title: Impact of the Central Blood Pressure Level in Cerebral Metabolic Aging: a 18F-FDG PET Study.

acronym: PACTEP

summary:
Cerebral glycolytic metabolism can be quantified by quantitative analysis of 18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET). This allows to identify neurological diseases at an early stage of functional abnormalities, before any anatomical lesions, and to differentiate them from the "normal" brain aging. Aging mainly leads to atrophy with a decrease in cerebral metabolism in the prefrontal cortex, with consequent deterioration of cognitive processes, in particular executive functions (5).

In a population of 92 "control" subjects, investigators have already quantified the importance of the aging in frontal cortex hypometabolism. These patients were referred for a 18F-FDG PET in the follow-up of lymphoma considered to be in complete remission (PET without cerebral step), without any chemoradiotherapy within 2 months and with normal neuropsychological tests (Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Battery FAB).

However, cerebral aging can be "accelerated" by vascular risk factors, including increased central blood pressure, as investigators have recently reported in a pilot study involving elderly patients. This central pressure, which is directly linked to the cerebral micro-vascularization, can be easily measured by applanation tonometry. In this pilot study, investigators showed that a central pulse pressure equal or greater than 50 mmHg was associated with a significant frontal hypometabolism in elderly patients. This confirmed, at a stage of pre-clinical remodeling, the worse prognostic significance for this criterion, as reported in large epidemiological studies (increased risk of stroke and cardiac vascular events).

However, it is not yet known whether the level of central blood pressure interfere with the brain metabolism of younger subjects, especially with regard to aging observed throughout life. If this hypothesis is confirmed, preventive therapeutic strategies for accelerated aging, could thus integrate the monitoring of central pressure and cerebral metabolism.

The objective of this study is to determine, in a population of control subjects and on a larger scale, the impact of central blood pressure on brain metabolic aging , by using 18F-FDG PET.

status: Active, not recruiting


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.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Les Hôpitaux Universitaires de Strasbourg

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Ongoing


title: Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock : a Randomised, Opened, Cross-over Study. Heart SHOCK-NORDOB Study

acronym: SHOCK-NORDOB

summary:
Cardiogenic shock is a frequent cause of admission and death in the intensive care unit.

Mortality is about 50%. Once the etiologic treatment has been done, for instance coronary revascularization, management of the shock state is the cornerstone of the treatment. Norepinephrine is the first-line vasopressor therapy because of its minor effect on heart rhythm. Morever norepinephrine is a inotrope. In a previous study, we demonstrated that increasing the norepinephrine dose increases cardiac index, cardiac power index, SVO2 and tissue perfusion without acceleration of heart rate. Nevertheless, dobutamine remains the first-line inotropic treatment. Dobutamine has a positive chronotropic effect that might cause higher myocardial oxygen consumption. As a result, combination of vasopressor / inotrope is still controversial.

The aim of this study was to compare hemodynamics and metabolics effects of 2 treatments strategies (norepinephrine dose increasing or addition of dobutamine) in patients with cardiogenic shock and optimised blood pressure level (MAP≥65 mmHg) under norepinephrine treatment.

The secondary objectives were :

To evaluate the efficacy of the treatments on micro- and macrocirculation parameters
To evaluate the tolerance of the treatments
To evaluate the dose and the admistration's kinetics of the treatments

status: Unknown status

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Drug

status_simplified: Unknown


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.

study_start_date_type: Actual

status: Recruiting

time_perspective: Retrospective

location_facility: Strasbourg University Hospitals - Anesthesia-intensive care unit


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).

intervention_type: Procedure


title: Parental Representations of the Impact of the Use of Screens on Their Preschool Children Health and Development. An Opinion Survey of Parents of 1096 2-6-years-old Children

acronym: ECRENFANT

summary:
The main objective of this study was to evaluate the distribution of parental representations concerning the use of screens by preschool children, expressed in qualitative surveys: perceptions of screens as a source of learning, a source of appeasement, a source of behavioral difficulties and a source of reduction in the social interactions of young children.

The hypothesis of this study was the representations expressed in the qualitative studies were the reflection of the opinion of a majority of parents of young children.

status: Completed

study_completion_date_type: Actual

time_perspective: Cross-Sectional

enrollment_type: Actual

status_simplified: Completed


title: Study of Efficacy of Zoledronic Acid in the Management of Osteoporosis in Children With Multiple Disabilities

acronym: ZOMETA

summary:
The main purpose of this study is the evaluation of the efficacy of zoledronic acid on bone density in children with osteoporosis caused by multiple disabilities.

Secondary purposes are:

Description of child population with osteoporosis in the context of motor impairment in Lorraine region
Description of osteoporosis stage (level of bone mineralization and clinical consequences) in children with multiple disabilities
Description of current osteoporosis preventive care
Description of risk factors associated to bone status (drugs)
Evaluation of zoledronic acid treatment on fracture numbers
Evaluation of zoledronic acid on phosphocalcic profile
Description of side effects of zoledronic acid in this indication
Description of treatment effects in the sub-population of children with Rett syndrome.


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.

intervention_type: Other


title: Outcome Children Born After Pregnancy Denial

acronym: DENIGRO

summary:
The objective of this study is to evaluate the impact of denial pregnancy on children's health ( anthropometric data, psychomotor development , disease) at different age of evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age).

The hypothesis is the denial of pregnancy may have repercussions on children's outcome.


title: Consequences of Temporomandibular Disorder on Balance Control

acronym: DAM

summary:
To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.

Parameters will be estimated by measures realized before the therapeutic care of the TMD (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

intervention_type: Diagnostic Test


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

intervention_type: Device


title: Life Quality of Children in Cancer Remission During School Reintegration

acronym: QdV leucémie

summary:
Few data about the evaluation of consequences of past life with cancer on life quality of children in school reintegration are available in literature. Nevertheless, some of these studies show that the reintegration impairs life quality of these children (school difficulties, conflictual relations with peers…). The hypothesis is that children with past life with cancer have more chances to have school integration difficulties with a consequent life quality degradation compared to healthy children.

The main objective of this project is to study the relation between the satisfaction of school reintegration of children in cancer remission and the evolution of life quality in the medium term (after getting back to school). More exactly, it is the question if the satisfaction of school reintegration influences life goals and priorities of these children.

The secondary objective is to study the role of psychological status of these children (anxiety, depressive symptoms) on satisfaction-life quality relation.

