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.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Strasbourg, France

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


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

study_type: Observational

time_perspective: Other

location_facility: Hematology Laboratory - Strasbourg University Hospitals


title: Cerebral and Cognitive Modifications in Retired Professional Soccer Players as Compared to Non Exposed to Repeated Cranial Impacts Sportsmen : Transverse Analytic Study

acronym: TC-FOOT

summary:
The objective of this study is to evaluate, using MRI, the microstructural consequences and the onset of any cognitive impairment in professional soccer players at the end of their career, who have experienced repeated minor head injuries. Over the long term, these head injuries could lead to morphological lesions and have an impact on soccer players' cognitive skills.

The main evaluation criterion corresponds to the modifications found on MRI in the professional soccer player group (diffusion tensor, cerebral perfusion, fMRI, cerebral volumetry and cortical thickness, spectroscopy, susceptibility imaging).

This is an exposure/nonexposure study assessing the onset of MRI abnormalities (diffusion tensor, cerebral perfusion, fMRI, volumetry and cortical thickness, spectroscopy, susceptibility imaging) in professional soccer players exposed to repeated mild head injuries, who are either at the end of their career or retired for approximately 10 years, compared to high-level athletes not exposed to head injuries.

design_allocation: Non-Randomized

primary_purpose: Screening

ReferenceType: derived

ReferenceCitation: Kepka S, Lersy F, Godet J, Blanc F, Bilger M, Botzung A, Kleitz C, Merignac J, Ohrant E, Garnier F, Pietra F, Noblet V, Deck C, Willinger R, Kremer S. Cerebral and cognitive modifications in retired professional soccer players: TC-FOOT protocol, a transverse analytical study. BMJ Open. 2022 Nov 9;12(11):e060459. doi: 10.1136/bmjopen-2021-060459.

intervention_type: Diagnostic Test


title: Study of the Immune Response to SARS-CoV-2 Vaccination in Patients With Systemic Lupus

acronym: LUPCELLVAX

summary:
The main objective is to study the impact of vaccination against Covid-19 on the specific humoral and cellular immune response (against SARS-CoV-2) and non-specific (evolution of the pathological immune system of the disease), in a lupus population.

The secondary objective is to study the impact of lupus disease activity on the humoral and cellular response of patients following vaccination against SARS-CoV-2.

The hypothesis is that disease activity and / or certain treatments used in lupus may interfere with the humoral and cellular immune response induced by vaccination against SARS-CoV-2.

time_perspective: Prospective

intervention_type: Biological


title: Follow-up of COVID-19 Vaccine Response in Strasbourg University Hospitals

acronym: COVACHUS

summary: Vaccination remains the main promising measure to fight against the COVID-19 pandemic. The presumed efficacy of the vaccines is quite remarkable since it varies between 62 and 95%. There is increasing evidence that sex-specific effects may lead to different outcomes of vaccine safety and efficacy. However, sex-disaggregated data after COVID-19 vaccine are lacking. The first purpose of the study is to determine antibody titers against SARS-CoV-2 spike after COVID-19 vaccination. The secondary purpose is to identify predictor factors of immune response including age, gender and biological factors.


title: Sleep Disorders in Patients Aged From 6 to 17 With Cystic Fibrosis: a Single-center Case-control Study at Strasbourg University Hospital

summary:
Our primary purpose is to compare the prevalence of sleep disorders in children aged 6 to 17 with cystic fibrosis versus controls with a Sleep disorder screening score, the SDSC. Our hypothesis is that patients aged 6 to 17 with cystic fibrosis have a higher prevalence of sleep disturbances than the general population of the same age group.

Our secondary hypothesis is that these sleep disorders are mixed and that there are non-respiratory causes, sometimes modifiable by simple non-medical treatment and that's why our secondary purpose is to identify the responsible factors, in particular non-respiratory factors in the 2 groups and to compare them.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Cross-Sectional

ipd_sharing: Undecided

intervention_type: Behavioral


title: Analysis of Clinical Data and Diagnosis in Any Person Requiring an Assay of Alzheimer Biomarkers in Cerebrospinal Fluid

acronym: Analzheimer

summary:
Cognitive neurodegenerative diseases are a major public health issue. At present, the diagnosis of certainty is still based on anatomopathological analyses. Even if the diagnostic tools available to clinicians have made it possible to improve probabilistic diagnosis during the patient's lifetime, there are still too many diagnostic errors and sub-diagnostic in this field. The arrival of biomarkers has made it possible to reduce these diagnostic errors, which were of the order of 25 to 30%. This high error rate is due to different parameters. These diseases are numerous and often present common symptoms due to the fact that common brain structures are affected. These diseases evolve progressively over several years and their early diagnosis, when the symptoms are discrete, makes them even more difficult to diagnose at this stage. In addition, co-morbidities are common in the elderly, further complicating the diagnosis of these diseases.

At present, the only cerebrospinal fluid (CSF) biomarkers that are routinely used for the biological diagnosis of neurodegenerative cognitive pathologies are those specific to Alzheimer's disease: Aβ42, Aβ40, Tau-total and Phospho-Tau. These biomarkers represent an almost indispensable tool in the diagnosis of dementia.

It is therefore important to determine whether Alzheimer's biomarkers can be disrupted in other neurodegenerative cognitive pathologies, but also to find biomarkers specific to these different pathologies by facilitating the implementation of clinical studies which will thus make it possible to improve their diagnosis.

location_facility: Service d'évaluation et Centre Mémoire de Ressources et de Recherche (CM2R), Hôpital de jour Saint François - Pôle de Gériatrie, Hôpitaux Universitaires de Strasbourg, Hôpital de la Robertsau


title: Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS

acronym: SEP-RR

summary:
Multiple Sclerosis (MS) is a chronic, autoimmune, neurodegenerative disease; clinical events are mainly attributed to myelin destruction and inflammatory of the central nervous system.

The diagnosis resides in clinical and radiological criteria according to 2017 McDonald criteria.

Once the diagnosis of MS has been made, treatment should be initiated promptly, in order to delay the onset of severe disability in the long-term, even more ocrelizumab are a treatment of high efficacy.

Ocrelizumab is used as a first-line or second-line treatment in Relapsing Remitting MS (RRMS) It is an anti-CD20 monoclonal antibody that provides rapid depletion of circulating CD20+ B lymphocytes by complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity.

The main objective is the retrospective evaluation of the impact of ocrelizumab on the outcome of MS.

The secondary objective is the search of predictive factors of response to treatment.

time_perspective: Retrospective

location_facility: Hautepierre Clinical Investigation Center - Strasbourg University Hospitals


title: Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

acronym: COVATRANS

summary:
Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. The efficacy of these vaccines ranges from 62 to 95%, which is particularly remarkable, especially for mRNA vaccines. Nevertheless, these studies do not report the vaccine response in organ transplant patients.

It is known that transplant patients have lower vaccine responses than immunocompetent patients due to some degree of immunosuppression.

Therefore, the investigators are interested in evaluating the vaccine response of organ transplant recipients after vaccination against SARS- CoV-2. For non-responder patients, new strategies can be proposed: 3rd or 4th boost of vaccine or perfusion/injection of antiS monoclonal antibodies. These strategies must be evaluated.


title: High Throughput Screening Device Based on 3D Nano-matrices and 3D Tumors With Functional Vascularization

acronym: TUMOVASC

summary:
Almost 85% of new therapeutic molecules are abandoned before the clinical trial stage. Most of these failures currently concern cancer therapies.

In order to optimize the development of these molecules and allow the development of precision medicine, an innovative screening device that is as close as possible to in vivo is necessary.

For this reason, the platform the investigators are setting up takes into account tumor vascularization as well as the 3D microenvironment.

The platform the investigators intend to set up is based on 4 cornerstones:

the formation of patient-derived organoids seems to be the best option to take into account the microenvironment and cellular interactions.
the vascular network: the formation of a peri-tumoral vascular network, either by using HUVECS cells or by using endothelial cells from the patient.
the extracellular matrix, and the set of proteins it contains, is a major element of in vivo interaction. Moreover, the presence of a matrix is a key element for the development of vascularization in vitro.
Functional tumor microenvironment: peri-tumor vascularization is necessary but not sufficient to claim to recreate a tumor microenvironment. It must be functionalized, and this implies the use of a microfluidic system.

This ready-to-use platform will be used on tumor biopsies of the patient, to constitute a tool for personalized medicine. This could even be a future component of decision at multidisciplinary board meetings.

The main objective of our research is the constitution of organoids derived from the patient in order to select, via a screening device, the best anti-tumor therapy to administer to the patient.

A secondary objective is to collect lymphocytes from the patient's blood in order to test the effectiveness of therapies mediated by the immune system (immunotherapy).

location_facility: Les Hôpitaux Universitaires de Strasbourg

intervention_type: Device


title: MRI-guided Focused Ultrasound for Bone Tumors Treatment: Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma

acronym: UFOGUIDE

summary:
Ufoguide is a prospective single arm open study to assess the feasibility of a new type of HIFU system to treat bone tumors.

HIFU is classically delivered by a transducer integrated in the MRI table. This study assesses a new type of approach in which the HIFU transducer is manually placed on the skin of the patient, under the assistance of optical navigation, and held in place by MR-compatible passive arms.

