReferenceCitation: Tindell K, Garfinkel R, Abu-Haydar E, Ahn R, Burke TF, Conn K, Eckardt M. Uterine balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: a systematic review. BJOG. 2013 Jan;120(1):5-14. doi: 10.1111/j.1471-0528.2012.03454.x. Epub 2012 Aug 13.

ReferenceCitation: Revert M, Cottenet J, Raynal P, Cibot E, Quantin C, Rozenberg P. Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study. BJOG. 2017 Jul;124(8):1255-1262. doi: 10.1111/1471-0528.14382. Epub 2016 Oct 25.

ReferenceCitation: Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

oa_host_type: repository

repositories_concat: PubMed Central

unpaywall_oa_status: green

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

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: TUB

titre: Evaluation de l'efficacité de la tamponnade intra-utérine par le ballonnet de Belfort-Dildy dans le traitement des hémorragies sévères du postpartum immédiat

nom_porteur: ROZENBERG

prenom_porteur: Patrick


title: Effect of the Color of the Intra-eye Implant in the Cataract Surgery on the Sleep

acronym: IOL et sommeil

summary:
The cataract surgery (550 000 operations per year in France) is to replace the cloudy lens with a refractive implant. Two colors of implants are available: white implants, filtering out ultraviolet and yellow implants, filtering and more blue light. No clinical data are available to assert the superiority of an implant according to its color and the choice is made according to the preference of the surgeon and / or "markets".

It is established in humans that blue light has an important role on the secretion of melanopsin, a key mediator of the circadian cycle. This "clock" regulates most neuroendocrine functions in the nycthémère (sleep, mood, temperature, cortisol, ..). The question of the impact of these neuro endocrine functions of the installation of a blue light filter into the eyes of patients operated thus arises.

location_facility: Service d'Ophtalmologie, Centre Hospitalier Paul Martinais


title: Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island. Impact of the "Say No to Diabetes" Intervention.

acronym: PREDIABRUN

summary:
The management of diabetes and its complications in Reunion island is one of the priority areas of health. Indeed, the impact of diabetes on the health of the Reunion island population is major: the prevalence of diabetes treated in Reunion island is the highest in France (10% of the population), and gestational diabetes is found in 10% of pregnancies. Reunionese diabetics develop severe complications, in particular cardiovascular (strokes, myocardial infarction).

This results in 3 times higher mortality linked to diabetes on Reunion Island, in particular among those under 65 years of age. Despite all the screening and prevention programs put in place, the weight of diabetic disease continues to increase in our island, and this is more accelerated than in the other French departments with 4,300 new cases of diabetes / year, 95% of which type 2 diabetics (T2D). The presentation of type 2 diabetic patients in Reunion island also differs from the Metropolis with subjects more often female (56%), thinner and younger at the discovery of diabetes. These data highlight the need to better understand the factors underlying the diabetes "epidemic" in Reunion island.

The rise in blood sugar until the onset of diabetes is a continuous phenomenon reflecting the progressive suffering of the organs used to maintain carbohydrate homeostasis. Thus, we talk about fasting hyperglycemia when the fasting blood sugar is between 1.10 and 1.25 g / L (6.1-6.9 mmol / l) and glucose intolerance when the blood sugar 2 hours after taking 75 g of glucose is between 1.40 and 1.99 g / L (7.8-11.0 mmol / l). Subjects with fasting hyperglycemia or glucose intolerance constitute the target population at very high risk of developing diabetes (up to 70% of these subjects). They have an increased risk of developing diabetes at 1 year multiplied by 5 to 10 compared to normoglycemic subjects, hence the name "prediabetic subjects". This great variability in the risk of developing diabetes highlights the presence of associated risk / protective factors which it is important to find in order to adapt the monitoring and management. It is important in Reunion island, in view of the specificities presented by our population, to understand the pre-diabetes / diabetes transition and the risk and protective factors.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: "Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"

summary: The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.

lead_sponsor: Danone Research


title: Study of Food Preferences After Bariatric Surgery

summary:
Bariatric surgery is currently considered the most effective treatment for achieving significant, sustained weight loss and reducing comorbidities associated with obesity. Every year in France, more than 55,000 undergo this surgery and nearly 450 000 French have a history of surgery for obesity. The mechanisms of action of bariatric surgery are multiple and are not limited to caloric restriction. Neuro-hormonal effects, changes in the anatomy of the digestive tract, vagal changes or bile circulation have been identified as contributing factors to weight loss and postoperative improvement of comorbidities. In addition, post-operative changes in dietary preferences have also been described, which could contribute to initial weight loss and its maintenance over time (aversion to lipid and sugar products).

The counterpart of the rapid and durable efficacy of bariatric surgery is the exposure of patients to a significant risk of protein-energy malnutrition. It should be noted that the protein intake, very limited in the first months after surgery, remains well below the recommended intake after the first postoperative year. Spontaneous consumption of meat and vegetable protein is significantly reduced during the first postoperative month and up to one year after surgery. Apart from the limitation of gastric volume induced by surgery, clinical experience indicates that many patients turn away from protein consumption by aversion. A parallel was made between the significant drop in protein consumption during the first months and the initial loss of lean mass. Thus changes in dietary preferences induced by bariatric surgery could also contribute to postoperative nutritional risk (protein aversion).

At the same time, it is noted that olfactory and taste modifications have been reported in previous studies that could be associated with these changes in food preferences.

The hypotheses of the current study are that the type of surgery may affect dietary preferences differently after obesity surgery and that surgical failure may be associated with preferences for high fat, high sweet and low protein foods postoperatively for both types of surgery.

As far as the investigating team is aware, no study compares dietary preferences between sleeve gastrectomy and gastric bypass using this approach.

time_perspective: Cross-Sectional