A group of children with cancer history sent to ordinary school is compared to a control group of children sent to school in the same conditions (sex and age matched). Data are collected with questionnaires some months to several years after school reintegration and same questionnaires 1 year later.

If the study hypothesis is confirmed, this study will show the necessity of a long term follow up of children in cancer remission and not only medical care, but also psychological and social care, in order to support a better school reintegration.

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.

ReferenceType: derived

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.

family: Muller

full_name: Marie Muller

given: Marie

sequence: first

family: Lefebvre

full_name: François Lefebvre

given: François

sequence: additional

family: Harlay

full_name: Marie-Line Harlay

given: Marie-Line

family: Glady

full_name: Ludovic Glady

given: Ludovic

family: Becker

full_name: Guillaume Becker

given: Guillaume

full_name: Charlotte Muller

given: Charlotte

family: Aberkane

full_name: Ouafaa Aberkane

given: Ouafaa

family: Tawk

full_name: Mira Tawk

given: Mira

family: Julians

full_name: Madoé Julians

given: Madoé

family: Romoli

full_name: Arnaud Romoli

given: Arnaud

family: Hecketsweiler

full_name: Stéphane Hecketsweiler

given: Stéphane

family: Schneider

full_name: Francis Schneider

given: Francis

family: Pottecher

full_name: Julien Pottecher

given: Julien

family: Chamaraux-Tran

full_name: Thiên-Nga Chamaraux-Tran

given: Thiên-Nga

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Laparoscopic Bariatric Surgery: Impact of the Level of Neuromuscular Blockade on Surgical Conditions - Comparison Between Moderate and Deep Neuromuscular Blockade

summary: The purpose of this study is to determine whether deep neuromuscular blockade compared to moderate neuromuscular blockade may improve the surgical conditions in patients undergoing laparoscopic bariatric surgery.

primary_purpose: Supportive Care

ReferenceCitation: Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jul;36(7):486-493. doi: 10.1097/EJA.0000000000000996.

family: Fuchs-Buder

full_name: Thomas Fuchs-Buder

given: Thomas

family: Schmartz

full_name: Denis Schmartz

given: Denis

family: Baumann

full_name: Cédric Baumann

given: Cédric

family: Hilt

full_name: Ludovic Hilt

family: Nomine-Criqui

full_name: Claire Nomine-Criqui

given: Claire

family: Meistelman

full_name: Claude Meistelman

given: Claude

family: Brunaud

full_name: Laurent Brunaud

given: Laurent

journal_name: European Journal of Anaesthesiology

oa_host_type: repository

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

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

version: submittedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health


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.


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: Role of the Renin Angiotensin Aldosterone System and Remodeling of the Matrix Cardiac Extra Cellular in the Mechanisms of Transition to Heart Failure in Abdominal Obesity: Prospective Longitudinal Study R2C2 II

summary: R2C2 study has shown that abdominal obesity is associated with a cardiac and vascular remodelling in healthy volunteers. This remodelling is correlated with renin-angiotensin aldosterone system (RAAS) activation and/or systemic fibrosis. R2C2 II study is designed to confirm the hypothesis that RAAS is associated with an early remodelling and implicated in the transition to cardiac failure in abdominal obesity.

location_facility: CIC-P - INSERM - Institut Lorrain du Cœur et des vaisseaux


title: Comparison of 2 Spa Therapy Protocols in Symptomatic Knee Osteoarthritis : a Randomised Trial

acronym: Nancythermal

summary:
Non-pharmacological treatments are recommended for the management of knee osteoarthritis (EULAR or OARSI recommendations) and some thermal modalities may be effective for relieving symptoms in knee Osteoarthritis. However supporting evidence is limited and nothing is known about the advantage of one modality of thermal therapy over another.

The main objective of the study is to compare the number of patients achieving a composite response criteria associating the minimal clinically important improvement at 6 months, defined as ≥ 19.9 mm on the visual analogue pain scale and/or ≥ 9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery in 2 spa therapy protocols (a "usual protocol" and an "active protocol") in knee osteoarthritis.

The secondary objectives are:

To compare the efficacy of the 2 protocols at 3 months.
To determine the evolution of quality of life and medical care consumption
To describe postural abnormalities
To determine predictive factors to a favourable response at 3 and 6 months


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.


title: Laboratory Effect on Platelet Activity of the First 300 mg Oral Dose Aspirin at the Acute Phase of Cerebral Ischemic Event.

acronym: Aspirin

summary:
Aspirin is the only anti-platelet medication used at the acute phase of ischemic stroke. The investigators would like to study laboratory effect of the first oral 300 mg dose of aspirin, given at hospital, after an ischemic event.

The principal hypothesis is that platelet activity would be able to recover during this day and could lead to ischemic recurrences.

Two blood samples are accomplished. The first 2 hours after aspirin intake and the second 23 hours after. Photometric aggregometry are performed with arachidonic acid and collagen induced platelet aggregation, measure of thromboxan B2 levels and reticular platelets count.


title: Arterial Function and Structure and Evolution of Cognitive Impairment in Elderly Hypertensive Subjects With Subjective Memory Complaints

summary:
In the cross sectional study "Adelahyde 1" which took place between 2001 and 2005, the investigators data suggest that vascular alterations may play a role in the setting of subjective memory complaints.

This longitudinal study (Adelahyde 2) aims to confirm the role of vascular factors in the evolution of cognitive function and dementia.


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.

time_perspective: Other


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.

apc_source: doaj

family: Gallais

full_name: Floriane Gallais

given: Floriane

family: Velay

full_name: Aurélie Velay

given: Aurélie

family: Nazon

full_name: Charlotte Nazon

family: Wendling

full_name: Marie-Josée Wendling

given: Marie-Josée

family: Partisani

full_name: Marialuisa Partisani

given: Marialuisa

family: Sibilia

full_name: Jean Sibilia

given: Jean

family: Candon

full_name: Sophie Candon

given: Sophie

family: Fafi-Kremer

full_name: Samira Fafi-Kremer

given: Samira

currency_apc_doaj: EUR

journal_name: Emerging Infectious Diseases

oa_colors: green diamond

evidence: oa repository (via free pdf)

repository_normalized: medRxiv

repositories:
PubMed Central
medRxiv

publisher: Centers for Disease Control and Prevention (CDC)

publisher_dissemination: Centers for Disease Control

publisher_group: Centers for Disease Control

publisher_normalized: Centers for Disease Control


title: A Phase III Prospective Randomized Comparison of Imatinib at a Dose of 400mg in Combination With Peg-Interferon-alpha2a (Peg-IFNa2a) or Cytarabine (Ara-C)Versus Imatinib at a Dose of 600mg Versus Imatinib a Dose of 400mg for Previously Untreated Chronic Myelogenous Leukemia (CML) in Chronic Phase

acronym: SPIRIT

summary:
To test whether increasing the dose of imatinib or combining it with IFNalpha or ara-C increases the rate of molecular response (as measured by the decrease in BCR-ABL transcripts after 12 months of treatment) in patients with previously untreated CML in chronic phase.