The primary goal of this study is to assess the feasibility of heating the tumor accurately with this new HIFU system. The evaluation and monitoring of the treatment will be performed by MR thermometry.

Secondary endpoints include the evaluation of clinical efficacy, quality of life and safety.

primary_purpose: Device Feasibility

ipd_sharing: No


title: Measurement of Noradrenaline Concentrations Using Different Dilution Methods

summary:
Norepinephrine is the vasopressor of choice for the treatment of peri-anesthetic arterial hypotension. The use of this drug at significantly lower concentrations (dilution factor between 40 and 200) than the commercial preparation is increasingly common in the operating room ("baby-noradrenaline").

In addition, dilution errors are potentially serious for the patient (hypertensive peak) The preparation of precise dilutions is an important factor for the safe use of this medically In this study, the investigators wish to compare the dilution method of the protocol with another method of preparation (left to the free choice of the participant).

location_facility: Strasbourg University Hospitals - Anesthesia-intensive care unit


title: Cognitive Hyperarousal in Insomnia Disorder

acronym: TIP

summary: Cognitive arousal has been identified as playing a key role in the inability to fall asleep or stay asleep. However, although people with insomnia frequently complain about racing thoughts appearing as soon as they get into bed, studies focusing on racing thoughts in insomnia are lacking. The aim of the present study is to investigate racing thoughts in insomnia disorder using a self-report questionnaire, the Racing and Crowded Thoughts Questionnaire. Specifically, the researchers seek to address three related goals: the comparison of RCTQ scores in adults with primary insomnia, healthy individuals, and patients with bipolar disorder in a manic/hypomanic episode; the variation of RCTQ scores relative to time of day; and the specific contribution of racing thoughts to insomnia severity, as compared to worry and rumination.

ReferenceCitation: Weiner L, Martz E, Kilic-Huck U, Siegel N, Bertschy G, Geoffroy PA, Weibel S, Bourgin P. Investigating racing thoughts in insomnia: A neglected piece of the mood-sleep puzzle? Compr Psychiatry. 2021 Nov;111:152271. doi: 10.1016/j.comppsych.2021.152271. Epub 2021 Sep 17.

location_facility: Center for Sleep Disorders - CIRCSom - Strasbourg University Hospitals


title: Impact Evaluation of Personalized Oral Hygiene Education on Periodontal Patients Stage I/II/III

acronym: HygParo

summary:
Evaluation of personalized oral hygiene education on plaque accumulation and gingival inflammation in periodontal patients stage I/II/III.

Evaluation of personalized oral hygiene education on clinical attachment level in periodontal patients stage I/II/III.

Evaluation of personalized oral hygiene education on the psychological determinants described by the Health Action Process Approach (HAPA) and the mediating role of these psychological determinants in oral hygiene habits and clinical parameters in periodontal patients stage I/II/III.


title: Dialectical Behavior Therapy for Adults With Autism Spectrum Disorders Without Intellectual Disability: a Randomized Controlled Trial

acronym: Autisemo

summary: Dialectical Behavior Therapy (DBT; Linehan, 1993) effectively diminishes emotion dysregulation and self-harm behaviors in a number of disorders. However, to our knowledge, no studies have investigated the efficacy of DBT to treat emotional dysregulation associated with self-harm and suicidal behaviors in adults with ASD without intellectual disability. This randomized controlled study trial aims to assess the efficacy of a 5-month DBT intervention in adults with ASD without intellectual disability who present with self-harm and/or suicidal behaviors.

design_allocation: Randomized

primary_purpose: Treatment


title: Air Pollution and Daily Mobility of Pregnant Women in the Eurometropole: Identification of Critical Windows of Exposure During Pregnancy

acronym: MOBIFEM

summary:
This study is conducted to assess the role of pregnant women's daily mobility living in the Eurometropole of Strasbourg in a context of the existence of environmental exposure disparities (PM10, PM2.5, NO2). Furthermore, this study will tend to identify the critical windows of exposure and of greater risk of the adverse pregnancy outcomes as low birth weight and prematurity.

A second question addressed in this work is to assess the relationship between the pregnant women's socio-economic status and the air pollution exposure (PM10, PM2.5, NO2).taking into account the spatio-temporal variations of the exposure as well as the critical windows of exposure during pregnancy.

The present work deals with the following question "how does the combination of environmental exposure, socio-economic status and women's daily mobility, could contribute to socio-spatial inequalities in the health of the newborn? The underlying hypothesis is that the accumulation, in given area, of environmental exposures (as PM10, PM2.5 and NO2), of unfavorable living conditions (socio-economic environment) and individual factors (specific spatio-temporal trajectory) would induce an increased risk for the health of the newborn, (more particularly in terms of birth weight and term of birth). This hypothesis is structured 4 sub-hypotheses: i) The misclassification of exposure is socially distributed among pregnant women living in the Eurometropole of Strasbourg. ii) Beyond maternal and fetal characteristics, pregnant women who reside in a more socio-economically deprived neighborhood and / or with higher levels of environmental exposure to PM10, PM2.5 and NO2 are more at risk of preterm newborn and low birth weight newborn. iii) The accumulation of environmental exposures of the pregnant women and their daily mobility over their territory during the pregnancy increase the health inequalities of the newborn. iv) The critical windows of fetal exposure to pollutants is related to the socioeconomic level of their neighborhood and to the daily mobility of the women in their territory during pregnancy. Women are included in the study at the time of their first or second trimester ultrasound. Here are the tools used in the study: Descriptive survey of their idividuals characteristics, descriptive survey of women's mobility to assess their exposure during each trimester of pregnancy.

ReferenceCitation: Simoncic V, Hamann V, Huber L, Deruelle P, Sananes N, Enaux C, Alter M, Schillinger C, Deguen S, Kihal-Talantikite W. Study protocol to explore the social effects of environmental exposure and lifestyle behaviours on pregnancy outcome: an overview of cohort of pregnant women study. BMJ Open. 2022 Sep 17;12(9):e058883. doi: 10.1136/bmjopen-2021-058883.


title: Diagnosis of Disseminated Lyme Borreliosis by Targeted Proteomics

acronym: DIALYD

summary:
Lyme borreliosis is a bacterial multisystemic infection transmitted by an Ixodes tick. It affects the skin, the joint and the brain. At the early phase, the diagnosis is clinical, relying on the presence of an erythema migrans at the site of the tick bite. The diagnosis of disseminated infections, more difficult to assess, mainly relies on indirect diagnosis test, i.e. serology.

This study will evaluate a new direct diagnosis method based on proteomics, which aims to demonstrate proteins of live bacteria in the skin and the synovial or cerebrospinal fluids in a direct manner.

intervention_type: Procedure


title: Clinical Evolution and Becoming of Adult Patients Infected With Covid-19 Hospitalized at the University Hospitals of Strasbourg : A Retrospective Observational Study

summary:
A SARS-CoV-2 infection emerged in China in December 2019, the severity of which is linked to acute respiratory distress syndrome1. The rate of emergency visits in Bas-Rhin for suspected Covid-19 increased, compared to the French average, at the end of the 10th week of 2020.

Compared to the onset of symptoms, Chinese studies estimate the onset of dyspnea on the 7th day3 and admission to the emergency room between the 5th and the 9th day4. But this duration varies according to the epidemic period5, the geographical location6 and a later emergency admission is associated with an increase in mortality in the Chinese population7.

The need for oxygen, which is not noted in Chinese studies8, is a reflection of the onset of respiratory worsening and a major factor in hospitalization. There is no study on the changing profile of the French population to date its onset.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

location_facility: Adult Emergency Department - Strasbourg University Hospitals

status_simplified: Completed


title: Validation of Two Self-questinnaires on Olfactory Disorders for French Speaking Patients: the Self-evaluation of Olfactory Capacities and Quality of Life Questionnaires

acronym: VIF-DOR

summary:
Sense of smell disorders are common and are said to affect up to 20% of the general population. They are often disabling and have a real impact on the quality of life. Smell disorders are most often assessed using a visual analogue scale and more rarely with objective tests (Sniffing Stick Test). Many ENT units do not have these objective tests because they are time-consuming and are not covered by health insurance.

Some teams, such as that of Dr Thomas Hummel of the Carl Gustav Carus University Clinic in Dresden Germany, have developed self-assessment questionnaires for the sense of smell in order to improve the overall care of patients with olfactory disorders. Two of these self-questionnaires seem to us to be particularly relevant for use in everyday practice.