To compare overall survival in a selected arm according to molecular response at 1 year from randomization with the reference arm.

ReferenceCitation: Bruzzoni-Giovanelli H, González JR, Sigaux F, Villoutreix BO, Cayuela JM, Guilhot J, Preudhomme C, Guilhot F, Poyet JL, Rousselot P. Genetic polymorphisms associated with increased risk of developing chronic myelogenous leukemia. Oncotarget. 2015 Nov 3;6(34):36269-77. doi: 10.18632/oncotarget.5915.

apc_source: openAPC

name: Université Paris Diderot, Sorbonne Paris Cité UMRS 1160 INSERM, Paris, France

name: Centre d'Investigations Cliniques 9504 INSERM-AP-HP Hôpital Saint-Louis, Paris, France

family: Bruzzoni-Giovanelli

full_name: Heriberto Bruzzoni-Giovanelli

given: Heriberto

name: Institut Municipal d'Investigació Mèdica (IMIM), Barcelona, Spain

name: CIBER Epidemiología y Salud Pública (CIBERESP), Spain Centre de Recerca en Epidemiologia Ambiental (CREAL), Barcelona, Spain

family: González

full_name: Juan R. González

given: Juan R.

name: Institut Universitaire d'Hématologie, Université Paris Diderot, Sorbonne Paris Cité, Paris, France

family: Sigaux

full_name: François Sigaux

given: François

name: Université Paris Diderot, Sorbonne Paris Cité UMRS 973 Inserm, Paris, France/Inserm, U973, Paris, France

family: Villoutreix

full_name: Bruno O. Villoutreix

given: Bruno O.

name: Laboratoire Central d'Hématologie, Hôpital Saint Louis, Paris, France

name: EA3518, Université Paris Diderot, Sorbonne Paris Cité, Paris, France

family: Cayuela

full_name: Jean Michel Cayuela

given: Jean Michel

name: Inserm CIC 0802, CHU de Poitiers, Poitiers, France

family: Guilhot

full_name: Joëlle Guilhot

given: Joëlle

name: Laboratoire d'Hématologie, Inserm, U837, CHRU, Lille, France/Université de Lille Nord, Institut de Recherche sur le Cancer de Lille, Lille, France

family: Preudhomme

full_name: Claude Preudhomme

full_name: François Guilhot

family: Poyet

full_name: Jean-Luc Poyet

given: Jean-Luc

name: Service d'Hématologie et d'Oncologie, Hôpital Mignot, Université Versailles, Saint-Quentin-en-Yvelines, France

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

journal_name: Oncotarget

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

evidence: oa repository (semantic scholar lookup)

publisher: Impact Journals, LLC

publisher_dissemination: Impact Journals, LLC

publisher_group: Impact Journals, LLC

publisher_normalized: Impact Journals, LLC

ReferenceCitation: Delord M, Rousselot P, Cayuela JM, Sigaux F, Guilhot J, Preudhomme C, Guilhot F, Loiseau P, Raffoux E, Geromin D, Génin E, Calvo F, Bruzzoni-Giovanelli H. High imatinib dose overcomes insufficient response associated with ABCG2 haplotype in chronic myelogenous leukemia patients. Oncotarget. 2013 Oct;4(10):1582-91.

ReferenceCitation: Johnson-Ansah H, Guilhot J, Rousselot P, Rea D, Legros L, Rigal-Huguet F, Nicolini FE, Mahon FX, Preudhomme C, Guilhot F. Tolerability and efficacy of pegylated interferon-α-2a in combination with imatinib for patients with chronic-phase chronic myeloid leukemia. Cancer. 2013 Dec 15;119(24):4284-9. doi: 10.1002/cncr.28328. Epub 2013 Sep 16.

name: Department of Hematology; Cote de Nacre University Medical Center; Caen France

family: Johnson-Ansah

full_name: Hyacinthe Johnson-Ansah

given: Hyacinthe

name: INSERM 0802, Center for Clinical Investigations; University Hospital of Poitiers; Poitiers France

full_name: Joelle Guilhot

given: Joelle

name: Hematology and Oncology Service; André Mignot University Hospital Versailles Saint Quentin en Yvelines; Le Chesnay France

name: Department of Hematology; Saint Louis Hospital; Paris France

name: Hematology Service; Archet Hospital; Nice France

name: Hematology Service; Purpan Hospital; Toulouse France

name: Department of Hematology; Edouard Herriot Hospital; Lyon France

name: 1NSERM U876; Victor Segalen University; Bordeaux France

name: Hematology Laboratory; Center for Biologic Pathology; Lille France

ReferenceCitation: Preudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Rea D, Jourdan E, Allard C, Delmer A, Rousselot P, Legros L, Berger M, Corm S, Etienne G, Roche-Lestienne C, Eclache V, Mahon FX, Guilhot F; SPIRIT Investigators; France Intergroupe des Leucémies Myéloïdes Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med. 2010 Dec 23;363(26):2511-21. doi: 10.1056/NEJMoa1004095.

title: Imatinib plus Peginterferon Alfa-2a in Chronic Myeloid Leukemia


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.

family: Kremer

full_name: Stéphane Kremer

given: Stéphane

family: Lersy

full_name: François Lersy

family: Anheim

full_name: Mathieu Anheim

given: Mathieu

family: Merdji

full_name: Hamid Merdji

given: Hamid

family: Schenck

full_name: Maleka Schenck

given: Maleka

family: Oesterlé

full_name: Hélène Oesterlé

given: Hélène

family: Bolognini

full_name: Federico Bolognini

given: Federico

family: Messie

full_name: Julien Messie

given: Julien

family: Khalil

full_name: Antoine Khalil

given: Antoine

family: Gaudemer

full_name: Augustin Gaudemer

given: Augustin

family: Carré

full_name: Sophie Carré

family: Alleg

full_name: Manel Alleg

given: Manel

family: Lecocq

full_name: Claire Lecocq

given: Claire

family: Schmitt

full_name: Emmanuelle Schmitt

given: Emmanuelle

family: Anxionnat

full_name: René Anxionnat

given: René

family: Zhu

full_name: François Zhu

family: Jager

full_name: Lavinia Jager

given: Lavinia

family: Nesser

full_name: Patrick Nesser

given: Patrick

family: Mba

full_name: Yannick Talla Mba

given: Yannick Talla

family: Hmeydia

full_name: Ghazi Hmeydia

given: Ghazi

family: Benzakoun

full_name: Joseph Benzakoun

given: Joseph

family: Oppenheim

full_name: Catherine Oppenheim

given: Catherine

family: Ferré

full_name: Jean-Christophe Ferré

given: Jean-Christophe

family: Maamar


title: Predictive Factors of Endothelial Function in Chronic Obstructive Disease Patients at the End of a Acute Exacerbation.

summary:
The main objective of the study is to evaluate the predictive factors of the endothelial function to the waning of an acute exacerbation in COPD. It will act to do a multivariate analysis to determine the respective weight of the parameters of the systemic inflammation, of the oxidative stress of the functional respiratory parameters and then functional respiratory parameters.

In exacerbated Chronic Obstructive Pulmonary Disease (COPD) patients, there is augmentation of hypoxia and the obstructive ventilatory disorders is more important. This is correlated with an increase in C-reactive Protein (CRP) and of inflammatory cytokines and oxidative stress. It has been demonstrated that there is an endothelial dysfunction in answer to hypoxia. Since the exacerbated COPD patients are hypoxic in most cases , we suppose they have an endothelial dysfunction during exacerbation. So we think we will find an augmentation of vascular resistances ,shown by a peripheral arterial tone too high. And this, certainly, play a part in physiopathology of the COPD exacerbation.

ReferenceType: background

ReferenceCitation: Malo O, Sauleda J, Busquets X, Miralles C, Agustí AG, Noguera A. [Systemic inflammation during exacerbations of chronic obstructive pulmonary disease]. Arch Bronconeumol. 2002 Apr;38(4):172-6. Spanish.

ReferenceCitation: Vassilakopoulos T, Katsaounou P, Karatza MH, Kollintza A, Zakynthinos S, Roussos C. Strenuous resistive breathing induces plasma cytokines: role of antioxidants and monocytes. Am J Respir Crit Care Med. 2002 Dec 15;166(12 Pt 1):1572-8. Epub 2002 Oct 3.

ReferenceCitation: Yende S, Waterer GW, Tolley EA, Newman AB, Bauer DC, Taaffe DR, Jensen R, Crapo R, Rubin S, Nevitt M, Simonsick EM, Satterfield S, Harris T, Kritchevsky SB. Inflammatory markers are associated with ventilatory limitation and muscle dysfunction in obstructive lung disease in well functioning elderly subjects. Thorax. 2006 Jan;61(1):10-6. Epub 2005 Nov 11.

ReferenceCitation: Barreiro E, de la Puente B, Minguella J, Corominas JM, Serrano S, Hussain SN, Gea J. Oxidative stress and respiratory muscle dysfunction in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 15;171(10):1116-24. Epub 2005 Feb 25.

ReferenceCitation: Lerman A, Zeiher AM. Endothelial function: cardiac events. Circulation. 2005 Jan 25;111(3):363-8. Review.

ReferenceType: result

ReferenceCitation: Mallia P, Johnston SL. Mechanisms and experimental models of chronic obstructive pulmonary disease exacerbations. Proc Am Thorac Soc. 2005;2(4):361-6; discussion 371-2. Review.

ReferenceCitation: Minet C, Vivodtzev I, Tamisier R, Arbib F, Wuyam B, Timsit JF, Monneret D, Borel JC, Baguet JP, Lévy P, Pépin JL. Reduced six-minute walking distance, high fat-free-mass index and hypercapnia are associated with endothelial dysfunction in COPD. Respir Physiol Neurobiol. 2012 Aug 15;183(2):128-34. doi: 10.1016/j.resp.2012.06.017. Epub 2012 Jun 18.

family: Minet

full_name: Clémence Minet

given: Clémence

family: Vivodtzev

full_name: Isabelle Vivodtzev

given: Isabelle

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Arbib

full_name: François Arbib

given: François

family: Wuyam

full_name: Bernard Wuyam

given: Bernard

family: Timsit

full_name: Jean-François Timsit

given: Jean-François

family: Monneret

full_name: Denis Monneret

given: Denis

family: Borel

full_name: Jean-Christian Borel

given: Jean-Christian

family: Baguet

full_name: Jean-Philippe Baguet

given: Jean-Philippe

family: Lévy

full_name: Patrick Lévy

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

journal_name: Respiratory Physiology & Neurobiology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Vivodtzev I, Minet C, Wuyam B, Borel JC, Vottero G, Monneret D, Baguet JP, Lévy P, Pépin JL. Significant improvement in arterial stiffness after endurance training in patients with COPD. Chest. 2010 Mar;137(3):585-92. doi: 10.1378/chest.09-1437. Epub 2009 Oct 31.

family: Vottero

full_name: Gabrielle Vottero

given: Gabrielle

title: Significant Improvement in Arterial Stiffness After Endurance Training in Patients With COPD

location_facility: France : Laboratoire EFCR - Functional Cardio-Respiratory Exploration Laboratory


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: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in ST Elevation Myocardial Infarction

acronym: HIBISCUS-STEMI

summary:
Ischemic heart disease is the leading cause of mortality with 7.2 million of death in industrialized countries (WHO data). Myocardial infarction corresponding to acute occlusion of a coronary artery is the most brutal form and the more severe ischemic myocardial disease. Every year in France, about 60,000 Myocardial infarctions hospitalized, 30,000 are diagnosed remotely and 30,000 are revealed by an inaugural sudden death. Although mortality from myocardial decreased by 30% over the past decade, the prognosis is pejorative and difficult to assess precisely. The management of the patient depends on these factors, and justifies an active search on these topics, including the mechanisms of the deleterious ventricular remodeling, myocardial inflammation, reperfusion injury which determines in particular the evolution to heart failure. Cohorts of patients with myocardial infarction are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool.

The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after acute myocardial infarction.