Since then, these questionnaires have already been validated in different languages (English, Chinese, Korean...), but have never been translated and validated in French. Translating and validating these questionnaires into French would make it possible to improve the management and follow-up of French patients with olfactory disorders and to assess the impact of loss of smell on their quality of life.


title: Clinical Study of Pregnant Women With COVID-19: A Retrospective Review of Medical Records at Strasbourg University Hospitals

acronym: PregWom-Covid

summary: A new pandemic, COVID-19, has spread rapidly around the world. She does not spare pregnant women. Little is known about the clinical course of pregnant women infected with COVID-19. As of April 1, 2020, six case series and one case report for a total of 61 pregnancies affected by COVID-19, all from the pandemic epicenter in China, except for one state case report -Unis, have been published. These preliminary reports suggest that pregnant women are not more seriously affected than the general population and show a certain gap with what we have observed in the care of pregnant women at HUS. For these reasons, additional information, especially from parts of the world other than China, as the severity of the disease can vary from country to country, is urgently needed to determine whether pregnant women with the disease of COVID-19 will not present with severe pneumonia to COVID-19.

location_facility: Department of Gynecology-Obstetrics and Fertility - Strasbourg University Hospitals


title: Study of the Evolution Profile of the Renal Doppler in the Perioperative Hepathic Transplantation - Interest in Predicting the Occurence of Acute Postoperative Renal Faillure

acronym: DOP-RENAL

summary: Liver transplantation is associated with a modification of the perfusion pressures of the abdominal organs (preoperative portal hypertension in connection with liver pathology, and normalization of the perfusion pressures during surgery). This abrupt change in the infusion regime is probably responsible for an alteration in renal function in some patients, and the identification of renal vascular profiles using Doppler could point to pathological profiles, which should be diagnosed early.


title: Incidence of Different Surgical Technics for Colorectal Deep Infiltrating EndoMetriosis on the Post-operative Fertility and Pregnancy Outcomes

acronym: Endo-Metrios

summary:
Endometriosis is a disease that is very present on the current media scene. Its symptoms are very nonspecific and numerous. (dysmenorrhea, dyspareunia, dyschezia, urinary functional signs, infertility, chronic pelvic pain, etc.) Its prevalence is estimated at 10% of women and 20% of them have deep pelvic endometriosis. Colorectal lesions involving the rectosigmoid junction and the rectum represent the most severe forms and affect 5.3 to 12% of patients with deep pelvic endometriosis. Endometriosis is found in 20 to 50% of patients consulting for infertility and the rate of spontaneous pregnancy in patients with deep endometriosis is estimated to be between 8.7 and 13%. Surgery appears to improve fertility in women. However, several surgical techniques for deep endometriosis at the digestive level have been described, conservative or radical, without any having demonstrated its superiority both in terms of symptoms and fertility.

The aim of this study was to evaluate the incidence of different surgical technics (shaving vs. bowel resection) on post-operative fertility among patients with bowel deep infiltrating endometriosis and the pregnancy outcome

location_facility: Department of Gynecology - Strasbourg University Hospitals


title: Retrospective Study on Anosmias and Ageusias Linked to Infection by SARS-Cov 2

summary:
Odor and taste disturbances have increased dramatically during this time of the COVID-19 pandemic. Currently, we have very little information on the demographic and clinical characteristics of the affected population, on the severity and course of the olfactory / taste loss.

The main objective of this research is to analyze the epidemiological, demographic and clinical characteristics of patients suspected or already confirmed of infection with SARS-Cov2 presenting with anosmia and / or ageusia.

location_facility: Strasbourg University Hospitals - Otorhino-Laryngology Department


title: Molecular Mechanisms of Tooth Eruption

summary: The main objective is to study the expression of molecules involved in tooth morphogenesis and eruption in healthy patients, and then to compare them with the results in patients with abnormalities of eruption (results obtained via a collection of biological samples of rare diseases already authorized).


title: Study of the Quality of Life in Surviving Lung Transplant Patients Between 2008 and 2018 by SF36 and St Georges's Questionnaires

summary:
The aim of this study is to study the quality of life in lung transplant patients. The cohort includes all of the surviving and transplanted patients at the New Civil Hospital in Strasbourg between 2008 and 2018. The main objective is to assess the quality of life of this cohort by two questionnaires which are the SF36 (generic score) and the saint Georges's questionnaire (specific score).

The secondary objectives are the measurement of survival after lung transplantation, the comparison of the quality of life of these patients with that of the general population by the SF36 questionnaire, the search for perioperative factors influencing the quality of life and finally the search for an association between quality of life and socio-professional life.


title: Health-related Quality of Life in Adults After Veno-arterial Extra-Corporeal Membrane Oxygenation

summary:
Extracorporeal Membrane Oxygenation (ECMO) is a salvage therapy used in patients with refractory cardiogenic shock. This rescue technique is associated to a high mortality rate and to many complications that can impact the quality of life of the survivors. The aim of this study is to evaluate the Health-related quality of life in adults after veino-arterial Extra-Corporeal Membrane Oxygenation. The quality of life will be evaluated thanks to several methods : the Short Form 36, the EQ 5D 5L and the return to work status.

Then, the investigators will analyze by subgroup the quality of life according to the cardiogenic shock etiology and try to determine the risk factors of an altered quality of life. The investigators will also evaluate current comorbidities of the patient thanks to the Groll Index.


title: Placement of a Laryngeal Allograft Aortic Implant After Total Laryngectomy to Rehabilitate Laryngeal Function

acronym: GRAAL

summary:
The larynx is a cartilaginous organ of the respiratory system located in the throat, which plays an essential role in respiratory function, swallowing and sound production.

In the case of advanced tumours, the surgical option most often remains total laryngectomy, with the corollary of a major impact on quality of life, not so much because of the loss of voice, but because of the presence of a definitive tracheostoma with particularly deleterious consequences.

The majority of the work of the different teams around the world has focused on restoring phonatory function, but no technique - apart from the artificial larynx developed in the ENT department of the Hautepierre Hospital - has yet succeeded in removing the tracheotomy orifice, requiring the restoration of a common passage between the respiratory and swallowing passages. If nutrition and phonatory function can still be supplemented after such an operation (oesophageal rehabilitation, implant placed between the trachea and oesophagus), natural breathing is no longer possible. Patients are forced to wear a permanent tracheotomy opening.

There are currently only 2 ways to try to restore all the functions of the larynx after total laryngectomy: i) laryngeal transplantation, but this procedure requires maintaining immunosuppressive treatment, which is not possible in patients suffering from cancer of the larynx, which is not a vital organ, ii) artificial larynx made of biomaterials (titanium), the first cases of which were performed worldwide in the ENT department of the Strasbourg University Hospital in 2012, results published in the NEJM (API 2008-2009 HUS No. 4493- IDRCB No.: 2011-A00032-39. However, difficulties were encountered with the use of the titanium prosthesis due to the bulk and rigidity of the removable and non-removable part, which caused residual swallowing difficulties (false routes).

It is now possible, due to the development of new allograft techniques in humans for tracheal replacement (studies published on a large number of cases with several years of hindsight, cf. references), to switch to the "all biological" using an aortic graft stented with a silicone stent. We wish to use these grafts in laryngeal restoration after total laryngectomy by our team, while exploiting all the data and experience acquired (unique in the world) within the ENT department of Hautepierre Hospital. This new conceptual leap should make it possible to significantly improve the patient's quality of life and the performance previously acquired in clinical trials on the artificial larynx in its entirety (breathing, phonation) or partially (swallowing).

The investigators thus propose to evaluate this new artificial larynx in aortic allograft, the objective of which is to supplement the respiratory, swallowing and phonation functions in patients laryngectomized for carcinological causes.

location_facility: ENT department-Hôpitaux Universitaires de Strasbourg


title: Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis

acronym: ScleroBross

summary:
Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life.

The aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to "standard" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.

primary_purpose: Prevention


title: Self in Dementia With Lewy Bodies: a Behavioral and Multimodal Neuroimaging Study

acronym: SELF-MCL

summary: The present project aims at exploring different components of Self-consciousness or 'the Self', such as autobiographical memory, self-concept and subjective sense of Self, in dementia with Lewy Bodies (DLB) compared to Alzheimer's disease and to normal ageing. Anatomical substrates will be studied in multimodal imaging, in terms of volume, anatomical and functional connectivity. We expect to find an alteration of the different components of the Self, consecutive to insular dysfunction, a key region within cerebral networks of self-consciousness, which is damaged early in the course of the disease.

primary_purpose: Other


title: Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia

acronym: LidoCovid

summary:
The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ARDS) due or not to Covid-19 pneumonia.

Half of the patients will receive intravenous lidocaine and the other half will receive intravenous NaCl 0,9 % as placebo.

ReferenceCitation: Muller M, Lefebvre F, Harlay ML, Glady L, Becker G, Muller C, Aberkane O, Tawk M, Julians M, Romoli A, Hecketsweiler S, Schneider F, Pottecher J, Chamaraux-Tran TN. Impact of intravenous lidocaine on clinical outcomes of patients with ARDS during COVID-19 pandemia (LidoCovid): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 11;22(1):131. doi: 10.1186/s13063-021-05095-x.

intervention_type: Drug


type: Other Identifier

title: TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.

acronym: TeleRea'nCo

summary:
Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term.

The results of this research will allow an improvement in the understanding and management of patients in the medium and long term.


title: Diabetic Cardiomyopathy: Diagonostic Value of 2D and 3D Left Ventricular Strains in Echocardiography in Type 2 Diabetic Patients

acronym: CarDiab

summary: Diabetes represents one of the 10 leading causes of death in the world and concerns 5% of the French population (> 3.3 million patients). About 30% of diabetic patients will develop heart failure. The specific and early identification of diabetic cardiomyopathy at a subclinical stage (asymptomatic patients with normal LVEF) will thus make it possible to predict the risk of the onset of heart failure and to strengthen their monitoring and further adapt their treatment.

status: Unknown status

location_facility: Service de Physiologie et d'Explorations Fonctionnelles

status_simplified: Unknown


title: Prospective Randomized Versus Placebo Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study

acronym: PlasmaFaisa

summary:
No randomized controlled trial (RCT) has investigated the effect of prophylactic fresh frozen plasma (FFP) transfusion in septic or critically ill patients with coagulation abnormalities. The last Surviving Sepsis Campaign therefore suggests with a very low quality of evidence "against the use of fresh frozen plasma during septic shock to correct clotting abnormalities in the absence of bleeding or planned invasive procedures". However, expert opinion highlights that FFP should be transfused "when there is a documented deficiency of coagulation factors (increased prothrombin time, international normalized ratio - INR, or partial thromboplastin time) and the presence of active bleeding or before surgical or invasive procedures". Disseminated intravascular coagulation (DIC) is responsible for such a severe deficiency of coagulation factors. Supplementing the intense deficit of coagulation factors with plasma containing non-activated coagulation factors is therefore a rational therapy in DIC patients.