Secondary objectives of the HIBISCUS-STEMI cohort to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas:

Descriptive epidemiology of myocardial infarction and myocardial reperfusion
Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs
Assessment of the long-term effect of the treatment on the occurrence of heart failure and sudden death
Quality of life and personal consequences, family, professional and social myocardial infarction
Research of new diagnostic and prognostic biomarkers
Research projects (e.g. risk of developing kidney failure or stroke in patients with myocardial infarction compared to the general population).

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility:
CHU de Tours
CHU Strasbourg
Hôpital Cardiovasculaire Louis Pradel


type: EudraCT Number

title: General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke

acronym: GASS

summary:
In France, the annual incidence rate of acute ischaemic stroke is around 150 000 patients, 65 % of whom keep long-term disability. Several multicentric randomized controlled trials have shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke on functional disability, compared to a medical treatment alone (thrombolysis).

The timeliness of revascularisation is an essential factor of good prognosis. This intra-arterial treatment, associated with thrombolysis if applicable, is the reference treatment of large-vessel occlusion. The stillness of the patient is required to control the safety of the recanalization. Currently, either a general anesthesia or a sedation can be performed.

Several studies have shown a trend to superiority of the sedation but none was conducted with a high level of proof methodology.

The aim of our multicentric randomized controlled trial is to compare sedation and general anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior cerebral circulation. The main outcome will be the efficacy on the functional neurological prognosis at 3 months.

ReferenceCitation: Maurice A, Ferré JC, Ronzière T, Devys JM, Subileau A, Laffon M, Laviolle B, Beloeil H; SFAR research network. GASS Trial study protocol: a multicentre, single-blind, randomised clinical trial comparing general anaesthesia and sedation during intra-arterial treatment for stroke. BMJ Open. 2019 Jun 1;9(5):e024249. doi: 10.1136/bmjopen-2018-024249.

family: Maurice

full_name: Axelle Maurice

given: Axelle

family: Ronzière

full_name: Thomas Ronzière

given: Thomas

family: Devys

full_name: Jean-Michel Devys

given: Jean-Michel

family: Subileau

full_name: Aurelie Subileau

given: Aurelie

family: Laffon

full_name: Marc Laffon

given: Marc

family: Laviolle

full_name: Bruno Laviolle

given: Bruno

family: Beloeil

full_name: Helene Beloeil

given: Helene

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Rennes University Hospital

location_facility: Service d'anesthésie-réanimation 1 - Hôpital Bretonneau, CHU de Tours

location_facility: Fédération d'anesthésie-réanimation - Hôpital Pontchaillou, CHU de Rennes

location_facility: Département d'anesthésie-réanimation - Hôpital de la Cavale Blanche, CHU de Brest

location_facility: Service d'anesthésie-réanimation - Fondation A. de Rothschild


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

acronym: MOOD

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

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

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

location_facility: Service de psychiatrie 2 - Hôpitaux Universitaires de Strasbourg


title: Return to Work After Acute Coronary Syndrome

acronym: ACS

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

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

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

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

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


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

acronym: STIMLEWY

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


title: 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.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

acronym: EHPAFAVE

summary: Due to the high thrombotic risk during the atrial fibrillation procedure, new guidelines have been proposed to maintain direct oral anticoagulant therapy during the perioperative period. This resulted in a significant change in the activated clotting time (ACT) at the beginning of the procedure, making it difficult to assess the level of heparinization during the procedure. The main objective of this study was to evaluate the correlation between laboratory hemostatic parameters, ACT and the dose of unfractionated heparin received. The secondary objective of this study was to correlate these results with hemorrhagic or thrombotic complications.

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


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

acronym: Ger-e-Tec

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

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


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

acronym: TransPédia

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

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

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


title: Geriatric COVID-19 Serology

acronym: SeroGerCov

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

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

location_facility: Service SSR Gériatrique - Hôpitaux Universitaires de Strasbourg


title: 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.

intervention_type: Genetic


title: Phenotyping of Primary Hyperoxaluria in Children and Adults

acronym: PHENO-HOPLA

summary:
985 / 5000 Résultats de traduction Primary hyperoxaluria is a rare autosomal recessive disease with an estimated prevalence of around 1 to 3 cases per million population. The most frequent attacks are urolithiasis disease and nephrocalcinosis, ultimately leading to end-stage chronic renal failure. The phenotype of this pathology is very heterogeneous, making the diagnosis difficult.

There is currently a significant diagnostic delay. This is potentially due to atypical forms, or to insufficient clinicians' awareness of its research.

However, the early diagnosis of this pathology is essential, since end-stage chronic renal failure can be avoided or at least delayed with early and appropriate management.

The objective of the study is to describe the phenotype of currently diagnosed primary hyperoxaluria, in order to identify the classic presentations but also the characteristics of atypical presentations

location_facility: Service de Néphrologie et Transplantation - Hôpitaux Universitaires de Strasbourg


title: Retrospective Analysis of Degenerative Scoliosis Corrections by Posterior Instrumentation

acronym: DS

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

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

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

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

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


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: PRAME Immunohistochemistry as an Adjunct for Evaluating Ambiguous Melanocytic Proliferation

acronym: ANTIPRAME

summary:
Skin melanoma is a common form of skin cancer. Its diagnosis is usually clinically suspected and then affirmed by histopathological examination.

In some cases, the histopathological analysis of these lesions is equivocal, and the malignant or benign nature of the proliferation is difficult to determine with certainty. In these cases, the use of expensive ancillary tests, which are hardly accessible and take a long time to set up (FISH - CGH-array), is usually required.

Anti-PRAME immunostaining, an inexpensive and readily available technic, has recently been described as highly sensitive and specific for diagnosing malignant melanocytic proliferations. Knowledge on its utility for evaluating ambiguous melanocytic neoplasms remains limited.

Our study aims to improve the current body of knowledge on the utility of PRAME immunohistochemistry for evaluating challenging samples of melanocytic proliferation. The secondary objective is to determine the PRAME immunoreactivity profile for each histological subtype of melanocytic proliferations (spitzoid tumors, cellular blue nevi, dysplastic nevi ...)


title: Study of the Effect of Systematic Screening of Residents and Caregivers by Nasopharyngeal Swab (RT-PCR) on the Incidence Rate of COVID-19 Infection in Medico-social Institutions for the Elderly

acronym: INMESO-Covid

summary:
The current COVID-19 epidemic has overwhelmed the health systems of many countries in which it has broken out, forcing various governments to institute population containment measures.