OctaplasLG® is a donor plasma product, with unique features compared to standard fresh frozen plasma: standardized concentrations of natural pro-/anti-coagulation factors; a standardized volume; pathogen free. OctaplasLG® should reduce the "inflammatory hit" on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma.


title: Optical Coherence Tomography Imaging in Systemic Sclerosis

acronym: OCTISS

summary:
Systemic sclerosis (SSc) is an autoimmune disorder characterized by early vascular endothelial involvement. SSc is a rare and devastating multi-visceral disease when fibrotic lesions extend to the skin and other tissues (heart, lungs, kidneys). The severity of skin involvement in SSc is correlated with functional prognosis and survival. To date, there is no validated tool for a reliable quantitative assessment of skin fibrosis.

Optical coherence tomography (OCT) is an innovative non-invasive skin imaging technique that allows micrometric analysis of the superficial layers of the skin. Previous study showed that OCT could detect the loss of the dermal-epidermal junction in an objective and non-invasive way, which is correlated with severity of skin fibrosis.

The aim of OCTISS study is to evaluate the skin involvement of patients with early SSc using OCT imaging. This will be early diagnosis of fibrosis lesions and help identify patients at an early stage.

status: Active, not recruiting


title: Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)

acronym: PRESAGE

summary: seroPREvalence vis-à-vis SARS-CoV2 and correlation with clinical forms of COVID-19 in patients followed in Pulmonology in the cluster area of the Grand-Est region.


title: SARS-CoV-2 Infection in Patients From Two Tertiary Inflammatory Bowel Disease (IBD) Centres: Frequency of Suspected and Confirmed Infections, Severity and Outcome Management

summary: Most of the inflammatory bowel disease (IBD: Crohn's disease and ulcerative colitis) in a tertiary expert Centre are on immunosuppressive and/or biological therapy. Theoretically, these treatments may increase patients' risk of infection, in particular viral infection. Therefore, the current SARS-Cov-2 pandemia, with its unprecedent worldwide morbidity and mortality, may have a negative impact on IBD patients' clinical course. Identifying an increased risk in this particular patients' population as well as the risk/protective factors is of outstanding importance, in order to adapt their treatment and surveillance. As a consequence, our aims were (i) to measure retrospectively the risk of SARS-CoV-2 (proven by biological testing or suspected due to record of potential clinical symptoms of COVID-19 infection) in this patients' cohort (principal objective), (ii) to identify risk or protective factors for SARS-CoV-2 infection in IBD, and (iii) to analyze the outcome of patients in case of suspected or confirmed COVID-19. The results of this study may be important to adjust our surveillance and therapeutic strategy in these patients, in particular if high virus circulation will occur in the future.

location_facility: Service Hépato-Gastroentérologie et Assistance Nutritive Hôpitaux Univesitaires de Strasbourg


title: Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)

summary:
Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,…). It is therefore necessary to provide a framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain unknow at this time. Study hypothesis is that COVID alters determining factors (physical or psychological) of quality of life after ICU hospitalisation. The aim of the study is to assess quality of life 3 months after ICU hospitalization.

Secondary purposes of the study are 1) assessment of quality of life 6 months and the evolution between the third and the sixth months after ICU hospitalization 2) description patients care after 3 and 6 months ICU left and their clinical status 3) convening and providing a "platform" within several physicians (neurologist, biologist, pneumologist…) will be able to follow up patients and perform complementary investigations according to patients injuries.

location_facility: Hôpitaux Universitaires de Strasbourg (Nouvel Hôpital Civil)


title: Sagittal Balance Through Ages

acronym: ESTA

summary: The parameters of the sagittal balance of the cervical, thoracic and lumbar spine vary according to the types of spino-pelvic organization (types 1-4 according to Roussouly). These parameters have been described as a function of age in previous scientific work without taking into account the pelvic anatomy (pelvic incidence and spino-pelvic organization). This work, carried out within the framework of a round table of the French Society of Spinal Surgery (SFCR), would make it possible to provide a more detailed repository of existing radiographic parameters.

ReferenceCitation: Charles YP, Prost S, Pesenti S, Ilharreborde B, Bauduin E, Laouissat F, Riouallon G, Wolff S, Challier V, Obeid I, Boissière L, Ferrero E, Solla F, Le Huec JC, Bourret S, Faddoul J, Abi Lahoud GN, Fière V, Vande Kerckhove M, Campana M, Lebhar J, Giorgi H, Faure A, Sauleau EA, Blondel B; French Spine Surgery Society (SFCR). Variation of cervical sagittal alignment parameters according to gender, pelvic incidence and age. Eur Spine J. 2022 May;31(5):1228-1240. doi: 10.1007/s00586-021-07102-w. Epub 2022 Jan 6. Erratum in: Eur Spine J. 2022 Mar 17;:.


title: COhort for Bardet-Bield Syndrome and Alström Syndrome for Translational Research Etude Interventionnelle Monocentrique

acronym: COBBALT

summary:
ALMS and BBS syndromes are rare diseases with overlapping features of multiple sensory and metabolic impairments, including diabetes mellitus. There are to date no specific treatments available and limited information on the natural history of the diseases. the investigators aim to establish a French cohort for these diseases to improve patient care and assess the effect of actual therapies on quality of life.

The purpose of this study is to establish a cohort of Bardet-Bield syndrome (BBS) and ALström syndrome (ALMS) patients in order to formalize and address questions concerning the in-depth natural clinical and biological history of the disease on the long term for a given patient, establish the impact on the quality of life of various clinical manifestations

primary_purpose: Supportive Care

intervention_type: Genetic


title: Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric

summary:
Consideration from the patient's point of view is an important step in improving postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a psychometrically validated questionnaire to measure the quality of postoperative functional recovery. it has been recommended in perioperative medecine however, this questionnaire was never adapted and validated for a pediatric surgical population.

The main objective of this protocol is to study the validity, reliability, acceptability and feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15 score.


title: High Prevalence of Deep Venous Thrombosis in Non-severe COVID-19 Patients Hospitalized for a Neurovascular Pathology

summary: Severe SARS-CoV-2 infection, responsible of COVID-19, is accompanied by many venous thromboembolic events. Antithrombotic treatment is the cornerstone of management of many neurovascular diseases (NVDs) and the benefit-risk ratio is crucial to avoid hemorrhagic complications. Therefore, in non-severe COVID-19 patients affected by NVDs, the diagnostic of deep venous thrombosis (DVT) is challenging. Using bedside Doppler ultrasonography (DUS) of lower limbs, this study investigated the rates of DVT in these patients in stroke unit.


title: Role of Circulating Microparticles in Covid-19 Infection

acronym: MICO

summary: Among the distinctive features of Covid-19, numerous reports have stressed the importance of vascular damages associated with coagulopathy onset. Microparticles (MPs) shed by apoptotic/stimulated cells are reliable markers of vascular damage released upon pro-inflammatory conditions and behave as active participants in the early steps of clot formation. In addition, MPs carry ACE1 and ACE2, the cell-entry receptor for SARS-Cov2 in the vasculature and up-regulate ACE1 expression in neighbouring endothelial cells. This may contribute to unopposed angiotensin II accumulation which further exacerbate tissue injury and promote both inflammation and thrombosis. The aim of the study is to evaluate the impact of circulating MPs on ACE2 expression, the cell-entry receptor for SARS-Cov2 on endothelial cells.


title: Bicentric Study on the Use of ECMO-VV or VA for Severe ARDS Associated With Covid-19

summary: Describes the cohort of patients receiving ECMO-VV or ECMO-VA in the management of severe ARDS refractory to SARS-CoV-2 in the Strasbourg and Louvain centres

location_facility: Service de Chirurgie Thoracique Nouvel Hôpital Civil Hôpitaux Universitaires de Strasbourg


title: RT-PCR SARS-CoV-2 at 1 Month of COVID-19 Infection in the Geriatric Population

summary:
Evaluation of the rate of positive RT-PCR SARS-CoV-2 test at 1 month of COVID infection among elderly people.

It is unclear how long an individual with COVID-19 will remain "sick" and "contagious". It appears that SARS-CoV-2 can be transmitted before symptoms appear and throughout the course of the disease.

They investigators did not find any study on a COVID + geriatric population reassessing carriage at 1 month even though age seems to be a risk factor for prolonged excretion as suggested in the study following study: Xu K, Chen Y, Yuan J, Yi P, Ding C, Wu W, et al. Factors associated with prolonged viral RNA shedding in patients with COVID-19. Clinical Infectious Diseases. 2020 Apr 9; ciaa351


title: Evolution of Cochleovestibular Schwannomas in the Internal Auditory Canal by Volume Measering With aTeslas MRI 3

summary:
Investigators want to know the natural history of the vestibular schwannomas: increasing, decreasing or stability, by monitoring more than 3 MRIs during a span of more than 2 years. They will obtain 3 groups: the volume increasing schwannomas which will be the most important group, the schwannomas that will be stable and a small group where the schwannomas will decrease.

The secondary purpose is that the investigators want to know the threshold values: a minimum volume under which we are sure that the schwannoma will not increase, a maximum value where it will increase and if its evolution can be correlated to clinical or radiological criteria.


title: Evaluation of the Evolution of Pregnancies in the First Trimester Following a Medically Assisted Procreation (MAR) Management During a COVD-19 Pandemic Period

summary: Because of the physiological changes inherent in pregnancy, pregnant women with lower respiratory tract infections often have more worrisome outcomes compared to non-pregnant individuals, including a higher rate of hospital and intensive care unit admissions.

location_facility: Service Clinico biologique d'Assistance Médicale à La Procréation


title: COVID-19 Respiratory Distress and Antithrombotic Drugs inSubject's Habits

acronym: CRASH

summary: Current management of VID-19 consists of oxygen support without specific treatment. Hospitalization may suddenly require delayed resuscitation. This evolution corresponds to an atypical acute respiratory distress syndrome (ARDS), the mechanism of which is poorly understood and difficult to predict. The general pathophysiology of ARDS, the vascular tropism of SARS-Cov2, the description of coagulopathy and numerous pulmonary artery thromboses in resuscitation and the encouraging investigation of antithrombotics in general ARDS

location_facility: Service Médecine Intensive et Réanimation


title: Study of Clinical, Biological and Genetic Prognostic Factors of SARS-CoV-2 Infection in Patients Admitted in the Strasbourg University Hospitals

acronym: Covid-HUS

summary:
COVID-19 is an emerging disease, for which no specific treatment options are currently available. Since the end of February 2020, and due to a SARS-CoV-2 superspreading event (religious meeting), the Strasbourg University Hospital (HUS) had faced a sudden increase of the number of COVID-19-positive patients in serious condition requiring hospitalization. At the same time, many people develop only mild or moderate symptoms. To date, the prognostic factors for the course of SARS-CoV-2 infection are unknown. The primary purpose of the "COVID-HUS" protocol is to investigate viral and host-related factors to understand the pathophysiology of COVID infection and to open the way for new diagnostic, prognostic and therapeutic strategies against SARS CoV-2 .

The secondary objectives are

Monitoring of viral replication of SARS-CoV-2 in the blood and respiratory tract in infected patients
Monitoring of the humoral and cellular response directed against SARS-CoV-2
Identification of factors leading to significant and / or prolonged viral replication of SARS-CoV-2 in the blood or respiratory samples
Evaluation of the benefit of possible treatments implemented following the diagnosis of SARS-CoV-2 infection
Exploration of the B and T immune repertoire sequences targeting SARS-CoV-2 in infected patients
Typing of the HLA system in infected patients

ReferenceCitation: Gallais F, Velay A, Nazon C, Wendling MJ, Partisani M, Sibilia J, Candon S, Fafi-Kremer S. Intrafamilial Exposure to SARS-CoV-2 Associated with Cellular Immune Response without Seroconversion, France. Emerg Infect Dis. 2021 Jan;27(1). doi: 10.3201/eid2701.203611. Epub 2020 Dec 1.


title: Psychological Impact of the Hospitalization of a Family Member in Intensive Care for Covid-19 Infection

acronym: Familles-COVID

summary:
The hospitalization of a patient in intensive care is a traumatic experience for his family members.

With the current COVID-19 epidemic, in view of the high risk of contamination, drastic measures to limit the transmission are necessary, with the creation of spaces dedicated to the care of Covid+ patients, and family are not allowed to visit.

At the Strasbourg University Hospital, visits were prohibited from the start of the epidemic. Information concerning the patient's state of health is therefore delivered to families by telephone, on call by the healthcare team only, every day before 6 p.m. or in the event of a serious event at any time.

The primary purpose of this project is to assess the psychological impact of the hospitalization of a loved one in intensive care for Covid-19 infection at 3 months post-hospitalization, in a context of pandemic with ban on visits.

ReferenceCitation: Cattelan J, Castellano S, Merdji H, Audusseau J, Claude B, Feuillassier L, Cunat S, Astrié M, Aquin C, Buis G, Gehant E, Granier A, Kercha H, Le Guillou C, Martin G, Roulot K, Meziani F, Putois O, Helms J. Psychological effects of remote-only communication among reference persons of ICU patients during COVID-19 pandemic. J Intensive Care. 2021 Jan 9;9(1):5. doi: 10.1186/s40560-020-00520-w.


title: Characterization of the Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in the Intensive Care Unit

summary:
Renal damage in patients hospitalized for ARDS in the ICU can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. Frequently observed abnormalities of cioagumation may also have a potential impact on renal structures, particularly glomerular capillaries.

The researchers wish to characterize and phenotype the renal impairment of patients hospitalized in intensive care with tables of severe Covid19 infections in ARDS: clinical, biological and histological (by performing post-mortem biopsies).

Translated with www.DeepL.com/Translator (free version)

ReferenceCitation: Beloncle F, Studer A, Seegers V, Richard JC, Desprez C, Fage N, Merdji H, Pavlovsky B, Helms J, Cunat S, Mortaza S, Demiselle J, Brochard L, Mercat A, Meziani F. Longitudinal changes in compliance, oxygenation and ventilatory ratio in COVID-19 versus non-COVID-19 pulmonary acute respiratory distress syndrome. Crit Care. 2021 Jul 15;25(1):248. doi: 10.1186/s13054-021-03665-8.


title: Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes : MIRE Trial

acronym: MIRE

summary:
Cystic fibrosis related diabetes (CFRD) is a major factor of morbidity and mortality at all disease stages. Insulin deficiency has serious clinical consequences by increasing malnutrition, since protein and lipid catabolism is accelerated in chronic infections. Traditionally, insulin is injected before a meal. Yet, in these patients with highly varied and often staggered nutritional intakes, insulin injection can result in an increased risk of postprandial hypoglycaemia, all the more so as CF patients exhibit decreased glucagon secretion.

Recent progress in the development of new insulins mimicking the physiological secretion more closely has led to ultra-fast insulins (fast aspart), allowing for postprandial hyperglycaemia to be better controlled. In Type 1 diabetics treated with basal-bolus, faster-acting aspart insulin injected after a meal enabled metabolic control comparable to injection of aspart insulin prior to the meal. Fast apart insulin is of particular interest with regard to CFRD, wherein postprandial hyperglycaemia occurs early. In CFRD, these insulins are likewise advantageous in that they can be injected after the meal, thus permitting more flexibility in patients with highly varied diets. Moreover, the insulin dose can be adapted depending on dietary intake, thus preventing hypoglycaemia secondary to highly-varied carbohydrate intakes. Due to its flexibility, this insulin therapy is likely to be better accepted by patients with cystic fibrosis.


title: Evaluation of a New Predictive Test of Preterm Birth in Case of Threatened Preterm Labor

acronym: PREMAQUICK

summary:
Threatened preterm labor (TPL) is defined by cervical changes and regular and painful uterine contractions occurring between 24 and 36 + 6 weeks of gestation that may or may not lead to premature labor and delivery. There is no reliable way to predict preterm delivery.

The study's hypothesis is that the Premaquick® test can improve the prediction of preterm delivery.

The investigators also want to compare this test with the Partosure® (Placental alpha microglobulin-1) test.


title: Automated Quantification of Radiological Pulmonary Involvement in Acute Respiratory Failure

summary:
Acute respiratory failure (ARF) is a common condition and a common reason for urgent medical consultation. Assessing the extent of respiratory impairment is important to improve the management of patients with ARF. When Acute respiratory failure is caused by pathology of the pulmonary parenchyma, quantification of pulmonary radiographic involvement may be a component of the initial assessment of severity. This radiographic quantification would only be usable in clinical routine if it can be automated and provide a real-time result.

The objective of this work is to assess the feasibility of an automated technique for quantifying radiological lung damage in situations of known or potential ARF.

location_facility: Service d' Anesthésie Réanimation Chirurgicale


title: Incidence of Acute Pulmonary Embolism in Covid-19 Patients on CT Angiography and Relationship to D-dimer Levels

acronym: COVID-APE

summary:
Reports of acute pulmonary embolism (APE) associated with COVID-19 have emerged in the literature. For example, Chen et al. described 25 pulmonary CT angiograms examinations from 1008 COVID-19 patients; 10 were positive for pulmonary embolism mostly as segmental or sub-segmental APE. Case reports of APE in Covid-19 patients have been published. Cui et al. found an incidence of deep venous thrombosis in intensive care unit (ICU) patients with severe Covid-19 pneumonia near to 25% (20/81), however without any correlation with potential APE.

Despite these initial reports, it is not clear whether APE is more frequent in Covid-19 patients or if the association is just random. In favor of the former, D-dimer levels have been reported as elevated in patients with Covid-19 by two studies, and it has been suggested an independent association between the severity of the disease and the level of D-dimer. Finally, Tang et al. showed that anticoagulant therapy is associated with a decreased mortality at Day-28 in severe Covid-19 patients, in favor of a possible associated coagulopathy. The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography.