Residents of medico-social institutions for the elderly are particularly at risk of developing severe forms because they have a large number of factors favoring the progression to a severe form (very advanced age, multiple comorbidities, dependence in activities of dayli life).

The specificity and positive predictive value of clinical signs are not very important in this population; which makes the diagnosis even more complicated.

One of the strategies to try to protect these residents, in addition to room containment and clinical surveillance, would be to carry out a systematic screening campaign of all residents and all caregivers, then to consider reorganizing the establishments with a sector "COVID +".

This was announced by the French Minister of Health Olivier VERAN on 04/06/2020 from the first confirmed case of COVID-19 in an institution.

However, asymptomatic subjects may have a "negative" RT-PCR test at one point but which is positive in the following days. And in this interval they would still be contagious.

It is therefore not excluded that the implementation of such a screening campaign will not be effective in reducing the number of new cases of COVID-19 in medico-social institutions for the elderly

location_facility: Service Gériatrie. Soins Médico-techniques Importants - Hôpitaux Universitaires de Strasbourg


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

acronym: NeuroBiomarK

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

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


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

acronym: SCAN-COV-HUS

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

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

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

location_facility: Service de Radiologie B - Hôpitaux Universitaires de Strasbourg


title: 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: Interdental Microbiota According to the Caries Risk Factors Among Adolescents Aged 15 to 17 Years.

acronym: MIARC

summary:
Adolescence remains a period during which tooth decay is still very active. There are few epidemiological studies in adolescents, and the majority of them were young people aged 15 and under. Early studies have characterized the interdental periodontal microbiota in healthy adults but, to our knowledge, no studies have analyzed the caries interdental microbiota in young people between 15 and 17 years of age. The main objective of this study is to describe the interdental microbiota in adolescents by a quantitative detection system using real-time PCR methodology. It will quantify 26 major interdental pathogens. The secondary objective is to analyse the distribution of these bacteria according to the level of caries risk and salivary risk.

Fifty Caucasian adolescents were recruited for this cross sectional study.

lead_sponsor: Université Montpellier


title: Assessment of Executive Functions in Preterm Children in 11 to 12 Year Old From the Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire

summary: Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidence of executive functions is not described for preterm infants.

lead_sponsor: Nantes University Hospital


title: Assessment of Executive Functions in Preterm Children in 3 to 4 Year Old From Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire

summary: Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidenceof executive functions is not described for preterm infants.


title: IMPACT: A Safety and Feasibility Study of the IOWA Approach Cardiac Ablation System

acronym: IMPACT

summary: IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.

lead_sponsor: Farapulse, Inc.

lead_sponsor_type: industriel


title: Efficacy of a Simulator Based (PickUpSimTM) Residents' Training Program for Oocyte Retrievals

summary:
Simulation is an educational approach that has recently found an application in healthcare.acquire. Angers university hospital has decided to acquire, in December 2016, the high-fidelity Oocyte Pick up (OPU) simulator PickUpSimTM, and the investigators have put in place a training novel program containing different simulation based courses. It is essential to analyze its impact on the clinical practice before implementing it on a larger scale. Initial hypothesis was that the residents' lack of specific training and inexperience would result in suboptimal oocyte retrievals, especially for their first cases

The investigators will undertake a prospective comparative study at the In Vitro Fertilization (IVF) unit of the Angers University Hospital between May 2019 and April 2022. The investigators will include all voluntary residents in rotation at the IVF unit in that time period. The participants will be divided in two groups: Group A will undergo the PickUpSimTM simulation training program whereas group B will only have the classic training with no simulation.

The primary objective is to assess the benefits of an OPU simulation training program using the PickUpSimTM simulator for teaching residents in a university-affiliated IVF center. The main criterion the investigators will use is the "oocyte retrieval rate" (ORR) during the first month following 15 days of simulation training. The ORR is calculated as the number of oocytes retrieved divided by the number of follicles aspirated.

Our secondary objectives are:

To assess the residents' satisfaction with the simulation training program.
To evaluate the learning curve of residents during the two weeks of training.
To compare the OPU complication rate between residents with and without previous simulation training.
To analyze the oocyte retrieval rate in the second and third month of REI rotation for residents, and compare it between those with and those without simulation training.

lead_sponsor: University Hospital, Angers


title: Transient Thermal Behavior and Diabetic Foot

acronym: PICOTE

summary: In our study, the investigators propose to analyze the transient thermal responses taken at the level of the sole of the foot, following the application of a cold stimulus. By combining a spatio-temporal analysis of these temperature fields and a thermal modeling of the heat transfer in the thickness of the foot, the investigators want to highlight differences between healthy feet vs. pathological feet. Therefore, the investigators will determine the transient thermal responses at the level of the sole of the foot and correlate them with the podological grade.

lead_sponsor: University Hospital, Montpellier


title: CATRIPCA - A Phase I Study of PD1 Monoclonal Antibody (Pembrolizumab) In Combination With a IAP Antagonist (Debio 1143) In (Exocrine) Pancreatic And Colorectal Non MSI-high Advanced/Metastatic Adenocarcinoma.

acronym: CATRIPCA

summary:
This trial is a Phase I study to be conducted in patients with non-MSI-high advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) or colorectal cancer (CRC) and is divided in two Parts.

Dose escalation Part :To determine the Maximum Tolerated Dose (MTD) and the Recommended Dose for Phase 2 (RP2D) of Debio1143 when combined with a fixed dose of Pembrolizumab.
Extension Part: To evaluate preliminary efficacy data of the proposed combination.