The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography.


title: Imaging Analysis of COVID-19 + Patients With Abnormal Neurological Examination

summary: To describe the radiological presentation of brain abnormalities in COVID-19 + patients

ReferenceCitation: Kremer S, Lersy F, Anheim M, Merdji H, Schenck M, Oesterlé H, Bolognini F, Messie J, Khalil A, Gaudemer A, Carré S, Alleg M, Lecocq C, Schmitt E, Anxionnat R, Zhu F, Jager L, Nesser P, Mba YT, Hmeydia G, Benzakoun J, Oppenheim C, Ferré JC, Maamar A, Carsin-Nicol B, Comby PO, Ricolfi F, Thouant P, Boutet C, Fabre X, Forestier G, de Beaurepaire I, Bornet G, Desal H, Boulouis G, Berge J, Kazémi A, Pyatigorskaya N, Lecler A, Saleme S, Edjlali-Goujon M, Kerleroux B, Constans JM, Zorn PE, Mathieu M, Baloglu S, Ardellier FD, Willaume T, Brisset JC, Caillard S, Collange O, Mertes PM, Schneider F, Fafi-Kremer S, Ohana M, Meziani F, Meyer N, Helms J, Cotton F. Neurologic and neuroimaging findings in patients with COVID-19: A retrospective multicenter study. Neurology. 2020 Sep 29;95(13):e1868-e1882. doi: 10.1212/WNL.0000000000010112. Epub 2020 Jul 17.


title: Efficacy of an Online Cognitive Behavioral Therapy (CBT) Programme Aiming at Reducing the Stress of Health Workers Involved in the Care of Patients During the Covid-19 Epidemic: a Randomized-controlled Trial

acronym: REST

summary: Some preliminary epidemiological research conduct in China in health workers involved in the care of Covid-19 patients has shown high rates of depression (>50%), generalized anxiety disorder (>44%), insomnia (>36%) and stress symptoms (>73%), which negatively impact their well-being as well as their ability to work effectively . These rates were observed during the epidemic peak, but they can also have a long-term mental health effect, both individually, but also in a systemic manner , similar to what has been reported relative to the SARS-CoV-1 . Cognitive behavioral therapy (CBT) is recognized as an effective treatment for stress-reduction, as well as for the prevention of multiple mental health problems in at-risk individuals . Moreover, CBT has been found to be effective in brief online formats , which could make it feasible during the current Covid-19 epidemic. To our knowledge, there are no online CBT programmes targeting stress problems in health workers involved in the care of patients during the current epidemic context. The aim of our study is to evaluate the efficacy of the online CBT programme we have developped to specifically address immediate perceived stress in health workers, as well as the prevention of mental health problems at 3- and 6-months follow-up

ReferenceCitation: Weiner L, Berna F, Nourry N, Severac F, Vidailhet P, Mengin AC. Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial. Trials. 2020 Oct 21;21(1):870. doi: 10.1186/s13063-020-04772-7.


title: STUDY ECMO-COVID-19 : Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19

summary: Describe COVID-19 patients who are receiving ECMO-VV respiratory replacement and what happens to them.


title: Effects of the Magnetic Transcranial Stimulation (TMS) in Healthy Volunteers

summary: The aim of the study is to check the role of the cerebellum in time prediction in healthy volunteers, by means of magnetic transcranial stimulation targeted on the cerebellum, and recording of behavioural measures indexing time prediction


title: Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg

acronym: NASH-SPE

summary: The aim of the present study is to assess, by using a simple algorithm combining FIB-4 and Fibroscan, the prevalence of NASH with advanced fibrosis in outpatients followed in various hospital specialty clinics other than hepato/gastroenterology and to examine risk factors associated with this condition. The prevalence of NASH will be investigated among 6 cohorts of outpatients followed in different hospital specialty clinics at Hôpitaux Universitaires de Strasbourg.


title: Quantitative Diaphragmatic Ultrasound Evaluation in Pleural Effusions

acronym: ADD-Echo

summary:
Malignant pleural effusions cause breathlessness and impairs quality of life. Thoracocentesis is frequently used to relieve breathlessness.

The severity of breathlessness correlates poorly with the size of the effusion. Symptom reduction from fluid drainage varies between patients. No predictors exist to identify which patients benefits more of pleural effusion. One study suggests that a inverted hemidiaphramatic (inverted shape) is associated with a greater dyspnea improvement. Others parameters of diaphragmatic motion have not been studied till now.

This study aims to evaluate the feasability of diaphragmatic ultrasound evaluation (shape by B-mode, quiet, deep inspiratory motion and sniff diaphragm motion by TM-mode) before and after pleural drainage.

Primary end point aims to evaluate the feasability of deep breath inspiratory excursion in ipsilateral side of thoracocentesis by anterior subcostal approach in the mid-clavicular line in the right in patients with malignant pleural effusions. The liver or spleen was identified as a window for each hemidiaphragm.

Secondary end points aim to evaluate

the feasability of quiet breath inspiratory motion ,
the feasability of sniff diaphragm motion
the feasability of deep breath inspiratory motion by posterior method
the comparaison of feasibility with different types of breathing and or anterior or posterior approach for ultrasound
the feasability of the shape by B-mode.
the correlation between the change of the shape of ipsilateral diaphragm and the evolution of dyspnea, before and after thoracocentesis.
the correlation between the volume of pleural effusion evacuated and the evolution of dyspnea, before and after thoracocentesis.
the comparaison of the changing of dyspnea in patients with noticed paradoxal movement of diaphragm before thoracocentesis and patients with persistent paradoxal/or non persistant paradoxal movement of ipsilateral hémidiaphragm.
the correlation between the feasability of diaphragmatic ultrasound motion measurments evaluation and the body mass index.
the comparaison between the different diaphragmatic ultrsound times for anterior or posterior approach.


title: Intravenous Immunoglobulins for Prevention of BKV Infection in Kidney Transplant Recipients According to BKV Genotype-specific Neutralizing Antibody Titers at the Day of Transplantation: A Multicenter Study

acronym: BKANIG

summary:
BK virus-associated nephropathy (BKVAN), a consequence of the strong immunosuppressive therapy given after kidney transplantation (KT), represents a growing medical problem in the KT setting. BKV replication occurs in 30-50% of recipients with progression to BKVAN in up to 10% of patients which ultimately leads to graft dysfunction and loss. Furthermore, early BKV replication after transplantation increases the risk of late acute rejection. At present, there are no BKV-specific antiviral therapies available. The current management of BKVAN relies on preemptive adaptation of immunosuppression according to viral load monitoring. However, due to its delayed nature, this empirical strategy is not always successful, and can increase the risk of donor specific antibodies, graft rejection and death. In a prospective longitudinal study, the investigators have demonstrated that the amount and kinetics of BKV genotype-specific neutralizing antibody (NAb) titers influence BKV disease severity after KT; and defined a cutoff NAb titer value of 4 log10 that allows stratification of recipients into lower and higher BKV disease risk groups prior to KT. Furthermore, our data on donor/recipient pairs provide support for the view reported by recent studies that early BKV replication in kidney transplant recipients is of donor origin. These data support the potential benefit of administering NAbs as a preventive strategy against BKV infection. The investigators and others have demonstrated the presence of high titers of BKV NAbs in commercial intravenous immunoglobulins (IVIG). The investigators further evaluated the titer of BKV NAbs in plasma samples of transplant recipients after administration of IVIG. The investigators demonstrated that all patients show an increase of NAb titers in plasma after IVIG administration. The aim of the investigators study is to investigate the efficacy of IVIG for prevention of BKV viremia after KT according to pre-transplant BKV genotype-specific NAb titers against the donor's BKV strain. The study is a multicentric prospective randomized open trial evaluating the impact of administration of IVIG for prevention of BKV viremia compared to no specific treatment in kidney transplant recipients harboring neutralizing antibody titers (NAbs) ≤ 4log10 against the BKV donor's genotype. Recipients harboring BKV NAb titer ≤ 4log10 against the BKV genotype of their matched donor and negative or non-detectable BKV load in blood at day of transplantation will be randomized to receive (experimental group) or not (control group) IVIG treatment. In the experimental group, patients will receive a single dose of IVIG at day 10+/- 4 days, day 41 +/- 7 days and day 62 +/- 7 days. The dose of IVIG is defined according the donor BKV genotype: genotype I: 0.4 g/Kg/day; genotype II and IV: 1g/kg/day.

The incidence of BKV viremia (> 4 log10 copies/mL) 6 months after transplantation will be evaluated and compared between the two groups.


title: Study of the Role of Interferon αon the Endothelial Dysfunction During Septic Shock

acronym: INTERSEP

summary:
Septic shock is the most severe form of a bacterial infection, affecting 24 million patients per year worldwide, with a high mortality (> 30%).

Septic shock is defined by an acute circulatory failure, with low blood pressure and insufficient oxygen supply to organs. This circulatory failure is related to vascular damages, in which the endothelial vascular tissue is impaired by inflammatory mechanisms, with release of circulating endothelial cells in the blood.

Therefore, modulating inflammation on the vascular endothelial tissue could be a therapeutic strategy, and the investigators focus on the role of the type I interferons on the endothelial tissue because of the demonstrated role of type I interferons during septic shock.