ReferenceCitation: Crawford N, Stott KJ, Sessler T, McCann C, McDaid W, Lees A, Latimer C, Fox JP, Munck JM, Smyth T, Shah A, Martins V, Lawler M, Dunne PD, Kerr EM, McDade SS, Coyle VM, Longley DB. Clinical Positioning of the IAP Antagonist Tolinapant (ASTX660) in Colorectal Cancer. Mol Cancer Ther. 2021 Sep;20(9):1627-1639. doi: 10.1158/1535-7163.MCT-20-1050. Epub 2021 Aug 13.

family: Crawford

full_name: Nyree Crawford

given: Nyree

family: Stott

full_name: Katie J. Stott

given: Katie J.

family: Sessler

full_name: Tamas Sessler

given: Tamas

family: McCann

full_name: Christopher McCann

given: Christopher

family: McDaid

full_name: William McDaid

given: William

family: Lees

full_name: Andrea Lees

given: Andrea

family: Latimer

full_name: Cheryl Latimer

given: Cheryl

family: Fox

full_name: Jennifer P. Fox

given: Jennifer P.

family: Munck

full_name: Joanne M. Munck

given: Joanne M.

family: Smyth

full_name: Tomoko Smyth

given: Tomoko

family: Shah

full_name: Alpesh Shah

given: Alpesh

family: Martins

full_name: Vanessa Martins

given: Vanessa

family: Lawler

full_name: Mark Lawler

given: Mark

family: Dunne

full_name: Philip D. Dunne

given: Philip D.

family: Kerr

full_name: Emma M Kerr

given: Emma M

family: McDade

full_name: Simon S. McDade

given: Simon S.

family: Coyle

full_name: Vicky M. Coyle

given: Vicky M.

family: Longley

full_name: Daniel B. Longley

given: Daniel B.

journal_name: Molecular Cancer Therapeutics

oa_colors: green hybrid

evidence: open (via free pdf)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Queen's University Belfast - Research Portal

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

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

publisher: American Association for Cancer Research (AACR)


type: Registry Identifier

title: Modeling and Pharmacological Targeting of Genetic Cardiomyopathy in Children Via Cardiomyocytes Derived From Induced Pluripotent Stem Cells

acronym: DMDstem

summary: Interventional, cross-sectional biomedical study of children with genetic cardiomyopathy and healthy children. The aim is to generate, via induced human pluripotent stem cells (hiPSC), "patient-specific" cardiomyocytes (CMs) (hiPSC-CMs) to study the molecular mechanisms of cardiomyopathies of genetic origin.

ReferenceCitation: Souidi M, Amédro P, Meyer P, Desprat R, Lemaître JM, Rivier F, Lacampagne A, Meli AC. Generation of three Duchenne Muscular Dystrophy patient-specific induced pluripotent stem cell lines DMD_YoTaz_PhyMedEXp, DMD_RaPer_PhyMedEXp, DMD_OuMen_PhyMedEXp (INSRMi008-A, INSRMi009-A and INSRMi010-A). Stem Cell Res. 2020 Dec;49:102094. doi: 10.1016/j.scr.2020.102094. Epub 2020 Nov 19.

family: Souidi

full_name: Monia Souidi

given: Monia

family: Amédro

full_name: Pascal Amédro

given: Pascal

family: Meyer

full_name: Pierre Meyer

given: Pierre

family: Desprat

full_name: Romain Desprat

given: Romain

family: Lemaître

full_name: Jean-Marc Lemaître

given: Jean-Marc

family: Rivier

full_name: François Rivier

given: François

family: Lacampagne

full_name: Alain Lacampagne

given: Alain

family: Meli

full_name: Albano C. Meli

given: Albano C.

currency_apc_doaj: USD

journal_name: Stem Cell Research

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


type: Other Identifier

title: Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.

acronym: FIBREC

summary: Peripheral nerve diseases can separately affect different kind of nerve fibres. Globally two kinds of fibres can be distinguished: large size and small size. The usual electromyogram only investigates large size fibres. Techniques to explore small size fibre function exist but are not used in common practice because of their very specialized aspect or their lack of diagnostic value. The purpose of this study is to develop a measurement technique of small size type C nerve fibre conduction velocity, to show that this velocity is reduced in patients suffering from polyneuropathies and to establish reference values in healthy patients.

ReferenceCitation: Arunodaya GR, Taly AB, Swamy HS. Sympathetic skin response in acute sensory ataxic neuropathy. J Neurol Sci. 1995 May;130(1):35-8.

ReferenceCitation: Vetrugno R, Liguori R, Cortelli P, Montagna P. Sympathetic skin response: basic mechanisms and clinical applications. Clin Auton Res. 2003 Aug;13(4):256-70. Review.

ReferenceCitation: Fagius J, Wallin BG. Sympathetic reflex latencies and conduction velocities in normal man. J Neurol Sci. 1980 Sep;47(3):433-48.

ReferenceCitation: Fagius J, Wallin BG. Sympathetic reflex latencies and conduction velocities in patients with polyneuropathy. J Neurol Sci. 1980 Sep;47(3):449-61.

ReferenceCitation: Tzeng SS, Wu ZA, Chu FL. The latencies of sympathetic skin responses. Eur Neurol. 1993;33(1):65-8.

ReferenceCitation: Soliven B, Maselli R, Jaspan J, Green A, Graziano H, Petersen M, Spire JP. Sympathetic skin response in diabetic neuropathy. Muscle Nerve. 1987 Oct;10(8):711-6.

ReferenceCitation: Valls-Sole J, Monforte R, Estruch R. Abnormal sympathetic skin response in alcoholic subjects. J Neurol Sci. 1991 Apr;102(2):233-7.

ReferenceCitation: Montagna P, Marchello L, Plasmati R, Ferlini A, Patrosso MC, Salvi F. Electromyographic findings in transthyretin (TTR)-related familial amyloid polyneuropathy (FAP). Electroencephalogr Clin Neurophysiol. 1996 Oct;101(5):423-30.

ReferenceCitation: Carmichael EA, Honeyman WM, Kolb LC, Stewart WK. Peripheral conduction rate in the sympathetic nervous system of man. J Physiol. 1941 Mar 25;99(3):338-43.

ReferenceCitation: Sourek K. [Reflex skin potential reactions in cases of surgically tested discopathies]. Acta Univ Carol Med (Praha). 1965:Suppl 21:99+. Multiple languages.

ReferenceCitation: Uncini A, Pullman SL, Lovelace RE, Gambi D. The sympathetic skin response: normal values, elucidation of afferent components and application limits. J Neurol Sci. 1988 Nov;87(2-3):299-306.

ReferenceCitation: Knezevic W, Bajada S. Peripheral autonomic surface potential. A quantitative technique for recording sympathetic conduction in man. J Neurol Sci. 1985 Feb;67(2):239-51.

ReferenceCitation: Elie B, Guiheneuc P. Sympathetic skin response: normal results in different experimental conditions. Electroencephalogr Clin Neurophysiol. 1990 Sep;76(3):258-67.

ReferenceCitation: Sequeira H, Hot P, Silvert L, Delplanque S. Electrical autonomic correlates of emotion. Int J Psychophysiol. 2009 Jan;71(1):50-6. doi: 10.1016/j.ijpsycho.2008.07.009. Epub 2008 Jul 23. Review.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre hospitalier intercommunal de Toulon La Seyne sur Mer


title: Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS

summary:
This study aims to validate a semi-automatized method to quantify cyclic hyperinflation on CT-scan of ARDS patients.