Thus the investigators proceed to an observational study, in which the primary purpose will be to show a higher expression of type I interferon receptors on circulating endothelial cells in patients with septic shock compared to control subjects.

Concerning secondary purposes, the investigators will record mortality at d3, d7 and d28, perform assays about types I, II and III interferons in plasma, and test anti-interferon on endothelial cells ex vivo


title: Effect of Azithromycin on Failure Proportion of Severe Periodontitis Non-surgical Treatment

acronym: AZITHROPARO

summary:
Primary purpose: Evaluate the effect of azithromycin on failure proportion of severe chronic periodontitis non-surgical treatment; failure characterized by the persistence of at least one periodontal pocket> 5mm at 6 months

Secondary purpose:

Evaluate the effect of azithromycin on the persistence of pathological periodontal pockets > 5mm during non-surgical treatment of severe chronic periodontitis at 3 months and 6 months
Evaluate the effect of azithromycin on the changes of clinical signs, periopathogen levels, expression of macrolides resistance genes, and expression of antimicrobial peptides (PAMs) during treatment of severe chronic periodontitis at 3 months and 6 months
Assess therapeutic observance and side effects of antibiotic treatment
Assess at 3 and 6 months the potential interactions of local, bacterial (periopathogen and resistance gene) clinical factors, and host defense (PAMs) with the effect of azithromycin, on failure proportion of severe chronic periodontitis non-surgical treatment


title: Studying the Association Between Folic Acid Deficiency and Social Isolation for Elderly Patients

summary:
Social isolation among elderly people is a frequent and major determinant for health.

The risk of premature death is 2 to 5 time higher for socially isolated people, similarly for morbidity, duration of healing and complications rate.

Denutrition is also frequent for elderly people with potentially serious consequences. Vitamin deficiency, especially in B9 and B12 vitamins, are often associated with denutrition among elderly people.

Folic acid (vitamin B9) is not influenced by inflammation and folic acid income are necessarily exogene. Vitamin B9 is provided by fresh fruits and vegetables, and giblets.

The investigators observed a high prevalence in folic acid deficiency for socially isolated elderly patients. The investigators made the hypothesis that a folic acid defiency is associated with social isolation for elderly people.

The primary purpose is the study of the association between folic acid deficiency (measured by dosing of plasma concentration of vitamin B9) and social isolation evaluated by Lubben Social Network Scale in 6 questions.

The secondary purposes are the study of the correlation between folic acid deficiency and social conditions, nutritional status, biological data, poly pharmacy, cognitive functions, dependency and length of stay at hospital.


title: Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients

acronym: BKV-Pneumo

summary:
BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time.

The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.


title: Clinicopathological Assessment of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region

summary:
Pancreatic Neuroendocrine tumors and carcinomas (pNET) see the last year their incidence and prevalence going up. On the basis of their grade of differentiation and proliferation ratio measured Ki67 staining, there are divided into 3 grade groups : Grade 1 with Ki67 between 1 and 3%, Grade 2 between 3 and 20% and well-differentiated neuroendocrine grade tumors 3 with KI67 greater than 20%, so undifferentiated carcinomas.

pNET is a heterogenous group of tumors with variable prognosis. The aim of this study is to identify the prognostic factors in this population, as well the place of neutrophil-to-lymphocyte ratio as a prognostic marker. The primary endpoint is the description of clinic and pathological parameters of patients from Alsace. The secondary endpoints are the identification of prognostic factors in this population


title: Multicenter Descriptive Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

summary:
The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery.

The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months.

The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.

ReferenceCitation: Charleux-Muller D, Hurel R, Fabacher T, Brigand C, Rohr S, Manfredelli S, Passot G, Ortega-Deballon P, Dubuisson V, Renard Y, Romain B. Slowly absorbable mesh in contaminated incisional hernia repair: results of a French multicenter study. Hernia. 2021 Aug;25(4):1051-1059. doi: 10.1007/s10029-020-02366-5. Epub 2021 Jan 25.

location_facility: Service de chirurgie générale et digestive


title: Use of Probabilist Broad-spectrum β-lactam for One-stage Replacement of Infected Hip / Knee Arthroplasties: Retrospective Analysis in a Center of Reference

acronym: β-SEPTIC

summary:
According to the official recommendations, infected prosthesis can be surgically treated by one or two-stage replacement. In Strasbourg, the investigators only perform one-stage surgery, which means that the new materiel is put directly into an infected site. To prevent re-infection, probabilist antibiotherapy has to be started the earlier as possible and to have the larger specter as possible. Official recommendations don't specify the best choice of antibiotherapy and let prescriptors make choice, according to the local epidemiology and patient's history.

In Strasbourg, the investigators systematically start an antibiotic against cocci gram positive: daptomycin. Sometimes, the investigators add tazocillin, a broad-spectrum β-lactam against bacillus gram negative. To determine if the investigators use the second one, they focalized on the presence of fistula or not. Indeed, enterobacteriae from gastro-intestinal tractus are also found on the skin and can move to the peri-prosthetic site if a fistula is created. The major disadvantage of this board-spectrum antibiotic is the selection and creation of resistant bacteriae, which can be responsible of failure, re-infection, or just spreading on the environnement.

The primary purpose is to evaluate retrospectively the prescription of tazocillin, judging it's necessity thanks to antibiograms performed on samples taken during surgery. The aim is to evaluate if the criteria " fistula or not " is a good one to guide the prescription of board-spectrum β-lactam.

Secondary purposes are to find the etiology of failures ( bacteriological failure or re-infection with a new pathogen), evaluate the apparition of multi-drug resistant bacteriae and infections they are responsible for, looking for others criterias which could help the investigators to choose the probablist antibiotherapy

location_facility: Service de Chirurgie Orthopédique Septique


title: Integration of Palliative Care in an Oncology and Hematology Unit : a Retrospective Monocentric Study

summary:
The main goal of this study is to assess retrospectively the integration of Palliative Care in an oncology and hematology unit. The investigators will study the last six month of life on advanced cancer patients and retrieve data from their medical file to obtain criterias of quality of care and integration of palliative care in this population.

Those criterias have been used before in other setting (Earle Criterias, ESMO Recommendations) and The investigators will compare our data to existing publications.

They also hope to see if it is retrospectively possible to assess the probability of death using the Pronopall score. This will help them asses if aggressive end of life care could have been avoided using the Pronopall Score


title: Analysis of the Capnography Curve Can Allow the Discrimination of Obstructive Patients - Modeling the Capnography Curve

acronym: CAPNOBST

summary:
Obstructive respiratory diseases such as asthma or COPD are a common reason for emergency room visits. Currently, nasal gill capnography and oxygen saturation measurement (SpO2) are the only two non-invasive means of continuously monitoring a respiratory pathology. To date, Respiratory Functional Explorations (CFE) and more particularly spirometry, are considered as the reference examinations for the diagnosis or monitoring of asthma or COPD. However, physical and physical constraints make their use almost impossible in the context of the emergency with patients presenting to emergencies in respiratory distress, often require oxygen therapy or even non-invasive ventilation. Only pulmonary auscultation can make the diagnosis of acute decompensation of obstructive pathology. This technique is qualitative and imprecise, sometimes leading to a diagnostic uncertainty resulting in delay in taking charge and inappropriate therapy.

Studies have shown a change in the capnography curve in obstructive airway disorder and a strong correlation between some capnography parameters and spirometry parameters such as the Tiffeneau ratio (FEV1 / FVC), suggesting capnography as a simple and effective technique for the diagnosis of obstructive syndrome of patients in emergencies.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study

acronym: PMSF-PVC

summary:
Acute renal failure is a frequent and severe postoperative complication of cardiac surgery performed under extracorporeal circulation.

It is an independent risk factor for mortality and significantly increases the length of hospital stay.

The origin of renal insufficiency after extracorporeal circulation is multifactorial (long duration of extracorporeal circulation, hemodynamic instability per and post-extracorporeal circulation, prolonged hypotension, transfusion ...).

Nevertheless, an entirely different pathophysiological mechanism, though not recent, is less often mentioned but shows renewed interest. This is the concept of renal venous congestion which may be responsible for impaired renal function in the absence of cardiac dysfunction. Based on Guyton's circulatory model, the investigators approach this systemic venous hypertension through the measurement of the Pmsf-PVC gradient.


title: Impact of Adult With Attention Deficit / Hyperactivity Disorder on Professional Activity, a Prospective Cohort Study

acronym: WORKTDA

summary:
Attention Deficit/Hyperactivity Disorder (ADHD), which is common and well known in children, persists into adulthood in more than 60% of cases, with significant impact on quality of life. Professional domain is particularly impaired.

The investigators hypothesize that ADHD symptoms causes professional difficulties, on the emotional, cognitive, physical and relational levels.

The main objective of this study is to better characterize these professional difficulties at to follow-up these difficulties after one year. Difficulties will be assessed by questionnaires and semi-directive interview.

The secondary objective is to determine what factors modulate these difficulties and what compensation strategies are implemented to address the patients.


title: Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.

summary:
After birth, the perineum has to be trained in order to recover its functions.

This study is designed to assess the quality of life evolution with the EMY connected device.

The secondary purposes are to evaluate patient compliance to the EMY probe, to observe the evolution of urine scores over the duration of the trial in order to consider a comparative study thereafter, and to evaluate the interest of using the EMY connected perineal probe in the context of stress urinary incontinence.


title: Analysis of Sexual Risks in Prep (Pre-exposure Prophylaxis) Users Followed-up in a University Care Centre (Le Trait d'Union)

acronym: PREP

summary:
Primary purpose of the study: to describe sexual behavior of Prep users, whatever mode of intake, ie continuous or on-demand; it has been shown in some studies, an increase of sexual risks in Prep users, and therefore an similar increase of STIs (sexually transmitted diseases); using a self-questionnaire, we'd like to evaluate sexual behavior before, and 6 months after, starting Prep.

Secondary purposes: to describe medical characteristics of Prep users (past medical condition, demographic characteristics, vaccinations, kidney function, serological results, urine and anal/pharyngeal swabs), clinical and biological Prep safety, STIs occurrence, and antibiotic prescriptions, continuous or on-demand intake, Prep indication.


title: Interest of High-throughput Sequencing of RNAs for the Diagnosis of Heterogeneous Genetic Diseases

summary:
The advent of high throughput genomic DNA sequencing has led to major advances in the diagnosis of genetic diseases of heterogeneous origin. Thus, our hospital laboratory has developed in recent years several diagnostic tests based on the targeted sequencing of coding sequences of gene panels (from about twenty genes for DNA repair diseases to nearly five hundred genes for the intellectual disability). These targeted analyzes, carried out by capture, have thus solved 25 to 80% of the cases according to the indications, without allowing the diagnosis of the totality of the patients.

For these negative cases, the search for mutations in the coding sequences was then extended to Whole Exome Sequencing, thus providing several additional diagnoses.

Patients still remain without diagnosis after this exome study. These could be complex cases of genetic or even non-genetic origin, but also monogenic pathologies linked to mutations that are not identifiable by coding sequence analyzes, and especially affecting messenger RNAs.


title: Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage

summary: To evaluate the regression characteristics of this Acoustic Neuroma population using volumetric data To study the relationship between regression and clinical characteristics including tinnitus, dizziness, hearing loss, and the intrinsic characteristics of the patients.

location_facility: Service D'Orl Et de Chirurgie Cervico-Faciale


title: Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

acronym: HemostVAD

summary:
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.

The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.


title: Comparison of Bonding Failure Rates of Fixed Mandibular Lingual Retainers in a French Sample Aged 11 or Older Comparing Prior Enamel Sandblasting With Conventional Pumice Polishing

acronym: CONTORTHO

summary:
At the completion of orthodontic treatment, the position of the mandibular canines and incisors is being maintained on a routine basis by bonding a multi-braided wire retainer onto their lingual surfaces. One of the adverse events that might occur with time is the debonding of the wire from one or several lower anterior teeth . This event which can unfortunately get unnoticed by the patient can lead to unwanted tooth displacement. When the practionner detects such a debonding, he has to go through a laborious and lengthy procedure to rebond the wire. When on the other hand the patient notices himself such a debonding, he is to call in emergency his practitioner to get his retainer repaired. This leads to emergency visits that are susceptible to affect adversely his timetable. The prevalence of these bonding failures is estimated at 37% at 18 month follow-ups. It has been reported that with prior enamel sandblasting, bonding failure rate is reduced to 8% at 24 month follow-ups. However, no study has reported yet the debonding rate of lower fixed, comparing wires that have been bonded after prior enamel pumicing to those that were put in place after prior enamel sandblasting.

The expected result of this trial is a significantly decrease in bonding failure rate of mandibular lingual retainer when enamel surfaces are initially sandblasted compared to the ones which are pumiced. This reduction would lower the risk of unwanted tooth movement of mandibular incisors and canines after orthodontic treatment and decrease the number of emergency appointments for the patient and the practitioner.

location_facility: Pôle de Médecine et Chirurgie Bucco-Dentaires


title: Neural Mechanisms Underlying Attention Lapses in Adult Attention Deficit Disorder: Towards a Better Clinical Diagnosis

acronym: AttLapse-TDA

summary:
ADHD is a common disorder, leading to a significant disability that often persists in adulthood. ADHD is characterized by attentional disturbances that are difficult to asses with standard neuropsychological tests.

Attention tends to stall after a certain time of fatigue (i.e. an attention lapse). The aim of this study is to study the electroencephalographic (EEG) characteristics of these attention lapses in a sustained attention task, comparing ADHD patients with healthy subjects.

location_facility: Hôpital Civil - service de Psychiatrie 2


title: TREatment of Uretral STRICTure With Self-catheterization : Tolerance Evaluation

acronym: TRESTRICTT

summary: Urethral stenosis has a recurrent character. The clean intermittent self-catheterization can be proposed for repeat stenosis. This study seeks to explore the tolerance of clean intermittent self-catheterization in the evolution of urethral stenosis after urethrotomy.


title: Comparison of Cardiorespiratory Responses to Treadmill Running at Different Slopes in Well-trained Athletes

summary: The purpose of this study is: i) to determine if maximal oxygen uptake in downhill running is significantly different versus flat or uphill running, and ii) to compare cardiorespiratory and muscle fatigue responses to uphill vs flat and downhill running at similar running velocity and similar metabolic power. The investigators hypothesized that maximal oxygen uptake will be lower in downhill running. The investigators also anticipate attenuated cardiorespiratory and muscle fatigue responses to downhill running when compared to flat or uphill running performed at similar velocity but not when the comparison is done at similar metabolic power.

primary_purpose: Health Services Research


title: Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit

acronym: EchoRéaPed

summary:
In pediatric intensive care unit of Strasbourg, two exams are easily used for pleural and pulmonary diagnosis : chest radiography, which is the "historic" and reference exam, and commonly systematically the lung ultrasound.

However, chest radiography produces radiation and is less accessible in our unit, because it depends on the radiology department.

On the opposite, the lung ultrasound doesn't produce radiation, is simple, reliable, easily accessible (the investigators have two ultrasound systems in the unit), and simply and quickly achievable at the patient's bedside, including for less experienced operator.

We will evaluate the diagnostic performances of lung ultrasound and chest radiography for pleural and pulmonary diagnosis in pediatric intensive care unit.

intervention_type: Radiation


title: National Multicenter Retrospective Study: PEComas: Natural History and Prognostic

acronym: PEComas

summary:
Perivascular epithelioid cell tumors are rare and characterized by the expression of myomelanocytic markers. They belong to a complex tumor family that includes angiomyolipomas, lymphangioleiomyomatosis and other soft-tissue tumors. Given their rarity, the natural history of pecomas is not yet understood, and a comprehensive classification that integrates clinical, pathological and molecular features has not been achieved as of today.

This study is a national multicenter retrospective study to better understand the natural history of PEComas, excluding lymphangioleiomyomatosis and classic triphasic angiomyolipomas.

The primary purpose is the identification of prognostic markers impacting the relapse. Secondaries purposes are to identify prognostic markers impacting the overall survival and to have a better understanding of natural history


title: Clinical Impact of 16S rDNA PCR, a Monocentric Retrospective Study

summary:
The main objective of this study is to evaluate the impact of a positive 16S rDNA PCR in various sites on patient's management.

The secondary objectives of the protocol are:

to evaluate bacterial identification performance
to evaluate the effect of previous antibiotic therapy
to analyze the management of discordant results between 16S PCR and culture identification

location_facility: Service de Maladies Infectieuses et Tropicales


title: Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia: A Randomized Controlled Trial

acronym: ERIS

summary:
Primary purpose:

Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia.

Primary outcomes:

Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS.

Secondary purposes:

improvement of quality of life
study of MRI performance to predict pudendal nerve entrapment topography
show the feasibility and safety of robotic pudendal nerve decompression

status: Terminated


title: SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy

acronym: SERRATHOR

summary:
Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS.

Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine.

The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.


title: Contribution of PRF (Platelet Rich Fibrin) in the Biological Functionalization of Prothetic Patch Closure : in Vitro Study

acronym: HECODIAP

summary: Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.


title: Histological and Imaging Assessment of the Structural Characteristics of the Femoro-popliteal Arterial Segment

summary:
The femoro-popliteal arterial segment is one of the most frequent locations for atherosclerosis. Its management is mainly endovascular (standard and coated-balloon angioplasty, stenting).

However, the structural features of the atherosclerotic disease in regards to patient's risk factors and past medical and surgical histories are not well studied. Furthermore, the histological analysis of the femoro-popliteal arterial segment is rare in the literature, and made difficult mostly because of the length of this segment.

There is a clinical need for better understanding of atherosclerotic lesions in this location, with as further goal, a better management of this disease.


title: Lung Nodule Characterization by Artificial Intelligence Techniques

acronym: CARANOD-IA

summary:
Management of incidental lung nodule is difficult and mainly based on simple morphometric characteristics such as maximum size and shape. Radiomics could play a role in simplifying this management by orientating towards a benign or a malignant origin, by comparing advanced characteristics to a large database of lung nodules.

The primary purpose is to evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography.

The secondary objectives are:

to evaluate the variation in the performances of the software based on various technical aspects of the CT, such as radiation dose, reconstruction algorithm, type of scanner,…
to compare the performances of this software to those of expert readers,
to analyze the potential impact of this software on patient's management.


title: Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light

acronym: DERMAPOL

summary:
Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions.

This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties.

This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.