The gold standard will be cyclic hyperinflation assessed on the same CT scan, using manual segmentation of the lung.


title: Contribution of 18F-FDG PET-CT in the Diagnosis and the Detection of Peripheral Emboli of Infectious Endocarditis on Native Valves

acronym: NATIVTEP

summary: The diagnosis of infectious endocarditis is not always easy and is based on several clinical and imaging arguments. Positron Emission Tomography - Computed Tomography (PET-CT) has been validated for endocarditis on prosthetic valves but few studies concern the native valves. The purpose of the study is to estimate the diagnostic sensitivity of [18F]-fluoro-2-deoxyglucose (18F-FDG) PET-CT in patients with endocarditis on native valves according to the European Society of Cardiology 2015 (ESC 2015) modified diagnostic criteria of infective endocarditis classified as definite at three months of follow-up (baseline test).

lead_sponsor: University Hospital, Bordeaux


title: Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

acronym: DELTOSUPEX

summary: The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety…) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Incidence and Factors Associated With Double-J Urinary Stent Infection (IJJ)

acronym: IJJ

summary: The aim of the study was to determine the incidence and factors associated with double-J urinary stent infection.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Prospective Study of the Quality of Sleep of Parents of Premature Children Hospitalized in Neonatology Compared to Parents of Full-term Children in Maternity

acronym: SLEEP-PP

summary: This study evaluate the incidence of sleep disorders in parents of premature children hospitalized in unit care of neonatalogy or intensive unit care of neonatalogy, compared to parents of full-term child in maternity.

lead_sponsor: University Hospital, Brest


title: Evaluation of a Screening Strategy of Fabry Disease in Patient With Renal Biopsy: Histo-Fab Study

acronym: HISTOFAB

summary:
Fabry disease is genetic X linked disease, with annual incidence of 1 in 100,000 that is certainly underestimate the true prevalence of the disease.

Renal biopsy in some patients does not allow determining the etiology of nephropathy. It is why investigators would like to evaluate the screening of Fabry patients from renal biopsy in patient with idiopathic nephropathy.

Investigator hypothesize to detect one or more cases of patients with Fabry disease in local idiopathic nephropathy population with renal biopsy.

That would allow reviewing and optimizing the target screening for Fabry Disease. The purpose would be to detect Fabry disease systematically in patients presenting a nephropathy of undetermined etiology in spite of the renal biopsy or presenting nonspecific histological characteristics.

In Fabry disease with renal impairment, proteinuria is the first sign, usually occurring in the second decade. The evolution is progressively towards end-stage renal failure during the fourth decade. The presence of renal impairment is globally associated with a poor prognosis.

Renal histology can be used to diagnose Fabry disease by revealing sphingolipid deposits identified by optical microscopy in the form of vacuoles in podocytes, distal tubule epithelial cells or in the media of the distal tubules. vascular walls. Resin inclusion with Toluidine blue staining is the staining of choice for visualizing lipid inclusions. However, this staining is not used as a first intention in routine. On the paraffin-fixed tissues, the vacuoles are less visible because they dissolve.

Thus, the renal histological analysis sometimes reveals only non-specific damage to the various structures of the kidney and may not allow identification of very evocative inclusions. Under the effect of oxidative stress induced by sphingolipid deposits, lesions of tubulo-interstitial fibrosis settle quite early. At the level of the glomerulus, glycosphingolipids lead to the production of angiotensin II and TGF-β leading to an excess production of constituents of the glomerular basement membrane inducing its thickening and glomerulosclerosis. Arteries of all sizes are also the seat of intimal thickening and media accelerating the process of intrarenal ischemia. These lesions, which may appear isolated or synchronous, and nonspecific, are sometimes in the foreground and do not point in the first line to the etiological diagnosis of Fabry disease.

Also, among the patients presenting a nephropathy of undetermined etiology in spite of the renal biopsy or presenting nonspecific histological characteristics, investigator propose to systematically detect the Fabry disease. Screening will be done in a selected population of renal biopsy patients using the dried blood spot kits.


title: Nasal Carrying by Staphylococcus Aureus ST398 Strains in Community and Hospital Settings

acronym: CONASA 398

summary: The aim of this study was to compare the prevalence of nasal carrying of SA ST398 strains in community and hospital settings, identify the factors associated with colonization of SA ST398, determine the distribution of imported and acquired cases among SA ST398 hospital cases and characterize the genetic structure of the ST398 SA population involved in colonization.


title: Evolution of Lung 18FDG Uptake in Patients With Idiopathic Pulmonary Fibrosis and Receiving Pirfenidone

acronym: PET-Fibrosis

summary: Idiopathic pulmonary fibrosis (IPF) is a rare and fatal lung disease characterized by unpredictable changes with variable kinetics of progression. Changes in pulmonary function (FVC, DLCO) assessed at the time of diagnosis, or decline in pulmonary function within 12 months after diagnosis, are the best predictors of survival, but poorly predicted disease activity and evolution. 18FDG positron emission tomography (18FDG PETscan) provides the ability to quantify cell metabolism in vivo and non-invasively using a labeled non-metabolizable substrate. Several parameters can be measured in an automated and reproducible way, such as the mean fixation intensity (SUV mean), the maximum fixation intensity (SUV max), the hyperfixing volume measurement (MLV) or the glycolytic activity measurement tissue or TLG (total lesions glycolysis). Several studies have demonstrated an increase of glycolytic activity in lung fibroblast from IPF patient. In a recent study, the investigators demonstrated a strong correlation between the lung uptake parameters and the lung function tests results (LFTs) and prognostic score GAP. In addition, MLV and TLG were factors prognostic and independently associated with progression-free survival at 12 months. In a preliminary study, the investigators studied the change of these parameters in twelve patients treated with pirfenidone for IPF who performed an 18FDG PETscan before the initiation of treatment and about twelve weeks later. A mean decrease of 30% in TLG value between the two evaluations was observed. These preliminary data suggest that pirfenidone influences lung metabolism in patients with IPF. The investigators aim to conduct a prospective study to confirm and refine the preliminary data.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Pneumologie A Centre constitutif de référence des maladies pulmonaires rares Hôpital Bichat Claude Bernard

intervention_type: Radiation